🏥 VAERS Vaccine Data Browser

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This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

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Data Interpretation

The presence of a report does not mean the vaccine caused the adverse event.
Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
Serious adverse events must be reported by law, even if unrelated to the vaccine.
The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

💡 Search Tips:

Select Year: Choose a specific year OR "All Years" to search across all data
All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
VAERS ID: Search for specific report by ID number
Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
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Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
Lot Number: Search specific vaccine lot (works great with "All Years")
Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

Reports are unverified: VAERS accepts all reports without medical verification
Not proof of causation: A report does not mean the vaccine caused the event
Anyone can report: Healthcare providers, patients, and family members can submit reports
Multiple vaccines: One report may list multiple vaccines given at the same time
Blank fields: Not all fields are required, so some data may be missing

Using the Table

Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
Expand text: Click "More" to see full narrative or symptom text
Navigate pages: Use pagination controls at top and bottom of table
Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

Year: VAERS ID: Age: Sex: State: Vaccine Type: Manufacturer: Lot Number: Site: Symptom: Death: Hospitalized:

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Showing 25,601 to 25,650 of 34,052 reports (Page 513 of 682)

« First ‹ Prev 1 ... 510 511 512 513 514 515 516 ... 682 Next › Last »

ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	⚠️
2832082	0.33	M		03/19/2025	HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Aggression, Aspiration, Chest X-ray abnormal, Crying, Drooling; Fall, Near drown... Aggression, Aspiration, Chest X-ray abnormal, Crying, Drooling; Fall, Near drowning, Pulmonary oedema, Small airways disease, Vomiting; Aggression, Aspiration, Chest X-ray abnormal, Crying, Drooling; Fall, Near drowning, Pulmonary oedema, Small airways disease, Vomiting; Aggression, Aspiration, Chest X-ray abnormal, Crying, Drooling; Fall, Near drowning, Pulmonary oedema, Small airways disease, Vomiting; Aggression, Aspiration, Chest X-ray abnormal, Crying, Drooling; Fall, Near drowning, Pulmonary oedema, Small airways disease, Vomiting; Aggression, Aspiration, Chest X-ray abnormal, Crying, Drooling; Fall, Near drowning, Pulmonary oedema, Small airways disease, Vomiting More	Near Drowning; This 11-month-old male subject was enrolled in a blinded study. The subject received ... Near Drowning; This 11-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 14th May 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 14th May 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 12th March 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 14th May 2019, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular) on 14th May 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 11th October 2019, 150 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Prevnar 13 and 213 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 near drowning. Serious criteria included hospitalization. Bexsero vs Placebo was continued with no change. Prevnar 13 was continued with no change. The outcome of near drowning was recovered/resolved on 11th October 2019. The investigator considered that there was no reasonable possibility that the near drowning may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13. Relevant Tests: On 11 Oct 2019, Chest X-ray (poster anterior and lateral) done, results showed Hilar and Perihilar changes suggest edema versus small airways disease. No Focal airspace opacities identified. Diagnostic results (unless otherwise stated, normal values were not provided): On 11th October 2019, Chest X-ray result was see text. GSK Receipt Date - 07-NOV-2019 Patient was taking bath with mom and throwing a temper tantrum with crying when she wouldn't give him a cup. He took a deep breath in to cry but at the same time fell forward and inhaled water. Immediately took him out and he seemed not to be able to take a breath. Started drooling water, no cyanosis. Stood him up then put him against her on side and ultimately called 911 but by then was crying. They recommended he still come in to be checked. Vomiting X1. Otherwise usual self but seems like he needs to burp. This occurred at 7pm because on phone with 911 by 7:03 per mom. 12Nov2019-Follow-up response regarding query. Date of hospital admission is 11Oct2019. Date of hospital discharge is 12Oct2019. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of near drowning, 150 days after receiving 3rd doses of Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, Hiberix and 213 days after receiving the 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 11-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. More		✓
2832083	0.33	F		03/19/2025	HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV MEN MEN MEN MEN MEN MEN MEN MEN MEN MEN MEN MEN MEN MEN MEN MMR MMR MMR MMR MMR MMR MMR MMR MMR MMR MMR MMR MMR MMR MMR PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal... Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal; Bacterial infection, Bacterial test negative, Band neutrophil count increased, Bandaemia, Blood albumin decreased; Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal; Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal; Bronchial hyperreactivity, Bronchial wall thickening, C-reactive protein increased, CSF cell count normal, CSF culture negative; CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive, Carbon dioxide normal; Chest X-ray abnormal, Computerised tomogram neck abnormal, Cough, Culture urine negative, Enterovirus test negative; Haematocrit normal, Haemoglobin normal, Hypophagia, Infant irritability, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lung opacity, Lymphadenopathy; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal; Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Otitis media acute, Platelet count normal; Procalcitonin increased, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cells urine negative; Red cell distribution width normal, Respiratory tract congestion, Scan with contrast abnormal, Streptococcus test negative, Tachycardia; Tonsillar hypertrophy, Tonsillitis, Urinary sediment present, Urinary squamous epithelial cells increased, Urine analysis abnormal; Viral infection, White blood cell count increased, White blood cells urine negative, pH urine normal; Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal; Bacterial infection, Bacterial test negative, Band neutrophil count increased, Bandaemia, Blood albumin decreased; Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal; Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal; Bronchial hyperreactivity, Bronchial wall thickening, C-reactive protein increased, CSF cell count normal, CSF culture negative; CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive, Carbon dioxide normal; Chest X-ray abnormal, Computerised tomogram neck abnormal, Cough, Culture urine negative, Enterovirus test negative; Haematocrit normal, Haemoglobin normal, Hypophagia, Infant irritability, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lung opacity, Lymphadenopathy; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal; Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Otitis media acute, Platelet count normal; Procalcitonin increased, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cells urine negative; Red cell distribution width normal, Respiratory tract congestion, Scan with contrast abnormal, Streptococcus test negative, Tachycardia; Tonsillar hypertrophy, Tonsillitis, Urinary sediment present, Urinary squamous epithelial cells increased, Urine analysis abnormal; Viral infection, White blood cell count increased, White blood cells urine negative, pH urine normal; Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal; Bacterial infection, Bacterial test negative, Band neutrophil count increased, Bandaemia, Blood albumin decreased; Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal; Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal; Bronchial hyperreactivity, Bronchial wall thickening, C-reactive protein increased, CSF cell count normal, CSF culture negative; CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive, Carbon dioxide normal; Chest X-ray abnormal, Computerised tomogram neck abnormal, Cough, Culture urine negative, Enterovirus test negative; Haematocrit normal, Haemoglobin normal, Hypophagia, Infant irritability, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lung opacity, Lymphadenopathy; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal; Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Otitis media acute, Platelet count normal; Procalcitonin increased, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cells urine negative; Red cell distribution width normal, Respiratory tract congestion, Scan with contrast abnormal, Streptococcus test negative, Tachycardia; Tonsillar hypertrophy, Tonsillitis, Urinary sediment present, Urinary squamous epithelial cells increased, Urine analysis abnormal; Viral infection, White blood cell count increased, White blood cells urine negative, pH urine normal; Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal; Bacterial infection, Bacterial test negative, Band neutrophil count increased, Bandaemia, Blood albumin decreased; Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal; Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal; Bronchial hyperreactivity, Bronchial wall thickening, C-reactive protein increased, CSF cell count normal, CSF culture negative; CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive, Carbon dioxide normal; Chest X-ray abnormal, Computerised tomogram neck abnormal, Cough, Culture urine negative, Enterovirus test negative; Haematocrit normal, Haemoglobin normal, Hypophagia, Infant irritability, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lung opacity, Lymphadenopathy; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal; Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Otitis media acute, Platelet count normal; Procalcitonin increased, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cells urine negative; Red cell distribution width normal, Respiratory tract congestion, Scan with contrast abnormal, Streptococcus test negative, Tachycardia; Tonsillar hypertrophy, Tonsillitis, Urinary sediment present, Urinary squamous epithelial cells increased, Urine analysis abnormal; Viral infection, White blood cell count increased, White blood cells urine negative, pH urine normal; Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal; Bacterial infection, Bacterial test negative, Band neutrophil count increased, Bandaemia, Blood albumin decreased; Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal; Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal; Bronchial hyperreactivity, Bronchial wall thickening, C-reactive protein increased, CSF cell count normal, CSF culture negative; CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive, Carbon dioxide normal; Chest X-ray abnormal, Computerised tomogram neck abnormal, Cough, Culture urine negative, Enterovirus test negative; Haematocrit normal, Haemoglobin normal, Hypophagia, Infant irritability, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lung opacity, Lymphadenopathy; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal; Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Otitis media acute, Platelet count normal; Procalcitonin increased, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cells urine negative; Red cell distribution width normal, Respiratory tract congestion, Scan with contrast abnormal, Streptococcus test negative, Tachycardia; Tonsillar hypertrophy, Tonsillitis, Urinary sediment present, Urinary squamous epithelial cells increased, Urine analysis abnormal; Viral infection, White blood cell count increased, White blood cells urine negative, pH urine normal; Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal; Bacterial infection, Bacterial test negative, Band neutrophil count increased, Bandaemia, Blood albumin decreased; Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal; Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal; Bronchial hyperreactivity, Bronchial wall thickening, C-reactive protein increased, CSF cell count normal, CSF culture negative; CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive, Carbon dioxide normal; Chest X-ray abnormal, Computerised tomogram neck abnormal, Cough, Culture urine negative, Enterovirus test negative; Haematocrit normal, Haemoglobin normal, Hypophagia, Infant irritability, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lung opacity, Lymphadenopathy; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal; Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Otitis media acute, Platelet count normal; Procalcitonin increased, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cells urine negative; Red cell distribution width normal, Respiratory tract congestion, Scan with contrast abnormal, Streptococcus test negative, Tachycardia; Tonsillar hypertrophy, Tonsillitis, Urinary sediment present, Urinary squamous epithelial cells increased, Urine analysis abnormal; Viral infection, White blood cell count increased, White blood cells urine negative, pH urine normal; Adenoidal hypertrophy, Adenovirus test positive, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal; Bacterial infection, Bacterial test negative, Band neutrophil count increased, Bandaemia, Blood albumin decreased; Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal; Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal; Bronchial hyperreactivity, Bronchial wall thickening, C-reactive protein increased, CSF cell count normal, CSF culture negative; CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive, Carbon dioxide normal; Chest X-ray abnormal, Computerised tomogram neck abnormal, Cough, Culture urine negative, Enterovirus test negative; Haematocrit normal, Haemoglobin normal, Hypophagia, Infant irritability, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lung opacity, Lymphadenopathy; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal; Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Otitis media acute, Platelet count normal; Procalcitonin increased, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cells urine negative; Red cell distribution width normal, Respiratory tract congestion, Scan with contrast abnormal, Streptococcus test negative, Tachycardia; Tonsillar hypertrophy, Tonsillitis, Urinary sediment present, Urinary squamous epithelial cells increased, Urine analysis abnormal; Viral infection, White blood cell count increased, White blood cells urine negative, pH urine normal More	Tonsillitis; This 15-month-old female subject was enrolled in a blinded study. The subject received ... Tonsillitis; This 15-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 28th June 2019. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 28th December 2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 2nd November 2018, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 28th December 2018, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 28th June 2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 28th June 2019, for prophylaxis. The subject received the 5th dose of Prevnar 13 (intramuscular) on 28th June 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 27th October 2019, 121 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, M-M-R II, Varivax and Prevnar 13, 303 days after receiving DTPa-HBV-IPV and Hiberix and 359 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 tonsillitis. Serious criteria included hospitalization. The subject was treated with amoxicillin + clavulanic acid (Augmentin), ampicillin-Sulbactam, lidocaine Cream, vancomycin, ceftriaxone sodium (Ceftrixone), ibuprofen, paracetamol (Tylenol) and cefdinir. The outcome of tonsillitis was recovered/resolved on 5th November 2019. The investigator considered that there was no reasonable possibility that the tonsillitis may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. Relevant Tests: On 31 Oct 2019 Mucous present (reference range none/hpf) and Chest x-ray Peripronchial cuffing is present, suggestive of underlying reactive airway disease vs viral illness. On 01Nov2019 CF Soft Tissue Neck with Contrast = Enlarged palatine tonsils and adenoids bilaterally consistent with history of tonsillitis. No evidence of focal abscess. Mildy enlarged cervical lymph nodes bilaterally, likely reactive. Heterogeneous groundglass opacity in left upper lobe raising question of early pneumonia vs atelectasis related to airways disease. On 01Nov2019 Lab results and fever were SUGGESTIVE of a serious bacterial infection. Therefore, additional tests were done. Spinal fluid was normal and meningitis was NOT confirmed. Diagnostic results (unless otherwise stated, normal values were not provided): On 31st October 2019, Alanine aminotransferase result was 24 u/L (normal low: 24.00, normal high: 59.00), Anion gap result was 9 mmol/L (normal low: 7, normal high: 15), Aspartate aminotransferase result was 39 u/L (normal low: 16.00, normal high: 57.00), Band neutrophil percentage result was 19 % (normal low: 0.00, normal high: 4.00), Blood albumin result was 3.6 g/dL (normal low: 3.50, normal high: 4.70), Blood alkaline phosphatase result was 400 u/L (normal low: 185.00, normal high: 383.00), Blood bilirubin result was 0.10 mg/dL (normal low: 0.20, normal high: 1.30), Blood calcium result was 9.4 mg/dL (normal low: 9.00, normal high: 11.00), Blood chloride result was 106 mmol/L (normal low: 98.00, normal high: 107.00), Blood creatinine result was 0.26 mg/dL (normal low: 0.20, normal high: 0.80), Blood culture result was no growth, Blood glucose result was 134, Blood glucose result was 149 mg/dL (normal low: 60, normal high: 100), Blood potassium result was 3.9 mmol/L (normal low: 3.50, normal high: 5.50), Blood sodium result was 137 mmol/L (normal low: 135.00, normal high: 144.00), Blood urea result was 10 mg/dL (normal low: 6.00, normal high: 17.00), C-reactive protein result was 138.20 mg/L (normal low: 0.00, normal high: 10.00), CSF cell count result was 5,2, CSF culture result was no growth, CSF glucose result was (Spinal fluid) 70 mg/dL (normal low: 40, normal high: 70), CSF lymphocyte count result was 80, 100 % (normal low: 40.0, normal high: 80.0), CSF protein result was (Spinal fluid) 18.0 mg/dL (normal low: 12.0, normal high: 60.0), CSF red blood cell count result was 85.21 /uL (normal high: less than equal to 2), CSF white blood cell count result was 5, 2 /uL (normal high: less than equal to 5), Carbon dioxide result was 22 mmol/L (normal low: 22.00, normal high: 32.00), Chest X-ray result was see text, Culture urine result was no growth, Enterovirus test result was not detected, Haematocrit result was 32.4 % (normal low: 33.00, normal high: 45.00), Haemoglobin result was 10.9 g/dL (normal low: 10.50, normal high: 13.50), Influenza A virus test result was negative, Influenza B virus test result was negative, Lumbar puncture result was negative for meningitis, fluid clear, Lymphocyte percentage result was 16 % (normal low: 15.00, normal high: 70.00), Mean cell haemoglobin result was 29.5 pg (normal low: 23.00, normal high: 31.00), Mean cell haemoglobin concentration result was 33.6 g/dL (normal low: 31.00, normal high: 37.00), Mean cell volume result was 87.6 fL (normal low: 75.00, normal high: 86.00), Mean platelet volume result was 9.4 fL (normal low: 8.60, normal high: 13.00), Monocyte percentage result was 14 % (normal low: 0.00, normal high: 10.00) and Monocyte percentage result was 20/Macrophages % (normal low: 15.0, normal high: 45.0). On 31st October 2019, Neutrophil count result was 15.90 x10e3/mcL (normal low: 1.50, normal high: 7.50), Neutrophil count result was 51 % (normal low: 15.00, normal high: 70.00), Platelet count result was 292 x10e3/mcL (normal low: 150.00, normal high: 420.00), Procalcitonin result was 3.31 ng/mL (normal high: less than 0.05), Protein total result was 6.3 g/dL (normal low: 6.00, normal high: 7.80), Red blood cell count result was 3.70 x10E6/mcL (normal low: 3.50, normal high: 5.50), Red blood cells urine result was 0-2 /HPF (normal low: 0, normal high: 2), Red cell distribution width result was 12.5 % (normal low: 11.00, normal high: 16.00), Streptococcus test result was Negative, Urinary sediment present result was 0-5 /HPF (normal low: 0, normal high: 5), White blood cell count result was 22.71 x10e3/mcL (normal low: 5.00, normal high: 16.00), White blood cells urine result was 0-2 /HPF (normal low: 0, normal high: 5) and pH urine result was 6.0 (normal low: 5.00, normal high: 8.50). On 1st November 2019, Adenovirus test result was detected. On 2nd November 2019, Blood glucose result was 85, C-reactive protein result was 80.9 mg/L (normal low: 0.00, normal high: 10.00), Haematocrit result was 33.1 % (normal low: 33.00, normal high: 45.00), Haemoglobin result was 10.4 g/dL (normal low: 10.50, normal high: 13.50), Mean cell haemoglobin result was 29.1 pg (normal low: 23.00, normal high: 31.00), Mean cell haemoglobin concentration result was 31.4 g/dL (normal low: 31.00, normal high: 37.00), Mean cell volume result was 92.5 fL (normal low: 75.00, normal high: 86.00), Mean platelet volume result was 9.2 fL (normal low: 8.60, normal high: 13.00), Platelet count result was 286 x10e3/mcL (normal low: 150.00, normal high: 420.00), Red blood cell count result was 3.58 x10E6/mcL (normal low: 3.50, normal high: 5.50), Red cell distribution width result was 13.2 % (normal low: 11.00, normal high: 16.00) and White blood cell count result was 12.67 x10e3/mcL (normal low: 5.00, normal high: 16.00). GSK Receipt Date - 08-NOV-2019 10/27:subject is taken to Urgent Care for cough and congestion lasting almost 1 month. Dx= acute suppurative otitis media. Antibiotic started. 10/30: subject is seen by PI/PCP for fever despite being on antibiotic, Tylenol and ibuprofen for 3 days. Dx Tonsilitis. 10/31: subject is taken to ER for fever of 104F. She has become increasingly fussy and unable to console, has decreased p.o intake, tachycardia and increasing fever over the past 2 days. Lab results and escalating fever are suggestive of a serious bacterial infection, source is uncertain. Labs show leukocytosis with bandemia and elevated CRP. Chest X-Ray did not reveal source of infection and urinalysis was clean. Ceftrixone and Vancomycin started for suspected bacterial meningitis. Parents are agreeable to proceed with Lumbar puncture negative for meningitis. Due to the lab results and fever concern, subject is transferred to the Hospital. Hospitalist concludes that the source of fever is likely Para pharyngeal due to the evidence of tonsillitis and persistent fever due to oral antibiotic could be due to inadequate coverage of cefdinir. Subject put on clear liquid diet and continued medications. Additional tests were done. Spinal fluid was normal and meningitis was NOT confirmed 11/2: Discharge dx fever in pediatric patient and tonsillitis. Condition at discharge was stable. Prescriptions include amoxicillin clavulanate for 4 days. Instructed to follow up with PCP within 7 days. No follow up labs recommended. 11/8: Hospital follow up with PI/PCP. Subject is alert and eating better, no fever. Instructions to stop antibiotics and to discuss possible tonsillectomy in the near future scheduled for 12/5/19. 11/14: Study Coordinator contact LAR/Mom who states that subject has fully recovered. She estimated the date of recovery for 11/5. No more wheezing or fever. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of tonsillitis, 121 days after receiving 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, 1st dose of M-M-R II and Varivax and 5th dose of Prevnar 13, 303 days after receiving 3rd dose of DTPa-HBV-IPV vaccine with DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe and Hiberix and 359 days after receiving 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 15-month -old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and and absence of biological plausibility . US-GLAXOSMITHKLINE-US2020119049: More		✓
2832084	0.33	M		03/19/2025	HIBV HIBV HIBV HIBV MEN MEN MEN MEN MMR MMR MMR MMR PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK VARCEL VARCEL VARCEL VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose incre... Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose increased, Constipation, Cyanosis; Diabetic ketoacidosis, Full blood count, Glycosylated haemoglobin increased, Insulin C-peptide normal, Lethargy; Malaise, Platelet count increased, Pyrexia, Respiratory syncytial virus test negative, Type 1 diabetes mellitus; White blood cell count normal; Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose increased, Constipation, Cyanosis; Diabetic ketoacidosis, Full blood count, Glycosylated haemoglobin increased, Insulin C-peptide normal, Lethargy; Malaise, Platelet count increased, Pyrexia, Respiratory syncytial virus test negative, Type 1 diabetes mellitus; White blood cell count normal; Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose increased, Constipation, Cyanosis; Diabetic ketoacidosis, Full blood count, Glycosylated haemoglobin increased, Insulin C-peptide normal, Lethargy; Malaise, Platelet count increased, Pyrexia, Respiratory syncytial virus test negative, Type 1 diabetes mellitus; White blood cell count normal; Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose increased, Constipation, Cyanosis; Diabetic ketoacidosis, Full blood count, Glycosylated haemoglobin increased, Insulin C-peptide normal, Lethargy; Malaise, Platelet count increased, Pyrexia, Respiratory syncytial virus test negative, Type 1 diabetes mellitus; White blood cell count normal; Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose increased, Constipation, Cyanosis; Diabetic ketoacidosis, Full blood count, Glycosylated haemoglobin increased, Insulin C-peptide normal, Lethargy; Malaise, Platelet count increased, Pyrexia, Respiratory syncytial virus test negative, Type 1 diabetes mellitus; White blood cell count normal; Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose increased, Constipation, Cyanosis; Diabetic ketoacidosis, Full blood count, Glycosylated haemoglobin increased, Insulin C-peptide normal, Lethargy; Malaise, Platelet count increased, Pyrexia, Respiratory syncytial virus test negative, Type 1 diabetes mellitus; White blood cell count normal; Anti-GAD antibody positive, Anti-insulin antibody increased, Blood glucose increased, Constipation, Cyanosis; Diabetic ketoacidosis, Full blood count, Glycosylated haemoglobin increased, Insulin C-peptide normal, Lethargy; Malaise, Platelet count increased, Pyrexia, Respiratory syncytial virus test negative, Type 1 diabetes mellitus; White blood cell count normal More	New Onset Type 1 Diabetes Mellitus; DKA (Diabetic Keto Acidosis; This 19-month-old male subject was ... New Onset Type 1 Diabetes Mellitus; DKA (Diabetic Keto Acidosis; This 19-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 13th August 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 4th February 2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 13th August 2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 13th August 2019, for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, Rota (Rotarix) for prophylaxis and MMR II for prophylaxis. Concomitant products included famotidine. On 5th March 2020, 205 days after receiving Bexsero vs Placebo, Varivax and Prevnar 13 and 395 days after receiving Hiberix, the subject developed severe - grade 3 diabetic ketoacidosis. Serious criteria included hospitalization. Additional event(s) included severe - grade 3 type i diabetes mellitus on 5th March 2020 20:25 with serious criteria of hospitalization. The subject was treated with insulin lispro (Humalog), glycerol (Glycerin Suppository), ondansetron (Zofran), human biosynthetic insulin (Novolin R), insulin detemir (Levemir), heparin (nos) (Heparin), glucose (Dextrose 10%), sodium chloride, potassium chloride, insulin glargine (Lantus) and insulin aspart (Novolog). The outcome of diabetic ketoacidosis was recovered/resolved on 7th March 2020. The outcome(s) of the additional event(s) included type i diabetes mellitus (not recovered/not resolved). The investigator considered that there was no reasonable possibility that the diabetic ketoacidosis and type i diabetes mellitus may have been caused by Bexsero vs Placebo, Hiberix, Varivax, Prevnar 13, DTPa-HBV-IPV (Pediarix), Rota (Rotarix) and MMR II. Diagnostic results (unless otherwise stated, normal values were not provided): On 6th March 2020, Anti-GAD antibody result was 8368.2 (Endocrinology)and Glycosylated haemoglobin result was 11.7. In March 2020, Blood glucose result was 421, Blood insulin result was 24 (Endocrinology), Full blood count result was not provided, Insulin C-peptide result was 0.3 (Endocrinology), Platelet count result was 587 (Hematology), Respiratory syncytial virus test result was Negative and White blood cell count result was 14.3 (Hematology). Investigator text: Subject's parent called CRC on 05 mar 2020. Child was struggling with constipation and had a fever. CRC discussed with mom all possible issues via phone and it was decided that child would be taken to ER. Mom called site to let CRC know that that he is constipated and that he was given a suppository and tested for RSV and sent home. Mom is still concerned. CRC discussed with mom that CRC would help monitor him through out the day. Contacted PI and let him know that child was still not feeling well. CRC spoke with mom of subject and PI multiple times on 05Mar2020. Per PI mom was supposed to push fluids and if necessary get another suppository for child if he still hadn't had a bowel movement. At 1810 CRC checked in on child, now child very lethargic, still running fever and drinking a lot and urinating a lot but still no Bowel movement. Mom then mentioned that child had "purplish color on his lips" CRC advised mom to take child back to the ER at this time. CRC called PI as well and he suggested possibly trying another suppository or enema at this time but if too lethargic, fever continues etc he would need to be seen. Mom decided to take child to hospital because she has never seen him like this. When child arrived at hospital, he was in DKA and it was determined that T1DM had developed and per mom first Blood glucose taken was 421. Subject stayed in hospital and was stabilized and treated until 10 Mar 2020. CRC has been in contact with subject each day. 07Apr2020 Subject has no blood cultures or genetic testing in history. 21Jul2021er the PI, constipation and fever would not be relevant or risk factors for the SAE. Additional Details: The Investigator reported SAE term as New Onset Type 1 Diabetes Mellitus, DKA (Diabetic Keto Acidosis. This case contains an event assessed by the investigator as a serious possible immune mediated disorder (pIMD). On 5th March 2020, 205 days after receiving 1st dose MMR II the subject developed severe - grade 3 diabetic ketoacidosis and i diabetes mellitus. On 5th March 2020, 395 days after receiving 3rd dose DTPa-HBV-IPV (Pediarix) the subject developed severe - grade 3 diabetic ketoacidosis and i diabetes mellitus. On 5th March 2020, 458 days after receiving 2nd Rota (Rotarix) the subject developed severe - grade 3 diabetic ketoacidosis and i diabetes mellitus. Follow up information received on 11-Mar-2025 End of study Unblinding completed. Upon internal review the case was updated on 18-Mar-2025. Study drugs updated.; Sender's Comments: A case of diabetic ketoacidosis and Type 1 diabetes mellitus, 205 days after receiving 4th dose of Bexsero vs Placebo and 1st doses of Varivax and Prevnar 13, and 395 days after receiving the 3rd dose of Hiberix, in a 19-month-old male subject. Insufficient information for causality assessment (no information available on genetic tests). More		✓
2832085	0.33	F		03/19/2025	HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK	Altered state of consciousness, Dehydration, Infant irritability, Pyrexia, Urina... Altered state of consciousness, Dehydration, Infant irritability, Pyrexia, Urinary tract infection; Vomiting; Altered state of consciousness, Dehydration, Infant irritability, Pyrexia, Urinary tract infection; Vomiting; Altered state of consciousness, Dehydration, Infant irritability, Pyrexia, Urinary tract infection; Vomiting; Altered state of consciousness, Dehydration, Infant irritability, Pyrexia, Urinary tract infection; Vomiting; Altered state of consciousness, Dehydration, Infant irritability, Pyrexia, Urinary tract infection; Vomiting More	Urinary Tract Infection; This 9-month-old female subject was enrolled in a blinded study. The subjec... Urinary Tract Infection; This 9-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 06-APR-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 06-APR-2020, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 06-APR-2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (intramuscular) on 20-JAN-2020, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 13-JUL-2020 22:38, 98 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 175 days after receiving Rotarix lyophilized formulation, the subject developed severe urinary tract infection (Verbatim: Urinary Tract Infection). Serious criteria included hospitalization. The subject was treated with ondansetron, sodium chloride (Saline), ceftriaxone and cefalexin (Cephalexin). Bexsero vs Placebo was continued with no change. The outcome of urinary tract infection was resolved on 15-JUL-2020 12:54. The investigator considered that there was no reasonable possibility that the urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. GSK Receipt Date: 16-JUL-2020, 08-SEP-2020, 09-SEP-2020, 14-SEP-2020, 23-SEP-2020, 30-SEP-2020, 14-OCT-2020, On 07.16.20 at 14:20 the subject's parent called to report the following series of events: The subject's parent stated that on the morning of 07.13.20 the subject was quite fussy and seemed to be ill (the subject was vomiting and unable to hold down any liquids). The parents were worried about dehydration as well as a spell of altered consciousness, so they took the subject to the emergency room later that night at approximately 22:38. The subject was admitted to the hospital on 07.13.20. While in the hospital the subject received 2 boluses of IVF and one dose of an IV drip of Ceftriaxone. The subject improved and was discharged on 07.15.20 at approximately 12:54. The subject was discharged on Cephalexin 250mg/5mL oral liquid 4mL QID for 8 days. The subject was currently stated to be doing well. Updated per medical records received on 09.08.20. Updated comments per request: On hospital day 2 the subject began to tolerate PO diet and had adequate UOP but developed a fever with a max of 38.8C. Physical performed on 07.14.20. Vitals were normal as well as overall function of the body. T: 37.4C HR: 146 RR: 28 BP:125/87 SpO2: 96 percent WT:7.935kg Follow-up information received on 23-OCT-2024 Summary of changes: Events Dehydration, Vomiting Bile and Spell of altered consciousness were deleted and narrative updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number of Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV was updated from World-MKT to World-INV. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Urinary tract infection , 98 days after receiving the 3rd dose of Bexsero vs Placebo and DTPa-HBV-IPV and 175 days after receiving the 2nd dose of Rotarix lyophilized formulation, in a 9-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility . More		✓
2832086	0.33	F		03/19/2025	HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Condition aggravated, Drooling, Gaze palsy, Hyporesponsive to stimuli, Pyrexia; ... Condition aggravated, Drooling, Gaze palsy, Hyporesponsive to stimuli, Pyrexia; Respiratory tract congestion, Rhinorrhoea, Seizure, Tremor; Condition aggravated, Drooling, Gaze palsy, Hyporesponsive to stimuli, Pyrexia; Respiratory tract congestion, Rhinorrhoea, Seizure, Tremor; Condition aggravated, Drooling, Gaze palsy, Hyporesponsive to stimuli, Pyrexia; Respiratory tract congestion, Rhinorrhoea, Seizure, Tremor; Condition aggravated, Drooling, Gaze palsy, Hyporesponsive to stimuli, Pyrexia; Respiratory tract congestion, Rhinorrhoea, Seizure, Tremor; Condition aggravated, Drooling, Gaze palsy, Hyporesponsive to stimuli, Pyrexia; Respiratory tract congestion, Rhinorrhoea, Seizure, Tremor More	Seizure; This 11-month-old female subject was enrolled in a blinded study titled. The subject receiv... Seizure; This 11-month-old female subject was enrolled in a blinded study titled. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 02-MAY-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 02-MAY-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 02-MAY-2019, for prophylaxis. Co-suspect products included Rota (Rotarix) for prophylaxis and Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 14-OCT-2019 20:00, 165 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix, the subject developed moderate - grade 2 seizure (Verbatim: Seizure). Serious criteria included clinically significant/intervention required. Bexsero vs Placebo was continued with no change. The outcome of seizure was resolved on 14-OCT-2019 20:02. The investigator considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix. The company considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix. Linked case(s) involving the same subject: US2019208712, US2021205451 GSK receipt date: 30-SEP-2021 INVESTIGATOR TEXT Subject had 8 day history of congestion and rhinorrhea. Parent used nasal saline rinse for congestion. Subject then had episode of decreased responsiveness, drooling, and looking upward with shaking which lasted less than 2 minutes. Subject was febrile (99.6 F axilla) upon arrival at ED which parents had not been aware of. Subject was observed in ED, given motrin, tylenol, and oral fluids. Subject had no seizure activity in the ED and was discharged home with instructions to control fever with antipyretics and follow up with pediatrician. Subject's father and paternal grandmother have a history of febrile seizures. Additional details: This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Date of first Seizure: 17 Nov 2019 Time of first Seizure: 19:00. Subject having Fever at the time or immediately before generalized convulsive seizure. Body temperature at the time of generalized convulsive seizure was 100.7 degrees Fahrenheit Duration of seizure in minutes: 3 Minutes Number of generalized convulsive seizures: 1 Past history of similar events: yes Type of Seizure: Febrile seizure associated with upper respiratory infection and fever. Fever History: yes. Familial history of similar events: Yes Type of Seizure: Febrile seizures experienced by both subject's father and paternal grandparents. Fever History: Yes Following a previous vacccination: No. Diagnostic certainty level:Level 5; Not a case of generalized convulsive seizure. The investigator considered that there was no reasonable possibility that the seizure may have been caused by Prevnar13 and Rotarix. On 14th October 2019 20:00, 234 days after receiving Rotarix, the subject developed moderate - grade 2 seizure. On 14th October 2019 20:00, 165 days after receiving Prevenar 13, the subject developed moderate - grade 2 seizure. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix, Rotarix, Prevenar 13 from World-MKT to World-INV. Device Rotarix ORAL APPLICATOR DEVICE, Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of seizure, 165 days after receiving 3rd dose of Bexsero vs Placebo, Pediarix, Hiberix, in a 11-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (upper respiratory tract infection) and alternative risk factor ( past H/o seizures and family H/o seizure in subject's father and paternal grandmother). US-GLAXOSMITHKLINE-US2019208712: US-GLAXOSMITHKLINE-US2021205451: More
2832087	0.33	M		03/19/2025	HIBV HIBV MEN MEN MMR MMR PNC13 PNC13 UNK UNK UNK UNK VARCEL VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white bloo... Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white blood cell count; Dyspnoea, Full blood count, Respiratory distress, SARS-CoV-2 test negative, Tachypnoea; Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white blood cell count; Dyspnoea, Full blood count, Respiratory distress, SARS-CoV-2 test negative, Tachypnoea; Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white blood cell count; Dyspnoea, Full blood count, Respiratory distress, SARS-CoV-2 test negative, Tachypnoea; Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white blood cell count; Dyspnoea, Full blood count, Respiratory distress, SARS-CoV-2 test negative, Tachypnoea; Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white blood cell count; Dyspnoea, Full blood count, Respiratory distress, SARS-CoV-2 test negative, Tachypnoea; Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white blood cell count; Dyspnoea, Full blood count, Respiratory distress, SARS-CoV-2 test negative, Tachypnoea; Asthma, Chest X-ray normal, Condition aggravated, Cough, Differential white blood cell count; Dyspnoea, Full blood count, Respiratory distress, SARS-CoV-2 test negative, Tachypnoea More	ASTHMA, UNSPECIFIED WITH ACUTE EXACERBATION; This 2-year-old male subject was enrolled in a blinded ... ASTHMA, UNSPECIFIED WITH ACUTE EXACERBATION; This 2-year-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 07-OCT-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 08-APR-2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 17-JAN-2020, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular, left thigh) on 07-OCT-2020, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 08-APR-2020, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 07-OCT-2020, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 07-OCT-2020, for prophylaxis. Concomitant products included influenza vaccine inact split 3v (Flulaval). On 30-SEP-2021, 358 days after receiving Bexsero vs Placebo, Prevnar 13, M-M-R II and Varivax, 540 days after receiving DTPa-HBV-IPV and Hiberix and 622 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 asthma aggravated (Verbatim: ASTHMA, UNSPECIFIED WITH ACUTE EXACERBATION). Serious criteria included hospitalization. The subject was treated with salbutamol (Ventolin), fluticasone propionate (Flovent), diphenhydramine hydrochloride (Benadryl), dexamethasone (Decadron), albuterol and paracetamol (Tylenol). The outcome of asthma aggravated was resolved on 03-OCT-2021. Relevant Tests: Labs CBC and DIFF was drawn in ER. However no results were obtained due to blood clotted in lab. X-ray of chest not remarkable. Covid 19 test was done, Covid not detected.. The investigator considered that there was no reasonable possibility that the asthma aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13, Hiberix, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the asthma aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13, Hiberix, M-M-R II and Varivax. Subject who had history of wheezing developed cough on 30SEP2021. Mom gave albuterol twice overnight but child continued to have to work for breathing so brought to ER on 01oct2021 AT 1114 AM. In the ER subject was initially tachypenic with respiratory distress and poor air entry so given Decadron and started on continuous Albuterol. High flow nasal cannula was added with improvement. Admitted to Hospital on 01OCT2021 at 1745 continued on continuous Albuterol, Respiratory status slowly improved. Given second dose Decadron. Stable on room air prior to discharge, vitals otherwise stable. Eating well without any need for IV fluids. Decision made to start on controller inhaler Flovent 2 puffs BID. Asthma education given. Discharged home on 02OCT2021 at 1318. Phoned mom on 13OCT2021. She said child was back to his normal self on 03OCT2021 Follow-up information received on 01-JUN-2022 this follow-up was consider significant. Summary of changes: Suspect drug Bexsero vs Placebo vaccination date updated, hospital admission date and discharge date updated, treatment drug updated. Follow-up information received on 16-JUN-2022. This follow-up was consider significant. Summary of changes: The treatment medicine were updated. Follow-up information received on 20-Sep-2022. This follow-up was consider significant. Summary of changes: Suspect product updated. Follow-up information received on 06-AUG-2024 Summary of changes: Frequency of ALBUTEROL (PROVENTIL/VENTOLIN) updated as QH Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of asthma aggravated, 358 days after receiving the 4th doses of Bexsero vs Placebo, Prevnar 13 and 1st doses of M-M-R II, Varivax, 540 days after receiving the 3rd doses of DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device and Hiberix and 622 days after receiving the 2nd dose of Rotarix lyophilized formulation with rotavirus vaccine oral applicator device in a 2-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. More		✓
2832088	0.33	M		03/19/2025	HIBV PNC13 UNK UNK UNK	UNKNOWN MANUFACTURER PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK	Adenovirus infection, Adenovirus test positive, Dehydration, Pyrexia; Adenovirus... Adenovirus infection, Adenovirus test positive, Dehydration, Pyrexia; Adenovirus infection, Adenovirus test positive, Dehydration, Pyrexia; Adenovirus infection, Adenovirus test positive, Dehydration, Pyrexia; Adenovirus infection, Adenovirus test positive, Dehydration, Pyrexia; Adenovirus infection, Adenovirus test positive, Dehydration, Pyrexia More	adenovirus infection; This 6-month-old male subject was enrolled in a blinded study. The subject rec... adenovirus infection; This 6-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 29-NOV-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 29-NOV-2022, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 29-NOV-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 06-OCT-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 29-NOV-2022, for prophylaxis. On 05-DEC-2022, 6 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13 and Hiberix and 60 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 adenovirus infection (Verbatim: adenovirus infection). Serious criteria included hospitalization. The subject was treated with ondansetron (Zofran Disintegrating Tablet (Ondansetron)). The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix was no change. The outcome of adenovirus infection was resolved on 21-DEC-2022. Diagnostic results (reference ranges are provided in parenthesis if available): Adenovirus test-In DEC-2022 Positive. The investigator considered that there was no reasonable possibility that the adenovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the adenovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix. GSK Receipt date: 16-DEC-2022 and 19-DEC-2022. patient was admitted to hospital with fever and dehydration on 06DEC2022. Discharged 06DEC2022 positive for adenovirus Follow-up information received on 24-JAN -2023. Summary of changes: Vaccination date updated, SAE term updated, TTO updated. Follow-up information received on 13-Feb-2023 Summary of Changes: Investigator Text and hospitalization details were updated. Follow-up information received on 13-Jul-2023. Summary of changes: Concomitant drug, event outcome date and outcome of event updated. Follow-up information received on 15-aug-2023. Summary of changes: Concomitant drug updated to treatment drug. Follow-up information received on 11-SEP-2023. Summary of changes: Narrative updated. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Adenovirus infections, 6 days after receiving the 3rd dose of Bexsero vs Placebo, 3rd dose of DTPa-HBV-IPV, 3rd dose of Prevnar 13, 2nd dose of Rotarix lyophilized formulation , 3rd dose of Hiberix. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. More		✓
2832089	0.33	M		03/19/2025	HIBV HIBV HIBV HIBV HIBV HIBV MEN MEN MEN MEN MEN MEN PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Acute respiratory failure, Alanine aminotransferase normal, Anion gap, Aspartate... Acute respiratory failure, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Blood urea normal, COVID-19; Carbon dioxide decreased, Cough, Decreased appetite, Dyspnoea, Protein total normal; Pyrexia, Respiratory distress, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, SARS-CoV-2 test positive; Upper respiratory tract infection; Acute respiratory failure, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Blood urea normal, COVID-19; Carbon dioxide decreased, Cough, Decreased appetite, Dyspnoea, Protein total normal; Pyrexia, Respiratory distress, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, SARS-CoV-2 test positive; Upper respiratory tract infection; Acute respiratory failure, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Blood urea normal, COVID-19; Carbon dioxide decreased, Cough, Decreased appetite, Dyspnoea, Protein total normal; Pyrexia, Respiratory distress, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, SARS-CoV-2 test positive; Upper respiratory tract infection; Acute respiratory failure, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Blood urea normal, COVID-19; Carbon dioxide decreased, Cough, Decreased appetite, Dyspnoea, Protein total normal; Pyrexia, Respiratory distress, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, SARS-CoV-2 test positive; Upper respiratory tract infection; Acute respiratory failure, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Blood urea normal, COVID-19; Carbon dioxide decreased, Cough, Decreased appetite, Dyspnoea, Protein total normal; Pyrexia, Respiratory distress, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, SARS-CoV-2 test positive; Upper respiratory tract infection More	Acute Hypoxic Respiratory Failure; Respiratory Syncytial Virus Bronchiolitis; Disease caused by 2019... Acute Hypoxic Respiratory Failure; Respiratory Syncytial Virus Bronchiolitis; Disease caused by 2019 Novel Coronavirus; This 7-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 20-OCT-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 20-OCT-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 20-OCT-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 08-AUG-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 22-NOV-2022, 33 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 106 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 respiratory syncytial virus bronchiolitis (Verbatim: Respiratory Syncytial Virus Bronchiolitis). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 coronavirus disease 2019 (Verbatim: Disease caused by 2019 Novel Coronavirus) on 22-NOV-2022 with serious criteria of hospitalization and severe - grade 3 acute hypoxic respiratory failure (Verbatim: Acute Hypoxic Respiratory Failure) on 29-NOV-2022 with serious criteria of hospitalization. The subject was treated with oxygen, remdesivir, sodium chloride (Normal Saline), ibuprofen, lidocaine;prilocaine (Emla), glucose;potassium chloride;sodium chloride (Dextrose;Potassium Chloride;Sodium Chloride), dexamethasone and paracetamol (Acetaminophen). The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation was no change. The outcome of respiratory syncytial virus bronchiolitis was resolved on 05-DEC-2022. The outcome(s) of the additional event(s) included acute hypoxic respiratory failure (resolved on 02-DEC-2022) and coronavirus disease 2019 (resolved on 05-DEC-2022). Relevant Tests: On DEC-2022 Additional Diagnostic Results: Lab Results not previously listed: C02 18 mmol/L, Anion Gap (Na Cl C02) 12 mmol/L, Glucose Level 86 mg/dL, BUN 9mg/dL. Diagnostic results (reference ranges are provided in parenthesis if available): Alanine aminotransferase- 02-DEC-2022 19 unit/litre. Aspartate aminotransferase- 02-DEC-2022 42 unit/litre. Blood albumin- 02-DEC-2022 4.1 g/dL. Blood alkaline phosphatase- 02-DEC-2022 121 unit/litre. Blood bilirubin- 02-DEC-2022 0.3 mg/dL. Blood calcium- 02-DEC-2022 10.5 mg/dL. Blood chloride- 02-DEC-2022 110 mmol/L. Blood creatine- 02-DEC-2022 0.28 mg/dL. Blood potassium- 02-DEC-2022 5.6 mmol/L. Blood sodium- 02-DEC-2022 140 mmol/L. Protein total- 02-DEC-2022 6.7 g/dL. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis, coronavirus disease 2019 and acute hypoxic respiratory failure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis, coronavirus disease 2019 and acute hypoxic respiratory failure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. GSK Receipt date: 25-Jan-2023. Assessment and Plan: Overall 7-month-old male on day 7 of upper respiratory tract infection with RFA positive for RSV and COVID-19 resulting in acute hypoxic respiratory failure weaned to wall nasal cannula. Mild respiratory distress remains. Receiving dexamethasone and remdesivir for COVID-19. Suctioning beneficial. reassuring exam without indication to advanced airway support. Anticipate child to remain hospitalized for continued monitoring and antiviral support until oxygen supplementation improved. Subject was hospitalized from 11/29/22 through 12/02/22. Follow-up information received on 03-APR-2023. Summary of changes: narrative updated. Follow-up information received on 11-APR-2023. Summary of changes: Narrative and type of drug was updated from concomitant to treatment medication. Follow-up information received on 10-MAY-2023. Summary of changes: Narrative and hospitalization dates were updated. Follow-up information received on 31-MAY-2023. Summary of changes: End date of event "Acute Hypoxic Respiratory Failure" were updated. Upon internal review the case was updated on 30-APR-2024. Subject was found COVID-19 Positive on 29/Nov/2022 The COVID-19 test was performed, and result was positive. The subject had not history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset. The subject had not visited any health care facility in the 14 days prior to symptom onset. The subject had taken concomitant medications, including experimental medications, to treat COVID-19. The subject had experienced cough, shortness of breath, fever, loss of appetite. The subject have contact with a confirmed or probable case in the 14 days prior to symptom onset was unknown. The subject had not experienced sore throat, nausea, vomiting, diarrhea, abdominal pain, loss of smell and loss of taste were unknown. The subject was not asymptomatic. The subject was not in home quarantine or isolation. summary of change: COVID-19 details was updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number was updated from 125265 to World-INV for Rotarix lyophilized formulation. Authorization number was updated from World-MKT to World-INV for DTPa-HBV-IPV and Hiberix. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of COVID-19, respiratory syncytial virus bronchiolitis and acute respiratory failure, 33 days after receiving the 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV in DTPa-HBV-IPV and 3rd dose of Hiberix and 106 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 7-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility ans alternative etiology (Viral infection) for Acute respiratory failure event. More		✓
2832090	0.25	F		03/19/2025	HIBV MEN MMR PNC13 UNK UNK VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK	Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Inter... Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Interstitial lung abnormality; Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Interstitial lung abnormality; Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Interstitial lung abnormality; Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Interstitial lung abnormality; Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Interstitial lung abnormality; Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Interstitial lung abnormality; Blood culture negative, Bronchiolitis, Bronchospasm, Chest X-ray abnormal, Interstitial lung abnormality More	Bronchiolitis; This 13-month-old female subject was enrolled in a blinded study. The subject receive... Bronchiolitis; This 13-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 13-APR-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 07-JUL-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 13-SEP-2022, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 13-APR-2023, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 13-APR-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 13-SEP-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. Concomitant products included famotidine (Pepcid). On 02-MAY-2023 16:00, 19 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 299 days after receiving Rotarix lyophilized formulation and 231 days after receiving Hiberix and DTPa-HBV-IPV, the subject developed mild - grade 1 bronchiolitis (Verbatim: Bronchiolitis). Serious criteria included hospitalization. The subject was treated with paracetamol (Acetaminophen), budesonide and salbutamol (Albuterol). The outcome of bronchiolitis was resolved on 13-MAY-2023 12:00. Relevant Tests: On unknown date in MAY 2023 X Rays: Chest and lateral Findings/Impressions: There is a normal cardiothymic silhourtte. There are prominent perihilar interstitial markings, as seen with bronchiolitis in the appropriate clinical setting. No consolidation or pulmonary edema. No pleural effusion. On unknown date in MAY 2023 Culture Blood Pediatric On unknown date in MAY 2023 Culture Blood Observations: No growth in 2 days. Diagnostic results (reference ranges are provided in parenthesis if available): X-ray-In MAY-2023 confirmed the Bronchiolitis diagnosis.. The investigator considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and DTPa-HBV-IPV. The company considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and DTPa-HBV-IPV. Linked case(s) involving the same subject: US2023118007, US2023148628 GSK Receipt Date: 05-MAY-2023, 10-MAY-2023 Serious adverse event 02MAY2023: The Serious adverse event started on 02 May 2023. 03MAY2023: The subject's mother took the subject to the hospital and the subject was hospitalized. Admitted due to fever and acute bronchospasm. 06MAY2023: The subject was discharge on 06MAY2023 with a good prognosis. 13MAY2023: Subject recovered without sequelae. The Serious adverse event was not related to the study vaccine. Follow-up information received on 26-MAY-2023, 30-MAY-2023, 31-MAY-2023. Concomitant medication reported as S-Budesonide and Albuterol 0.042 percent Summary of changes: Narrative updated , Concomitant medication added, Lab data updated. Follow-up information received on 07-JUN-2023. Summary of changes: Concomitant drugs updated to Treatment. Follow up information received on 12-Jun-2024 Summary of change : New concomitant medication Pepcid was added , lab data and narrative updated. Follow up information received on 22-NOV-2024 Summary of change: Concomitant medication Pepcid end date updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number of Hiberix was updated from 125347 to World-INV. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of bronchiolitis,19 days after receiving 4th dose of Bexsero vs Placebo, 4th dose of Prevnar 13,1st dose of M-M-R II and 1st dose of Varivax, 299 days after receiving 2nd dose of Rotarix lyophilized formulation and 231 days after receiving 3rd dose of Hiberix and 3rd dose of DTPa-HBV-IPV in a 13-month-old female subject. Report is inconsistent with causal relation to the vaccine products considering absence of biological plausibility. US-GSK-US2023148628: US-GSK-US2023118007: More		✓
2832091	0.25	F		03/19/2025	HIBV MEN MMR PNC13 UNK UNK VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK	Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus te... Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus test positive; Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus test positive; Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus test positive; Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus test positive; Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus test positive; Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus test positive; Chest X-ray abnormal, Coxsackie viral infection, Influenza, Influenza B virus test positive More	Coxsackie A16 virus; Influenza B virus; This 18-month-old female subject was enrolled in a blinded s... Coxsackie A16 virus; Influenza B virus; This 18-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 13-APR-2023. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 13-SEP-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 13-SEP-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 07-JUL-2022, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 13-APR-2023, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 13-APR-2023, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. Concomitant products included famotidine (Pepcid) and ceftriaxone sodium (Rocephin). On 15-OCT-2023 08:50, 185 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 397 days after receiving DTPa-HBV-IPV and Hiberix and 465 days after receiving Rotarix lyophilized formulation, the subject developed mild - grade 1 coxsackie viral infection (Verbatim: Coxsackie A16 virus). Serious criteria included hospitalization. Additional event(s) included mild - grade 1 influenza b virus infection (Verbatim: Influenza B virus) on 15-OCT-2023 08:50 with serious criteria of hospitalization. The subject was treated with oseltamivir phosphate (Tamiflu), budesonide (Pulmicort) and salbutamol (Albuterol). The outcome of coxsackie viral infection was resolved on 24-OCT-2023 08:00. The outcome(s) of the additional event(s) included influenza b virus infection (resolved on 24-OCT-2023 08:00). Relevant Tests: On Unk-Oct-2023 X Rays Chest bilateral Findings/Impressions was Abnormal On Unk-Oct-2023 Influenza B virus was positive. The investigator considered that there was no reasonable possibility that the coxsackie viral infection and influenza b virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the coxsackie viral infection and influenza b virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. Linked case(s) involving the same subject: US2023065422, US2023118007 GSK Receipt Date: 26-OCT-2023, 27-OCT-2023, 30-OCT-2023 SAE 15OCT2023: The SAE started on 15 OCT 2023. The subject's mother took the subject to the hospital and the subject was hospitalized. Admitted due to Influenza B virus positive. During hospitalization, the subject was also diagnosed with coxsackie A16 virus. 06MAY2023: The subject was discharge on 19OCT2023 with a good prognosis. 24OCT2023: Subject recovered without sequelae. The SAE is not related to the study vaccine. Follow up information received on 02-Nov-2023. Summary of changes: Concomitant and treatment medications added. Relevant test and narrative updated. Follow up information received on 12-JUL-2024 Summary of changes: Treatment drug (Rocephin) route updated. Upon internal review the case was update don 07-Feb-2025. Authrization number of Rotarix lyophilized formulation was updated from World-MKT to World-INV. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Coxsackie viral infection and Influenza, 185 days after receiving 4th dose of Bexsero vs Placebo, 4th dose of Prevnar 13, 1st dose of M-M-R II, and 1st dose of Varivax, 397 days after receiving 3rd dose of DTPa-HBV-IPV, 397 days after receiving 3rd dose of Hiberix, and 465 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 18-month-old female infant. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset. US-GSK-US2023065422: US-GSK-US2023118007: More		✓
2832092	0.33	M		03/19/2025	HIBV MEN PNC13 UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK	Dehydration, Diarrhoea, Gastroenteritis viral, Vomiting; Dehydration, Diarrhoea,... Dehydration, Diarrhoea, Gastroenteritis viral, Vomiting; Dehydration, Diarrhoea, Gastroenteritis viral, Vomiting; Dehydration, Diarrhoea, Gastroenteritis viral, Vomiting; Dehydration, Diarrhoea, Gastroenteritis viral, Vomiting; Dehydration, Diarrhoea, Gastroenteritis viral, Vomiting More	Gastroenteritis; This 14-month-old male subject was enrolled in a blinded study. The subject receive... Gastroenteritis; This 14-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 10-OCT-2023, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 10-OCT-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 10-OCT-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 10-OCT-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 10-AUG-2023, for prophylaxis. On 11-JUN-2024 14:00, 245 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV and Hiberix and 306 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 gastroenteritis (Verbatim: Gastroenteritis). Serious criteria included hospitalization. The subject was treated with famotidine (Pepcid). Bexsero vs Placebo was interrupted. The outcome of gastroenteritis was resolved on 15-JUN-2024. The investigator considered that there was no reasonable possibility that the gastroenteritis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the gastroenteritis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Linked case(s) involving the same subject: US2024075244 GSK Receipt Date:17-JUN-2024, 18-JUN-2024, 20-JUN-2024, 24-JUN-2024 On 11 JUN 2024 subject had vomiting and was taken to the ER (emergency room), subject was diagnosed with dehydration and hospitalized for observation and IV (intravenous) fluids. Subject was discharged 12 JUN 2024. On 14 JUN 2024 subject had 4-6 loose stools and was taken to the ER, subject was diagnosed with viral gastroenteritis and hospitalized for observation with IV fluids and Pepcid for GI (gastrointestinal) protection. Subject was discharged on 15 JUN 2024. The subject received treatment medication IV Fluids start date 11/Jun/2024 End date 12/Jun/2024 Route of administration was Intravenous Medical indication was Hydration. The subject received treatment medication IV Fluids start date 14/Jun/2024 End date 15/Jun/2024 Route of administration was Intravenous Medical indication was Hydration. On 21-Jun-2024 GSK case ID US2024075244 was identified as duplicate of US2024075241. All future correspondence will be submitted to US2024075241. Follow up information received 29-AUG-2024, 03-SEP-2024 Summary of changes: Treatment medication Pepcid route of administration updated. Follow up information received 23-Oct-2024. Summary of changes: Event Dehydration deleted. Follow up information received on 27Dec2024 Summary of changes : Event onset date updated from, 14Jun2024 to 11Jun2024, TTO updated. Follow up information received on 11-Mar-2025. End of study Unblinding completed. Upon internal review the case was updated on 18-Mar-2025. Study drug's device updated.; Sender's Comments: A case of Gastroenteritis, 245 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV, 3rd dose of Hiberix and 2nd dose of Rotarix lyophilized formulation in a 14-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (viral). US-GSK-US2024075244: More		✓
2832093	18	F	KY	03/19/2025	IPV	SANOFI PASTEUR	X1C891M	No adverse event, Product storage error No adverse event, Product storage error	temperature excursion of ipol; max/low temperature reached: 46.7 f (8. 2 c)for 20 minutes, which was... temperature excursion of ipol; max/low temperature reached: 46.7 f (8. 2 c)for 20 minutes, which was administered post excursion with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves temperature excursion of IPV (Vero) [IPOL]; max/low temperature reached: 46.7 f (8. 2 c) for 20 minutes, which was administered to a 18 years old female patient, post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine [Fluzone (Influenza Vaccine)]; and Meningococcal vaccine A/C/Y/W conj (Tet Tox) (Menquadfi) both for Immunisation. On 11-Mar-2025, caller reported that 0.5ml dose of suspect IPV (VERO) (opened), Suspension for injection (Strength Standard) (Frequency once) lot X1C891M with Expiry date 31-Oct-2026, via intramuscular route in the right arm for Immunization, was exposed to a max/low temperature reached: 46.7 f (8. 2 c) for 20 minutes was administered to patient with no reported adverse event (poor quality product administered) (Latency Same day). Reportedly, Product/s: fluzone NP, menquadfi and IPOL (Unopened), IPOL (opened); Reason: Power outage; Human error: no; Administered post-excursion: yes; Previous Excursion: none; Does extended stability data cover the excursion: No, for opened IPOL. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832101	0.33	F		03/19/2025	HIBV HIBV MMR MMR PNC13 PNC13 UNK UNK UNK UNK UNK UNK VARCEL VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, I... Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, Influenza; Respiratory distress, Viral infection, Viral upper respiratory tract infection, Wheezing; Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, Influenza; Respiratory distress, Viral infection, Viral upper respiratory tract infection, Wheezing; Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, Influenza; Respiratory distress, Viral infection, Viral upper respiratory tract infection, Wheezing; Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, Influenza; Respiratory distress, Viral infection, Viral upper respiratory tract infection, Wheezing; Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, Influenza; Respiratory distress, Viral infection, Viral upper respiratory tract infection, Wheezing; Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, Influenza; Respiratory distress, Viral infection, Viral upper respiratory tract infection, Wheezing; Bronchial hyperreactivity, Condition aggravated, Dyspnoea, Febrile convulsion, Influenza; Respiratory distress, Viral infection, Viral upper respiratory tract infection, Wheezing More	Viral Syndrome; Reactive Airway Disease Exacerbation; Reactive Airway Disease Exacerbation; This 15-... Viral Syndrome; Reactive Airway Disease Exacerbation; Reactive Airway Disease Exacerbation; This 15-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 18-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 26-APR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 26-APR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 18-OCT-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 15-FEB-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 18-OCT-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. The subject's past medical history included influenza a virus infection. Concurrent medical conditions included reactive airways disease. On 02-FEB-2020, 107 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 282 days after receiving DTPa-HBV-IPV and Hiberix and 352 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 viral syndrome (Verbatim: Viral Syndrome). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 reactive airways disease (Verbatim: Reactive Airway Disease Exacerbation) on 02-FEB-2020 with serious criteria of hospitalization and severe - grade 3 condition aggravated (Verbatim: Reactive Airway Disease Exacerbation) on 02-FEB-2020 with serious criteria of hospitalization. The subject was treated with dexamethasone, ibuprofen, salbutamol (Albuterol), budesonide, ipratropium and dexamethasone sodium succinate (Dexamethasone Sodium). The outcome of viral syndrome was resolved on 06-FEB-2020. The outcome(s) of the additional event(s) included reactive airways disease (resolved on 16-FEB-2020) and condition aggravated (resolved on 16-FEB-2020). The investigator considered that there was no reasonable possibility that the viral syndrome, reactive airways disease and condition aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II, Rotarix lyophilized formulation and Varivax. The company considered that there was no reasonable possibility that the viral syndrome, reactive airways disease and condition aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II, Rotarix lyophilized formulation and Varivax. Linked case(s) involving the same subject: US2020029361 GSK Receipt Date:18-FEB-2020 15 Month girl with history of reactive airway disease, admitted for wheezing and rapid onset of respiratory distress in setting of a viral upper respiratory infection. Family had been giving 1 dose of budesonide and albuterol and bedtime. Day of admission, she had increasing work of breathing and so was given multiple doses of albuterol nebs and puffs, then went to ED (emergency department). Received dexamethasone, albuterol b x2, ipratropium x1, and was placed on continuous albuterol at 5mg/hr. Swas quickly weaned overnight to 3 puffs every 4 hours with normalized work of breathing and no wheezes. Was also recently hospitalized from 13JAN2020 to 15JAN2020 for complex febrile convulsions and Influenza A. Subject admitted to hospital on 02FEB2020 and discharged on 03FEB2020 Follow-up information received on 23-Mar-2022. This follow-up was considered significant. Summary of Changes: added suspect drugs, subject linked case and updated narrative Follow-up information received on 03-JUN-2022. This follow-up was considered non-significant. Summary of Changes: Concomitant product updated. Follow-up information received on 2nd August 2022. This follow-up was considered significant. Summary of changes: Suspect and Medical condition updated. Follow-up information received on 17-AUG-2023 Summary of changes: new treatment drug Dexamethasone added and narrative updated. Follow up information received on 25-OCT-2024 Summary of changes: Treatment medication Albuterol 0.5% Nebulizer 5mg/mL End date updated, Additional Event condition aggravated updated. Follow up information received on 14-JAN-2025 Reported medication name Budesonide 0.25mL/2mL Nebulizer, Albuterol 0.5% Nebulizer 5mg/mL, Albuterol 90 mcg/actuation HPA MDI, Ipratropium 0.02% Nebulizer Summary of changes: Treatment medication Albuterol 0.5% Nebulizer 5mg/mL unit updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of viral infection, bronchial hyperreactivity and Condition aggravated 107 days after receiving 4th dose of Bexsero vs Placebo, Prevnar 13, M-M-R II and Varivax, 282 days after receiving DTPa-HBV-IPV and Hiberix and 352 days after receiving Rotarix lyophilized formulation in a 15-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility for the event viral infection and considering alternate etiology (reactive airways disease and underlying infection) based on the medical history for the event bronchial hyperreactivity. US-GLAXOSMITHKLINE-US2020029361: More		✓
2832102	0.33	M		03/19/2025	HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Cough, Otitis media acute, Pyrexia, Respiratory syncytial virus infection, Respi... Cough, Otitis media acute, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Respiratory tract congestion, Wheezing; Cough, Otitis media acute, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Respiratory tract congestion, Wheezing; Cough, Otitis media acute, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Respiratory tract congestion, Wheezing; Cough, Otitis media acute, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Respiratory tract congestion, Wheezing; Cough, Otitis media acute, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Respiratory tract congestion, Wheezing More	Respiratory Syncytial Virus Infection; This 5-month-old male subject was enrolled in a blinded study... Respiratory Syncytial Virus Infection; This 5-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 31st October 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 11th December 2018, 41 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed severe - grade 3 respiratory syncytial virus infection. Serious criteria included hospitalization. The subject was treated with sodium chloride. Bexsero vs Placebo was continued with no change. Prevnar 13 was continued with no change. DTPa-HBV-IPV was continued with no change. Hiberix was continued with no change. The outcome of respiratory syncytial virus infection was recovered/resolved on 9th January 2019. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Diagnostic results (unless otherwise stated, normal values were not provided): On 13th December 2018, Respiratory syncytial virus test result was positive. GSK Receipt Date: 17-DEC-2018 Patient presented to clinic on 12/13/18 with complaints of fever, congestion, and cough. Congestion for a week and cough for two days and fever started over night. Subject was tested for RSV and test results were positive. Subject returned to the clinic on 12/15/18 with worsening of fever, cough and congestion and now had wheezing. Was diagnosed with still having RSV and Bilateral Acute Otitis Media. Due to symptoms being worse patient was sent to ED for admission for RSV. While in hospital patient received Rocephin, iv fluids, and sodium chloride updraft. Patient was discharged on 12/17/18 and came to clinic on 12/18/18 for a follow up visit and patient is improving. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus infection, 41 days after receiving 2nd dose of Bexsero vs Placebo, 2nd dose of Prevnar 13, 2nd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, 2nd dose of Hiberix, 2nd dose of Rotarix lyophilized formulation (Rotarix Oral Applicator Device) co-administered with PCV and routine vaccines in a 5-month-old male subject . Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. More		✓
2832103	0.33	M		03/19/2025	HIBV PNC13 UNK UNK UNK	UNKNOWN MANUFACTURER PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK	Bronchiolitis, Chest X-ray normal, Cough, Respiratory syncytial virus infection,... Bronchiolitis, Chest X-ray normal, Cough, Respiratory syncytial virus infection, Urine analysis normal; Bronchiolitis, Chest X-ray normal, Cough, Respiratory syncytial virus infection, Urine analysis normal; Bronchiolitis, Chest X-ray normal, Cough, Respiratory syncytial virus infection, Urine analysis normal; Bronchiolitis, Chest X-ray normal, Cough, Respiratory syncytial virus infection, Urine analysis normal; Bronchiolitis, Chest X-ray normal, Cough, Respiratory syncytial virus infection, Urine analysis normal More	Respiratory syncytial virus; This 5-month-old male subject was enrolled in a blinded study. The subj... Respiratory syncytial virus; This 5-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 13th December 2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (intramuscular) on 13th December 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 21st December 2018 00:01, 8 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed moderate - grade 2 respiratory syncytial virus infection. Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol Hfa), salbutamol (Albuterol) and acetaminophen. The outcome of respiratory syncytial virus infection was recovered/resolved on 31st December 2018 10:29. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Diagnostic results (unless otherwise stated, normal values were not provided): In December 2018, Chest X-ray result was no focal infiltrate and Urine analysis result was no significant results. GSK Receipt Date - 31-DEC-2018 Subject was taken to the local ED on 12/25/2018 for worsening coughing symptoms (which began on 12/21/2018). Local ED discharged patient home on 12/25/2018 with acute bronchiolitis. Patient returned to ED on 12/27/2018 and was diagnosed with acute bronchiolitis and discharged home (did not receive any medications). Patient returned to local ED on 12/30/2018 where patient was transferred to hospital and admitted for RSV bronchiolitis and monitoring. SAE paperwork has been completed and a follow up call is scheduled for later this week per study requirements. Patient was treated for RSV with albuterol inpatient. No other medications or treatment given except for supportive care. Patient discharged following day and requested to return to primary care for continuing followup. The Investigator reported the SAE as Respiratory syncytial virus. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus infection, 8 days after receiving the 2nd doses of Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, Hiberix and Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 5-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering the absence of biological plausibility. More		✓
2832104	0.25	F		03/19/2025	HIBV HIBV HIBV HIBV MEN MEN MEN MEN PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood glucos... Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood glucose normal, Blood potassium normal; Blood sodium normal, Blood urea normal, Carbon dioxide normal, Cough, Hypophagia; Nasal congestion, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Urinary retention, Vomiting; Wheezing; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood glucose normal, Blood potassium normal; Blood sodium normal, Blood urea normal, Carbon dioxide normal, Cough, Hypophagia; Nasal congestion, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Urinary retention, Vomiting; Wheezing; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood glucose normal, Blood potassium normal; Blood sodium normal, Blood urea normal, Carbon dioxide normal, Cough, Hypophagia; Nasal congestion, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Urinary retention, Vomiting; Wheezing; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood glucose normal, Blood potassium normal; Blood sodium normal, Blood urea normal, Carbon dioxide normal, Cough, Hypophagia; Nasal congestion, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Urinary retention, Vomiting; Wheezing; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood glucose normal, Blood potassium normal; Blood sodium normal, Blood urea normal, Carbon dioxide normal, Cough, Hypophagia; Nasal congestion, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Urinary retention, Vomiting; Wheezing More	Respiratory Syncytial Virus bronchiolitis; This 4-month-old female subject was enrolled in a blinded... Respiratory Syncytial Virus bronchiolitis; This 4-month-old female subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 4th December 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 30th December 2018, 26 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed moderate - grade 2 respiratory syncytial virus bronchiolitis. Serious criteria included hospitalization. The subject was treated with electrolytes nos + glucose (Pedialyte), 5% dextrose + potassium chloride + 0.9% sodium chloride iv, phenylephrine, ondansetron, albuterol and sodium chloride. Bexsero vs Placebo was continued with no change. The outcome of respiratory syncytial virus bronchiolitis was recovered/resolved on 10th January 2019. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Diagnostic results (unless otherwise stated, normal values were not provided): On 1st January 2019, Respiratory syncytial virus test result was Positive for RSV (normal high: negative). On 2nd January 2019, Blood calcium result was 9.3 mg/dL (normal low: 8.00, normal high: 10.50), Blood chloride result was 106 mmol/L (normal low: 97.00, normal high: 108.00), Blood creatine result was 0.3 mg/dL (normal low: 0.10, normal high: 0.40), Blood potassium result was 4.9 mmol/L (normal low: 3.50, normal high: 5.80), Blood sodium result was 137 mmol/L (normal low: 130.00, normal high: 145.00), Blood urea result was 10 mg/dL (normal low: 6.00, normal high: 17.00) and Carbon dioxide result was 25.0 mmol/L (normal low: 15.00, normal high: 28.00). In January 2019, Blood glucose result was 93 mg/dL (normal low: 54, normal high: 117). GSK Receipt Date: 02-JAN-2019 Subject presented to emergency room on 01Jan2019 with complaint of nasal congestion, cough, poor oral intake and less wet diapers starting 30Dec2018. Complaint of wheezing with start date of 01Jan2019. Mom states vomiting as well after cough. Subject positive for RSV. Subject received deep suctioning, Zofran, and Pedialyte in emergency room. Subject received albuterol treatment with no improvement. Subject admitted for observation, suctioning, and IV hydration. Subject was discharged from hospital on 02Jan2019. Subject is still ill per parent report on 03Jan2019 continuing Pedialyte and phenylephrine nose drops at home. 01Feb2019 mom reports all symptoms resolved as of 10Jan2019. On 07 Mar 2019, investigator confirmed that 'Respiratory Syncytial Virus bronchiolitis' is not an AESI. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchiolitis, 26 days after receiving 2nd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe, Hiberix and Rotarix lyophilized formulation with rotavirus vaccine oral applicator device in a 4-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. More		✓
2832105	0.33	M		03/19/2025	HIBV MEN PNC13 UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK	Adenovirus test positive, Chest X-ray normal, Respiratory syncytial virus bronch... Adenovirus test positive, Chest X-ray normal, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Wheezing; Adenovirus test positive, Chest X-ray normal, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Wheezing; Adenovirus test positive, Chest X-ray normal, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Wheezing; Adenovirus test positive, Chest X-ray normal, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Wheezing; Adenovirus test positive, Chest X-ray normal, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive, Wheezing More	RSV bronchiolitis; This 4-month-old male subject was enrolled in a blinded study. The subject receiv... RSV bronchiolitis; This 4-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 17-JAN-2019, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 17-JAN-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 17-JAN-2019, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular, right thigh) on 17-JAN-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 02-FEB-2019, 16 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed severe - grade 3 respiratory syncytial virus bronchiolitis (Verbatim: RSV bronchiolitis). Serious criteria included hospitalization and GSK medically significant. The subject was treated with salbutamol (Albuterol), prednisolone sodium phosphate (Orapred), methylprednisolone and glucose;potassium chloride;sodium chloride. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory syncytial virus bronchiolitis was resolved on 11-FEB-2019. Relevant Tests: On 04-FEB2-019 Chest X-ray showed negative results. On 04-FEB-2019 Viral PCR(polymerase chain reaction) Panel was positive for RSV(Respiratory syncytial virus) and adenovirus.. Diagnostic results (reference ranges are provided in parenthesis if available): Oxygen saturation- 04-FEB-2019 96 percent. Respiratory rate- 04-FEB-2019 66. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV,Rotarix lyophilized formulation and Hiberix. . The company considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV,Rotarix lyophilized formulation and Hiberix. GSK Receipt date : 04-FEB-2019 Subject was a direct admit to hospital from office on 04-FEB-2019 with 2 days of wheezing and worsening respiratory status with respiratory rate of 66 and oxygen saturation of 96 percent. In hospital, subject responded well to albuterol and IV steroids and never had an oxygen requirement. As his respiratory status improved, he was weaned off IV fluids for nutritional support and discharged home on 08-FEB2-019 with diagnosis of RSV Bronchiolitis. Subject was stable at office follow up on 11-FEB-2019. Medication name was reported as D5 1/2 NS with 20 mEq KCl Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchiolitis, 16 days after receiving the 2nd doses of Bexsero vs Placebo co-administered with PCV and routine vaccines, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, Hiberix and Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 4-month-old male subject. Report is inconsistent with causal relation to the vaccine products, considering the absence of biological plausibility. More		✓
2832106	0.17	F		03/19/2025	HIBV HIBV PNC13 PNC13 UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Abdominal X-ray, Escherichia test positive, Intestinal dilatation, Intussuscepti... Abdominal X-ray, Escherichia test positive, Intestinal dilatation, Intussusception, Laboratory test abnormal; Respiratory tract infection viral, Ultrasound abdomen abnormal, Urinary tract infection, Vomiting, X-ray abnormal; Abdominal X-ray, Escherichia test positive, Intestinal dilatation, Intussusception, Laboratory test abnormal; Respiratory tract infection viral, Ultrasound abdomen abnormal, Urinary tract infection, Vomiting, X-ray abnormal; Abdominal X-ray, Escherichia test positive, Intestinal dilatation, Intussusception, Laboratory test abnormal; Respiratory tract infection viral, Ultrasound abdomen abnormal, Urinary tract infection, Vomiting, X-ray abnormal; Abdominal X-ray, Escherichia test positive, Intestinal dilatation, Intussusception, Laboratory test abnormal; Respiratory tract infection viral, Ultrasound abdomen abnormal, Urinary tract infection, Vomiting, X-ray abnormal; Abdominal X-ray, Escherichia test positive, Intestinal dilatation, Intussusception, Laboratory test abnormal; Respiratory tract infection viral, Ultrasound abdomen abnormal, Urinary tract infection, Vomiting, X-ray abnormal More	Urinary Tract Infection; Respiratory Viral Syndrome; This 3-month-old female subject was enrolled in... Urinary Tract Infection; Respiratory Viral Syndrome; This 3-month-old female subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 04-JAN-2019, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, right thigh) on 04-JAN-2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 04-JAN-2019, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 04-JAN-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 27-FEB-2019, 54 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed moderate - grade 2 respiratory tract infection viral (Verbatim: Respiratory Viral Syndrome). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 urinary tract infection (Verbatim: Urinary Tract Infection) on 04-MAR-2019 with serious criteria of hospitalization. The subject was treated with cefdinir, ceftriaxone, dextrose, acetaminophen and sodium chloride. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory tract infection viral was resolved on 12-MAR-2019. The outcome(s) of the additional event(s) included urinary tract infection (resolved on 13-MAR-2019). Relevant Tests: On 27-FEB-2019: Rapid antigen test was done in ER (Emergency Room). Results = POSITIVE abnormal On 27-FEB-2019 XR (X-ray) Abdomen single view Indications = increasing emesis Conclusion = multiple loops of dilated small bowel in the mid abdomen. Gas-filled colon appears decompressed. Findings are worrisome for small bowel obstruction. In this age group, etiologies may include intussusception and Meckel's divericulitis On 27-FEB-2019: US (Ultrasound) abdomen limited Indication = recent imaging suspicious for intussusception Conclusion = Concentric target appearance of bowel in the left lower quadrant is highly suspicious for an intussusception. It is favored to be small bowel. No ascites. On 03-FEB-2019: Urine culture tested positive for E. Coli. Presumed to be caused by untreated UTI.. The investigator considered that there was no reasonable possibility that the respiratory tract infection viral and urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the respiratory tract infection viral and urinary tract infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. Linked case(s) involving the same subject: US2019056671, US2019059404 GSK receipt date: 28-MAR-2019 2/27/19: subject was seen by a colleague of PI who sent her directly to the ER for RSV. ER did some tests and transferred her to a larger ER across down. Subject was admitted for RSV and suspicion of intussusception. 2/28/19: Intussusception clinically resolved without intervention or surgery. 3/4/19 Hospital progress note: Urine culture from 3/2/19 resulted positive for E. Coli and subject was given ceftriaxone. Was thought to possibly be contaminant as it was from a bagged specimen. Given age and presumed duration of untreated UTI, subject was kept an additional 24 hours for observation. 3/5/19: Subject discharged and given prescription for 8 days of cefdinir. Will need RBUS near the completion of antibiotic therapy. 3/5/19: subject discharged 3/8/19: LAR/Mom brought subject for 4 mos WCC and study visit 2. At this time informed site that subject had been hospitalized and discharged 3 days prior. Visit is rescheduled for 3/22/19. On 23 Apr 2019, case US2019056671 and US2019059404 were identified as duplicate of US2019056670. All future correspondence will be added US2019056670. Reported medication name was Sodium chloride nasal Upon internal review the case was updated on 23-Jan-2025 FU GSK Receipt Date was updated and Narrative updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Respiratory tract infection viral and urinary tract infection, 54 days after receiving 1st doses of Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, Hiberix and Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 3-month-old female subject . Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. US-GLAXOSMITHKLINE-US2019056671: US-GLAXOSMITHKLINE-US2019059404: More		✓
2832107	0.33	M		03/19/2025	HIBV HIBV HIBV HIBV HIBV HIBV HIBV HIBV PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Anion gap, Basophil percentage decreased, Blood calcium normal, Blood chloride n... Anion gap, Basophil percentage decreased, Blood calcium normal, Blood chloride normal, Blood creatine decreased; Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal, Carbon dioxide decreased; Chest X-ray abnormal, Decreased activity, Dyspnoea, Eosinophil percentage decreased, Haematocrit normal; Haemoglobin normal, Influenza virus test negative, Lower respiratory tract infection viral, Lung opacity, Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage, Neutrophil count increased; Neutrophil percentage increased, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology present, Red cell distribution width normal; Respiratory distress, Respiratory syncytial virus test negative, Urinary retention, Use of accessory respiratory muscles, Viral upper respiratory tract infection; Wheezing, White blood cell count normal; Anion gap, Basophil percentage decreased, Blood calcium normal, Blood chloride normal, Blood creatine decreased; Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal, Carbon dioxide decreased; Chest X-ray abnormal, Decreased activity, Dyspnoea, Eosinophil percentage decreased, Haematocrit normal; Haemoglobin normal, Influenza virus test negative, Lower respiratory tract infection viral, Lung opacity, Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage, Neutrophil count increased; Neutrophil percentage increased, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology present, Red cell distribution width normal; Respiratory distress, Respiratory syncytial virus test negative, Urinary retention, Use of accessory respiratory muscles, Viral upper respiratory tract infection; Wheezing, White blood cell count normal; Anion gap, Basophil percentage decreased, Blood calcium normal, Blood chloride normal, Blood creatine decreased; Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal, Carbon dioxide decreased; Chest X-ray abnormal, Decreased activity, Dyspnoea, Eosinophil percentage decreased, Haematocrit normal; Haemoglobin normal, Influenza virus test negative, Lower respiratory tract infection viral, Lung opacity, Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage, Neutrophil count increased; Neutrophil percentage increased, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology present, Red cell distribution width normal; Respiratory distress, Respiratory syncytial virus test negative, Urinary retention, Use of accessory respiratory muscles, Viral upper respiratory tract infection; Wheezing, White blood cell count normal; Anion gap, Basophil percentage decreased, Blood calcium normal, Blood chloride normal, Blood creatine decreased; Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal, Carbon dioxide decreased; Chest X-ray abnormal, Decreased activity, Dyspnoea, Eosinophil percentage decreased, Haematocrit normal; Haemoglobin normal, Influenza virus test negative, Lower respiratory tract infection viral, Lung opacity, Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage, Neutrophil count increased; Neutrophil percentage increased, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology present, Red cell distribution width normal; Respiratory distress, Respiratory syncytial virus test negative, Urinary retention, Use of accessory respiratory muscles, Viral upper respiratory tract infection; Wheezing, White blood cell count normal; Anion gap, Basophil percentage decreased, Blood calcium normal, Blood chloride normal, Blood creatine decreased; Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal, Carbon dioxide decreased; Chest X-ray abnormal, Decreased activity, Dyspnoea, Eosinophil percentage decreased, Haematocrit normal; Haemoglobin normal, Influenza virus test negative, Lower respiratory tract infection viral, Lung opacity, Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage, Neutrophil count increased; Neutrophil percentage increased, Platelet count increased, Red blood cell count normal, Red blood cell nucleated morphology present, Red cell distribution width normal; Respiratory distress, Respiratory syncytial virus test negative, Urinary retention, Use of accessory respiratory muscles, Viral upper respiratory tract infection; Wheezing, White blood cell count normal More	Lower Respiratory Tract Infection (LRTI); Upper Respiratory Infection (URI); This 9-month-old male s... Lower Respiratory Tract Infection (LRTI); Upper Respiratory Infection (URI); This 9-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular, left thigh) on 15-FEB-2019, for prophylaxis. The subject received DTPa-HBV-IPV on an unknown date. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 07-DEC-2018, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 15-FEB-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 07-MAY-2019, 81 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines and Hiberix, an unknown time after receiving DTPa-HBV-IPV and 151 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 lower respiratory tract infection (Verbatim: Lower Respiratory Tract Infection (LRTI)). Serious criteria included hospitalization and GSK medically significant. Additional event(s) included moderate - grade 2 upper respiratory tract infection (Verbatim: Upper Respiratory Infection (URI)) on 07-MAY-2019 with serious criteria of hospitalization. The subject was treated with ceftriaxone sodium (Ceftriaxone), ipratropium bromide (Ipratropium), ibuprofen sodium (Ibuprofen), prednisolone sodium phosphate (Orapred) and salbutamol sulfate (Albuterol). Rotarix lyophilized formulation was continued with no change. The outcome of lower respiratory tract infection was resolved on 09-MAY-2019. The outcome(s) of the additional event(s) included upper respiratory tract infection (resolved on 09-MAY-2019). Relevant Tests: On 08May2019 Chest X-ray results: left lung has patchy opacity in the midportion superimposed on the fourth anterior rib. Mild airway thickening is noted. Cardiac and mediastinal contours are normal. No pneumothorax or pleural effusion. No acute osseous abnormality. On an unknown date in May 2019, NRBC AB WAM = 0.03 10e3/uL (range = 0.03-0.12). Diagnostic results (reference ranges are provided in parenthesis if available): Anion gap-In MAY-2019 13 mmol/L, (7-15). Basophil count- 08-MAY-2019 0.20 %, (0.00-1.00). Blood calcium- 08-MAY-2019 9.4 mg/dL, (9.00-11.00). Blood chloride- 08-MAY-2019 109 mmol/L, (98.00-107.00). Blood creatine- 08-MAY-2019 0.18 (0.20-0.50). Blood glucose- 08-MAY-2019 153 mg/dL, (60.00-100.00). Blood potassium- 08-MAY-2019 3.4 mmol/L, (3.50-5.50). Blood sodium- 08-MAY-2019 140 mmol/L, (131.00-140.00). Blood urea- 08-MAY-2019 11 mg/dL, (6.00-17.00). Carbone dioxide- 08-MAY-2019 18 mmol/L, (22.00-32.00). Chest X-ray- 08-MAY-2019 see text. Eosinophil count- 08-MAY-2019 0.70 %, (0.00-4.00). Granulocyte count- 08-MAY-2019 0.06 x10e3/mcL, (0.00-0.22). Haematocrit- 08-MAY-2019 31.90 %, (33.00-45.00). Haemoglobin- 08-MAY-2019 10.40 g/dL, (10.50-13.50). Influenza virus test-In MAY-2019 negative. Mean cell haemoglobin- 08-MAY-2019 27.40 pg, (23.00-31.00). Mean cell haemoglobin concentration- 08-MAY-2019 32.60 g/dL, (31.00-37.00). Mean cell volume- 08-MAY-2019 83.90 fL, (75.00-86.00). Mean platelet volume- 08-MAY-2019 9.30 fL, (8.60-13.00). Monocyte count- 08-MAY-2019 6.90 %, (0.00-10.00). Neutrophil count- 08-MAY-2019 75.00 %, (15.00-45.00) and 08-MAY-2019 10.97 x10e3/mcL, (1.50-5.00). Platelet count- 08-MAY-2019 543.00 x10e3/mcL, (150.00-420.00). Red blood cell count- 08-MAY-2019 3.8 x10E6/mcL, (3.50-5.50). Red cell distribution width- 08-MAY-2019 13.60 %, (11.00-16.00). Respiratory syncytial virus test-In MAY-2019 negative. White blood cell count- 08-MAY-2019 14.63 x10e3/mcL, (5.50-18.00). The investigator considered that there was no reasonable possibility that the lower respiratory tract infection and upper respiratory tract infection may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the lower respiratory tract infection and upper respiratory tract infection may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. INVESTIGATOR TEXT 5/8/19: Subject presented to the clinic with increased work of breathing, decreased activity and urine output for 24 hours. PI saw her immediately and performed physical, also monitoring O2 stats. Subject also had elevated temperature of 100.2F. Initial sat 90-91%; was given 3 nebs, 10 mg steroid burst. After first neb PI felt that the subject was in respiratory distress and called EMS. After 3rd neb treatment, air flow appeared to be improved, but with continued considerable retractions and wheezing felt subject should be transported to ER. ER ordered chest x-ray and labs. Chest X-ray results: "left lung has patchy opacity in the midportion superimposed on the fourth anterior rib. Mild airway thickening is noted. Cardiac and mediastinal contours are normal. No pneumothorax or pleural effusion. No acute osseous abnormality." Negative for Influenza and RSV Metabolic Panel: Sodium = 140 Potassium = 3.4 Chloride = 109 Co2 total = 18 Anion Gap = 13 Glucose = 153 BUN = 11 Calcium = 9.4 Creatinine = 0.18 CBC Panel: WBC Count = 14.63 RBC Count = 3.8 Hemoglobin = 10.4 Hematocrit = 31.9 MCV = 83.9 MCH = 27.4 MCHC = 32.6 RDW-CV = 13.6 Platelet Count = 543 MPV = 9.3 Prelim Neut AB WAM = 10.97 NRBC WAM = 0 NRBC AB WAM = 0.03 Segmented Neutrophil WAM = 75.0 Immature Granulocytes WAM = 0.4 Lymphocyte WAM = 16.8 Monocyte WAM = 6.9 Eosinophil WAM = .7 Basophil WAM = .2 Neutrophil WAM = 10.97 IMM Granulocyte AB WAM = 0.06 Lymphocyte ABS WAM = 2.46 Monocyte WAM = 1.01 Eosinophil WAM = 0.10 Basophil WAM = 0.03 No premature birth or history of chest injury. Findings were concerns for pneumonia, subject was treated with IV and antibiotics. ER Physician felt he need to be admitted for observation overnight. 5/9/19: Subject was discharged with diagnosis of Viral Upper (URI) and Lower Respiratory Tract (LRTI) Infections. Instructions to follow up with PCP 5/13 or 5/14 or with ER if needed. Upon internal review the case was updated on 18-Mar-2025. Comparator vaccines updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of the Lower respiratory tract infection and Upper respiratory tract infection, 81 days after receiving Placebo and 3rd dose of DTPa-HBV-IPV and Hiberix, 2nd dose of Rotarix lyophilized formulation, and Prevenar 13 in a 9-month-old male subject. Placebo case following unblinding, causality assessment non applicable. Report is inconsistent with causal relation to the vaccine product, considering an implausible time to onset and absence of biological plausibility. More		✓
2832108	0.33	F		03/19/2025	HIBV HIBV HIBV HIBV MEN MEN MEN MEN PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Bronchiolitis, Chest X-ray abnormal, Cough, Culture urine negative, Dehydration;... Bronchiolitis, Chest X-ray abnormal, Cough, Culture urine negative, Dehydration; Hypophagia, Infant irritability, Influenza A virus test negative, Influenza B virus test negative, Influenza like illness; Pyrexia, Respiratory pathogen panel, Respiratory syncytial virus test negative, Respiratory tract congestion, Rubulavirus test positive; Urine ketone body present; Bronchiolitis, Chest X-ray abnormal, Cough, Culture urine negative, Dehydration; Hypophagia, Infant irritability, Influenza A virus test negative, Influenza B virus test negative, Influenza like illness; Pyrexia, Respiratory pathogen panel, Respiratory syncytial virus test negative, Respiratory tract congestion, Rubulavirus test positive; Urine ketone body present; Bronchiolitis, Chest X-ray abnormal, Cough, Culture urine negative, Dehydration; Hypophagia, Infant irritability, Influenza A virus test negative, Influenza B virus test negative, Influenza like illness; Pyrexia, Respiratory pathogen panel, Respiratory syncytial virus test negative, Respiratory tract congestion, Rubulavirus test positive; Urine ketone body present; Bronchiolitis, Chest X-ray abnormal, Cough, Culture urine negative, Dehydration; Hypophagia, Infant irritability, Influenza A virus test negative, Influenza B virus test negative, Influenza like illness; Pyrexia, Respiratory pathogen panel, Respiratory syncytial virus test negative, Respiratory tract congestion, Rubulavirus test positive; Urine ketone body present; Bronchiolitis, Chest X-ray abnormal, Cough, Culture urine negative, Dehydration; Hypophagia, Infant irritability, Influenza A virus test negative, Influenza B virus test negative, Influenza like illness; Pyrexia, Respiratory pathogen panel, Respiratory syncytial virus test negative, Respiratory tract congestion, Rubulavirus test positive; Urine ketone body present More	Bronchiolitis; dehydration; Influenza-Like Illness; This 6-month-old female subject was enrolled in ... Bronchiolitis; dehydration; Influenza-Like Illness; This 6-month-old female subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 22nd August 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. Concurrent medical conditions included upper respiratory tract infection. Concomitant products included influenza virus vaccine inactivated (Fluarix) and ciprofloxacin + dexamethasone (Ciprodex (Ciprofloxacin And Dexamethasone)). On 11th October 2019, 50 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13, the subject developed severe - grade 3 influenza like illness. Serious criteria included hospitalization. Additional event(s) included severe - grade 3 bronchiolitis on 18th October 2019 with serious criteria of hospitalization and severe - grade 3 dehydration on 18th October 2019 with serious criteria of hospitalization. The subject was treated with ibuprofen (Advil), ceftriaxone sodium (Rocephin), oseltamivir phosphate (Tamiflu), paracetamol (Tylenol), dextrose + saline infusion and sodium chloride 0.9% bolus. Bexsero vs Placebo was continued with no change. DTPa-HBV-IPV was continued with no change. Hiberix was continued with no change. Prevnar 13 was continued with no change. The outcome of influenza like illness was recovered/resolved on 23rd October 2019. The outcome(s) of the additional event(s) included dehydration (recovered/resolved on 23rd October 2019) and bronchiolitis (recovered/resolved on 31st October 2019). The investigator considered that there was no reasonable possibility that the influenza like illness, bronchiolitis and dehydration may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13. Relevant Tests: On 18 Oct 2019, RPP by PCR showed Parainfluenza 4 PCR detected RSV and Influenza A/B amplified probesRSV and Influenza A/B amplified probes. Diagnostic results (unless otherwise stated, normal values were not provided): On 18th October 2019, Culture urine result was No growth after 1 day of incubation, Influenza A virus test result was Neg, Influenza B virus test result was Neg, Polymerase chain reaction result was See text, Respiratory syncytial virus test result was neg and X-ray result was chest, bronchiolitis- no consolidative pneumonia. Investigator text 6 mo.term, healthy female presenting with 5 days of fever, with cough, congestion and decreased PO intake in the setting of a sibling who has confirmed influenza. On exam, she appears clinically dehydrated and extremely fussy. Given history of URI symptoms and no focal findings on CXR, presentation most consistent with dehydration secondary to decreased PO intake in setting of viral process. She has the clinical findings of bronchiolitis. UA with ketones also consistent with dehydration without UTI. Will treat prophylactically for flu given young age and sick contact, will continue supportive care, including fluid rehydration therapy. Respiratory Pathogen Panel by PCR -Parainfluenza 4 PCR detected (A) Patient admitted 18Oct2019. Diagnosis: Influenza-like illness in pediatric patient Primary, Dehydration. Bronchiolitis. Additional details: The suspect vaccine M-M-R II and Varivaxboth were administered after SAE onset date on 22Apr2020 via subcutaneous. Upon internal review the case was updated on 18-Mar-2025. Reported causality updated for devices updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Influenza like illness, bronchiolitis and Dehydration, 50 days after receiving 2nd dose of Bexsero vs Placebo , DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13, in a 6 months old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility . More		✓
2832109	0.33	M		03/19/2025	HIBV HIBV HIBV MEN MEN MEN MMR MMR MMR PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Abdominal pain, C-reactive protein increased, Decreased activity, Enema administ... Abdominal pain, C-reactive protein increased, Decreased activity, Enema administration, Faecal calprotectin normal; Faecal occult blood negative, Hypophagia, Infant irritability, Red blood cell sedimentation rate increased, Ultrasound abdomen normal; Urinary system X-ray, Urine analysis normal, White blood cell count normal, X-ray normal; Abdominal pain, C-reactive protein increased, Decreased activity, Enema administration, Faecal calprotectin normal; Faecal occult blood negative, Hypophagia, Infant irritability, Red blood cell sedimentation rate increased, Ultrasound abdomen normal; Urinary system X-ray, Urine analysis normal, White blood cell count normal, X-ray normal; Abdominal pain, C-reactive protein increased, Decreased activity, Enema administration, Faecal calprotectin normal; Faecal occult blood negative, Hypophagia, Infant irritability, Red blood cell sedimentation rate increased, Ultrasound abdomen normal; Urinary system X-ray, Urine analysis normal, White blood cell count normal, X-ray normal; Abdominal pain, C-reactive protein increased, Decreased activity, Enema administration, Faecal calprotectin normal; Faecal occult blood negative, Hypophagia, Infant irritability, Red blood cell sedimentation rate increased, Ultrasound abdomen normal; Urinary system X-ray, Urine analysis normal, White blood cell count normal, X-ray normal; Abdominal pain, C-reactive protein increased, Decreased activity, Enema administration, Faecal calprotectin normal; Faecal occult blood negative, Hypophagia, Infant irritability, Red blood cell sedimentation rate increased, Ultrasound abdomen normal; Urinary system X-ray, Urine analysis normal, White blood cell count normal, X-ray normal; Abdominal pain, C-reactive protein increased, Decreased activity, Enema administration, Faecal calprotectin normal; Faecal occult blood negative, Hypophagia, Infant irritability, Red blood cell sedimentation rate increased, Ultrasound abdomen normal; Urinary system X-ray, Urine analysis normal, White blood cell count normal, X-ray normal More	Abdominal Pain; This 12-month-old male subject was enrolled in a blinded study. The subject received... Abdominal Pain; This 12-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 9th January 2020. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 24th June 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 23rd April 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 24th June 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 9th January 2020, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 9th January 2020, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 17th January 2020, 8 days after receiving Bexsero vs Placebo, M-M-R II and Prevnar 13, 207 days after receiving DTPa-HBV-IPV and Hiberix and 269 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 abdominal pain. Serious criteria included hospitalization. The subject was treated with phosphoric acid, sodium salt (Sodium Phosphate Enema), morphine, macrogol (Polyethylene Glycol) and paracetamol (Acetaminophen). The outcome of abdominal pain was recovered/resolved on 21st January 2020. The investigator considered that there was no reasonable possibility that the abdominal pain may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Prevnar 13. Diagnostic results (unless otherwise stated, normal values were not provided): On 20th January 2020, C-reactive protein result was 6.8 mg/dL (normal low: less than equal to 0.9), Red blood cell sedimentation rate result was 84 (normal low: 0, normal high: 15), Ultrasound scan result was negative for intussusception and White blood cell count result was normal no fever. KUB without air fluid levels. On 29th January 2020, Faecal calprotectin result was less than 16 ug/g (normal low: less than equal to 50), Occult blood result was Negative, Ultrasound scan result was see text and Urine analysis result was Negative. GSK Receipt Date - 21-JAN-2020 12 Month old male presented to emergency department on 20JAN2020 at 1449 with intermittent abdominal pain (the pain started 17JAN2020). Also reported decreased po, decreased activity and fussier than usual. Mom noted that something similar happened a few months ago but seemed to get better on its own. In the emergency room he was noted to have intermittent bouts of pain, given morphine and normal saline bolus that helped a bit with the pain. Ultrasound negative for intussusception. Elevated inflammatory markers (Erythrocyte sedimentation rate and C-reactive Protein) present. Admitted from Emergency room to Hospital 20JAN2020 at 2155. Negative urinalysis, normal white blood cell count, no fever. KUB without air fluid levels but lots of people looking stool in rectum and stool in ascending and descending colon. Stool removed with enema and Miralax. Discharged home from hospital on 21JAN2020 at 1140. I phoned mom at 1400. Baby sleeping. Without abdominal pain. Response to query from 24FEB2020. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of abdominal pain 8 days after receiving 4th dose of Bexsero vs Placebo and Prevnar 13, 207 days after receiving 3rd dose of DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device and Hiberix, 269 days after receiving 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, 8 days after receiving 1st dose of M-M-R II and Varivax co-administered with PCV and routine vaccines in a 12-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. Causal relation is indeterminate considering insufficient definitive evidence for Rotarix lyophilized formulation with Rotarix Oral Applicator Device causing the temporaly related AE. More		✓
2832110	0.33	M		03/19/2025	HIBV HIBV HIBV MMR MMR MMR PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK VARCEL VARCEL VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium norma... Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium normal, C-reactive protein increased; Carbon dioxide decreased, Cellulitis, Groin abscess, Lymphadenitis, Lymphocyte count increased; Mass, Pyrexia, Skin warm, Staphylococcus test positive, White blood cell count normal; Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium normal, C-reactive protein increased; Carbon dioxide decreased, Cellulitis, Groin abscess, Lymphadenitis, Lymphocyte count increased; Mass, Pyrexia, Skin warm, Staphylococcus test positive, White blood cell count normal; Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium normal, C-reactive protein increased; Carbon dioxide decreased, Cellulitis, Groin abscess, Lymphadenitis, Lymphocyte count increased; Mass, Pyrexia, Skin warm, Staphylococcus test positive, White blood cell count normal; Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium normal, C-reactive protein increased; Carbon dioxide decreased, Cellulitis, Groin abscess, Lymphadenitis, Lymphocyte count increased; Mass, Pyrexia, Skin warm, Staphylococcus test positive, White blood cell count normal; Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium normal, C-reactive protein increased; Carbon dioxide decreased, Cellulitis, Groin abscess, Lymphadenitis, Lymphocyte count increased; Mass, Pyrexia, Skin warm, Staphylococcus test positive, White blood cell count normal; Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium normal, C-reactive protein increased; Carbon dioxide decreased, Cellulitis, Groin abscess, Lymphadenitis, Lymphocyte count increased; Mass, Pyrexia, Skin warm, Staphylococcus test positive, White blood cell count normal; Blood chloride normal, Blood culture, Blood potassium normal, Blood sodium normal, C-reactive protein increased; Carbon dioxide decreased, Cellulitis, Groin abscess, Lymphadenitis, Lymphocyte count increased; Mass, Pyrexia, Skin warm, Staphylococcus test positive, White blood cell count normal More	lymphadenitis; Cellulitis; This 14-month-old male subject was enrolled in a blinded study. The subje... lymphadenitis; Cellulitis; This 14-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 18th November 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 20th May 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 4th March 2019, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular) on 20th May 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 18th November 2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 18th November 2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 18th November 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. Concomitant products included fentanyl and salbutamol (Albuterol Inhaler). On 21st January 2020 06:45, 64 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 246 days after receiving DTPa-HBV-IPV and Hiberix and 323 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 cellulitis. Serious criteria included hospitalization. Additional event(s) included severe - grade 3 lymphadenitis on 22nd January 2020 with serious criteria of hospitalization. The subject was treated with ibuprofen, paracetamol (Tylenol), sodium chloride, glucose (Dextrose) and clindamycin. The outcome of cellulitis was recovered/resolved on 10th February 2020 15:46. The outcome(s) of the additional event(s) included lymphadenitis (recovered/resolved on 10th February 2020 15:46). The investigator considered that there was no reasonable possibility that the cellulitis and lymphadenitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. Diagnostic results (unless otherwise stated, normal values were not provided):In January 2020, Culture result was no strict anaerobic growth and Culture result was moderate staphylococcus aureus (MRSA) . On 22nd January 2020, Blood chloride result was 102 mmol/L (normal low: 99.00, normal high: 111.00), Blood potassium result was 3.8 mmol/L (normal low: 3.40, normal high: 4.70), Blood sodium result was 136 mmol/L (normal low: 136.00, normal high: 145.00), C-reactive protein result was 3.30 mg/dL, Carbon dioxide result was 19.00 mmol/L (normal low: 20.00, normal high: 36.00), Lymphocyte count result was 4.70 x10e9/L (normal low: 1.50, normal high: 7.00) and White blood cell count result was 14.3 x10e9/L (normal low: 6.00, normal high: 11.00). Investigator Text: Subject's mom/LAR called CRC on 21 Jan 2020 at 0645 to let CRC know that subject had a fever of 100.5. Mom was giving him Tylenol and was not overly concerned as child did not have other symptoms at this time. CRC educated mom that if other symptoms did develop or if fever spiked or if she had concerns to let CRC know. Mom of subject agreed to do that. At 2025 on 21 Jan 2020 LAR/Mom called CRC after hours to express concern about a bump in his groin area that "popped" but nothing came out except blood. Mom stated also that child is still running a fever of 101.3 with Tylenol given. CRC consulted with Sub I. Per Sub I, instructed Mom to not push or squeeze area (area is right groin area, not injection site) any more, place warm compress for comfort, keep on Tylenol and site will schedule child to be seen first thing in the morning. Also instructed parent that if subject spikes a fever or is inconsolable, or any other emergent situation than he should be taken into ER before morning. Mom of subject expressed understanding. 1000 22 Jan 2020 subject was brought to site and seen by Sub I. Per mom child had ran a high fever most of the night. She did attempt to take him to ER overnight but it was so "crazy and busy" that they finally gave up and went home. Sub I and PI consulted on the situation and the infant was direct admitted to the hospital due to fever in office (102.5 and appearance of area of bump-raised, hard, warm to touch). Subject was admitted to hospital at 1157 for cellulitis and Lymphadenitis. CELLULITIS WAS NO AT THE INJECTION SITE. THE SITE WAS IN THE RIGHT GROIN AREA AND RESULTED FROM ABSCESS. THE CULTURE WAS POSITIVE FOR MRSA. SUBJECT HAS A HISTORY OF MULTIPLE URI'S; TORTICOLLIS; INFANTILE ECZEMA; RSV; THEN THE ABSCESS OCCURRED. Subject was discharged on 25 Jan 2020 Investigator Comment: The subject had concomitant medication Decadron from 22 Jan 2020 to 22 Jan 2020, once only intravenously for indication anesthesia stop. The subject had concomitant medication Culturelle Capsule from 24 Jan 2020 to 25 Jan 2020, 1 capsule, bid orally for indication preventative/supplement. Follow-up information received on 25-MAR-2022. This follow-up was considered significant. Investigator Comment The investigator considered that there was no reasonable possibility that the cellulitis may have been caused by Prevnar 13. The relationship of the lymphadenitis to treatment with Prevnar 13 was not reported. Summary of Changes: Vaccination and event onset time, Seriousness criteria. Follow up information received on 05-Oct-2022. This follow-up was considered Non.significant. Summary of changes: The Unit of Concomitant drug fentanyl changed from mcg/mg to ml. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of lymphadenitis and cellulitis, 64 days after receiving 4th dose of Bexsero vs Placebo and Prevnar 13, 246 days after receiving 3rd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, 323 days after receiving 2nd dose of Rotarix vaccine oral applicator device in a Rotarix Oral Applicator Device, 246 days after receiving 1st dose of Hiberix, 64 days after receiving 1 st dose of M-M-R II and Varivax co-administered with PCV and routine vaccines in a 14-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and infantile eczema as a risk factor based on medical history. More		✓
2832111	0.33	F		03/19/2025	HIBV HIBV HIBV HIBV HIBV MEN MEN MEN MEN MEN PNC13 PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal... Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal; Blood bilirubin, Blood bilirubin increased, Blood calcium normal, Blood chloride increased, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Carbon dioxide decreased, Clostridium difficile colitis; Clostridium test positive, Diarrhoea, Escherichia test negative, Giardia test negative, Haematochezia; Haemoglobin normal, Mean cell volume normal, Mucous stools, Platelet count normal, White blood cell count normal; Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal; Blood bilirubin, Blood bilirubin increased, Blood calcium normal, Blood chloride increased, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Carbon dioxide decreased, Clostridium difficile colitis; Clostridium test positive, Diarrhoea, Escherichia test negative, Giardia test negative, Haematochezia; Haemoglobin normal, Mean cell volume normal, Mucous stools, Platelet count normal, White blood cell count normal; Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal; Blood bilirubin, Blood bilirubin increased, Blood calcium normal, Blood chloride increased, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Carbon dioxide decreased, Clostridium difficile colitis; Clostridium test positive, Diarrhoea, Escherichia test negative, Giardia test negative, Haematochezia; Haemoglobin normal, Mean cell volume normal, Mucous stools, Platelet count normal, White blood cell count normal; Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal; Blood bilirubin, Blood bilirubin increased, Blood calcium normal, Blood chloride increased, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Carbon dioxide decreased, Clostridium difficile colitis; Clostridium test positive, Diarrhoea, Escherichia test negative, Giardia test negative, Haematochezia; Haemoglobin normal, Mean cell volume normal, Mucous stools, Platelet count normal, White blood cell count normal; Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal; Blood bilirubin, Blood bilirubin increased, Blood calcium normal, Blood chloride increased, Blood creatine normal; Blood glucose normal, Blood potassium increased, Blood sodium normal, Carbon dioxide decreased, Clostridium difficile colitis; Clostridium test positive, Diarrhoea, Escherichia test negative, Giardia test negative, Haematochezia; Haemoglobin normal, Mean cell volume normal, Mucous stools, Platelet count normal, White blood cell count normal More	Intestinal infection due to clostridium difficile; This 7-month-old female subject was enrolled in a... Intestinal infection due to clostridium difficile; This 7-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 2nd January 2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 2nd January 2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 29th October 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 2nd January 2020, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Prevnar 13 (Non-GSK Comparator) (Prevnar 13) for prophylaxis. On 7th February 2020, 36 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 101 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 intestinal infection due to clostridium difficile. Serious criteria included hospitalization. The subject was treated with vancomycin hydrochloride, famotidine and metronidazole. Bexsero vs Placebo was continued with no change. Prevnar 13 was continued with no change. The outcome of intestinal infection due to clostridium difficile was recovered/resolved on 10th March 2020. The investigator considered that there was no reasonable possibility that the intestinal infection due to clostridium difficile may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. Diagnostic results (unless otherwise stated, normal values were not provided): On 21st February 2020, Alanine aminotransferase result was 110 u/L (normal low: 10.00, normal high: 65.00), Aspartate aminotransferase result was 56 u/L (normal low: 20.00, normal high: 60.00), Blood albumin result was 4.4 g/dL (normal low: 3.90, normal high: 5.60), Blood alkaline phosphatase result was 189 u/L (normal low: 72.00, normal high: 307.00), Blood bilirubin result was 0.3mcv40 mg/dL (normal low: 0.00, normal high: 1.90), Blood bilirubin result was 10 mg/dL (normal low: 0.00, normal high: 1.90), Blood calcium result was 10.3 mg/dL (normal low: 8.50, normal high: 10.60), Blood chloride result was 114 mmol/L (normal low: 99.00, normal high: 109.00), Blood creatine result was 0.29 mg/dL (normal low: 0.10, normal high: 0.58), Blood potassium result was 4.0 mmol/L (normal low: 3.60, normal high: 6.80), Blood sodium result was 139 mmol/L (normal low: 135.00, normal high: 145.00), Carbon dioxide result was 12 mmol/L (normal low: 20.00, normal high: 28.00), Clostridium test result was positive, Clostridium test result was positive (Tox Ag), Escherichia test result was negative (Shiga toxin), Giardia test result was negative (Giardia Antigen Stool), Haemoglobin result was 13.0 g/dL (normal low: 11.50, normal high: 13.50), Mean cell volume result was 84.8 fL (normal low: 70.00, normal high: 86.00), Platelet count result was 405 K/uL (normal low: 250.00, normal high: 600.00) and White blood cell count result was 9.59 K/uL (normal low: 6.00, normal high: 17.50). INVESTIGATOR TEXT Subject is a 7 month old female who presented to the ED with intermittent bloody stools and chronic diarrhea. Mother stated the diarrhea has been intermittent and waxing and waning over the past month. She occasionally has soft stools, but throughout the day her stools become more watery. Her mother first noted dark red blood and mucous in the stool about 3 weeks ago, this self-resolved. The PCP switched the patient's formula over to nutramigen, but the patient did not tolerate this (possibly due to flavor). She continued to have intermittent diarrhea. In hospital it was felt milk protein allergy was most likely, but that infectious cause should be ruled out. Stool cultures for yersina, giardia, and C. Diff were sent in addition to CMP and CBC. In all, patient was found to be positive for C Diff NAAT and toxin. Her inital electrolytes improved as well. She was discharged on oral metronidazole for 10 day course. Subject was admitted to the hospital on 21FEB2020 and discharged on22FEB2020 at 15:50pm. No history of C-Diff Lab 02/21/20 1228 WBC 9.59 HGB 13.0 MCV 84.8 PLT 405 Lab 02/21/20 1228 NA 139 K 4.0 CL 114 CO2 12 ANIONGAP 13 BUN 10 CREA 0.29 GLU 66 Lab 02/21/20 1228 CALCIUM 10.3 Recent Labs Lab 02/21/20 1228 ALBUMIN 4.4 ALT 110 AST 56 ALKPHOS 189 BILITOT 0.3 Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Clostridium difficile colitis, 36 days after receiving 3rd doses of Bexsero vs Placebo, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device and Hiberix and 101 days after receiving the 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 7-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. More		✓
2832112	0.33	F		03/19/2025	HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Abdominal distension, Abdominal mass, Neuroblastoma, Pleural effusion, Tumour bi... Abdominal distension, Abdominal mass, Neuroblastoma, Pleural effusion, Tumour biopsy; Ultrasound abdomen abnormal, Vomiting; Abdominal distension, Abdominal mass, Neuroblastoma, Pleural effusion, Tumour biopsy; Ultrasound abdomen abnormal, Vomiting; Abdominal distension, Abdominal mass, Neuroblastoma, Pleural effusion, Tumour biopsy; Ultrasound abdomen abnormal, Vomiting; Abdominal distension, Abdominal mass, Neuroblastoma, Pleural effusion, Tumour biopsy; Ultrasound abdomen abnormal, Vomiting; Abdominal distension, Abdominal mass, Neuroblastoma, Pleural effusion, Tumour biopsy; Ultrasound abdomen abnormal, Vomiting More	Malignant Neuroblastoma; This 12-month-old female subject was enrolled in a blinded study. The subje... Malignant Neuroblastoma; This 12-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 26th June 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 19th August 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Prevnar 13 (Non-GSK Comparator) (Prevnar 13) for prophylaxis. On 18th February 2020, 183 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 237 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 neuroblastoma. Serious criteria included hospitalization and GSK medically significant. Bexsero vs Placebo was discontinued. DTPa-HBV-IPV was discontinued. Hiberix was discontinued. The outcome of neuroblastoma was not recovered/not resolved. The investigator considered that there was no reasonable possibility that the neuroblastoma may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. Relevant Tests: On 18Feb2020 Abdominal ultrasound: 12 x 13 x 5 x 9cm abdominal mass and small pleural effusion on right. Diagnostic results (unless otherwise stated, normal values were not provided): On 18th February 2020, Ultrasound abdomen result was see text. On 21st February 2020, Biopsy result was Neuroblastoma (Tumor biopsy). Investigator text 18FEB2020 Subject brought to Emergency Room for emesis x2 and abdominal distention. Exam revealed right upper quadrant mass. Chemotherapy to begin 27FEB2020. Spoke with mother 26FEB2020 Subject has discontinued the study and no further information can be obtained. Additional Details: Investigator reported SAE as Malignant Neuroblastoma. Subject withdrawn from study due to this event. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of neuroblastoma, 183 days after receiving 3rd doses of Bexsero vs Placebo, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe and Hiberix, and 237 days after receiving the 1st dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. More		✓
2832113	0.25	M		03/19/2025	HIBV MEN MMR PNC13 UNK UNK VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK	Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsill... Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsillectomy; Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsillectomy; Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsillectomy; Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsillectomy; Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsillectomy; Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsillectomy; Adenoidal hypertrophy, Adenoidectomy, Obstructive sleep apnoea syndrome, Tonsillectomy More	Adenoidal hypertrophy; Obstructive sleep apnea syndrome; This 14-month-old male subject was enrolled... Adenoidal hypertrophy; Obstructive sleep apnea syndrome; This 14-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, unknown deltoid) on 17-SEP-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 09-JAN-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 05-MAR-2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 17-SEP-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 05-MAR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 17-SEP-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 17-SEP-2019, for prophylaxis. The subject's past medical history included streptococcal pharyngitis and streptococcal pharyngitis. Concurrent medical conditions included snoring. On 30-NOV-2019, 74 days after receiving Bexsero vs Placebo, Prevnar 13, M-M-R II and Varivax, 325 days after receiving Rotarix lyophilized formulation and 270 days after receiving DTPa-HBV-IPV and Hiberix, the subject developed moderate - grade 2 adenoidal hypertrophy (Verbatim: Adenoidal hypertrophy). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 obstructive sleep apnea syndrome (Verbatim: Obstructive sleep apnea syndrome) on 04-AUG-2020 with serious criteria of hospitalization. The subject was treated with paracetamol (Tylenol). The outcome of adenoidal hypertrophy was resolved on 20-AUG-2020. The outcome(s) of the additional event(s) included obstructive sleep apnea syndrome (resolved on 20-AUG-2020). The investigator considered that there was no reasonable possibility that the adenoidal hypertrophy and obstructive sleep apnea syndrome may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Prevnar 13, Hiberix, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the adenoidal hypertrophy and obstructive sleep apnea syndrome may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Prevnar 13, Hiberix, M-M-R II and Varivax. GSK Receipt date: 05-AUG-2020 Mom stated the child had planned adenoidectomy and tonsillectomy on 04Aug2020. The child was admitted overnight due to age per the mom. No complications. The child was discharged on 05Aug2020 at 13:00. subject was prescribed Tylenol with codeine. The parent stated she had not administered Tylenol with codeine but she did administer a pediatric Tylenol chewable tablet. The surgery was not planned prior to enrollment. The procedure normally does not require in-patient hospitalization. However, subject was admitted due to age. Subsequently site reported as SAE. Follow-up information received on 07-DEC-2022 Summary of changes : Frequency for treatment medication (Tylenol Chewable) has been updated. Follow-up information received on 12-JUN-2023 Summary of changes : Device products and narrative updated. Follow-up information received on 30-DEC-2024 The subject received treatment drug General anesthesia on 4/Aug/2020 to 4/Aug/2020 Once only via intravenous for Adenotonsillar hypertrophy. Summary of changes: General anesthesia unit updated unknown, Narrative updated. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix, Rotarix lyophilized formulation, DTPa-HBV-IPV-HIB from World-MKT to World-INV. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Obstructive sleep apnoea syndrome and adenoidal hypertrophy, 322 days and 74 days respectively after receiving the 4th dose of Bexsero vs Placebo, the 4th dose of Prevnar 13, 1st dose of M-M-R II and 1st dose of Varivax, 518 days and 270 days respectively after receiving the 3rd dose of DTPa-HBV-IPV, the 3rd dose of Hiberix and 573 days and 325 days respectively after receiving 2nd dose of Rotarix lyophilized formulation, in a 14-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (adeno-tonsillar hypertrophy) for Obstructive sleep apnoea syndrome . More		✓
2832114	0.33	M		03/19/2025	HIBV HIBV MEN MEN MMR MMR PNC13 PNC13 UNK UNK UNK UNK VARCEL VARCEL	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC.	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive... Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care; Nausea, Skull fracture, Somnolence, Vomiting; Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care; Nausea, Skull fracture, Somnolence, Vomiting; Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care; Nausea, Skull fracture, Somnolence, Vomiting; Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care; Nausea, Skull fracture, Somnolence, Vomiting; Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care; Nausea, Skull fracture, Somnolence, Vomiting; Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care; Nausea, Skull fracture, Somnolence, Vomiting; Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care; Nausea, Skull fracture, Somnolence, Vomiting More	Skull Fracture; This 20-month-old male subject was enrolled in a blinded study. The subject received... Skull Fracture; This 20-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 29th May 2020, for prophylaxis. On 12th February 2021, 259 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed severe - grade 3 skull fracture. Serious criteria included hospitalization. The subject was treated with paracetamol (Acetaminophen) and midazolam (Versed (Midazolam)). The outcome of skull fracture was recovered/resolved on 18th March 2021. The investigator considered that there was no reasonable possibility that the skull fracture may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. Relevant Tests: On 13Feb2021 CT Head Result showed Calvarium left paracentral occipital acute fracture. Diagnostic results (unless otherwise stated, normal values were not provided): On 13th February 2021, Computerised tomogram head result was see text. Investigator Text On 12Feb2021 subject sustained an occipital skull fracture after falling backwards in his booster chair. The fall was witnessed by the mother. There was no loss of consciousness and he cried right away. He was not as playful and took 2 naps and vomited 4 times before his arrival to the emergency department on 12Feb2021 at 2103. CT head showed Calvarium left paracentral occipital acute fracture. 13Feb2021 at 0127 admitted to Hospital (transferred to pediatric intensive care unit from emergency department) for overnight observation. He was given 2 doses of Midazolam (Versed) via IV route and one dose of IV Acetaminophen. Diet was advanced from clears to regular in the morning and he did not have further episodes of emesis or unusual irritability. After demonstrating an ability to tolerate solid foods and with resolved nausea and vomiting, he was discharged home on 13Feb2021 at 1356 with follow up by pediatric neurosurgery in 2 to 4 weeks. 18Mar2021: Follow up phone consultation with peds neurosurgery reported full recovery. Follow up information received on 11-Mar-2025 End of study Unblinding completed. Upon internal review the case was updated on 18-Mar-2025. Study drugs updated.; Sender's Comments: A case of skull fracture, 259 days after receiving 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, in a 20-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (H/O falling backwards in his booster chair). More		✓
2832115	0.17	M		03/19/2025	HIBV MEN PNC13 UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK	Adenovirus infection, Bronchiolitis, Respiratory syncytial virus infection, Resp... Adenovirus infection, Bronchiolitis, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinovirus infection; Adenovirus infection, Bronchiolitis, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinovirus infection; Adenovirus infection, Bronchiolitis, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinovirus infection; Adenovirus infection, Bronchiolitis, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinovirus infection; Adenovirus infection, Bronchiolitis, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Rhinovirus infection More	Respiratory Syncytial virus; This 4-month-old male subject was enrolled in a blinded study. The subj... Respiratory Syncytial virus; This 4-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 10-AUG-2022, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, left thigh) on 10-AUG-2022, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 10-AUG-2022, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 10-AUG-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 25-OCT-2022, 76 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed severe - grade 3 respiratory syncytial virus infection (Verbatim: Respiratory Syncytial virus). Serious criteria included hospitalization. The subject was treated with ibuprofen (Motrin), paracetamol (Tylenol) and oxygen. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory syncytial virus infection was resolved on 01-NOV-2022. Diagnostic results (reference ranges are provided in parenthesis if available): Polymerase chain reaction- 28-OCT-2022 Positive RSV detected (0.00-0.00). The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK receipt date: 03-NOV-2022 Subject was diagnosed with adenovirus, bronchiolitis, and rhinovirus infection. Subject was primarily treated for RSV. s/s of adenovirus, bronchiolitis, and rhinovirus were the same as RSV, with same start and stop date. Adenovirus, bronchiolitis, and Rhinovirus were diagnosed on 26Oct2022 hospital admit date 28Oct2022 hospital discharge date 01Nov2022. Follow-up information received on 10-FEB-2023, 14-FEB-2023. The case was amended on 17FEB2023: The (Product tab) was amended from (Concomitant vaccine added). Summary of changes: Investigator text updated, Lab details updated, treatment medication updated, concomitant vaccines added Follow-up information received on 23-FEB-2023 Summary of changes: Investigator text updated Follow-up information received on 26-APR-2023 and 04-MAY-2023. Co-suspect products include dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. Summary of changes: Treatment medication Dose and unit updated. Follow-up information received on 15-JUN-2023. Summary of changes: General narrative comment updated. Follow-up information received on 03-JUL-2023 Summary of changes: Frequency of Treatment drugs (motrin, Tylenol) updated. Follow-up information received on 29-MAY-2024 Summary of changes: General narrative comments were updated. Follow-up information received on 30-DEC-2024 The subject received Treatment medication oxygen high flow(dosage regimen of 28-OCT-2022) and oxygen Nasal canula(dosage regimen of 28-OCT-2022 to 01-NOV-2022) Summary of changes: Treatment medication name updated from oxygen 15L Nasal canula to oxygen Nasal canula Follow-up information received on 07-JAN-2025 Summary of changes: Treatment medication name updated from oxygen 8L high flow to oxygen high flowalso narrative was updated. Upon internal review the case was updated on 08-JAN-2025, Action taken changes from not applicable to no change for DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevenar 13. Follow-up information received on 09-JAN-2025 Summary of changes: Action taken with study drug was updated from Not applicable to no change and narrative was updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number was updated from World-MKT to World-INV for DTPa-HBV-IPV. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Respiratory syncytial virus infection ,76 days after receiving 1st dose of Bexsero vs Placebo, 1st dose of Prevnar 13, 1st dose of Hiberix, 1st dose of DTPa-HBV-IPV, 1st dose of Rotarix lyophilized formulation in a 4-month-old male subject. Report is inconsistent with causal relation to the vaccine product ,considering implausible time to onset and alternative risk factors (Subject was diagnosed with adenovirus, bronchiolitis, and rhinovirus infection) based on medical history. More		✓
2832116	0.33	M		03/19/2025	HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Anaphylactic reaction, Condition aggravated, Eczema, Rash pruritic, Swelling fac... Anaphylactic reaction, Condition aggravated, Eczema, Rash pruritic, Swelling face; Urticaria; Anaphylactic reaction, Condition aggravated, Eczema, Rash pruritic, Swelling face; Urticaria; Anaphylactic reaction, Condition aggravated, Eczema, Rash pruritic, Swelling face; Urticaria; Anaphylactic reaction, Condition aggravated, Eczema, Rash pruritic, Swelling face; Urticaria; Anaphylactic reaction, Condition aggravated, Eczema, Rash pruritic, Swelling face; Urticaria More	anaphylaxis; This 7-month-old male subject was enrolled in a blinded study. The subject received the... anaphylaxis; This 7-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 28-FEB-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 28-FEB-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 28-FEB-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 10-JAN-2023, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. Concurrent medical conditions included peanut allergy. On 23-APR-2023, 54 days after receiving Bexsero vs Placebo, Hiberix and DTPa-HBV-IPV and 103 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 anaphylaxis (Verbatim: anaphylaxis). Serious criteria included hospitalization. The subject was treated with cetirizine hydrochloride (Zyrtec), acrivastine (Benadryl) and epinephrine (Epipen). The outcome of anaphylaxis was resolved on 24-APR-2023. The investigator considered that there was no reasonable possibility that the anaphylaxis may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the anaphylaxis may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. GSK Receipt Date: 25-APR-2023 Subject hospitalized due to anaphylaxic reaction to peanut butter. Medical records pending. The subject had no medical history at randomization. The discharge diagnosis for subject was "anaphylaxis". He was treated withepipen x 2, benadryl x 1, and zyrtec x 1. He has been diagnosed with eczema, which has been reported as an AE. He does take benadryl prn for itchy rash. He went to the ED on 23APR2023, admitted for observation and discharged on 24APR2023. His symptoms were hives and swelling of face, improved post 2nd EpiPen. Monitored overnight, without requiring any further epinephrine. Rash and swelling improving throughout admission. Meds given were epipen x2, one hour apart, 1st for respitory, 2nd for hives. Also received Benadryl x1, and Zyrtec x1. Has eczema which has been recorded. He takes hydrocortisone 2% ointment prn for eczema. He was prescribed Benadryl 2.5 ml prn for allergies. Follow-up information received on 23-MAY-2023. Summary of changes: Narrative updated. Follow-up information received on 06-JUN-2023. Summary of changes: Event outcome and narrative updated. Follow-up information received on 15-JUN-2023. Summary of changes: Narrative updated, SAE peanut allergy added Follow-up information received on 29-JUN-2023 and 04-jul-2023. Summary of changes: Event term updated from anaphylaxis from peanut butter to anaphylaxis, additional event peanut allergy deleted, treatment drugs added Follow up information received on 13-JAN-2025 and 16-JAN-2025 Medication name was reported as Epipen (NOS) Summary of changes: Medication name was updated from Epinephrine to Epipen (NOS) Upon internal review case was updated on 20-JAN-2025 Suspect vaccine coding was updated from DTPa-HBV-IPV to Pediarix. Medication Benadryl was coded with generic name acrivastine Follow-up information received on 06-Feb-2025. Summary of changes: Medical condition peanut allergy added. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Anaphylactic reaction, 54 days after receiving 3rd dose of Bexsero, DTPa-HBV-IPV, Prevenar 13 and Hiberix and 103 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 7-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (anaphylaxic reaction to peanut butter). More		✓
2832117	0.33	M		03/19/2025	HIBV HIBV MEN MEN PNC13 PNC13 UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Cellulitis, Erythema, Exposure to communicable disease, Herpes simplex test nega... Cellulitis, Erythema, Exposure to communicable disease, Herpes simplex test negative, Lymphocyte count increased; Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased, Staphylococcus test positive; Cellulitis, Erythema, Exposure to communicable disease, Herpes simplex test negative, Lymphocyte count increased; Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased, Staphylococcus test positive; Cellulitis, Erythema, Exposure to communicable disease, Herpes simplex test negative, Lymphocyte count increased; Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased, Staphylococcus test positive; Cellulitis, Erythema, Exposure to communicable disease, Herpes simplex test negative, Lymphocyte count increased; Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased, Staphylococcus test positive; Cellulitis, Erythema, Exposure to communicable disease, Herpes simplex test negative, Lymphocyte count increased; Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased, Staphylococcus test positive More	Left Finger Cellulitis; This 11-month-old male subject was enrolled in a blinded study. The subject ... Left Finger Cellulitis; This 11-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 16-MAR-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 16-MAR-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 22-DEC-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 16-MAR-2023, for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis. On 22-JUL-2023, 128 days after receiving Bexsero vs Placebo, Hiberix and DTPa-HBV-IPV and 212 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 cellulitis of finger (Verbatim: Left Finger Cellulitis). Serious criteria included hospitalization. The subject was treated with clindamycin, lidocaine;prilocaine (Emla), vancomycin hydrochloride (Vancocin), ceftriaxone sodium (Rocephin), cefalexin (Keflex), ibuprofen (Motrin) and paracetamol (Tylenol). Bexsero vs Placebo was continued with no change. The outcome of cellulitis of finger was resolved on 04-AUG-2023. Relevant Tests: On 25JUL2023, Methicillin-Resistant Staphylococcus Test Data showed Positive (heavy growth Methicillin-Resistant Staphylococcus Aureus (Normal Range: Negative, No Growth). On 24JUL2023, Erythrocyte Sedimentation rate-Test done showed 31 (normal range 0-15). On 24JUL2023, Lymphocytes-Test done showed 94 (normal range 20-70).. The investigator considered that there was no reasonable possibility that the cellulitis of finger may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV. The company considered that there was no reasonable possibility that the cellulitis of finger may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV. GSK receipt date: 15-SEP-2023 Admit to hospital 25JUL2023 at 0014. Discharge from hospital 26JUL2023 at 0958. 11 Month old mail, born at term with no ongoing medical concerns, presenting with increasing erythema and swelling of his left third finger. A small area of erythema was first noticed on 22JUL2023, also had fever up to 104.0F (axillary), (fever noted 22JUL2023 to 23JUL2023). Pediatrician started Cephalexin and swabbed for Herpes Simplex Virus (which was negative). The erythema and swelling continued to spread so child was admitted to hospital for antibiotics and monitoring of left finger cellulitis. There was household contact with active/recent MRSA (Methicillin-Resistant Staphylococcus Aureus) infection. Child discharged home on oral antibiotics. Follow up information received on 15-NOV-2024 Summary of changes: The frequency of treatment medication Cleocin (Clindamycin) was updated from blank to tid, Narrative updated Upon internal review on 26-NOV-2024 The Study Center ID was added./ Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Cellulitis,128 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of Hiberix and 3rd dose of DTPa-HBV-IPV and 212 days after receiving 2nd dose of Rotarix lyophilized formulation, in 11-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (household contact with active/recent MRSA infection). More		✓
2832118	0.25	M		03/19/2025	HIBV HIBV HIBV PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	Chest X-ray abnormal, Cough, Dyspnoea, Hypoxia, Influenza virus test negative; P... Chest X-ray abnormal, Cough, Dyspnoea, Hypoxia, Influenza virus test negative; Pain, Pyrexia, Respiratory symptom, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive; SARS-CoV-2 test negative; Chest X-ray abnormal, Cough, Dyspnoea, Hypoxia, Influenza virus test negative; Pain, Pyrexia, Respiratory symptom, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive; SARS-CoV-2 test negative; Chest X-ray abnormal, Cough, Dyspnoea, Hypoxia, Influenza virus test negative; Pain, Pyrexia, Respiratory symptom, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive; SARS-CoV-2 test negative; Chest X-ray abnormal, Cough, Dyspnoea, Hypoxia, Influenza virus test negative; Pain, Pyrexia, Respiratory symptom, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive; SARS-CoV-2 test negative; Chest X-ray abnormal, Cough, Dyspnoea, Hypoxia, Influenza virus test negative; Pain, Pyrexia, Respiratory symptom, Respiratory syncytial virus bronchiolitis, Respiratory syncytial virus test positive; SARS-CoV-2 test negative More	RSV Bronchiolitis; This 10-month-old male subject was enrolled in a blinded study. The subject recei... RSV Bronchiolitis; This 10-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 25-JUL-2023, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 25-JUL-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 25-JUL-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 25-JUL-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 19-MAY-2023, for prophylaxis. Concomitant products included paracetamol (Tylenol) and ibuprofen (Motrin). On 16-DEC-2023 11:44, 144 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV and Hiberix and 211 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 respiratory syncytial virus bronchiolitis (Verbatim: RSV Bronchiolitis). Serious criteria included hospitalization. The subject was treated with dexamethasone (Decadron) and salbutamol (Albuterol). Bexsero vs Placebo was continued with no change. The outcome of respiratory syncytial virus bronchiolitis was resolved on 21-DEC-2023. Diagnostic results (reference ranges are provided in parenthesis if available): Influenza virus test- 10-DEC-2023 negative. Oxygen saturation- 18-DEC-2023 88 %, (95.00-100.00). Respiratory syncytial virus test- 18-DEC-2023 positive. SARS-CoV-2 test- 10-DEC-2023 negative. X-ray- 18-DEC-2023 shows changes consistent with a bronchiolitis. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. GSK Receipt Date: 20-MAR-2024 Subject came into clinic after hours with symptoms of URI (Upper respiratory infection) and fever for 1-2 days on 12/18/2023. Mom was worried because cough was getting worse and difficulty breathing. Clinic gave a nebulizer treatment stats mostly 90-91 percent even after treatments. A Decadron shot was also given in clinic with but did not seem to help. Stats were mid 80 percent and was sent to the ER. The ER checked O2 (oxygen) and it was low 90's with an increased work of breathing. ER (Emergency Room) admitted to the peds floor of the hospital for observation and from there was admitted an albuterol treatment was given on 12/18 and 12/19 with no change in stats. Subject was then put on oxygen via nasal cannula on 12/19/23 child was given acetaminophen and ibuprofen on 12/19/23 to help with fever and pain. on 12/21/23 subject was discharged from hospital where oxygen levels were in the upper 90's with no trouble breathing and symptoms getting better. Follow up information received on 03-APR-2024 Summary of changes: Concomitant, treatment, action taken and lab data were updated. Follow up information received on : 01-JUL-2024 The investigator confirmed that Hypoxemia was deleted due to it being a symptom of RSV Summary of change : Event Hypoxemia was deleted , Lab data and narrative updated. Follow up information received on 16-DEC-2024 Summary of changes: oxygen saturation lab data unit and range was updated. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Respiratory syncytial virus bronchiolitis, 144 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV, 3rd dose of Hiberix and 211 days after receiving the 2nd dose of Rotarix lyophilized formulation in a 10-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility, alternative etiology (Respiratory syncytial virus) and alternate risk factor (Age) based on medical history. More		✓
2832119		F	NC	03/19/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS		Gastrointestinal disorder, Lethargy, Malaise Gastrointestinal disorder, Lethargy, Malaise	out and sick for like a month; tummy issues; lethargy; This non-serious case was reported by a nurse... out and sick for like a month; tummy issues; lethargy; This non-serious case was reported by a nurse via call center representative and described the occurrence of lethargy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Previously administered products included Covid vaccine (after the second dose). Concurrent medical conditions included autoimmune disorder, ehlers-danlos syndrome, lyme disease, drug allergy (gelatin) and meat allergy. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced lethargy (Verbatim: lethargy), sickness (Verbatim: out and sick for like a month) and abdominal disorder (Verbatim: tummy issues). The outcome of the lethargy was resolved (duration 3 weeks) and the outcome of the sickness and abdominal disorder were unknown. It was unknown if the reporter considered the lethargy, sickness and abdominal disorder to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the lethargy, sickness and abdominal disorder to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAR-2025 The retired nurse stated her spouse has a gelatin allergy and last year was given a dose of Tdap vaccine instead of just tetanus and had a bad reaction. This occurred last year, and she was out, and sick for like a month. The brand of Tdap administered was unknown. The patient had immediately had to hit the inhaler way more than she should have, which lasted for two days, use of Benadryl constantly and lethargy for three weeks after, as well as tummy issues, which she declined to provide further details about. The patient had a history of reaction to the Covid vaccine after the second dose, and her provider told her she should not get any booster doses. The patient had a history of untreated Lyme disease, which originated approximately 30 years ago, and resulted in gelatin, meat, and alpha gal allergies as well as EDS (clarified as Ehlers-danlos syndrome) and autoimmune issues. Brand of Tdap was unknown to nurse. It was difficult to keep the nurse on-topic, and specialist was unable to get permission for safety follow up. No further details were provided. More
2832120	72	F		03/19/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	579F4	Expired product administered Expired product administered	patient received an expired dose of Arexvy; This non-serious case was reported by a pharmacist via c... patient received an expired dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 579F4, expiry date 23-JAN-2025) for prophylaxis. On 10-MAR-2025, the patient received Arexvy. On 10-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Arexvy). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 10-MAR-2025 Pharmacist reported a patient received an expired dose of AREXVY on 10th March 2025, which led to Expired vaccine used. More
2832121	11	F	MT	03/19/2025	HPV9 MNQ TDAP	MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS	Y007991 X7R4Z X449Y	Injection site erythema, Injection site induration, Injection site swelling; Inj... Injection site erythema, Injection site induration, Injection site swelling; Injection site erythema, Injection site induration, Injection site swelling; Injection site erythema, Injection site induration, Injection site swelling More	hard red swelling on right upper arm. hard red swelling on right upper arm.
2832122	27	M	IL	03/19/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	EN6200 EN6200 EN6200 EN6200 EN6200 EN6200 EN6200 EN6200	Angina pectoris, Arrhythmia, Atelectasis, Atrial fibrillation, Blood test abnorm... Angina pectoris, Arrhythmia, Atelectasis, Atrial fibrillation, Blood test abnormal; Cardiac arrest, Cardiac failure congestive, Cardiac stress test abnormal, Cardiomegaly, Chest X-ray abnormal; Chest discomfort, Chest pain, Chronic left ventricular failure, Death, Dilated cardiomyopathy; Dyspnoea, Electrocardiogram abnormal, Genetic testing, Haematemesis, Headache; Hepatomegaly, Hypoaesthesia, Myocardial oedema, Nausea, Night sweats; Orthopnoea, Oxygen saturation decreased, Palpitations, Peripheral swelling, Pulmonary infarction; Respiratory distress, Sepsis, Sinus tachycardia, Systemic lupus erythematosus, Tachypnoea; Thrombosis, Vision blurred, Vitamin D decreased, Vomiting; Angina pectoris, Arrhythmia, Atelectasis, Atrial fibrillation, Blood test abnormal; Cardiac arrest, Cardiac failure congestive, Cardiac stress test abnormal, Cardiomegaly, Chest X-ray abnormal; Chest discomfort, Chest pain, Chronic left ventricular failure, Death, Dilated cardiomyopathy; Dyspnoea, Electrocardiogram abnormal, Genetic testing, Haematemesis, Headache; Hepatomegaly, Hypoaesthesia, Myocardial oedema, Nausea, Night sweats; Orthopnoea, Oxygen saturation decreased, Palpitations, Peripheral swelling, Pulmonary infarction; Respiratory distress, Sepsis, Sinus tachycardia, Systemic lupus erythematosus, Tachypnoea; Thrombosis, Vision blurred, Vitamin D decreased, Vomiting More	Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe... Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body More	✓	✓	✓
2832123	14	M	ID	03/19/2025	HPV9 IPV MMRV	MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC.	Y006773	No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More	Inappropriate age vaccine (subQ) given into Deltoid muscle on 3/12/2025 at 15:00. MD notified and MD... Inappropriate age vaccine (subQ) given into Deltoid muscle on 3/12/2025 at 15:00. MD notified and MD notified patients mother. No current symptoms. More
2832162		F	OH	03/19/2025	VARCEL	MERCK & CO. INC.	X007373	Expired product administered, No adverse event Expired product administered, No adverse event	No additional adverse event; HCP called to report a patient received an expired dose of VARIVAX. The... No additional adverse event; HCP called to report a patient received an expired dose of VARIVAX. The expiration date was 03/12/2025 and the product was administered 03/14/2025. No side effects or symptoms reported. Caller verified no temperature excursions occurred. No Additiona; This spontaneous report was received from a registered nurse and refers to a 15-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-MAR-2025, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka-Merck) (VARIVAX) injection, 0.5 ml, lot #X007373, expiration date: 12-MAR-2025 (dose number, route of administration and anatomical location were not provided), for prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (route of administration, anatomical location, lot# and expiration date were not reported). No side effects or symptoms reported. The reporter verified no temperature excursions occurred and requested to review stability information. No additional adverse event was reported (No adverse event). More
2832163		M	OK	03/19/2025	HPV9	MERCK & CO. INC.	Y014510	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	No additional AE; 65 year-old male received Gardasil 9 in the left arm; This spontaneous report was ... No additional AE; 65 year-old male received Gardasil 9 in the left arm; This spontaneous report was received from a nurse and refers to a 65-year-old male patient. The patient's medical history, current conditions, and concomitant medications were not provided. On 25-FEB-2025, the patient was vaccinated with a single dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection (lot #Y014510 who had been verified to be a valid lot number, expiration date was not provided but upon internal validation assessed as 01-NOV-2026) administered in left arm as prophylaxis (exact dose was not provided) (product administered to patient of inappropriate age). No additional adverse event. More
2832165		F		03/19/2025	COVID19 VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Death, Herpes zoster; Death, Herpes zoster Death, Herpes zoster; Death, Herpes zoster	patient died; got the shingles; This serious case was reported by a consumer via interactive digital... patient died; got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. On an unknown date, the patient received Shingles vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced death (Verbatim: patient died) (serious criteria death and GSK medically significant) and shingles (Verbatim: got the shingles). The outcome of the shingles was not reported. The reported cause of death was unknown. It was unknown if the reporter considered the death and shingles to be related to Shingles vaccine. The company considered the death to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her mother-in-law at age got the singles vaccination, then immediately got the shingles. Then a month or two after getting shingles she took the covid vaccination. The reporter begged her not to. She said if anything happens to her, she lived a great life. She took the jab and died a month later. It was unknown if the reporter considered the death and shingles to be related to COVID-19 vaccine.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Unknown cause of death More	✓
2832166		F		03/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Death Death	My mom died a week after the shingle vaccine; This serious case was reported by a consumer via inter... My mom died a week after the shingle vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included dementia. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: My mom died a week after the shingle vaccine) (serious criteria death and GSK medically significant). The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The company considered the unknown cause of death to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient's child via interactive digital media. The patient (mom) passed (died) away one week after that Shingles vaccine. She had dementia but otherwise was very healthy on a couple of medications; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Unknown cause of death More	✓
2832167				03/19/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Arthralgia, Incomplete course of vaccination; Arthralgia, Incomplete course of v... Arthralgia, Incomplete course of vaccination; Arthralgia, Incomplete course of vaccination More	knuckles hurting; Incomplete course of vaccination; This non-serious case was reported by a consumer... knuckles hurting; Incomplete course of vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in joint involving hand in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In OCT-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in joint involving hand (Verbatim: knuckles hurting) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the pain in joint involving hand was not resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the pain in joint involving hand to be related to Shingrix. It was unknown if the company considered the pain in joint involving hand to be related to Shingrix. Additional Information: GSK receipt date: 09-MAR-2025 Patient stated that they wanted to know why his knuckles are still hurting after getting only 1 shingles shot which was they believed in October 2023, which was 1 year and 7 months ago. No more questions other than knuckles hurting. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. More
2832168		F		03/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	got the 50 yr old single Shingles shot years ago.; This non-serious case was reported by a consumer ... got the 50 yr old single Shingles shot years ago.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got the 50 yr old single Shingles shot years ago. ). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that this was exactly why afraid to get the shots. The warnings on the commercials scare of that. The patient got the 50 years old single Shingles shot years ago. Apparently that the patient had witness her boyfriend and father go through this. She thought she only had measles when was younger and after her boyfriend got shingles, had a blood test to confirm indeed had chicken pox. As much as did not ever wish to experience shingles, the shot(s) side affects scare me and said sorry that had such a horrible experience. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2832169		F		03/19/2025	RVX	UNKNOWN MANUFACTURER	UNK	Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure	Suspected vaccination failure; still goi it; This serious case was reported by a consumer via intera... Suspected vaccination failure; still goi it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: still goi it). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 12-MAR-2025 and 14-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that she had a shot and still got it. This case was considered as suspected vaccination failure as details regarding time to onset for Respiratory syncytial virus infection and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine. More
2832170				03/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Pruritus, Vaccination failure Herpes zoster, Pruritus, Vaccination failure	Suspeceted vaccination failure; I had the vaccine and still got shingles a milder case however/terri... Suspeceted vaccination failure; I had the vaccine and still got shingles a milder case however/terrible itching/skin looks terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine and still got shingles a milder case however/terrible itching/skin looks terrible). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 12-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles it was milder case, however he/she was recovering from shingles but just terrible itching and his/her skin looks terrible. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2832171				03/19/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspected vaccination failure; had the shingles twice; This serious case was reported by a consumer ... Suspected vaccination failure; had the shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the shingles twice). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media The patient had the shingles twice, but had taken all the shots. The reporter said stop sending these ads. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). More
2832172				03/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Nerve injury, Pain, Vaccination failure Herpes zoster, Nerve injury, Pain, Vaccination failure	Suspected vaccination failure; shingles; nerve damage; This serious case was reported by a consumer ... Suspected vaccination failure; shingles; nerve damage; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and nerve damage (Verbatim: nerve damage). The outcome of the vaccination failure, shingles and nerve damage were not reported. It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and nerve damage to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media. Patient had the shingles vaccine but ended up getting shingles. It was the worst pain ever, and it caused nerve damage. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2832173				03/19/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 18 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The patient got shingles 18 months after receiving the second shot. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(Dose 1 & 2).. More
2832174				03/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; had shingles again; This serious case was reported by a consumer via ... Suspected vaccination failure; had shingles again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles again). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had shingles, got the Shingles shot, and have had shingles again which was not fair. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2832175				03/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster Herpes zoster	I got them; This non-serious case was reported by a consumer via interactive digital media and descr... I got them; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got them). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that he/she got them after first vaccine was deemed ineffective, and they asked if he/she got them from the new vaccine or without. More
2832176		M		03/19/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administ... Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure More	Suspected vaccination failure; Then came down with shingles that lasted a year; Then he was given a ... Suspected vaccination failure; Then came down with shingles that lasted a year; Then he was given a double dose; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Then came down with shingles that lasted a year) and extra dose administered (Verbatim: Then he was given a double dose). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 13-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her brother-in-lawgot the shingles shot. Then came down with shingles that lasted a year and then he was given a double dose, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2). More
2832177				03/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected Vaccination failure; had the vaccine and still got shingles; This serious case was reporte... Suspected Vaccination failure; had the vaccine and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media The patient had the Shingles vaccine and still got shingles This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More

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