🏥 VAERS Vaccine Data Browser

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About This Site

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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Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
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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)
State: Enter 2-letter state code (e.g., CA, NY, TX)
Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
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:

🔄 Reset 📥 Export CSV

Showing 25,751 to 25,800 of 34,052 reports (Page 516 of 682)

« First ‹ Prev 1 ... 513 514 515 516 517 518 519 ... 682 Next › Last »

ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	♿
2831856	0.17	M		03/18/2025	HIBV HIBV HIBV HIBV PNC13 PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK	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 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	Atelectasis, Blood potassium normal, Body temperature increased, COVID-19, Capil... Atelectasis, Blood potassium normal, Body temperature increased, COVID-19, Capillary nail refill test abnormal; Chest X-ray abnormal, Dyspnoea, Grunting, Hypophagia, Livedo reticularis; Oxygen saturation decreased, Pneumonia, Posture abnormal, Respiratory failure, Respiratory syncytial virus infection; Respiratory syncytial virus test positive, Rhonchi, SARS-CoV-2 test positive, Tracheal disorder, Urine output decreased; Atelectasis, Blood potassium normal, Body temperature increased, COVID-19, Capillary nail refill test abnormal; Chest X-ray abnormal, Dyspnoea, Grunting, Hypophagia, Livedo reticularis; Oxygen saturation decreased, Pneumonia, Posture abnormal, Respiratory failure, Respiratory syncytial virus infection; Respiratory syncytial virus test positive, Rhonchi, SARS-CoV-2 test positive, Tracheal disorder, Urine output decreased; Atelectasis, Blood potassium normal, Body temperature increased, COVID-19, Capillary nail refill test abnormal; Chest X-ray abnormal, Dyspnoea, Grunting, Hypophagia, Livedo reticularis; Oxygen saturation decreased, Pneumonia, Posture abnormal, Respiratory failure, Respiratory syncytial virus infection; Respiratory syncytial virus test positive, Rhonchi, SARS-CoV-2 test positive, Tracheal disorder, Urine output decreased; Atelectasis, Blood potassium normal, Body temperature increased, COVID-19, Capillary nail refill test abnormal; Chest X-ray abnormal, Dyspnoea, Grunting, Hypophagia, Livedo reticularis; Oxygen saturation decreased, Pneumonia, Posture abnormal, Respiratory failure, Respiratory syncytial virus infection; Respiratory syncytial virus test positive, Rhonchi, SARS-CoV-2 test positive, Tracheal disorder, Urine output decreased; Atelectasis, Blood potassium normal, Body temperature increased, COVID-19, Capillary nail refill test abnormal; Chest X-ray abnormal, Dyspnoea, Grunting, Hypophagia, Livedo reticularis; Oxygen saturation decreased, Pneumonia, Posture abnormal, Respiratory failure, Respiratory syncytial virus infection; Respiratory syncytial virus test positive, Rhonchi, SARS-CoV-2 test positive, Tracheal disorder, Urine output decreased More	Respiratory failure with hypoxia; This 3-month-old male subject was enrolled in a blinded study. The... Respiratory failure with hypoxia; This 3-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-AUG-2022, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 01-AUG-2022, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 01-AUG-2022, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, left thigh) on 01-AUG-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 03-SEP-2022, 33 days after receiving Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV, the subject developed severe - grade 3 hypoxic respiratory failure (Verbatim: Respiratory failure with hypoxia). Serious criteria included hospitalization. The subject was treated with ampicillin;sulbactam, paracetamol (Tylenol), ibuprofen (Motrin), salbutamol (Proventil), oxygen, remdesivir and dexamethasone. The action taken with Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV was no change. The outcome of hypoxic respiratory failure was resolved on 09-SEP-2022. Relevant Tests: On 03Sep2022 Subject seen at PCP (primary care physician) and was diagnosed with COVID 19 and RSV (Respiratory Syncytial Virus). Subject treated with antibiotics and oxygen. On an unknown date in Sep-2022 chest x-ray showed right upper lobe atelectasis versus pneumonia. The ED (emergency department) attendings felt more likely atelectasis so did not start antibiotics.. Diagnostic results (reference ranges are provided in parenthesis if available): Body temperature-In SEP-2022 103. The investigator considered that there was no reasonable possibility that the hypoxic respiratory failure 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 hypoxic respiratory failure may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV. GSK receipt date: 06-SEP-2022 Subject seen at PCP (primary care physician) on 03Sep2022 and was diagnosed with COVID 19 and RSV (Respiratory syncytial virus). Subject's condition declined at home and he was admitted to the hospital on 05Sep2022. He was currently receiving IV (intravenous) antibiotics and oxygen and was still currently hospitalized. Would update when more information was received. On day of admission he developed increased WOB (work of breathing) with tracheal tugging, head bobbing and grunting at home. He had decreased PO intake and decreased UOP (urine output). In ER (emergency room) temp was 103. He had suprasternal retractions and diffuse rhonchi. Cap refill was delayed and his feet appeared mottled. He was suctioned and placed on HFNC (high flow nasal canula) 9L (1.5 L/kg). His Fi)2 required some adjustment due to desats in the ED (emergency department) to the mid 80s and he was captured at 55 percent. He got a NS (normal saline) bolus. ED (emergency department) attendings felt more likely atelectasis so did not start abx (antibiotics). Subject was discharged from the hospital on 09Sep2022 The subject received Dextrose 5 percent and 0.9 percent NaCl with KCl 20 meq from 06-Sep-2022 to 06-Sep-2022 at a dose of 25ml single via intravenous route for the treatment of potassium levels normal. Follow-up information received on 14-SEP-2022. This follow-up was considered significant. Summary of changes: Event date, Outcome of the event and Covid-19 details updated. Follow-up information received on 15-NOV-2022. Summary of changes : Covid-19 details updated, Treatment medication added. Follow-up information received on 07-DEC-2022. Summary of changes : End date for Remdesivir updated Follow-up information received on 13-DEC-2022, 19-DEC-2022. Summary of changes : Lab details updated Follow-up information received on 20-DEC-2022 Summary of changes :Treatment medication updated Follow-up information received on 30-DEC-2022 Summary of change:Investigator text ,Hospitalization stop date updated, AESI statement was removed. Follow-up information received on 20-Feb-2023 Summary of Changes: Treatment drug added. Follow-up information received on 22-Apr-2023 and 27-Apr-2023. Summary of changes: Narrative updated, covid-19 event removed. Follow-up information received on 20-MAY-2023. Summary of changes: Suspect vaccine details and treatment drugs were added. Follow-up information received on 30-MAY-2023. Summary of changes: Event start date updated. Follow-up information received on 08-JUN-2023. Summary of changes: Narrative was updated. Follow-up information received on 28-JUN-2023. Summary of changes: treatment medication updated Upon internal review the case was updated on 07-Feb-2025. Authorization number was updated from World-MKT to World-INV for Hiberix and Rotarix lyophilized formulation. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Dextrose 5 percent and 0.9 percent NaCl with KCl 20 meq details updated in narrative and removed from product tab. Follow-up information received on 11-FEB-2025 Summary of changes: Lab test updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Respiratory failure, 33 days after receiving 1st dose of Bexsero vs Placebo, 1st dose of Rotarix lyophilized formulation, 1st dose of Hiberix , 1st dose of Prevnar 13, 1st dose of DTPa-HBV-IPV, in a 3-months-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 (SARS-CoV-2 test and RSV test positive) More		✓
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Agitation, Asthenia, Bacterial test positive, Balance disorder, Blood calcium increased; Blood glucose normal, Blood potassium decreased, Blood pressure decreased, Cerebral amyloid angiopathy, Cerebral small vessel ischaemic disease; Chest X-ray normal, Cognitive disorder, Creatinine urine abnormal, Culture urine negative, Death; Decreased activity, Decreased appetite, Diarrhoea, Dysarthria, Dysstasia; Emotional distress, Failure to thrive, Fatigue, Gait disturbance, Hydronephrosis; Hyporesponsive to stimuli, Lethargy, Lip dry, Magnetic resonance imaging head abnormal, Malaise; Mobility decreased, Posture abnormal, Protein urine present, Pyuria, Red blood cells urine positive; Renal impairment, Somnolence, Tongue dry, Toxic encephalopathy, Ultrasound kidney normal; Ureteral disorder, Urinary incontinence, Urine abnormality, Urine analysis abnormal, Walking aid user; White blood cells urine positive; Agitation, Asthenia, Blood potassium, Blood potassium decreased, Death; Decreased appetite, Diarrhoea, Fatigue, Hypersomnia, Urinary incontinence; Agitation, Anion gap, Asthenia, Balance disorder, Blood calcium; Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood glucose; Blood glucose increased, Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased; Blood urea, Blood urea abnormal, Cerebral amyloid angiopathy, Computerised tomogram, Condition aggravated; Decreased appetite, Dehydration, Diarrhoea, Dysphagia, Dysstasia; Encephalopathy, Fatigue, Gait disturbance, Glomerular filtration rate, Glomerular filtration rate decreased; Hydroureter, Hypercalcaemia, Hypersomnia, Hypokalaemia, Lethargy; Magnetic resonance imaging, Metabolic encephalopathy, Mucosal dryness, Protein urine present, Pyuria; Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality; Urine analysis, Urine analysis abnormal, White blood cells urine positive; Agitation, Asthenia, Bacterial test positive, Balance disorder, Blood calcium increased; Blood glucose normal, Blood potassium decreased, Blood pressure decreased, Cerebral amyloid angiopathy, Cerebral small vessel ischaemic disease; Chest X-ray normal, Cognitive disorder, Creatinine urine abnormal, Culture urine negative, Death; Decreased activity, Decreased appetite, Diarrhoea, Dysarthria, Dysstasia; Emotional distress, Failure to thrive, Fatigue, Gait disturbance, Hydronephrosis; Hyporesponsive to stimuli, Lethargy, Lip dry, Magnetic resonance imaging head abnormal, Malaise; Mobility decreased, Posture abnormal, Protein urine present, Pyuria, Red blood cells urine positive; Renal impairment, Somnolence, Tongue dry, Toxic encephalopathy, Ultrasound kidney normal; Ureteral disorder, Urinary incontinence, Urine abnormality, Urine analysis abnormal, Walking aid user; White blood cells urine positive; Agitation, Asthenia, Blood potassium, Blood potassium decreased, Death; Decreased appetite, Diarrhoea, Fatigue, Hypersomnia, Urinary incontinence; Agitation, Anion gap, Asthenia, Balance disorder, Blood calcium; Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood glucose; Blood glucose increased, Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased; Blood urea, Blood urea abnormal, Cerebral amyloid angiopathy, Computerised tomogram, Condition aggravated; Decreased appetite, Dehydration, Diarrhoea, Dysphagia, Dysstasia; Encephalopathy, Fatigue, Gait disturbance, Glomerular filtration rate, Glomerular filtration rate decreased; Hydroureter, Hypercalcaemia, Hypersomnia, Hypokalaemia, Lethargy; Magnetic resonance imaging, Metabolic encephalopathy, Mucosal dryness, Protein urine present, Pyuria; Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality; Urine analysis, Urine analysis abnormal, White blood cells urine positive; Agitation, Asthenia, Bacterial test positive, Balance disorder, Blood calcium increased; Blood glucose normal, Blood potassium decreased, Blood pressure decreased, Cerebral amyloid angiopathy, Cerebral small vessel ischaemic disease; Chest X-ray normal, Cognitive disorder, Creatinine urine abnormal, Culture urine negative, Death; Decreased activity, Decreased appetite, Diarrhoea, Dysarthria, Dysstasia; Emotional distress, Failure to thrive, Fatigue, Gait disturbance, Hydronephrosis; Hyporesponsive to stimuli, Lethargy, Lip dry, Magnetic resonance imaging head abnormal, Malaise; Mobility decreased, Posture abnormal, Protein urine present, Pyuria, Red blood cells urine positive; Renal impairment, Somnolence, Tongue dry, Toxic encephalopathy, Ultrasound kidney normal; Ureteral disorder, Urinary incontinence, Urine abnormality, Urine analysis abnormal, Walking aid user; White blood cells urine positive; Agitation, Asthenia, Blood potassium, Blood potassium decreased, Death; Decreased appetite, Diarrhoea, Fatigue, Hypersomnia, Urinary incontinence; Agitation, Anion gap, Asthenia, Balance disorder, Blood calcium; Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood glucose; Blood glucose increased, Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased; Blood urea, Blood urea abnormal, Cerebral amyloid angiopathy, Computerised tomogram, Condition aggravated; Decreased appetite, Dehydration, Diarrhoea, Dysphagia, Dysstasia; Encephalopathy, Fatigue, Gait disturbance, Glomerular filtration rate, Glomerular filtration rate decreased; Hydroureter, Hypercalcaemia, Hypersomnia, Hypokalaemia, Lethargy; Magnetic resonance imaging, Metabolic encephalopathy, Mucosal dryness, Protein urine present, Pyuria; Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality; Urine analysis, Urine analysis abnormal, White blood cells urine positive; Agitation, Asthenia, Bacterial test positive, Balance disorder, Blood calcium increased; Blood glucose normal, Blood potassium decreased, Blood pressure decreased, Cerebral amyloid angiopathy, Cerebral small vessel ischaemic disease; Chest X-ray normal, Cognitive disorder, Creatinine urine abnormal, Culture urine negative, Death; Decreased activity, Decreased appetite, Diarrhoea, Dysarthria, Dysstasia; Emotional distress, Failure to thrive, Fatigue, Gait disturbance, Hydronephrosis; Hyporesponsive to stimuli, Lethargy, Lip dry, Magnetic resonance imaging head abnormal, Malaise; Mobility decreased, Posture abnormal, Protein urine present, Pyuria, Red blood cells urine positive; Renal impairment, Somnolence, Tongue dry, Toxic encephalopathy, Ultrasound kidney normal; Ureteral disorder, Urinary incontinence, Urine abnormality, Urine analysis abnormal, Walking aid user; White blood cells urine positive; Agitation, Asthenia, Blood potassium, Blood potassium decreased, Death; Decreased appetite, Diarrhoea, Fatigue, Hypersomnia, Urinary incontinence; Agitation, Anion gap, Asthenia, Balance disorder, Blood calcium; Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood glucose; Blood glucose increased, Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased; Blood urea, Blood urea abnormal, Cerebral amyloid angiopathy, Computerised tomogram, Condition aggravated; Decreased appetite, Dehydration, Diarrhoea, Dysphagia, Dysstasia; Encephalopathy, Fatigue, Gait disturbance, Glomerular filtration rate, Glomerular filtration rate decreased; Hydroureter, Hypercalcaemia, Hypersomnia, Hypokalaemia, Lethargy; Magnetic resonance imaging, Metabolic encephalopathy, Mucosal dryness, Protein urine present, Pyuria; Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality; Urine analysis, Urine analysis abnormal, White blood cells urine positive; Agitation, Asthenia, Bacterial test positive, Balance disorder, Blood calcium increased; Blood glucose normal, Blood potassium decreased, Blood pressure decreased, Cerebral amyloid angiopathy, Cerebral small vessel ischaemic disease; Chest X-ray normal, Cognitive disorder, Creatinine urine abnormal, Culture urine negative, Death; Decreased activity, Decreased appetite, Diarrhoea, Dysarthria, Dysstasia; Emotional distress, Failure to thrive, Fatigue, Gait disturbance, Hydronephrosis; Hyporesponsive to stimuli, Lethargy, Lip dry, Magnetic resonance imaging head abnormal, Malaise; Mobility decreased, Posture abnormal, Protein urine present, Pyuria, Red blood cells urine positive; Renal impairment, Somnolence, Tongue dry, Toxic encephalopathy, Ultrasound kidney normal; Ureteral disorder, Urinary incontinence, Urine abnormality, Urine analysis abnormal, Walking aid user; White blood cells urine positive; Agitation, Asthenia, Blood potassium, Blood potassium decreased, Death; Decreased appetite, Diarrhoea, Fatigue, Hypersomnia, Urinary incontinence; Agitation, Anion gap, Asthenia, Balance disorder, Blood calcium; Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood glucose; Blood glucose increased, Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased; Blood urea, Blood urea abnormal, Cerebral amyloid angiopathy, Computerised tomogram, Condition aggravated; Decreased appetite, Dehydration, Diarrhoea, Dysphagia, Dysstasia; Encephalopathy, Fatigue, Gait disturbance, Glomerular filtration rate, Glomerular filtration rate decreased; Hydroureter, Hypercalcaemia, Hypersomnia, Hypokalaemia, Lethargy; Magnetic resonance imaging, Metabolic encephalopathy, Mucosal dryness, Protein urine present, Pyuria; Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality; Urine analysis, Urine analysis abnormal, White blood cells urine positive; Agitation, Asthenia, Bacterial test positive, Balance disorder, Blood calcium increased; Blood glucose normal, Blood potassium decreased, Blood pressure decreased, Cerebral amyloid angiopathy, Cerebral small vessel ischaemic disease; Chest X-ray normal, Cognitive disorder, Creatinine urine abnormal, Culture urine negative, Death; Decreased activity, Decreased appetite, Diarrhoea, Dysarthria, Dysstasia; Emotional distress, Failure to thrive, Fatigue, Gait disturbance, Hydronephrosis; Hyporesponsive to stimuli, Lethargy, Lip dry, Magnetic resonance imaging head abnormal, Malaise; Mobility decreased, Posture abnormal, Protein urine present, Pyuria, Red blood cells urine positive; Renal impairment, Somnolence, Tongue dry, Toxic encephalopathy, Ultrasound kidney normal; Ureteral disorder, Urinary incontinence, Urine abnormality, Urine analysis abnormal, Walking aid user; White blood cells urine positive; Agitation, Asthenia, Blood potassium, Blood potassium decreased, Death; Decreased appetite, Diarrhoea, Fatigue, Hypersomnia, Urinary incontinence; Agitation, Anion gap, Asthenia, Balance disorder, Blood calcium; Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood glucose; Blood glucose increased, Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased; Blood urea, Blood urea abnormal, Cerebral amyloid angiopathy, Computerised tomogram, Condition aggravated; Decreased appetite, Dehydration, Diarrhoea, Dysphagia, Dysstasia; Encephalopathy, Fatigue, Gait disturbance, Glomerular filtration rate, Glomerular filtration rate decreased; Hydroureter, Hypercalcaemia, Hypersomnia, Hypokalaemia, Lethargy; Magnetic resonance imaging, Metabolic encephalopathy, Mucosal dryness, Protein urine present, Pyuria; Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality; Urine analysis, Urine analysis abnormal, White blood cells urine positive More	My father was 94 years old when he received both his covid and flu shots on 10/6/24. He began having... My father was 94 years old when he received both his covid and flu shots on 10/6/24. He began having new health issues soon thereafter. He went to the ER on 10/10/24, and he was in and out of the ER, hospital, and inpatient rehab for four weeks. My family and I finally got him back home on 11/5/24. A week later on 11/11/24, he was in the ER again. The next day my family decided to put him on hospice at home He passed away at home on 11/25/24. I was his primary caregiver. Please see my detailed description below about what happened. PLEASE NOTE: I strongly feel that people of advanced age like my Dad should only receive one vaccination at a time, and that this should also be the case for people with dementia/Alzheimer's. If a vulnerable person has just completed a round of antibiotics, perhaps a specified period of time--longer than just a couple of days--should be allowed to pass before a person receives a vaccination. I urge the government to consider modifying its vaccination recommendations accordingly. My father received his annual flu and covid shots during the same pharmacy visit on Sunday, October 6, 2024. He had received both shots at the same time the previous year without a single side effect. However, in October 2024 he was a year older, and his dementia had presumably progressed some since the fall of 2023. Prior to receiving covid and flu shots on 10/6/2024, Dad had been taking a 2-week round of antibiotics to treat an H-pylori infection. From Friday, 9/20/2024 through Thursday, 10/3/24, Dad was taking the following antibiotics and other related medications at the direction of his pharmacy care doctor's office: amoxicillin; levofloxacin; omeprazole; and probiotics. At my sister's suggestion, I purchased Culturelle Ultimate Strength Probiotic to help ensure that at 94 years old, my Dad's body would be able to handle his ingestion of antibiotics multiple times a day for two weeks. Fortunately, he tolerated the regimen very well. On 9/30/24 I contacted Dad's primary care doctor's office to ask when it would be okay for Dad to receive his covid and flu shots. I was told that once his antibiotic regimen had been completed, I could take him on or after the following day. Dad completed his antibiotic regimen on Thursday, 10/3/24. I figured I'd wait a couple of days before introducing additional drugs, i.e. the vaccines, into his body, and so took him to get his covid and flu vaccines at 3:00 p.m. on Sunday, 10/6/24. That night, I noticed something a bit unusual. I generally served Dad supper sometime between 7:30 p.m. and 8:15 p.m., per his preference. He would sometimes say he wasn't hungry, and I would then encourage him to eat something in order to stay strong. I would suggest he just eat what he could. On the vast majority of these occasions, he would then eat at least part of his supper. When I tried to serve him supper the night of October 6, though, he said emphatically, I'm sick of eating! He had said this recently before on 10/4, but tonight he seemed to be more agitated about it. He quickly calmed down and went on to eat the food I had brought him. His level of agitation had been fleeting but noteworthy, as it as a new development. I had occasionally seem him that agitated before, but never over supper. The previous year on 10/19/23, my Dad had unfortunately fallen and broken his wrist. Since then, my siblings and I had cared for Dad 24/7. I lived with him and cared for him the vast majority of the time. I helped him with a variety of his ADLs, or Activities of Daily Living. This included walking with him to and from the bathroom. As we walked, I held the back of his belt with my left hand, and gave him my right hand to hold. This was a technique we had learned from visiting occupational therapist, who had come to the house in 2023 to help us after Dad's fall. Since Dad's fall I had also assisted Dad in the bathroom, cleaning him, changing his disposable brief as needed, etc. It was not unusual for use to get up during the overnight hours so he could use the toilet. However, during the first overnight following his 10/6/24 vaccinations, I noticed during our visit to the bathroom that he had not held all his urine until he sat on the commode. This happened again during our bathroom visit early in the morning of 10/7/24. This continued to occur intermittently thereafter. It was another new development since his vaccinations on 10/6. Additionally, he had an episode of diarrhea just before 4 p.m. on 10/7. Later that day I decided to have him start taking the Culturelle Ultimate Strength Probiotic again, hoping that might help his gastrointestinal system. I re-started him on this daily probiotic just before 6:30 p.m. on 10/7. Usually when we left the bathroom, Dad and I would typically take a walk around the house. This was a way to incorporate exercise into his daily routine. When leaving the bathroom in the early evening of 10/7, he was not up to walking our usual route, so we walked a shorter route. I also noticed he had napped much of the day on 10/7. This was not entirely unusual, as he previously had sometimes had days when he would nap quite a bit. But I made a note of it in Dad's health log. In the early afternoon of 10/7, I asked Dad how he was feeling, and he said very good. I took his temperature, and he did not have a fever. Around 4:45 a.m. on 10/8/24, Dad needed to use the toilet. On our way back to his recliner chair, where he liked to sleep, we used our usual walking technique. As I held the back of his belt and his right hand while I walked with him, I noticed he seemed to momentarily lose his balance a couple of times. This was quite unusual. I asked him how he felt and he said fine. As he was a Type 2 diabetic, I checked his blood sugar with his Freestyle Libre 14-day system. The first reading was 91. A short time later it was a bit higher. At 5:06 a.m., it was 101. He didn't seem to have low blood sugar. Dad and I went back to sleep and got up around 7:30/7:45 a.m. so he could use the bathroom. I was noticing on our trips to and from the bathroom since the day before that he seemed more hunched over when he walked and when he stood at the bathroom sink to wash his hands. After we returned to his recliner, I asked him if he felt okay, and he said yes. I offered him coffee and sugar-free cookies, which he normally had early in the morning as his start-of-the-day snack. He would typically enjoy them as he watched the program on TV. But this time, he declined and went back to sleep. I had checked his blood sugar at 7:33 a.m. and 7:49 a.m. and got readings of 128 and 123 respectively. At 8:22 a.m. on 10/8 I called Dad's primary care doctor's office to report that Dad had not been himself. I explained the recent changes I had observed in him. At 8:56 a.m., the doctor's office called me back and said Dad's primary care doctor wanted to see him at 10 a.m. that morning. I woke Dad up around 9 a.m. and explained Dr. wanted to see him and why. I offered him coffee and cookies before leaving, and he declined. I'm not a cookie guy, he said. This was completely out of character. I always made sure we were well-stocked with his favorite sugar-free cookies, which he normally ate daily. Fortunately on 10/8 he was willing to drink some high-protein drink instead before we went to see Dr. As we left the house to go to his appointment, he was able to walk with me out the front door, across the porch, and down the front porch stairs. As he tried to get into the car, I noticed he was having a harder time than usual with that, but he was able to do it When we arrived at the doctor, I walked over to the building entrance area and got a wheelchair for Dad, which I normally did. Dad was able to get out of the car and into the wheelchair okay, but as I wheeled him in to the building, I noticed he was slouched over a bit to one side. When we saw Dr., she examined him and we discussed his recent symptoms. She said his recent fatigue, premature urination, diarrhea, etc. could all be side effects from his having received the flu and covid vaccines. She recommended I monitor Dad another 48 hours, and if there was no improvement, I should collect a urine sample from him and get it to the lab for analysis. She would have a urinalysis and culture test done to see if Dad had a urinary tract infection. She asked if I had seen blood in his urine, and I told her no. Because Dad was in remission from bladder cancer, I often looked in the toilet after he peed to see if I could spot any blood, and I never did. After returning home from seeing Dr., I prepared for Dad his usual eggs and sausage for breakfast. By the time I served them to him with coffee, it was late morning. Normally he would consume all of it, and sometimes have a cookie or two afterward. But this morning he only ate about half of the eggs and sausages and drank only half a cup of coffee. Also, he needed me to place a pillow behind his back to help support him while he was sitting up to eat, something he had not previously needed. Around 12:30 or so on 10/8, I suggested Dad go to the bathroom, as he hadn't used the toilet in several hours. He agreed, and as he stood and held the grab bar on the wall by the toilet, I pulled down his Depends-like brief. As I did so, liquid stool came out of him. I also discovered his brief contained a significant amount of mostly liquid stool. This was his second episode of diarrhea since his 10/6 covid and flu vaccinations. Around 3:45 p.m. on 10/8, I checked Dad's blood pressure, blood sugar, and oxygen level. All were fine. A couple of hours later on our way out of the bathroom, he walked quite slowly and was pretty hunched over, but we made it back to his recliner. Afterward he ate half a sandwich with coffee. I normally gave him half a sandwich for lunch because he had said repeatedly that a whole sandwich was too much. I normally gave him a full cup of coffee with it. But this time I brought him half a cup of coffee to start with. As he tried to drink it, quite a bit of his coffee ended up on his sweatshirt, which was not normal. I could see he was gradually getting weaker. On 10/9, around 12:30 a.m., Dad needed to use the toilet so we went to the bathroom. On our way back to his recliner, he had to work very hard to walk the approximately 20-foot distance in between. I was worried his legs might give out, but thankfully, he made it. Around 10 a.m. that day when he needed to use the bathroom, he initially had trouble standing up from his recliner chair, so he sat back down. After a few moments he tried again and managed to stand. But he again had difficulty walking to and from the bathroom. When we finally got back to his chair, he was unable to center himself on the chair because he was unable to comfortably walk to the center. As had been happening recently, he ended up sitting toward the right side of the chair, i.e., the side nearest the bathroom. That day, 10/9, I decided to better do two things: contact the local Council for Aging for a loaner wheelchair; and contact Dad's primary care doctor to see if I should get a urine sample in now rather than wait a full 48 hours. Dr. was out of the office that day. After waiting a while to hear back from the covering doctor, I decided on my own to just get a urine sample to the lab. With the help of my sister, we got hold of a loaner wheelchair, and also got a urine sample to the lab in the early afternoon of 10/9. Later that afternoon I spoke with Dr.'s nurse about Dad's increasing weakness. She said it could be due to the vaccines or a possible UTI; she would let Dr. know and see what Dr. wanted to do when she returned to the office the following morning. In the meantime, Dad and I tried to use the wheelchair to get him to and from the bathroom, with mixed results. It took more effort than usual for us to get him into the wheelchair. Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it. I also noticed during this process that initially he had a little trouble following my commands. I spoke with him about the option of placing the commode with its bucket close to his recliner, but he preferred using the commode over the toilet. At one point on 10/9, I checked Dad's blood pressure, heart rate, blood sugar level and oxygen level, and all were okay. Around 5 a.m. on Thursday, 10/10/24, Dad wanted to go to the bathroom. As much as he tried to stand up from his recliner chair, he wasn't quite able to stand up all the way. Even though he couldn't stand up, I somehow managed to help him urinate into a urinal. As soon as Dr.'s office opened, I called for help. Soon thereafter I spoke with one of Dr.'s nurses. She said Dad's urine culture results were still pending, and the doctor did not want to put Dad on more antibiotics prematurely. The nurse said something else might be going on with Dad, and recommended he go to the hospital for a full evaluation. I hated to call 911 because Dad's two previous trips to the hospital over the last year had been very stressful for him. Before his advanced age and dementia, he had by nature been an easygoing person with a high threshold of pain even when he was away from home. But later in life, going to the ER and/or the hospital were significantly more difficult for him. Unfortunately, on the morning of 10/10/24, I didn't have a choice. I called 911 and Dad was transported to the ER, where blood and urine samples were collected. His blood resulted low in potassium and high in calcium. His urinalysis resulted high in white blood cells, etc., so a UTI was suspected. He was given IV antibiotics and potassium fluids while in the ER. From the ER he was admitted to the hospital, where he received IV potassium fluids for several days. To my knowledge, Dad had not previously had a potassium deficiency, so this was something new for him. The calcium supplements previously prescribed by his PCP were discontinued. When a culture resulted from Dad's urine sample that I had collected at home on 10/9, the culture showed only 10,000-50,000 mixed gram positive organisms. Antibiotic were discontinued. NP was the hospitalist who coordinated Dad's care for his first five days in the hospital. When I spoke with her on 10/11/24, Dad's first full day in the hospital, she said she did not think Dad had a UTI. She said the combination of flu and covid vaccines Dad had recently received could be affecting him. She had seen other cases of people receiving 2024 covid and flu vaccines together and then experiencing more significant symptoms than they had in the past. She said generally vaccine side effects can affect someone for about 48 hours. But for someone of Dad's age at 94 years old, side effects could last longer. Additionally in Dad's case, the reduction in his food and drink intake in recent days could be contributing to his health problems. She said his Alzheimer's Disease could also be playing a role, as it can cause physical as well as cognitive decline. In her written report about Dad on 10/11/24, NP stated, Suspect patient has sudden onset of weakness is related to the combination COVID and flu vaccine in advanced elderly patient. Her 10/11 report also stated, Urine cultures unremarkable. Discontinue antibiotics, and, No evidence of UTI. A copy of her 10/11/24 is enclosed as Attachment A. My family and I noticed while visiting Dad on 10/12/24 that his speech was not normal, as he was having some difficulty clearly articulating his words. He spent much of that day trying to get out of his bed, as he wanted desperately to go home. He pleaded with me to help him leave and go home. I tried to explain it was not yet safe for him to leave, and that people at the hospital were trying to help him get stronger so he could leave. I said we wanted to get him home as soon as he was strong enough for me to safely take care of him. At one point on 10/12, two of the hospital staff used a hoya lift to transfer Dad from his bed to a recliner chair that had been placed right next to his bed. After he was seated in the chair, he allowed the nurse to feed him a bit of lunch. Suddenly she had to leave to tend to another patient. After she left, Dad said he wanted to get out of his chair and walk to another chair. I told him that wouldn't be safe for him to try to do, as he was not yet strong enough to walk. This didn't seem to register with him cognitively, as he continued to be very focused on getting out of his recliner chair. Two staff then used the hoya lift to return him to bed. He then repeatedly tried to escape from his bed. I felt so badly for him. He probably didn't understand what was happening, and I know at least some of the time he did not know where he was. He just knew he wasn't home, and that's where he wanted to be. I was told by hospital staff multiple times that hospital patients with dementia can experience what's called hospital delirium, which can add to their confusion. The nurse gave Dad a low dose of Ativan to help alleviate his agitation. It seemed to work for a while but then wear off. The night of 10/12/24, Dad was given a low dose of Seroquel to ameliorate his agitation. At some point on 10/12/24, Dad was started on IV magnesium fluids, and he was still receiving IV potassium fluids. Also on 10/12, Dad was taken for an MRI scan, as NP wanted to see what it could tell us about his brain. On 10/13/24, Dad was minimally responsive to hospital staff or family visitors. It seemed the Seroquel given to him the night before was taking a very long time to wear off. NP came to see Dad, and she let me know his 10/12 brain MRI showed severe microvascular disease and amyloid deposits, which cause dementia. But there was no evidence of a stroke, major hemorrhage, or tumor. For much of Monday, 10/14/24, Dad was still drowsy and mostly sleeping. When NP stopped in to his room, she indicated to make that she was dubious his current condition was a result of Seroquel medication he had taken two nights before. She said it was possible he would come out of his current state, but she didn't know if he would. This was a particularly scary time for my family and me. NP said the MRI showed Dad had advanced dementia. She said amyloid angiopathy was a progressive disease and was contributing significantly to Dad's advanced dementia. Severe microvascular disease was also contributing to it, she said. She told me she ordered thiamine be given to Dad intravenously to see if that would help him. It is very noteworthy that Dad was seen around 8 a.m. on the morning of 10/14 by Neurohospitalist. In his related report, Dr. described Dad's condition upon the doctor's examination as follows: He was currently sleepy, wakes with repeated stimulation and acknowledges examiner but unable to provide any meaningful history. He states he feels 'lousy.' He denies any focal weakness but feels generally weak. In his report, Dr. indicated he had reviewed Dad's 10/12/24 MRI results. He went on to say the following about Dad. On examination he was encephalopathic without focality. His presentation appears most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, in the background of poor cognitive reserve and failure to thrive...Ensure glucose and other electrolytes are stable. Consider course of empiric thiamine... A copy of Dr.'s report is enclosed as Attachment B. From Dad's medical records, it appears Dad was stated on IV thiamine at 9:34 a.m. on 10/14/24 (see enclosed copy of IV thiamine administration record, enclosed as Attachment C). Also on 10/14/24, Dad was re-started on IV antibiotics, specifically, ceftriaxone. A urine sample had been collected on 10/13, and the ensuing urinalysis showed bacteria with WBCs in clumps, according to NP's 10/14 report regarding Dad. She also noted, Prognosis remained guarded. A copy of her 10/14/24 report is enclosed as Attachment D. According to Dad's medical records, ceftriaxone was re-started at 3:27 p.m. on 10/14. (A copy of the related section of Dad's hospital Medication Administration record is enclosed as Attachment E.) Before antibiotics were re-started for a possible UTI on 10/14/24, a wonderful development occurred. At approximately 2:20 p.m. that day, my brother went to my father's bedside and began talking to him, even though Dad's eyes were closed. Within moments, Dad opened his eyes and started chatting with him! Soon thereafter, I went to Dad's bedside and joined them in conversation! My brother and I were elated that Dad had finally come to, and also that he was articulating his words better than he had been on Saturday, 10/12. Dad told us some of his stories, and even did a little laughing and singing. He seemed content and comfortable. A nurse and assistant came to check his brief, etc., and were happy to see him awake and alert. After they left, brother and I talked with Dad a bit more. Then brother asked him if he was tired, and he indicated he was. So we let him rest. Later when a couple of other visitors came to see him, he woke up and spoke with them briefly. When brother went to say goodnight to him, Dad woke up and they chatted a bit. When I saw him open his eyes on his own several times, I went over to speak with him, and he spoke with me briefly before falling back to sleep. But this afternoon and evening, he was opening his eyes more, was more communicative, and was not agitated. This was all major progress for Dad. Dad continued to receive thiamine and antibiotics daily for the remainder of his hospital stay, i.e., for three more day (10/15 through 10/17/24). A culture resulting from Dad's 10/13 urine sample was negative. However, it was thought this may have been a false negative due to Dad's recent receipt of antibiotics. When I arrived at Dad's hospital room around 11 a.m. on 10/15/24, he was sitting in his chair bright and alert, and he was working with a Physical Therapist and Occupational Therapist. With their assistance and the aid of a rolling walker, he had been able to stand up from his bed and walk a few feet to his chair. Given his condition less than 24 hours prior, this was a major development for him. Soon thereafter he was working with a Speech Therapist. After her evaluation of Dad's swallowing ability, she decided he should be on a diet of pureed foods and nectar-thickened liquids. Apparently, Dad had unfortunately developed some dysphagia during his recent episode of somnolence. When NP came to see Dad on 10/15, she said perhaps his recent long-term somnolence on 10/13-10/14 had in fact been due to receiving Ativan during the day on 10/12 and then Seroquel on the night of 10/12, and now the effects of those medications had worn off. She said the antibiotics and thiamine Dad had been receiving since 10/14 might also be helping him. She noted in her 10/15 report that Dad had had some degree of encephalopathy, and that, Encephalopathy has improved on 10/15/2024. (A copy of her 10/15/24 report is enclosed as Attachment F). Dad continued receiving potassium supplementation on 10/15, this time by mouth. Around 7:15 pm on 10/15, Dad was able to engage in a FaceTime call with my sister. He only saw/spoke with her for a few minutes, but it made them both very happy. She told me afterward that he sounded like his usual self. I also thought his speech had progressed back to baseline. Dad was doing well when I arrived at his hospital room on Wednesday, 10/16/24. Soon lunch arrived and he ate a little pureed food and all of a Magic Cup, which is a fortified ice cream-type food. He also drank some thickened coffee. I was told he had eaten a little breakfast and drunk most of his Mighty Shake that morning. While visiting with him on 10/16, I gave him multiple teaspoons full of thickened water. I spoke with NP, Dad's new hospitalist coordinating his care. She said she wanted to keep Dad in the hospital one more night, and if all went well, discharge him to a skilled nursing/rehab facility the following day. Around 4:45 p.m., I learned Dad's blood sample taken earlier that day showed his potassium level was finally back to normal. Unfortunately, no physical, occupational or speech therapist was able to see him on 10/16. While I was visiting with Dad on 10/16, he expressed to me that he wanted to go home. I told him it wasn't safe yet for him to come home with only me there to help him. But, I said, he could go home when he was stronger. I said he would probably leave the hospital tomorrow and go to a place where physical therapy would help him get stronger, and I would be with him there every day to help him. He then said he wanted to go home, but he couldn't, and he thought he would never go home. I told him that wasn't the case, but he didn't seem to believe me. When supper came, he refused to eat or drink; he said he would eat when he got home. I said I wanted to get him home, but it's going to take some time so he can get stronger first. I told him eating would help him get stronger, to no avail. Trying to reason with a loved one who has Alzheimer's and vascular dementia isn't always successful. So that night I decided to say goodnight to Dad earlier than usual in order to give him some space. I assured him I would come see him the next day. On my way out of his room, I spoke with a nurse about the situation, and she said a nurse or aide would try in a little while to get him to eat something. When I called the nurses' station from home later that evening, I learned that did not have any better luck trying to get Dad to eat some supper. The next morning, 10/17/24, I called the nurses' station to see how Dad was doing. Dad's nurse said he had eaten about 25 percent of his breakfast. She said he was confused about where he was, and when she told him he was in the hospital, he asked if I knew he was there. She told him yes, and he then told her he felt a lot better knowing that I knew he was there, she said. She confirmed the plan was still to discharge Dad to a rehab sometime that day. I told her I wanted to be present for his discharge. When I arrived in Dad's hospital room in the early afternoon, he was in better spirits than he had been the night before, but he still wanted to go home. I broke my heart that I couldn't take him home yet. By 2 p.m., a medical transport team had arrived. Dad was discharged from the hospital and taken to the rehab, located nearby. I followed in my car and met him there. After my brother got out of work, he stopped by the rehab to visit with Dad as well. Later, after my brother said goodnight and left the rehab, Dad talked with me again about wanting to go home. He didn't want me to leave him at the rehab and was extremely upset about the prospect of me going home that night without him. I tried to explain to him that he needed to meet with a lady at the rehab the next day, a lady who would assess how strong he was and whether he was strong enough to go home. He wanted to talk to my brother to see if he would get him out of there. I got my brother on the phone, and he basically told Dad the same thing I had said. He encouraged Dad to get some rest tonight and we'll see how strong he is tomorrow, and we'll go from there. He told Dad we were just looking out for him. Dad seemed to calm down after he spoke to my brother, but he did ask me how long his stay at the rehab would last. I suggested he get some rest tonight and we'll see how tomorrow goes. After he finally went to sleep, I went home to eat and get some sleep so that I could be ready the next day to look out for him. Unfortunately, Dad hadn't eaten much on 10/17/24, I wanted to get him home as soon as possible, not only because he wanted desperately to go home, but because being home might help improve his appetite and willingness to eat. Over the next three weeks, Dad continued to be given a daily thiamine supplement. He worked with PT, OT and Speech Therapy staff at the rehab and made significant progress. His swallowing improved enough that he could safely eat ground meat, and also drink plan water between meals. He gained enough body strength to et up and walk many feet using a walker; a therapist was always with him using a gait belt and/or wheelchair to help him if he lost his balance or grew too tired to continue. One day he was able to go to the toilet with the aid of his walker and one staff person. This was all exciting for my family and me. But unfortunately Dad also had setbacks during his three weeks at rehab. He still was not eating enough. And on two occasions, he went to the Emergency Room. Both ER visits were prompted by the condition I had found him in when I arrived at the rehab for may daily visit with him. On both 10/16/24 and 11/4/24, he was extremely lethargic upon my arrival at the rehab and barely responded to me when I spoke to him. During his 10/16/24 ER visit, he was given IV fluids. After a while, he opened his eyes and was more alert. He spoke briefly, but much more normally, with my brother and me. It seemed to my brother and me that the fluids were helping Dad. A nurse at rehab had suspected he was experiencing dehydration. However, the ER nurse initially said his blood work did not show dehydration. However, after that nurse and her colleague changed Dad's disposable brief, I asked her what they had found. She said the used brief contained a small amount of feces but no urine even though Dad was been receiving IV fluids. She looked at his blood work results again, and after we discussed his kidney function history, she realized his current kidney function was below normal. She said perhaps he had come into the ER with borderline dehydration and needed fluids after all. Dad's blood work in the ER that day showed his potassium level was fine. Dad woke up a second time in the ER, at which time he again spoke with my brother and me, and he also sang and hummed. When we asked how he was feeling, he said good. A urine sample was collected and analyzed, and his ER nurse suspected he had a UTI. She said his urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein. When the nurse returned a little later, she said they were in fact going to treat Dad for a UTI, and she started him on antibiotics. Dad also underwent a scan to see if he had a kidney stone. The scan was negative for kidney and ureter stones, but the image of one kidney and ureter was not normal compared with a PET scan Dad had undergone for his oncologist a couple of years before. Dad was admitted to the hospital. When I visited Dad the following afternoon, I could see he was continuing to do better. That evening while I was still with Dad, I learned from the hospitalist and an in-house urologist that they did not think Dad had a UTI after all. His culture result from the urine sample taken in the ER the day before was negative. However, the CT scan of Dad's pelvic area taken on 10/26 showed his left ureter was swollen. I was told Dad's regular urologist would be contacted with a request to come to the hospital to see Dad and review his case. Dr., and before him Dr., had been monitoring Dad's bladder with regular cystoscopies because of Dad's history of bladder cancer. The following morning, 10/28/24, a urology PA went to the hospital to see Dad instead. PA called me afterward, as did Dad's hospitalist. Dad's blood work was not showing normal kidney function and normal creatinine level. Their recommendation was for Dad to undergo another scan I two weeks to see if his ureter swelling had gone down. They explained multiple possible causes for the swelling. If the ureter swelling did not resolve on its own, we could discuss potential next steps. They felt Dad could be discharged from the hospital that day, 10/28, and seen thereafter on an outpatient basis. It is noteworthy that in PA's report on Dad, he stated that Dad "was hospitalized he More	✓	✓	✓
2831858	62	M	CA	03/18/2025	RSV	PFIZER\WYETH	LG9829	Abdominal pain, Angina pectoris, Dizziness, Hyperhidrosis, Pruritus Abdominal pain, Angina pectoris, Dizziness, Hyperhidrosis, Pruritus	Reported Symptoms: 10000081: ABDOMINAL PAIN; 10002391: ANGINAL PAIN; 10012703: DIAPHORESIS; 10013573... Reported Symptoms: 10000081: ABDOMINAL PAIN; 10002391: ANGINAL PAIN; 10012703: DIAPHORESIS; 10013573: DIZZINESS; 10037087: PRURITUS; Narrative: 62 yo male with idiopathic angioedema and many medication allergies experienced allergic reaction to RSV vaccine minutes after the vaccination. The symptoms improved with treatment, then recurred several hours later, then resolved after a second dose of epi-pen in the emergency department. Other Relevant HX: Other: diaphoresis, pruritus, abdominal pain More
2831859	77	M		03/18/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	DA7P5	No adverse event No adverse event	Reported Symptoms: 10067481:NO ADVERSE DRUG REACTION; Narrative: at approximately 1430 on 12/5, pat... Reported Symptoms: 10067481:NO ADVERSE DRUG REACTION; Narrative: at approximately 1430 on 12/5, patient's son contacted PACT team by phone. He had questions as to if the patient had received a flu shot. he stated his father came home with a band-aid on his arm and said he thought he had gotten a flu shot. Upon review of patient's chart, there was a flu shot administered at his appt the morning of his 12/5 appt. The son stated his father is allergic to flu shots and should not receive them, due to a hx of guillian barre. RN advised the son to take his father to the ER with any s/s of reaction. At time of entry no noted reactions on patient chart after nearly 2 weeks since administration. Other Relevant HX: Other: Pt has h/o gullian barre no reaction noted More
2831901		F	NC	03/18/2025	UNK	UNKNOWN MANUFACTURER		Injection site pain Injection site pain	injection site stinging; This spontaneous report was received from an Other health professional via ... injection site stinging; This spontaneous report was received from an Other health professional via a company representative and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) INJ 168 mcg/ml (dose, lot # and expiration date were not reported) via intramuscular (IM) route for prophylaxis. On an unknown date, the patient experienced injection site stinging at the time of administration. At the reporting time, the outcome of injection site stinging was unknown. The causal relationship between the event of injection site stinging and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown. This is one of two cases from the same reporter. More
2831903	14	F	AL	03/18/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Postural orthostatic tachycardia syndrome; Postural orthostatic tachycardia synd... Postural orthostatic tachycardia syndrome; Postural orthostatic tachycardia syndrome More	POTS/autoimmune, autonomic, and neurological, injuries; Gardasil-induced autoimmune disorder; autoim... POTS/autoimmune, autonomic, and neurological, injuries; Gardasil-induced autoimmune disorder; autoimmune, autonomic, and neurological injuries; Information has been received from a lawyer and refers to a female patient of 14-year-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unspecified date in April 2016, the patient received the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, lot #, and expiration date were not reported), and received the second dose of vaccine in August 2016. Patient agreed to received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) by being convinced by company marketing that was very safe and prevent cancer. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, on an unspecified date the patient was diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome (POTS). Her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to POTS, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Gardasil or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorder. As a result of her post-Gardasil symptoms, patient had been unable to engage in activities that a normal young person would enjoy. At the reporting time, the outcome of the events was unknown. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). Upon internal review the event autoimmune disorder was considered as medically significant. The event POTS was considering as disabling. More			✓
2831904			KY	03/18/2025	HEPA	MERCK & CO. INC.		No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	Nurse calling to report that a 15 month old patient was inadvertently administered the adult formula... Nurse calling to report that a 15 month old patient was inadvertently administered the adult formulation of VAQTA. No symptoms reported. Caller declined to report the AE at this time. No additional AE/No PQC.; No additional AE; This spontaneous report was received from a nurse on 17-Mar-2025 and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with the adult formulation of Hepatitis A Vaccine, Inactivated (VAQTA), (lot # and expiration date were not reported) as prophylaxis (Product administered to patient of inappropriate age). No symptoms reported. No additional AE (no adverse event). Lot # is being requested and will be submitted if received. More
2831905	0.33	M		03/18/2025	HIBV HIBV HIBV MEN MEN MEN PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER 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	Breath sounds abnormal, Chest X-ray normal, Cough, Dyspnoea, Hypophagia; Pyrexia... Breath sounds abnormal, Chest X-ray normal, Cough, Dyspnoea, Hypophagia; Pyrexia, Respiratory syncytial virus bronchitis, Respiratory syncytial virus test positive, Respiratory tract congestion, Rhinorrhoea; Tachypnoea, Use of accessory respiratory muscles; Breath sounds abnormal, Chest X-ray normal, Cough, Dyspnoea, Hypophagia; Pyrexia, Respiratory syncytial virus bronchitis, Respiratory syncytial virus test positive, Respiratory tract congestion, Rhinorrhoea; Tachypnoea, Use of accessory respiratory muscles; Breath sounds abnormal, Chest X-ray normal, Cough, Dyspnoea, Hypophagia; Pyrexia, Respiratory syncytial virus bronchitis, Respiratory syncytial virus test positive, Respiratory tract congestion, Rhinorrhoea; Tachypnoea, Use of accessory respiratory muscles; Breath sounds abnormal, Chest X-ray normal, Cough, Dyspnoea, Hypophagia; Pyrexia, Respiratory syncytial virus bronchitis, Respiratory syncytial virus test positive, Respiratory tract congestion, Rhinorrhoea; Tachypnoea, Use of accessory respiratory muscles; Breath sounds abnormal, Chest X-ray normal, Cough, Dyspnoea, Hypophagia; Pyrexia, Respiratory syncytial virus bronchitis, Respiratory syncytial virus test positive, Respiratory tract congestion, Rhinorrhoea; Tachypnoea, Use of accessory respiratory muscles More	Acute Bronchitis Due to Respiratory Syncytial Virus; This 4-month-old male subject was enrolled in a... Acute Bronchitis Due to Respiratory Syncytial Virus; This 4-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-FEB-2019, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 01-FEB-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 01-FEB-2019, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular, right thigh) on 01-FEB-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 07-FEB-2019, 6 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed severe - grade 3 respiratory syncytial virus bronchitis (Verbatim: Acute Bronchitis Due to Respiratory Syncytial Virus). Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol) and paracetamol (Tylenol). The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix was no change. The outcome of respiratory syncytial virus bronchitis was resolved on 11-FEB-2019. Relevant Tests: On 07-Feb-2019 Respiratory Syncytial viral swab (RSV PCR)-positive result (normal=reference) On 08-Feb-2019 Chest X-RayResult was no acute process identified.. Diagnostic results (reference ranges are provided in parenthesis if available): Chest X-ray-In FEB-2019 negative. Oxygen saturation- 08-FEB-2019 95 percent and in FEB-2019 on room air was 95-96 percent. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchitis 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 bronchitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK Receipt date : 11-FEB-2019 Subject was brought to the Emergency Department on 07-Feb-2019 for fever, cough, and shortness of breath. On physical examination subject was tachypneic, had subcostal retractions, and coarse breath sounds Subject was treated with albuterol and Tylenol and nasal suctioning was performed. Subject was discharged home with albuterol nebulizer treatments, Tylenol and nasal suctioning to be performed as needed. Subject was discharged in stable condition with the final diagnosis of 'RSV Bronchiolitis'. On 08-Feb-2019 subject was brought to a MD appointment with worsening cough, congestion, and difficulty breathing.Subject had increasing tachypnea and retractions. Parents were finding it increasingly difficult to perform nasal suctioning. Subject was admitted to the pediatric unit from the MD appointment on 08-Feb-2019 with increased workof breathing, increased nasal secretions, decreased oral intake, fever and diagnosis 'Acute Bronchiolitis due to RSV (respiratory syncytial virus) '. Subject's oxygen saturation remained stable on room air. During the hospital course the subject had frequent nasal suctioning and albuterol nebulizer treatments. Subject was discharged home on 09Feb2019 in stable condition. Per parent report on 11-Feb-2019 subject has completely recovered.There was another child at Daycare who was RSV (respiratory syncytial virus) positive. Follow up information received on 12-FEB-2025 Summary of changes : Unit for treatment medication Albuterol was updated from mg/ml to mg. Upon internal review case was updated on 14-FEB-2025 lab test Respiratory Syncytial viral swab and Chest X-RayResult was added in Relevant lab test. Lab test Chest X-ray, Oxygen saturation were coded in lab data and removed from narrative. Narrative updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchitis, 6 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. Causal relation is indeterminate considering insufficient definitive evidence for DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device causing the temporaly related AE. More		✓
2831906	72	F	NJ	03/18/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Abdominal discomfort, Chills, Fatigue, Headache, Mobility decreased; Myalgia, Na... Abdominal discomfort, Chills, Fatigue, Headache, Mobility decreased; Myalgia, Nasal congestion, Pyrexia, Rhinorrhoea More	also began having fatigue so severe; Muscle pain; Shivering; Upset stomach; Runny nose; Nasal conges... also began having fatigue so severe; Muscle pain; Shivering; Upset stomach; Runny nose; Nasal congestion; Headache; couldn't get out of bed; she began feeling feverish,of 101.5 degrees Fahrenheit.; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypertension, arthritis and pain. Concomitant products included amlodipine, tramadol and paracetamol (Tylenol). On 01-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 01-MAR-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: she began feeling feverish,of 101.5 degrees Fahrenheit.). On 02-MAR-2025, the patient experienced fatigue (Verbatim: also began having fatigue so severe), muscle pain (Verbatim: Muscle pain), shivering (Verbatim: Shivering), upset stomach (Verbatim: Upset stomach), runny nose (Verbatim: Runny nose), nasal congestion (Verbatim: Nasal congestion), headache (Verbatim: Headache) and bedridden (Verbatim: couldn't get out of bed). The outcome of the fever was resolving and the outcome of the fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion and headache were not resolved and the outcome of the bedridden was not reported. It was unknown if the reporter considered the fever, fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion, headache and bedridden to be related to Shingrix. It was unknown if the company considered the fever, fatigue, muscle pain, shivering, upset stomach, runny nose, nasal congestion, headache and bedridden to be related to Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and that in the evening of vaccination day she began feeling feverish. The following day she was having a fever of 101.5 degrees Fahrenheit. She also began having fatigue so severe she couldn't get out of bed and other symptoms also began on that day which were muscle pain, headache, shivering, upset stomach, runny nose and nasal congestion. The fever has abated as of on the day of reporting and the remaining symptoms were ongoing. She took amlodipine, Tylenol and Tramadol daily. More
2831907		F		03/18/2025	HEP VARZOS	UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More	I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.; Injectio... I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.; Injection site itchy; Injection site red; Very sore; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Hepatitis b vaccine for prophylaxis. On 06-MAR-2025, the patient received Shingrix .5 ml and the 2nd dose of Hepatitis b vaccine. On 07-MAR-2025, 1 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.), injection site itching (Verbatim: Injection site itchy), injection site erythema (Verbatim: Injection site red) and injection site pain (Verbatim: Very sore). The outcome of the injection site swelling, injection site itching, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site erythema and injection site pain to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site itching, injection site erythema and injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 08-MAR-2025 The reporter reported that she have a 2 inch diameter red swollen area at the injection site, very sore, somewhat itchy. The reporter reported that the she had never had this reaction to a vaccine before. but, to be clear, also got her second Hep B shot at the same time. More
2831908		F	TX	03/18/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Fear, Headache, Incomplete course of vaccination, Laboratory test, Malaise; Musc... Fear, Headache, Incomplete course of vaccination, Laboratory test, Malaise; Musculoskeletal discomfort, Neurological symptom More	ended up having stroke like symptoms 2-3 weeks after shingrix, luckily it was not a stroke but thoug... ended up having stroke like symptoms 2-3 weeks after shingrix, luckily it was not a stroke but thought was having one and thought was going to die; several headaches/severe headaches; neck issues; For several months I was not well; This serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 23-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). In SEP-2024, 2 weeks after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: ended up having stroke like symptoms 2-3 weeks after shingrix, luckily it was not a stroke but thought was having one and thought was going to die) (serious criteria hospitalization), headache (Verbatim: several headaches/severe headaches) (serious criteria hospitalization), neck discomfort (Verbatim: neck issues) (serious criteria hospitalization) and feeling unwell (Verbatim: For several months I was not well) (serious criteria hospitalization). The patient was treated with vitamin b2 and ubidecarenone (Co Q10). The outcome of the feeling abnormal, headache, neck discomfort and feeling unwell were not resolved. The reporter considered the feeling abnormal, headache, neck discomfort and feeling unwell to be possibly related to Shingrix. The company considered the feeling abnormal, headache, neck discomfort and feeling unwell to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 About 2 weeks after Shingrix the patien had stroke like symptoms, never have had any complications with vaccine until this Shingrix. As of March-2025 the patient still having symptoms of several headaches and neck issues have not been the same since. Back in September 2024, had a medical situation, 2 to 3 weeks prior to having this medical situation received Shingrix vaccine for shingles. The patient ended up having stroke-like symptoms 2 to 3 weeks after the injection, luckily it was not a stroke, but the patient thought she was having one and thought she was going to die. After having numerous tests, nerve injections, severe headaches a physician informed that it was due to receiving the shingle injections. For several months the patient was not well. Ever since received the Shingrix had issues that still dealing with today, and it's March 2025. The patient's issue was she was not aware that would be dealing with these issues this long after receiving the shingles vaccine. The patient did not have these issues until received the vaccine. All the symptoms actually listed and or complications that can occur actually known. The patient had other vaccines and never had any complications, so when received this shingles vaccine and had these medical issues was really concerned. The patient stated had never in life felt so scared that she really thought was dying. The worst feeling ever. The patient felt that she really needed to say something. She did not receive second Shingrix shot. Since he was the physician who thinks that that the events she was experiencing were related to the Shingrix. When asked her for concomitant medications she misunderstood the question and told about treatment medications. She indicated that she saw two neurologists and had two nerve blocks performed but they did not work. Then she went to see another neurologist, physician and he put her on two over-the-counter medications: 300 mg of Co-Q10 and 400 mg of Vitamin B2.; Sender's Comments: Feeling abnormal and Musculoskeletal discomfort are unlisted events which are considered unrelated to GSK vaccine Shingrix. Headache and Malaise are listed events which, due to the following criteria (insufficient information regarding medical history, concurrent conditions, concomitant medications) are considered unrelated to GSK vaccine Shingrix. More		✓
2831909		F	MI	03/18/2025	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; she received the 2-dose series of Shingrix in 2017 and has had severa... Suspected vaccination failure; she received the 2-dose series of Shingrix in 2017 and has had several flare ups of Shingles since that time; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female 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 (intramuscular) and the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she received the 2-dose series of Shingrix in 2017 and has had several flare ups of Shingles since that time). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 11-MAR-2025 The patient reported that she had received the 2-dose series of Shingrix in 2017 and had several flare ups of Shingles since that time. She had a case right now that affects under her right arm and to comes and goes with no warning. The batch lot number of Shingles vaccine she could not remember. The expiry date of Shingles vaccine was unknown. She was going to the doctor on Thursday, 13th March 2025. This case was considered as suspected vaccination failure since the details regarding, 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 vaccine Shingrix (Dose 1 & 2). More
2831910	75	M	NY	03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Chills, Pyrexia Chills, Pyrexia	he had chills; he had fever; This non-serious case was reported by a consumer via call center repres... he had chills; he had fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On 07-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 07-MAR-2025, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: he had chills) and fever (Verbatim: he had fever). The outcome of the chills and fever were resolved. It was unknown if the reporter considered the chills and fever to be related to Shingrix. It was unknown if the company considered the chills and fever to be related to Shingrix. Additional Information: GSK receipt date: 10-MAR-2025 The patient wife reporting on behalf of her husband. She stated that her husband received his first dose of Shingrix vaccine and experienced chills and a fever. The reporter stated that her husband was better on the day of reporting and was at the gym working out. The reporter reported that her husband had a past medical history of shingles. Reporter declines follow up for her husband or with the primary care physician for her husband. No further information was obtained/provided including what arm the husband had the vaccine administered in. The consumer was unable to locate lot number on material provided from pharmacy. Lot number may not had been provided to consumer.; Sender's Comments: US-GSK-US2025029170:same reporter, female patient More
2831911		F		03/18/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Stress, Vaccination failure; Herpes zoster, Stress, Vaccination f... Herpes zoster, Stress, Vaccination failure; Herpes zoster, Stress, Vaccination failure More	Suspected vaccination failure; I got the shingles; a lot of stress; This serious case was reported b... Suspected vaccination failure; I got the shingles; a lot of stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female 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), shingles (Verbatim: I got the shingles) and stress (Verbatim: a lot of stress). The outcome of the vaccination failure and stress were not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure, shingles and stress 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 and stress to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAR-2025 The case was received from the patient via interactive digital media. The patient have had both shots also but after a lot of stress got the shingles, only thankful he/she did as they are much lighter and had not lasted as long. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (Dose 1 & 2). More
2831912		M		03/18/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	Suspeceted vaccination failure; I got the shingle vaccination about twenty years ago and got two mor... Suspeceted vaccination failure; I got the shingle vaccination about twenty years ago and got two more vaccinations about three years ago, but then I got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly 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 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingle vaccination about twenty years ago and got two more vaccinations about three years ago, but then I got the 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 and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter got the Shingle vaccination about twenty years ago and got two more vaccinations about three years ago, but then he got the shingles and after two years the pain was still there. This case was considered as suspected vaccination failure as details regarding 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2831913		F		03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; I have them now; This serious case was reported by a consumer via int... Suspected vaccination failure; I have them now; 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 Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have them now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 11-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the she had them now they had knocked the wind out of her sails. She had the shingles shots too. 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 Shingrix. More
2831914				03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Missed shingrix 2nd dose; This non-serious case was reported by a consumer via interactive digital m... Missed shingrix 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). 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: Missed shingrix 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 08-MAR-2025 The patient enquired that if he/she got a Shingrix vaccine part 1 but not part 2 what was the recommended course of action. The patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination More
2831916	67	M	PA	03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	mg5s9	Discomfort, Musculoskeletal disorder, Pain, Pain in extremity Discomfort, Musculoskeletal disorder, Pain, Pain in extremity	severe pain in arm that radiated down to hand, loss of full motor control in the hand as of 3/17/25,... severe pain in arm that radiated down to hand, loss of full motor control in the hand as of 3/17/25, pain so severe at times can not get comfortable, treated with course of prednisone More
2831917	28	F	WI	03/18/2025	COVID19	PFIZER\BIONTECH	LM2223	Skin warm Skin warm	Warmness of the arm Warmness of the arm
2831918	50	F	NC	03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Heart rate increased, Pyrexia, Respiratory rate increased Heart rate increased, Pyrexia, Respiratory rate increased	High Fever, Elevated heart rate and elevated breathing High Fever, Elevated heart rate and elevated breathing
2831919	55	F	TN	03/18/2025	VARCEL	MERCK & CO. INC.	Y014939	Inappropriate schedule of product administration Inappropriate schedule of product administration	Gave the Varicella vaccine before the 28 days live window. Pt had received an MMR vaccine on 02/25/2... Gave the Varicella vaccine before the 28 days live window. Pt had received an MMR vaccine on 02/25/2025. More
2831920	9	M	TX	03/18/2025	HPV9	MERCK & CO. INC.	Y018389	Fall, Head injury, Syncope Fall, Head injury, Syncope	patient was sitting on parents lap on bench when recieved vaccine. After the vaccine was given child... patient was sitting on parents lap on bench when recieved vaccine. After the vaccine was given child was upset at parent becuase recieved vaccine. He stood up against the table and syncope episode happened and child fell to the floor and hit hit on childs chair More
2831921				03/18/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Ophthalmic herpes zoster, Vaccination failure, Visual impairment Ophthalmic herpes zoster, Vaccination failure, Visual impairment	Suspected vaccination failure; You can get shingles on the inside of your eyes/My eyesight was ruine... Suspected vaccination failure; You can get shingles on the inside of your eyes/My eyesight was ruined/still got it; 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 ophthalmic herpes zoster (Verbatim: You can get shingles on the inside of your eyes/My eyesight was ruined/still got it) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAR-2025 The case was received from the patient via interactive digital media. The reporter reported that you can get shingles on the inside of your eyes. The reporter's eyesight was ruined. The reporter had all shingles vaccines and still got it. The reporter reported, so just know the vaccine does not prevent all cases of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary 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. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2831922	28	M	CT	03/18/2025	COVID19	PFIZER\BIONTECH	ln0588	Syncope, Unresponsive to stimuli Syncope, Unresponsive to stimuli	Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: ... Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: seqiris; LotNumber: 946636; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN More
2831923	56	F	NJ	03/18/2025	PPV	MERCK & CO. INC.	y009239	Injection site erythema, Injection site pain, Injection site swelling, Periphera... Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling More	Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: swelling or left arm-Medium, Additional Details: patient's main complaint was swelling and redness of the left arm. went to the urgent care. More
2831924	66	M	FL	03/18/2025	VARZOS VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	93kk4 93kk4 93kk4	Asthenia, Brain scan normal, Cardiac imaging procedure normal, Dizziness, Fatigu... Asthenia, Brain scan normal, Cardiac imaging procedure normal, Dizziness, Fatigue; Flushing, Hyperhidrosis, Lethargy, Syncope, Unresponsive to stimuli; Yawning More	Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: After vaccine, pt stayed with wife sitting when he suddenly closed his eyes. 911 was called. Pt was breathing and had heart beat. Pt was weak, tired, and yawning and sweating a lot but would respond. Response team took him to hospital. The day after, I called the wife who stated the hospital did scans of heart and brain and everything came back good. Pt was home doing well and recovering well per wife. Wife states drs told them this was probably due to lack of sleep and overwhelmed over vaccine., Other Vaccines: VaccineTypeBrand: Capvaxive; Manufacturer: Merck; LotNumber: y019158; Route: IM; BodySite: Left arm; Dose: ; VaxDate: 03/08/2025 More
2831925	65	M	TN	03/18/2025	PNC20	PFIZER\WYETH	lg5576	Arthralgia, Injection site erythema, Injection site pain, Injection site swellin... Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Joint injury More	Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)- More			✓
2831926	31	F	OH	03/18/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	3d72s	Injection site pain Injection site pain	Site: Pain at Injection Site-Severe Site: Pain at Injection Site-Severe
2831927	15	F	VA	03/18/2025	COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	lp1780 lp1780 lp1780	Blindness, Blood pressure decreased, Fall, Flushing, Hyperhidrosis; Hypotension,... Blindness, Blood pressure decreased, Fall, Flushing, Hyperhidrosis; Hypotension, Loss of consciousness, Nausea, Pallor, Tremor; Visual impairment More	Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic... Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: patient fell over after pfizer vaccine was given immunizer was able to catch pt in catch. She lost consciousness after a few second mom was called into the room, 911 called. pt stated she felt nauseous, became pale and stated she could not see any thing. ems arrived on seen with in a few minutes and took over. I called mom later on in the day she said pt blood dropped really low and they will follow up with cardiolgist. More
2831928	60	M	MA	03/18/2025	PNC21 PNC21	MERCK & CO. INC. MERCK & CO. INC.	y019158 y019158	Eye swelling, Injection site erythema, Injection site swelling, Mouth swelling, ... Eye swelling, Injection site erythema, Injection site swelling, Mouth swelling, Pyrexia; Swelling face, Swollen tongue More	Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fever-Medium, Additional Details: The patient is a prescriber so he knows what happened and he reported that he had injection site swelling, fever, redness, and the area hurt so he had to take ibuprofen OTC and we advised to take benadryl (50mg) at bedtime in case it was allergic reaction More
2831929	81	F	CA	03/18/2025	PNC21 PNC21 PNC21 PNC21 PNC21 PNC21	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Y013009 Y013009 Y013009	Chills, Pruritus; Arthralgia, Chills, Pain, Pruritus, Skin ulcer; Sleep disorder... Chills, Pruritus; Arthralgia, Chills, Pain, Pruritus, Skin ulcer; Sleep disorder; Chills, Pruritus; Arthralgia, Chills, Pain, Pruritus, Skin ulcer; Sleep disorder More	Systemic: Allergic: Itch Generalized-Medium, Systemic: Chills-Medium, Additional Details: Per pt she... Systemic: Allergic: Itch Generalized-Medium, Systemic: Chills-Medium, Additional Details: Per pt she started to feel Chills at night on 02/10/2025 and start to feel itchy on 02/11/2025. She saw her primary dr. and dermatologist. Dr. have her on benadryl , hydrocortisone topical, and rx topical for itchiness but no improvment. (No epipen no benadryl was given in the pharmacy since symptom on set a day later.) More
2831930	65	F	PA	03/18/2025	PNC20	PFIZER\WYETH	lj5283	Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling	Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection... Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild More
2831931	52	F	CA	03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	5y4tl	Injection site erythema, Injection site pruritus, Injection site swelling, Rash Injection site erythema, Injection site pruritus, Injection site swelling, Rash	Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Inje... Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient said it started as mild redness at injection site, but then began to spread downwards. Will be contacting her doctor for evaluation More
2831932	20	M	TX	03/18/2025	HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC.	y012508 y012508	Dizziness, Fatigue, Flushing, Hyperhidrosis, Hypotension; Lethargy, Nausea, Trem... Dizziness, Fatigue, Flushing, Hyperhidrosis, Hypotension; Lethargy, Nausea, Tremor More	Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / ... Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Other Vaccines: VaccineTypeBrand: Flucelvax Trival 2024-2025; Manufacturer: Seqirus; LotNumber: 946637; Route: IM; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN More
2831933	73	F	MI	03/18/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	lm2210 lm2210	Cold sweat, Dizziness, Loss of consciousness, Nausea, Palpitations; Tachycardia Cold sweat, Dizziness, Loss of consciousness, Nausea, Palpitations; Tachycardia	Systemic: racing heart, clammy, felt like going to pass out-Severe, Systemic: Nausea-Medium, Systemi... Systemic: racing heart, clammy, felt like going to pass out-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: patient stated 1 hour after receiving the vaccine she felt clammy, had a racing heart beat which monitored with her watch, and felt like she was going to pass out. These symptoms lasted on and off for one hour. Patient would like to note that this has never happened with the previous pfizer vaccines she has received More
2831934	75	M	PA	03/18/2025	PPV	MERCK & CO. INC.	x027348	Dizziness, Hypertension Dizziness, Hypertension	Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Mild Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Mild
2831935	74	F	VA	03/18/2025	COVID19	PFIZER\BIONTECH	ln0590	Injection site erythema, Injection site pain, Injection site swelling, Pyrexia Injection site erythema, Injection site pain, Injection site swelling, Pyrexia	Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient's daughter contacted the pharmacy to report patient has been experiencing redness, swelling, soreness at injection site, and fever all starting after receipt of vaccines on 3/10/2025, Other Vaccines: VaccineTypeBrand: Arexvy (RSV); Manufacturer: ; LotNumber: 24m94; Route: IM; BodySite: Right arm; Dose: unknown; VaxDate: 03/10/2025, VaccineTypeBrand: Boostrix (TdAP); Manufacturer: ; LotNumber: AK334; Route: IM; BodySite: Right arm; Dose: unknown; VaxDate: 03/10/2025 More
2831936	61	F	KY	03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	55TH4	Injection site erythema Injection site erythema	Site: Redness at Injection Site-Medium Site: Redness at Injection Site-Medium
2831937	72	F	IN	03/18/2025	COVID19	PFIZER\BIONTECH	ln059	Pruritus, Rash, Sleep disorder Pruritus, Rash, Sleep disorder	Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient cam... Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient came in 3 days later with a large red area that is very itchy and keeping patient awake at night. She is applying hydrocortisone cream and taking zyrtec at bedtime. she may call her primary md to get something stronger for the itching More
2831938				03/18/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Feeling abnormal Feeling abnormal	Vaccine made me feel awful for 2 days; This non-serious case was reported by a consumer via interact... Vaccine made me feel awful for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful 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 feels awful (Verbatim: Vaccine made me feel awful for 2 days). The outcome of the feels awful was resolved (duration 2 days). It was unknown if the reporter considered the feels awful to be related to Shingles vaccine. It was unknown if the company considered the feels awful 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. Vaccine made him/her feel awful for 2 days. Never again. More
2831939	69	F	FL	03/18/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	A2F3R A2F3R	Condition aggravated, Injection site erythema, Injection site pain, Injection si... Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia; Rosacea More	Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Additional Details: PATIENT EXPRESSED PAIN ON LEFT ARM AROUND THE INJECTION SITE FOR A TOTAL OF 6 DAYS WHEN SHE CAME IN TO REPORT. THE NEXT DAY AFTER GETTING VACCINE SHE HAD A FEVER IN WHICH SHE USED A FEVER REDUCER BUT THE PAIN WOULD NOT RESOLVE WITH OTC PAIN MEDICATION. SHE ALSO HAD REDNESS ALONG THE ARM BUT SHE DID SPECIFY SHE HAD ROSACEA AND THAT WAS A FLARE UP ALONG WITH HER INJECTION SITE PAIN. SHE MAY BE ALLERGIC TO VACCINE BUT WANTED TO DOCUMENT AND TOLD PATIENT TO GO TO URGENT CARE IF PAIN CONSISTS More
2831940	73	F	MI	03/18/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	D7447	Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling	Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injecti... Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient shows up to pharmacy 3 days post-administration. Injection site is red and swollen. Explained that it's possibly an allergic reaction. Advised to take Benadryl and if that does not work in the next several days or if symptoms worsen to see her primary care physician. Patient was satisfied with advice. More
2831941	52	M	NJ	03/18/2025	PNC21	MERCK & CO. INC.	Y013009	Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling	Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injecti... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium More
2831942	86	M	FL	03/18/2025	COVID19	PFIZER\BIONTECH	LN0588	Gait disturbance, Hypoaesthesia, Muscular weakness, Nervous system disorder, Par... Gait disturbance, Hypoaesthesia, Muscular weakness, Nervous system disorder, Paraesthesia More	Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, ... Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Medium, Additional Details: Guillain-Barr� syndrome (severe muscle weakness) was observed after vaccination. Patient reported still having a lot of weakness and still needs assistance walking., Other Vaccines: VaccineTypeBrand: FLUZONE HIGH-DOSE TRI-VALENT; Manufacturer: SANOFI; LotNumber: UT8419BA; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: 1; VaxDate: 10/23/2024 More		✓
2831943	64	F	TX	03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	52f7m	Injection site bruising, Injection site erythema, Injection site pain, Injection... Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More	Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Medium, Site: Pain at Injec... Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild More
2831944	53	F	AL	03/18/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	7kdsb	Injection site pruritus, Pruritus Injection site pruritus, Pruritus	Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M... Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: pt called pharmacy saying she had itching at injection site as well as itching on the palms of her hands and feet. she called her doc who informed her to call us. i told her to take some benadryl and it should go away., Other Vaccines: VaccineTypeBrand: heplisavb; Manufacturer: dynavax; LotNumber: 945602; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: capvaxive; Manufacturer: merck; LotNumber: y013009; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: shingrix; Manufacturer: glaxcosmith; LotNumber: ts525; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN More
2831945	61	M	OH	03/18/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	7zm55	Dizziness, Presyncope Dizziness, Presyncope	near syncope episode, dizziness near syncope episode, dizziness
2831946	9	F	VA	03/18/2025	DTAP	GLAXOSMITHKLINE BIOLOGICALS	7HM5J	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	DTaP given, should have been TDaP due to age. Vaccine given on 1/25/2024 - clinic notified of error ... DTaP given, should have been TDaP due to age. Vaccine given on 1/25/2024 - clinic notified of error on 3/13/2025. More
2831947	1	M	MI	03/18/2025	VARCEL	MERCK & CO. INC.	X006980	Expired product administered, No adverse event Expired product administered, No adverse event	The patient received a Varicella Vaccine on 3/12/25. Vaccine Expired 3/7/25. No s/sx of adverse rea... The patient received a Varicella Vaccine on 3/12/25. Vaccine Expired 3/7/25. No s/sx of adverse reaction was reported. The writer called Merck National Service Center and spoke with someone on 3/18/25. Verbal statement: While Merck never recommends using an expired vaccine, data supports that it was a valid dose/potent at the time of administration as long as all storage and handling were followed. However, could not put in writing or email to writer of the statements made. Writer called the father and spoke with him. Dad stated he would talk to his wife and was ok with patient getting a third dose if needed. More
2831948	56	M	TN	03/18/2025	VARCEL	MERCK & CO. INC.	Y014939	Inappropriate schedule of product administration Inappropriate schedule of product administration	Varicella vaccine given prior to the 28 days live window. Pt received an MMR vaccine on 02/25/2025. Varicella vaccine given prior to the 28 days live window. Pt received an MMR vaccine on 02/25/2025.

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