| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2831648 | F | NY | 03/17/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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patient can take the second dose approximately 13 months after the first dose; This non-serious case...
patient can take the second dose approximately 13 months after the first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 98-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in March 2024). 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: patient can take the second dose approximately 13 months after the first dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-MAR-2025 Registered nurse wanted to know if a 98-year-old patient can take the second dose approximately 13 months after the first dose or if she had to restart the administration scheme. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2831649 | 67 | F | IN | 03/17/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N222 |
Incorrect route of product administration
Incorrect route of product administration
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intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call...
intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 67-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 08-MAR-2025, the patient received Priorix (intramuscular). On 08-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-MAR-2025 The reporter reported that the intramuscular administration of Priorix to patient , which led to subcutaneous injection formulation administered by other route. This was 1 of 3 linked cases , reported by the same reporter. ; Sender's Comments: US-GSK-US2025029891:Same reporter/Different patient US-GSK-US2025029889:Same reporter/Different patient
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| 2831650 | 25 | F | 03/17/2025 |
COVID19 |
MODERNA |
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Mechanical urticaria
Mechanical urticaria
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Developed dermatographia 2 weeks later; This spontaneous case was reported by a patient and describe...
Developed dermatographia 2 weeks later; This spontaneous case was reported by a patient and describes the occurrence of MECHANICAL URTICARIA (Developed dermatographia 2 weeks later) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 14-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (Developed dermatographia 2 weeks later). At the time of the report, MECHANICAL URTICARIA (Developed dermatographia 2 weeks later) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no risk factor. No concomitant medication was reported. It was reported that post Moderna Covid booster vaccination patient was developed symptom of dermatographia 2 weeks later. She was experienced whole body intense itchy, and patent was reported that when she scratches the red marks appeared and then disappeared approximately 30 minutes later. It was reported that the patient can write words on the skin that used to disappear. This symptom was lasted for about 1.5-2 years for patient. It had gotten better over time for patient but still the symptom showed the red marks when she scratched the skin. The patient did not experience any additional symptoms/events. There were no lab data/results available. No treatment medication was reported. Reporter causality was not reported.
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| 2831651 | 46 | F | TX | 03/17/2025 |
TYP |
SANOFI PASTEUR |
W1A441M |
Expired product administered
Expired product administered
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administration of expired typhim VI vaccine with no reported adverse event; Initial information rece...
administration of expired typhim VI vaccine with no reported adverse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 46 years old female patient who received expired typhoid VI polysaccharide vaccine [typhim VI] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Mar-2025, the patient received an expired unknown dose of suspect typhoid VI polysaccharide vaccine, Solution for injection (lot W1A441M and expiry date: 07-Mar-2025) (Frequency: once and strength: standard) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Patient tried to contact the HCP (health care professional) who gave the vaccine to confirm if it was a typographical error, but they haven't responded to her. She wanted to know if the expiration date is correct based on the lot number. She refused to provide address. MIS (Management Information System) advised to contact healthcare provider to confirm the information. Patient advised that she needs the information (with regards to the expiration date) urgently as she will be travelling, and that the HCP cannot be reached. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2831655 | 1 | M | IA | 03/17/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Wrong age; administered the wrong vaccine to a patient; Inappropriate schedule of vaccine administer...
Wrong age; administered the wrong vaccine to a patient; Inappropriate schedule of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis. Previously administered products included Vaxelis (received first dose of Vaxelis on 11-OCT-2023), Vaxelis (received second dose of Vaxelis on 21-NOV-2023) and Vaxelis (received third dose of Vaxelis on 22-JAN-2024). On 05-MAR-2025, the patient received Kinrix. On 05-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age), wrong vaccine administered (Verbatim: administered the wrong vaccine to a patient) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAR-2025 The other health professional reported that they administered the wrong vaccine to a patient which led to wrong vaccine administered. Kinrix was given and patient was 19 months old which led to inappropriate age at vaccine administration. The patient got 3 prior Vaxelis doses which led to inappropriate schedule of vaccine administered.
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| 2831656 | 0.5 | M | WA | 03/17/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Kinrix was the patient's 3rd dose of DTaP and IPV; nurse assistant administered Kinrix to an un...
Kinrix was the patient's 3rd dose of DTaP and IPV; nurse assistant administered Kinrix to an underage child; administered Kinrix to an underage child instead of separate Dtap and Polio vaccines; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. On 05-MAR-2025, the patient received Kinrix. On 05-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix was the patient's 3rd dose of DTaP and IPV), inappropriate age at vaccine administration (Verbatim: nurse assistant administered Kinrix to an underage child) and wrong vaccine administered (Verbatim: administered Kinrix to an underage child instead of separate Dtap and Polio vaccines). The outcome of the inappropriate schedule of vaccine administered, inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-MAR-2025 A nurse assistant administered Kinrix which was the patient's 3rd dose of DTaP and IPV to an underage child instead of separate Dtap and Polio vaccines which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2831658 | F | NV | 03/17/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse effects were reported; extra dose of GARDASIL 9; This spontaneous report was received fro...
No adverse effects were reported; extra dose of GARDASIL 9; This spontaneous report was received from a nurse and refers to a 16-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-FEB-2025, the patient received an extra dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), at 0.5 mL for prophylaxis, after previously completing the 3 doses series on 10-MAR-2021 (injection site, route of administration, expiration date, and lot # were not reported), (extra dose administered). No adverse effects were reported.
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| 2831659 | 0.33 | M | 03/17/2025 |
HIBV HIBV HIBV MMR MMR MMR PNC13 PNC13 PNC13 UNK UNK UNK UNK UNK UNK UNK UNK UNK VARCEL VARCEL VARCEL |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophag...
Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophagia, Laboratory test normal; Lymphadenopathy, Metabolic function test normal, Pyrexia, Tonsillar erythema, Tonsillar hypertrophy; Viral pharyngitis, White blood cell count decreased; Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophagia, Laboratory test normal; Lymphadenopathy, Metabolic function test normal, Pyrexia, Tonsillar erythema, Tonsillar hypertrophy; Viral pharyngitis, White blood cell count decreased; Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophagia, Laboratory test normal; Lymphadenopathy, Metabolic function test normal, Pyrexia, Tonsillar erythema, Tonsillar hypertrophy; Viral pharyngitis, White blood cell count decreased; Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophagia, Laboratory test normal; Lymphadenopathy, Metabolic function test normal, Pyrexia, Tonsillar erythema, Tonsillar hypertrophy; Viral pharyngitis, White blood cell count decreased; Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophagia, Laboratory test normal; Lymphadenopathy, Metabolic function test normal, Pyrexia, Tonsillar erythema, Tonsillar hypertrophy; Viral pharyngitis, White blood cell count decreased; Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophagia, Laboratory test normal; Lymphadenopathy, Metabolic function test normal, Pyrexia, Tonsillar erythema, Tonsillar hypertrophy; Viral pharyngitis, White blood cell count decreased; Computerised tomogram neck abnormal, Drooling, Full blood count normal, Hypophagia, Laboratory test normal; Lymphadenopathy, Metabolic function test normal, Pyrexia, Tonsillar erythema, Tonsillar hypertrophy; Viral pharyngitis, White blood cell count decreased
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Bilateral tonsillar hypertrophy; This 13-month-old male subject was enrolled in a blinded study. The...
Bilateral tonsillar hypertrophy; This 13-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 13th November 2019. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 15th May 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 7th March 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 15th May 2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 13th November 2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 13th November 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 11th December 2019, 28 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 210 days after receiving DTPa-HBV-IPV and Hiberix and 279 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 tonsillar hypertrophy. Serious criteria included clinically significant/intervention required. The subject was treated with sodium chloride, iohexol, ibuprofen and dexamethasone (Decadron (Dexamethasone)). The outcome of tonsillar hypertrophy was recovered/resolved on 18th December 2019 15:45. The investigator considered that there was no reasonable possibility that the tonsillar hypertrophy may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Varivax. The investigator considered that there was a reasonable possibility that the tonsillar hypertrophy may have been caused by M-M-R II. Other possible cause(s) of the tonsillar hypertrophy included concurrent medication M-M-R II vaccine. Relevant Tests: On 14Dec2019, CT scan, Impression was Mild cervical lymph node enlargement, probably reactive. No abscess. Diagnostic results (unless otherwise stated, normal values were not provided): On 14th December 2019, Computerised tomogram result was See text and White blood cell count result was 5.4 K/uL (normal low: 6.00, normal high: 14.00). Investigator Text: 13 month old male presents to ED on 14 Dec 2019 for decreased PO intake, drooling, fever. Pt had a fever for about 2 days, starting 4 days prior to ED visit. Pt had shown improvement on 13 DEC 2019 but on 14 Dec had almost no PO intake, pt had been drooling and mother stated the pt. does not open his mouth to eat drink or talk. no fever, vomiting or diarrhea on 14 Dec 2019.On exam: patient was awake, alert, non toxic appearing, keeping his mouth closed w/ occasional drooling. No trismus, no obvious neck masses or facial masses. Exam of posterior pharynx revealed moist mucous membranes w. bilateral tonsillar hypertrophy and erythema, no asymmetry, lungs clear, abd, soft. Rotates neck normally but resistant on extension; breathing w/o distress. Assessment and plan: CT scan, CBC and BMPCT scan and labs fairly unremarkable. No indication of retropharyngeal abscess or other serious etiologies of the symptoms. CT scan impression: mild cervical lymph node enlargement, probably reactive, no abscess. WBC consistent w/ viral process. BMP unremarkable Pt. Was treated with IV Decadron, IV Sodium Chloride 0.9% (NS) bolus, and Oral Ibuprofen. symptoms improved and pt was discharged home with mother. PI Narrative note for possible :relationship between bilateral hypertrophy of tonsils and the MMRII vaccine: There is a low likelihood that these symptoms are related to the MMR vaccine given, as they occurred nearly 4 weeks after administration. They are most likely related to a viral pharyngitis. However, given the severity of the symptoms requiring both a CT, IV decadron and IV Fluids, he cannot definitely say they were not vaccine related. Additional details: Investigator reported SAE term as Bilateral tonsillar hypertrophy. The investigator considered that there was no reasonable possibility that the tonsillar hypertrophy may have been caused by Prevenar 13. On 11Dec2019, 28 days after 4th dose of Prevenar 13 (Non-GSK product, taken as prophylaxis), the subject experienced Bilateral tonsillar hypertrophy. Case US2019229557 and US2019229558 is a duplicate of case US2019229555. Case US2019229557 and US2019229558 was deleted. All further information will be entered in case US2019229555. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Tonsillar hypertrophy, 28 days after receiving Placebo, 210 days after receiving 3rd dose of Hiberix and DTPa-HBV-IPV, 279 days after receiving 2nd dose of Rotarix, 28 days after receiving 1st dose of M-M-R II and Varivax co-administered with PCV and routine vaccine, Hiberix and Rotarix lyophilized formulation in a 13-month-old male subject. Placebo case following unblinding, causality assessment non applicable. Report is inconsistent with causal relation to the vaccine product, considering alternate etiology (concurrent MMR II vaccine) based on medical history. US-GLAXOSMITHKLINE-US2019229557:
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| 2831662 | 54 | M | CA | 03/17/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
N/A N/A |
Death, Fall, Myocardial infarction; Death, Fall, Myocardial infarction
Death, Fall, Myocardial infarction; Death, Fall, Myocardial infarction
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Online report mid 50's male. Victim was employed as a bus operator since at least 2011 to the d...
Online report mid 50's male. Victim was employed as a bus operator since at least 2011 to the day of his death. His employer conducted a purged COVID-19 vaccines non-recipients by 11/01/2021. His son did a fundraiser after the victim's sudden death on 12/08/021. His son stated that around 04:15am the victim suffered a double heart attack and fell down the stairs prior to his shift. He was transported to hospital and died the same day. Based on these facts I suspect this victim was a recipient of a COVID-19 vaccine. Unable to obtain other info, dates, lot#, etc.
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| 2831663 | 67 | F | MA | 03/17/2025 |
PNC20 |
PFIZER\WYETH |
HH4202 |
Cellulitis, Deafness, Pruritus, Swelling face, Swelling of eyelid
Cellulitis, Deafness, Pruritus, Swelling face, Swelling of eyelid
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Swelling of face, eye lids (can provide picture) noted 6/10/2024 RX Methylprednisolone 4 mg 21 qty. ...
Swelling of face, eye lids (can provide picture) noted 6/10/2024 RX Methylprednisolone 4 mg 21 qty. 6/25/24 Prednisone 10 mg (42 tabs) 6 tabs X2 daily, 2 days, 4qdX2D, 3qdx2d, 2 daily x 3 days 1 qd. 9/13/2024 Admin at urgent care for repeat of swelling/itching. Diagnosed with cellulitis Dr The course of prednisone relieved in June 2024 was repeated with Doxycyline Monohydrate 100 x 7 days. December 5, 2024 loss of hearing -> Dec. 9, 2024. disimpactim of both ears at clinic
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| 2831707 | 27 | F | IL | 03/17/2025 |
MMR |
MERCK & CO. INC. |
X000177 |
Expired product administered
Expired product administered
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No additional AE; Indicate at which point in the process the medication error occured: preparation f...
No additional AE; Indicate at which point in the process the medication error occured: preparation for administration; HCP called to report an expired dose of MMRII was administered to a patient; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 14-FEB-2025, the patient was vaccinated with an expired dose (Expired product administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection, at a dose of 0.5 milliliters (ml), as prophylaxis, lot number X000177, which has been verified to be valid, expiration date reported and validated as 22-JAN-2025) plus a sterile diluent (BAXTER STERILE DILUENT). Follow up received from nurse on 20-FEB-2025. The report regarding 27-year-old female patient. The patient's pertinent medical history included being not immune to mumps. Concomitant medication included Vitamin d (Ergocalciferol), 50 mg Desvenlafaxine, Extended-release tablets (Desvenlafaxine fumarate) and Skyla (Levonorgestrel). It was updated that patient was vaccinated in left arm. It was indicated that medication error occurred at point of preparation for administration (product preparation error). On 14-FEB-2025, The patient was return to the office after discovering she was not immune to mumps. The person which was administering the vaccine retrieved it from the refrigerator, logged it to the appropriate page, and brought it to the room. She had the patient sign the consent and administered the vaccine. It wasn't until the patient left what she noticed that vaccine was expired. She returned to refrigerator and saw that all the MMR vaccines in the box ere expired and removed them. The patient was informed about the event through a call and was assured that the vaccine would cause no harm and they would not be needed to revaccinate.
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| 2831708 | WA | 03/17/2025 |
VARCEL |
MERCK & CO. INC. |
R013566 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No additional AE reported. No PQC; Inbound call from medical assistant who is requesting expiration...
No additional AE reported. No PQC; Inbound call from medical assistant who is requesting expiration date for VARIVAX. Caller provides lot number and OMC confirmed expiry date. Based on confirmed expiry date this product was administered to a patient one day post expiry. Date of admini; This spontaneous report was received from an other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-MAY-2020, the patient was vaccinated with expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection, lot #R013566 and expiration date 13-MAY-2020 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired vaccine used). No side effects/symptoms reported (no adverse event)
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| 2831709 | 9 | M | ND | 03/17/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y008284 |
Product storage error
Product storage error
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Improper storage of product in use; No adverse event; This spontaneous report was received from a nu...
Improper storage of product in use; No adverse event; This spontaneous report was received from a nurse referring to a 9-year-old male patient. Information regarding the patient's concurrent conditions, medical history was not provided. Concomitant medications included hepatitis a vaccine inact (HAVRIX), influenza vaccine inact sag 4v (FLUCELVAX) hepatitis b vaccine rHBsAg (yeast) (ENGERIX B). . On 05-Dec-2024, the patient was vaccinated with an improperly storage of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, administered subcutaneously in the left arm (valid lot number Y008284 with an expiration date on 21-OCT-2025) for prophylaxis. There was no adverse effect reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 07/25/2015 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2831710 | 66 | M | NY | 03/17/2025 |
PPV PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y016291 Y016291 Y016291 |
Bone pain, Chills, Decreased appetite, Dizziness, Erythema; Fatigue, Malaise, Pa...
Bone pain, Chills, Decreased appetite, Dizziness, Erythema; Fatigue, Malaise, Pain in extremity, Peripheral swelling, Pyrexia; Rhinorrhoea, Sleep disorder
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feel ill with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for...
feel ill with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days.; did not eat for 2-3 days.; pain in his upper arm; pain in his upper arm that escalated to include swelling and redness; pain in his upper arm that escalated to include swelling and redness; tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up; bones ached all through his body; felt so bad; This spontaneous report was received from a 65-year-old male patient referring to himself. The patient's medical history was not reported. The patient's concurrent conditions included hay fever in spring. Concomitant medications included Trazodone HCL (Trazodone hydrochloride), Ibuprofen (Ibuprofen), 25 mg Losartan (Losartan potassium), Aspirin (Acetylsalicylic acid) and medications reported as Amphetaphine and Vluvoxamine . On 27-FEB-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) (lot #Y016291 reported as YOU16291, expiration date: 06-Dec-2026) 0.5 mL (0.5mL / once), administered by Intramuscular route as prevention of Pneumonia. The patient began feeling pain in his upper arm the same day the vaccine was administered that escalated to include swelling and redness. Then began to feel "ill" the next day with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days. The patient stated his symptoms included headaches so back "he did not know what to do" that he used Tylenol and Ibuprofen to treat which helped but then the pain would come back when the medication wore off. The patient also stated his bones ached all through his body and he spiked a fever with chills for two days after the vaccine which has resolved. He felt so bad he tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up. The consumer stated his symptoms began to improve on 03-MAR-2025 and continue to improve today, 04-MAR-2025. The only symptoms that remained at the time of the report were a swollen, painful, red arm where the injection site and runny nose. The consumer did not report the adverse issues and side effects to his healthcare professional nor did he seek medical attention. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) was not provided.
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| 2831711 | 80 | F | PA | 03/17/2025 |
PNC20 |
PFIZER\WYETH |
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Erythema, Peripheral swelling, Pruritus, Rash pruritic
Erythema, Peripheral swelling, Pruritus, Rash pruritic
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color of upper arm became red, itchy raised skin, some lumps--spread the length of the outer upper a...
color of upper arm became red, itchy raised skin, some lumps--spread the length of the outer upper arm ---skin red and itchy breakouts continuing intermittently to this day, especially on upper arm and wrist.
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| 2831712 | 64 | F | NH | 03/17/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Injection site erythema, Injection site irritation, Injection site pruritus
Injection site erythema, Injection site irritation, Injection site pruritus
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PATIENT HAD LOCALIZED IRRITATION. THE VACCINE SITE WAS RED AND ITCHY.
PATIENT HAD LOCALIZED IRRITATION. THE VACCINE SITE WAS RED AND ITCHY.
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| 2831713 | 56 | F | PA | 03/17/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LX2497 LX2497 |
Asthenia, Erythema, Fatigue, Headache, Malaise; Pain in extremity, Pruritus, Rhi...
Asthenia, Erythema, Fatigue, Headache, Malaise; Pain in extremity, Pruritus, Rhinorrhoea, Sneezing
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Severe fatigue; More than usual redness, swelling, itching and pain in left arm. Constant headache ...
Severe fatigue; More than usual redness, swelling, itching and pain in left arm. Constant headache across forehead. Weakness sensation and overall feeling of being unwell with running nose and sneezing.
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| 2831714 | 81 | M | IA | 03/17/2025 |
COVID19 |
MODERNA |
3043332 |
Chronic obstructive pulmonary disease, Condition aggravated
Chronic obstructive pulmonary disease, Condition aggravated
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Hospice for dx COPD
Hospice for dx COPD
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| 2831715 | 67 | M | MI | 03/17/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LC5485 35STS |
Polymyalgia rheumatica; Polymyalgia rheumatica
Polymyalgia rheumatica; Polymyalgia rheumatica
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POLYMYALGIA RHEUMATICA
POLYMYALGIA RHEUMATICA
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| 2831716 | 31 | F | PA | 03/17/2025 |
TDAP |
SANOFI PASTEUR |
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Exposure during pregnancy, Nerve injury, Product administered at inappropriate s...
Exposure during pregnancy, Nerve injury, Product administered at inappropriate site
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Tdap (please note Tdap of unknown manufacturer,due to being administered @ OB/GYN) to patient 28 wee...
Tdap (please note Tdap of unknown manufacturer,due to being administered @ OB/GYN) to patient 28 weeks pregnant. Adverse event axillary nerve damage due to improper vaccine administration site.
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| 2831717 | 1.58 | F | VT | 03/17/2025 |
DTAP HEPA HIBV |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
3CA25C1 T5727 UK107AB |
Decreased appetite, Diarrhoea, Fatigue, Pyrexia; Decreased appetite, Diarrhoea, ...
Decreased appetite, Diarrhoea, Fatigue, Pyrexia; Decreased appetite, Diarrhoea, Fatigue, Pyrexia; Decreased appetite, Diarrhoea, Fatigue, Pyrexia
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fever, fatigue, not eating solid food, stools a little looser than normal
fever, fatigue, not eating solid food, stools a little looser than normal
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| 2831718 | 77 | F | MI | 03/17/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
HG2649 HG2649 |
Abdominal pain, Acute kidney injury, Blood pressure decreased, COVID-19, Compute...
Abdominal pain, Acute kidney injury, Blood pressure decreased, COVID-19, Computerised tomogram abdomen abnormal; Diverticulitis, Heart failure with reduced ejection fraction, Oropharyngeal pain, Umbilical hernia
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Name: Medical Record #: Age: 79 y.o. DOB: 2/xx/19xx Admit date: 3/8/2025 Discharge date: 3/1...
Name: Medical Record #: Age: 79 y.o. DOB: 2/xx/19xx Admit date: 3/8/2025 Discharge date: 3/10/2025 Admitting Physician: MD Attending Physician at the Time of Discharge: MD Primary Care Physician: MD Reason for Admission: Abdominal pain with concerns for small-bowel obstruction that was clinically ruled out Brief Summary of Hospital Stay: Patient is a 79 y.o. female with h/o incarcerated hernia s/p repair in 2019, anxiety disorder, GERD, hypertension, CVA, dysphagia, asthma, anxiety would presented with sore throat for the past 4 days secondary to COVID-19 though did have intermittent bouts of abdominal pain for which CT of the abdomen pelvis was performed which showed findings suspicious for partial small bowel obstruction related to an internal hernia with transition point near the back containing umbilical hernia. General surgery consulted and evaluated patient and assessed that patient did not have small-bowel obstruction clinically and patient was able tolerate general diet without any issues and discharge home on 03/10. Patient with some soft blood pressures around time of discharge with systolics in the 90s to 100s for which patient's losartan 50 and Lasix 40 mg daily were paused though these can be restarted at next PCP visit if blood pressure is stable. Issues Requiring Follow Up: -follow up to ensure that blood pressures were not restarting home losartan 50 and Lasix 40 daily Patient Active Problem List Diagnosis Date Noted ? Abdominal pain 03/09/2025 ? Umbilical hernia 03/08/2025 ? COVID 03/08/2025 ? Chronic HFrEF (heart failure with reduced ejection fraction) (HCC) 06/16/2024 ? Acute diverticulitis 06/16/2024 ? AKI (acute kidney injury) (HCC) 06/16/2024 ? Incarcerated umbilical hernia 08/23/2022 ? Osteopenia 11/20/2019 Discharged to Home
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| 2831719 | 77 | F | MI | 03/17/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
3043334 3043334 3043334 |
Acute respiratory failure, Atrial fibrillation, Brain natriuretic peptide increa...
Acute respiratory failure, Atrial fibrillation, Brain natriuretic peptide increased, COVID-19, Chest X-ray normal; Chronic obstructive pulmonary disease, Condition aggravated, Decreased appetite, Dyspnoea, Hyponatraemia; Hypotension, Neutropenia, Oxygen saturation decreased, SARS-CoV-2 test positive
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BRIEF OVERVIEW: Admission Date: 3/5/2025 Discharge Date: Mar 11, 2025 Discharge Disposition: home o...
BRIEF OVERVIEW: Admission Date: 3/5/2025 Discharge Date: Mar 11, 2025 Discharge Disposition: home or self care Active Issues Requiring Follow-up: Follow-up progressive lung cancer recently started on chemotherapy with Oncology; follow up neutropenia with Oncology, they will get repeat CBC with Diff on 3/14, precautions given to family re neutropenic fever with recommendations to call oncology if she has fever, follow-up with pulmonology regarding patient's advanced chronic obstructive pulmonary disease and hypoxia with exertion recovering from COVID-19 infection having completed 5 day course of remdesivir being discharged on Decadron 6 mg daily to complete 10 day course. Follow up with Cardiology regarding patient's paroxysmal atrial fibrillation with transitioned from carvedilol to diltiazem due to her severe lung disease. Follow up with Cardiology and primary care history of hypertension with patient normotensive off of her home losartan which was discontinued on discharge. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Elevated brain natriuretic peptide (BNP) level [R79.89] Chronic obstructive pulmonary disease with (acute) exacerbation [J44.1] Acute hypoxic respiratory failure [J96.01] COVID-19 [U07.1] 70-year-old widowed female with past medical history significant for longstanding nicotine dependence with ongoing tobacco abuse, severe chronic obstructive pulmonary disease (GOLD 3) in the setting of panlobular emphysema, left lower lobe adenocarcinoma/right middle lobe squamous cell carcinoma with progression in the right and left upper lungs recently started on combination chemo/immunotherapy with Taxol, carboplatin and Keytruda presented with worsening shortness a breath found to acute respiratory failure with hypoxia in the setting of respiratory viral panel positive for COVID-19. Chest x-ray showed no evidence of consolidation. HOSPITAL COURSE: Patient was started on supplemental oxygen plus IV remdesivir 5 day protocol and dexamethasone 6 mg daily. She was initially continued on her home beta-blocker and oral apixaban for her paroxysmal atrial fibrillation. She was noted to have intermittent rapid ventricular rate on her home non cardioselective beta-blocker. Notably patient has preserved left ventricular ejection fraction on prior echocardiogram. Patient had intermittently low blood pressures and we held her home angiotensin receptor blocker. She remained normotensive off of her losartan. After extensive discussion with pulmonology was decided to transitioned from non cardioselective beta-blocker diltiazem for rate control of her atrial fibrillation. She did have some intermittent slow ventricular rate during the transitioned but once on diltiazem long-acting 240 mg daily her rate was well-controlled in the 60s. Discussed informally with Cardiology who is in agreement. Patient was weaned off supplemental oxygen felt better each day. She had no evidence of fevers or other focal signs of new infection and was discharged in stable condition. Walking oxygen desaturation test on day of discharge did show desaturation to 85% with exertion so patient was sent home on 2 L of supplemental oxygen by nasal cannula to be used with exertion and for recovery. She was noted to be neutropenic. Discussed with Oncology. Plan to repeat CBC with Diff on 3/14 and monitor for fevers at home. On separate note, patient had issues with poor appetite and was started on Megace as an appetite stimulant. Patient was counseled regarding importance of smoking cessation and felt she was going to make a concerted effort to stop smoking. She denied any need for nicotine replacement therapy reporting smoking less than 5 cigarettes per day. And was for patient to stay with her son and daughter-in-law for her 1st week of recovery. Discharged to Home.
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| 2831720 | 1 | M | GA | 03/17/2025 |
HEPA HEPA MMRV MMRV PNC20 PNC20 VARCEL VARCEL HEPA HEPA MMRV MMRV PNC20 PNC20 VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
j4k4x j4k4x Y016874 Y016874 LX2497 LX2497 Y015557 Y015557 |
Wrong patient; Wrong product administered; Wrong patient; Wrong product administ...
Wrong patient; Wrong product administered; Wrong patient; Wrong product administered; Wrong patient; Wrong product administered; Wrong patient; Wrong product administered; Wrong patient; Wrong product administered; Wrong patient; Wrong product administered; Wrong patient; Wrong product administered; Wrong patient; Wrong product administered
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Patient here in office for his 12M HC, triaged patient and placed in clinic room. Health check compl...
Patient here in office for his 12M HC, triaged patient and placed in clinic room. Health check completed and schedule changed to "Immunizations". Would usually give immunizations but was drawing labs on another patient. Therefore, someone else offered to give immunizations to patient. After clinic had closed both employees came into my office and explained patient had received an MMRV and also a Varicella along with the rest of his 12M shots. I then stated they need to make an incident report and call the OPM. I personally called the OPM the next morning to report incident.
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| 2831721 | 60 | F | PA | 03/17/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Headache, Injection site erythema, Injection site reaction, Injection site warmt...
Headache, Injection site erythema, Injection site reaction, Injection site warmth
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injection site reaction : redness , warm to touch traveling down arm, slight headache
injection site reaction : redness , warm to touch traveling down arm, slight headache
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| 2831723 | 68 | F | FL | 03/17/2025 |
PNC20 |
PFIZER\WYETH |
lx4482 |
Extra dose administered
Extra dose administered
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patient got the prevnar 20 2 years ago and got one on 3/16/2025
patient got the prevnar 20 2 years ago and got one on 3/16/2025
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| 2831724 | 38 | F | IN | 03/17/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
D4J9L |
Cerebrovascular accident, Peripheral coldness, Seizure
Cerebrovascular accident, Peripheral coldness, Seizure
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stroke, seizure, cold hands and feet
stroke, seizure, cold hands and feet
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| 2831725 | 4 | F | MT | 03/17/2025 |
DTAPIPV |
SANOFI PASTEUR |
U7656aa |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Pt did not have an adverse reaction. This nurse gave an expired dose of DTap/IPV.
Pt did not have an adverse reaction. This nurse gave an expired dose of DTap/IPV.
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| 2831726 | 45 | M | 03/17/2025 |
FLU3 |
SANOFI PASTEUR |
U8515EA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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High dose administered by mistake.
High dose administered by mistake.
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| 2831727 | 1.67 | M | AL | 03/17/2025 |
DTAP PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
9PT2F LG5575 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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Mom reported redness on left thigh, as well as leg swelling on 3/12 at 1021. Mom went to emergency ...
Mom reported redness on left thigh, as well as leg swelling on 3/12 at 1021. Mom went to emergency room at Hospital on same day at 1504. At 2215 that night, mom reported ED wanted them to follow up with us in clinic, they came to a 1530 appointment the next day on 03/13/2025. MD saw patient and explained to mom that it seemed to be a localized reaction that should continue to improve.
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| 2831728 | 92 | F | 03/17/2025 |
UNK |
UNKNOWN MANUFACTURER |
UT8437BA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Med error-incorrectly administered flu vaccine again on 3/6/2025. No adverse reactions observed.
Med error-incorrectly administered flu vaccine again on 3/6/2025. No adverse reactions observed.
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| 2831729 | 17 | F | NY | 03/17/2025 |
MNQ |
SANOFI PASTEUR |
U8369BA |
Condition aggravated, Pyrexia, Seizure
Condition aggravated, Pyrexia, Seizure
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Breakthrough seizure. She took her medications at 7:30AM as per usual. Had a breakthrough seizure ...
Breakthrough seizure. She took her medications at 7:30AM as per usual. Had a breakthrough seizure at 9:00AM. Waited for seizure to stop. Clammy hands post seizure and low grade fever.
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| 2831730 | 1 | F | FL | 03/17/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Pyrexia, Rash
Pyrexia, Rash
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Fever after vaccines. Rash 5 days after vaccines.
Fever after vaccines. Rash 5 days after vaccines.
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| 2831731 | 0.83 | M | IN | 03/17/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Hyperresponsive to stimuli, Infantile back arching, Lethargy, Pyrexia, Tremor
Hyperresponsive to stimuli, Infantile back arching, Lethargy, Pyrexia, Tremor
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At the time, my 10-month-old was fine until that evening, fever spiked 102.7, he became lethargic, s...
At the time, my 10-month-old was fine until that evening, fever spiked 102.7, he became lethargic, shaking and arching his back. Within the five days after, he became very disconnected. He was Un responding to his name, decline in smiles and engagement with parents and others. He was not the same baby and two weeks later is finally back to himself.
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| 2831732 | 61 | F | OH | 03/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood pressure increased, Contusion, Erythema, Local reaction, Nausea
Blood pressure increased, Contusion, Erythema, Local reaction, Nausea
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Localized reaction, with erythema and bruising, elevated Blood pressure, nausea
Localized reaction, with erythema and bruising, elevated Blood pressure, nausea
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| 2831733 | 27 | F | TX | 03/17/2025 |
MMR |
MERCK & CO. INC. |
W032493 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse event rxn. Patient received expired dose - MMR II lot expired 10/11/24
No adverse event rxn. Patient received expired dose - MMR II lot expired 10/11/24
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| 2831734 | 50 | M | NV | 03/17/2025 |
COVID19 FLU3 PNC20 VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
lp1780 u8432aa lc1281 3x97j |
Myalgia, Pain, Pyrexia, Respiratory tract congestion; Myalgia, Pain, Pyrexia, Re...
Myalgia, Pain, Pyrexia, Respiratory tract congestion; Myalgia, Pain, Pyrexia, Respiratory tract congestion; Myalgia, Pain, Pyrexia, Respiratory tract congestion; Myalgia, Pain, Pyrexia, Respiratory tract congestion
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Muscle Aches / Body Pain / Congestion / Fever 99.7 f
Muscle Aches / Body Pain / Congestion / Fever 99.7 f
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| 2831735 | 1.08 | F | NH | 03/17/2025 |
MMR |
MERCK & CO. INC. |
XO11632 |
Cough, Decreased appetite, Pyrexia, Rash maculo-papular
Cough, Decreased appetite, Pyrexia, Rash maculo-papular
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EXATHEMATOUS MACULAPAPULAR RASH ON FACE, SCALP, NECK, CHEST, ARMS, BUTTOCKS AND LOWER LEGS,. PALMS O...
EXATHEMATOUS MACULAPAPULAR RASH ON FACE, SCALP, NECK, CHEST, ARMS, BUTTOCKS AND LOWER LEGS,. PALMS OF HANDS AND TOPS OF FEET SPARED. PT WAS EVALUATED BY PROVIDER, MOTHER TO MONITOR FOR FEVER NOT CONTROLLED BY FEVER REDUCER, COUGH, DECREASED APPETITE, LETHARGY OR CHANGE IN BEHAVIOR AND REACH OUT TO OFFICE WITH ANY OF THESE SYMPTOMS
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| 2831736 | 23 | F | ND | 03/17/2025 |
FLU3 MENB |
SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS |
TFAA2427 2Y393 |
Injection site erythema, Injection site pain; Injection site erythema, Injection...
Injection site erythema, Injection site pain; Injection site erythema, Injection site pain
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Client received Bexsero doses 1 and 2 in 2018 at a different clinic and these doses were invalid due...
Client received Bexsero doses 1 and 2 in 2018 at a different clinic and these doses were invalid due to storage and handling. This dose (counted as her first) was the third time she received Bexsero. Today, she noticed non-raised redness in vaccination arm that extended halfway to her elbow. She denies tenderness (except slight tenderness at injections sites) and itchiness. She has a wellness visit scheduled and so will discuss reaction with her provider.
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| 2831737 | 38 | F | MN | 03/17/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site pain, Ultrasound scan
Injection site pain, Ultrasound scan
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PAIN AT INJECTION SITE- ONGOING
PAIN AT INJECTION SITE- ONGOING
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| 2831738 | 0.33 | M | IA | 03/17/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
2081735 |
Diarrhoea, Rotavirus test positive; Diarrhoea, Rotavirus test positive; Diarrhoe...
Diarrhoea, Rotavirus test positive; Diarrhoea, Rotavirus test positive; Diarrhoea, Rotavirus test positive
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diarrhea for 3-4 weeks after the vaccine
diarrhea for 3-4 weeks after the vaccine
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| 2831739 | 11 | M | SC | 03/17/2025 |
DTAP HPV9 MNQ |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR |
M52GG X024727 U8370AA |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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PATIENT WAS INADVERTENTLY GIVEN DTAP INSTEAD OF TDAP AT 11 YEARS OLD. No Harm or adverse event symp...
PATIENT WAS INADVERTENTLY GIVEN DTAP INSTEAD OF TDAP AT 11 YEARS OLD. No Harm or adverse event symptoms to patient. But at well child visit next year will vaccinate with TDaP.
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| 2831740 | 16 | F | NV | 03/17/2025 |
HPV9 |
MERCK & CO. INC. |
Y008640 |
Extra dose administered
Extra dose administered
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Pt vaccine record was not printed before administration resulting in an extra dose being given
Pt vaccine record was not printed before administration resulting in an extra dose being given
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| 2831741 | 63 | M | VA | 03/17/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ff2587 ff2590 |
Balance disorder, Dizziness, Hydrocephalus, Hypertension, Magnetic resonance ima...
Balance disorder, Dizziness, Hydrocephalus, Hypertension, Magnetic resonance imaging head abnormal; Balance disorder, Dizziness, Hydrocephalus, Hypertension, Magnetic resonance imaging head abnormal
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Dizziness High blood pressure can not maintain balance
Dizziness High blood pressure can not maintain balance
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| 2831742 | 3 | F | CA | 03/17/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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On 3/14/25 at approximately 1pm the patient was given Tdap instead of Dtap.
On 3/14/25 at approximately 1pm the patient was given Tdap instead of Dtap.
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| 2831743 | 56 | F | AZ | 03/17/2025 |
PNC20 |
PFIZER\WYETH |
LG5575 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
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Large area of redness, swelling, itching, and pain to touch around the site of injection (Left delto...
Large area of redness, swelling, itching, and pain to touch around the site of injection (Left deltoid).
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| 2831744 | 23 | F | 03/17/2025 |
HPV9 |
MERCK & CO. INC. |
y014510 |
Local reaction, Skin warm
Local reaction, Skin warm
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Large local reaction, warm to touch and bigger than size of palm.
Large local reaction, warm to touch and bigger than size of palm.
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| 2831745 | 60 | F | ND | 03/17/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
LN5464 LN5464 |
Contusion, Epistaxis, Immune thrombocytopenia, Laboratory test, Migraine; Petech...
Contusion, Epistaxis, Immune thrombocytopenia, Laboratory test, Migraine; Petechiae, Platelet count decreased, Transfusion
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On 2/13/25 pt started having a nosebleed that lasted until the afternoon on 2/14/25. Also had a migr...
On 2/13/25 pt started having a nosebleed that lasted until the afternoon on 2/14/25. Also had a migraine headache. Both of those resolved and then pt noticed bruising and petechiae. Sought medical attention on 2/15/25 and was admitted to the hospital with ITP diagnosis. Platelet count was 5 upon admission. Pt was in hospital for two days and continues to monitor platelet levels which have fluctuated. Pt received FFP in addition to other treatments.
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| 2831746 | 63 | F | MN | 03/17/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL0140 Unknown Unknown GH9697 |
Cough, Dyspnoea, Laboratory test, Pyrexia; Cough, Dyspnoea, Laboratory test, Pyr...
Cough, Dyspnoea, Laboratory test, Pyrexia; Cough, Dyspnoea, Laboratory test, Pyrexia; Cough, Dyspnoea, Laboratory test, Pyrexia; Cough, Dyspnoea, Laboratory test, Pyrexia
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Cough, shortness of breath, intermittent fevers
Cough, shortness of breath, intermittent fevers
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| 2831747 | 8 | M | MA | 03/17/2025 |
TDAP |
SANOFI PASTEUR |
3CA22C1 |
Extra dose administered
Extra dose administered
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Administered what I thought would beTdap #2 using catch-up schedule, I did not account for the Td ad...
Administered what I thought would beTdap #2 using catch-up schedule, I did not account for the Td administered by the panel physician so the Tdap administered on 1/15/2025 is not valid
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