๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

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.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • 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.
  • No Liability: We are not responsible for decisions made based on this data.

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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

โš ๏ธ 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
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2857947 69 M 09/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Asthenia, Atrial fibrillation, Cardiac perfusion defect, Cardioversion, Chest X-... Asthenia, Atrial fibrillation, Cardiac perfusion defect, Cardioversion, Chest X-ray normal; Dyspnoea, Echocardiogram, Ejection fraction normal, Fatigue, Scan myocardial perfusion More
new onset Atrial Fibrillation; This 69-year-old male subject was enrolled in a blinded study. The su... new onset Atrial Fibrillation; This 69-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-JUL-2021, for prophylaxis. Concurrent medical conditions included coronary artery disease. On 06-MAR-2022, 237 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: new onset Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with rivaroxaban (Xarelto). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was not resolved. Relevant Tests: requested records On Unk-Mar-2022 update -chest x-ray showed no evidence of acute cardio pulmonary disease On Unk-Mar-2022 Nuclear stress testing was performed demonstrating " This is a large inferior apical fixed perfusion defect at rest and at stress however with somewhat preserved wall motion suggesting attenuation artifact rather than old inferior MI.... Diagnostic results (reference ranges are provided in parenthesis if available): Ejection fraction-In MAR-2022 50 percent. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. GSK Receipt Date: 22Mar2022 Subject was a 69 yo male with h/o CAD with HFrEF s/p PPM-ICD who had been experiencing intermittent tiredness, weakness, episodes of SOB for weeks. on 3/6/2022,while on vacation , his device alerted he was in Atrial Fibrillation. His cardiologist started Xarelto and follow up on return home. On 3/15/2022 symptoms worsening and went to ED and was found to be in Atrial Fibrillation. He was admitted to the hospital with successful cardioversion to NSR. TEE performed during hospitalization revealed EF of 50%. Nuclear stress testing was performed demonstrating " Clinical correlation recommended this is a low risk stress test without reversible ischemia. He otherwise had an uneventful hospitalization and was discharge on 3/19/2022 to f/u with cardiologist. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI Follow-up information received on 13-APR-2022. This follow-up was considered significant. Summary of Changes: Investigator text updated Follow-up information received on 26-APR-2022. This follow-up was considered significant. Summary of Changes: added diagnostic test. Follow-up Receipt date: 30-Jun-2022. This follow-up was considered significant. Summary of changes: The Outcome and SAE stop date were updated. Follow up information received on 25-Apr-2023. Summary of changes: Action taken for study vaccine updated. Upon internal review the case was updated on 27-Nov-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: AESI sentence added in narrative. Lab data and general narrative updated. Follow up information received on 29-Nov-2023. Summary of changes: Narrative updated. Follow up information received on 20-DEC-2023 Summary of changes: Relevant medical condition updated, General Narrative comments updated. Follow up information received on 02-MAY-2024 Summary of changes: Event onset date was changed from 07-MAR-2022 to 06-MAR-2022 and event outcome was updated from recovered/resolved to not recovered/not resolved. Follow-up information received on 29-May-2024 Summary of changes: End date was updated for Treatment medication Xarelto as ongoing Follow up information received on 04-Jul-2024 End of study unblinding completed.; Sender's Comments: A case of atrial fibrillation, 237 days after receiving 1st dose of RSVPreF3, in a 69-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (known history of coronary heart disease with Heart failure with reduced ejection fraction [HFrEF] ) based on medical history. More
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2857948 73 M 09/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Acute kidney injury, Atrial fibrillation, Blood creatinine increased, Cardiac fa... Acute kidney injury, Atrial fibrillation, Blood creatinine increased, Cardiac failure acute, Catheterisation cardiac abnormal; Dyspnoea, Intracardiac pressure increased, Troponin increased, Weight increased More
A fib with rapid ventricular rate; Acute decompensated heart failure; This 74-year-old male subject ... A fib with rapid ventricular rate; Acute decompensated heart failure; This 74-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 27-AUG-2021, for prophylaxis. The subject's past medical history included myocardial infarction. Concurrent medical conditions included ischemic heart disease, atrial fibrillation, hypertension, congestive heart failure, hypercholesterolemia, coronary artery disease and type ii diabetes mellitus. Concomitant products included acetylsalicylic acid (Aspirin), rivaroxaban (Xarelto), spironolactone, pravastatin, metoprolol, metformin, glimepiride, furosemide and insulin glargine (Insulin Lantus). In 2022, less than 2 years after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 acute decompensated heart failure (Verbatim: Acute decompensated heart failure). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation with rapid ventricular response (Verbatim: A fib with rapid ventricular rate) on 15-SEP-2022 with serious criteria of hospitalization. The outcome of acute decompensated heart failure was resolved on 25-SEP-2022. The outcome(s) of the additional event(s) included atrial fibrillation with rapid ventricular response (resolved on 25-SEP-2022). Diagnostic results (reference ranges are provided in parenthesis if available): Blood creatinine-In SEP-2022 3.3. Troponin-In SEP-2022 elevated. The investigator considered that there was no reasonable possibility that the acute decompensated heart failure and atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the acute decompensated heart failure and atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2021GSK239453, US2022150567 GSK Receipt Date: 22-SEP-2022 Subject was admitted 15 SEP 2022 through 25 SEP 2022 His primary admitting diagnosis was acute decompensated heart failure and secondary diagnosis was atrial fibrillation with rapid ventricular rate. He presented 15 SEP to the hospital with progressive shortness of breath for approximately 10 days. He hadn't been taken Lasix for approximately 10 days and had subsequently gained 7 lbs. He was found to have an elevated troponin but there was no concern for acute MI during this hospitalization. he was found to have atrial fibrillation with rapid ventricular rate and was started on Amiodarone (discontinued due to intolerance by subject) Had a right heart catheterization that demonstrated elevated right sided filling pressures. Developed AKI (creatinine peaked at 3.3) during hospitalization. Acute decompensation of heart failure, afib, and AKI resolved prior to discharge 25 Sep 2022, and he was discharged in stable condition. Follow-up information received on 28-Sep-2022, 29-Sep-2022 this follow-up was consider significant. Summary of changes: event outcome updated Follow-up information received on 19-OCT-2022. Summary of changes: event term and onset date of event were updated. Follow-up information received on 21-OCT-2022. Summary of changes: Investigator text updated. Follow-up information received on 26-OCT-2023, 27-OCT-2023 and 31-OCT-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: Medical history and concomitant medications added. Lab data updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation and Cardiac failure acute, 384 days after receiving 1st dose of RSVPreF3 in a 74-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, alternative risk factors (ischemic heart disease, hypertension, congestive heart failure, coronary artery disease and type ii diabetes mellitus) and alternate etiology (known atrial fibrillation) based in medical history. US-GSK-US2021GSK239453: US-GSK-US2022150567: More
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2857949 72 F 09/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Atrial flutter, Cough, Dyspnoea, Enterovirus infection, Hypoxia; Palpitations, P... Atrial flutter, Cough, Dyspnoea, Enterovirus infection, Hypoxia; Palpitations, Pneumonia viral, Pyrexia, Rhinovirus infection, Wheezing More
atrial Flutter; This 72-year-old female subject was enrolled in a blinded study. The subject receive... atrial Flutter; This 72-year-old female subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular) on 8th July 2021, for prophylaxis. On 8th March 2022, 243 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial flutter. Serious criteria included hospitalization. The outcome of atrial flutter was not recovered/not resolved. The investigator considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vs Placebo. Investigator text: Subject was admitted to the hospital 08 March 2022-20 March 2022 with aflutter. She was eventually found to have Rhinovirus/Enterovirus pneumonia. She had symptoms of dyspnea, cough, wheezing, fever, and hypoxia. At that time, she was noted to be in Atrial Flutter. She was discharged on Eliquis for this. The study participant could not afford Eliquis at discharge and the cardiologist's office (per participant's report) would not call her back about this issue. So she had been without anticoagulation for this condition and is in the process of finding a new cardiologist to manage this. She also had been symptomatic with heart palpitations, so this condition appears to be ongoing. She was withdrawn from the study for this condition as, in my opinion as the PI, it was an unstable chronic illness. GSK Receipt Date : 26SEP2022 Follow-up information received on 29-Sep-2022. This follow-up was considered significant. Summary of changes: Event onset date and Investigator text , hospitalization start and end date and also time to onset for the event Atrial flutter was updated Follow-up information received on 29-Sep-2022. This follow-up was considered significant. Case update: The study ID has been updated. Follow-up information received on 18 Oct 2022 Summary of Changes: narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial flutter, 243 days after receiving 1st dose of RSVPreF3 , in a 72-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. More
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2857950 62 M 09/10/2025 RSV
 UNKNOWN MANUFACTURER
 UNK
Atrial fibrillation Atrial fibrillation
atrial fibrillation; This 64-year-old male subject was enrolled in an open label study. The subject ... atrial fibrillation; This 64-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 15-APR-2021, for prophylaxis. On 12-OCT-2022, 545 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: atrial fibrillation). Serious criteria included hospitalization. The action taken with RSVPreF3 vaccine + AS01E was no change. The outcome of atrial fibrillation was resolved on 13-OCT-2022. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2021216613 GSK receipt date: 14-Oct-2022 Subject was taken to the ER (emergency room) and admitted on 12Oct2022 due to a work injury and diagnosed with atrial fibrillation. Subject discharged to home 13OCT2022 to follow up with PCM (Patient-Centric Mobile). This was an AESI. Follow up information received on 14-DEC-2022. Summary of changes: Investigator text updated. Follow up information received on 10-JUL-2024 Summary of changes: General narrative comments were updated. Follow up information received on 18-JUL-2024 Summary of change : Narrative updated. Upon internal review case was updated on 22-Jul-2024, AESI sentence was added. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of change : Analysis tab was updated. Follow up information received on 15-Aug-2024 Summary of change: General narrative comment updated.; Sender's Comments: A case of Atrial fibrillation, 545 days after receiving 1st dose of RSVPreF3 vs Placebo, in a 64-year old male subject .Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (Hypertension) as per linked case. US-GSK-US2021216613: More
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2857951 66 M 09/10/2025 UNK
 UNKNOWN MANUFACTURER
Atrial fibrillation Atrial fibrillation
Atrial Fibrillation (not exacerbation); This 67-year-old male subject was enrolled in a blinded stud... Atrial Fibrillation (not exacerbation); This 67-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 21-JUL-2021, for prophylaxis. Co-suspect products included clopidogrel bisulfate (Plavix) for coronary artery disease. On 28-JAN-2023, 556 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation (not exacerbation)). Serious criteria included hospitalization. The outcome of atrial fibrillation was resolved on 30-JAN-2023. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Other possible cause(s) of the atrial fibrillation included concurrent medication. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023GSK014869 GSK receipt date: 30-jan-2023 Subject reports he had an Atrial Fibrillation on 28 Jan 2023 and was hospitalized that same night. Subject was still under observation and mentions his physician stated that his medications might have caused this event. Subject was discharged from hospital on 30 Jan 2023. Subject reports he was told to stop taking Plavix. Follow-up information received on 06-Feb-2023. Summary of changes: Action taken updated, Study medication start date, dose number and TTO updated. Follow-up information received on 14-Feb-2023. Summary of changes: event outcome and outcome date was updated. Follow-up information received on 03-MAR-2023. Summary of changes: SAE term updated from Atrial Fibrillation exacerbation to Atrial Fibrillation. Follow-up information received on 15-MAR-2023. Summary of changes: Narrative, hospital discharge date were updated. Follow-up information received on 21-Mar-2023. Summary of changes: Event verbatim updated. Follow-up information received on 28-NOV-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: AESI sentence was updated. Follow-up information received on 04-DEC-2023 Summary of changes: General narrative comments were updated. Follow-up information received on 20-DEC-2023 Summary of changes: General Narrative comments updated. Follow-up information received on 03-JAN-2024 On 28-JAN-2023, 23 years after receiving Plavix, the subject developed moderate grade 2 atrial fibrillation. The investigator considered that there was reasonable possibility that the atrial fibrillation may have been caused by Plavix. Summary of Changes: New medication Plavix was added as cause of AE. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 556 days after receiving 1st dose of RSVPreF3, in a 67-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (h/o concurrent medication clopidogrel bisulfate (Plavix) for coronary artery disease). US-GSK-US2023GSK014869: More
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2857952 83 F 09/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Atrial fibrillation, Cerebrovascular accident, Computerised tomogram head abnorm... Atrial fibrillation, Cerebrovascular accident, Computerised tomogram head abnormal, Electrocardiogram abnormal, Fall; Hemiparesis, Magnetic resonance imaging head abnormal, Mental status changes, Speech disorder More
Atrial Fibrillation; This 83-year-old female subject was enrolled in an open label study. The subjec... Atrial Fibrillation; This 83-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 07-DEC-2022, for prophylaxis. Concomitant products included heparin sodium (Heparin). On 25-JAN-2023, 49 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with atorvastatin calcium (Atorvastatin) and apixaban. The action taken with RSVPreF3 vaccine + AS01E was unknown. The outcome of atrial fibrillation was resolved on 30-JAN-2023. Diagnostic results (reference ranges are provided in parenthesis if available): Computerised tomogram head-In JAN-2023 cerebrovascular accident. Electrocardiogram-In JAN-2023 new onset a-fib. Magnetic resonance imaging head-In JAN-2023 showed cerebrovascular accident. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. GSK receipt date: 10-MAR-2023. Subject presented to emergency dept on 25Jan2023 following a fall and altered mental state. Subject had left sided weakness and abnormal speech. Cause of stroke likely related to new onset atrial fibrillation. subject discharged home on 30jan2023 with instructions to f/u with neurology and start physical therapy. Follow-up information received on 19-APR-2023 Summary of changes: lab data and blinding Status were updated. Follow-up information received on 22-AUG-2023. SAE was not caused by activities related to study participation other than Study Treatment. Hospitalization Admission Date was 25-Jan-2023. Hospitalization Discharge Date was 31-Jan-2023. Summary of changes: SAE term (From Cerebrovascular accident to Atrial Fibrillation) updated, Narrative updated. Follow-up information received on 08-Nov-2023. Summary of changes: New concomitant medication ATORVASTATIN added. Follow up information received on 15-NOV-2023 Summary of changes: Treatment medication apixaban updated. Follow up information received on 22-NOV-2023 Summary of changes: Concomitant drug heparin , type of drug of Atorvastatin was updated from concomitant to treatment. Follow up information received on 06-Dec-2023. Summary of changes: General narrative updated.; Sender's Comments: A case of atrial fibrillation, 49 days after receiving 1st dose of RSVPreF3 vaccine + AS01E, in an 83-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (stroke likely related to new onset atrial fibrillation). More
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2857953 30 F NY 09/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2hj99
Wrong product administered Wrong product administered
Wrong vaccine administered; This non-serious case was reported by a nurse via call center representa... Wrong vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old female patient who received Herpes zoster (Shingrix) (batch number 2hj99, expiry date 04-APR-2027) for prophylaxis. Co-suspect products included Varicella zoster vaccine (Varicella vaccine) for prophylaxis. On 28-JUL-2025, the patient received Shingrix. The patient did not receive Varicella vaccine. On 28-JUL-2025, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the wrong vaccine administered was not applicable. Additional Information: GSK Receipt Date: 13-AUG-2025 A 30-year-old immunocompetent patient had her titers done but since there was no immunity the indication was to received Varicella vaccine. A patient inadvertently received Shingrix instead of the varicella vaccine which led to wrong vaccine administered. The reporter wanted to know if there was any guidance on what to do. More
2857954 F IL 09/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient has not received the 2nd dose yet; This non-serious case was reported by a nurse and descri... patient has not received the 2nd dose yet; This non-serious case was reported by a nurse and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (a 71-year-old female received the 1st dose of Shingrix last year 2024 (unknown date, Lot/Exp date), 0.5 mL administered intramuscularly). The patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has not received the 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable. More
2857955 F CA 09/10/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
missed dose; This non-serious case was reported by a consumer via patient support programs and descr... missed dose; This non-serious case was reported by a consumer via patient support programs and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 2 doses in 2010). The patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: missed dose). The outcome of the incomplete course of vaccination 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: 26-AUG-2025 Customer reported that she might have received Twinrix back in 2010 but that she only received 2 doses. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. More
2857956 09/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rash Rash
rash; This non-serious case was reported by a consumer via interactive digital media and described t... rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced rash (Verbatim: rash). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Herpes Zoster vaccine. It was unknown if the company considered the rash to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 11-AUG-2025 The reporter asked that how long does it last and how do they know when they are not contagious and how long does the rash long. More
2857957 09/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
got shingles the very next day; This non-serious case was reported by a consumer via interactive dig... got shingles the very next day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles the very next day). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine the 1st of 2 and got shingles the very next day. The patient still had to go get the 2nd half. More
2857958 09/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
sick; This non-serious case was reported by a consumer via interactive digital media and described t... sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR110641 Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient got so sick with first vaccine.; Sender's Comments: US-GSK-US2025AMR110641: More
2857959 09/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Dry skin, Herpes zoster, Pain, Pruritus, Vaccination failure; Dry skin, Herpes z... Dry skin, Herpes zoster, Pain, Pruritus, Vaccination failure; Dry skin, Herpes zoster, Pain, Pruritus, Vaccination failure More
Suspected vaccination failure; still got shingles over 4 months ago; This serious case was reported... Suspected vaccination failure; still got shingles over 4 months ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles over 4 months ago). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 01-SEP-2025 The patient got both shingles vaccines and still got shingles over 4 months ago. The pain had gone for the biggest part, but the itchy dry skin continued. Some days the symptoms appeared to be resolved but then the next day or week it comes right back. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine (dose 1 and dose 2), in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2857960 KY 09/10/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Incomplete course of vaccination; Incomplete course of vaccination; Incomplete c... Incomplete course of vaccination; Incomplete course of vaccination; Incomplete course of vaccination; Incomplete course of vaccination More
Forgot to the the 2nd shot; This non-serious case was reported by a consumer via sales rep and descr... Forgot to the the 2nd shot; This non-serious case was reported by a consumer via sales rep and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 16-JUL-2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Forgot to the the 2nd shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:03-SEP-2025 The patient received a shingles (Shingrix) vaccination and forgot to the 2nd shot. The reporter asked can I just get one more now or do I need 2 more. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2857961 09/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; very mild case of Shingles; This serious case was reported by a cons... Suspected vaccination failure; very mild case of Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: very mild case of Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-SEP-2025 The patient had the shots and a very mild case of shingles. The reporter said they were so lucky to have this vaccine available. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2857962 09/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Last year I got Shingles; This serious case was reported by a consume... Suspected vaccination failure; Last year I got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Last year I got Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-SEP-2025 This case was reported by a patient via interactive digital media. Patient got the Shingles shot a few years ago. Last year (in 2024) patient got Shingles. Patient was glad for the shot as patient only had small patch under his/her arm by the arm pits. It still hurt like a bugger. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2857963 09/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; got shingles again; This serious case was reported by a consumer via ... Suspected vaccination failure; got shingles again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles again). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by a friend of the patient via interactive digital media. The reporter mentioned that he/she too got shingles again, after both the vaccines and so did a friend (patient) of his/her. 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. This case was linked with US2025AMR115053, reported by same reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine (doses 1 and 2), in a subject. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR115053:different patient More
2857964 09/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected Vaccination failure; why am I getting shingles; This serious case was reported by a consum... Suspected Vaccination failure; why am I getting shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: why am I getting 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 to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-SEP-2025 This case was reported by a patient via interactive digital media. Patient already had the latest shingles vaccine-both the initial and booster. The patient asked then why he/she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine (doses 1 and 2), in a subject. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2857965 09/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I had the Shingrix and still got shingles; This serious case was repo... Suspected vaccination failure; I had the Shingrix and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (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 had the Shingrix and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 06-SEP-2025 This case was reported by a patient via interactive digital media. 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: A case of Vaccination failure, unknown time after receiving Shingrix, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2857966 F VA 09/10/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9K74F
9K74F
Inappropriate schedule of product administration, Underdose; Inappropriate sched... Inappropriate schedule of product administration, Underdose; Inappropriate schedule of product administration, Underdose More
administered two pediatric doses of Engerix-B to an adult patient; administered two pediatric doses ... administered two pediatric doses of Engerix-B to an adult patient; administered two pediatric doses of Engerix-B to an adult patient; Administration dates were on February 4th 2025 and April 3rd 2025; administered two pediatric doses of Engerix-B to an adult patient; administered two pediatric doses of Engerix-B to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis. Co-suspect products included HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis. On 03-APR-2025, the patient received the 2nd dose of Engerix B pediatric. On 04-FEB-2025, the patient received the 1st dose of Engerix B pediatric. On 04-FEB-2025, not applicable after receiving Engerix B pediatric and an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administered two pediatric doses of Engerix-B to an adult patient) and underdose (Verbatim: administered two pediatric doses of Engerix-B to an adult patient). On 03-APR-2025, the patient experienced adult use of a child product (Verbatim: administered two pediatric doses of Engerix-B to an adult patient), underdose (Verbatim: administered two pediatric doses of Engerix-B to an adult patient) and drug dose administration interval too long (Verbatim: Administration dates were on February 4th 2025 and April 3rd 2025). The outcome of the adult use of a child product, underdose, adult use of a child product, underdose and drug dose administration interval too long 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: 13-AUG-2025 The nurse reported that they administered two pediatric doses of Engerix B to an adult patient (23 years old), which led to adult use of a child product and underdose. The reporter was ask should gave the patient an adult dose, when did had to did it. The health care professional mentioned that patient already had Hepatitis B but did not seroconvert with the first set in 2002 when the patient was a baby. Upon transfer to a second line it was confirmed that Hep B surface antigens were tested in January 2025. The nurse states that Hep B vaccine was received in 2002 and was unknown if it was Engerix-B. She had had the series, and did not seroconvert so this was her second set of shots, the doctor was aware of the error. More
2857967 F TX 09/10/2025 HEPA
HEPA
HEPA
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error More
Administration after a temperature excursion; This non-serious case was reported by a other health p... Administration after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-month-old female patient who received HAV (Havrix) for prophylaxis. On 22-AUG-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a temperature excursion). The outcome of the incorrect storage of drug 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: 28-AUG-2025 On 22nd August 2025, a 12-month-old female patient was given Havrix after temperature excursion which led to incorrect storage of drug.; Sender's Comments: US2025AMR113209:same reporter US2025AMR113210:same reporter US2025AMR113211:same reporter US2025AMR113212:same reporter US2025AMR113213:same reporter US2025AMR113214:same reporter US2025AMR113215:same reporter US2025AMR113216:same reporter US2025AMR113217:same reporter US2025111056:same reporter US2025AMR113219:same reporter US2025AMR113220:same reporter US2025AMR113221:same reporter US2025AMR113222:same reporter US2025AMR113223:same reporter US2025AMR113224:same reporter US2025AMR113225:same reporter US2025AMR113226:same reporter US2025AMR113208:same reporter US2025AMR113231:same reporter US2025AMR113230:same reporter US2025AMR113227:same reporter US2025AMR113228:same reporter US2025AMR113229:same reporter More
2857968 1 M SC 09/10/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 JE9PP
Expired product administered Expired product administered
inadvertent administration of an Expired dose; This non-serious case was reported by a other health ... inadvertent administration of an Expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received MMR (Priorix) (batch number JE9PP, expiry date 01-SEP-2025) for prophylaxis. On 05-SEP-2025, the patient received Priorix. On 05-SEP-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: inadvertent administration of an Expired dose). The outcome of the expired vaccine used was not applicable. It was unknown if the reporter considered the expired vaccine used to be related to Priorix and Priorix Pre-Filled Syringe Device. It was unknown if the company considered the expired vaccine used to be related to Priorix and Priorix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-SEP-2025 The health care provider together with a nurse called to report the inadvertent administration of an expired dose of Priorix vaccine to the patient, which led to expired vaccine used. They wanted to know how to proceed after the incident and if the dose should be considered valid or repeat it. The vaccine administration facility was the same as primary reporter. More
2857969 AZ 09/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Maladministration of the AS01B Adjuvant of Shingrix Alone (Vial and Vial Presentation); Maladministr... Maladministration of the AS01B Adjuvant of Shingrix Alone (Vial and Vial Presentation); Maladministration of the AS01B Adjuvant of Shingrix Alone (Vial and Vial Presentation); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone (Vial and Vial Presentation)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone (Vial and Vial Presentation)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 05-SEP-2025 A pharmacist from a pharmacy distributor reported that a patient from another clinic had received the second dose of Shingrix without reconstitution, only the adjuvant component had been administered, and the lyophilized antigen (powder) had not been included. More
2857972 M NC 09/10/2025 COVID19
 MODERNA
Fatigue, Vaccination site pain Fatigue, Vaccination site pain
had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at ... had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site; had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, eighth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, ninth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, tenth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and eleventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site). At the time of the report, FATIGUE (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) outcome was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had 12 doses of Covid vaccines in the past with similar side effect like some fatigue and mild tenderness at the vaccination site. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to MOD-2025-789111 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2025: Live non-significant follow-up received: Reference added. More
2857973 M NC 09/10/2025 COVID19
 MODERNA
Fatigue, Vaccination site pain Fatigue, Vaccination site pain
Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tendernes... Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site; Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Previous 11 doses) and Spikevax NOS (Previous 11 doses). Past adverse reactions to the above products included Fatigue with Spikevax NOS; and Vaccination site tenderness with Spikevax NOS. In March 2025, the patient received twelfth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site). At the time of the report, FATIGUE (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were provided. The patient Doctor did not want to prescribe the vaccine for unknown reasons. Patient finally managed to get vaccinated at a pharmacy. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to MOD-2025-789111 (Patient Link). More
2857974 78 09/10/2025 COVID19
 MODERNA
Neoplasm malignant Neoplasm malignant
Recently finished cancer treatment; This spontaneous case was reported by a consumer and describes t... Recently finished cancer treatment; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Recently finished cancer treatment) in a 78-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Recently finished cancer treatment) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Recently finished cancer treatment) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient was due for another shot on September 27th. The patient did not know whether to go ahead and get the existing mNexspike then if ACIP had not acted. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: Lack of information on patient๏ฟฝs medical history, concomitant medication and latency precludes a more meaningful assessment. Further information is being requested. The benefit-risk relationship of product is not affected by this report. More
2857975 F 09/10/2025 COVID19
 MODERNA
Neoplasm malignant Neoplasm malignant
having a cancer; This spontaneous case was reported by a consumer and describes the occurrence of NE... having a cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (having a cancer) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (having a cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (having a cancer) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication use information was not provided by reporter. The patient had cancer and received Moderna COVID-19 shots before. It was not specified if the cancer developed after the Moderna COVID-19 shots. The reporter narrated that now some pharmacies required a prescription, even though the patient qualified because she was over 65 and a cancer patient. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter.; Reporter's Comments: Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2857976 F 09/10/2025 COVID19
 MODERNA
Dysstasia, Fatigue Dysstasia, Fatigue
Just can't get up without my help with my husband; Feeling very tired; This spontaneous case wa... Just can't get up without my help with my husband; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Just can't get up without my help with my husband) and FATIGUE (Feeling very tired) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (Just can't get up without my help with my husband) and FATIGUE (Feeling very tired). At the time of the report, DYSSTASIA (Just can't get up without my help with my husband) and FATIGUE (Feeling very tired) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. No concomitant medication was reported. The patient had moderna flu shot and felt very tired and unable to get up without help with her husband. No treatment medication was reported. More
2857977 76 F 09/10/2025 COVID19
 MODERNA
Chills, Pyrexia Chills, Pyrexia
she experienced side effects after taking the Moderna vaccine, including chills and fever; she exper... she experienced side effects after taking the Moderna vaccine, including chills and fever; she experienced side effects after taking the Moderna vaccine, including chills and fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (she experienced side effects after taking the Moderna vaccine, including chills and fever) and CHILLS (she experienced side effects after taking the Moderna vaccine, including chills and fever) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PYREXIA (she experienced side effects after taking the Moderna vaccine, including chills and fever) and CHILLS (she experienced side effects after taking the Moderna vaccine, including chills and fever). At the time of the report, PYREXIA (she experienced side effects after taking the Moderna vaccine, including chills and fever) and CHILLS (she experienced side effects after taking the Moderna vaccine, including chills and fever) had resolved. No concomitant medication was reported. She had always received the Moderna COVID-19 vaccine and experienced side effects after taking the Moderna vaccine, including chills and fever, which occurred a year ago. The patient did not have her vaccination record with her. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. Reporter did not allow further contact More
2857978 F NC 09/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
I am positive; I am positive; This is a spontaneous report received from a Consumer or other non HCP... I am positive; I am positive; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: I have a history of asthma; "I am a cancer survivor" (unspecified if ongoing), notes: I told you that I had cancer, well then I have some conditions. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Sep2025, outcome "unknown" and all described as "I am positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Sep2025) positive, notes: my husband had a little box of the test, and it turns out, I am positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Brief Description of event: COVID After Paxlovid. Event description (include event onset and end dates and event outcomes, whenever possible):During an inbound call for financial assistance, the patient, (name), stated, "she had COVID, she got the COVID vaccine on the 15th, which she was due to get. she got it in (name). She had been traveling here for a few days, and that was on the 15th. On Monday night, she started to feel a little bad, and on Tuesday, she woke up terribly, and she took the test on Wednesday. She thought it might've been something else on Wednesday, which it was last night, her husband had a little box of the test, and it turns out, she was positive. She was 78 years old she had a history of asthma. She had always gotten the Moderna that vaccine, but well, Pfizer was very good too, and here they didn't have Moderna, and she said no, give her Pfizer, since it was very good too, so she received her vaccine. Well, then Wednesday, last night, her husband gave her the test, and indeed, she had COVID. She was a cancer survivor; in addition, she had asthma, so she was the age, the asthma, and the cancer. So, she was very afraid because she don't even have her family there, and her doctor called (name), which was where she received the vaccine, and he told her you hurry and take the Paxlovid pills. So, he sent the order, and she went out because she was feeling terrible, she went out to look for i. She called her insurance and they told her, look, understand, the only thing they can do for her was give her this person who has a program to see if they can help her, because she was running a huge risk like this she was not at home, she don't have her family, and with all the risk that she had" When being offered the enrolment options, (name) stated, "she was 78 years old, she feel like a dog but look how she was now, she don't feel up to go in-what she had is an (name), with this discomfort that she had, she was having too many difficulties to breathe. She'd rather talk to a human, not with the computer, that's all it's going to stress her and she was going to put her worse.She don't have the money to pay (dollar) for a pill. She'll tell them, 8 more or less or 9 months ago, her granddaughter got the A-Flu, and she, without knowing it was so contagious, she got close to her, she kissed her, rubbed and everything that was 8 or 9 months ago. When her son gets from work, he says 'Mom, what he was doing? they can get sick. What were they thinking? Go hurry call to (name).' Who was her primary doctor? She called him and he sent me Paxlovid, and it cost her (name), that was 8 months ago. She was terribly afraid that she'll drown and die here like an idiot" When asked if this was the address where she resides, (name) stated, "Well, look, she was here because her husband was working here, but it's not permanent. When confirming that was her address, she asked for a moment, and (name) can be heard in the background stating, "she was really sick, she think she had COVID. She feel really sick, she was kind of drowning, and she don't want to infect them. She don't want them to come in and get sick" Then (name) and states, "She can't receive anyone, nor open the door, nor infect them with this disease" When asked to confirm if she has a prescription for the medication, (name) stated, "Yes, yes, everything, and today was the last day that the doctor wants her to take it because then afterwards she can't." When being explained about the program income requirement, (name) stated, "she was retired. she's an old lady. She was a decorator. She was left without of job, so like she told them that she had cancer, well then she had some conditions because she had 36 radiotherapies on the rectum and then they burned her rectum guts, they burned her bladder, they know, those were damages that appear later on, so she can't be working a lot either. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2857979 M SC 09/10/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



COVID-19, Vaccination failure; Aneurysm, Nodule; COVID-19, Vaccination failure; ... COVID-19, Vaccination failure; Aneurysm, Nodule; COVID-19, Vaccination failure; Aneurysm, Nodule More
COVID after Pfizer COVID shot; COVID after Pfizer COVID shot; This is a spontaneous report received ... COVID after Pfizer COVID shot; COVID after Pfizer COVID shot; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization Series Completed.), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer COVID shot". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2857982 13 F MD 09/10/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE reported.; patient received her first dose of GARDASIL 9 on 03SEP2014 "when sh... No additional AE reported.; patient received her first dose of GARDASIL 9 on 03SEP2014 "when she was 13 years old", she received her second dose on 20AUG2018 and her third dose on 26JUN2025 and is now 24 years old; This spontaneous report was received from a Nurse and refers to a 24-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-Sep-2014, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, (dose 1), (lot # and expiration date were not reported); On 20-Aug-2018, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 2, (dose 2), (lot # and expiration date were not reported) and finally, on 26-Jun-2025, with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 3, (dose 3), (lot # and expiration date were not reported). All the doses administered as prophylaxis. The reporting nurse called and reported that there was a patient that wanted to know if she needed any additional doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) or if the series needed to be restarted. Because the patient received her first dose "when she was 13 years old" and she received her third dose now at 24 years old. No additional adverse events were reported. More
2857983 F CA 09/10/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Exposure during pregnancy, Foetal heart rate abnormal, Secondary transmission, S... Exposure during pregnancy, Foetal heart rate abnormal, Secondary transmission, Stillbirth; Exposure during pregnancy, Foetal heart rate abnormal, Secondary transmission, Stillbirth More
secondary transmission; Information has been received from a 31-year-old female consumer with a hist... secondary transmission; Information has been received from a 31-year-old female consumer with a history of varicella. It was noted that the woman had been pregnant and testing prior to pregnancy confirmed that she previously had varicella. She had no known allergies, no significant medical history and was not on any medications. On 09OCT2000, her sixteen-month-old son was vaccinated with varicella virus vaccine live and measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD). At the time of her son's vaccination, she was 36.5 weeks pregnant. On 23OCT2000, her unborn baby had no heartbeat and was still born. On an unspecified date, the patient was hospitalized. Additional information is not expected. This is an amended report. (MSD) has been added after measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) in the narrative. This is an amended report, the event of fetal death and maternal exposure were deleted.; Reported Cause(s) of Death: still born More
2857985 F 09/10/2025 COVID19
 PFIZER\BIONTECH
Chills, Pyrexia Chills, Pyrexia
received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; ... received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (dose 1, single), for Covid-19 immunization, reaction(s): "Chills", "fever"; Bnt162b2 nos (dose 2, single), for Covid-19 immunization, reaction(s): "Chills", "fever"; Bnt162b2 nos (dose 3, single), for Covid-19 immunization, reaction(s): "Chills", "fever". The following information was reported: CHILLS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever". Additional information: A consumer inquired whether the COMIRNATY (2025-2026 Formula) includes the new variant Stratus or the current variant. Another inquiry was made regarding the difference between the 2024-2025 and 2025-2026 formulations. Additionally, the consumer reported having received five prior COVID-19 vaccines with similar side effects, including chills and slight fever, and asked whether the current 2025-2026 formulation would cause the same side effects. In a separate inquiry, the consumer asked whether individuals aged 5 through 64 years who work as privacy are eligible to receive the vaccine or if a doctor's prescription is required. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500176826 same patient, different doses; More
2857987 M 09/10/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
shoulder started getting sore; felt sore/prior experience with previous administration; This is a sp... shoulder started getting sore; felt sore/prior experience with previous administration; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "shoulder started getting sore", "shoulder started getting sore"; Comirnaty (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "shoulder started getting sore", "shoulder started getting sore"; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "shoulder started getting sore", "shoulder started getting sore". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder started getting sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt sore/prior experience with previous administration". Additional information: Patient's arm and shoulder started getting sore as it has on previous occasions. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2857988 M FL 09/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Decreased appetite, Drug ineffective, SARS-CoV-2 antibody test COVID-19, Decreased appetite, Drug ineffective, SARS-CoV-2 antibody test
I did get the Pfizer shots, COVID shots back in 2020, but I got COVID; I did get the Pfizer shots, C... I did get the Pfizer shots, COVID shots back in 2020, but I got COVID; I did get the Pfizer shots, COVID shots back in 2020, but I got COVID; I'm no longer hungry/I don't have the appetite at all; This is a spontaneous report and received from Consumer or other non HCPs. A 60-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I did get the Pfizer shots, COVID shots back in 2020, but I got COVID"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I'm no longer hungry/I don't have the appetite at all". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: positive, notes: that's when he ended up taking the COVID test, because he's been there for about a week now. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID after Pfizer Shots. Event Description (include event onset and end dates and event outcomes, whenever possible): During an inbound call for financial assistance, the patient's nephew, (withheld) advised, "He was calling because his uncle tested positive. They contacted his doctor's office. His doctor's office put in for Paxlovid." Later while gathering the patient's demographics to search for the patient's account, (withheld) stated, "He's a resident of (withheld), but he's currently visiting family in (withheld), and that's when he ended up taking the COVID test, because he's been there for about a week now." Later, after conferencing the patient (withheld) to the call. While on hold, (withheld) asked the patient (withheld), "He have been eating anything at least?" (withheld) replied, " Not much, he had been definitely hydrating himself a lot, but he know that when he go back home, he bet him he was going to be under weight. He think when he got back home. He was going to be under weight" (withheld) also stated, "He mean he was eating, he was forcing himself to eat a little bit, but he was no longer hungry, the only thing he had been doing, he had been hydrating himself though. So that he had been doing a lot of." Then (withheld) asked, " So he haven't been eating a whole meal?" (withheld) replied, "No. Like he eat like, he don't know, maybe 1 and a half meals a day." (withheld) also added, "No, he don't have the appetite at all. Even the oatmeal he struggled to eat. Yep and that doesn't happen too much." Later, while holding, (withheld) stated, " he did get the Pfizer shots, COVID shots back in 2020, but he got COVID." Later on (withheld) can heard speaking to someone in the back ground, (withheld) stated, "just coughing." Suspect Pfizer Product(s): Pfizer Product Name: COVID Shots. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2857990 NM 09/10/2025 TDAP
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
94 years old was prescribed Adacel with no reported adverse event; Initial information received on 0... 94 years old was prescribed Adacel with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 94-year-old and unknown gender patient who was prescribed Diphtheria-2/Tetanus/5 AC Pertussis vaccine [ADACEL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, a 94-year-old patient was prescribed a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection (frequency-once) (lot number, strength and expiry date-unknown) via intramuscular route in unknown administration site for protection against tetanus, diphtheria, and pertussis disease (Immunisation) with no reported adverse event (off label use). Reportedly- As per package insert, Adacel is approved for use in persons 10 yrs through 64 years of age Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. More
2857992 79 F WA 09/10/2025 COVID19
 MODERNA
 3052030
Contusion Contusion
patient came back on 9/10/25 to ask about her bruise. looks like bruise on her right deltoid area. patient came back on 9/10/25 to ask about her bruise. looks like bruise on her right deltoid area.
2857993 56 F NC 09/10/2025 PNC20
RSV
VARZOS
 PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 MA2523
MD5465
3E27G
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa... Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm More
Patient called on Saturday 09/06/25 complaining of her left arm with redness, swelling, and warm to ... Patient called on Saturday 09/06/25 complaining of her left arm with redness, swelling, and warm to touch. Patient got Prevnar 20 and shingrix on the left arm. Patient was advised to put ice and take some ibuprofen for pain by the pharmacist on duty that morning. Patient did visit urgent care on 09/06/25 and was prescribed antibiotics. Follow up phone call was made to customer on 09/10/25, she is doing much better and is feeling well and she did visit her PCP on 09/10/25 for additional consult. She is doing much better now and the swelling and redness is resolving. More
2858011 17 M OH 09/10/2025 MNQ
 SANOFI PASTEUR
CSF immunoglobulin increased, CSF protein increased, Guillain-Barre syndrome, Pa... CSF immunoglobulin increased, CSF protein increased, Guillain-Barre syndrome, Paraesthesia More
Child started with tingly fingers and toes. After pediatrician mis diagnosed and the Dr. was not hea... Child started with tingly fingers and toes. After pediatrician mis diagnosed and the Dr. was not hearing my concerns we went to the ER More
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2858012 78 F FL 09/10/2025 PNC20
 PFIZER\WYETH
 LX4486
Extra dose administered Extra dose administered
patient was given a second dose of prevnar 20 when only one dose is recommended. First dose given 09... patient was given a second dose of prevnar 20 when only one dose is recommended. First dose given 09/23/20222 More
2858013 12 F AZ 09/10/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052583
u8823aa
Seizure, Tremor; Seizure, Tremor Seizure, Tremor; Seizure, Tremor
1 minute after administration of vaccinations patient had a seizure with her head knocking back and ... 1 minute after administration of vaccinations patient had a seizure with her head knocking back and legs going up shaking. seizure lasted about 30 seconds. after seizure patient was seen visibly shaking. we called paramedics to have her evaluated. she got an IV and was taken to the hospital for further diagnosis More
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2858014 9 M MN 09/10/2025 FLU3
 SEQIRUS, INC.
 948404
Dizziness, Syncope Dizziness, Syncope
Patient fainted about 5 minutes after receiving the shot. After patient received the shot. he decid... Patient fainted about 5 minutes after receiving the shot. After patient received the shot. he decided to stand up while his parents were getting their shots. About 5 minutes later, he said he felt dizzy and before we could get to him to sit down, he start falling backwards between the father and I. We caught him and laid him down. He recovered right away and we gave him water to drink and sat in the lobby for fresh air. He was monitored for about 15 minutes, regained his color and felt better afterwards. They left the store with himself walking with his parents. More
2858015 63 M WA 09/10/2025 FLU3
 SANOFI PASTEUR
 UT8763FA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
pt is only 63 years old, instead of 65. pt is only 63 years old, instead of 65.
2858016 76 M FL 09/10/2025 FLU3
 SANOFI PASTEUR
 u8855da
Injected limb mobility decreased, Pain, Pain in extremity Injected limb mobility decreased, Pain, Pain in extremity
Sharp shooting pain in left arm. Unable to move arm or reach behind back. Sharp shooting pain in left arm. Unable to move arm or reach behind back.
2858017 84 F GA 09/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 4ya34
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse events noted. Duplication of vaccine given in error. 1st dose given 4/2/2025 & repeat... No adverse events noted. Duplication of vaccine given in error. 1st dose given 4/2/2025 & repeated in error 9/5/2025. More
2858018 12 M CA 09/10/2025 HPV9
 MERCK & CO. INC.
 Z002580
Dizziness, Loss of consciousness, Syncope Dizziness, Loss of consciousness, Syncope
Dizziness, syncopal event with loss of consciousness for less than 10 seconds. Patient was placed in... Dizziness, syncopal event with loss of consciousness for less than 10 seconds. Patient was placed in recumbent position, provided juice to drink and monitored. Returned to baseline within a few minutes. More
2858019 63 F CA 09/10/2025 FLU3
VARZOS
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 406986
23AH3
Injection site erythema, Injection site pain, Injection site rash, Injection sit... Injection site erythema, Injection site pain, Injection site rash, Injection site warmth; Injection site erythema, Injection site pain, Injection site rash, Injection site warmth More
Patient reports developing a rash on right arm, about 3 inches away from injection site and approxim... Patient reports developing a rash on right arm, about 3 inches away from injection site and approximately 3x2 inches in size. Patient states feeling a burning sensation and itching at location of rash, and reports the skin is warm and red. At time of report six days total have passed since date of administration. Use of Benadryl and topical hydrocortisone was recommended by pharmacy at this time. More
2858020 40 M CO 09/10/2025 FLU3
TDAP
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 406986
h4k35
Injected limb mobility decreased, Injection site discolouration; Injected limb m... Injected limb mobility decreased, Injection site discolouration; Injected limb mobility decreased, Injection site discolouration More
Round yellowish discoloration around the vaccinated area. patient says he is having difficulty movin... Round yellowish discoloration around the vaccinated area. patient says he is having difficulty moving his arm after 8 days of vaccination. More
2858021 68 F OR 09/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3273H
Furuncle Furuncle
Patient developed boils on the left foot while in the facility. When she reached home, there was 4 ... Patient developed boils on the left foot while in the facility. When she reached home, there was 4 boils on the left foot which resolved by itself in 7 days. More
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