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
2858034 45 M 09/11/2025 UNK
 UNKNOWN MANUFACTURER
 UNK
Atrial fibrillation, Condition aggravated, Palpitations Atrial fibrillation, Condition aggravated, Palpitations
Exacerbation Paroxysmal Atrial Fibrillation; Exacerbation Paroxysmal Atrial Fibrillation; This 45-ye... Exacerbation Paroxysmal Atrial Fibrillation; Exacerbation Paroxysmal Atrial Fibrillation; This 45-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) .5 ml on 08-JUL-2024, for prophylaxis. The subject's past medical history included fecal immunochemical test positive. Previously administered products included Covid-19 mRNA vaccine Pfizer (Subject received Covid-19 mRNA vaccine Pfizer 1st dose on 10-MAR-2021 and 2nd dose on 31-MAR-2021 via intramuscular route for indication of prophylaxis). Concurrent medical conditions included paroxysmal atrial fibrillation, paroxysmal supraventricular tachycardia, hypercholesterolemia, body mass index increased (Elevated), insulin resistance, congenital hypertrophy of the retinal pigment epithelium, generalized anxiety disorder, major depressive disorder, attention deficit hyperactivity disorder, obstructive sleep apnea, achilles tendon injury (left) and back pain. Concomitant products included diltiazem and bupropion. On 14-JUL-2024, 6 days after receiving RSVPreF3 vaccine + AS01E, the subject developed mild - grade 1 paroxysmal atrial fibrillation (Non-serious, Verbatim: Exacerbation Paroxysmal Atrial Fibrillation). Additional event(s) included mild - grade 1 condition aggravated (Verbatim: Exacerbation Paroxysmal Atrial Fibrillation). The outcome of paroxysmal atrial fibrillation was resolved on 18-JUL-2024. The outcome(s) of the additional event(s) included condition aggravated (resolved on 18-JUL-2024). The investigator considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and condition aggravated may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and condition aggravated may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt Date: 08-JAN-2025 and 09-JAN-2025 Subject received IP (Investigational product) 08-JUL-2024. He had a history paroxysmal a fib. Subject reported to his PCP (Primary care physician) on 18-JUL-24 an episode of a fib occurring the "other day" and subject was noted to have an irreg rhythm during that visit 18-JUL-24. Subject only symptom was palpitations. No EKG (electrocardiogram) or other testing was done during or around the episodes. They were self-limited and resolved spontaneously. There were no changes to medication regimen (Subject took 2 tabs of 120mg diltiazem in morning and 1 tab in evening). Principal Investigator did not feel this was related to IP. They would grade it as mild. It was felt that per the protocol this qualifies as non-serious AF episode that meets AESI criteria as it occurred less than 30 days after vaccination. The protocol also states only AF (Atrial fibrillation) meeting SAE (Serious Adverse Event) definition would be reported in electronic Expedited AEs Report and in the specific AF follow-up questionnaire. Non-serious AF would be reported as non-serious adverse event eCRF screen and in the AF follow up questionnaire. Per PI, "the only information available were details of score. There would be no previous calculation different then this one. " CHADS-Vasc CHF-no 0 HTN-no-0 Age- less than 64 is equal to 0 Diabetes-no is equal to 0 Sex-Male 0 Vasc (Stroke/TIA)-no 0 Per PI, Last symptomatic episode was in April 2024. Frequency was rare: Less than monthly, more than yearly. AE was not related to study treatment. SAE was not Related to Study Participation Activities other than Study Treatment This case contains an event assessed by the investigator as a non-serious adverse event of special interest (AESI). This event was Exacerbation of existing Disease. Follow up information received on 14-Jan-2025 Summary of changes: Event verbatim updated from Atrial fibrillation to Exacerbation Paroxysmal Atrial Fibrillation. Additional event added of condition aggravated. Follow up information received on 23-JAN-2025, 27-JAN-2025 Summary of changes: General narrative comments updated. More
2858035 64 M 09/11/2025 COVID19-2
UNK
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
 UNK
UNK
Atrial fibrillation, Chest X-ray, Ejection fraction, Troponin; Atrial fibrillati... Atrial fibrillation, Chest X-ray, Ejection fraction, Troponin; Atrial fibrillation, Chest X-ray, Ejection fraction, Troponin More
Worsening of Atrial Fibrillation; This 65-year-old male subject was enrolled in an open label study.... Worsening of Atrial Fibrillation; This 65-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, right deltoid) 120 ๏ฟฝg on 17-JUN-2024, for prophylaxis. The subject received the 1st dose of Comirnaty omicron XBB.1.5 (intramuscular, right deltoid) 30 ๏ฟฝg on 16-MAY-2024, for prophylaxis. The subject's past medical history included appendectomy. Previously administered products included Covid 19 AstraZeneca (Subject received Covid 19 AstraZeneca 1st dose on 4-DEC-2020 via Intramuscular route for indication of Prophylaxis.). Concurrent medical conditions included attention deficit hyperactivity disorder, back pain and paroxysmal atrial fibrillation. Concomitant products included ibuprofen and gabapentin. On 18-NOV-2024, 154 days after receiving RSVPreF3 vaccine + AS01E and 186 days after receiving Comirnaty omicron XBB.1.5, the subject developed moderate - grade 2 atrial fibrillation aggravated (Verbatim: Worsening of Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis), flecainide, metoprolol succinate, enoxaparin sodium (Lovenox) and zinc. The outcome of atrial fibrillation aggravated was resolved on 18-NOV-2024. Relevant Tests: On an unspecified date in NOV-2024 ECHO (Echocardiogram) demonstrated normal left ventricular size abnormal septal wall motion consistent with intraventricular conduction delay, possible diastolic dysfunction. On an unspecified date in NOV-2024 Cardiac pharmacologic non-stress test showed negative for ischemia. Diagnostic results (reference ranges are provided in parenthesis if available): Chest X-ray- 18-NOV-2024 No acute cardiopulmonary disease (negative). Ejection fraction-In NOV-2024 estimated at 50-55 percent. Troponin- 18-NOV-2024 x3 which were negative and 18-NOV-2024 0.03 ng/mL, (0-0.04). The investigator considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. The company considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. GSK Receipt Date- 09-JAN-2025 and 10-JAN-2025 PI (principal investigator) reached out to subject by phone on 09JAN2025 to review symptoms that led to hospitalization on 18NOV2025. Subject reported a history of intermittent atrial fibrillation. In November, subject stated he woke up one morning and started having symptoms of palpitations, lightheadedness, poor effort tolerance, chest pain and dyspnea. He was admitted to the hospital and cardiology was consulted. They moved him to a different hospital to perform cardioversion; however, prior to cardioversion he went back into sinus rhythm spontaneously. Subject also reported that he received an echocardiogram and a stress test during his stay. He did smoke 1/2 ppd and took a zinc supplement. He was very active; he walked 2-3 miles a day and did manual labor. He was placed on Eliquis and Flecainide during his hospitalization. Subject agreed to sign a medical record release. No known family history of Atrial fibrillation.Update - After reviewing subject's medical records it was discovered that he was admitted from 18-NOV-2024 to 20-NOV-2024. Testing was completed during that time. A 12 lead ECG was obtained; however, the record that was sent was incomplete and not legible. ECG records had been requested to be resent. Subject was also started on metoprolol succinate and enoxaparin sodium during their hospital stay. AE(Adverse event) was not related to study treatment. SAE (Serious adverse event) was not Related to Study Participation Activities other than Study Treatment. This event was Exacerbation of existing Disease. Date event became serious:18-NOV-2024. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 17-JAN-2025 Summary of changes: The event term was updated as Atrial Fibrillation from Worsening of Atrial Fibrillation. Follow up information received on 27-JAN-2025 Summary of changes: The event term was updated as Worsening of Atrial Fibrillation from Atrial Fibrillation. Follow up information received on 18-Feb-2025. Summary of changes: Treatment medications Eliquis and flecainide added. General narrative and lab data was updated. Follow up information received on 14-MAR-2025 Summary of changes: Event start date and hospitalization admission date was updated from unk-DEC-2024 to 18-NOV-2024, Hospitalization details, general narrative and TTO was updated. Concomitant medication and historical vaccine were added. Upon internal review case was updated on 21-MAR-2025 Lab test with unknown results added in relevant test and removed from diagnostic test. Follow up information received on 17-MAR-2025 Summary of changes : Event end date was updated to 20-Nov-2024.Date event became serious was updated from UNK-DEC-2024 to 18-NOV-2024.General narrative was updated. Lab data was updated.Treatment medication Metoprolol Succinate XL and Lovenox were added in product tab. Follow up information received on 21-MAR-2025 Summary of changes : Treatment medication Zinc supplement was added. Follow up information received on 27-MAR-2025 Summary of changes: End date of event was updated to 18-Nov-2024 from 20-Nov-2024. Treatment medication details of Eliquis (start date and end date), Fleccanide (start date) were updated. Follow up information received on 28-MAR-2025 Summary of changes: general narrative was updated. Upon internal review case was updated on 04-APR-2025 Generic name for treatment medication Lovenox was updated to enoxaparin sodium, Lab test pharmacological non-stress test was coded with Cardiac pharmacologic stress test. Follow-up information received on 04-APR-2025 Summary of changes: General narrative comments were updated. Follow-up information received on 07-APR-2025 Summary of changes: Concurrent medical condition Paroxysmal Atrial fibrillation was updated. Upon internal review case was updated on 10-APR-2025 Lab test Cardiac pharmacologic stress test was updated in relevant test section. Follow up information received on 08-Apr-2025. Summary of changes: Lab data of Tropnin 0.03 was added.; Sender's Comments: A case of Atrial fibrillation aggravated, 154 days after receiving the 1st dose of RSVPreF3 vaccine + AS01E and 186 days after receiving 1st dose of Comirnaty omicron XBB.1.5, in a 65-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset. More
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2858036 68 M 09/11/2025 COVID19-2
COVID19-2
COVID19-2
COVID19-2
UNK
UNK
UNK
UNK
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
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Atrial flutter, Blood creatine, Blood iron, Blood potassium, Blood thyroid stimu... Atrial flutter, Blood creatine, Blood iron, Blood potassium, Blood thyroid stimulating hormone; Brain natriuretic peptide, C-reactive protein, Haemoglobin, Iron binding capacity total, N-terminal prohormone brain natriuretic peptide; Platelet count, Red blood cells urine, Serum ferritin, Transferrin saturation, Troponin T; White blood cell count; Atrial flutter, Blood creatine, Blood iron, Blood potassium, Blood thyroid stimulating hormone; Brain natriuretic peptide, C-reactive protein, Haemoglobin, Iron binding capacity total, N-terminal prohormone brain natriuretic peptide; Platelet count, Red blood cells urine, Serum ferritin, Transferrin saturation, Troponin T; White blood cell count More
Paroxysmal Atrial Flutter; This 69-year-old male subject was enrolled in an open label study. The su... Paroxysmal Atrial Flutter; This 69-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, right deltoid) 120 ๏ฟฝg on 06-JUN-2024, for prophylaxis. The subject received the 1st dose of Comirnaty omicron XBB.1.5 (intramuscular, right deltoid) 30 ๏ฟฝg on 06-MAY-2024, for prophylaxis. Concurrent medical conditions included hearing loss unilateral (Right Ear), tinnitus, obstructive sleep apnea (Chronic) and alcohol use disorder. Concomitant products included furosemide (Lasix). On 31-AUG-2024, 86 days after receiving RSVPreF3 vaccine + AS01E and 117 days after receiving Comirnaty omicron XBB.1.5, the subject developed severe - grade 3 paroxysmal atrial flutter (Verbatim: Paroxysmal Atrial Flutter). Serious criteria included hospitalization. The subject was treated with amiodarone, rivaroxaban (Xarelto) and apixaban (Eliquis). The outcome of paroxysmal atrial flutter was not resolved. Relevant Tests: On 2-SEP-2024 ECG (Electrocardiogram): ST Elevations in V4-V5 Telemetry: 15 beat run of nonsustained ventricular tachycardia, 3 min run of atrial flutter, otherwise no significant events, HR predominantly 60s to 80s On 1-SEP-2024 ECHO : Dilated left ventricle w eccentric LVH and left atrial enlargement, severely reduced LVEF (22 percent) w global LV systolic dysfunction, reduced LV global longitudinal peak systolic strain On 1-SEP-2024 ECHO continued : Likely moderate to severe mitral valve regurgitation, moderate right heart enlargement/dysfunction w estimated mild-moderately elevated RV systolic pressures, Mildly dilated ascending aorta. On 31-AUG-2024 CT (Computed tomography)Angio Chest : No CTA evidence of acute aortic syndrome. Small-moderate R and small left pleural effusions w assoc. passive atelectasis of bilateral lower lobes. Mild coronary artery calcifications. On 31-AUG-2024 CR Angio Chest continued : Significant enlargement of the left ventricle measuring at least 6.9 cm intraluminally On 12-SEP-2024, TEE with Cardioversion showed Dialated hypertrophied LV w severly reduced LVEF (25 percent), global wall motion abnormalities, mild RV enl/dysfunction, bi-atrial enl, mod mitral regurgitation, mod tricuspid regurgitation On 03-SEP-2024, Cardiac Catherization showed mild (non-obstructive) CAD, elevated R/L sided filling pressures, reduced cardiac index (Vo2 calculated using Lafarge formula) On 11-SEP-2024, Chest X-Ray Frontal and Lateral Projections showed Lungs: bibasilar airspace opacities, L greater than R, increased from prior, Pleural space: small bilateral effusions, mildly increased from prior, Chest Airways: Normal, Heart/Mediastinum: Unchanged. Diagnostic results (reference ranges are provided in parenthesis if available): Blood creatine- 04-SEP-2024 1.48 mg/dL, (.67-1.17). Blood iron- 13-SEP-2024 170 ug/litre, (450-1700). Blood potassium- 02-SEP-2024 4.6 mmol/L, (3.3-5.1). Blood thyroid stimulating hormone- 02-SEP-2024 .99 m[iU]/mL (.27-4.2). Brain natriuretic peptide- 02-SEP-2024 7346 pg/mL, (0-900). C-reactive protein- 02-SEP-2024 189 mg/L, (0-8). Haemoglobin- 02-SEP-2024 12.9 g/dL, (12.0-17.0). Iron binding capacity total- 13-SEP-2024 2200 ug/litre, (2500-4000). N-terminal prohormone brain natriuretic peptide- 13-SEP-2024 16598 pg/mL, (0-900). Platelet count- 02-SEP-2024 242 x10(3)/uL, (150-450). Red blood cells urine- 02-SEP-2024 32 mm/h, (0-20). Serum ferritin- 13-SEP-2024 875 ng/mL, (20-250). Transferrin saturation- 13-SEP-2024 163 mg/dL, (200-360). Troponin T- 31-AUG-2024 13 ng/L, (0-11) and 13-SEP-2024 28 ng/L, (0-11). White blood cell count- 02-SEP-2024 13.9 x10(3)/uL, (4500-11000). The investigator considered that there was no reasonable possibility that the paroxysmal atrial flutter may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. The company considered that there was no reasonable possibility that the paroxysmal atrial flutter may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. Linked case(s) involving the same subject: US2024153241, US2025015242, US2025015245, US2025041478 GSK Receipt date: 05-FEB-2025 and 17-FEB-2025 Subject was admitted to the hospital on 31Aug2024 and discharged on 05Sep2024. Subject had paroxysmal atrial flutter throughout his hospitalization and was started on xarelto and low dose beta blocker. Paroxysmal atrial flutter (AESI due to Atrial Fibrillation) was all felt to be unrelated to his previous study vaccines (given on 06-MAY-2024 and 06-JUN-2024). Subject prescribed Amiodarone and Rivaroxaban for treatment of Paroxysmal Atrial Flutter. Diagnosis was believed to be related to recent diagnosis of cardiomyopathy. As of EOS (End of Study), adverse event was still ongoing. Addendum. Late entry. Subject's initial diagnosis of CHF(Congestive heart failure) felt to be due to newly diagnosed Cardiomyopathy. Cardiomyopathy was added as AE (adverse event). Cardiomyopathy was felt likely to be secondary to heavy alcohol use. Please refer to progress notes in source. SAE of Paroxysmal Atrial Flutter is a chronic condition therefore, is no end date. AE was not related to study treatment SAE was not Related to Study Participation Activities other than Study Treatment This event is a New Disease. This case contains an event assessed by the investigator as a non-serious adverse event of special interest (AESI). Follow-up information received on 24-FEB-2025 Summary of changes: Lab test updated. Follow-up information received on 06-MAR-2025 Summary of changes: General narrative comments were updated. Follow-up information received on 10-MAR-2025 Summary of changes: Lab data of TIBC, iron, Transferrin Saturation, FERRITIN, TROPONT, NT-pro BNP were updated. Follow-up information received on 11-MAR-2025 Summary of changes: Historical conditions Sleep Apnea / Chronic Obstructive and alcohol use disorder were updated, treatment medication Apixaban (Eliquis) was updated. Follow-up information received on 21-MAR-2025 Summary of changes: Lab data was updated. Follow up information received on 27-MAR-2025 Summary of changes : Lab data was updated. Upon internal review case was updated on 30-MAR-2025 Lab test NT-pro BNP was coded with N-terminal prohormone brain natriuretic peptide instead of Brain natriuretic peptide and RBCU was coded with red blood cells urine. Follow up information received on 02-APR-2025 Summary of changes: General narrative was updated. Upon internal review case was updated on 08-APR-2025 Dose for suspect vaccine was updated from 20 to 120ug Follow up information received on 03-APR-2025 Summary of changes: Lab data K, TSH (Thyroid Stimulating Hormone), HGB and PLAT deleted. Lab units and normal ranges updated. Upon internal review case was updated on 16-APR-2025. AESI statement updated. Follow up information received on 21-APR-2025 Summary of changes: Lab data section updated. Follow up information received on 22-APR-2025 Summary of changes: General narrative comment was updated. Follow up information received on 23-APR-2025 Summary of changes: Lab unit for TSH (Thyroid Stimulating Hormone) was updated to m[iU]/mL Upon internal review case was updated on 25-APR-2025 Lab date for Troponin T was updated from 02-SEP-2024 to 31-AUG-2024 Follow up information received on 28-APR-2025 Summary of changes: General narrative comments updated. Follow up information received on 30-May-2025 Summary of changes: Case upgraded to serious from non-serious. Seriousness criteria Hospitalization updated. Severity of the event upgraded to Severe. General narrative comment, hospital admission date and discharge date updated.; Sender's Comments: A case of Atrial flutter, 86 days after receiving the 1st dose of RSVPreF3 vaccine + AS01E and 117 days after receiving the 1st dose of Comirnaty omicron XBB.1.5, in a 69-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology(alcohol use disorder, newly diagnosed Cardiomyopathy;On 1-SEP-2024 ECHO showed : Dilated left ventricle w eccentric LVH and left atrial enlargement, severely reduced LVEF (22 percent) ,Likely moderate to severe mitral valve regurgitation). US-GSK-US2025015242: US-GSK-US2025015245: US-GSK-US2024153241: US-GSK-US2025041478: More
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2858037 78 F 09/11/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Atrial fibrillation, Bradycardia, Cardiac monitoring, Cardiac stress test normal... Atrial fibrillation, Bradycardia, Cardiac monitoring, Cardiac stress test normal, Chest X-ray normal; Dyspepsia, Echocardiogram normal, Electrocardiogram abnormal, Eructation More
New onset Atrial Fibrillation; This 78-year-old female subject was enrolled in an open label study. ... New onset Atrial Fibrillation; This 78-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) .5 ml on 15-AUG-2024, for prophylaxis. Previously administered products included Influenza vaccine (The subject was received Influenza Vaccine on 25-OCT-2023 via Intramuscular for prophylaxis). Concomitant products included metformin, glimepiride, lisinopril, furosemide, colecalciferol (Vitamin D3), salbutamol sulfate (Ventolin Hfa), biotin, paracetamol (Acetaminophen) and pioglitazone. On 23-JAN-2025, 161 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: New onset Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis). The outcome of atrial fibrillation was resolved on 24-JAN-2025. Diagnostic results (reference ranges are provided in parenthesis if available): Cardiac stress test-In JAN-2025 normal. Chest X-ray-In JAN-2025 no acute lung findings. Echocardiogram-In JAN-2025 normal. Electrocardiogram-In JAN-2025 showing AFib, age heart rate score 5. Heart rate-In JAN-2025 anywhere from low 100s to 130s. 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: 19-FEB-2025 Subject presented to the hospital with new onset AFib (Atrial fibrilation). Did not had any chest pain or palpitations but did had frequent belching and dyspepsia. Cardiac monitor noted that heart rate was anywhere from low 100s to 130s.Subject given one dose of Cardizem which improved heart rate. Subject still bradycardic upon discharge so placed on Eliquis. ECHO (Echocardiogram) and stress test normal and cleared by cardiology and hospital for discharge. AE (adverse event) was not related to study treatment. Hospital Admission date was 23-Jan-2025 Hospital Discharge date was 24-Jan-2025 SAE (serious adverse event) was not Related to Study Participation Activities other than Study Treatment. Date event became serious: 23-Jan-2025 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 26-MAR-2025 Summary of changes: Treatment medication Eliquis was updated, Lab data was updated and General narrative comment was updated.; Sender's Comments: A case of Atrial fibrillation, 161 days after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 78-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (Age, concomitant lisinopril and furosemide). More
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2858038 68 M 09/11/2025 COVID19-2
COVID19-2
UNK
UNK
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Atrial flutter, Blood iron, Brain natriuretic peptide, Iron binding capacity tot... Atrial flutter, Blood iron, Brain natriuretic peptide, Iron binding capacity total, N-terminal prohormone brain natriuretic peptide; Serum ferritin, Transferrin saturation, Troponin T; Atrial flutter, Blood iron, Brain natriuretic peptide, Iron binding capacity total, N-terminal prohormone brain natriuretic peptide; Serum ferritin, Transferrin saturation, Troponin T More
Rapid Atrial Flutter; This 69-year-old male subject was enrolled in an open label study. The subject... Rapid Atrial Flutter; This 69-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, right deltoid) 120 ๏ฟฝg on 06-JUN-2024, for prophylaxis. The subject received the 1st dose of Comirnaty omicron XBB.1.5 (intramuscular, right deltoid) 30 ๏ฟฝg on 06-MAY-2024, for prophylaxis. Concurrent medical conditions included hearing loss unilateral (Right ear), tinnitus, obstructive sleep apnea (Chronic) and alcohol use disorder. Concomitant products included atorvastatin, metoprolol succinate, empagliflozin, rivaroxaban (Xarelto), sacubitril;valsartan (Entresto), spironolactone, furosemide (Lasix), colchicine, apixaban (Eliquis), losartan potassium (Cozaar), valsartan (Diovan), thiamine, folic acid and carvedilol (Coreg). On 10-SEP-2024, 96 days after receiving RSVPreF3 vaccine + AS01E and 127 days after receiving Comirnaty omicron XBB.1.5, the subject developed severe - grade 3 atrial flutter with rapid ventricular response (Verbatim: Rapid Atrial Flutter). Serious criteria included hospitalization. The subject was treated with digoxin. The outcome of atrial flutter with rapid ventricular response was resolved on 14-SEP-2024. Relevant Tests: On 11-SEP-2024 Chest X-Ray Frontal and Lateral Projections showed Lungs: bibasilar airspace opacities, L more than R, increased from prior, Pleural space: small bilateral effusions, mildly increased from prior, Chest Airways: Normal, Heart/Mediastinum: Unchanged On 12-SEP-2024 TEE with Cardioversion showed Dilated hypertrophied LV (left ventricular) w severely reduced LVEF (Left Ventricular Ejection Fraction) (25 percent), global wall motion abnormalities, mild RV (right ventricular) enl/dysfunction, bi-atrial enl, mod mitral regurgitation, mod tricuspid regurgitation.. Diagnostic results (reference ranges are provided in parenthesis if available): Blood iron- 13-SEP-2024 170 ug/litre, (450-1700). Brain natriuretic peptide-In SEP-2024 16k. Iron binding capacity total- 13-SEP-2024 2200 ug/litre, (2500-4000). N-terminal prohormone brain natriuretic peptide- 13-SEP-2024 16598 pg/mL, (0-900). Serum ferritin- 13-SEP-2024 875 ng/mL, (20-250). Transferrin saturation- 13-SEP-2024 163 mg/dL, (200-360). Troponin T- 13-SEP-2024 28 ng/L, (0-11). The investigator considered that there was no reasonable possibility that the atrial flutter with rapid ventricular response may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. The company considered that there was no reasonable possibility that the atrial flutter with rapid ventricular response may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. Linked case(s) involving the same subject: US2024153241, US2025015242, US2025015244, US2025015245 GSK Receipt Date: 07-APR-2025 Per medical records, subject presented 12-Sep at the direction of outpatient cardiologist after being found in acute heart failure likely secondary to rapid atrial flutter with 2:1 conduction. Subject underwent TEE (Transesophageal Echocardiogram)/Cardioversion on 12-Sep which was successful in conversion to NSR(Normal Sinus Rhythm) after one shock. Subject then initiated on oral amiodarone for rhythm control. NICM, (Nonischemic Cardiomyopathy) Moderate MR (Mitral Regurgitation), Moderate TR (Tricuspid Regurgitation), HFrEF (Heart Failure with Reduced Ejection) Exacerbation likely secondary to significant alcohol use; exacerbation likely 2/2 recurrent rapid atrial flutter. Per PI - The diagnosis in the medical records was "Atrial Flutter (by a cardiologist). Since atrial flutter and atrial fibrillation are typically considered in the same medical category, PI (Principal Investigator) considered atrial flutter as an equivalent to atrial fibrillation and reported this as an AESI (Adverse Event of Special Interest). Additionally, the cardiology fellow noted a diagnosis of atrial fibrillation/atrial flutter in a hospital progress note. SAE (Serious adverse event) was not related to study treatment. Hospital Admission date was 12-Sep-2024 Hospital Discharge date was 14-Sep-2024 SAE (serious adverse event) was not Related to Study Participation Activities other than Study Treatment. This a new disease of an existing disease Date event became serious was 10-Sep-2024 Reported medication name Metoprolol Succinate (Toprol XL and Kapspargo Sprinkle) This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information was received on 21-APR-2025 Summary of changes: Lab test Troponin T unit updated from ng/dL to ng/L.; Sender's Comments: A case of Atrial flutter, 96 days after receiving 1st dose of RSVPreF3 vaccine + AS01E and 127 days after receiving 1st dose of Comirnaty omicron XBB1.5, in a 69-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (Concurrent medical conditions included obstructive sleep apnea (Chronic) and alcohol use disorder. Age, h/o Cardiac failure congestive) as per linked case. US-GSK-US2024153241: US-GSK-US2025015244: More
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2858039 71 F ME 09/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
had her first dose of Shingrix, administered in 2018 and her second dose administered on 02-SEP-2025... had her first dose of Shingrix, administered in 2018 and her second dose administered on 02-SEP-2025 longer than recommended interval; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2018). Concomitant products included Fluconazole (Flu). On 02-SEP-2025, the patient received the 2nd dose of Shingrix. On 02-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: had her first dose of Shingrix, administered in 2018 and her second dose administered on 02-SEP-2025 longer than recommended interval). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 04-SEP-2025 The patient self-reported this case for herself. More
2858040 F 09/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; RSV; This serious case was reported by a consumer via call center rep... Suspected vaccination failure; RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy. Linked case(s) involving the same patient: US2025AMR114326 Additional Information: GSK Receipt Date: 01-SEP-2025 This case received from the patient via interactive digital media. The patient had received the RSV vaccine (Arexvy) but still contracted respiratory syncytial virus infection. She inquired whether she should receive an RSV booster. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting. This was 1 of the 2 linked cases reported by the same reporter for her husband.; Sender's Comments: A case of Vaccination failure,an unknown time after receiving Arexvy, in a female 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
2858110 4 M OK 09/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Diarrhoea, Erythema, Swelling, Vomiting Diarrhoea, Erythema, Swelling, Vomiting
Severe swelling and redness, vomiting, diarrhea Severe swelling and redness, vomiting, diarrhea
2858111 4 M CT 09/11/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 52D72
Z008865
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More
Patient began with red and swollen arm the evening of 9/8/25. Localized swelling and redness had inc... Patient began with red and swollen arm the evening of 9/8/25. Localized swelling and redness had increased Tuesday, prompting mom to call our office to report. Area also felt hot to touch. Of note, pt tends to get significant local reaction to bug bites. Parents drew an outline around the redness Monday night, and redness had spread beyond the outline on Tuesday. Advised mom over the phone to make appointment for evaluation of site. Patient also reported the area was itchy. More
2858112 27 F NC 09/11/2025 FLU3
 SEQIRUS, INC.
 388522
Rash pruritic, Urticaria Rash pruritic, Urticaria
An itchy rash began on the face about 30 minutes after vaccine administration. An antihistamine was ... An itchy rash began on the face about 30 minutes after vaccine administration. An antihistamine was taken, which relieved symptoms until about 12 hours later. Around 3 am, I awoke with generalized hives from my neck down to my feet. I was seen by a medical provider and started on a 5-day course of prednisone 20 mg daily, Pepcid AC, Claritin, and Benadryl. The hives slowly improved and fully resolved about 5 days later. More
2858113 3 M NY 09/11/2025 FLU3
 SANOFI PASTEUR
 UT8779LA
Injection site erythema, Injection site rash, Injection site swelling, Injection... Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth More
On the day after administration of vaccine, patient developed increasing redness, swelling and warmt... On the day after administration of vaccine, patient developed increasing redness, swelling and warmth near injection site. Over the course of the day, redness spread. Small bumps developed around injection site with clear fluid. No fevers. More
2858114 0.17 F MO 09/11/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 Vaxelis
HM0310
JT57K
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event More
Patient was giving on 9/10/25 Prevnar 20 that expired in June 2025. No adverse reaction at this ti... Patient was giving on 9/10/25 Prevnar 20 that expired in June 2025. No adverse reaction at this time. More
2858115 79 M PA 09/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
PATIENT RECEIVED THIRD DOSE OF ZOSTER (SHINGRIX). HE COMPLETED DOSES 1 AND 2 ON 11/13/2019 AND 3/18/... PATIENT RECEIVED THIRD DOSE OF ZOSTER (SHINGRIX). HE COMPLETED DOSES 1 AND 2 ON 11/13/2019 AND 3/18/2020, RESPECTIVELY. More
2858116 78 F IN 09/11/2025 FLU3
RSV
 SEQIRUS, INC.
PFIZER\WYETH
 U8847BA
MF2195
Chills, Dizziness, Syncope; Chills, Dizziness, Syncope Chills, Dizziness, Syncope; Chills, Dizziness, Syncope
Pt husband calling to report that pt was in bed shaking with chills and has collapsed twice this mor... Pt husband calling to report that pt was in bed shaking with chills and has collapsed twice this morning. Pt seemed like she might have a seizure, got dizzy and collapsed. Pt rcvd RSV and Flu shot yesterday at appt. More
2858117 62 F WI 09/11/2025 COVID19
 PFIZER\BIONTECH
 my9547
Immunisation reaction, Injection site pain Immunisation reaction, Injection site pain
Patient described "having covid arm" unlike she has had before, sounded like soreness in t... Patient described "having covid arm" unlike she has had before, sounded like soreness in the area of the injection site. More
2858118 19 M IN 09/11/2025 COVID19
 MODERNA
 3046979
Incorrect dose administered Incorrect dose administered
Patient was given the wrong dosage. Patient was given 06 months until 12, instead of 12 years and ol... Patient was given the wrong dosage. Patient was given 06 months until 12, instead of 12 years and older More
2858120 0.17 F WV 09/11/2025 PNC15
PNC20
RV1
 MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 x022475
LX2496
3Z34X
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Vaxneuvance and prevnar 20 were administered with rotarix instead of routine vaxelis, prevnar 20 and... Vaxneuvance and prevnar 20 were administered with rotarix instead of routine vaxelis, prevnar 20 and rotarix at 2 months. More
2858121 80 F SC 09/11/2025 FLU3
 SEQIRUS, INC.
 407253
Injection site nodule, Injection site swelling Injection site nodule, Injection site swelling
Once the injection was given, a swelling and nodule the size of a large grape appeared. Instructed h... Once the injection was given, a swelling and nodule the size of a large grape appeared. Instructed her to see her PCP out of precaution. More
2858122 28 M WI 09/11/2025 HEP
MMR
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 A5DP7
Y015834
Headache, Hyperacusis, Nausea, Pain, Vomiting; Headache, Hyperacusis, Nausea, Pa... Headache, Hyperacusis, Nausea, Pain, Vomiting; Headache, Hyperacusis, Nausea, Pain, Vomiting More
Sudden onset of headache, complaining of white noise and nausea and vomiting. Onset 24 hrs. post vac... Sudden onset of headache, complaining of white noise and nausea and vomiting. Onset 24 hrs. post vaccine administration. More
2858123 4 F PA 09/11/2025 MMRV
 MERCK & CO. INC.
 Y004996
Expired product administered Expired product administered
Patient was to receive the ProQuad vaccine at today's visit - dose and vial were checked by two... Patient was to receive the ProQuad vaccine at today's visit - dose and vial were checked by two RN's prior to administration - following administration, it was noted that the vaccine had expired on 08/26/2025. I called and spoke with employee at company - who stated that based on the information provided, they could support the potency of the vaccine. Called patient mother to make her aware - no answer - left voicemail to return a call to the office More
2858124 49 F MO 09/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4G3X7
Injection site necrosis, Injection site pain, Injection site swelling, Ultrasoun... Injection site necrosis, Injection site pain, Injection site swelling, Ultrasound scan abnormal More
Golf ball sized swelling and pain localized to injection site. Ultra sounded and determined to be ne... Golf ball sized swelling and pain localized to injection site. Ultra sounded and determined to be necrotic. More
2858125 12 M AL 09/11/2025 HPV9
 MERCK & CO. INC.
 Y012776
Bell's palsy Bell's palsy
Bells Palsy, pt being treated with 8 days of orals steriod Bells Palsy, pt being treated with 8 days of orals steriod
2858126 63 F KS 09/11/2025 FLU3
HEP
MMR
TDAP
VARZOS
 SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8832BA
946065
Y017528
PX3P7
ny2at
Erythema, Skin mass, Skin warm; Erythema, Skin mass, Skin warm; Erythema, Skin m... Erythema, Skin mass, Skin warm; Erythema, Skin mass, Skin warm; Erythema, Skin mass, Skin warm; Erythema, Skin mass, Skin warm; Erythema, Skin mass, Skin warm More
Patient came in to pharmacy stating that she had a reaction to vaccine administered yesterday. Arm i... Patient came in to pharmacy stating that she had a reaction to vaccine administered yesterday. Arm is red, warm to touch, and feels like there is a lump under the skin. Vaccines administered in left arm were Tdap, Shingrix, and MMR II. Advised to apply compress, take Tylenol, and follow up with PCP. More
2858127 56 F CT 09/11/2025 FLU3
FLU3
FLU3
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2FAA2502
2FAA2502
2FAA2502
3273H
3273H
3273H
3237H
3237H
3237H
Blood test, Dizziness, Injection site urticaria, Injection site warmth, Pyrexia;... Blood test, Dizziness, Injection site urticaria, Injection site warmth, Pyrexia; Tinnitus; Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia; Blood test, Dizziness, Injection site urticaria, Injection site warmth, Pyrexia; Tinnitus; Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia; Blood test, Dizziness, Injection site urticaria, Injection site warmth, Pyrexia; Tinnitus; Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia More
pt says that her arm has a hive where the shingles vaccine was injected that is hot to the touch. Sh... pt says that her arm has a hive where the shingles vaccine was injected that is hot to the touch. She became extremely dizzy and had fever. She could feel the pulse in her head. She went to ER. She was given fluids and meds to help with the dizziness. She was discharged and to follow up with PCP if her symptoms continued. She was dizzy by the time she got home from the ER. She is still feeling dizzy, her arm is still hot to the touch but her fever is gone. More
2858128 8 F MI 09/11/2025 DTAPIPV
 SANOFI PASTEUR
 U8009AB
No adverse event, Wrong product administered No adverse event, Wrong product administered
DTaP given to 8 year old. It should have been Tdap. There was no adverse reaction. DTaP given to 8 year old. It should have been Tdap. There was no adverse reaction.
2858129 0.58 M WI 09/11/2025 DTAPHEPBIP
MNQ
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH
MERCK & CO. INC.
 9C295
EK7DG
MF0146
2124039
Product administered to patient of inappropriate age, Wrong product administered... Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
lot EK7DG was given, this is the 1-Vial Menveo formulation that is only licensed for ages 10-55 yrs.... lot EK7DG was given, this is the 1-Vial Menveo formulation that is only licensed for ages 10-55 yrs. o This infant should have received the 2-vial menveo formulation, this is licensed for ages 2mo-55 years ((Within ADVOCATE and VFC we use this formulation for ages 2mo 9 yrs.) More
2858130 4 M IL 09/11/2025 MMRV
 MERCK & CO. INC.
 Y010291
Rash, Varicella post vaccine Rash, Varicella post vaccine
This patient received this vaccine and within 48 hours developed a moderately severe varicella rash.... This patient received this vaccine and within 48 hours developed a moderately severe varicella rash. He was evaluated in the ED and not treated or tested. He recovered after 2 weeks uneventfully.none More
2858131 64 M AZ 09/11/2025 COVID19
 MODERNA
Monoplegia Monoplegia
Pt lost nerve function in his hand, unable to completely close the hand after almost a year of thera... Pt lost nerve function in his hand, unable to completely close the hand after almost a year of therapy. initially it was paralyzed and would not close at all. More
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2858132 41 F MS 09/11/2025 COVID19
 JANSSEN
Ear disorder, Tympanic membrane perforation, Vaginal haemorrhage Ear disorder, Tympanic membrane perforation, Vaginal haemorrhage
Vaginal bleeding, burst ear drums bilateral Vaginal bleeding, burst ear drums bilateral
2858133 57 M WI 09/11/2025 COVID19
 PFIZER\BIONTECH
Rash, Rash erythematous, Rash macular Rash, Rash erythematous, Rash macular
I developed a red blotchy rash mainly on my torso and thighs, some spread to my back and arms. I developed a red blotchy rash mainly on my torso and thighs, some spread to my back and arms.
2858134 64 M AZ 09/11/2025 FLU3
 SEQIRUS, INC.
Facial spasm, Paraesthesia oral Facial spasm, Paraesthesia oral
Tingling and spasms in lower lip. Lasted 36 hours. Tingling and spasms in lower lip. Lasted 36 hours.
2858135 0.5 M NM 09/11/2025 VARCEL
 MERCK & CO. INC.
Wrong product administered Wrong product administered
I grabbed the Varicella and not the MMR. I came to the front and drew up the vaccine and gave the v... I grabbed the Varicella and not the MMR. I came to the front and drew up the vaccine and gave the vaccine in the right thigh. When going to input the vaccine i saw that the lot numbers didn't match up I also doubled checked in the freezer and saw that i gave the wrong vaccine I went to inform my manager and she informed me to get with the provider and then the parents. More
2858136 27 F OH 09/11/2025 UNK
 UNKNOWN MANUFACTURER
Dyspnoea, Peripheral swelling, Rash, Urticaria Dyspnoea, Peripheral swelling, Rash, Urticaria
Severe swelling rash/swelling/Hives entire forearm area from elbow to wrist right arm. SOB Severe swelling rash/swelling/Hives entire forearm area from elbow to wrist right arm. SOB
2858137 44 F OH 09/11/2025 FLU3
 SANOFI PASTEUR
Dyspnoea, Wheezing Dyspnoea, Wheezing
SOB/Wheezing w/in 15 min of receiving immunization. I not exactly sure of which influenza vaccine i... SOB/Wheezing w/in 15 min of receiving immunization. I not exactly sure of which influenza vaccine it was. Had to go to physician office. Received steroid injection and breathing tx's. More
2858139 39 F CA 09/11/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Feeling hot, Hot flush, Neuralgia, Pruritus, Rash; Rash erythematous, Temperatur... Feeling hot, Hot flush, Neuralgia, Pruritus, Rash; Rash erythematous, Temperature regulation disorder More
Overheating/temperature regulation issues/hot flashes: started late in the evening day of vaccine la... Overheating/temperature regulation issues/hot flashes: started late in the evening day of vaccine lasted through morning 9/10/25 (3 days later). Itching tops of both feet: started the next day (9/8/25) and is still happening. At night on the right foot it feels a little like nerve pain as it rubs against the sheets. Witch Hazel seems to help the itching. Light wrist rash on interior right arm: Started this morning (9/11/25). It doesn't itch. Just a band of small raised red bumps. So far it doesn't seem to be expanding. More
2858141 73 F MN 09/11/2025 COVID19
 MODERNA
 046A21A
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
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2858142 27 F OH 09/11/2025 MMR
 MERCK & CO. INC.
Dyspnoea, Injection site swelling, Wheezing Dyspnoea, Injection site swelling, Wheezing
Soft ball size swelling at area of injection sob wheezing Soft ball size swelling at area of injection sob wheezing
2858143 86 F PA 09/11/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.
 MY9550
MY9550
407246
407246
Cold sweat, Fall, Feeling abnormal, Head injury, Hyperhidrosis; Pain, Skin lacer... Cold sweat, Fall, Feeling abnormal, Head injury, Hyperhidrosis; Pain, Skin laceration; Cold sweat, Fall, Feeling abnormal, Head injury, Hyperhidrosis; Pain, Skin laceration More
Patient received a flu and COVID vaccine. Patient got up from the chair using her walker and went ab... Patient received a flu and COVID vaccine. Patient got up from the chair using her walker and went about 50 feet to the elevator then fell and hit her head on the wall within 5 minutes of vaccination. Pharmacy vaccination clinic staff and nursing home staff were at the patient's side. 911 was called immediately at 12:09 pm. Pt was not unconscious but dazed, sweaty and clammy, and breathing. An emergency kit was brought to the patient and patient's blood pressure was taken, BP was 180/110. Patient had a bleeding laceration on the back of the head and reported being in pain. As the patient became more aware and conscious she was sat up, pressure applied to the wound, cleaned wounds with nurse from facility, and a gauze wrap/bandage was applied. Staff sat with patient until paramedics arrived. Ambulance arrived at 12:29 PM. Paramedics loaded patient on stretcher to take her to the hospital for further evaluation. More
2858144 46 F OH 09/11/2025 FLU3
 SANOFI PASTEUR
Dyspnoea, Immediate post-injection reaction, Wheezing Dyspnoea, Immediate post-injection reaction, Wheezing
SOB/Wheezing immediately following immunization, I believe I went to Phys office and received steroi... SOB/Wheezing immediately following immunization, I believe I went to Phys office and received steroid injection and breathing tx More
2858145 49 F NC 09/11/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH



Arthralgia, Brain fog, Exercise tolerance decreased, Fatigue, Imaging procedure;... Arthralgia, Brain fog, Exercise tolerance decreased, Fatigue, Imaging procedure; Insomnia, Limb injury, Mobility decreased; Arthralgia, Brain fog, Exercise tolerance decreased, Fatigue, Imaging procedure; Insomnia, Limb injury, Mobility decreased More
SHOULDER RELATED INJURY- SHARP PAIN, LIMITED RANGE OF MOTION - TREATMENT AND PHYSICAL THERAPY JUNE T... SHOULDER RELATED INJURY- SHARP PAIN, LIMITED RANGE OF MOTION - TREATMENT AND PHYSICAL THERAPY JUNE TO JULY 2021 2X A WEEK. NOTHING HELPED SO I AM NOW ON 800 MG IBUPROFIN 3x A DAY EVER SINCE. PVS- FATIGUE, BRAIN FOG, EXERCISE INTOLERANCE AND INSOMNIA ONGOING. NO TREATMENT FOUND. PAIN MANAGEMENT TREATED BY MY PRIMARY CARE DOCTOR. More
2858146 32 F TX 09/11/2025 HPV9
 MERCK & CO. INC.
 Z00K7847
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Immunizer accidently gave an OB patient (G3, P2, 27w 1d, EDD: 12/07/2025) a Gardasil vaccine instead... Immunizer accidently gave an OB patient (G3, P2, 27w 1d, EDD: 12/07/2025) a Gardasil vaccine instead of a Rhogam injection. Immunizer quickly realized the mistake after she gave her the injection and notified doctor. Immunizer and Dr. both made me aware of this incident immediately. Dr. spoke to the patient and gave her some Up To Date HPV exposure in pregnancy literature and also offered to refer her to see a Maternal Fetal Medicine specialist for further testing/counseling to ease her mind. More
2858147 25 F NY 09/11/2025 DTAP
 SANOFI PASTEUR
 U8670BA
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth More
Left arm (deltoid area) is sore, red, warm to touch , itching and swollen. Pt denies any fever. Pt... Left arm (deltoid area) is sore, red, warm to touch , itching and swollen. Pt denies any fever. Pt has tried tylenol and ice with no relief. pt is currently 36 weeks 6 days pregnant. Was advised by office to take Benadryl 25mg PO and update within hour. pt called back, states site decreased in size, itching decreased, remains red and warm to touch. Advised pt to proceed to emergency room for further evaluation. More
2858148 55 F PA 09/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5A4XG
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Red swollen area around injection site approximately 4 inches in circumference. Site is sore & ... Red swollen area around injection site approximately 4 inches in circumference. Site is sore & warm to the touch. More
2858149 21 M VA 09/11/2025 FLU3
 SANOFI PASTEUR
 ut8770ma
Abdominal discomfort, Hyperhidrosis, Malaise, Pallor, Respiratory rate increased Abdominal discomfort, Hyperhidrosis, Malaise, Pallor, Respiratory rate increased
patient was fine following administration. left pharmacy area and was walking around store with car... patient was fine following administration. left pharmacy area and was walking around store with caregiver. patient began to feel poorly about 20-25 minutes following administration. sat down on floor/layed down on floor. pharmacy was notified and went to assess patient. patient was found to be sweaty, pale, rapid breathing stated did not feel well, complained of upset stomach. Applied ice pack to back of patient neck while laying on floor, got patient to slow breathing (in thru nose, out thru mouth). after about 5 minutes patient was breathing better, was able to sit up. kept applying ice pack to back of patient neck. patient felt better enough for some sips of water. after about 15-20 minutes patient felt well enough to get up and was helped to vehicle to go home. Declined assessment by emergency services. More
2858150 32 F NC 09/11/2025 TDAP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 9JT4S
Y015557
Injection site rash, Rash; Injection site rash, Rash Injection site rash, Rash; Injection site rash, Rash
Patient received her first dose of the varicella series and a tetanus vaccination at the health depa... Patient received her first dose of the varicella series and a tetanus vaccination at the health department on 08/12/2025. She reports that 1-2 days later she began to break out in an extensive rash, which appeared in sites all over her body (arms, hands, scalp, etc) some of which was still present during her visit today on 09/09/2025. Patient states that the rash does not itch or burn and started around the injection site of the Varicella vaccine. Patient went to urgent care a couple days (exact time unknown) after the rash started and was advised to make an appointment with an allergy specialist. More
2858151 86 M ND 09/11/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
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2858152 67 F TN 09/11/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Mobility decreased, Neck pain Arthralgia, Mobility decreased, Neck pain
Extreme shoulder back and neck pain to the point I was so much pain I could even move. I have had Co... Extreme shoulder back and neck pain to the point I was so much pain I could even move. I have had Covid shots before and have never experienced this ever. It lasted for approximately one week. There is nothing else that I did that would've caused this. It started within about an hour after I received the vaccine. More
2858153 67 M MN 09/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
PFIZER\BIONTECH
 041B21A
025C21A
031H21A
045L21A
HF9300
Cough, Oropharyngeal pain, Viral test; Cough, Oropharyngeal pain, Viral test; Co... Cough, Oropharyngeal pain, Viral test; Cough, Oropharyngeal pain, Viral test; Cough, Oropharyngeal pain, Viral test; Cough, Oropharyngeal pain, Viral test; Cough, Oropharyngeal pain, Viral test More
Cough, sore throat, Cough, sore throat,
2858154 45 M MI 09/11/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 044B21A
044B21A
023C21A
023C21A
Computerised tomogram, Injected limb mobility decreased, Magnetic resonance imag... Computerised tomogram, Injected limb mobility decreased, Magnetic resonance imaging, Parkinson's disease, Pyrexia; Tremor; Computerised tomogram, Injected limb mobility decreased, Magnetic resonance imaging, Parkinson's disease, Pyrexia; Tremor More
high fever after 1st shot and couldn't pick up right arm for 2 days. had to call into work. aft... high fever after 1st shot and couldn't pick up right arm for 2 days. had to call into work. after 2d shot, tremor developed in right hand as observed by wife first. tremor progressed to right arm. in august 2022, patient diagnosed as parkinson's disease More
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2858155 0.17 F KS 09/11/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 9C295
Y020467
LN4929
7YS93
Decreased eye contact, Eczema infantile; Decreased eye contact, Eczema infantile... Decreased eye contact, Eczema infantile; Decreased eye contact, Eczema infantile; Decreased eye contact, Eczema infantile; Decreased eye contact, Eczema infantile More
WITHIN 2 DAYS OF VACCINES LOST EYE CONTACT, WOULDN'T TRACK PARENTS, WOULDN'T SMILE FOR 4 W... WITHIN 2 DAYS OF VACCINES LOST EYE CONTACT, WOULDN'T TRACK PARENTS, WOULDN'T SMILE FOR 4 WEEKS AFTER THE VACCINES. WITHIN 5 DAYS OF VACCINES GOT SEVERE ECZEMA ON FACE, TRUNK, ARMS, LEGS. More
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