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
2836200 M SC 04/15/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Intercepted product prescribing error Intercepted product prescribing error
prescription for Bexsero for a patient that is older than 25; This non-serious case was reported by ... prescription for Bexsero for a patient that is older than 25; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 32-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: prescription for Bexsero for a patient that is older than 25). The outcome of the intercepted drug prescribing error 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: 04-APR-2025 Other HCP reported that a prescription for Bexsero for a patient that was older than 25 but the doctor send it specifically, because he was trying to get a transplant so, he was getting lots of vaccines. The one they got was, they noticed that it said that it was up to 25, which led to intercepted drug prescribing error. So they wanted to know if he still get that one, they were requiring him to get a meningococcal vaccine. More
2836201 18 F 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3T5L9
Expired product administered Expired product administered
Engerix B Administration of expired vaccine; This non-serious case was reported by a nurse via call ... Engerix B Administration of expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis. On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix B Administration of expired vaccine). The outcome of the expired vaccine used 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: 04-APR-2025 A nurse practitioner mentioned that patient received an expired dose of Engerix-B yesterday on 03 April 2025 which led to Expired vaccine used. The nurse asked if the patients should be re vaccinated.; Sender's Comments: US-GSK-US2025040981:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient US-GSK-US2025040987:same reporter/ Different patient US-GSK-US2025040989:same reporter/ Different patient US-GSK-US2025040991:same reporter/ Different patient More
2836202 M 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3T5L9
Expired product administered Expired product administered
Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via ca... Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis. On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Administration of expired vaccine.). The outcome of the expired vaccine used 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: 04-APR-2025 The nurse practitioner mentioned that a patient received an expired dose of Engerix-B on 3rd April 2025 which led to expired vaccine used. The nurse asked if the patients should be re vaccinated. This case was one of 5 cases, reported by same reporter; Sender's Comments: US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient US-GSK-US2025040981:same reporter/ Different patient US-GSK-US2025040987:same reporter/ Different patient US-GSK-US2025040989:same reporter/ Different patient More
2836203 16 M 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3T5L9
Expired product administered Expired product administered
Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via ca... Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis. On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Administration of expired vaccine.). The outcome of the expired vaccine used 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: 04-APR-2025 The nurse practitioner mentioned that a patient received an expired dose of Engerix-B on 3rd April 2025 which led to expired vaccine used. The nurse asked if the patients should be re vaccinated. The case is 1 of the 5 linked case, by same reporter.; Sender's Comments: US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient More
2836204 F WA 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 95D74
Expired product administered Expired product administered
Engerix-B expired dose; This non-serious case was reported by a other health professional via call c... Engerix-B 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 9-month-old female patient who received HBV (Engerix B) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis. On 04-APR-2025, the patient received Engerix B. On 04-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B expired dose). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 04-APR-2025 Other HCP reported that an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used. More
2836205 18 F TX 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 EP724
Expired product administered, Inappropriate schedule of product administration Expired product administered, Inappropriate schedule of product administration
expired vaccine administered; Late second dose; This non-serious case was reported by a nurse via ca... expired vaccine administered; Late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 25-MAR-2025, the patient received the 2nd dose of Engerix B. On 25-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired vaccine administered) and drug dose administration interval too long (Verbatim: Late second dose). The outcome of the expired vaccine used 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: 04-APR-2025 Nurse explained that an 18-year-old patient got an expired dose of Engerix- B on March 25th 2025, the vaccine expired on March 14th 2025,which led to expired vaccine used. Patient received 1 prior dose of Engerix-B on January 14th 2025. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2836206 17 M MA 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 553J7
Expired product administered Expired product administered
Expired dose administered; This non-serious case was reported by a nurse via call center representat... Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HBV (Engerix B) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis. On 07-APR-2025, the patient received Engerix B. On 07-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used 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: 07-APR-2025 Nurse explained that they administered an expired dose of Engerix-B to a patien, which led to expired vaccine used. The reporter consented to follow up. More
2836207 KS 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
expired drug used; This non-serious case was reported by a consumer via sales rep and described the ... expired drug used; This non-serious case was reported by a consumer via sales rep and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used 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: 08-APR-2025 The field representative reported a healthcare office inadvertently administered an expired pediatric dose of Engerix-B which led to expired vaccine used. GSK rep called this report in one callback placed to the reporting HCP but did not reach her. More
2836208 M NY 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 79S54
Incorrect dose administered Incorrect dose administered
Inappropriate dose; Inappropriate dose; This non-serious case was reported by a nurse via call cente... Inappropriate dose; Inappropriate dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis. On 03-APR-2025, the patient received the 1st dose of Engerix B adult. On 03-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Inappropriate dose) and adult product administered to child (Verbatim: Inappropriate dose). The outcome of the overdose and adult product administered to child 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: 08-APR-2025 The reporter called to inform that he/she had a 19-year-old patient that received the adult dose of Engerix-B, which led to overdose and adult product administered to child. According to reporter, such dose was the 1st of the series and was administered in 3rd April 2025. Also, according to reporter, the patient was going to turn 20 years-old in 15th May 2025. The reporter consented to follow up. More
2836209 12 F SD 04/15/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9KB9G
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
12-year-old patient was administered Infanrix; This non-serious case was reported by a nurse via cal... 12-year-old patient was administered Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number 9KB9G) for prophylaxis. On 10-MAR-2025, the patient received Infanrix. On 10-MAR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 12-year-old patient was administered Infanrix). The outcome of the inappropriate age at vaccine administration 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: 08-APR-2025 Nurse stated that a 12-year-old patient was administered Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Healthcare professional did not have expiration date at the time of the call. More
2836210 0.5 M SD 04/15/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT9T
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
6-month-old patient was administered Kinrix; This non-serious case was reported by a nurse via call ... 6-month-old patient was administered Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT9T) for prophylaxis. On 17-MAR-2025, the patient received Kinrix. On 17-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6-month-old patient was administered Kinrix). The outcome of the inappropriate age at vaccine administration 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: 08-APR-2025 The nurse stated that the 6-month-old patient was administered Kinrix which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. More
2836211 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and... Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose over a year ago). On 08-APR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 08-APR-2025 Reporter stated that a patient missed their second Shingrix dose. Patient went on the day of reporting for a Shingrix vaccine and saw they were over a year overdue. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2836212 65 M VA 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2P359
Inappropriate schedule of product administration Inappropriate schedule of product administration
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center repres... Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 2P359, expiry date 16-JUN-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 14-SEP-2022). On 08-APR-2025, the patient received the 2nd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date:08-APR-2025 The Vaccine Administration Facility was the same as Primary Reporter. Only one lot number and expiration date were provided. The agent asked for the lot and expiration date of the first dose and the health care provider gave the ones that are registered in this report. But the agent suspected that the pharmacist might have given the data of the second dose, instead of that first dose asked. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up. More
2836213 M TN 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received 2nd dose of shingrix late; This non-serious case was reported by a other health professiona... received 2nd dose of shingrix late; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine in 2023). In FEB-2025, the patient received the 2nd dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received 2nd dose of shingrix late). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 08-APR-2025 The patient was older than 50 years old. The other health professional reported that they had a patient who received a Shingrix vaccine in 2023, and then waited another year before getting their second one. It was usually stated that, in such cases, when an individual had received the Shingrix vaccine, they got the first dose, waited two to six months for the second dose, and were then considered set. Reporter was enquiring what was recommended for people that have missed one that they had just one injection and then whether they were waiting a year or they never got their second injection also if they did start over. Patient received 2nd dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule. More
2836214 0.33 F MD 04/15/2025 DTAPHEPBIP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2G273
K4JH7
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
accidentally received a dose of Pediarix and Engerix-B administration (same day); This non-serious c... accidentally received a dose of Pediarix and Engerix-B administration (same day); This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2G273) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number K4JH7) for prophylaxis. On 08-APR-2025, the patient received Pediarix and Engerix B. On 08-APR-2025, an unknown time after receiving Pediarix and Engerix B, the patient experienced accidental overdose (Verbatim: accidentally received a dose of Pediarix and Engerix-B administration (same day)). The outcome of the accidental overdose 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: 08-APR-2025 The office manager called and reported that the patient was accidentally received a dose of Pediarix as well as Hepatitis B (Engerix-B) at the same time, which led to accidental overdose for hepatitis B antigen. The Vaccine Administration Facility is the same as Primary Reporter. More
2836215 VA 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received Engerix B late second dose; This non-serious case was reported by a other health professio... received Engerix B late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (received 1st dose in October 2024). In APR-2025, the patient received the 2nd dose of Engerix B. In APR-2025, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received Engerix B late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 08-APR-2025 The wellness center supervisor called to report multiple patients received late second doses for Engerix-B. The reporter stated that they had individuals that got the vaccine in October 2024, and they were getting their second dose in April 2025, six months later which led to, drug dose administration interval too long. We are probably giving about sixty of these vaccines in the last few months, not all of them were late second doses. Somehow, had about five or six people slip through the cracks in October and they did not know how that happened, but it happened. The reporter mentioned that when asked about patients details information was declined. Patient details, vaccination dates or more specific information was asked but declined during the call. More
2836216 65 M 04/15/2025 COVID19
 MODERNA
Immune thrombocytopenia, Procedural haemorrhage Immune thrombocytopenia, Procedural haemorrhage
Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory... Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy; intraoperative bleeding; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) in a 65-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) (seriousness criteria hospitalization and medically significant) and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) (seriousness criteria hospitalization and medically significant). The patient was treated with Romiplostim for Secondary immune thrombocytopenic purpura, at an unspecified dose and frequency; Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) for Secondary immune thrombocytopenic purpura, at an unspecified dose and frequency and Surgery (two sub-selective splenic artery embolization and elective robotic splenectomy) for Immune thrombocytopenia. At the time of the report, IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) outcome was unknown and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: platelets rebounded to adequate levels. For mRNA-1273 (Spikevax) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) to be related. Concomitant medications were not reported. Reported that patient with no significant past medical history presented six days after his second dose of the Moderna COVID-19 vaccine, complaining of diffuse purpura on all extremities, two episodes of melena, dizziness, and fatigue and was diagnosed with immune thrombocytopenic purpura (ITP). ITP was secondary to the second COVID-19 vaccine and refractory to refractory to medical and surgical therapy and patient underwent robotic splenectomy. After failing multiple cycles of high-dose corticosteroids, IVIG (intravenous immunoglobulin), and romiplostim, the patient underwent sub-selective splenic artery embolization (SAE). After 26 months, the spleen retained its size, and he underwent a second sub-selective SAE followed by an elective robotic splenectomy, which converted to an open procedure due to intraoperative bleeding. Seven days post-op, the patient's platelets rebounded to adequate levels, and he was discharged on post-op day eight. The patient had evidence of thrombocytopenia at follow-up on postoperative day 24 that rebounded by postoperative day 66. This patient's unique treatment course highlights various medical and surgical challenges in the armamentarium for patients with ITP.; Reporter's Comments: The event Procedural haemorrhage was considered as not related to the Moderna vaccine as this was a complication presented during the surgery, in the context of the chronic immune thrombocytopenic purpura. The benefit-risk relationship of the product is not affected by this report More
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2836217 79 M 04/15/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Biopsy kidney, Blood creatinine, Chest X-ray, Colonoscopy, Computerised tomogram... Biopsy kidney, Blood creatinine, Chest X-ray, Colonoscopy, Computerised tomogram abdomen; Computerised tomogram pelvis, Exposure to SARS-CoV-2, Glomerulonephritis membranous, Hepatitis B virus test, Hepatitis C virus test; Oesophagogastroduodenoscopy, Prostatic specific antigen, Proteinuria, Syphilis test More
Membranous Nephropathy; exposure to the Covid-19 virus; This spontaneous case was reported by a phys... Membranous Nephropathy; exposure to the Covid-19 virus; This spontaneous case was reported by a physician and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Membranous Nephropathy) in a 79-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hemoglobinopathy. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth 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, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Membranous Nephropathy) (seriousness criterion medically significant) and EXPOSURE TO SARS-COV-2 (exposure to the Covid-19 virus). The patient was treated with Telmisartan at a dose of 1 dosage form; Nebivolol hydrochloride (Nebivolol) at a dose of 1 dosage form; Dapagliflozin propanediol monohydrate (Dapagliflozin) at a dose of 1 dosage form; Metformin hydrochloride (Metformin) at a dose of 1 dosage form; Glipizide at a dose of 1 dosage form; Evolocumab at a dose of 1 dosage form and Atorvastatin calcium (Atorvastatin) at a dose of 1 dosage form. At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Membranous Nephropathy) had resolved and EXPOSURE TO SARS-COV-2 (exposure to the Covid-19 virus) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: showed membranous nephropathy, stage 2 of 4. On an unknown date, Blood creatinine: 1.01 to 1.40 mg/dl and 1.14 mg/dl. On an unknown date, Chest X-ray: not shown malignancy. On an unknown date, Colonoscopy: not shown malignancy. On an unknown date, Computerised tomogram abdomen: not shown malignancy. On an unknown date, Computerised tomogram pelvis: not shown malignancy. On an unknown date, Hepatitis B virus test: Negative. On an unknown date, Hepatitis C virus test: Negative. On an unknown date, Oesophagogastroduodenoscopy: not shown malignancy. On an unknown date, Prostatic specific antigen: not shown malignancy. On an unknown date, Proteinuria: 2888 milligram, 2112 milligram 21 days later after the final vaccine administration and 203 milligram nineteen months after the final vaccine administration. On an unknown date, Treponema test: Negative. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. The patient was presented with ankle edema and 2888 mg proteinuria after 5 doses of mRNA 1273. The mRNA 1273 vaccination for Covid-19 was given on 19, 18, 10, and 3 months before symptom onset. 5th dose was given one month prior. Patient's saliva was sent for Renasight panel. Homozygosity for HBB beta hemoglobinopathy was detected. Heterozygosity for HOGA1, ROBO2, BCS1L, C1QB, MAG12, INVS, and MEFV were detected-none of which had a definitive association with membranous nephropathy. Nineteen months after administration of his last Covid vaccine, repeated 24-hour urine measures and found that 203 mg proteinuria, and the serum creatinine was 1.14 mg/dl. Immunostaining for PLA2R, EXT2, NELL1, and THSD7A were performed at Clinic Laboratories and interpreted negative. Light microscopic, immunofluorescence staining for IgG, and electron microscopy specimens were shown. Antibody cross-reactivity to components of the glomerular basement membrane versus deposition of antigen antibody conjugated in the glomerular basement membrane were possible etiologies. Boosted with five doses of the vaccine and exposure to the Covid-19 virus might all had exacerbated that autoimmune response. The diminution of proteinuria from 2888 milligrams to 2112 milligrams 21 days later to 203 mg, nineteen months after the final vaccine administration suggested that the antigen antibody complexes deposited in the glomerular basement membrane cleared and that the biopsy documented membranous nephropathy at the time of the acute proteinuria resolved.; Reporter's Comments: Medical history of exposure to COVID-19 could be a confounding factor for the case. The benefit-risk relationship of product is not affected by this report. More
2836218 F 04/15/2025 COVID19
 MODERNA
Chronic inflammatory demyelinating polyradiculoneuropathy, Migraine, Thyroid dis... Chronic inflammatory demyelinating polyradiculoneuropathy, Migraine, Thyroid disorder, Tinnitus More
I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis; Migr... I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis; Migraine; Had my thyroid removed; Tinnitus; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis) and THYROID DISORDER (Had my thyroid removed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis) (seriousness criteria disability and medically significant) and MIGRAINE (Migraine). In April 2021, the patient experienced THYROID DISORDER (Had my thyroid removed) (seriousness criterion medically significant) and TINNITUS (Tinnitus). The patient was treated with Surgery (Thyroid removed) for Thyroid disorder. At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis) outcome was unknown and THYROID DISORDER (Had my thyroid removed), TINNITUS (Tinnitus) and MIGRAINE (Migraine) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Developed CIDP. On an unknown date, Nerve conduction studies: Developed CIDP. No concomitant medications provided by the reporter. It was reported that patient had her Moderna Covid-19 vaccination in March-2021 and April-2021. After the second Moderna Covid-19 vaccination patient had experienced sever symptom of tinnitus, fatigue optic nerve inflammation. Patient had her thyroid removed. Patient had also experienced symptom of parenthesis, migraines. Patient balance was off, and she started falling a lot. Patent had undergone tests of MRI; nerve conduction test and it was found that patient had developed CIDP. Patient had considered for a wheelchair for her filed work. Patient requested for research for her present symptom, and she would send her blood and hair sample for research. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
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2836219 66 F TX 04/15/2025 COVID19
 PFIZER\BIONTECH
 LM2224
COVID-19, Drug ineffective COVID-19, Drug ineffective
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a C... tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Nov2024 as dose 1, single (Lot number: LM2224) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: Always gets allergies and, sinuses always flare up in spring; "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Mfg number, NDC: 59267-1000-02, EXP: 30Jun2021, LOT: unknown, Both vaccines in left arm), administration date: 18Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, NDC, LOT, EXP: Thinks it is all same as first dose, both listed under same category, the 2 doses. , Both vaccines in left arm), administration date: 08Apr2021, for Covid-19 immunization; BNT162b2 (DOSE 3, SINGLE, NDC: 59267-1000-02, EXP: 31Jul2021, Pfizer LOT: FJ1611 or CJ1611, left arm, Everything given in left arm), administration date: 04Jan2022, for Covid-19 immunization; pfizer omicron (DOSE 4, SINGLE, LOT: GJ2524, NDC, EXP: Unknown, This dose originally provided as fifth dose, later clarified, it was fourth dose.), administration date: 04Oct2022, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2025, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2025) Positive. More
2836220 0.5 F 04/15/2025 MEN
 UNKNOWN MANUFACTURER
Injection site bruising, Product administered to patient of inappropriate age Injection site bruising, Product administered to patient of inappropriate age
mistakenly given the vaccine, which was not indicated for her age; light bruising at the injection s... mistakenly given the vaccine, which was not indicated for her age; light bruising at the injection site; Initial information received on 09-Apr-2025 regarding an unsolicited valid non-serious case received from a Patient's Father. This case involves a 6 months old female patient who was mistakenly given MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], which was not indicated for her age and had light bruising at the injection site The patient's past medical history, medical treatment(s) and family history were not provided. No other vaccines On 07-Apr-2025, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) vaccine Solution for injection, which was not indicated for her age, (Frequency: Once, strength: standard; expiry date and lot number not reported) via intramuscular route in the left thigh for Immunization (Immunization) (product administered to patient of inappropriate age) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested On an unknown date in Apr-2025 the patient developed light bruising at the injection site (vaccination site bruising) (latency: approximately few hours to few days) Reportedly, Patient's Father was further advised to monitor and speak with their HCP (healthcare professional) Action taken was not applicable Corrective treatment: none for vaccination site bruising At time of reporting, the outcome was Unknown for the event vaccination site bruising. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2836221 84 F NC 04/15/2025 TDAP
 SANOFI PASTEUR
 U8115AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
ADACEL was given to an 84 year old patient, with no reported adverse event; Initial information rece... ADACEL was given to an 84 year old patient, with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 84 years old female patient who received 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 18-Mar-2025, the 84 years old patient received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, expiry date- 31-MAR-2026 and lot U8115AA) once via intramuscular route in the left arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2836222 77 M NM 04/15/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
2CA69C1
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Boostrix should still be given to a patient that was incorrectly administered with ADACEL with no ad... Boostrix should still be given to a patient that was incorrectly administered with ADACEL with no adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 77 years old male patient to whom vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was incorrectly administered instead of being administered with Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025 at 01:20 pm, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, Frequency: once, expiry date: 20-Jul-2025 and lot 2CA69C1) via intramuscular route in the left arm as prophylactic vaccination (immunization) instead of Boostrix with no adverse event (wrong product administered) (latency: same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2836223 19 M OH 04/15/2025 RAB
 SANOFI PASTEUR
 W1C431M
Extra dose administered, No adverse event Extra dose administered, No adverse event
The patient received the first dose on 02-Apr-2025 and was trying to receive the second dose on 11-A... The patient received the first dose on 02-Apr-2025 and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 years old male patient who received the first dose of rabies (HDC) vaccine [Imovax Rabies] on 02-Apr-2025 and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Apr-2025, the patient received an unknown dose 1 of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength- standard, expiry date- 31-OCT-2025 and lot W1C431M) via unknown route in unknown administration site and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event (routine immunisation schedule not administered). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2836226 66 M MI 04/15/2025 COVID19
 MODERNA
 939903
Chest pain, Fatigue, Memory impairment Chest pain, Fatigue, Memory impairment
Memory fogginess, Tired and Chest pains Memory fogginess, Tired and Chest pains
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2836227 52 M PA 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Fatigue, Headache, Pyrexia Chills, Fatigue, Headache, Pyrexia
Fatigue, Chills and Fever, and Headache Fatigue, Chills and Fever, and Headache
2836228 4 F TN 04/15/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
No adverse event No adverse event
NO SIGNS AND SYMPTOMS REPORTED NO SIGNS AND SYMPTOMS REPORTED
2836229 9 F TX 04/15/2025 HPV9
 MERCK & CO. INC.
 y013712
Urticaria Urticaria
Hives starting 4 hr after vaccine Hives starting 4 hr after vaccine
2836230 4 F TX 04/15/2025 DTAP
HEPA
IPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
 sh773
23223
w1c831m
022921
Erythema, Pyrexia, Rash; Erythema, Pyrexia, Rash; Erythema, Pyrexia, Rash; Eryth... Erythema, Pyrexia, Rash; Erythema, Pyrexia, Rash; Erythema, Pyrexia, Rash; Erythema, Pyrexia, Rash More
Fever for a day. Red and rash Fever for a day. Red and rash
2836231 78 M FL 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74nc9
Abdominal operation, Abdominal pain Abdominal operation, Abdominal pain
Patient stated experiencing pain in abdomen above belly button. Patient had abdominal surgery (uncle... Patient stated experiencing pain in abdomen above belly button. Patient had abdominal surgery (unclear what type). Physician told patient he did not think it was related to the Shingles vaccine but to go ahead and proceed with reporting adverse reaction. More
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2836232 15 M MN 04/15/2025 COVID19
 MODERNA
 3043335
Dizziness, Heart rate decreased, Hyperhidrosis, Nausea Dizziness, Heart rate decreased, Hyperhidrosis, Nausea
Patient became nauseated, diaphoretic, and dizzy after vaccination. Blood pressure was 90/60 with a ... Patient became nauseated, diaphoretic, and dizzy after vaccination. Blood pressure was 90/60 with a low heart rate of 56. EMT were called and recorded vitals of 104/56 with a heart rate of 56. patient states he did not eat well that day, provided fluids. at 4:08pm EMS was called, EMS arrived at 4:17pm. EMS took over the care of the patient at 4:20pm. Facility contact was notified at 4:18pm. The school was notified. Parent was with the patient the entire time. More
2836233 1 M MI 04/15/2025 MMR
 MERCK & CO. INC.
 Y010046
Pyrexia, Rash Pyrexia, Rash
Fever 104 with rash Fever 104 with rash
2836234 89 M MN 04/15/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 304335
388486
Memory impairment; Memory impairment Memory impairment; Memory impairment
Patient went to dining room per facility staff and client stated "I'm Falling" did no... Patient went to dining room per facility staff and client stated "I'm Falling" did not fall but blanked out per residents at the dining room table. denies breathing problems, denies check, back or arm pain, no nausea. EMS notified per facility staff. Pt. took BP medics this am and had supra pubic catheter flushed. Wife present during event. More
2836235 35 M MN 04/15/2025 COVID19
FLUC4
 MODERNA
SEQIRUS, INC.
AW3227 A
Feeling hot, Syncope; Feeling hot, Syncope Feeling hot, Syncope; Feeling hot, Syncope
At 11:05am the patient fainted following second shot. Nurse moved patient to floor and elevated feet... At 11:05am the patient fainted following second shot. Nurse moved patient to floor and elevated feet. BP 134/80. at 11:07am patient alert "feels hot" observed for 5 minutes, patient received water to drink. 11:15am pt sitting in chair with BP of 120/73 then sat in the waiting area 15 mins and received 2nd glass of water. 11:28am up walking recovered. S/O continued to observe in the office. More
2836236 69 F CO 04/15/2025 FLU3
 SANOFI PASTEUR
 u8515ca
Wrong product administered Wrong product administered
Patient wanted to get a covid shot, but was given a flu shot in error. Patient wanted to get a covid shot, but was given a flu shot in error.
2836237 51 M OR 04/15/2025 COVID19
 MODERNA
 B0005
No adverse event, Product storage error No adverse event, Product storage error
No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained vi... No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna. More
2836238 0.08 F OH 04/15/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 D252F
2R3BY
LJ5282
HP495
Breath holding, Crying, Hypotonic-hyporesponsive episode; Breath holding, Crying... Breath holding, Crying, Hypotonic-hyporesponsive episode; Breath holding, Crying, Hypotonic-hyporesponsive episode; Breath holding, Crying, Hypotonic-hyporesponsive episode; Breath holding, Crying, Hypotonic-hyporesponsive episode More
Liklely hypotonic hyporesponsive episode versus pallid breath holding spell based on response to inj... Liklely hypotonic hyporesponsive episode versus pallid breath holding spell based on response to injections. No syncope, but patient was "silent" crying for a few moments after her injections, appeared dazed and limp, returned to normal crying and normal responsiveness after approx 30 seconds. Advised that this is likely not dangerous, but to keep a close eye on her for today to ensure no recurrence. Discussed reasons to seek urgent/emergent eval. More
2836239 66 M WI 04/15/2025 COVID19
 PFIZER\BIONTECH
 E29264
Tinnitus Tinnitus
Ringing in ears. Apparently this is not treatable. The ringing continues to this day, 4 years late... Ringing in ears. Apparently this is not treatable. The ringing continues to this day, 4 years later, both ears. More
2836240 74 F WV 04/15/2025 PNC21
 MERCK & CO. INC.
 Y019157
Fatigue, Hypersomnia, Peripheral swelling, Pyrexia, Urticaria Fatigue, Hypersomnia, Peripheral swelling, Pyrexia, Urticaria
Patient felt very tired the evening after and woke up the next morning still feeling very tired and ... Patient felt very tired the evening after and woke up the next morning still feeling very tired and slept most of the day. Upon waking later in the day, she found that her left arm was very swollen and she was covered in hives and had a low grade fever. She went to the emergency room and received a steroid injection which she said helped significantly. She felt better after 2-3 days. More
2836241 47 F MN 04/15/2025 COVID19
 MODERNA
 083J21A
Seizure Seizure
Seizure in left leg for 2 min Seizure in left leg for 2 min
2836242 67 M OR 04/15/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 324436
UT8454CA
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained vi... No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna. More
2836243 63 F UT 04/15/2025 DTAP
UNK
 SANOFI PASTEUR
UNKNOWN MANUFACTURER
 PG3RP
md3414
Musculoskeletal stiffness, Pain, Pain in extremity; Musculoskeletal stiffness, P... Musculoskeletal stiffness, Pain, Pain in extremity; Musculoskeletal stiffness, Pain, Pain in extremity More
Patient reported that the vaccine might have been administered too high in the arm. She reported sti... Patient reported that the vaccine might have been administered too high in the arm. She reported stiffness and pain when raising her arm. She said this is getting better with time. I asked her to see a doctor to which she declined. More
2836244 4 F IN 04/15/2025 VARCEL
 MERCK & CO. INC.
 Y019319
Injection site discolouration, Injection site erythema, Injection site papule, I... Injection site discolouration, Injection site erythema, Injection site papule, Injection site reaction, Skin lesion More
Lesions tiny subcutaneous papule palpable under the skin to anterolateral L thigh where last week�... Lesions tiny subcutaneous papule palpable under the skin to anterolateral L thigh where last week's Variax vaccine was administered. There is a 1.5cm periphery of light purple. Then 0.5cm band of clearing, then an outer eryth ring - total diameter is 4.5cm. blanchable, NT, no d/c, no streaking, no ulcers, no pustules, no crusting, no excoriation. ๏ฟฝ Color and pigmentation were normal. More
2836245 43 M TX 04/15/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 I don't know
I don't know
I don't know
Anger, Balance disorder, Blood test, Brain fog, Condition aggravated; Headache, ... Anger, Balance disorder, Blood test, Brain fog, Condition aggravated; Headache, Heart rate increased, Impaired work ability, Memory impairment, Mood swings; Neck pain, Neuralgia, Palpitations, Postural orthostatic tachycardia syndrome More
It was similar to what happened in 2021 after a bad case of Covid. About 2 or so weeks after the sh... It was similar to what happened in 2021 after a bad case of Covid. About 2 or so weeks after the shot, I started having brain stem, neck, and spinal cord pain. I have a blown disc and 2 bulging discs and we thought it may be that so I went back to phy. therapy. Things were only getting worse. About a week later around 10/25, I had one of the worst headaches ever (similar to the ones I had in 2021) About a week after that, I started having severe brain fog. So bad my boss recommended that I go on medical leave. I went to see my orthopedic surgeon and he said absolutely nothing had changed and he thought something else may be going on. My balance was out of whack, severe headaches, neck aches, and pain below the skull up inside sort of near the brain stem. Once the brain fog began, my pre-frontal cortex was definitely out of whack. Severe mood swings, uncontrollable anger, memory problems....then a few weeks after that I started having palpitations and racing heart any time I'd stand up..similar to 2021. Dr. believes it's all POTS related and that possibly the vaccine flared everything back up More
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2836246 72 F CO 04/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 F9X4P
F9X4P
Blindness, Injection site discolouration, Injection site swelling, Injection sit... Blindness, Injection site discolouration, Injection site swelling, Injection site vesicles, Photopsia; Visual impairment More
Patient reported back to pharmacy on 4/15/25 & stated that the day after vaccination while watch... Patient reported back to pharmacy on 4/15/25 & stated that the day after vaccination while watching TV she had a visual disturbance, including flashing lights & vision loss. Also, on 4/15/25, patient returned to pharmacy & showed the injection site which now had 3 raised, blistered areas & discoloration. More
2836247 44 M OR 04/15/2025 COVID19
FLU3
HEPA
 MODERNA
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 B0005
391417
4T93R
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained vi... No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna. More
2836248 27 M OR 04/15/2025 COVID19
FLU3
TDAP
 MODERNA
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 B0005

3RE73
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained vi... No adverse event reported. Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna. More
2836249 19 M FL 04/15/2025 HEP
HPV9
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 YY37B
X024560
U7950AA
Hyporesponsive to stimuli, Syncope; Hyporesponsive to stimuli, Syncope; Hyporesp... Hyporesponsive to stimuli, Syncope; Hyporesponsive to stimuli, Syncope; Hyporesponsive to stimuli, Syncope More
Client had a syncope episode that started right after being given the last vaccine (HPV9). Client w... Client had a syncope episode that started right after being given the last vaccine (HPV9). Client was seated in a chair the entire time, so no fall or injury took place. RN immediately got the client some water which he drank a little and a fan was retrieved and plugged in beside client to try and cool him off. I was unable to move patient to the exam table due to being the only nurse in the clinic, so client remained in the chair the entire time. Client did not recover promptly as I have seen in the past. I called for assistance from our clerk and had her place a call to 911. During that time, I opened up an ammonia wipe to place under client's nose. Client then became a little more alert, but still kept closing his eyes and laying his head down. After a few more minute's client was fully alert and oriented x3. Client was aware of what was going on but said nothing like that had ever happened to him. Client did not want rescue called, so I canceled the rescue at that time. Client stayed in clinic for monitoring x15 minutes. Vitals including BP was taken after client recovered and were stable and client then left clinic. More
2836250 63 M FL 04/15/2025 COVID19
 PFIZER\BIONTECH
Death, Ischaemic stroke Death, Ischaemic stroke
ischemic stroke caused death ischemic stroke caused death
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2836251 FL 04/15/2025 MMR
 MERCK & CO. INC.
Arthralgia, Gait inability, Musculoskeletal discomfort, X-ray limb normal Arthralgia, Gait inability, Musculoskeletal discomfort, X-ray limb normal
Assumed right ankle pain/discomfort. Prior to vaccine, infant was ambulating well, taking 15+ steps ... Assumed right ankle pain/discomfort. Prior to vaccine, infant was ambulating well, taking 15+ steps when walking. After vaccine, did not walk for about 2 weeks. Negative x-ray. Self-resolved. More
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