🏥 VAERS Vaccine Data Browser

🔒 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.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 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:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ 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?

⚠️ 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
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2839564 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Shingles 2 times). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles 3 times, the last time was after first shot of the vaccine. More
2839565 05/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Blood pressure increased, Chills, Fatigue, Influenza, Malaise; Pyrexia Blood pressure increased, Chills, Fatigue, Influenza, Malaise; Pyrexia
made you feel like you have the flu,; made their blood pressure go sky high; Shivers; fever; so tire... made you feel like you have the flu,; made their blood pressure go sky high; Shivers; fever; so tired; Shingrix made a lot of people sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza (Verbatim: made you feel like you have the flu,), blood pressure high (Verbatim: made their blood pressure go sky high), shivers (Verbatim: Shivers ), fever (Verbatim: fever), tiredness (Verbatim: so tired) and sickness (Verbatim: Shingrix made a lot of people sick). The outcome of the influenza, blood pressure high, shivers, fever, tiredness and sickness were not reported. It was unknown if the reporter considered the influenza, blood pressure high, shivers, fever, tiredness and sickness to be related to Shingrix. It was unknown if the company considered the influenza, blood pressure high, shivers, fever, tiredness and sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a consumer via interactive digital media. The Shingrix vaccine made a lot of people (patients) sick, made their blood pressure go sky high and made you feel like you have the flu, shivers, fever and so tired This case has been linked to the US2025AMR037927 case reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR037927:Same reporter case created for multiple patient More
2839566 CA 05/05/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
TS525
TS525
TS525
Injection site discharge, Underdose; Exposure via skin contact, Incorrect route ... Injection site discharge, Underdose; Exposure via skin contact, Incorrect route of product administration, Injection site discharge, Injection site erythema, Injection site induration; Injection site mass, Injection site swelling, Underdose; Injection site discharge, Underdose; Exposure via skin contact, Incorrect route of product administration, Injection site discharge, Injection site erythema, Injection site induration; Injection site mass, Injection site swelling, Underdose More
After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately pu... After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?; This non-serious case was reported by a consumer via call center representative and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?). The outcome of the underdose was not applicable. Additional Information: GSK Receipt Date: 25-APR-2025 The reporter reported that after the pharmacist gave shot noticed the shot site was leaking the Shingrix. The patient immediately put pressure on it . The reporter was ask did get enough of the vaccine or did it need to be repeated, which led to underdose. The patient have had shingles in the past. More
2839567 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected accination failure; had them 6 times; This serious case was reported by a consumer via int... Suspected accination failure; had them 6 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected accination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them 6 times). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that just got over shingles again and had them 6 times even got the shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with US2025AMR054251, reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2839568 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; had them three times even after the vaccine; This serious case was re... Suspected vaccination failure; had them three times even after the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them three times even after the vaccine). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-APR-2025 The patient had them three times even after the vaccine. The reporter wanted to know why. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2839569 F 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; got it after they got the shot; This serious case was reported by a c... Suspected Vaccination failure; got it after they got the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got it after they got the shot). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient's child via interactive digital media. The patient (parents) had got it after they got the Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR053264, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR053264:Original Case : US2025AMR051995 More
2839570 05/05/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. Reporter had both shots and still got shingles. It was a very mild case. Reporter stated that he/she could not imagine what it would have been like without them. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2). More
2839571 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
sick; This non-serious case was reported by a consumer via interactive digital media and described t... sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. The 1st shot made patient so sick. He/she did not want to take the 2nd one. More
2839572 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Headache Headache
mild headache for about five hours; This non-serious case was reported by a consumer via interactive... mild headache for about five hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: mild headache for about five hours). The outcome of the headache was resolved (duration 5 hrs). It was unknown if the reporter considered the headache to be related to Shingles vaccine. It was unknown if the company considered the headache to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-APR-2025 The case was received from the patient via interactive digital media. The reporter got his/her a few years back. Only side affect he/she had was a very mild headache for about five hours. Much better than getting shingles's. More
2839573 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nerve injury Nerve injury
permanent nerve damage; This non-serious case was reported by a consumer via interactive digital med... permanent nerve damage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 04-FEB-2019, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve damage (Verbatim: permanent nerve damage). The outcome of the nerve damage was not resolved. It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine. It was unknown if the company considered the nerve damage to be related to Shingles vaccine. Additional Information: GSK receipt date: 27-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that they had received the round of medication on 04th February 2019 and when the first round did not work, they underwent a second round and unfortunately, this resulted in permanent nerve damage. The re[porter mentioned that by 2025, they were still suffering. More
2839574 OK 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
received a dose of Shingrix reconstituted with sterile water; received a dose of Shingrix reconstitu... received a dose of Shingrix reconstituted with sterile water; received a dose of Shingrix reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: received a dose of Shingrix reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: received a dose of Shingrix reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 21-APR-2025 The director of pharmacy called to report that they administered Shingrix reconstituted with sterile water to a patient over 50 years old which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter had a questioned was there any guidance or did the patient needs another dose. More
2839575 60 F OK 05/05/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3ER79
Product administered to patient of inappropriate age, Product preparation issue Product administered to patient of inappropriate age, Product preparation issue
A 60 years old female patient received only the sterile water portion of Priorix.; A 60 years old fe... A 60 years old female patient received only the sterile water portion of Priorix.; A 60 years old female patient received only the sterile water portion of Priorix.; A 60 years old female patient received Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received MMR (Priorix) (batch number 3ER79, expiry date 28-NOV-2028) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: A 60 years old female patient received only the sterile water portion of Priorix.), inappropriate dose of vaccine administered (Verbatim: A 60 years old female patient received only the sterile water portion of Priorix.) and inappropriate age at vaccine administration (Verbatim: A 60 years old female patient received Priorix). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration 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: 22-APR-2025 The nurse manager reported that they administered only the sterile water component of Priorix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Lot number was 2JX7Y and expiration date 01st June 2026 of Priorix that was not administered. The reporter asked was there any potential harm to the patient. The patient received a dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration. More
2839576 F TX 05/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Exposure during pregnancy, Product administered to patient of inappropriate age,... Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue More
pregnant patient was administered Arexvy; pregnant patient was administered Arexvy; pregnant patient... pregnant patient was administered Arexvy; pregnant patient was administered Arexvy; pregnant patient was administered Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included pregnancy. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient was administered Arexvy), drug use in unapproved age group (Verbatim: pregnant patient was administered Arexvy) and inappropriate age at vaccine administration (Verbatim: pregnant patient was administered Arexvy). The outcome of the vaccine exposure during pregnancy, drug use in unapproved age group and inappropriate age at vaccine administration were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 23-APR-2025 Other HCP reported that a pregnant patient was administered Arexvy, which led to vaccine exposure during pregnancy and drug use in unapproved population. This was reported to him by the patient's mother. More
2839577 0.17 F GA 05/05/2025 DTAP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 m52gg
2G273
Accidental overdose; Accidental overdose Accidental overdose; Accidental overdose
accidental overdose; This non-serious case was reported by a other health professional via call cent... accidental overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2G273, expiry date 15-APR-2027) for prophylaxis. Co-suspect products included DTPa (Infanrix) (batch number m52gg, expiry date 07-SEP-2026) for prophylaxis. On 21-APR-2025, the patient received the 1st dose of Pediarix and the 1st dose of Infanrix. On 21-APR-2025, an unknown time after receiving Pediarix and Infanrix, the patient experienced accidental overdose (Verbatim: accidental overdose). 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: 25-APR-2025 The reporter stated that a 2 months female baby received Pediarix and Infanrix on the same clinic day, which led to accidental overdose. More
2839578 F IN 05/05/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 TC47K
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pediarix was administered to a 7-years; This non-serious case was reported by a other health profess... Pediarix was administered to a 7-years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis. On 24-APR-2025, the patient received Pediarix. On 24-APR-2025, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix was administered to a 7-years). 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: 25-APR-2025 The clinical coordinator called to report Pediarix was administered to a 7-years and 5-months old patient, which led to inappropriate age at vaccine administration. More
2839579 62 F NJ 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 HA5HL
Product preparation issue Product preparation issue
administering the liquid portion only; administering the liquid portion only; This non-serious case ... administering the liquid portion only; administering the liquid portion only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number HA5HL, expiry date 13-NOV-2026) for prophylaxis. On 22-APR-2025, the patient received Shingrix. On 22-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administering the liquid portion only) and inappropriate preparation of medication (Verbatim: administering the liquid portion only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK receipt date: 29-APR-2025 The nurse called to verify when the dose of Shingrix could be repeated after administering the liquid portion only which led to, inappropriate dose of vaccine administered and inappropriate preparation of medication. The Vaccine Administration Facility is the same as Primary Reporter. More
2839580 11 M NM 05/05/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 XL223
PJ3RP
Product storage error; Product storage error Product storage error; Product storage error
Administration after temp. excursion of Boostrix and Menveo; This non-serious case was reported by a... Administration after temp. excursion of Boostrix and Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number XL223) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number PJ3RP) for prophylaxis. On 23-APR-2025, the patient received Menveo and Boostrix. On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temp. excursion of Boostrix and Menveo). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 29-APR-2025 The reporter called to report a temperature excursion then healthcare professional asked that between the time that the excursion happened until one day before the reporting date, there was 8 vaccines administered, and that's completely fine, correct. The vaccine administration facility was the same as primary reporter. The reporter mentioned that after the temperature excursion, they administered 8 vaccines. This patient received Boostrix and Menveo (1 vial) after temperature excursion, which led to incorrect storage of drug. More
2839581 M 05/05/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Death; Death Death; Death
Caller had a friend and his wife died from the Covid 19 vaccine; This spontaneous case was reported ... Caller had a friend and his wife died from the Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller had a friend and his wife died from the Covid 19 vaccine) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. This case was created for reporter's friend. No concomitant medications were reported. It was reported that the reporter had a friend and his wife who died from the Moderna Covid-19 vaccine. The caller was asked if there was an adverse event that happened regarding flu shot, and the reporter asked if Pfizer or manufacturer of the shot be financially liable for the damages incurred from an adverse event or not. The reporter had lots of questions regarding Covid vaccine, he never got it and never got sick but reported that everybody that he knew who got the vaccine always became sick. The reporter did not mention the brand of Covid vaccine. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-785520, US-MODERNATX, INC.-MOD-2025-785519 (E2B Linked Report).; Reporter's Comments: Company Comments. The time between vaccination and the patient`s death is unknown. Tozinameran remained co-suspect product. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785520:Invalid case for other patient's US-MODERNATX, INC.-MOD-2025-785519:Wife's case; Reported Cause(s) of Death: Death unexplained More
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2839582 AL 05/05/2025 PNC20
 PFIZER\WYETH
 LN4927
Device breakage Device breakage
Broken upon arrival; The initial case was missing the following minimum criteria: adverse event. Upo... Broken upon arrival; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a nurse from product quality group. A patient (age and gender not provided) received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4927, Expiration Date: 30Jun2026) for immunisation, Device Lot Number: LN4927, Device Expiration Date: 30Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 23Apr2025, outcome "unknown", described as "Broken upon arrival". Causality for "broken upon arrival" was determined associated to device constituent of Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (malfunction). Additional Information: The reporting laboratory nurse was calling to report issue with Prevnar 20 vaccine (NDC Number: 0005200010). When they received shipment on 23Apr2025, one vial was broken upon arrival. She opened the box and was going to put in Accuvax but one was broken, it is a prefilled syringe that was broken. She was calling to see what the process was and if needed to return the broken Prevnar 20 prefilled syringe to the company. The sample of the product was available to be returned. She is requesting replacement and confirms no patient involvement. More
2839583 17 F FL 05/05/2025 MENB
 PFIZER\WYETH
 FL5302
Chest pain, Dizziness, Dyspnoea Chest pain, Dizziness, Dyspnoea
Dizziness while sitting; chest pain; shortness of breath; This is a spontaneous report received from... Dizziness while sitting; chest pain; shortness of breath; This is a spontaneous report received from a Physician. A 17-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 23Apr2025 at 08:00 as dose 2, single (Lot number: FL5302) at the age of 17 years, in left arm for immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL (XR). Vaccination history included: Meningococcal vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Immunization. The following information was reported: DIZZINESS (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering", described as "Dizziness while sitting"; CHEST PAIN (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering"; DYSPNOEA (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering", described as "shortness of breath". Therapeutic measures were taken as a result of dizziness, chest pain, dyspnoea. Additional information: Vaccine was administered at Doctor's office/urgent care. Patient did not receive any other vaccines on the same date as the suspect vaccine. Patient did not receive any other vaccines within 4 weeks PRIOR to the suspect vaccine. Patient was taking other medications within 2 weeks of the event starting. Dizziness while sitting, chest pain and shortness of breath 14 hours after having her well visit and Trumenba. Treatment received for the adverse event was IVF (intravenous fluid treatment) in the ER.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events Dizziness, Dyspnoea, Chest pain and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
2839584 M MO 05/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
had COVID at least three times; had COVID at least three times; This is a spontaneous report receive... had COVID at least three times; had COVID at least three times; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID at least three times". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2839585 79 M IL 05/05/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.
 LM2223
LM2223
388466
388466
Atrophy, Bell's palsy, Blood glucose, Blood glucose increased, Ear disorder... Atrophy, Bell's palsy, Blood glucose, Blood glucose increased, Ear disorder; Headache, Investigation, Muscle twitching; Atrophy, Bell's palsy, Blood glucose, Blood glucose increased, Ear disorder; Headache, Investigation, Muscle twitching More
twitching in the muscles in his face and neck; wiggle his ears. Initially he was not able to wiggle ... twitching in the muscles in his face and neck; wiggle his ears. Initially he was not able to wiggle the right side ear, he could hardly move it to where you could see it wiggle; headache behind his right ear; atrophy of his right arm bicep; blood glucose went up; Bell's palsy/face was drooping on his right side; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Aug2024 as dose 1, 0.3 ml single (Lot number: LM2223) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 29Aug2024 as dose number unknown, single (Lot number: 388466), in left arm for immunisation. The patient's relevant medical history included: "Gout", start date: 1983 (ongoing); "High cholesterol", start date: 2004 (ongoing); "Pacemaker", start date: 2017 (ongoing); "Bladder cancer and surgery", start date: 2019 (unspecified if ongoing); "Bladder cancer and surgery", start date: 2019 (unspecified if ongoing); "Has an atrophy of his right arm bicep" (unspecified if ongoing); "for his heart/blood thinner" (ongoing); "for his thyroid" (ongoing); "Acid reflux (esophageal)" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased, start date: 2004 (ongoing); ELIQUIS taken for anticoagulant therapy, cardiac disorder, start date: Oct2016 (ongoing); DOFETILIDE taken for cardiac disorder, start date: Sep2017 (ongoing); PROBENECID taken for gout, start date: 1983 (ongoing); LEVOTHYROXINE taken for thyroid disorder, start date: 1987 (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2010. The patient also took other concomitant therapy. Vaccination history included: pfizer biontech vaccines (dose number unknown; initial, the next set, and all 7 or 8 of them), administration date: 09Sep2023, for COVID-19 immunization; pfizer biontech vaccines (dose number unknown; initial, the next set, and all 7 or 8 of them), administration date: 28Mar2024, for COVID-19 immunization; Pfizer biontech vaccines (primary series completed; initial, the next set, and all 7 or 8 of them), for COVID-19 immunization; Pfizer biontech vaccines (dose number unknown; initial, the next set, and all 7 or 8 of them), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 03Sep2024, outcome "recovering", described as "Bell's palsy/face was drooping on his right side"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching in the muscles in his face and neck"; EAR DISORDER (non-serious), outcome "unknown", described as "wiggle his ears. Initially he was not able to wiggle the right side ear, he could hardly move it to where you could see it wiggle"; HEADACHE (non-serious), outcome "unknown", described as "headache behind his right ear"; ATROPHY (non-serious), outcome "unknown", described as "atrophy of his right arm bicep"; BLOOD GLUCOSE INCREASED (non-serious), outcome "recovered", described as "blood glucose went up". The event "bell's palsy/face was drooping on his right side" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: went up; went back down to normal; testing: everything was normal. Therapeutic measures were taken as a result of bell's palsy, headache. Clinical course: The patient informed that his pharmacist administered the covid vaccine he also got the annual flu shot. He has had all of the covid vaccines, initial, the next set, and all 7 or 8 of them, stated that they were all the Pfizer BioNTech vaccines. Up through the vaccine that he had in 09Sep2023 and then 28Mar2024, prior to the one he just got he has had no reaction or anything. At the end of August, 29Aug2024, later in the beginning of Sep2024 he developed Bell's palsy. Since he had no experience with Covid vaccines prior, it was rather suspect that the vaccine he received in Aug2024 caused him to get bell's palsy. It could be stress or something else. On 03Sep2024, he was having lunch with his daughter and when he took off his N95 mask, his daughter said his face was drooping on his right side and they went to the Emergency Room and they ruled out stroke and told him he had Bell's palsy. They normally give Acyclovir, and they gave him that for a period of time and also gave him prednisone, a corticosteroid. After researching if you take a corticosteroid within 2 weeks after a Covid vaccine, was said that the vaccine may not be as effective. When he went to pick up his prescriptions on Friday, they offered him to take the same covid vaccine that he had in Aug2024, a repeat of the same dose. He told them he had Bell's palsy and the told him to report it to Pfizer. Also told him to speak to his physician about getting another dose. They did not show anything that it causes bell's palsy, but he could be a rare case. He still has a little droop in his smile, but not much. He was getting some twitching in the muscles in his face and neck, like his muscles were trying to wake up. Also reported that he can wiggle his ears. Initially he was not able to wiggle the right side ear, he could hardly move it to where you could see it wiggle. He also had a headache behind his right ear, but was not bad, just a little bit. Treated with Tylenol that seemed to help. Overtime he can now wiggle his ear. Has an atrophy of his right arm bicep and he got his shots in the left arm. They did routine testing and everything was normal, because of the shock of it, blood glucose went up, but went back down to normal. He said that there was no interaction between the flu shot and corticosteroid. The reporter informed that the NDC was 00069-2432-10. More
2839587 IL 05/05/2025 RSV
 PFIZER\WYETH
Device issue, Discomfort, Needle issue, Pain Device issue, Discomfort, Needle issue, Pain
rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled; rubb... rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled; rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled; causes a little bit more pain and discomfort than it should be; causes a little bit more pain and discomfort than it should be; This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEVICE ISSUE (non-serious), NEEDLE ISSUE (non-serious), outcome "unknown" and all described as "rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown" and all described as "causes a little bit more pain and discomfort than it should be". Therapeutic measures were not taken as a result of device issue, needle issue, vaccination site pain, vaccination site discomfort. Additional information: The vaccine was clarified as Abrysvo Act-O-Vial. It had all in one dose that came in the vial. The pharmacist said, when they used the Act-O-Vial kit that they put the needle into the kit to withdraw the vaccine that they felt like the rubber stopper/plunger was thicker than normal. They felt the stopper/plunger was so thick that it caused the needle as it went through and when they withdraw and stuck it into the patient's arm, it caused the patient a little bit more pain and discomfort than it should be. In pharmacist's opinion the rubber stopper was a little bit more thicker than normal that it caused the needle to be dulled. That was the pharmacist opinion. There was no lab work in past two weeks. The packaging sealed and intact. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2839588 48 M MD 05/05/2025 PNC20
 PFIZER\WYETH
 G5579
Diabetes mellitus Diabetes mellitus
diabetes; This is a spontaneous report received from an Other HCP, Program ID:. A 48-year-old male ... diabetes; This is a spontaneous report received from an Other HCP, Program ID:. A 48-year-old male patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 23Apr2025 as dose number unknown, 0.5 ml single (Lot number: G5579) at the age of 48 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes".; Sender's Comments: There is not a reasonable possibility that the reported event diabetes was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate. More
2839589 05/05/2025 COVID19
 PFIZER\BIONTECH
Thrombosis Thrombosis
Thrombosis; This is a spontaneous report received from a Physician from a sales representative. A p... Thrombosis; This is a spontaneous report received from a Physician from a sales representative. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
2839590 05/05/2025 COVID19
 PFIZER\BIONTECH
Immunisation reaction Immunisation reaction
I've had Pfizer boosters which I've had a pretty significant immune responses to; This is ... I've had Pfizer boosters which I've had a pretty significant immune responses to; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00240 (Novavax). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Novavax covid-19 vaccine (Primary Immunization series complete), for Immunization. The following information was reported: IMMUNISATION REACTION (non-serious), outcome "unknown", described as "I've had Pfizer boosters which I've had a pretty significant immune responses to". Additional information: Patient was part of the original Novavax trial and following that patient was trying to get a booster. Patient have had Pfizer boosters which patient have had a pretty significant immune response to. Patient wanted to stay away from mRNA. Patient was having a hard time finding anyone that's carrying Novavax. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2839591 F VA 05/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got COVID-19; got COVID-19; This is a spontaneous report received from a Consumer or other non HCP, ... got COVID-19; got COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 68-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19". The clinical course was reported as follows: The patient got the Pfizer vaccines and then the first time she got COVID-19, and received nirmatrelvir;ritonavir (PAXLOVID) as a treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2839592 32 M WA 05/05/2025 FLU3
 SANOFI PASTEUR
 UT8415NA
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient did not have an adverse reaction but did receive an extra dose of flu vaccine. It was noted... Patient did not have an adverse reaction but did receive an extra dose of flu vaccine. It was noted in the database after the fact he received a 2024-2025 dose on 10/23/2024. More
2839593 51 F MN 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 47N3Y
Pyrexia, Skin discolouration, Urticaria Pyrexia, Skin discolouration, Urticaria
Fever 102, welts and describes arm as being "black and blue" Fever 102, welts and describes arm as being "black and blue"
2839594 51 F IA 05/05/2025 PNC20
 PFIZER\WYETH
 LK6650
Pyrexia, Rash, Rash erythematous, Rash macular, Skin warm Pyrexia, Rash, Rash erythematous, Rash macular, Skin warm
Red rash with heat on arm and fever then spreading over the next 6 days to include inner arm then ch... Red rash with heat on arm and fever then spreading over the next 6 days to include inner arm then chest then blotches on lower half. Fever was highest at 102.7. Patient was given Sulfamethoxazole Trimethoprim on 4/10/25 and prednisone on 4/14/25 when the rash spread further. Took a full 28 days to resolve. Patient had no problem with Prevnar 23 when given LAST TIME. More
2839595 57 F PA 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 FJ9A7
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given a 3rd dose of Shingrix. Patient had gotten two doses already at a different pharma... Patient was given a 3rd dose of Shingrix. Patient had gotten two doses already at a different pharmacy.- No adverse reaction More
2839596 2 M ID 05/05/2025 COVID19
 PFIZER\BIONTECH
 LN6739
Product storage error Product storage error
This vaccine was deemed non-viable as it was stored in a regular freezer and not an ultra-freezer fo... This vaccine was deemed non-viable as it was stored in a regular freezer and not an ultra-freezer for 77 days prior to administration. More
2839597 1.5 F ID 05/05/2025 FLU3
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 79K45
X025908
Expired product administered; Expired product administered Expired product administered; Expired product administered
The hepatitis A vaccines expired 4/24/25 but was given 5/5/25. Patient did not experience any advers... The hepatitis A vaccines expired 4/24/25 but was given 5/5/25. Patient did not experience any adverse signs or symptoms to my knowledge at the time of the report. Patient's parent was notified of error, and the need to revaccinate, and to let us know if patient needs anything due to error. More
2839598 12 M CA 05/05/2025 YF
 SANOFI PASTEUR
 UK134AA
Dyspnoea, Hypersensitivity, Pruritus, Swelling, Swelling face Dyspnoea, Hypersensitivity, Pruritus, Swelling, Swelling face
Yellow fever vaccine was administered to the patient on 4/26/25. It is for a family of 4. The mother... Yellow fever vaccine was administered to the patient on 4/26/25. It is for a family of 4. The mother came on 5/2/25 to pick up a prescription and upon counseling, I asked how the family was. The mom then told me that patient had an allergic reaction to the YF vaccine 20 minutes later while they were grocery shopping. Patient felt itching on his body. She then gave him Benadryl to take. Still a few minutes later, he was still complaining and swelling of the face and neck was observed. He complained of difficulty breathing. They took him to ER. In ER they administered Epi-pen and Solu-medrol. He was in observation for 4 hours. Swelling went down. Released him with an oral Prednisone. Mom was somewhat okay when I saw her on 5/2/25 and the 3 other family had no reaction whatsoever. More
2839602 61 M MO 05/05/2025 FLU3
 SEQIRUS, INC.
 946626
Dry mouth, Dysphagia, Myasthenia gravis Dry mouth, Dysphagia, Myasthenia gravis
pt had some dryness in mouth and some difficulty in swallowing, went to dr on 2/13/25 and was diagno... pt had some dryness in mouth and some difficulty in swallowing, went to dr on 2/13/25 and was diagnosed with myasthenia gravis and given some steroids. Symptoms improved some, but didn't resolve completely. At end of March pt had worsening symptoms, went back to dr for more steroids, and ended up going to the ER around 3/31/25. Was released from hospital to rehab, and now back home. Neither patient or doctor indicated that they thought his myasthenia gravis was an adverse reaction to the flu shot, but wanted to report it. Pt seemed to feel that his previous illness, meds, etc. made his immune system go haywire and may have initiated the the myasthenia gravis episode. More
2839603 64 F FL 05/05/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 z002626
z002626
Arthralgia, Diarrhoea, Headache, Injection site erythema, Injection site swellin... Arthralgia, Diarrhoea, Headache, Injection site erythema, Injection site swelling; Pain in jaw, Pyrexia, Sleep disorder More
HEADACHE, FEVER, DIARRHEA, [PAIN FROM JAW TO WAIST, CANNOT SLEEP ON LEFT SIDE - PATIENT HAD FEVER, ... HEADACHE, FEVER, DIARRHEA, [PAIN FROM JAW TO WAIST, CANNOT SLEEP ON LEFT SIDE - PATIENT HAD FEVER, SWELLING, REDNESS - INJECTION SITE REACTION - ADMINISTERED 4/30, STILL RED AND SWOLLEN More
2839604 65 F IL 05/05/2025 COVID19
 MODERNA
 3043160
Arthralgia, Malaise, Pyrexia Arthralgia, Malaise, Pyrexia
Patient reports experiencing fever, joint pain, malaise for days after Covid-19 vaccination Patient reports experiencing fever, joint pain, malaise for days after Covid-19 vaccination
2839605 1 F AZ 05/05/2025 MMRV
 MERCK & CO. INC.
 Y009589
Extra dose administered Extra dose administered
pt was inadvertently given MMRV & VARICELLA, reviewed side effects with mother & she verbali... pt was inadvertently given MMRV & VARICELLA, reviewed side effects with mother & she verbalized her understanding. as per mother was given Tylenol & will informed us of any other symptoms. More
2839606 59 F AZ 05/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Injection site erythema, Injection site pruritus, Injection site swelling, Myalg... Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia, Pruritus; Pyrexia, Rash More
PATIENT IS REPORTING IMMUNE RESPONSE (SYSTEMIC) REACTIONS (FEVER, MUSCLE ACHES) THAT LASTED OVER 3 D... PATIENT IS REPORTING IMMUNE RESPONSE (SYSTEMIC) REACTIONS (FEVER, MUSCLE ACHES) THAT LASTED OVER 3 DAYS AND AN INJECTION SITE REACTION (REDNESS, SWELLING AROUND THE INJECTION SITE) ALONG WITH SEVERE ITCHING AND RASH. SHE REPORTED THAT THE ITCHING BEGAN THROUGHOUT HER ENTIRE LEFT SIDE, BUT HAS SINCE DECREASED TO ONLY BEING AROUND THE INJECTION SITE NOW. ADVISED PATIENT TO SEEK MEDICAL ATTENTION, AND AS MAY BE SIGNS OF AN ALLERGIC REACTION, TO DISCUSS SECOND DOSE WITH PROVIDER AND OBTAIN ONLY IN A MEDICAL OFFICE WHERE SHE CAN BE CLOSELY MONITORED IF DOCTOR WANTS TO ADMINISTER. More
2839608 68 F IL 05/05/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Red reaction below the injection site, she felt under the weather the couple days after the vaccine,... Red reaction below the injection site, she felt under the weather the couple days after the vaccine, then today on 5/5/25 she reported a red mark underneath the injection site that is painful to touch. I advised her to take benadryl and ice the area and to report back to us if she was not improving More
2839609 55 F OR 05/05/2025 PNC21
 MERCK & CO. INC.
 z004301
Injection site erythema Injection site erythema
Patient's injection site turned red about 3 inches wide, and 6 inches long but was not swollen,... Patient's injection site turned red about 3 inches wide, and 6 inches long but was not swollen, and not itching. It was not getting better but not getting worse after 3 days. More
2839610 40 F AZ 05/05/2025 COVID19
 MODERNA
Pancreatic disorder, Type 1 diabetes mellitus Pancreatic disorder, Type 1 diabetes mellitus
Attacked pancreas and now doesn?t work and is now a type 1 diabetic that has created other issues Attacked pancreas and now doesn?t work and is now a type 1 diabetic that has created other issues
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2839611 53 F IA 05/05/2025 PNC21
 MERCK & CO. INC.
 Y019158
Chills, Erythema, Malaise, Peripheral swelling, Pyrexia Chills, Erythema, Malaise, Peripheral swelling, Pyrexia
3/31/25 cellulitis type redness up and down arm with swelling. Started the day following vaccination... 3/31/25 cellulitis type redness up and down arm with swelling. Started the day following vaccination. Patient sought follow-up with a provider on 3/31/25 and was prescribed ciprofloxacin. Due to her history of arrythmias, her husband (another provider) prescribed bactrim ds. She started with bactrim ds and then ciprofloxacin. On 4/2/25 more swelling occurred and her primary provider gave prednisone taper. Patient did not seek any more followup and never responded to requests for more information. Following vaccination also patient said she had chills, fever, and feeling of illness for around 3 days following. More
2839612 39 F TX 05/05/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FF2588
FF2588
FF2588
Abnormal menstrual clots, Asthenia, Chronic lymphocytic leukaemia, Confusional s... Abnormal menstrual clots, Asthenia, Chronic lymphocytic leukaemia, Confusional state, Dysmenorrhoea; Fatigue, Heart rate decreased, Influenza like illness, Menstruation irregular, Sluggishness; Somnolence More
Within minutes I felt fatigued, exhausted, confused, sluggish, felt a drop in my heart rate. Once I ... Within minutes I felt fatigued, exhausted, confused, sluggish, felt a drop in my heart rate. Once I got home I fell asleep on the floor for several hours. I experienced flu like symptoms for months. Within a week of getting the initial vaccine, my menstrual cycle came again that same month and was horrible! Blood clotting and cramping, but much more strange and worse than ever. I even brought it to the attention of my gynecologist around March of 2022, I believe. More
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2839613 47 F KY 05/05/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL 0412
EL 0412
EL 0412
EL 9261
EL 9261
EL 9261
Antinuclear antibody, Arthralgia, Blood culture negative, Blood test, Hip arthro... Antinuclear antibody, Arthralgia, Blood culture negative, Blood test, Hip arthroplasty; Knee arthroplasty, Magnetic resonance imaging, Osteoarthritis, Pain, Red blood cell sedimentation rate; White blood cell count increased, X-ray; Antinuclear antibody, Arthralgia, Blood culture negative, Blood test, Hip arthroplasty; Knee arthroplasty, Magnetic resonance imaging, Osteoarthritis, Pain, Red blood cell sedimentation rate; White blood cell count increased, X-ray More
Jan. 2021 Sudden onset of joint pain in all of joints starting with both shoulders, both hips, and ... Jan. 2021 Sudden onset of joint pain in all of joints starting with both shoulders, both hips, and right knee. Joint pain in ankles and hands. Started in shoulders within 2 weeks in injection. Severe pain in Right knee, milder pain on both hips. Treated with steroid injections in both shoulders, both hips and right knee throughout 2021. Knee pain progressed rapidly that lead to Total Knee replacement in Nov. 2021 and Hip Replacement in 2024. 2021-2025 Multiple visits to doctors that were unable to diagnose an autoimmune disease or a cause for rapid onset of Osteoarthritis other than adverse effect of COVID vaccine which is only documented by rheumatology, no other physician would document this finding.. Sudden onset of all over body aches and pain lead to ER visitOct . 31 2021. WBC count over 18, blood cultures were negative, one night in hospital, with treatment for pain. No diagnosis. Rheumatology every 6 months. Currently take Diclofenac and anti steroidal pain relievers. Anticipating left hip replacement this year. More
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2839989 78 F NC 05/05/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 016M20A
016M20A
016M20A
Body temperature increased, Cardiac failure congestive, Coronary arterial stent ... Body temperature increased, Cardiac failure congestive, Coronary arterial stent insertion, Death, Myocardial infarction; Pain, Peripheral swelling, Rectal haemorrhage, Skin weeping, Thrombectomy; Thrombosis More
Thier are so many see intire Packet sent along with form will list. First. EMS. Call Emergency to Ho... Thier are so many see intire Packet sent along with form will list. First. EMS. Call Emergency to Hospital. Legs swelling temp 105 Blood Press 217/110 unberable pain #2 Hospital Bleeding from Rectum. #3 Hospital Leg swelling. Had Heart attack in Emergency room #4 Hospital Put in a shunt on Heart Blood vessel. Diag swollen legs Remove massive blood clots from both legs. The clots stated by Doc Surgeon. Never have seen these kinds of Blood clots. Never seen by mankind. #5 Hospital congestive Heart failure fluid leak from skin #6 Hospital Congestive Heart Failure Fluid lek from skin More
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2839990 45 F OH 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3959S
Product preparation issue Product preparation issue
Pt came in to health department for second dose of Shingrix. Nurse on clinic has never given this pa... Pt came in to health department for second dose of Shingrix. Nurse on clinic has never given this particular vaccine before and was unaware that the dilutent was included in the box with single does vials. Nurse reconstituted dose with sterile water. Vaccine was administered. Approx 1.5 weeks later during inventory the dilutent was was discovered left in the fridge. It was then discovered vaccine was reconstituted incorrect agent. Nurse that administered vaccine was made aware at this time. CDC was contacted for further advice at this time. Administering nurse reviewed Education material sent by CDC. Below is the answer from the CDC: Question: A dose of Shingrix was given with the sterile MMR/varicella diluent instead of the diluent provided in the box, does this dose of vaccine count or does it need to be repeated? If it does need repeated does there need to be an interval between the doses? CDC Response: Yes, the dose needs to be repeated. Diluents are not interchangeable unless specified by the manufacturer, and vaccine doses prepared using the wrong diluent are invalid. The diluent required to reconstitute the lyophilized component of Shingrix contains an AS01B adjuvant, which helps create a stronger immune response in people receiving the vaccine. The MMR/varicella diluent is unadjuvanted sterile water. The two diluents are not interchangeable; therefore, this was a vaccination error. Because the vaccination was invalid, the dose must be repeated. Since the vaccine is non-live and administered without the approved diluent, the repeated dose can be administered at any interval after the invalid dose (no minimum interval recommended). For all vaccine administration error: Inform the recipient of the vaccine administration error. Consult with the state immunization program and / or immunization information system (IIS) to determine how the dose should be entered into the ISS. Determine how the error occurred and implement strategies to prevent it from happening again. A discussion on strategies to prevent errors can be found in the "Vaccine Administration" chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Additional resources can be found on the CDC's vaccine administration web page, including a job aid for preventing errors. In addition, if not already done, we encourage you to report this error to the Vaccine Adverse Event Reporting System (VAERS) event if the patient has not symptoms. Reports to VAERS are important because they can help CDC and Food and Drug Administration (FDA) detect new or unusual adverse events or patterns that could indicate a problems with vaccines. To file an electronic report, see the VAERS website. More
2839991 78 M HI 05/05/2025 COVID19
COVID19
 JANSSEN
JANSSEN
 1808982
1808982
Cerebral thrombosis, Laboratory test, Myelopathy, Nerve injury, Pain; Pneumonia Cerebral thrombosis, Laboratory test, Myelopathy, Nerve injury, Pain; Pneumonia
Nerve damage Pain Pneumonia brain blood clot Spinal cord degenation Nerve damage Pain Pneumonia brain blood clot Spinal cord degenation
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2839355 78 F TX 05/04/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA

8081260
8081260
Gait inability, Lethargy, Mobility decreased; Mobility decreased; Gait inability... Gait inability, Lethargy, Mobility decreased; Mobility decreased; Gait inability, Lethargy, Mobility decreased; Mobility decreased More
I started to feel lethargic about 4 hours after receiving the vaccine. About 8 hours later, I neede... I started to feel lethargic about 4 hours after receiving the vaccine. About 8 hours later, I needed to urinate. I was unable to walk to bathroom. I tried crawling but my lower appendages would not move. At this point I urinated on myself & seemed to have passed out. While sitting on floor, I tried to remove clothing but I was unable to lift my core . Eventually, I was able to creep back into bed. For the next 12 hours I felt very lethargic. I continued to improve from that point on. More
2839356 57 F MI 05/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 Unsure
Chills, Fatigue, Nausea, Pain, Pyrexia Chills, Fatigue, Nausea, Pain, Pyrexia
High fever, chills, nausea, tiredness, body aches (likely from tensed muscles from the chills). High fever, chills, nausea, tiredness, body aches (likely from tensed muscles from the chills).
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