🏥 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 💀 🏥 🚑 ♿ ⚠️
2839252 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
painful thing I've ever experienced/agony; This non-serious case was reported by a consumer via... painful thing I've ever experienced/agony; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: painful thing I've ever experienced/agony). The outcome of the pain was resolved (duration 29 days). It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that the most painful thing he/she had ever experienced. Twenty nine days of pure agony because he/she forgot to get the second vaccine.. More
2839253 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with lysine. 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: 23-APR-2025 This case was reported by a patient via interactive digital media. Patient had shingles, patient was vaccinated and still had after-effects. Patient stated that lysine or zosterex that contains lysine in its composition, it makes the virus sleep, helped them a lot. Also reported that when immunity drops, it starts to disturb, that's why they use this medication. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2839254 05/02/2025 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was resolved (duration 1 month). 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: 25-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that the patient got the shingles shot and within two weeks had the shingles for almost a month. More
2839255 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Ophthalmic herpes zoster, Vaccination failure Ophthalmic herpes zoster, Vaccination failure
Suspected vaccination failure; ended up with shingles in my eye; This serious case was reported by a... Suspected vaccination failure; ended up with shingles in my eye; 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, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: ended up with shingles in my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date : 26-APR-2025 This case was reported by a patient via interactive digital media. The patient received the shingles shot and a month later ended up with shingles in his/her eye. The patient stated that never again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine More
2839256 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise, Pain in extremity Malaise, Pain in extremity
I was sick; arm felt like it was broken it hurt so bad; This non-serious case was reported by a cons... I was sick; arm felt like it was broken it hurt so bad; 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 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I was sick) and pain in arm (Verbatim: arm felt like it was broken it hurt so bad). The outcome of the sickness was resolved and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the sickness and pain in arm to be related to Shingles vaccine. It was unknown if the company considered the sickness and pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-APR-2025 The case was received from the patient via interactive digital media. The reporter got the vaccine on the second dose he/she was sick for over a week and his/her arm felt like it was broken it hurt so bad. But the reporter was still glad he/she got it because of all the bad stories of the shingles. More
2839257 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. The patient took this shot and still got it. It was not as bad as others but wished had not taken it. Patient mom had and it was reason to get the shot. The patient remembered her painful time. They did not know what it was till she went to doctor. 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
2839258 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; gotten shingles was after they got the vaccine; This serious case was... Suspected vaccination failure; gotten shingles was after they got 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: gotten shingles was after they got 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 This case was reported by a patient via interactive digital media. Consumer reported that ironically the only people he/she know that had gotten shingles was after they got the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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
2839259 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; everyone that comes to him with shingles has had the shot; This serio... Suspected vaccination failure; everyone that comes to him with shingles has had the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: everyone that comes to him with shingles has had 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 reporter via interactive digital media. Reporter's physician told him/her that everyone that comes to him with shingles has had the shot, and it does nothing but made big pharma richer. He also told reporter not to waste time and put that in his/her body, it was no good. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2839260 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; took 3 visits to get diagnosed; This serious case was reported by a c... Suspected vaccination failure; took 3 visits to get diagnosed; 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: took 3 visits to get diagnosed). 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 via interactive digital media. The patient had the shots too and it took 3 visits to get diagnosed, emergency room, urgent care and family physician 10 out of 10 on the pain chart. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2839261 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspeceted vaccination failure; Shingels; This serious case was reported by a consumer via interacti... Suspeceted vaccination failure; Shingels; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingels). 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: 25-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that you could get shingles even with the vaccine.; 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
2839262 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
got the first shot over a year, ago but never got the second; This non-serious case was reported by ... got the first shot over a year, ago but never got the second; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (Received the first shot over a year). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: got the first shot over a year, ago but never got the second). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient got the first shot over a year ago but never got the second, so do the patient need to start all over? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2839263 05/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
I got sick; This non-serious case was reported by a consumer via interactive digital media and descr... I got 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. Previously administered products included Shingles vaccine (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I got 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: 28-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got sick with the second dose. Th patient stated it was first time they ever had a reaction to a vaccine. But they figured way better than getting shingles. More
2839264 05/02/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; rsv three weeks later; This serious case was reported by a consumer v... Suspected vaccination failure; rsv three weeks later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 3 weeks after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: rsv three weeks later). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK receipt date: 26-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that took the rsv shot and came down with rsv (respiratory syncytial virus infection) three weeks later. This case was considered as suspected vaccination failure as laboratory confirmation regarding respiratory syncytial virus infection 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 the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine More
2839265 19 M FL 05/02/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
Intramuscular administration of Priorix; This non-serious case was reported by a nurse via call cent... Intramuscular administration of Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 19-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 28-APR-2025, the patient received Priorix (intramuscular). On 28-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 28-APR-2025 The nurse practitioner gave patient the MMR vaccine, the Priorix, the only thing was it was given intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administration by other route. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional mentioned that the birth gender of the patient was male, but the legal gender was female. More
2839266 11 M NM 05/02/2025 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; This non-serious case was reported by a other health professio... Administration after temp. excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 11-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 22-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). 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
2839267 63 M MN 05/02/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 82B72
Incorrect route of product administration Incorrect route of product administration
A 63 years old male patient received Priorix IM instead of subcutaneous; This non-serious case was r... A 63 years old male patient received Priorix IM instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 63-year-old male patient who received MMR (Priorix) (batch number 82B72, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A 63 years old male patient received Priorix IM instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-APR-2025 On 29th April 2025, a pharmacist had called to report that a 63 year old male patient had received Priorix intramuscularly instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route. The pharmacist had stated that it had probably not reached the muscle completely because she had used a 5/8 inch needle. More
2839268 17 F PA 05/02/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
F5L5E
Expired product administered, Interchange of vaccine products; Expired product a... Expired product administered, Interchange of vaccine products; Expired product administered, Interchange of vaccine products More
EXPIRED DOSE ADMINISTERED; INTERCHANGE OF VACCINES.; This non-serious case was reported by a physici... EXPIRED DOSE ADMINISTERED; INTERCHANGE OF VACCINES.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired drug administered in a 17-year-old female patient who received HBV (Engerix B) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis. On 21-APR-2025, the patient received the 1st dose of Engerix B. In MAR-2025, the patient received Heplisav b. On 21-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired drug administered (Verbatim: EXPIRED DOSE ADMINISTERED) and interchange of vaccine products (Verbatim: INTERCHANGE OF VACCINES.). The outcome of the expired drug administered and interchange of vaccine products were not applicable. Additional Information: GSK Receipt Date: 30-APR-2025 The physician reported that a patient received Engerix on April 21st and unfortunately we found out later that the vaccine had expired on April 11th, which led to expired vaccine used. The reporter was ask what are the adverse effects on that also ask unfortunately received as well heplisav a month prior and we found out after that the Heplisav is not approved for her age range, which led to interchange of vaccine products. The reporter was ask if they should expect any adverse effects for administering an expired Engerix and if there is like additional adverse effects to be expected for her receiving Heplisav a month before that. More
2839269 M 05/02/2025 COVID19
 UNKNOWN MANUFACTURER
COVID-19, Vaccination failure COVID-19, Vaccination failure
Diagnosed with covid; Diagnosed with covid; This is a spontaneous report received from a Consumer or... Diagnosed with covid; Diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: . A 77-year-old male patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), on 17Apr2025 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2025, outcome "unknown" and all described as "Diagnosed with covid". The event "diagnosed with covid" required emergency room visit. Clinical course: Caller stated that he was diagnosed with covid on Saturday (26Apr2025) at the ER and was taken to the hospital by an ambulance. He didn't know when the symptoms started. He had a vaccine for covid on 17Apr2025. He didn't have any symptoms for a few days. He was told Paxlovid works if you take the medicine within so many days of your first symptoms. First symptom could have been maybe within 5 or 6 days afterwards when it was the 17th and today (28Apr2025) the 11th day after he had the vaccine. And maybe 6 or 7 days after he first noticed the symptoms. He doesn't know if Paxlovid would still be of benefit for him or not because there are some guidelines you need to take it within so many days of first having symptoms of Covid. He added that ha hasn't taken Paxlovid. If it's over 5 days it's not beneficial reporter asked. He was prescribed last Saturday and the pharmacy was closed on Sunday and they called him this Morning. He have not started taking the medicine yet. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2839270 63 M CA 05/02/2025 COVID19
RSV
 PFIZER\BIONTECH
PFIZER\WYETH

Back disorder, Gait inability, Illness, Muscle spasms, Pain in extremity; Back d... Back disorder, Gait inability, Illness, Muscle spasms, Pain in extremity; Back disorder, Gait inability, Illness, Muscle spasms, Pain in extremity More
can hardly walk/not been able to walk anymore; has pain in his legs; it has a lot of connection with... can hardly walk/not been able to walk anymore; has pain in his legs; it has a lot of connection with leg cramp and spasm; Patient also took some "Licodine" for back and legs, but it did not work after he got sick; Patient also took some "Licodine" for back and legs, but it did not work after he got sick; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 63-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for immunisation. The patient's relevant medical history included: "Seizures" (ongoing). Concomitant medication(s) included: LEVETIRACETAM taken for seizure (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: GAIT INABILITY (medically significant), outcome "not recovered", described as "can hardly walk/not been able to walk anymore"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "has pain in his legs"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "it has a lot of connection with leg cramp and spasm"; BACK DISORDER (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "Patient also took some "Licodine" for back and legs, but it did not work after he got sick". The events "can hardly walk/not been able to walk anymore", "has pain in his legs", "it has a lot of connection with leg cramp and spasm" and "patient also took some "licodine" for back and legs, but it did not work after he got sick" required physician office visit. Therapeutic measures were taken as a result of gait inability, pain in extremity, muscle spasms, back disorder, illness. Clinical course: Patient called after he was administered the RSV flu shot and Pfizer's covid-19 vaccine concomitantly. He went to the pharmacy, and they told him that it was safe to receive both vaccines at the same time. He mentioned that he received the vaccines at the same time, the same arm in the same minute. Additionally, he said that he went online to report it at the (withheld) website. This would be the fourth time getting the shot of Covid but after the last administration he's not been able to walk anymore, before he used to walk 16-18 miles a day. Wants to know if this is a known AE, because it's not normal. He's already went to his PCP, Neurologist and told him that he's fine. Additionally, he was prescribed medications which made his problem worse. Mentioned that from his work he was obliged to get the vaccines. Patient can hardly walk, has pain in his legs, it has a lot of connection with leg cramp and spasm and in an unnecessary painful situation. Other treatment included Voltaren which did not do any good. Patient also took some "Licodine" for back and legs, but it did not work after he got sick. The patient further stated, "Yes, of course, I need to walk. It is impossible for a healthy man which is the suggested by my neurologist and my doctor, my everything. I got like 4 different doctors even my psychologist said nothing wrong with you. Then, overnight my life changed because of this shot, it got to be something wrong and as far as I read, it has a lot of connection with leg cramp and spasm." The information on the batch/lot number for BNT162b2 omicron (kp.2), rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2839271 73 F NC 05/02/2025 COVID19
 PFIZER\BIONTECH
Hypersensitivity, Rash erythematous, Rash pruritic Hypersensitivity, Rash erythematous, Rash pruritic
a very bright red rash all over face and down both arms/rash was very red and itchy; a very bright r... a very bright red rash all over face and down both arms/rash was very red and itchy; a very bright red rash all over face and down both arms/rash was very red and itchy; allergic reaction to the Pfizer Covid 19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left lower forearm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: QSYMIA oral taken for weight decreased, start date: Sep2024 (ongoing); OMEPRAZOLE oral taken for dyspepsia (ongoing); MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] oral taken for prophylaxis (ongoing); CITRACAL [CALCIUM CITRATE] oral taken for bone disorder (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL5262), administration date: 23Jan2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EN6201), administration date: 13Feb2021, for Covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE, Lot: Has two numbers, FM0698, WAG12853), administration date: 28Mar2022, for Covid-19 immunization; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), administration date: 2023, for Covid-19 immunization; Bnt162b2 nos (DOSE 5 (BOOSTER), SINGLE), administration date: 2023, for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), administration date: Mar2024, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset 05Apr2025, outcome "recovered" (Apr2025) and all described as "a very bright red rash all over face and down both arms/rash was very red and itchy"; HYPERSENSITIVITY (non-serious) with onset 05Apr2025, outcome "recovered" (Apr2025), described as "allergic reaction to the Pfizer Covid 19 vaccine". Therapeutic measures were taken as a result of rash pruritic, rash erythematous, hypersensitivity. Additional information: patient had allergic reaction to it, had Pfizer Comirnaty on 04Apr2025. Clarified the reaction patient had been a very bright red rash all over face and down both arms. This was the first one patient ever had an allergic reaction to for the COVID shots. Patient always had Pfizer COVID shots except on one occasion when patient had Moderna COVID shot. Went to the doctor on 06Apr2025 since it was a weekend and was given prednisone and Benadryl. Rash didn't show up until the next day, 05Apr2025, and the rash didn't go away until the last day of the medications, which was about 10 days later. Patient with a question, didn't know if had any advice regarding whether or not patient should take another COVID shot or not take another Pfizer COVID shot or anything like that. patient can't think of more details. patient worked in a health office, clarified patient was not an HCP, the caller was an administrator. Bright red rash all over face and down both arms: Rash didn't show up until the next day, 05Apr2025, and the rash didn't go away until the last day of the medications, which was about 10 days later. Stop date, outcome: Confirmed rash is not ongoing, recovered completely. Concomitant products: Just regular medications, patients then provided information in formal fields from pill box. Patient and patient's husband couldn't think of the name of the multivitamin patient takes; patient then clarified it is Centrum multivitamin. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2839272 F 05/02/2025 COVID19
 PFIZER\BIONTECH
Dyspnoea Dyspnoea
breathes heavy ever since; This is a spontaneous report received from a Consumer or other non HCP, P... breathes heavy ever since; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 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. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "breathes heavy ever since". Additional information: The reporter stated, "I had blood clots right away years ago but my mom also took the shot she breathes heavy ever since". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2839274 0.92 M NY 05/02/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
 U7899AA
U7899AA
LC5484
LC5484
Malaise, Oral disorder, Peripheral swelling, Poor feeding infant, Purpura; Rash,... Malaise, Oral disorder, Peripheral swelling, Poor feeding infant, Purpura; Rash, Rhinorrhoea, Skin lesion; Malaise, Oral disorder, Peripheral swelling, Poor feeding infant, Purpura; Rash, Rhinorrhoea, Skin lesion More
severe purpuric rash of the face and extremities, swelling of the hands, feet and oral lesions assoc... severe purpuric rash of the face and extremities, swelling of the hands, feet and oral lesions associated with malaise, cough, rhinorrhea and poor oral intakewhich began within 24 hours of the vaccines and progressed over the course of a week and the remnants of which are still present 2 1/2 mo later. Was admitted to the hospital and given supportive care and IV antibiotics for an infectious complication of the rash. More
2839275 5 F NH 05/02/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Bone pain, Product administered at inappropriate site Bone pain, Product administered at inappropriate site
My daughter had her vaccine yesterday and complained that her bone hurt a few hours later in her lef... My daughter had her vaccine yesterday and complained that her bone hurt a few hours later in her left arm. As a medical assistant myself, I looked at where the injection site was, and it was too close to the shoulder. The placement was too high and too close to shoulder. Patient woke up this morning with the pain being worse than the day before. More
2839276 0.17 F MA 05/02/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS


Pyrexia; Pyrexia; Pyrexia Pyrexia; Pyrexia; Pyrexia
Fever of 101F Fever of 101F
2839277 31 M MA 05/02/2025 ANTH
 EMERGENT BIOSOLUTIONS
 300216A
Injection site pain Injection site pain
Severe L deltoid pain around the injection site with limited ROM w/ abduction, trx includes NSAIDS, ... Severe L deltoid pain around the injection site with limited ROM w/ abduction, trx includes NSAIDS, activit mod and ice More
2839278 39 F MA 05/02/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012921
Y012921
Chills, Dizziness, Headache, Influenza like illness, Nausea; Pyrexia Chills, Dizziness, Headache, Influenza like illness, Nausea; Pyrexia
about 3 hours after injection was received, pt complained of significant flu-like symptoms (fever of... about 3 hours after injection was received, pt complained of significant flu-like symptoms (fever of 101, chills, nausea and lightheadedness. Also complained of headache. Pt was referred to PCP for evaluation for flu and COVID testing More
2839279 86 F NH 05/02/2025 COVID19
 PFIZER\BIONTECH
Cough, Pain in extremity, SARS-CoV-2 test negative Cough, Pain in extremity, SARS-CoV-2 test negative
c/o arm pain the day after injection. Day three developed cough requiring treatment. c/o arm pain the day after injection. Day three developed cough requiring treatment.
2839280 88 F NH 05/02/2025 COVID19
 PFIZER\BIONTECH
Chest X-ray normal, Cough, Influenza virus test negative, SARS-CoV-2 test negati... Chest X-ray normal, Cough, Influenza virus test negative, SARS-CoV-2 test negative, Wheezing More
developed wheezing 4/27 with subsequent onset of cough requiring treatment with steroids and antibio... developed wheezing 4/27 with subsequent onset of cough requiring treatment with steroids and antibiotics. More
2839281 17 F WV 05/02/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 Z92L4
Dizziness Dizziness
Patients reaction was light headed and dizzy. Patients reaction was light headed and dizzy.
2839282 90 F NH 05/02/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chest X-ray abnormal, Cough, Hypervolaemia, Influenza virus test negative, Oxyge... Chest X-ray abnormal, Cough, Hypervolaemia, Influenza virus test negative, Oxygen saturation decreased; Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative, Vomiting More
onset of cough and congestion 4/28 with decreased oxygen levels and vomiting onset of cough and congestion 4/28 with decreased oxygen levels and vomiting
✓
2839283 62 M CT 05/02/2025 COVID19
 PFIZER\BIONTECH
 LP1776
No adverse event No adverse event
NO ADVERSE EVENT HAPPENED TO THE PATIENT NO ADVERSE EVENT HAPPENED TO THE PATIENT
2839284 59 F ND 05/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 mg5s9
Back pain, Injection site erythema, Injection site reaction, Paraesthesia, Skin ... Back pain, Injection site erythema, Injection site reaction, Paraesthesia, Skin exfoliation More
Tingling to right hand, upper back pain that started "pretty quickly after the shot." Flak... Tingling to right hand, upper back pain that started "pretty quickly after the shot." Flaking of skin at injection site and redness at injection site in addition to tingling of right hand and arm and back pain on right upper back. More
2839285 62 F TX 05/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 33FD3
Pain in extremity, Peripheral swelling Pain in extremity, Peripheral swelling
arm soreness and swelling arm soreness and swelling
2839286 17 M IN 05/02/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
9M2R7
Fall, Head injury, Loss of consciousness; Fall, Head injury, Loss of consciousne... Fall, Head injury, Loss of consciousness; Fall, Head injury, Loss of consciousness More
Patient came in today for a well child appointment at 4:20pm. He was also due for two vaccines, men... Patient came in today for a well child appointment at 4:20pm. He was also due for two vaccines, menveo and bexsero. He had previously gotten the first dose and was scheduled to receive the second dose today. No noted reaction to any vaccine in our office previously. Grandma accompanied him to his appointment today, called mom and got verbal consent for patient to get his vaccines. He was talkative while the MA went in to give him the shots. Afterwards, they went to checkout, patient was talking to the receptionist scheduling his next appointment. Suddenly he said 'I think I have to' then fell down. He hit his bottom first then fell back and hit the back of his head on the floor, grandma was unable to catch him. Our phlebotomist came running thinking the patient had labs done. Dr. and MAs were close and came running. Patient was out for a few minutes then woke up. Dr. did an exam, no bump or bleeding, she didn't find anything abnormal. He was given ice for his head and water to drink. He sat on the floor for another 5 minutes drinking water and talking to staff. Patient said that he felt fine, he was able to get up unassisted, and walked to their vehicle. Patient was advised that the next time he gets vaccines or a blood draw to make sure he stays seated for 10 minutes afterward so that it doesn't happen again. I don't think that it was preventable because it had never happened to him before per his report, but after the fact grandma mentioned that it did happen to patient's father once or twice. More
2839287 0.67 M IL 05/02/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 42Y93
Y009106
No adverse event; No adverse event No adverse event; No adverse event
No adverse reaction. Administration error. Vaccines for client's sibling inadvertently administ... No adverse reaction. Administration error. Vaccines for client's sibling inadvertently administered to this client with appointments at the same time and in the same room. Parent informed of error and provided instructions for follow-up care if needed. More
2839288 27 F FL 05/02/2025 HEP
IPV
TDAP
VARCEL
 DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 945660
Y1A201M
U8115AA
Y015558
Pallor, Syncope, Unresponsive to stimuli; Pallor, Syncope, Unresponsive to stimu... Pallor, Syncope, Unresponsive to stimuli; Pallor, Syncope, Unresponsive to stimuli; Pallor, Syncope, Unresponsive to stimuli; Pallor, Syncope, Unresponsive to stimuli More
Patient fainted after vaccine administration. Patient was pale, and requested water prior to event. ... Patient fainted after vaccine administration. Patient was pale, and requested water prior to event. Patient was non-responsive for 15 seconds. Patient left facility fully recovered within 20 minutes. More
2839289 36 F IN 05/02/2025 VARCEL
 MERCK & CO. INC.
 Y014511
Fatigue, Oropharyngeal pain, Pain, Pruritus, Rash Fatigue, Oropharyngeal pain, Pain, Pruritus, Rash
body aches, itchy skin, sore throat, fatigue, rash. Was given diphenhydramine 50mg injectable, patie... body aches, itchy skin, sore throat, fatigue, rash. Was given diphenhydramine 50mg injectable, patient was feeling better when leaving clinic. More
2839290 73 F AR 05/02/2025 COVID19
 MODERNA
 012A21A
COVID-19 COVID-19
covid infection with hospitalization after vaccination covid infection with hospitalization after vaccination
2839291 71 M AR 05/02/2025 COVID19
 MODERNA
 030B21A
COVID-19 COVID-19
covid infection with hospitalization after vaccination covid infection with hospitalization after vaccination
2839292 79 F MI 05/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 BY4NA
Product preparation issue Product preparation issue
Vaccine was not reconstituted, RN administered only the diluent. Patient was contacted, no concerns ... Vaccine was not reconstituted, RN administered only the diluent. Patient was contacted, no concerns at the inj sight. Patient aware of need to readminister vaccine after 1 month then follow continued guidelines for done #2 to finish the series 2-6 months after. More
2839293 65 F MI 05/02/2025 COVID19
 PFIZER\BIONTECH
 lr6262
Malaise, Viral test positive Malaise, Viral test positive
tested r/t complaints of not feeling well tested r/t complaints of not feeling well
2839294 30 F MI 05/02/2025 PNC21
 MERCK & CO. INC.
 Y019158
Cellulitis, Erythema, Swelling Cellulitis, Erythema, Swelling
large redness area slightly swollen and patient was seen at ER at local hospital. She was told she&#... large redness area slightly swollen and patient was seen at ER at local hospital. She was told she's having cellulitis and being treated with Doxycycline and Ibuprofen. Two days later, she mentioned that the redness spread and was treated at the hospital with IV antibiotics. More
2839295 51 F PA 05/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Biopsy skin, Pain in extremity, Peripheral swelling, Rash Biopsy skin, Pain in extremity, Peripheral swelling, Rash
My arm swelled up and painful, then I developed rashes on my arms, legs, and stomach. and my right l... My arm swelled up and painful, then I developed rashes on my arms, legs, and stomach. and my right leg is painful. More
2839296 4 F CA 05/02/2025 MMRV
 MERCK & CO. INC.
 Y012341
Injection site erythema, Injection site induration, Injection site vesicles, Inj... Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth More
Below is statement from emergency room report : ... Below is statement from emergency room report : " Medical Decision Making 4 yo previously healthy fully vaccinated F who presents with 2 days of blisters and erythema, induration, and warmth to left upper extremity following vaccine administration. On exam, she has nearly circumferential erythema of the left upper extremity with area of induration and few blisters, 1 of which has been denuded, the entire area warm to touch. Overall most consistent with cellulitis. -Considered abscess but lack of fluctuance points against. -Considered sepsis/bacteremia but well appearance, lack of fever, normal perfusion and MS point against. -Considered compartment syndrome given near circumferential nature of cellulitis but compartments still soft, nvi. -Considered MRSA but no h/o such and no fhx recurrent boils. -Considered anaphylaxis but isolated rash to distinct area of arm with no other s/s points against. -Considered varicella or measles given recent vaccine administration but distribution and appearance are not consistent with either rash. Labs were considered but not performed given low suspicion for sepsis/bacteremia and no GI sx to suggest electrolyte abnormality, so these were thought to not change clinical management. Imaging (US soft tissue) was considered but not performed given low suspicion for abscess at this time. Reassured family of low concern for reaction or allergy to vaccine contents given localized distribution, no signs of anaphylaxis. Plan: - Given allergy to Keflex, will prescribe clindamycin for 5-day course per IDMP. First Dose given in ED. - Borders of erythema drawn with pen -May give Tylenol or ibuprofen for discomfort or fever -Strict return precautions discussed, including worsening erythema outside the borders of the outline, pain, induration, fever despite antibiotics. Family agreeable with plan, all questions answered" More
2839297 55 F KS 05/02/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 47n3y
47n3y
Erythema, Herpes simplex, Inflammation, Malaise, Mobility decreased; Oropharynge... Erythema, Herpes simplex, Inflammation, Malaise, Mobility decreased; Oropharyngeal pain, Pain in extremity, Peripheral swelling More
After 2 hours arm begin to show signs of redness. Approximately 24 hours had outbreak of HSV2 . Ar... After 2 hours arm begin to show signs of redness. Approximately 24 hours had outbreak of HSV2 . Arm swollen from shoulder to elbow, inflamed and swore. Difficulty in moving arm in any motion. Also patient says she had sore throat and not very well. More
2839298 11 F TN 05/02/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 2G3S9
U8375AA
Inappropriate schedule of product administration, Wrong product administered; In... Inappropriate schedule of product administration, Wrong product administered; Inappropriate schedule of product administration, Wrong product administered More
pt was due for 3 vaccines today, Tdap/HPV and Men A. Pt came in for a WCC with Brother who was also ... pt was due for 3 vaccines today, Tdap/HPV and Men A. Pt came in for a WCC with Brother who was also due for vaccines. while I was preparing vaccines there was a mistake and Men A was ordered as Menveo instead of the MenQuadfi which confused me. once it was fixed, I made sure Lot # was in for every vaccine, I grabbed both trays in which the vaccines were in and walked into room, I verified DOB and sat Pt down and proceeded to give the 2 vaccines ( MenA/Men B). my mistake was not verifying again with mom the vaccines each pt was getting. I was overwhelmed already that it flew over my head and made the mistake in not verifying first. it is my first time working in this location and I was stressed out in where everything is at that I forgot to verify that one important thing before giving vaccine. after I realized what had happened, I stopped what I was doing and told mom I was going to step out for a min. i informed my coworker on what had happened, and doctor was informed right away too. the doctor then told me to explain to mom that Men B giving early was not going to hurt Pt, in which I apologized and informed pt Mom. Mom was in a rush and wanted to wait on pt getting HPV and Tdap for another day, I apologized and assured pt mom again that giving Men B early was not a problem. Pt mom agreed in understanding and asked if it was ok to checkout now. More
2839299 0.17 M NY 05/02/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U7921AA
LJ5282
LL455
Cyanosis, Lethargy; Cyanosis, Lethargy; Cyanosis, Lethargy Cyanosis, Lethargy; Cyanosis, Lethargy; Cyanosis, Lethargy
15min post vaccination very lethargic, cyanotic 15min post vaccination very lethargic, cyanotic
2839300 0.58 M NY 05/02/2025 COVID19
 PFIZER\BIONTECH
Decreased appetite, Irritability, Pyrexia, Somnolence Decreased appetite, Irritability, Pyrexia, Somnolence
Fever (highest recorded temp was 102.7 F) lasting at least 72 hours, with irritability, loss of appe... Fever (highest recorded temp was 102.7 F) lasting at least 72 hours, with irritability, loss of appetite, and sleepiness accompanying. Treating with Motrin and Tylenol. More
2839301 0.17 M CA 05/02/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U8265AA
MF0415
EX434
Infantile vomiting, Underdose; Infantile vomiting, Underdose; Infantile vomiting... Infantile vomiting, Underdose; Infantile vomiting, Underdose; Infantile vomiting, Underdose More
While giving the oral Rotarix, baby began to spit up a little bit. We stopped administering and clea... While giving the oral Rotarix, baby began to spit up a little bit. We stopped administering and cleaned spit up and began again. Baby began spit up more than the first time. Medical assistant asked mom if she had fed baby before coming in and she stated no, We then stopped administering completely and notified provider about the adverse reaction. Provider went back into exam room to assess the patient. Pt was doing well and left clinic 15 min later. More
2839302 18 M 05/02/2025 MENB
MENB
 PFIZER\WYETH
PFIZER\WYETH

Headache, Injection site discomfort, Injection site erythema, Injection site pai... Headache, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling; Loss of personal independence in daily activities More
24 hours after the meningitis B vaccine, my son's arm at the injection site was very red, raise... 24 hours after the meningitis B vaccine, my son's arm at the injection site was very red, raised, and it spread to an area approximately 4" wide x 8" long, and he complained of discomfort and soreness. Then 36-38 hours after he complained of an excruciating headache. The vaccine was Tuesday afternoon, he missed school yesterday and today. He is in bed. And says his head hurts worse when he sits up. Doctor suggested alternating advil and tylenol, which we are doing. And he is icing his head. More
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