🏥 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 💀 🏥 🚑 ♿ ⚠️
2838101 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
didn't get a second shot. Then I got another shot in 2024; This non-serious case was reported b... didn't get a second shot. Then I got another shot in 2024; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (I got a shot in 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: didn't get a second shot. Then I got another shot in 2024). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 21-APR-2025 Consumer reported that got a shot in 2018 and didn't get a second shot. Then he/she got another shot in 2024, which led to drug dose administration interval too long. Consumer wanted to know need more a seconds hot or not . This case has been linked with US2025AMR049030, US2025AMR049045 and US2025AMR049051, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR049030:same reporter different patient US-GSK-US2025AMR049045:same reporter different patient US-GSK-US2025AMR049051:same reporter different patient More
2838102 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
first Shingrix shot more than 5 years ago never got the second shot; This non-serious case was repor... first Shingrix shot more than 5 years ago never got the second shot; 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 (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first Shingrix shot more than5 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first Shingrix shot more than 5 years ago never got the second shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 21-APR-2025 The patient had first Shingrix shot more than 5 years ago. Never got the second shot. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025AMR049030:same reporter different patient US-GSK-US2025AMR049026:same reporter different patient US-GSK-US2025AMR049051:same reporter different patient US-GSK-US2025AMR049030:same reporter different patient More
2838103 04/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected Vaccination failure; I had the shot and still got it; This serious case was reported by a ... Suspected Vaccination failure; I had the shot and still got it; 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, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: I had the shot and still got it). 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: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot and still got it This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine More
2838104 04/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Aphonia, Arthralgia Aphonia, Arthralgia
joint pain; Lost my voice; This non-serious case was reported by a consumer via interactive digital ... joint pain; Lost my voice; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced joint pain (Verbatim: joint pain) and loss of voice (Verbatim: Lost my voice). The outcome of the joint pain and loss of voice were not resolved. It was unknown if the reporter considered the joint pain and loss of voice to be related to RSV vaccine. It was unknown if the company considered the joint pain and loss of voice to be related to RSV vaccine. Additional Information: GSK Receipt Date: 21-APR-2025 The patient self reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient have never had bad reactions to vaccines, so he/she did not hesitate to get the RSV one. Patient still having joint pain a month and a half after receiving it. Lost his/her voice and it was still not back to normal. It turned out that vaccine effects could be unpredictable. More
2838105 04/25/2025 COVID19
COVID19
COVID19
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Fatigue, Illness; Fatigue, Illness; Fatigue, Illness; Fatigue, Illness Fatigue, Illness; Fatigue, Illness; Fatigue, Illness; Fatigue, Illness
I have been sick for 6 months; Fatigue the worst; This non-serious case was reported by a consumer v... I have been sick for 6 months; Fatigue the worst; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis, COVID-19 vaccine for prophylaxis and COVID-19 vaccine for prophylaxis. On an unknown date, the patient received RSV vaccine, COVID-19 vaccine, the 2nd dose of COVID-19 vaccine and the 1st dose of COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: I have been sick for 6 months) and fatigue (Verbatim: Fatigue the worst). The outcome of the sickness and fatigue were not resolved. It was unknown if the reporter considered the sickness and fatigue to be related to RSV vaccine. It was unknown if the company considered the sickness and fatigue to be related to RSV vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 The patient got the Respiratory Syncytial Virus vaccine shot, two covid and a booster vaccine. The patient has been sick for 6 months many symptoms , fatigue the worst. Could be post Viral Fatique or long Covid. The physician did not know what causes it or how to treat it. The reporter did not know how long it lasts. A couple of weeks to years. It was getting more prevalent. The patient did own background research on AI. Talked to many other seniors same story. The patient did not know the answer. The patient took the shots because of a new born in the house. It was unknown if the reporter considered the sickness and fatigue to be related to COVID-19 vaccine. More
2838106 F 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Immediate post-injection reaction Herpes zoster, Immediate post-injection reaction
my girlfriend got the shot and got shingles right after; This non-serious case was reported by a con... my girlfriend got the shot and got shingles right after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: my girlfriend got the shot and got shingles right after). 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: 20-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his girlfriend got the shot and got shingles right after. More
2838107 04/25/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Road traffic accident, Stress, Vaccination failure; Herpes zoster... Herpes zoster, Road traffic accident, Stress, Vaccination failure; Herpes zoster, Road traffic accident, Stress, Vaccination failure More
Suspected vaccination failure; I had both shots and still got it; This serious case was reported by ... Suspected vaccination failure; I had both shots and still got it; 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: I had both shots and still got it). 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 : 21-APR-2025 This case was reported by a patient via interactive digital media. He/she had both shots and still got it after his/her car accident . It was the stress from the accident. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2838108 04/25/2025 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; 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. 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: 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: 21-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that it was frustrating to have received both shots for prevention and been diagnosed with 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).. More
2838109 04/25/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected Vaccination failure; got the shingles and suffering from it already seven months; This ser... Suspected Vaccination failure; got the shingles and suffering from it already seven months; 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, 1 month after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles and suffering from it already seven months). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 20-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the two shots of (Shingles) vaccine and The patient reported that after the month he/she got the shingles and that he/she is suffering from it already seven months. This case was considered as suspected vaccination failure as details 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2). More
2838110 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster oticus, Pain, Vaccination failure Herpes zoster oticus, Pain, Vaccination failure
Suspected vaccination failure; Ramsey Hunt Syndrome / Shingles on left side ear; This serious case w... Suspected vaccination failure; Ramsey Hunt Syndrome / Shingles on left side ear; 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 ramsay-hunt syndrome (Verbatim: Ramsey Hunt Syndrome / Shingles on left side ear) (serious criteria GSK medically significant). The outcome of the vaccination failure and ramsay-hunt syndrome were not reported. It was unknown if the reporter considered the vaccination failure and ramsay-hunt syndrome to be related to Shingles vaccine. The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 19-APR-2025 The patient had all the shingles vaccines and recently diagnosed with Bell's palsy and later found out it was Ramsey Hunt Syndrome. The patient had shingles on left side ear. It was very painful. 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2838111 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspeceted vaccination failure; I got my shot but still got shingles; This serious case was reported... Suspeceted vaccination failure; I got my shot but 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. 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: I got my shot but 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. 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: 21-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that if you were 50 make sure you get your shingles shot. The patient reported that he/she got his/her shot but still got shingles. The patient reported his/her father/mother told him/her said he/she had a much milder case because he/she did had the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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
2838112 M 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pericarditis, Vaccination failure Herpes zoster, Pericarditis, Vaccination failure
Suspeceted vaccination failure; pericarditis; Shingles; This serious case was reported by a consumer... Suspeceted vaccination failure; pericarditis; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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), pericarditis (Verbatim: pericarditis) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure, pericarditis and shingles were not reported. It was unknown if the reporter considered the vaccination failure, pericarditis and shingles to be related to Shingles vaccine. The company considered the vaccination failure and pericarditis 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: 19-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that reporter son got the shingles and pericarditis after the jab. The doctor told him so. 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 has been linked to the US2023AMR040441 case 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 vaccine Shingles vaccine. Pericarditis is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. US-GLAXOSMITHKLINE-US2023AMR040441:same reporter More
2838113 04/25/2025 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; 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. 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: 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: 19-APR-2025 This case was reported by a patient via interactive digital media. The patient had the two shots, and still got shingles. 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2) More
2838114 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
arm never hurt so much; This non-serious case was reported by a consumer via interactive digital med... arm never hurt so much; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: arm never hurt so much). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK receipt date: 20-APR-2025 This case was reported by a patient via interactive digital media. Patient had two shots and arm never hurt so much, but indicated that it was worth it. More
2838115 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected Vaccination failure; had additional outbreaks; This serious case was reported by a consume... Suspected Vaccination failure; had additional outbreaks; 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. The patient's past medical history included shingles. Concurrent medical conditions included lyme disease (have chtonic lyme disease). 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 additional outbreaks). The patient was treated with duloxetine hydrochloride (Cymbalta). 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 : 20-APR-2025 This case was reported by a patient via interactive digital media. He/she had chronic Lyme disease which activated shingles and herpes. Pain and suffered unbearable. He/she took cymbalta. He/she did get the shots but also have had additional outbreaks. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2838116 F 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Dizziness, Dizziness postural Dizziness, Dizziness postural
felt dizziness; This non-serious case was reported by a consumer via interactive digital media and d... felt dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness 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 dizziness (Verbatim: felt dizziness). The outcome of the dizziness was not reported. It was unknown if the reporter considered the dizziness to be related to Shingles vaccine. It was unknown if the company considered the dizziness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 Patient had the vaccine and she felt dizziness after lowering her body and standing back up. More
2838117 F KS 04/25/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Product preparation issue Product preparation issue
It was not reconstituted with the antigen component; Priorix diluent only was administered to a pati... It was not reconstituted with the antigen component; Priorix diluent only was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of active ingredient not added to diluent in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced active ingredient not added to diluent (Verbatim: It was not reconstituted with the antigen component) and inappropriate dose of vaccine administered (Verbatim: Priorix diluent only was administered to a patient). The outcome of the active ingredient not added to diluent and inappropriate dose of vaccine administered were not applicable. It was unknown if the reporter considered the active ingredient not added to diluent and inappropriate dose of vaccine administered to be related to Priorix and Priorix Pre-Filled Syringe Device. It was unknown if the company considered the active ingredient not added to diluent and inappropriate dose of vaccine administered to be related to Priorix and Priorix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-APR-2025 Pharmacist reported that the Priorix diluent only was administered to a patient. It was not reconstituted with the antigen component which led to active ingredient not added to diluent and inappropriate dose of vaccine administered. Consented to follow up. More
2838118 9 F IL 04/25/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 EK7DG
Wrong patient received product Wrong patient received product
administered the one vial presentation of Menveo to a nine year old patient accidentally. It was sup... administered the one vial presentation of Menveo to a nine year old patient accidentally. It was supposed to be administered to her brother; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong patient received product in a 9-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong patient received product (Verbatim: administered the one vial presentation of Menveo to a nine year old patient accidentally. It was supposed to be administered to her brother). The outcome of the wrong patient received product was not applicable. Additional Information: GSK Receipt Date: 21-APR-2025 Medical Assistant reported he administered the one vial presentation of Menveo to a nine year old patient accidentally. It was supposed to be administered to her brother which led to Wrong patient received product. More
2838119 F FL 04/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 PG3RP
Product storage error Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number PG3RP, expiry date 11-JUL-2027) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 21-APR-2025 The nurse called to report a temperature excursion and to find out what to, what we should be doing moving forward with the vaccines. The name of the vaccine is Boostrix, was the only one, the highest temperature it reached was 11.2 degrees Celsius it was been out of temperature for 55 days. These have been administered to a patient which led to incorrect storage of drug. This case has been linked to the US2025048460 case reported by the same reporter.; Sender's Comments: US-GSK-US2025048460:same reporter More
2838120 70 F NJ 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 TS525
Inappropriate schedule of product administration Inappropriate schedule of product administration
Second dose 5 years after first dose; This non-serious case was reported by a pharmacist via call ce... Second dose 5 years after first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number TS525, expiry date 10-MAR-2027) for prophylaxis. Previously administered products included Shingrix (the first dose was given 5 years ago). On 21-APR-2025, the patient received the 2nd dose of Shingrix. On 21-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Second dose 5 years after first dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 20-APR-2025 Other HCP reported that pharmacist mentioned that on the day of reporting, a patient received the second dose of Shingrix. However, the first dose was given 5 years ago. Reporter asked if the patient should received a booster dose. Consented to follow up. The patient received 2nd dose of Shingrix,?later than the recommended interval, which led to lengthening of vaccinations schedule. More
2838121 IN 04/25/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Intramuscular administration of Priorix; This non-serious case was reported by a other health profes... Intramuscular administration of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a specified number of patients who received MMR (Priorix) 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: 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: 21-APR-2025 On 21 Apr 2025, a clinical pharmacy manager called to inform the following about Priorix unfortunately some of them have been administered intramuscularly which led to Subcutaneous injection formulation administered by other route. The reporter clarified that two patients had received Priorix via intramuscular administration. The gender of the patients was unknown, as well as other details such as lot number, expiration date or date of administration. More
2838122 63 M MO 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 92NN2
Product preparation issue Product preparation issue
Shingrix adjuvant only administration; Shingrix adjuvant only administration; This non-serious case ... Shingrix adjuvant only administration; Shingrix adjuvant only administration; 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 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 92NN2, expiry date 30-MAR-2027) for prophylaxis. On 18-APR-2025, the patient received Shingrix. On 18-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only administration) and inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administration). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 Licensed practical nurse wanted to know how much time she needs to wait before giving a full dose of Shingrix after the patient only received the adjuvant portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. More
2838123 13 F CA 04/25/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 F5L5E
Expired product administered Expired product administered
Engerix-B Administration of expired dose; This non-serious case was reported by a nurse via call cen... Engerix-B Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HBV (Engerix B) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis. On 17-APR-2025, the patient received Engerix B. On 17-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B Administration of expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-APR-2025 A nurse reported that the patient received and expired dose of Engerix-B, which led expired vaccine used. The nurse asked if the patient should be re-vaccinated. The reporter consented to follow up. More
2838124 74 M KY 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
not received shingrix second dose; This non-serious case was reported by a pharmacist via call cente... not received shingrix second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (The patient received Shingrix first dose on 08 July 2022 (lot number: P7K5P exp 10 September 2023)). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received shingrix second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 An adult male patient received Shingrix first dose on 08 July 2022. The patient was going to have a transplant soon. The patient was not considered immunocompromised right now. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient did not receive second dose of Shingrix which led to incomplete course of vaccination. Consented to follow up. More
2838125 70 F 04/25/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER
 3044202
COVID-19, Drug ineffective, Smear test; COVID-19, Drug ineffective, Smear test COVID-19, Drug ineffective, Smear test; COVID-19, Drug ineffective, Smear test
The patient had COVID; have COVID; This spontaneous case was reported by a non-health professional a... The patient had COVID; have COVID; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (The patient had COVID) and DRUG INEFFECTIVE (have COVID) in an 8-decade-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3044202) for COVID-19 immunisation. Co-suspect product included non-company product Influenza vaccine (Flu) for Immunisation. Previously administered products included for Immunisation: FLU VACCINE VII (DOSE NUMBER UNKNOWN, SINGLE, Lot: 1204201) on 10-Sep-2012, Pneumococcal vaccine (DOSE 1, SINGLE, Lot: H010515) on 10-Sep-2012, FLU VACCINE VII (DOSE NUMBER UNKNOWN, SINGLE, Lot: 1307601) on 07-Oct-2013, Pneumococcal vaccine on 12-Jul-2022, Pneumococcal vaccine (Dose 2, single) on 07-Dec-2022, FLU VACCINE VII (DOSE NUMBER UNKNOWN, SINGLE) on 11-Sep-2023, Zoster (Dose 1, single) on 03-Oct-2023, Zoster (Dose 2 and single) on 04-Dec-2023; for COVID-19 immunisation: BNT162b2 (Dose 1, single (Lot number: EN5318)) on 28-Jan-2021, BNT162b2 (Dose 2, single (Lot number: EN6201)) on 18-Feb-2021, BNT162b2 (Dose 3 (booster), single (Lot number: FF2589)) on 27-Sep-2021, BNT162b2 (Dose 4 (booster), single (Lot number: FM0698)) on 08-Mar-2022, BNT162b2 (Dose 5 (booster) and single (Batch/Lot number: unknown)) on 08-Nov-2022. Past adverse reactions to the above products included No adverse effect with BNT162b2, BNT162b2, BNT162b2, BNT162b2, BNT162b2, FLU VACCINE VII, FLU VACCINE VII, FLU VACCINE VII, Pneumococcal vaccine, Pneumococcal vaccine, Pneumococcal vaccine, Zoster and Zoster. Concurrent medical conditions included Vision abnormal. On 11-Dec-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 01-Mar-2025, the patient experienced COVID-19 (The patient had COVID) (seriousness criterion medically significant) and DRUG INEFFECTIVE (have COVID) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient had COVID) and DRUG INEFFECTIVE (have COVID) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear test: Positive. Concomitant product information was not provided by the reporter. It was reported that the patient had COVID and was too sick and all by herself. When offered an online enrollment, patient stated that "when you get old, you can't see". Patient cannot even spell her name anymore when she was sick. The patient had never been this sick in her life and she had eight COVID shots. It was reported that patient's neighbor had to go to pick up her stuff. She could not go as she was too sick. On 07-Apr-2025, it was reported that the patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient was not allergic to any previous vaccination, medications, food or other products and there were no other diagnosed illnesses/medical history/chronic health conditions to report. This case was linked to MOD-2025-784895 (Patient Link). Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2838126 47 M SC 04/25/2025 COVID19
 MODERNA
Cerebellar stroke Cerebellar stroke
bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he... bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Controlled hypertension. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) (seriousness criteria disability and medically significant). The patient was treated with Meclozine hydrochloride (Meclizine) at an unspecified dose and frequency. At the time of the report, CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) had not resolved. No concomitant medications were reported. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. The reporter stated that, her husband's vertigo started after the second vaccine. He went to a couple of doctors for that, they prescribed Meclizine. Was also told it could be allergies, etc. Nothing helped and he progressively got worse with vertigo. He drove an hour to work after 12 days off for the holidays, which was 03-Jan. Once he got to work, he badged in but then fell down. They tried to help him up and he fell again, speech slurred, and he started vomiting. They took him to the closest hospital. He suffered a bilateral cerebellar stroke. He was then permanently disabled and would never work or drive again. At the time of reporting, he was 50 years old with no quality of life. The patient did not experience any additional symptoms/events. There were no lab data/results available.; Reporter's Comments: Concurrent medical condition Controlled hypertension is a confounder for the event. . The benefit -risk relationship of product is not affected by this report. More
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2838127 04/25/2025 COVID19
 PFIZER\BIONTECH
Seizure Seizure
patient ended up in the hospital after each one because patient had a very bad seizure; This is a sp... patient ended up in the hospital after each one because patient had a very bad seizure; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had epilepsy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "patient ended up in the hospital after each one because patient had a very bad seizure". The event required physician office visit. Clinical course: The patient has epilepsy history and when patient had the Covid vaccine (Pfizer Covid-19 vaccine), had three of them, patient ended up in the hospital after each one because patient had a very bad seizure. Patient have not had any more of those because the doctor told the risk was not worth the benefit. Patient was only in the hospital for maybe six hours with each of them and the neurologist has said the patient has not have any more of those because it's not good for people with epilepsy. Patient was asking if the Pneumonia vaccine a onetime vaccine and the other is have there been any report of side effects like seizure with the Pneumonia vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087405 Same patient/event, different dose;US-PFIZER INC-202500087406 Same patient/event, different dose; More
2838128 04/25/2025 COVID19
 PFIZER\BIONTECH
Seizure Seizure
I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a... I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as does 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOES 1, SINGLE), for COVID-19 immunization, reaction(s): "Seizure". The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure". The events "i had three of them (covid-19 vaccine) and i ended up in the hospital after each one because i had a very bad seizure" required physician office visit. Clinical course: when patient had the Covid vaccine (Pfizer Covid-19 vaccine), patient had three of them and ended up in the hospital after each one because patient had a very bad seizure and so, patient had not had any more of those because the doctor said the risk was not worth the benefit. Patient was only in the hospital for maybe six hours with each of them. Patient had been told by the neurologist not to have any more of those because it's not good for those people with epilepsy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087121 Same patient/event, different dose;US-PFIZER INC-202500087406 Same patient/event, different dose; More
2838129 04/25/2025 COVID19
 PFIZER\BIONTECH
Seizure Seizure
I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a... I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Seizure"; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Seizure". The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "I had three of them (Covid-19 Vaccine) and I ended up in the hospital after each one because I had a very bad seizure". The events "i had three of them (covid-19 vaccine) and i ended up in the hospital after each one because i had a very bad seizure" required physician office visit and emergency room visit. Clinical course: The patient has epilepsy and when patient had the Covid vaccine (Pfizer Covid-19 vaccine), had three of them, patient ended up in the hospital after each one because patient had a very bad seizure. Patient have not had any more of those because the doctor told the risk was not worth the benefit. Patient was only in the hospital for maybe six hours with each of them and the neurologist has to not have any more of those. Patient was asking if the Pneumonia vaccine a onetime vaccine and the other is have there been any report of side effects like seizure with the Pneumonia vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087121 Same patient/event, different dose;US-PFIZER INC-202500087405 Same patient/event, different dose; More
2838141 67 F WV 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Asthenia, Cold sweat, Nausea, Syncope Asthenia, Cold sweat, Nausea, Syncope
Vaccine was administered at 4:36pm, Patient became faint, clammy/cool skin, slight nausea at about 4... Vaccine was administered at 4:36pm, Patient became faint, clammy/cool skin, slight nausea at about 4:41pm. Patient was responsive. Provided patient with a cool compress for her neck, talked to her and massaged her hand and leg to keep her stimulated, gave her water to sip. Patient verbalized she was feeling better and left the store (walked with assistance) by about 4:55 pm. I spoke with patient at approximately7:15 pm - she stated she was improving, still a little weak, resting at home. More
2838142 4 F CA 04/25/2025 MMRV
 MERCK & CO. INC.
 Y019464
Injection site erythema, Injection site induration, Injection site vesicles, Inj... Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth More
Child was brought in by mother with concerns about swelling at injection site on 04/25/2025. Injecti... Child was brought in by mother with concerns about swelling at injection site on 04/25/2025. Injection site was red, hot to the touch, hardened, and had blisters forming. Provider was consulted and child was advised to go to the ER. More
2838143 74 M CT 04/25/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Dizziness, Vertigo Dizziness, Vertigo
Patient experienced extreme vertigo and feeling of whooziness that lasted from 04/17/25 through 04/2... Patient experienced extreme vertigo and feeling of whooziness that lasted from 04/17/25 through 04/21/25. More
2838144 80 F FL 04/25/2025 PNC20
 PFIZER\WYETH
 LK6651
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
PATIENT RECEIVED PREVNAR 20 ON 12/16/2023 AND AGAIN ON 04/24/2025. PATIENT STATES TO HAVE NO ADVERSE... PATIENT RECEIVED PREVNAR 20 ON 12/16/2023 AND AGAIN ON 04/24/2025. PATIENT STATES TO HAVE NO ADVERSE EVENTS, SHE DID SAY HER ARM WAS SORE. More
2838168 16 M AZ 04/25/2025 MNQ
MNQ
 SANOFI PASTEUR
SANOFI PASTEUR
 U8375AA
U8375AA
Blood creatinine increased, Blood immunoglobulin M increased, Chest X-ray abnorm... Blood creatinine increased, Blood immunoglobulin M increased, Chest X-ray abnormal, Cough, Erythema multiforme; Fatigue, Pain, Pneumonia, Pyrexia, Vomiting More
Fatigue, Achy, fever, erythema multiforme rash, vomiting, with cough. Received IVF, ceftriaxone, azi... Fatigue, Achy, fever, erythema multiforme rash, vomiting, with cough. Received IVF, ceftriaxone, azithromycin, and fluconazole. Discharged on Augmentin only and cetirizine rash improved. Kidney function returned to normal. More
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2837666 M 04/24/2025 UNK
 UNKNOWN MANUFACTURER
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
the site was red and felt hot for about 3 days; experienced diffuse redness around and below the inj... the site was red and felt hot for about 3 days; experienced diffuse redness around and below the injection site; This spontaneous report was received from a consumer referring to a male patient, age was not provided. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate (CAPVAXIVE) injection, administered intramuscularly as a dose of 0.5 ml for prophylaxis (anatomical location, lot number and expiration date were not reported). On an unknown date, reported as 1 day after vaccination, the patient experienced diffuse redness around and below the injection site (Redness), the site was red and felt hot (Vaccination site warmth) for about 3 days and then subsided without intervention or medication. At the time of the reporting, the outcome of the event was recovered. The causal relationship between the events and the suspect therapy was not provided. More
2837667 04/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; still got the shingles so painful.; This serious case was reported by... Suspected vaccination failure; still got the shingles so painful.; 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: still got the shingles so painful.). 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The patient reported to have had the vaccine and still got the shingles and was so painful. 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 Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2837668 04/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Furuncle Furuncle
Boils; This non-serious case was reported by a consumer via interactive digital media and described ... Boils; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of boil 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 boil (Verbatim: Boils). The outcome of the boil was not reported. It was unknown if the reporter considered the boil to be related to Shingrix. It was unknown if the company considered the boil to be related to Shingrix. Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingrix vaccine and had boils The reporter asked can you develop boils after taken the vaccine. The case is 1 of the 6 linked case, by same reporter.; Sender's Comments: US-GSK-US2025AMR046237:same reporter US-GSK-US2025AMR046239:same reporter US-GSK-US2025AMR046242:same reporter US-GSK-US2025AMR046246:same reporter US-GSK-US2025AMR046250:same reporter More
2837669 F 04/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
injected only the diluent portion of the vaccine; injected only the diluent portion of the vaccine; ... injected only the diluent portion of the vaccine; injected only the diluent portion of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female 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 inappropriate preparation of medication (Verbatim: injected only the diluent portion of the vaccine) and inappropriate dose of vaccine administered (Verbatim: injected only the diluent portion of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 Pharmacist reported that if a patient got accidentally injected only the diluent portion of the vaccine, without mixing the powder, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. And also enquiring how they would go about getting an extra diluent, so that the patient can be injected the whole thing. This case is linked with US2025AMR046222, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR046222:same reporter More
2837670 M 04/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 85 years old male patient accidentally received a dose of Menveo; This non-serious case was report... A 85 years old male patient accidentally received a dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 85-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: A 85 years old male patient accidentally received a dose of Menveo). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date: 15-APR-2025 The Pharmacist reported that they accidentally administered a dose of Menveo (could be the 2-vial presentation) to an 85 year old patient which led to, Inappropriate age at vaccine administration. The reporter had a questioned should they revaccinate with the correct vaccine. More
2837671 M 04/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 333SK
Incorrect route of product administration Incorrect route of product administration
They administered Boostrix, the patient was supposed to get a ppd instead; Patient received Boostrix... They administered Boostrix, the patient was supposed to get a ppd instead; Patient received Boostrix in the left lower fore arm intradermal; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong product administered in a 22-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 333SK, expiry date 28-SEP-2025) for prophylaxis. Co-suspect products included tuberculin ppd (Ppd Disposable) for product used for unknown indication. On an unknown date, the patient received Boostrix (intradermal, left lower forearm) and did not receive Ppd Disposable. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong product administered (Verbatim: They administered Boostrix, the patient was supposed to get a ppd instead) and intramuscular formulation administered by other route (Verbatim: Patient received Boostrix in the left lower fore arm intradermal). The action taken with Ppd Disposable was unknown. The outcome of the wrong product administered and intramuscular formulation administered by other route 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: 14-APR-2025 On 14 April 2025 an office manager called to report that they administer Boostrix in error and in a wrong area to a 22 years old male patient. They administered Boostrix in the left lower fore arm intradermal. The patient was supposed to get a ppd instead which led to wrong product administered and intramuscular formulation administered by other route. The reporter wanted to know if there are any possible side effects to consider. Consented to follow up. More
2837672 12 F 04/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMA8030A
Product preparation issue Product preparation issue
only diluent portion was accidentally given to female; only diluent portion was accidentally given t... only diluent portion was accidentally given to female; only diluent portion was accidentally given to female; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA8030A, expiry date 30-APR-2025) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only diluent portion was accidentally given to female) and inappropriate dose of vaccine administered (Verbatim: only diluent portion was accidentally given to female). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 The nurse reported that a dose of Menveo after only the diluent portion was accidentally given to a female 12 year old patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2837673 04/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; I know several people who were vaccinated and still had bad cases of ... Suspected Vaccination failure; I know several people who were vaccinated and still had bad cases of shingles and they had them in very unusual places; 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 patients 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: I know several people who were vaccinated and still had bad cases of shingles and they had them in very unusual places). 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: 16-APR-2025 This case was reported by a consumer via interactive digital media. The reporter knew several patients who were vaccinated with Shingles vaccine and still had bad cases of shingles and they had them in very unusual places and a private area. 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 US2025AMR046807, 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-US2025AMR046807:same reporter different patient More
2837674 04/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Burning sensation Burning sensation
burning on my back; This non-serious case was reported by a consumer via interactive digital media a... burning on my back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation 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 burning sensation (Verbatim: burning on my back). The outcome of the burning sensation was not reported. It was unknown if the reporter considered the burning sensation to be related to Shingrix. It was unknown if the company considered the burning sensation to be related to Shingrix. Additional Information: GSK receipt date: 14-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that after Shingrix vaccination patient experienced burning on his/her back. More
2837675 04/24/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Paraesthesia, Skin warm, Vaccination failure; Herpes zoster... Herpes zoster, Pain, Paraesthesia, Skin warm, Vaccination failure; Herpes zoster, Pain, Paraesthesia, Skin warm, Vaccination failure More
Suspected vaccination failure; I've had shingles on my face; hasn't shown, or caused the s... Suspected vaccination failure; I've had shingles on my face; hasn't shown, or caused the severe pain; hot to the touch; Poke on the hairline above my ear on both sides of my face months apart, I feel like slivers of glass; 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), facial herpes zoster (Verbatim: I've had shingles on my face), pain (Verbatim: hasn't shown, or caused the severe pain), feeling hot (Verbatim: hot to the touch) and tingling skin (Verbatim: Poke on the hairline above my ear on both sides of my face months apart, I feel like slivers of glass). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster, pain, feeling hot and tingling skin were not resolved. It was unknown if the reporter considered the vaccination failure, facial herpes zoster, pain, feeling hot and tingling skin 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 facial herpes zoster, pain, feeling hot and tingling skin to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had got the 2 shingles shots, and twice he/she had felt like he/she had shingles on face. It just had not shown, or caused the severe pain that it can. Poke on the hairline above ear on both sides of his/her face months apart. He/she felt like slivers of glass. It was in his/her face. It was hot to touch. But when he/she put a cold compass on it, it felt 10 times better. He/she was going through that right now. For the second time on the right side of his/her cheek near ear and hairline. He/she was told that the shingles vaccine did not prevent the shingles. It just prevents the shingles from being at its worst, any feedback. 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
2837676 04/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; several friends who got the shingles from the vaccine; This serious c... Suspected vaccination failure; several friends who got the shingles from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in the 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: several friends who got the shingles from the vaccine). The outcome of the vaccination failure and shingles were not reported. 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. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The reporter stated that he/she had several friends who got the shingles from the (Shingles) vaccine. 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
2837677 1 M GA 04/24/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3D72S
Product storage error Product storage error
Dose administered after temperature excursion/patient given MMR(Priorix) that was frozen prior to re... Dose administered after temperature excursion/patient given MMR(Priorix) that was frozen prior to reconstitution; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. Concomitant products included Priorix. On 10-MAR-2025, the patient received Priorix (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Dose administered after temperature excursion/patient given MMR(Priorix) that was frozen prior to reconstitution). 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: 15-APR-2025 The reporter stated they given Priorix that was frozen prior reconstitution which le to, which led to incorrect storage of vaccine. This was 1 of 6 linked report, reported by same reporter. More
2837678 52 F GA 04/24/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3D72S
Product administered to patient of inappropriate age, Product storage error Product administered to patient of inappropriate age, Product storage error
patient given MMR(Priorix) that was frozen prior to reconstitution; 53 year old patient received pri... patient given MMR(Priorix) that was frozen prior to reconstitution; 53 year old patient received priorix vaccine; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 53-year-old female patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. Concomitant products included Priorix. On 12-FEB-2025, the patient received Priorix (subcutaneous) .5 ml. On 12-FEB-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: 53 year old patient received priorix vaccine). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: patient given MMR(Priorix) that was frozen prior to reconstitution). The outcome of the incorrect storage of drug 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: 15-APR-2025 The reporter stated they given Priorix that was frozen prior reconstitution which le to, which led to incorrect storage of vaccine. The 53 year old patient received a dose of Priorix vaccine which led to inappropriate age at vaccine administration. This was 1 of 6 linked report, reported by same reporter. More
2837679 63 F GA 04/24/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3D72S
Product administered to patient of inappropriate age, Product storage error Product administered to patient of inappropriate age, Product storage error
patient given MMR(Priorix) that was frozen prior to reconstitution; Priorix received to 63 years pat... patient given MMR(Priorix) that was frozen prior to reconstitution; Priorix received to 63 years patient; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 63-year-old female patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. Concomitant products included Priorix. On 07-JAN-2025, the patient received Priorix (subcutaneous) .5 ml. On 07-JAN-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Priorix received to 63 years patient). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: patient given MMR(Priorix) that was frozen prior to reconstitution). The outcome of the incorrect storage of drug 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: 15-APR-2025 Healthcare Provider stated they stored Priorix in the freezer instead of the fridge and lowest temperature reached would be probably minus 17 degrees Fahrenheit and the vaccine was administered after the temperature excursion, which led to incorrect storage of vaccine. Caller did not have any patient demographics or dates of administration. The Priorix administered to 63 years patient which led to inappropriate age at vaccine administration. The reporter consented to follow up. Reporter stated that patient given Mmr (Priorix) that was frozen prior to reconstitution.; Sender's Comments: US-GSK-US2025034230:Same reproter diffrent patient More
2837680 04/24/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Rash, Vaccination failure; Herpes zoster, Rash, Vaccination failu... Herpes zoster, Rash, Vaccination failure; Herpes zoster, Rash, Vaccination failure More
Suspected Vaccination failure; mild shingles rash; This serious case was reported by a consumer via ... Suspected Vaccination failure; mild shingles rash; 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: mild shingles rash). 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: 15-APR-2025 This case was reported by a patient via interactive digital media. The patient had all his/her Shingles shots and had a very, very mild shingles rash. The patient said that he/she had hated to think what it would have been like without being vaccinated. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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 clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2). More
2837681 FL 04/24/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; i got shingles; This serious case was reported by a consumer via call... Suspected vaccination failure; i got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 17-APR-2025 The patient reported that he/she had the two shot Shingrix vaccine several years ago and got shingles. The patient asked that he/she should had a second round of the vaccine and/or how long the vaccine was effective. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 vaccine Shingrix (dose 1 and 2) More
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