🏥 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 💀 🏥 🚑 ♿ ⚠️
2835122 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Influenza like illness Influenza like illness
flu like reaction; This non-serious case was reported by a consumer via interactive digital media an... flu like reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (Received 1st dose of vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: flu like reaction). The outcome of the influenza-like symptoms was resolved (duration 3 days). It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine. It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-Mar-2025 The reporter said on the public media to please get the vaccine, one and a booster three months later. After the second dose of vaccine, the reporter had a flu like reaction for about three days which was not uncommon. Also reported that it was well worth it as the reporter watched someone close to the reporter, suffer with shingles and the horrible pain it causes. Shingles definitely was not a one and done illness, as a person can develop it multiple times. It also can have long term effects. More
2835123 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The 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: 31-MAR-2025 This case was reported by a patient via interactive digital media. Patient reported that shots did not worked for him/her and he/she still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2835124 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Skin burning sensation, Vaccination failure Herpes zoster, Skin burning sensation, Vaccination failure
Suspected vaccination failure; had the shingles vaccines and I still got shingles; This serious case... Suspected vaccination failure; had the shingles vaccines and I 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the shingles vaccines and I 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: 29-MAR-2025 This case was reported by a patient via interactive digital media. Patient had the shingles vaccines and still got shingles. Patient reported that It was been weeks with face on fire. Patient was told it would have been worse without the 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. The follow-up could not be possible as no contact details were available.; 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
2835125 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; now recovering from shingles, it never occurred I could still get the... suspected vaccination failure; now recovering from shingles, it never occurred I could still get them; 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: now recovering from shingles, it never occurred I could still get them). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. 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: 30-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shot and the patient was now (at the time of reporting) recovering from shingles, it never occurred could still get them. The patient reported it was pure hell but only lasted a week or so might be it helped the recovery. 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; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2835126 M 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles again; This serious case was reported by a consumer via inte... Suspected vaccination failure; shingles again; 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. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles again). 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: 29-MAR-2025 This case was reported by a patient's wife via interactive digital media. The patient got the shingles and then he took the vaccine and got them again. 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 (h/o shingles, 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
2835127 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
got the vaccine and it gave shingles/ suspected vaccination failure; Shingles; This serious case was... got the vaccine and it gave shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine and it gave shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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: 30-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and it gave shingles to the patient. 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
2835128 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Post herpetic neuralgia, Vaccination failure Herpes zoster, Post herpetic neuralgia, Vaccination failure
Suspected vaccination failure; Patient got the worst cause of shingles on left side of body and lowe... Suspected vaccination failure; Patient got the worst cause of shingles on left side of body and lower back; Nerve pain after 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. In MAR-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Patient got the worst cause of shingles on left side of body and lower back) and post herpetic neuralgia (Verbatim: Nerve pain after shingles). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine three years ago. The two weeks ago as in March 2025 patient got the worst cause of shingles and on the left side of my body and lower back and right now the nerve pain was killing. 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. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2835129 OR 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
No adverse event, Underdose No adverse event, Underdose
Adult was given a pediatric dose of Hepatitis B; Adult was given a pediatric dose of Hepatitis B; Th... Adult was given a pediatric dose of Hepatitis B; Adult was given a pediatric dose of Hepatitis B; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult was given a pediatric dose of Hepatitis B) and adult use of a child product (Verbatim: Adult was given a pediatric dose of Hepatitis B). The outcome of the underdose and adult use of a child product were not applicable. Additional Information: GSK receipt date: 28-MAR-2025 The healthcare professional called to report that an adult was given a pediatric dose of Hepatitis B, which led to underdose and adult use of a child product. Upon speaking with the reporter, identified it was a GlaxoSmithKline vaccine, Engerix. Caller did not provide additional details and ended call to make the call to the other manufacturer. No adverse side effects were reported. No additional information available at this time. No additional adverse event/no product quality complaint (PQC) were reported. More
2835130 04/09/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Back pain, Herpes zoster, Pain, Vaccination failure; Back pain, Herpes zoster, P... Back pain, Herpes zoster, Pain, Vaccination failure; Back pain, Herpes zoster, Pain, Vaccination failure More
Suspected vaccination failure; was diagnosed with shingles; This serious case was reported by a cons... Suspected vaccination failure; was diagnosed with 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: was diagnosed with shingles). 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: 31-MAR-2025 The case was received from the patient via interactive digital media. The patient had two vaccines for shingles. Last one about a year ago. The patient have been having burning pain in his/her back. The patient went to the physician and was diagnosed with shingles. The patient felt it was a mild case as it was not as painful as what it sounds most experience. 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
2835131 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Immediate post-injection reaction Arthralgia, Immediate post-injection reaction
shoulder developed severe pain; This non-serious case was reported by a consumer via interactive dig... shoulder developed severe pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a 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 shoulder pain (Verbatim: shoulder developed severe pain). The outcome of the shoulder pain was not reported. It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine. It was unknown if the company considered the shoulder pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that took the vaccine and shoulder developed severe pain immediately and needed physical therapy. Patient did not know if it works. His/her parents never got shingles and never took a vaccine. More
2835132 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspeceted vaccination failure; had the vaccine in 2022 and woke up yesterday with the shingles; Thi... Suspeceted vaccination failure; had the vaccine in 2022 and woke up yesterday with the 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 29-MAR-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine in 2022 and woke up yesterday with the 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: 30-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had the Shingles vaccine in 2022 and woke up day before reporting with the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2835133 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Pruritus, Vaccination failure Herpes zoster, Pain, Pruritus, Vaccination failure
Suspected vaccination failure; I did still got them and I'm still have them 8mon; This serious ... Suspected vaccination failure; I did still got them and I'm still have them 8mon; 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: I did still got them and I'm still have them 8mon). 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. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date : 29-MAR-2025 This case was reported by a patient via interactive digital media. Got the vaccine he/she did still got them and he/she was still had them 8 months. Later still really itchy. The stabbing pain was unreal. 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 Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine Shingles vaccine." More
2835134 M 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Eye operation, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure Eye operation, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Suspected vaccination failure; got a terrible case on his forehead that went to his eye/had to have ... Suspected vaccination failure; got a terrible case on his forehead that went to his eye/had to have eye surgery to save it; got a terrible case on his forehead; 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: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: got a terrible case on his forehead that went to his eye/had to have eye surgery to save it) (serious criteria GSK medically significant and clinically significant/intervention required) and shingles (Verbatim: got a terrible case on his forehead). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster 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: 29-MAR-2025 This case was reported by a patient's wife via interactive digital media. The patient got the shot but still got a terrible case on his forehead that went to his eye. He had to have eye surgery to save it. She also reported getting the shot did not keep you from getting shingles. 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. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2835135 M 04/09/2025 DTAP
DTAPHEPBIP
FLU3
FLU4
FLU4
HEPA
HEPA
HIBV
PNC13
RV5
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
FX6077
FX6077
Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered... Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered; Autopsy, Death, Extra dose administered More
The boy passed away while napping; Overdose; This serious case was reported by a consumer via other ... The boy passed away while napping; Overdose; This serious case was reported by a consumer via other manufacturer and described the occurrence of unknown cause of death in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis, DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, Influenza vaccine (Fluzone) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (batch number FX6077) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch number FX6077) for prophylaxis, HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for prophylaxis and HEPATITIS A VACCINE INACT (VAQTA) for prophylaxis. Previously administered products included Prevenar (Received dose 1 on 03-NOV-2022; Lot Number: FN5555, received on Doctor's office/urgent care) and Prevenar (received dose 2 on 29-DEC-2022; Lot Number: FN5555, received on Doctor's office/urgent care). Concurrent medical conditions included drug allergy. On 02-MAR-2023, the patient received Pediarix, FluLaval Quadrivalent 2022-2023 season, Fluarix Quadrivalent 2022-2023 season, Infanrix, Havrix, Fluzone, ROTATEQ, the 3rd dose of PREVNAR 13, PEDVAXHIB and VAQTA. On 02-MAR-2023, not applicable after receiving Pediarix, Fluarix Quadrivalent 2022-2023 season, Infanrix and Havrix and an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced overdose (Verbatim: Overdose). On 09-MAR-2025, the patient experienced unknown cause of death (Verbatim: The boy passed away while napping) (serious criteria death and GSK medically significant). The outcome of the overdose was not applicable. The patient died on 09-MAR-2025. The reported cause of death was unknown. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Fluarix Quadrivalent 2022-2023 season, Infanrix, Infanrix Pre-Filled Syringe Device and Havrix. The company considered the unknown cause of death to be unrelated to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season, Fluarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device and Havrix. 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: 31-Mar-2025 The 2 years old boy passed away while napping with no previous conditions on 09 March 2025. An autopsy was performed. Autopsy remarks were reported as pending. The reported cause of death was unknown. No other vaccines were administered within four weeks prior to the suspect vaccine. It was unknown if other medications were administered within two weeks of the event.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Pediarix, Pediarix PRE-FILLED SYRINGE DEVICE, FluLaval Quadrivalent 2022-2023 season, FluLaval Tetra PRE-FILLED SYRINGE DEVICE, Fluarix Quadrivalent 2022-2023 season, Fluarix PRE-FILLED SYRINGE DEVICE, Infanrix, Infanrix PRE-FILLED SYRINGE DEVICE and Havrix.; Reported Cause(s) of Death: unknown cause of death More
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2835136 M 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Decreased appetite, Feeling abnormal, Herpes zoster, Insomnia Arthralgia, Decreased appetite, Feeling abnormal, Herpes zoster, Insomnia
got it and wrist pain; still felt pretty bad; Didn't sleep; Did not eat; This non-serious case ... got it and wrist pain; still felt pretty bad; Didn't sleep; Did not eat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got it and wrist pain), sleeplessness (Verbatim: Didn't sleep), appetite absent (Verbatim: Did not eat) and feeling bad (Verbatim: still felt pretty bad). The outcome of the shingles was not reported and the outcome of the sleeplessness and appetite absent were resolved (duration 1 week) and the outcome of the feeling bad was not resolved. It was unknown if the reporter considered the shingles, sleeplessness, appetite absent and feeling bad to be related to Shingles vaccine. It was unknown if the company considered the shingles, sleeplessness, appetite absent and feeling bad to be related to Shingles vaccine. Additional Information: GSK receipt date: 28-MAR-2025 This case was reported by a patient via interactive digital media. Patient had one of the shots but got it and like you said it was the wrist pain patient had never experienced, non stop pain. Did not sleep or eat for over a week . Patient saw doctor and got a med that helped but still felt pretty bad. Also was told to use oil of oregano and that helped, too. The follow-up could not be possible as no contact details were available. More
2835137 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I received my first Shingrix in 2020. I never received my second vaccine; This non-serious case was ... I received my first Shingrix in 2020. I never received my second vaccine; 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 the 1st dose of Shingrix vaccine in 2020). 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: I received my first Shingrix in 2020. I never received my second vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 01-APR-2025 The reporter reported that received my first Shingrix in 2020. Patient never received his/her second vaccine. Reporter asked that did he/she needed to go back and start the process over or did just take the second vaccine now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835138 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; shingles 2 times; This serious case was reported by a consumer via in... Suspected vaccination failure; shingles 2 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 2 times). 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: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient stated shingles were very painful, he/she had the shot and had shingles 2 times, 1 time was not very bad. 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
2835139 F 04/09/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours... Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination More
shingles about a month later; hasn't gotten the second shot of it; This non-serious case was re... shingles about a month later; hasn't gotten the second shot of it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 90-year-old female 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 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles about a month later) and incomplete course of vaccination (Verbatim: hasn't gotten the second shot of it). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was not applicable. 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: 31-MAR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she did not get vaccines but patient had a fear of getting shingles. Patient's 90 heart old mother got her first vaccine six months ago. Who never had them, and got shingles about a month later. Of course she was told it was not from getting the vaccine, but that was hard to believe. She had not gotten the second shot of it. Till the time of reporting patient did not received second dose of Shingrix which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available. More
2835140 M 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Feeling abnormal, Herpes zoster Feeling abnormal, Herpes zoster
got shingles; This non-serious case was reported by a consumer via interactive digital media and des... got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: The case was received from the patient via interactive digital media. The patient was the brother of reporter. The reporter reported that the patient (his/her seventy plus brother) got the shot, and about 2 weeks later got shingles. He was miserable.; Sender's Comments: US-GSK-US2025AMR040112:Same reporter More
2835141 04/09/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected Vaccination failure; got shingles full blown now; This serious case was reported by a cons... Suspected Vaccination failure; got shingles full blown now; 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: got shingles full blown now). 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: 01-APR-2025 This case was reported by a patient via interactive digital media. The patient got the shot, while getting the second part patient got shingles. It was just the beginning. It was full blown now and 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2) More
2835142 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
shingles appeared exactly one week later on 5-01-2024; This non-serious case was reported by a consu... shingles appeared exactly one week later on 5-01-2024; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 24-APR-2024, the patient received Shingles vaccine. On 01-MAY-2024, 7 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles appeared exactly one week later on 5-01-2024). The patient was treated with gabapentin and diphenhydramine hydrochloride (Benadryl). The outcome of the shingles was not resolved. 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: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient got Shingles shot and the shingles appeared exactly one week later and the doctor said they were going to come out anyway (had nothing to do with getting the shot) and it was now 11 months and the patient was still taking Gabapentin and rubbing with Benadryl (for the itch) every day and went to a neurologist and he increased the Gabapentin to 300mg, 4 times a day as well the patient was about to approach one year anniversary on 1st May 2025 and it was absolutely awful. More
2835143 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Arthropod bite, Feeling abnormal, Herpes zoster Arthropod bite, Feeling abnormal, Herpes zoster
i got shingles right on the back of my neck leadIng into my hairline; thought I was going to die; do... i got shingles right on the back of my neck leadIng into my hairline; thought I was going to die; doctor on call told me I had an insect bite; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: i got shingles right on the back of my neck leadIng into my hairline), feeling abnormal (Verbatim: thought I was going to die) and insect bite nos (Verbatim: doctor on call told me I had an insect bite). The outcome of the shingles, feeling abnormal and insect bite nos were not reported. It was unknown if the reporter considered the shingles, feeling abnormal and insect bite nos to be related to Shingles vaccine. It was unknown if the company considered the shingles, feeling abnormal and insect bite nos to be related to Shingles vaccine. Additional Information: GSK receipt date: 01-APR-2025 This case was reported by a patient via interactive digital media. The patient got the first vaccine and was two weeks away from getting the second dose. Then he/she got shingles alright, internal shingles right on the back of his/her neck leading into his/her hairline. The patient thought he/she was going to die. He/she went to the emergency room and the physician on call told him/her heshe had an insect bite it was a male nurse that had been a nurse for 40 years that diagnosed him/her. The patient never even knew shingles could be internal. More
2835144 04/09/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Pain; Pain Pain; Pain
hurt like hell; This non-serious case was reported by a consumer via interactive digital media and d... hurt like hell; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 pain (Verbatim: hurt like hell). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that both the shots hurt like hell, but no sickness. More
2835145 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; can still get shingles again; This serious case was reported by a con... Suspected Vaccination failure; can still get shingles again; 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: can still get shingles again). 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: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient said even if you were vaccinated, you could still get shingles again and it happened to the patient. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2835146 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Influenza like illness Influenza like illness
Got second shingle vaccine last week had flu-like symptoms; This non-serious case was reported by a ... Got second shingle vaccine last week had flu-like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on an unknown date). In MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Got second shingle vaccine last week had flu-like symptoms). In MAR-2025, the outcome of the influenza-like symptoms was resolved (duration 3 days). It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine. It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient got second shingle vaccine last week and had flu-like symptoms for about 3 days. The patient did not feel great, but it was over and done with. The patient was glad that it was only 2 doses. More
2835147 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; got the shot Now I get shingles every two weeks; This serious case wa... Suspected Vaccination failure; got the shot Now I get shingles every two weeks; 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: got the shot Now I get shingles every two weeks). 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: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient never had shingles until he/she got the Shingles shot and now the patient got shingles every two weeks. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination 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
2835148 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The 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. 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: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient had administered with shingles shots and got shingles right now, but they were not as bad as they would have been if did not have the shots. 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. The follow-up could not be possible as no contact details were available.; 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. More
2835149 69 F NC 04/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 35P2C
Asthenia, Injection site discolouration, Mobility decreased, Pain, Pain in extre... Asthenia, Injection site discolouration, Mobility decreased, Pain, Pain in extremity More
2 inches purple color around injection site below the skin; weakness; limiting the motion of patient... 2 inches purple color around injection site below the skin; weakness; limiting the motion of patient's arm; sore arm/arm hurts during movements; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35P2C, expiry date 30-NOV-2025) for prophylaxis. On 08-JAN-2025, the patient received the 1st dose of Arexvy (left arm). In JAN-2025, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm/arm hurts during movements). In MAR-2025, the patient experienced mobility decreased (Verbatim: limiting the motion of patient's arm). On an unknown date, the patient experienced injection site discoloration (Verbatim: 2 inches purple color around injection site below the skin) and weakness (Verbatim: weakness). The outcome of the injection site discoloration, pain in arm, mobility decreased and weakness were unknown. It was unknown if the reporter considered the injection site discoloration, pain in arm, mobility decreased and weakness to be related to Arexvy. It was unknown if the company considered the injection site discoloration, pain in arm, mobility decreased and weakness to be related to Arexvy. Additional Information: GSK Receipt Date: 18-MAR-2025 The reporter reported that a patient received Arexvy vaccine and two days later arm sored. A week later, the arm still sored, this was continued. Patient started using massages and it did help a little while but then it comes back right on patient's side, right where the needle went in, there was a purple 2 inches across like a very sore to touch below the skin. Also, when patient goes to left her arm up, because patient did yoga, it wants to stop and it hurts to go pass that high. It was like weakness. It was 2 months later and it was limiting the motion of patient arm. It was slowing getting better but patient can not find anything online talking about long term side effects with Arexvy. More
2835150 18 F TX 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 H39Z4
Incorrect dose administered Incorrect dose administered
pediatric patient received an adult dose; pediatric patient received an adult dose; This non-serious... pediatric patient received an adult dose; pediatric patient received an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis. On 03-MAR-2025, the patient received Engerix B adult. On 03-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: pediatric patient received an adult dose) and overdose (Verbatim: pediatric patient received an adult dose). The outcome of the adult product administered to child and overdose 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: 18-MAR-2025 Nurse called to inform that a pediatric patient received an adult dose of Engerix-B, which led to adult product administered to child and overdose. More
2835151 57 F 04/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 F3Y25
Expired product administered, Underdose Expired product administered, Underdose
pediatric havrix vaccine administered to a 57 years old adult; pediatric havrix vaccine administered... pediatric havrix vaccine administered to a 57 years old adult; pediatric havrix vaccine administered to a 57 years old adult; Expired Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 57-year-old female patient who received HAV (Havrix pediatric) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis. On 18-MAR-2025, the patient received Havrix pediatric. On 18-MAR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric havrix vaccine administered to a 57 years old adult), underdose (Verbatim: pediatric havrix vaccine administered to a 57 years old adult) and expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the adult use of a child product, underdose and expired vaccine used 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: 18-MAR-2025 Pharmacist reported that a pediatric havrix vaccine was administered to a 57 years old adult which led to adult use of a child product and underdose. The vaccine had actually expired on 15 February 2025 which led to expired vaccine used. Over a month ago so, it was still in the stock. The reporter wanted to know if there was a recommendation to revaccinate with an adult dose The reporter was not sure which number of dose it was and she did not know the date of birth of the patient. More
2835152 12 F WI 04/09/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Expired product administered, Inappropriate schedule of product administration; ... Expired product administered, Inappropriate schedule of product administration; Expired product administered, Inappropriate schedule of product administration More
administer an Engerix-B vaccine and it was expired; Drug dose administration interval too long; This... administer an Engerix-B vaccine and it was expired; Drug dose administration interval too long; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received HBV (Engerix B) (expiry date 09-MAR-2025) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Engerix-B (received the 1st dose of Engerix-B in 29-JUL-2024). On 18-MAR-2025, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, the patient received the 2nd dose of Engerix B. On 23-OCT-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 18-MAR-2025, the patient experienced expired vaccine used (Verbatim: administer an Engerix-B vaccine and it was expired). The outcome of the expired vaccine used and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-MAR-2025 On 19-Mar-2025 a Registered Nurse called and reported that had a medical assistant, before the day of reporting, who administered an Engerix-B vaccine and it was expired, it expired 09-Mar-2025. The Vaccine Administration Facility was the same as Primary Reporter. The vaccines was administered on 18-Mar-2025, the patient received prior Engerix-B doses on 29-July-2024 and 23-Oct-2024, which led to expired vaccine used and drug dose administration interval too long. More
2835153 54 F VA 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3ZE3E
Product preparation issue Product preparation issue
administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Pr... administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix; administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 54-year-old female patient who received MMR (Priorix) (batch number 3ZE3E, expiry date 22-NOV-2028) for prophylaxis. On 17-MAR-2025, the patient received Priorix. On 17-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix) and inappropriate preparation of medication (Verbatim: administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication 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: 19-MAR-2025 The reporter reported that the patient was administered only the diluent (sterile water) without mixing with the powder (lyophilized part) of Priorix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Can it be diluted with other sterile water? The vaccine administration facility is the same as primary reporter.; Sender's Comments: US-GSK-US2025033667:Same reporter/Different patient More
2835154 M VA 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3ZE3E
Product preparation issue Product preparation issue
administered only the diluent; administered only the diluent; This non-serious case was reported by ... administered only the diluent; administered only the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 56-year-old male patient who received MMR (Priorix) (batch number 3ZE3E, expiry date 22-NOV-2028) for prophylaxis. On 17-MAR-2025, the patient received Priorix. On 17-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administered only the diluent ) and inappropriate preparation of medication (Verbatim: administered only the diluent ). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication 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: 19-MAR-2025 Reporter stated that they administered only the diluent (sterile water) without mixing with the powder (lyophilized part) of Priorix. Also asked if can it be diluted with other sterile water. The patient received only adjuvant of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with the case US2025033666,reported by the same reporter.; Sender's Comments: US-GSK-US2025033666:Same reporter/Different patient More
2835155 0.33 M GA 04/09/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 D252F
Hypersensitivity, Injection site rash Hypersensitivity, Injection site rash
rash on injection site; got an allergic reaction from it; This non-serious case was reported by a nu... rash on injection site; got an allergic reaction from it; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site rash in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number D252F) for prophylaxis. On 27-FEB-2025, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced injection site rash (Verbatim: rash on injection site) and allergic reaction (Verbatim: got an allergic reaction from it). The outcome of the injection site rash was unknown and the outcome of the allergic reaction was not reported. It was unknown if the reporter considered the injection site rash and allergic reaction to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the company considered the injection site rash and allergic reaction to be related to Pediarix and Pediarix 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 : 19-MAR-2025 Registered nurse called and reported the followed they gave one of our patient, a baby, the Hepatitis B vaccine, and then the baby got an allergic reaction from it, they had sent the baby to an allergist and now the allergist asked like a sample for the vaccine so they could do a skin test. More
2835156 63 F OH 04/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 P7M3Z
Expired product administered Expired product administered
it was expired; This non-serious case was reported by a other health professional via call center re... it was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number P7M3Z, expiry date 02-MAR-2025) for prophylaxis. On 20-MAR-2025, the patient received Arexvy. On 20-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: it was expired). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The other health professional reported that the RSV vaccine was given on the day of reporting and did not realize that it was expired which led to expired vaccine used. More
2835157 NJ 04/09/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
adult patient needing the hepatitis B vaccine and he inadvertently received the Pediarix vaccine; ad... adult patient needing the hepatitis B vaccine and he inadvertently received the Pediarix vaccine; adult patient inadvertently received the pediarix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Hepatitis b vaccine for prophylaxis. On an unknown date, the patient received Pediarix and did not received Hepatitis b vaccine. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: adult patient needing the hepatitis B vaccine and he inadvertently received the Pediarix vaccine) and adult use of a child product (Verbatim: adult patient inadvertently received the pediarix vaccine). The outcome of the wrong vaccine administered and adult use of a child product 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: 20-MAR-2025 Clinical Pharmacist specifically had a question in regard to the Pediarix vaccination. They had an adult patient needing the hepatitis B vaccine and he inadvertently received the Pediarix vaccine which led to Adult use of a child product and Wrong vaccine administered. So, pharmacist just wondering if there were any safety concerns or like if have to re-do the hepatitis B vaccine. The pharmacist only knew that the patient was an adult and that he was starting the schedule for hepatitis B vaccine. More
2835158 WA 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4H79Y
Product preparation issue Product preparation issue
only one patient that received the antigen alone; received the antigen alone; This non-serious case ... only one patient that received the antigen alone; received the antigen alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 4H79Y, expiry date 13-NOV-2026) 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: only one patient that received the antigen alone) and inappropriate dose of vaccine administered (Verbatim: received the antigen alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 On 20/Mar/2025, a nurse called to inform that it was discovered in a box of Shingrix that there were 3 vials left of Shingrix the vial that was left over out of the 3 was the gE antigen component. According to reporter, it was only one patient that received the antigen alone, and there were 9 suspect patients. No more information was provided by the reporter about this incident as it was unknown who the patient was. The Vaccine Administration Facility is the same as Primary Reporter. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2835159 NY 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Injection site pain, Injection site rash Erythema, Injection site pain, Injection site rash
bullseye rash in the arm where Shingrix was administered; Injection site pain; Redness; This non-ser... bullseye rash in the arm where Shingrix was administered; Injection site pain; Redness; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for an unknown indication. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site rash (Verbatim: bullseye rash in the arm where Shingrix was administered), injection site pain (Verbatim: Injection site pain) and injection site erythema (Verbatim: Redness). The action taken with Shingrix was unknown. The outcome of the injection site rash, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site rash, injection site pain and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site rash, injection site pain and injection site erythema to be related to Shingrix. Additional Information: GSK receipt date: 20-MAR-2025 Physician stated that a patient experienced bullseye rash in the arm where Shingrix was administered. Reporter asked if the patient get the second shot if their first reaction was painful, redness, and a bullseye effect or not. More
2835160 F IN 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 42B22
Underdose Underdose
a patient that received the hepatitis B vaccine for pediatric when it should have been for adult; a ... a patient that received the hepatitis B vaccine for pediatric when it should have been for adult; a patient that received the hepatitis B vaccine for pediatric when it should have been for adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: a patient that received the hepatitis B vaccine for pediatric when it should have been for adult) and underdose (Verbatim: a patient that received the hepatitis B vaccine for pediatric when it should have been for adult). The outcome of the adult use of a child product and underdose 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: 20-MAR-2025 The nurse reported that a patient that received the hepatitis B vaccine for pediatric when it should have been for adult, which led to adult use of a child product and underdose. The reporter need to know if that should be repeated or know, what should be done about that. The first dose was administered a couple of weeks ago. More
2835161 2 F CA 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 EP724
Expired product administered Expired product administered
MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.MA called ... MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HBV (Engerix B 10 mcg) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis. On 19-MAR-2025, the patient received Engerix B 10 mcg. On 19-MAR-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced expired vaccine used (Verbatim: MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter reported that newest medical assistant administered an expired Engerix B one day before the reporting to a patient, which led to expired vaccine used. The vaccine expired on 14-Mar-2025. More
2835162 8 F KY 04/09/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
Extra dose administered, Product administered to patient of inappropriate age Extra dose administered, Product administered to patient of inappropriate age
8 year old female patient received Kinrix second dose; 8 year old female patient received Kinrix sec... 8 year old female patient received Kinrix second dose; 8 year old female patient received Kinrix second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. Previously administered products included Kinrix (received 1st dose of Kinrix in 2022). On 20-MAR-2025, the patient received the 2nd dose of Kinrix. On 20-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 year old female patient received Kinrix second dose) and extra dose administered (Verbatim: 8 year old female patient received Kinrix second dose). The outcome of the inappropriate age at vaccine administration and extra dose administered 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: 20-MAR-2025 The doctor reported that an 8 year old female patient received Kinrix second dose on 20th March 2025 which led to inappropriate age at vaccine administration and extra dose administration. The first Kinrix was in 2022. The Vaccine Administration Facility was the same as Primary Reporter. More
2835163 F TX 04/09/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
The patient has never received Twinrix second dose.; This non-serious case was reported by a pharmac... The patient has never received Twinrix 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 45-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Patient received first dose of Twinrix 10 years ago). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: The patient has never received Twinrix second dose.). The outcome of the incomplete course of vaccination 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: 20-MAR-2025 The pharmacist reported that a 45 year-old female patient received Twinrix first dose 10 years ago in another facility and she has never received Twinrix second dose. Till the time of reporting, the patient did not received the second dose of Twinrix which led to incomplete course of vaccination. The Vaccine Administration Facility is the same as primary reporter. More
2835164 83 M CA 04/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Incorrect dose administered, Product preparation issue Incorrect dose administered, Product preparation issue
Pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed; one of t... Pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed; one of those patients was given an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 83-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis. On 20-MAR-2025, the patient received Arexvy. On 20-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed) and inappropriate dose of vaccine administered (Verbatim: one of those patients was given an incomplete dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The pharmacist asked about guidance on revaccination on two patient that was vaccinated, nevertheless after mixing doses, the pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed and one of those patients was given an incomplete dose. The pharmacist did not know which of this patient was given the incomplete dose. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025034229:same reporter different patient More
2835165 61 M 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 XX9N4
Incorrect route of product administration Incorrect route of product administration
administered a dose of Priorix intramuscularly instead of subcutaneously; This non-serious case was ... administered a dose of Priorix intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 61-year-old male patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis. On 21-MAR-2025, the patient received Priorix (intramuscular). On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: administered a dose of Priorix intramuscularly instead of subcutaneously). 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-MAR-2025 Pharmacist called to report that on 21st March 2025 has administered a dose of Priorix intramuscularly instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route. More
2835166 OH 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 A2B72
Incorrect route of product administration Incorrect route of product administration
Intramuscular administration; This non-serious case was reported by a other health professional via ... Intramuscular administration; 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 patient who received MMR (Priorix) (batch number A2B72, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular administration). 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-MAR-2025 The patient had received a dose of Priorix via intramuscular instead of subcutaneous, which led subcutaneous injection formulation administered by other route. The reporter consented to follow up. More
2835167 F CO 04/09/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received one dose of Twinrix; This non-serious case was reported by a pharmacist via call center rep... received one dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose of Twinrix on 19-SEP-2024), Heplisav b (received first dose of Heplisav b on 19-SEP-2024) and Heplisav b (received second dose of Heplisav b on 19-OCT-2024). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received one dose of Twinrix ). The outcome of the incomplete course of vaccination 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-MAR-2025 and 22-MAR-2025 The pharmacist reported that a patient received one dose of Twinrix and one of Heplisav-B and a second dose of Heplisav-B on. The pharmacist provided the lot number and expiration date of one of the Heplisav-B vaccines administered was 944915 and 19th September 2026. That was the only vaccine from which she had that kind of information. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient did not receive the second dose of Twinrix which led to incomplete course of vaccination. More
2835168 F CA 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
I administered the vaccine IM instead of SQ by accident; This non-serious case was reported by a pha... I administered the vaccine IM instead of SQ by accident; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 21-MAR-2025, the patient received Priorix. On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: I administered the vaccine IM instead of SQ by accident). 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-MAR-2025 The pharmacist reported that they administered Priorix vaccine by intramuscular route instead of subcutaneous route, which led to subcutaneous injection formulation administered by other route. More
2835169 M SC 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 X3M3D
Incorrect route of product administration Incorrect route of product administration
Wrong Route of Administration; Administration to adult patient; This non-serious case was reported b... Wrong Route of Administration; Administration to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a adult male patient who received MMR (Priorix) (batch number X3M3D) 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: Wrong Route of Administration) and inappropriate age at vaccine administration (Verbatim: Administration to adult patient). The outcome of the subcutaneous injection formulation administered by other route 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: 21-MAR-2025 The pharmacist stated that the Priorix was administered intramuscularly instead of subcutaneous and to an adult patient which led to subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration. More
2835170 72 F GA 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5y4tl
Product preparation issue Product preparation issue
Reconstitution error/administered the liquid portion only of Shingrix; Reconstitution error/administ... Reconstitution error/administered the liquid portion only of Shingrix; Reconstitution error/administered the liquid portion only of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 5y4tl, expiry date 31-JAN-2027) for prophylaxis. On 19-MAR-2025, the patient received Shingrix. On 19-MAR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Reconstitution error/administered the liquid portion only of Shingrix) and inappropriate preparation of medication (Verbatim: Reconstitution error/administered the liquid portion only of Shingrix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 24-MAR-2025 Lead Medical Assistant called to report that one of the office nurses administered the liquid portion only of Shingrix on March 19th 2025 which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The reporter asked when the complete dose should be repeated. More
2835171 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Priorix via IM; This non-serious case was reported by a pharmacist via call center representative an... Priorix via IM; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix via IM ). 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: 24-MAR-2025 The reporter reported that the patient received the Priorix via Intramuscular route, which led to subcutaneous injection formulation administered by other route. More
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