🏥 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 💀 🏥 🚑 ♿ ⚠️
2835172 KY 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Priorix was administered to a patient via intramuscular route; This non-serious case was reported by... Priorix was administered to a patient via intramuscular route; 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 22-MAR-2025, the patient received Priorix (intramuscular). On 22-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was administered to a patient via intramuscular route). 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 Priorix was administered to a patient via intramuscular route, which led subcutaneous injection formulation administered by other route. The reporter consented to follow up. More
2835173 M FL 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never got around to get the 2nd dose; This non-serious case was reported by a physician via call cen... never got around to get the 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine in March 2024). 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: never got around to get the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 24-MAR-2025 On 24th March 2025, a physician had called on behalf of himself to inform about Shingrix. He had gotten his first dose a year ago in March 2024, but he had never gotten around to getting the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835174 CA 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
when the vaccine (PRIORIX) was left in the freezer for a short period of time (twenty minutes) a dos... when the vaccine (PRIORIX) was left in the freezer for a short period of time (twenty minutes) a dose was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 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 incorrect storage of drug (Verbatim: when the vaccine (PRIORIX) was left in the freezer for a short period of time (twenty minutes) a dose was administered to a patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-MAR-2025 The Clinical Operations Manager needed stability data (general question) when the Priorix vaccine was left in the freezer for a short period of time (twenty minutes) a dose was administered to a patient which led to incorrect storage of drug. The Clinical Operations Manager did not know specifics on lowest temperature the vaccine reached. More
2835175 M KS 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 447N4
Expired product administered Expired product administered
received a dose of Priorix that had expired; This non-serious case was reported by a nurse via call ... received a dose of Priorix that had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received MMR (Priorix) (batch number 447N4, expiry date 11-MAY-2024) for prophylaxis. On 21-MAR-2025, the patient received Priorix. On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: received a dose of Priorix that had expired). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-MAR-2025 The nursing supervisor reported that a patient received a dose of Priorix that had expired, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. More
2835176 F WV 04/09/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 MD9SL
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Engerix-B adult dose to 19-year-old; Engerix-B adult dose to 19-year-old; This non-serious case was ... Engerix-B adult dose to 19-year-old; Engerix-B adult dose to 19-year-old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B) (batch number MD9SL, expiry date 08-DEC-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On 24-MAR-2025, the patient received the 2nd dose of Engerix B. On 21-FEB-2025, the patient received the 1st dose of Engerix B. On 21-FEB-2025, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: Engerix-B adult dose to 19-year-old). On 24-MAR-2025, the patient experienced overdose (Verbatim: Engerix-B adult dose to 19-year-old). The outcome of the overdose and overdose were not applicable. Additional Information: GSK Receipt Date: 24-MAR-2025 The pharmacist called to report the adult dose 20mcg/1ml of Engerix-B was inadvertently administered to a 19-year-old patient for her first and second dose, which led to overdose. Suspect Vaccine Start Date was 2-21-2025. More
2835177 53 F FL 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 24M7E
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose; This non-serious case was reported by a pharmacist via call center representative ... Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 24M7E, expiry date 06-APR-2026) for prophylaxis. Previously administered products included Shingrix (patient had First dose on January 3rd 2022 Lot number 9EY93, expiry date April 15th 2023 ). On 11-NOV-2024, the patient received the 2nd dose of Shingrix. On 11-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 24-MAR-2025 Other HCP reported that a patient got first dose of Shingrix on January 3rd 2022 and a late second dose on November 11th 2024, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) More
2835178 11 M PA 04/09/2025 MEN
MENB
 UNKNOWN MANUFACTURER
NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
TP294
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Bexsero administration instead of Menquadfi; This non-serious case was reported by a other health pr... Bexsero administration instead of Menquadfi; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31-OCT-2024) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On 03-NOV-2023, the patient received Bexsero. On an unknown date, the patient did not receive Menquadfi. On 03-NOV-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero administration instead of Menquadfi). The outcome of the wrong vaccine administered 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 health care professional wanted to know how to proceed after realizing that a patient received more than one year ago Bexsero instead of Menquadfi, which led to wrong vaccine administered (according to the patient's administration schedule) when he was 11 years old. The vaccine administration facility was the same as primary reporter. More
2835179 FL 04/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Product storage error Product storage error
Improper Storage Error; This non-serious case was reported by a other health professional via call c... Improper Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis. In MAR-2025, the patient received Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-MAR-2025 The health care professional requested data for Bexsero, Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liquid) stored at 0 degree Celsius unknown amount of time. Excursion started on 20-MAR-2025. No signs of freezing or slushing. Vaccines had been used in patients but not aware of number of patients, which led to incorrect storage of drug. More
2835180 66 M NC 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
Given intramuscularly; This non-serious case was reported by a pharmacist via call center representa... Given intramuscularly; 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 66-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 30-SEP-2026) for prophylaxis. On 24-MAR-2025, the patient received Priorix (intramuscular). On 24-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Given intramuscularly). 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: 25-MAR-2025 The patient was inadvertently given the Priorix intramuscularly instead of subcutaneously, which led subcutaneous injection formulation administered by other route. The reporter consented to follow up. More
2835181 74 F CA 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
recently got another one on January; This non-serious case was reported by a pharmacist via call cen... recently got another one on January; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix in 2018). On 20-JAN-2025, the patient received the 2nd dose of Shingrix. On 20-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: recently got another one on January). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 25-MAR-2025 The pharmacist's mother received a first dose on 2018 and recently got another one on 20 January 2025, which led to drug dose administration interval too long. Pharmacist wanted to ask if efficacy was affected once there had been more than six months after the first dose.; Sender's Comments: US-GSK-US2025035954:same reporter More
2835182 CA 04/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Inappropriate schedule of product administration Inappropriate schedule of product administration
first dose at age 10 and second dose at age 16; This non-serious case was reported by a consumer via... first dose at age 10 and second dose at age 16; This non-serious case was reported by a consumer via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 1st dose at the age 10). On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: first dose at age 10 and second dose at age 16). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-MAR-2025 The doctor enquired if she needs to continue a possible 3rd dose of Bexsero vaccine if the adolescent received first dose at age 10 and second dose at age 16. The patient did not received second dose of vaccine within the recommended timeframe which led to drug dose administration interval too long. The case was raised for the apparent deviation of the recommended schedule, but no more data available. More
2835183 AZ 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never received their 2nd dose due to COVID and pandemic; This non-serious case was reported by a oth... never received their 2nd dose due to COVID and pandemic; This non-serious case was reported by a other health professional via sales rep and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2020). On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: never received their 2nd dose due to COVID and pandemic). The outcome of the social problem was not reported. Additional Information: GSK Receipt Date: 26-MAR-2025 The reporter reported that they had several patients that received 1st dose in 2020 and then never received their 2nd dose due to Covid and pandemic. The reporter asked should these patients restart the series or just get the 2nd dose. More
2835184 F PA 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 EP724
Expired product administered Expired product administered
the dose had expired on March 14th 2025; This non-serious case was reported by a nurse via call cent... the dose had expired on March 14th 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis. On 26-MAR-2025, the patient received Engerix B. On 26-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: the dose had expired on March 14th 2025). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 26-MAR-2025 Engerix B was administered on March 26th 2025 and the dose had expired on March 14th 2025 which led to expired vaccine used. More
2835185 51 M IN 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3K3E7
Product preparation error Product preparation error
received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that come... received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix; received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3K3E7, expiry date 09-JUN-2026) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix) and inappropriate dose of vaccine administered (Verbatim: received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 26-MAR-2025 A Nurse called to report that they administered to a 51-year-old male patient Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted to know what exactly is in the liquid adjuvant, is there any vaccine in the liquid that comes with Shingrix? More
2835186 69 F CA 04/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Havrix late second dose; This non-serious case was reported by a pharmacist via call center represen... Havrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received 1st dose of Havrix vaccine in 16-APR-2008). On 04-JUN-2024, the patient received the 2nd dose of Havrix. On 04-JUN-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: Havrix late second dose). The outcome of the drug dose administration interval too long 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: 26-MAR-2025 The pharmacist asked if she could administer a third dose of Havrix to a patient due to a wide range of time between the first two doses. First dose on 16 April 2008 and the second in 4 June 2024, which led to drug dose administration interval too long. More
2835187 PA 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation error Product preparation error
accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder; acciden... accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder; accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder) and inappropriate dose of vaccine administered (Verbatim: accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 26-MAR-2025 Other HCP reported that one of their Medical Assistants accidentally reconstituted the Shingrix vaccine with a sterile diluent instead of the lyophilized powder when the 1st dose was administered to a patient. Reporter would like to know if it's still okay to administer the 2 doses of Shingrix to the patient since the initial dose was prepared and administered to the patient incorrectly. What should they do in this situation and is it safe for the patient or not. Reporter asked if there are any additional side effects for the patient they should be aware of. The patient received Shingrix vaccine with a sterile diluent instead of the lyophilized powder of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2835188 F NJ 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
hadn't received the 2nd dose yet.; This non-serious case was reported by a pharmacist via call ... hadn't received the 2nd dose yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 22-OCT-2023 with batch number L227A and lot expiry 30-SEP-2025). 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: hadn't received the 2nd dose yet.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-MAR-2025 The pharmacist reported that a patient received 1st dose of Shingrix on 22-OCT-2023, but had not received the 2nd dose yet. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835189 F 04/09/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
short 3rd dose; This non-serious case was reported by a pharmacist via call center representative an... short 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix) and Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). In MAR-2025, the patient received the 3rd dose of Twinrix. In MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: short 3rd dose). The outcome of the drug dose administration interval too short 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: 26-MAR-2025 The patient received 3 doses of Twinrix, a month apart each. It was unclear if the 3rd dose was administered on 13-March-2025 or 14-March-2025. The patient received 3rd dose in shorter interval which led to shortening of vaccination schedule. The reporter did not consent to follow-up. More
2835190 F AR 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose; This non-serious case was reported by a nurse via call center representative and desc... Late 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (had the 1st dose 3 to 4 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 On 27th March 2025, a nurse practitioner called to inform that a patient had received the first dose 3 to 4 years earlier, but she had never received the second one. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835191 M NY 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
now he wants to get the second dose of Shingrix.; This non-serious case was reported by a pharmacist... now he wants to get the second dose of Shingrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix 3 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: now he wants to get the second dose of Shingrix.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-MAR-2025 The reporter reported that a pharmacist called to ask if a 79 year old male patient could get the second dose of Shingrix if the first dose was administered 3 years ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835192 47 F KY 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 42B22
Underdose Underdose
adult female patient received Engerix-B pediatric first dose; adult female patient received Engerix-... adult female patient received Engerix-B pediatric first dose; adult female patient received Engerix-B pediatric first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis. On 27-MAR-2025, the patient received the 1st dose of Engerix B pediatric. On 27-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult female patient received Engerix-B pediatric first dose) and adult use of a child product (Verbatim: adult female patient received Engerix-B pediatric first dose). The outcome of the underdose and adult use of a child product were not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 The nurse reported that, on the day of reporting, an adult patient received Engerix-B pediatric first dose, which led to an underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. More
2835193 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
More than three years interval between the first and second dose of Shingrix; This non-serious case ... More than three years interval between the first and second dose of Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient took first dose on unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: More than three years interval between the first and second dose of Shingrix). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 The reporter told that if more than three years went by between the first and second dose of the vaccination did the patient needed to start the series over or just give the second dose now. The interval between first and second dose of the Shingrix was more than three years which led to drug dose administration interval too long. The reporter did not want to provided personal information but yes that what occurred. The second dose of Shingrix which it appeared correct based on CDC guidelines but wanted to double check. No worries if it was not a simple yes or no answer and chat dropped while attempting to obtain additional information. More
2835194 18 M CA 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4bx39
Incorrect dose administered Incorrect dose administered
adult dose administered inadvertently to adolescent; adult dose administered inadvertently to adoles... adult dose administered inadvertently to adolescent; adult dose administered inadvertently to adolescent; 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 male patient who received HBV (Engerix B adult) (batch number 4bx39, expiry date 29-JUL-2027) for prophylaxis. On 27-MAR-2025, the patient received Engerix B adult. On 27-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: adult dose administered inadvertently to adolescent) and overdose (Verbatim: adult dose administered inadvertently to adolescent). 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: 27-MAR-2025 Other HCP reported that an adult dose of Engerix B was administered to an 18 year old patient today, which led to adult product administered to child and overdose. More
2835195 CA 04/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Product storage error Product storage error
administered doses of Bexsero to multiple patients after a temperature excursion out of range and ou... administered doses of Bexsero to multiple patients after a temperature excursion out of range and out of the supported in house extended stability data; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) and (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis. On an unknown date, the patients received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patients experienced incorrect storage of drug (Verbatim: administered doses of Bexsero to multiple patients after a temperature excursion out of range and out of the supported in house extended stability data). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 27-MAR-2025 A pharmacist called to report that they administered Bexsero to multiple patients after a temperature excursion, which led to incorrect storage of drug. The reporter asked that it was a valid dose. The Bexsero vaccine was exposed to 67 degree fahrenheit for 67 hours 48 minutes. No prior excursions. The reporter asked that you have any stability data that exceeds 48 hours of stability for Bexsero. Medical information specialist (MIS) tried to get more details of the patients involved but pharmacist stated that he did not have more information of their initials, ages or gender. More
2835196 0.42 F OR 04/09/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
5 months and 17 days that was inadvertently given the kinrix vaccine; This non-serious case was repo... 5 months and 17 days that was inadvertently given the kinrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. On 27-MAR-2025, the patient received Kinrix. On 27-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 5 months and 17 days that was inadvertently given the kinrix vaccine). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-MAR-2025 The clinic director reported that they had a patient who was 5 months and 17 days that was inadvertently given the Kinrix vaccine. The reporter just wanted to know if that was not harmful. The reporter did not know what number of Dtap-ipv dose was or which vaccine was supposed to be administered instead of Kinrix. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. More
2835197 M MD 04/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9L944
9K2MA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Multiple vaccines given/received 3rd dose in 2023; Multiple vaccines given/received 4th dose; This n... Multiple vaccines given/received 3rd dose in 2023; Multiple vaccines given/received 4th dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2027) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 9K2MA) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021 with batch number PF454) and Shingrix (received 2nd dose in 2022 with batch number NR2X5). On 27-MAR-2025, the patient received the 4th dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On 27-MAR-2025, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Multiple vaccines given/received 4th dose). On an unknown date, the patient experienced extra dose administered (Verbatim: Multiple vaccines given/received 3rd dose in 2023). The outcome of the extra dose administered and extra dose administered were not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 The pharmacist request information about the administration of Shingrix every year, specifying that they wish to receive recommendations on how to proceed after a patient got the vaccine today and after speaking with the patient they commented that they try and get the vaccine every single year. They did specify that the previous vaccines were administered in 2021, 2022, 2023 and on 27-MAR-2025, which led to extra dose administered. The lot number for the vaccine that was administered in 2021 was PF454, the lot number for the vaccine that was administered on 2022 was NR2X5, the lot number that was administered in 2023 was 9K2MA and the lot number of the vaccine that was administered on March 27th 2025 was 9L944 and the expiration date was March 30th 2027. They did state that they did not have any information about the expiration date for the previous vaccines. The vaccine administration facility was the same as primary reporter. More
2835198 4 F MA 04/09/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Administration of less of the standard dose; This non-serious case was reported by a nurse via call ... Administration of less of the standard dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. On 27-MAR-2025, the patient received Kinrix. On 27-MAR-2025, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: Administration of less of the standard dose). The outcome of the incomplete dose administered 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: 27-MAR-2025 The nurse reported that the patient received Kinrix less than 0.5 standard dose because of child movements, which led to incomplete dose administered. More
2835199 F FL 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Priorix via intramuscular instead of subcutaneous; This non-serious case was reported by a pharmacis... Priorix via intramuscular instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix via intramuscular instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-MAR-2025 A pharmacist called to inform that the patient received a dose of Priorix via intramuscular instead of subcutaneous which led to incorrect route of administration. The reporter didn't have any more details available at the moment of the call. The vaccine administration facility was the same as primary reporter. More
2835200 M FL 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
received a dose of Priorix via intramuscular instead of subcutaneous; This non-serious case was repo... received a dose of Priorix via intramuscular instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a male patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received a dose of Priorix via intramuscular instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-MAR-2025 The pharmacist reported that two patients received a dose of Priorix via intramuscular instead of subcutaneous which led to subcutaneous injection formulation administered by other route. The Vaccine Administration Facility was the same as Primary Reporter. More
2835201 NJ 04/09/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
someone who was 6 months late for their second dose of Twinrix; This non-serious case was reported b... someone who was 6 months late for their second dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: someone who was 6 months late for their second dose of Twinrix). The outcome of the drug dose administration interval too long 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: 27-MAR-2025 The pharmacist called with inquiry and while in conversation said through a friend she heard of someone who was 6 months late for their second dose of Twinrix which led to drug dose administration interval too long. More
2835202 52 F 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 LG749
Underdose Underdose
received the child hep B, the Engerix-B ped dose instead of the adult dose; received the child hep B... received the child hep B, the Engerix-B ped dose instead of the adult dose; received the child hep B, the Engerix-B ped dose instead of the adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 52-year-old female patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b). On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: received the child hep B, the Engerix-B ped dose instead of the adult dose) and adult use of a child product (Verbatim: received the child hep B, the Engerix-B ped dose instead of the adult dose). The outcome of the underdose 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: 27-MAR-2025 Medical assistant called to provide the information as a patient received her second dose of Hepatitis B, Engerix-B pediatric dose instead of the adult dose, which led to underdose and adult use of a child product. She had her first dose February first the regular dose that she was supposed to have. That was Heplisav which you guys did not have, so, she received that one and for her second one a kids dose. So, they were just wondering if like, she need a third dose of the kid's to be up to date with her two hepatitis B series. The reporter requested to not store her personally identifiable information (PII). For pharmacovigilance follow-up the reporter's information was stored at member of public/the reporter's details in upper section. More
2835203 71 F OK 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Wrong route of administration; This non-serious case was reported by a other health professional via... Wrong route of administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 05-FEB-2025, the patient received the 1st dose of Shingrix (subcutaneous). On 05-FEB-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong route of administration). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 The healthcare professional explained that a patient received their first dose of Shingrix on 5th February 2025, but it was given subcutaneously instead of intramuscular which led to intramuscular formulation administered by other route. More
2835204 NJ 04/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Product storage error Product storage error
Administration after temperature excursion; This non-serious case was reported by a other health pro... Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-MAR-2025 A CMA (certified medical assistant) started a chat and informed that she believed a patient had received a dose of Bexsero that was in a temperature excursion with the following conditions: 30.71 degrees F, 186 hours and 35 mins, which led to an incorrect storage of drug. No previous excursion was reported. Reporter did not have any details about the patient. More
2835205 M AZ 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 A5T73
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
An 18 years old male patient accidentally received a dose of Shingrix instead of Varivax.; administe... An 18 years old male patient accidentally received a dose of Shingrix instead of Varivax.; administered Shingrix instead of Varivax; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old male patient who received Herpes zoster (Shingrix) (batch number A5T73, expiry date 28-MAR-2027) for prophylaxis. Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis. On an unknown date, the patient received Shingrix and Varivax. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: An 18 years old male patient accidentally received a dose of Shingrix instead of Varivax.) and wrong vaccine administered (Verbatim: administered Shingrix instead of Varivax). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. Additional Information: GSK receipt date: 28-MAR-2025 The medical assistant called to report that they accidentally administered Shingrix instead of Varivax to a 18 years old patient which led to, inappropriate age at vaccine administration and wrong vaccine administered. The reporter had a questioned how long should they wait to give the correct vaccine. Did they had to give him the second dose of Shingrix. More
2835206 0.33 M DC 04/09/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7745R
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Kinrix administration instead of Infanrix; Kinrix under recommended age administration; This non-ser... Kinrix administration instead of Infanrix; Kinrix under recommended age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 24-FEB-2025, the patient received Kinrix. On an unknown date, the patient received Infanrix. On 24-FEB-2025, immediately after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix administration instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Kinrix under recommended age administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:28-MAR-2025 Registered Nurse wanted to know how to proceed with a patient that received Kinrix instead of Infanrix and if there was any possible harm for him in this situation, which led to wrong vaccine administered and inappropriate age at vaccine administration. Information her inquiries and also for Kinrix under recommended age administration was given. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. More
2835207 M MN 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4ZC23
Incorrect route of product administration Incorrect route of product administration
Inappropriate Route of Administration; This non-serious case was reported by a other health professi... Inappropriate Route of 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 25-year-old male patient who received MMR (Priorix) (batch number 4ZC23, expiry date 01-SEP-2025) for prophylaxis. On 25-NOV-2024, the patient received Priorix (intramuscular). On 25-NOV-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Inappropriate Route of 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: 28-MAR-2025 The reporter reported that an intramuscular administration of Priorix vaccine to a patient, which led to subcutaneous injection formulation administered by other route. The patient demographics, vaccine detail and vaccination date were obtained during this call. No further information was provided from the Vaccine Coordinator�s end in this call. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. More
2835208 12 M TX 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 H39Z4
Extra dose administered Extra dose administered
5 doses administered; This non-serious case was reported by a nurse via call center representative a... 5 doses administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received HBV (Engerix B) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis. On 28-MAR-2025, the patient received the 5th dose of Engerix B. On 28-MAR-2025, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: 5 doses administered). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-MAR-2025 On 28th March 2025, a nurse called to inform that earlier that day, a patient had received a dose of Engerix-B but had already completed their vaccination series, making it an additional dose. The reporter confirmed that it had been the fifth dose of Engerix-B the patient had received, which led to Extra dose administered. More
2835209 F CA 04/09/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose - Inappropriate Schedule (wrong accelerated schedule); This non-serious case was re... Late second dose - Inappropriate Schedule (wrong accelerated schedule); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 31-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 27-MAR-2025, the patient received the 2nd dose of Twinrix. On 27-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose - Inappropriate Schedule (wrong accelerated schedule)). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-MAR-2025 and 01-APR-2025 Registered Pharmacist asked for the following patient�s Twinrix schedule, when the third dose could be administered. The vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained from the Registered Pharmacist�s end. The reporter consented to follow up. The Vaccine administration Facility was the same as Primary Reporter. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. More
2835210 52 F NE 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 A5T73
Product preparation issue Product preparation issue
only the adjuvant portion of the Shingrix vaccine was administered to a patient.; only the adjuvant ... only the adjuvant portion of the Shingrix vaccine was administered to a patient.; only the adjuvant portion of the Shingrix vaccine was administered to a patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number A5T73, expiry date 28-MAR-2027) for prophylaxis. On 28-MAR-2025, the patient received Shingrix. On 28-MAR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only the adjuvant portion of the Shingrix vaccine was administered to a patient.) and inappropriate dose of vaccine administered (Verbatim: only the adjuvant portion of the Shingrix vaccine was administered to a patient.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-MAR-2025 The nurse reported that the adjuvant portion of the Shingrix vaccine was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. More
2835211 NY 04/09/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Early 3rd dose; Early 2nd dose; This non-serious case was reported by a nurse via call center repres... Early 3rd dose; Early 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Engerix b (patient received first dose on 17th October, 2024). On 06-MAR-2025, the patient received the 3rd dose of Engerix B. On 30-OCT-2024, the patient received the 2nd dose of Engerix B. On 30-OCT-2024, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). On 06-MAR-2025, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too short 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: 31-MAR-2025 Other HCP reported that a patient had received the series of Engerix-B with the schedule, 1st dose on 17th October 2024, 2nd dose on 30th October 2024 and 3rd dose on 6th March 2025. Reporter did not give more details about this and declined follow-up by safety team. The patient received 2nd dose of Engerix B,?earlier than the recommended interval, which led to shortening of vaccinations schedule. Patient received 3rd dose of Engerix B,?later than the recommended interval, which led to lengthening of vaccinations schedule. More
2835212 9 M CO 04/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 HR4RB
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
9-year-old patient received an adult dose of Havrix this morning; 9-year-old patient received an adu... 9-year-old patient received an adult dose of Havrix this morning; 9-year-old patient received an adult dose of Havrix this morning; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old male patient who received HAV (Havrix 1440 adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis. On 31-MAR-2025, the patient received the 1st dose of Havrix 1440 adult. On 31-MAR-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: 9-year-old patient received an adult dose of Havrix this morning) and adult product administered to child (Verbatim: 9-year-old patient received an adult dose of Havrix this morning). The outcome of the overdose and adult product administered to child were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:31-MAR-2025 The reporter stated that a 9-year-old patient received an adult dose of Havrix this morning, which led to overdose and adult product administered to child. The reporter consented to follow up via postal. The Vaccine Administration Facility is the same as Primary Reporter. More
2835213 53 M FL 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose; This non-serious case was reported by a pharmacist via call center representative ... Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 25th September 2022). On 02-OCT-2024, the patient received the 2nd dose of Shingrix. On 02-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt date: 31-MAR-2025 The patient who came to get Shingrix shots on 25th September 2022 and 2nd October 2024 (2 years apart) wanted to get a 3rd dose. The reporter consented to follow up. The lot and expiration date of 2nd dose not available during call. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. More
2835214 12 F MA 04/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 88G34
Wrong product administered Wrong product administered
administer a Bexsero vaccine instead of a Menveo; This non-serious case was reported by a nurse via ... administer a Bexsero vaccine instead of a Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number 88G34, expiry date 30-SEP-2027) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 10-MAR-2025, the patient received the 1st dose of Bexsero. On an unknown date, the patient received Menveo. On 10-MAR-2025, an unknown time after receiving Bexsero and not applicable after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: administer a Bexsero vaccine instead of a Menveo). The outcome of the wrong vaccine administered 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: 31-MAR-2025 The registered nurse called and mentioned to administer a Bexsero vaccine instead of a Menveo to a patient which led to, wrong vaccine administered. The nurse explained that the Bexsero vaccine was approved for patients between 10 to 25 years old, but as this was an inadvertent administration. The vaccine administration facility was the same as primary reporter. More
2835215 64 F MA 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 342RC
Product preparation issue Product preparation issue
AE Priorix - Administration of only the diluent.; AE Priorix - Administration of only the diluent.; ... AE Priorix - Administration of only the diluent.; AE Priorix - Administration of only the diluent.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 64-year-old female patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis. On 28-FEB-2025, the patient received Priorix. On 28-FEB-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: AE Priorix - Administration of only the diluent.) and inappropriate preparation of medication (Verbatim: AE Priorix - Administration of 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: 31-MAR-2025 The nurse reported that the two patients that likely received an incomplete Priorix dose, but they could not confirm which patient received only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The nurse thought they should revaccinate both patients but one of them would receive an extra dose. The nurse asked for information about a patient receiving an extra dose of Priorix or if they could check titers prior to revaccination and asked what was the recommendation in that situation. This case is linked with US2025038563, reported by same reporter.; Sender's Comments: US-GSK-US2025038563:Same reporter/Different Patient More
2835216 51 F MA 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 342RC
Product preparation issue Product preparation issue
patient received only the diluent portion; patient received only the diluent portion; This non-serio... patient received only the diluent portion; patient received only the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis. On 13-MAR-2025, the patient received Priorix. On 13-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine 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: 31-MAR-2025 The nurse reported that the two patients that likely received an incomplete Priorix dose, but they could not confirm which patient received only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The nurse thought they should revaccinate both patients but one of them will receive an extra dose. The nurse asked for information about a patient receiving an extra dose of Priorix or if they could check titers prior to revaccination and asked what was the recommendation in that situation. This case is linked with US2025038566, reported by same reporter.; Sender's Comments: US-GSK-US2025038566:Same reporter/Different Patient More
2835217 AR 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
A patient received Priorix via IM instead of SC; This non-serious case was reported by a pharmacist ... A patient received Priorix via IM instead of SC; 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) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A patient received Priorix via IM instead of SC). 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: 31-MAR-2025 The pharmacist called to report that a patient received Priorix via IM (intramuscular) instead of SC (subcutaneous), which led to subcutaneous injection formulation administered by other route. The reporter wanted to know do they need to repeat the dose. More
2835218 55 F NC 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 TJ534
Product preparation issue Product preparation issue
accidentally administered only the adjuvant portion of Shingrix; received only the adjuvant portion ... accidentally administered only the adjuvant portion of Shingrix; received only the adjuvant portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ534, expiry date 23-OCT-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: accidentally administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 31-MAR-2025 A practice administrator called to report that they accidentally administered only the adjuvant portion of Shingrix to a patient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter wanted to know was it ok for the patient, any side effect they should consider or do they need to revaccinate. More
2835219 29 F NM 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3H3RX
Expired product administered Expired product administered
Engerix-B, it was expired back in July 2024; This non-serious case was reported by a pharmacist via ... Engerix-B, it was expired back in July 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis. On 31-MAR-2025, the patient received Engerix B. On 31-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B, it was expired back in July 2024). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-MAR-2025 On 31-Mar-2025 a Registered pharmacist called and reported that a patient of mine received a vaccine Engerix-B, it was expired back in July 2024, which led to expired vaccine used. Reporter was wondering if had information on extended expiration on that, or what the revaccination guidelines were for this particular accident. The Vaccine Administration Facility is the same as Primary Reporter. The patient received the vaccine on the day of reporting, 31-Mar-2025. More
2835220 FL 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Paraesthesia Paraesthesia
tingling in fingertips; This non-serious case was reported by a physician via call center representa... tingling in fingertips; This non-serious case was reported by a physician via call center representative and described the occurrence of tingling of extremity in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: tingling in fingertips). The outcome of the tingling of extremity was unknown. It was unknown if the reporter considered the tingling of extremity to be related to Shingrix. It was unknown if the company considered the tingling of extremity to be related to Shingrix. Additional Information: GSK Receipt Date:31-MAR-2025 The reporter asked regarding tingling in fingertips after the first Shingrix vaccine. The reporter asked any data around this and if second dose still be received. More
2835221 NY 04/09/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation error Product preparation error
they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administ... they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient; they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient) and inappropriate dose of vaccine administered (Verbatim: they reconstituted a Hiberix vaccine with Vaccine sterile water rather than saline and then administered it to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 01-APR-2025 The pharmacist reported that they reconstituted a Hiberix vaccine with sterile water rather than saline and then administered it to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked was there any harm to the patient and asked the vaccine needed to be repeated. More
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