๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

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

Limitations:

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

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2815789 56 F NY 12/12/2024 FLU3
FLU3
FLUC4
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 946618
946618
946618
Acupuncture, Immediate post-injection reaction, Injected limb mobility decreased... Acupuncture, Immediate post-injection reaction, Injected limb mobility decreased, Injection site discolouration, Pain; Product administered at inappropriate site, Sleep disorder, X-ray; Joint injury More
Vaccine was given very high up in the shoulder. Needle felt like it went directly into the bone. I... Vaccine was given very high up in the shoulder. Needle felt like it went directly into the bone. Immediately hurt, area turned black and blue. Since I have difficulty lifting my arm forward and to the side. Cannot lay or sleep on that side, am unable to pull blankets up due to extreme pain. I have seen the ortho doctor twice, I've been in physical therapy since November 5th, last week I tried acupuncture. More
2802377 61 M TN 10/25/2024 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9R397
9R397
9R397
Injected limb mobility decreased, Injection site induration, Injection site pain... Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site swelling, Pain; Pain in extremity, Product administered at inappropriate site; Joint injury More
The actual injection was more painful than any other previous vaccine received. After the injection,... The actual injection was more painful than any other previous vaccine received. After the injection, there was pain that continued to worsen throughout day 1. The pain additionally radiated down the entire arm to the hand by evening of day 1. The next morning, day 2, patient had limited range of motion and continued pain. The pain continued to worsen throughout day 2, and by mid-day, patient could not raise his arm without significant sharp, throbbing pain - pain scale rating 9-10 out of 10. Patient stated it felt like a nail had been driven into the shoulder. Pain was more localized, less pain than previous day throughout his entire arm. Morning of day 3, the injection area is swollen and firm. There is slight improvement in both range of motion and pain - pain scale rating 5-6 out of 10 at rest, and 7-8 out of 10 with movement or touch. Of note, the injection was administered too high in the arm, which has good muscle mass. Also, patient stated that pharmacist was leaning over a counter and in an awkward position when administering the vaccine. The records at the pharmacy indicate it was given in the left deltoid, but it was administered in the right arm/shoulder area. Patient has taken several doses of OTC ibuprofen, with some relief. More
2826435 U 02/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Feeling cold, Headache, Pyrexia, Swelling Feeling cold, Headache, Pyrexia, Swelling
fever; swelling; freezing to death; head hurts; This non-serious case was reported by a consumer via... fever; swelling; freezing to death; head hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine with an associated reaction of pain in extremity (Patient received first dose on an unknown date). On 17-JAN-2025, the patient received the 2nd dose of Shingles vaccine. In JAN-2025, less than a week after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever), swelling (Verbatim: swelling), feeling cold (Verbatim: freezing to death) and headache (Verbatim: head hurts). The outcome of the fever, swelling, feeling cold and headache were not resolved. It was unknown if the reporter considered the fever, swelling, feeling cold and headache to be related to Shingles vaccine. It was unknown if the company considered the fever, swelling, feeling cold and headache to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient received second one dose of vaccine and got a fever, swelling, and stated that he/she was freezing to death, head was hurting, also said that he/she was warned about this. More
2826436 U 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
Arm is still a bit sore; This non-serious case was reported by a consumer via interactive digital me... Arm is still a bit sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 16-JAN-2025, the patient received the 1st dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm is still a bit sore). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she received Shingrix vaccine and after vaccination the arm was still a bit sore but no other issues. The patient was now worried about the second one, but he/she would did it. More
2826437 U 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal Feeling abnormal
second dose felt worse than the first/felt bad; This non-serious case was reported by a consumer via... second dose felt worse than the first/felt bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of feeling abnormal (1st dose received on an 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 feeling bad (Verbatim: second dose felt worse than the first/felt bad). Rechallenge with Shingrix was positive. The outcome of the feeling bad was resolved. It was unknown if the reporter considered the feeling bad to be related to Shingrix. It was unknown if the company considered the feeling bad to be related to Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by patient itself. The patient felt bad on both shots of Shingrix. The patient stated the second dose felt worse than the first. More
2826438 U 02/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
I had the shingles shot and my arm is still sore; This non-serious case was reported by a consumer v... I had the shingles shot and my arm is still sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: I had the shingles shot and my arm is still sore). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient received the shingles vaccine and patient arm was still sore. More
2826439 U 02/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles outbreak; This serious case was reported by a consumer via i... Suspected vaccination failure; Shingles outbreak; 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 outbreak). The patient was treated with lysine. The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 03-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that supplement of lysine prevented Shingles outbreaks. The reporter mentioned that he/she had 3 outbreaks even with the vaccine. The reporter mentioned that he/she took Lysine daily. During one outbreak, he/she took 7 grams at once, which shrank the shingles. He/she took 1 to 2 grams daily, mine were caused by arginine, not by stress. This case was considered as suspected vaccination failure since the details regarding 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
2826440 U 02/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I still have shingles outbreaks; This serious case was reported by a ... Suspected vaccination failure; I still have shingles outbreaks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still have shingles outbreaks). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 08-FEB-2025 This case was reported by a patient via interactive digital media. The patient reported that the Shingles shot only had about 50 percent efficacy. Take the second shot, only about 70 percent efficacy. The patient did both Shingles shots, and he/she still had shingles outbreaks. Th patient thought he/she would never suffer again. Then patient read up on it and further he/she stated if you have had chicken pox, you would get shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2826441 M KS 02/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
accidental administration of a dose of Kinrix to a 2 month old patient; This non-serious case was re... accidental administration of a dose of Kinrix to a 2 month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. On 23-JAN-2025, the patient received the 1st dose of Kinrix. On 23-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidental administration of a dose of Kinrix to a 2 month old patient). The outcome of the inappropriate age at vaccine administration was unknown. 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: 23-JAN-2025 A nurse reported that there was accidental administration of a dose of Kinrix to a 2 month old patient, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. More
2826442 U WA 02/17/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVA987A
Expired product administered Expired product administered
expired dose of Menveo administered to a patient.; This non-serious case was reported by a pharmaci... expired dose of Menveo administered to a patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA987A, expiry date 31-OCT-2024) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo administered to a patient.). The outcome of the expired vaccine used was unknown. Additional Information: GSK receipt date: 23-JAN-2025 Other HCP reported that in the clinic an expired dose of a Menveo two vial dose that was administered to a patient, which led to expired vaccine used. Reporter wanted to receive guidance on this topic. No vaccination date or patient demographics were provided. More
2826443 11 F IN 02/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 423nl
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient got her 2nd dose of Havrix too early; This non-serious case was reported by a other health p... patient got her 2nd dose of Havrix too early; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 11-year-old female patient who received HAV (Havrix 720) (batch number 423nl, expiry date 16-NOV-2025) for prophylaxis. Previously administered products included Havrix 720 (received 1st dose of Havrix vaccine on 16-OCT-2024). On 22-JAN-2025, the patient received the 2nd dose of Havrix 720. On 22-JAN-2025, an unknown time after receiving Havrix 720, the patient experienced drug dose administration interval too short (Verbatim: patient got her 2nd dose of Havrix too early). The outcome of the drug dose administration interval too short was unknown. 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: 23-JAN-2025 The reporter reported that patient got her 2nd dose of Havrix too early, which led to drug dose administration interval too short. 1st dose was administered on 16-OCT-2024. Second dose was administered 22-JAN-2025. More
2826444 0.67 F AR 02/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 PE9G5
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
received an Adult Hep B vaccine instead of the pediatric dosage; received an Adult Hep B vaccine ins... received an Adult Hep B vaccine instead of the pediatric dosage; received an Adult Hep B vaccine instead of the pediatric dosage; 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 8-month-old female patient who received HBV (Engerix B adult) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis. Previously administered products included Engerix B adult (received 1st dose of Engerix B adult on unknown date) and Engerix B adult (received 2nd dose of Engerix B adult on unknown date). On 23-JAN-2025, the patient received the 3rd dose of Engerix B adult. On 23-JAN-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: received an Adult Hep B vaccine instead of the pediatric dosage) and overdose (Verbatim: received an Adult Hep B vaccine instead of the pediatric dosage). The outcome of the adult product administered to child and overdose were unknown. 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: 23-JAN-2025 The reporter reported that a patient received an Adult Hepatitis B vaccine instead of the pediatric dosage, which led to adult product administered to child and overdose. Consented to follow up. More
2826445 69 M CA 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Possible late second dose; This non-serious case was reported by a other health professional via cal... Possible late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 02-FEB-2024 with batch number J294K). On 23-JAN-2025, the patient received the 2nd dose of Shingrix. On 23-JAN-2025, 356 days after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Possible late second dose). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that the possible administration of a 3rd dose of Shingrix to a patient who does not remember receiving a 2nd dose of Shingrix, which led to extra dose administered. The manager stated that they needed data about the indication from GlaxoSmithKline. After the call, they stated that if the second dose had not been given, this would possibly qualify as a late second dose. As neither the patient nor the healthcare professional can clarify if the dose was given or not, a possible. More
2826446 6 F NE 02/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 9R5LC
Expired product administered Expired product administered
administered a dose of Havrix which had a November 2024 expiration date; This non-serious case was r... administered a dose of Havrix which had a November 2024 expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis. Previously administered products included Havrix (1st dose on unknown date). On 23-JAN-2025, the patient received the 2nd dose of Havrix. On 23-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Havrix which had a November 2024 expiration date). The outcome of the expired vaccine used was unknown. 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-JAN-2025 Other HCP reported that a 6 year old female patient was administered a dose of Havrix which had a November 2024 expiration date, which led to expired vaccine used. Reporter stated that this was the patient's second dose in the series. Also, at the time of reporting, a repeat dose has not been administered. More
2826447 U 02/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
the patient had not received the 2nd dose yet; This non-serious case was reported by a pharmacist vi... the patient had not 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 patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose 6 months 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 had not received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown. 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-JAN-2025 A pharmacist called to informed that the patient got the 1st dose 6 months ago and at the moment of the call, the patient had not received the 2nd dose yet. The reporter did not agree to disclose any more information about the adverse event than the one present in this report and refused follow up by the team. Till the time of reporting, the patient did not receive 2nd dose of Twinrix which led to incomplete course of vaccination. More
2826448 25 F NY 02/17/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9PT2F
Underdose Underdose
they gave a dose of Infanrix to a 25 year old patient; This non-serious case was reported by a physi... they gave a dose of Infanrix to a 25 year old patient; 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 25-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis. Previously administered products included Tetanus Diphtheria and Pertussis vaccine (received vaccine on 29-OCT-2011 with batch number AC528067BA). On 24-JAN-2025, the patient received Infanrix. On 24-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: they gave a dose of Infanrix to a 25 year old patient). The outcome of the inappropriate age at vaccine administration was unknown. 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-JAN-2025 Information received via Web Chat. The physician explained they gave a dose of Infanrix to a 25 year old patient on 24th January 2025 which led to inappropriate age at vaccine administration. The reporter mentioned that patient received a shot of Tetanus, Diphtheria, and Pertussis vaccine back on 29th October 2011 (they did not know the brand name, the only information was lot AC528067BA, GlaxoSmithKline). More
2826449 M TX 02/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2553
Inappropriate schedule of product administration Inappropriate schedule of product administration
given a third dose of TWINRIX too close together to second dose; This non-serious case was reported ... given a third dose of TWINRIX too close together to 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 short in a 30-year-old male patient who received HAB (Twinrix) (batch number 2553, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose on an unknown date). Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 09-SEP-2024, the patient received the 3rd dose of Twinrix. On 09-SEP-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: given a third dose of TWINRIX too close together to second dose). The outcome of the drug dose administration interval too short was unknown. 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-JAN-2025 The pharmacist reported that a patient was given a third dose of Twinrix too close together to second dose (one month apart), which led to drug dose administration interval too short. The vaccination date, vaccine detail and patient demographics were obtained during this call. No further information was provided from the pharmacist๏ฟฝs end. The vaccine administration facility was the same as primary reporter. More
2826450 F PA 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PC5Y3
Inappropriate schedule of product administration, Product preparation issue Inappropriate schedule of product administration, Product preparation issue
Administered vaccine reconstituted with sterile water; Administered vaccine reconstituted with steri... Administered vaccine reconstituted with sterile water; Administered vaccine reconstituted with sterile water; receveid 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number PC5Y3, expiry date 30-JAN-2027) for prophylaxis. Previously administered products included Shingrix (received 1st on 09-MAR-2024 with expiry date 2P5E9 and expiry date 18-APR-2026). On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 24-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered vaccine reconstituted with sterile water), inappropriate dose of vaccine administered (Verbatim: Administered vaccine reconstituted with sterile water) and drug dose administration interval too long (Verbatim: receveid 2nd dose). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were unknown. Additional Information: GSK Receipt Date: 24-JAN-2025 The nurse explained that on 24th January 2025 they administered a dose of Shingrix but the powder was diluted with sterile water instead of the adjuvant component provided by the manufacturer which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. More
2826451 82 F MD 02/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 95DB2
Expired product administered Expired product administered
patient received today an expired dose of Havrix; This non-serious case was reported by a other heal... patient received today an expired dose of Havrix; 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 82-year-old female patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. On 27-JAN-2025, the patient received Havrix. On 27-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient received today an expired dose of Havrix). The outcome of the expired vaccine used was unknown. 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-JAN-2025 Other HCP reported that a patient received an expired dose of Havrix, which led to expired vaccine used. The vaccine expired on 13th December, 2024. The HCP asked if the dose is considered valid. More
2826452 F AR 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
she had not received her second dose; This non-serious case was reported by a consumer via call cent... she had not received her second dose; This non-serious case was reported by a consumer 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 (patient received her first dose of Shingrix before the Covid-19 pandemic). 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: she had not received her second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK receipt date: 29-JAN-2025 Reporter was the patient who received her first dose of Shingrix before the Covid 19 pandemic. She has not received her second dose. More
2826453 U 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
pt got 1st shot 3 years ago; This non-serious case was reported by a other health professional via c... pt got 1st shot 3 years ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient got 1st shot 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: pt got 1st shot 3 years ago). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK receipt date: 29-JAN-2025 HCP reported that a patient got 1st shot 3 years ago. Also asked if they need to restart or finish up with 2nd dose. Till the time of reporting patient did not receive 2nd dose of shingrix which led to incomplete course of vaccination. More
2826454 F LA 02/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
the first dose was administered on June 28th 2024 and the 2nd dose on December 4th 2024.; This non-s... the first dose was administered on June 28th 2024 and the 2nd dose on December 4th 2024.; 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 35-year-old female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (Received 1st dose on 28 June 2024). On 04-DEC-2024, the patient received the 2nd dose of Engerix B. On 04-DEC-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: the first dose was administered on June 28th 2024 and the 2nd dose on December 4th 2024.). The outcome of the drug dose administration interval too long was unknown. 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: 30-JAN-2025 The reporter reported that a patient that came to receive the 3 dose of Engerix B, the first dose was administered on 28 June 2024 and the 2nd dose on 4 December 2024 which led to drug dose administration interval too long. The reporter want to know when the 3rd dose should be administered. More
2826455 U IN 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site pain Injection site pain
Pain on injection site/patient that experienced a lot of pain in the deltoid muscle; This non-seriou... Pain on injection site/patient that experienced a lot of pain in the deltoid muscle; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain 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 injection site pain (Verbatim: Pain on injection site/patient that experienced a lot of pain in the deltoid muscle). The outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK receipt date: 06-FEB-2025 The registered Nurse reported that they had a patient that experienced a lot of pain in the deltoid muscle. The reporter had a question can they administer the vaccine in the ventral gluteal area. No vaccination date, vaccine detail or patient demographics were provided from the registered nurse. More
2826456 F NJ 02/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not received a second dose yet; This non-serious case was reported by a nurse via call center re... has not received a second dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 38-year-old female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix-B (received 1st dose of vaccine in 2016). On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: has not received a second dose yet). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 Reporter called to report in 2016 a patient received a first dose of Engerix-B and has not received a second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination. More
2826457 43 F NY 02/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 K4JHJ
Underdose Underdose
pediatric dose of Engerix-B was administered to adult patient; Accidental underdose; This non-seriou... pediatric dose of Engerix-B was administered to adult patient; Accidental underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 43-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JHJ) for prophylaxis. On 06-FEB-2025, the patient received Engerix B pediatric. On 06-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Engerix-B was administered to adult patient) and accidental underdose (Verbatim: Accidental underdose). The outcome of the adult use of a child product and accidental underdose were unknown. 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: 06-FEB-2025 The reporter called to report that they accidentally administered a pediatric dose of Engerix-B to a female adult patient who is 43 years old which led to adult use of child product and underdose. The reporter enquired does the patient needs another dose for 20 years and older More
2826458 M VA 02/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Hepatitis B antibody negative Hepatitis B antibody negative
patient had a negative titer test; This non-serious case was reported by a physician via call center... patient had a negative titer test; This non-serious case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a adolescent male patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: patient had a negative titer test). The outcome of the therapy non-responder was unknown. 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: 07-FEB-2025 The patient had a negative titer test, so the physician asked us what was the appropriate booster volume dose for Engerix-B. During the call the health care professional informed that the patient complete their Engerix-B vaccine scheme as a child, but due to the titer negative test, they were looking for the appropriate Engerix-B booster volume dose. Health care professional mentioned that the patient had the titer test in 02-Oct-2024. We report this as an adverse event because the patient had a titer negative test, so can consider this as vaccine failure. More
2826459 11 F SD 02/17/2025 DTAP
DTAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 M52GG
Product administered to patient of inappropriate age, Wrong product administered... Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
1st Infanrix dose when she was 19 months and 29 days; 11-year-old a Dtap, the Infanrix, she should h... 1st Infanrix dose when she was 19 months and 29 days; 11-year-old a Dtap, the Infanrix, she should have gotten the Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number M52GG, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 06-FEB-2025, the patient received Infanrix. On an unknown date, the patient received the 1st dose of Infanrix and Boostrix. On 06-FEB-2025, an unknown time after receiving Infanrix and not applicable after receiving Infanrix and Boostrix, the patient experienced wrong vaccine administered (Verbatim: 11-year-old a Dtap, the Infanrix, she should have gotten the Boostrix). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: 1st Infanrix dose when she was 19 months and 29 days). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. 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: 07-FEB-2025 The health care professional mentioned that the patient received the 1st Infanrix dose when she was 19 months and 29 days, which led inappropriate age at vaccine administration. The nurse reported the patient received Dtap, the Infanrix, she should have gotten the Boostrix the Tdap, which led wrong vaccine administered. The reporter needs to know if she needs to be revaccinated or what recommendations. The reporter consented to follow up. More
2826460 F NH 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Feeling abnormal Feeling abnormal
Felt Horrible; This non-serious case was reported by a consumer via call center representative and d... Felt Horrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of feels awful in a elderly female 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 feels awful (Verbatim: Felt Horrible). The outcome of the feels awful was unknown. It was unknown if the reporter considered the feels awful to be related to Shingrix. It was unknown if the company considered the feels awful to be related to Shingrix. Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by patient itself. The patient felt horrible after receiving Shingrix. The patient could not elaborate on what she experienced as she could not remember but remembers only that she felt horrible. The patient could not remember when the first dose was given, but was schedule for the second dose on this day (07-February-2025). More
2826461 U MI 02/17/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Product preparation error; Product preparation error Product preparation error; Product preparation error
Arexvy reconstituted with a different diluent; Shingrix reconstituted with a different diluent; This... Arexvy reconstituted with a different diluent; Shingrix reconstituted with a different diluent; 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 patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Arexvy and Shingrix. On an unknown date, an unknown time after receiving Arexvy and not applicable after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Arexvy reconstituted with a different diluent) and wrong solution used in drug reconstitution (Verbatim: Shingrix reconstituted with a different diluent). The outcome of the wrong solution used in drug reconstitution and wrong solution used in drug reconstitution were unknown. Additional Information: GSK Receipt Date: 07-FEB-2025 Nurse reported that she realized that her staff has been using other diluents to reconstitute Shingrix and Arexvy vaccines, probably sterile water, which led wrong solution used in drug reconstitution. At the moment of the call, there was no patient information available. The reporter consented to follow up. More
2826463 59 F CT 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient who received her first dose of Shingrix in November 2023 and second dose in December 2024; T... patient who received her first dose of Shingrix in November 2023 and second dose in December 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix in November 2023). In DEC-2024, the patient received the 2nd dose of Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient who received her first dose of Shingrix in November 2023 and second dose in December 2024). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK receipt date: 12-FEB-2025 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2826464 U TN 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
patients received only adjuvant; patients received only adjuvant; This non-serious case was reported... patients received only adjuvant; patients received only adjuvant; This non-serious case was reported by a consumer via call center representative 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: patients received only adjuvant) and inappropriate dose of vaccine administered (Verbatim: patients received only adjuvant ). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 12-FEB-2025 Reporter stated that 3 doses of Shingrix were given in office without being reconstituted and wanted to know how to get adjuvant for their remaining 3 vials of Shingrix. The 3 patients received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2826472 26 F 02/17/2025 COVID19
 MODERNA
 808080301003
Dizziness, Injection site pain, Injection site reaction, Muscle twitching, Parae... Dizziness, Injection site pain, Injection site reaction, Muscle twitching, Paraesthesia More
Following immunization, my arm was more sore than usual than with other immunizations, I felt very l... Following immunization, my arm was more sore than usual than with other immunizations, I felt very light headed, and then a few days later started getting tingling in my feet and hands as well as muscle twitching at the site of injection as well as throughout my lower extremities. I plan to go see my provider. More
2826474 M IN 02/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received only first dose of Twinrix; This non-serious case was reported by a pharmacist via call cen... received only first 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 46-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (patient received the first dose of Twinrix on October 9, 2017 with batch no. L5SH5). 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 only first dose of Twinrix). The outcome of the incomplete course of vaccination was unknown. 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-JAN-2025 Other HCP reported that a 46 years old male patient received the first dose of Twinrix on October 9th, 2017. Reporter asked if the patient need to start over the series. Till the time of reporting patient did not receive 2nd dose of Twinrix which led to incomplete course of vaccination. More
2826475 U PA 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Headache, Nausea Chills, Headache, Nausea
Chills; Nausea; Headache; This non-serious case was reported by a physician via call center represen... Chills; Nausea; Headache; This non-serious case was reported by a physician via call center representative and described the occurrence of chills 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 chills (Verbatim: Chills), nausea (Verbatim: Nausea) and headache (Verbatim: Headache). The outcome of the chills, nausea and headache were unknown. It was unknown if the reporter considered the chills, nausea and headache to be related to Shingrix. It was unknown if the company considered the chills, nausea and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that the patient had adverse reactions to 1st dose of Shingrix and the symptoms included headache, nausea, and chills and wanted to knew if patient should be given the second dose More
2826476 F LA 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
the patient had not received the 2nd dose yet.; This non-serious case was reported by a pharmacist v... the patient had not 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 elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2020 batch number 5SB37 and expiry date 19-jun-22). 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: the patient had not received the 2nd dose yet.). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 12-FEB-2025 The patient received one dose of Shingrix. VAERS details reported for 1st dose of Shingrix. The reporter asked question did they need to restart it? Reporter mentioned that at the time of reporting, the patient had not received the 2nd dose yet, which led incomplete course of vaccination. The reporter consented to follow up. More
2826508 0.25 F 02/17/2025 DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
MMR
MMR
PNC13
PNC13
RV1
RV1
UNK
UNK
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A vir... Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative; SARS-CoV-2 test negative; Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative; SARS-CoV-2 test negative; Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative; SARS-CoV-2 test negative; Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative; SARS-CoV-2 test negative; Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative; SARS-CoV-2 test negative; Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative; SARS-CoV-2 test negative; Blood culture negative, Culture stool negative, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative; SARS-CoV-2 test negative More
Acute Gastroenteritis; This 14-month-old female subject was enrolled in a study. The subject receive... Acute Gastroenteritis; This 14-month-old female subject was enrolled in a study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 13-APR-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 13-SEP-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 07-JUL-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 13-SEP-2022, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 13-APR-2023, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 13-APR-2023, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 15-JUN-2023 08:00, 63 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 275 days after receiving Hiberix and DTPa-HBV-IPV and 343 days after receiving Rotarix lyophilized formulation, the subject developed mild - grade 1 acute gastroenteritis (Verbatim: Acute Gastroenteritis). Serious criteria included hospitalization. The subject was treated with saline and famotidine (Pepcid). The outcome of acute gastroenteritis was resolved on 19-JUN-2023 09:00. Relevant Tests: The subject underwent to the following: On 15JUN2023, Stool Culture was Negative On 15JUN2023, Blood Culture was Negative On 15JUN2023, Sars-Cov-2AG was Nonreactive On 15JUN2023, Flu A was Negative On 15JUN2023, Flu B was Negative.. The investigator considered that there was no reasonable possibility that the acute gastroenteritis may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation, DTPa-HBV-IPV, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the acute gastroenteritis may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation, DTPa-HBV-IPV, M-M-R II and Varivax. Linked case(s) involving the same subject: US2023065422, US2023148628 GSK receipt date: 29-AUG-2023, 01-SEP-2023 SAE 15JUN2023: The SAE started on 15 Jun 2023. The subject's mother took the subject to the hospital and the subject was hospitalized. Admitted due to Acute Gastroenteritis. The subject was administered with Probiotics, Pepcid and saline solution. 19JUN2023: The subject was discharge on 19JUN2023 with a good prognosis. Subject recovered without sequelae. The SAE is not related to the study vaccine. The subject received treatment medication Probiotics from 15-JUN-2023 to 19-JUN-2023, unknown dose and frequency for the Indication of Acute Gastroenteritis orally. Follow-up information received on 11-SEP-2023 Summary of changes: Type of drug updated from concomitant to treatment. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix from 125347 to World-INV, Rotarix lyophilized formulation from 125265 to World-INV, DTPa-HBV-IPV updated to World-INV, Prevenar 13 updated to World-INV. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Start date, dose number and time to onset for suspect vaccines Bexsero vs Placebo, Prevenar 13 and DTPa-HBV-IPV were updated, Suspect vaccines M-M-R II and Varivax were updated.; Sender's Comments: A case of Gastroenteritis, 63 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 275 days after receiving Hiberix and DTPa-HBV-IPV and 343 days after receiving Rotarix lyophilized formulation, in a 14-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. US-GSK-US2023148628: US-GSK-US2023065422: More
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2826509 U 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Pain in extremity, Pruritus Erythema, Pain in extremity, Pruritus
my arm is still sore; itchy; red pattern; This non-serious case was reported by a consumer and descr... my arm is still sore; itchy; red pattern; This non-serious case was reported by a consumer and described the occurrence of pain in arm 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 pain in arm (Verbatim: my arm is still sore), itchy upper limbs (Verbatim: itchy) and erythema (Verbatim: red pattern). The outcome of the pain in arm, itchy upper limbs and erythema were not resolved. It was unknown if the reporter considered the pain in arm, itchy upper limbs and erythema to be related to Shingrix. It was unknown if the company considered the pain in arm, itchy upper limbs and erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2025 Reporter reported that he/she could not believed his/her arm was still sore and itchy after shingles vaccination. It had been 12 days now. It was not swollen but he/she could see the red pattern when he/she came out of the shower. More
2826510 U 02/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
White blood cell count increased White blood cell count increased
My white blood count is elevated; This non-serious case was reported by a consumer via interactive d... My white blood count is elevated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of white blood cell count increased 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 white blood cell count increased (Verbatim: My white blood count is elevated). The outcome of the white blood cell count increased was not reported. It was unknown if the reporter considered the white blood cell count increased to be related to Shingles vaccine. It was unknown if the company considered the white blood cell count increased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-FEB-2025 This case was reported by a patient via interactive digital media. The patient just got first dose shingles vaccine and had a blood test done and white blood count was elevated. The reporter wanted to ask if the vaccine could cause this or not. More
2826511 F AL 02/17/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Extra dose administered Extra dose administered
a patient received an extra MemB (Bexsero); This non-serious case was reported by a nurse via call c... a patient received an extra MemB (Bexsero); This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 20-NOV-2027) for prophylaxis. Previously administered products included Bexsero (received 1st dose of Bexsero vaccine on 15-MAR-2023) and Bexsero (received 2nd dose of Bexsero vaccine on 18-APR-2023). On 08-JAN-2025, the patient received the 3rd dose of Bexsero. On 08-JAN-2025, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: a patient received an extra MemB (Bexsero)). The outcome of the extra dose administered was unknown. 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-JAN-2025 The reporter reported that a patient received an extra dose of Bexsero vaccine, which led to extra dose administered. The Vaccine Administration Facility is the same as Primary Reporter. The 1st dose was received on 15-Mar-2023, 2nd dose was received on 18-Apr-2023 and 3rd dose was received on 08-Jan-2025. More
2826512 0.33 F FL 02/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
Wrong product administered Wrong product administered
Wrong Vaccine Administered; This non-serious case was reported by a other health professional via ca... Wrong Vaccine Administered; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Engerix B (received a dose of Engerix B vaccine on 02-SEP-2024). On 06-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Pediarix. On 06-JAN-2025, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: Wrong Vaccine Administered). The outcome of the wrong vaccine administered was unknown. 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-JAN-2025 The Healthcare professional reported that a 4 month old patient was administered Kinrix instead of Pediarix on January 6, 2025, which led to wrong vaccine administered. The patient was administered Engerix-B at birth. More
2826513 F 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Burning sensation, Erythema, Pruritus Burning sensation, Erythema, Pruritus
She experienced itchiness; redness; burning on the left arm; This non-serious case was reported by a... She experienced itchiness; redness; burning on the left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose of shingrix on an unknown date). In JAN-2025, the patient received the 2nd dose of Shingrix (left arm). In JAN-2025, 24 hrs after receiving Shingrix, the patient experienced pruritus (Verbatim: She experienced itchiness), erythema (Verbatim: redness) and burning sensation (Verbatim: burning on the left arm). The patient was treated with acrivastine (Benadryl). (Dechallenge was positive). Rechallenge with Shingrix was positive. The outcome of the pruritus was resolved and the outcome of the erythema and burning sensation were not resolved. It was unknown if the reporter considered the pruritus, erythema and burning sensation to be related to Shingrix. It was unknown if the company considered the pruritus, erythema and burning sensation to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2025 Reporter was the patient who received her second dose of SHINGRIX about 2 and a half days ago. She experienced itchiness, redness, and burning on the left arm. Patient received the dose on her left arm as well. The itching started about 24 hours after the dose and had resolved. The redness started within 48 hours and was still present. It was about 5 inches by 1 inches long. She took one dose of Benadryl last night. More
2826514 0.17 F TX 02/17/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Wrong administration route; This non-serious case was reported by a other health professional via ca... Wrong administration route; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis. On 16-JAN-2025, the patient received Rotarix lyophilized formulation. On 16-JAN-2025, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Wrong administration route). The outcome of the inappropriate route of vaccination was unknown. 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-JAN-2025 A medical assistant called and reported that they gave out a Rotarix lyophilized to a 2 month old baby, instead of an oral administration, they injected the medication which led to inappropriate route of vaccination. It was given in the left thigh, instead of oral. The vaccine administration facility is the same as primary reporter. During the call, the healthcare professional did not provide any lot number nor expiry date, however, she said that this was the Rotarix lyophilized version. More
2826515 5 M CT 02/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 DN273
Inappropriate schedule of product administration Inappropriate schedule of product administration
got second dose prior to the recommended six months; This non-serious case was reported by a nurse v... got second dose prior to the recommended six months; 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 5-year-old male patient who received HAV (Havrix) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis. Previously administered products included Havrix (recived 1st dose on 29-JUL-2024 with batch number: LM99N and expiry date: 04-MAR-2026). On 17-JAN-2025, the patient received the 2nd dose of Havrix. On 17-JAN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: got second dose prior to the recommended six months). The outcome of the drug dose administration interval too short was unknown. Additional Information: GSK receipt date: 21-JAN-2025 The licensed practitioner nurse reported that they administered to a Havrix vaccine, then 4 years old child, who was now 5 years old, roughly 10 days prior to the six months, prior to the recommended six months. The reporter had a question for second dose, and she just wanted to know was that an issue and did the patient need to be revaccinated. The patient received 2nd dose of Havrix vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled. More
2826516 0.17 F PA 02/17/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 AE2J7
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administration of Flulaval to a 2 month old baby; This non-serious case was reported by a nurse via ... administration of Flulaval to a 2 month old baby; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AE2J7, expiry date 16-JUN-2025) for prophylaxis. On 20-JAN-2025, the patient received FluLaval 2024-2025 season. On 20-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Flulaval to a 2 month old baby). The outcome of the inappropriate age at vaccine administration was unknown. 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-JAN-2025 A nurse called to report the administration of Flulaval to a 2 month old patient which led inappropriate age at vaccine administration. The reporter consented to follow up. More
2826517 F FL 02/17/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Cancer surgery Cancer surgery
just have surgery to remove cancer; This serious case was reported by a pharmacist via call center r... just have surgery to remove cancer; This serious case was reported by a pharmacist via call center representative and described the occurrence of cancer surgery in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included immunocompromised. On 18-SEP-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cancer surgery (Verbatim: just have surgery to remove cancer) (serious criteria clinically significant/intervention required). The outcome of the cancer surgery was not reported. It was unknown if the reporter considered the cancer surgery to be related to Arexvy. The company considered the cancer surgery to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 03-FEB-2025 The registered pharmacist reported that they had a patient that was severely immunocompromised on radiation and chemotherapy and just had surgery to remove cancer and had her 1st dose for Arexvy back in 2023. The reporter asked could she get another dose and stated that she was not sure that at the moment of the 1st dose if the patient was already immunocompromised The reporter requested for the information to see if the patient was eligible for a 2nd dose. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: Cancer surgery is an unlisted event which is considered unrelated to GSK vaccine Arexvy. More
2826518 U GA 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Mycobacterium avium complex infection Mycobacterium avium complex infection
she has been just diagnosed with MAC; This serious case was reported by a pharmacist via call center... she has been just diagnosed with MAC; This serious case was reported by a pharmacist via call center representative and described the occurrence of mycobacterium avium complex infection in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced mycobacterium avium complex infection (Verbatim: she has been just diagnosed with MAC) (serious criteria GSK medically significant). The patient was treated with rifampin and ethambutol. The outcome of the mycobacterium avium complex infection was unknown. It was unknown if the reporter considered the mycobacterium avium complex infection to be related to Shingrix. It was unknown if the company considered the mycobacterium avium complex infection to be related to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The reporter had a patient who wanted to take Shingrix but had just been diagnosed with mycobacterium avium complex infection and was on rifampin and ethambutol. They didn't know if it was a good idea since this had just started. This was to be the second dose. She had received the first dose in October 2024. During the chat, the HCP asked if it was possible to administer the second Shingrix dose to the patient. The HCP mentioned that the first dose was in October 2024 but did not specify the date. They set this as 01-Oct-2024 because the system does not allow setting only the month and year.; Sender's Comments: Mycobacterium avium complex infection is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2826519 M CA 02/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never received his second dose; This non-serious case was reported by a pharmacist via call center r... never received his 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 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose on an unknown date). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received his second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 The primary reporter was the Health Care Professional (pharmacist) who stated that a patient received his first dose of shingrix vaccine more than 6 months ago and never received his second dose, which led to incomplete course of vaccination. This case is linked with US2025015904 reported by the same reporter.; Sender's Comments: US-GSK-US2025015904:Same reporter More
2826520 M WV 02/17/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 4293K
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration before the recommended age for a booster; This non-serious case was reported by a nur... Administration before the recommended age for a booster; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 4293K, expiry date 31-JUL-2025) for prophylaxis. Previously administered products included Menveo (received 1st dose on an unknown date). On 08-AUG-2024, the patient received the 2nd dose of Menveo. On 08-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration before the recommended age for a booster). The outcome of the inappropriate age at vaccine administration was unknown. Additional Information: GSK Receipt Date: 11-FEB-2025 A registered nurse contacted GSK to request data about the administration of a second dose of Menveo to a 12 year old male patient which took place on 8th August 2024, months after the initial dose which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. More
2826521 U MS 02/17/2025 DTAP
DTAPIPV
HIBV
MNQ
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS




Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
RN requests stability data for Menveo (1-vial), Kinrix, Infanrix, Hiberix, Rotarix (liq) stored; Thi... RN requests stability data for Menveo (1-vial), Kinrix, Infanrix, Hiberix, Rotarix (liq) stored; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Hib (Hiberix) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis. On an unknown date, the patient received Menveo, Kinrix, Infanrix, Hiberix and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Menveo, Kinrix, Infanrix, Hiberix and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: RN requests stability data for Menveo (1-vial), Kinrix, Infanrix, Hiberix, Rotarix (liq) stored). The outcome of the incorrect storage of drug was unknown. 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: 11-FEB-2025 The register nurse requested stability data for Menveo (1-vial), Kinrix, Infanrix, Hiberix, Rotarix (liq) stored at negative 17 degree Fahrenheit for 30 days which led to incorrect storage of drug. The vaccines had been used in patients during this time as they were not frozen. The patient data was not available at time of call. More
2826522 16 F CO 02/17/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMXB056A
Product preparation issue Product preparation issue
administration of the diluent portion only of Menveo (2-vial) vaccine; administration of the diluent... administration of the diluent portion only of Menveo (2-vial) vaccine; administration of the diluent portion only of Menveo (2-vial) vaccine; 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 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXB056A, expiry date 31-DEC-2026) for prophylaxis. On 12-FEB-2025, the patient received Menveo. On 12-FEB-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administration of the diluent portion only of Menveo (2-vial) vaccine) and inappropriate dose of vaccine administered (Verbatim: administration of the diluent portion only of Menveo (2-vial) vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 12-FEB-2025 The health care professional reported that the inadvertent administration of the diluent portion only of Menveo (2-vial) vaccine to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
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