🏥 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 💀 🏥 🚑 ♿ ⚠️
2850177 F 07/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Underdose Underdose
Administered pediatric Engerix-B dose to a 20 year old patient; Administered pediatric Engerix-B dos... Administered pediatric Engerix-B dose to a 20 year old patient; Administered pediatric Engerix-B dose to a 20 year old patient; This non-serious case was reported by a physician via sales rep and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received the 1st dose of Engerix B pediatric (unknown arm). On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Administered pediatric Engerix-B dose to a 20 year old patient) and underdose (Verbatim: Administered pediatric Engerix-B dose to a 20 year old patient). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 10-JUL-2025 The physician reported that they administered pediatric Engerix-B dose to a 20-year-old patient, which led to adult use of a child product and underdose More
2850178 F 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza like illness, Malaise, Pain Influenza like illness, Malaise, Pain
flu like symptoms; malaise; ache/ Pain; This non-serious case was reported by a consumer via call ce... flu like symptoms; malaise; ache/ Pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 27-JUN-2025, the patient received the 1st dose of Shingrix. In JUN-2025, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), malaise (Verbatim: malaise) and pain (Verbatim: ache/ Pain). The outcome of the influenza-like symptoms, malaise and pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, malaise and pain to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms, malaise and pain to be related to Shingrix. Additional Information: GSK receipt date: 15-JUL-2025 The reporter was the patient who received her first dose of Shingrix and 12 hours after the dose, she experienced flu like symptoms, malaise, aches and pain. She wished to remain anonymous. More
2850179 07/17/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Sore especially the shoulder; Arm pain; You won't feel like swimming; This non-serious case was... Sore especially the shoulder; Arm pain; You won't feel like swimming; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced shoulder soreness (Verbatim: Sore especially the shoulder), pain in arm (Verbatim: Arm pain) and feeling abnormal (Verbatim: You won't feel like swimming). The outcome of the shoulder soreness, pain in arm and feeling abnormal were resolving. It was unknown if the reporter considered the shoulder soreness, pain in arm and feeling abnormal to be related to RSV vaccine. It was unknown if the company considered the shoulder soreness, pain in arm and feeling abnormal to be related to RSV vaccine. Additional Information: GSK receipt date: 07-JUL-2025 This case was reported by a patient via interactive digital media. Patient just had the vaccine and stated that there were some effects. Indicated that you won't feel like swimming, the arm they stick will be sore especially the shoulder. After 4 days still sore but patient was feeling better. Also stated it protects immune and respiratory system. More
2850180 NH 07/17/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administered priorix (in error) 1 year after receiving a dose of priorix; This non-serious case was ... administered priorix (in error) 1 year after receiving a dose of priorix; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-year-old patient who received MMR (Priorix) for prophylaxis. Previously administered products included Priorix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered priorix (in error) 1 year after receiving a dose of priorix). 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: 09-JUL-2025 The nurse reported that she was seeking some literature to provide to her corporate team about the potential side effects to a patient 5 years old who was administered Priorix vaccine in error 1 year after receiving a dose of Priorix, which led to inappropriate age at vaccine administration. More
2850181 07/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Asthenia, Herpes zoster, Vaccination failure, Vertigo; Asthenia, Herpes zoster, ... Asthenia, Herpes zoster, Vaccination failure, Vertigo; Asthenia, Herpes zoster, Vaccination failure, Vertigo More
Suspected vaccination failure; vertigo; weakness; still contracted the shingles / Mine was on my sca... Suspected vaccination failure; vertigo; weakness; still contracted the shingles / Mine was on my scalp, neck and chin; 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), shingles (Verbatim: still contracted the shingles / Mine was on my scalp, neck and chin), vertigo (Verbatim: vertigo) and weakness (Verbatim: weakness). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 13 weeks) and the outcome of the vertigo and weakness were not resolved. It was unknown if the reporter considered the vaccination failure, shingles, vertigo and weakness 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, vertigo and weakness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 10-JUL-2025 This case was reported by a patient via interactive digital media. The patient did get all the vaccines and still contracted the shingles which was located on the scalp, neck and chin and it lasted about thirteen weeks and the patient still having aftereffects. The patient would like to hear from anyone else that has experienced a similar situation. The patient went through two rounds of Valtrex, and I'm still having problems with vertigo and weakness. 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 completion of primary vaccination schedule, time to onset and regarding laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2). More
2850182 1 OK 07/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 4T93R
Extra dose administered, Product administered to patient of inappropriate age Extra dose administered, Product administered to patient of inappropriate age
adult dose of Harvix to a 19-Month-Old pediatric patient; adult dose of Harvix to a 19-Month-Old ped... adult dose of Harvix to a 19-Month-Old pediatric patient; adult dose of Harvix to a 19-Month-Old pediatric patient; patient received 3 doses of Harvix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 18-month-old patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. Previously administered products included Havrix (Upon review two other doses were also given (1st on unknown date)) and Havrix (Upon review two other doses were also given (2nd on unknown date)). On 20-JUN-2025, the patient received Havrix 1440 adult. On 20-JUN-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: adult dose of Harvix to a 19-Month-Old pediatric patient), overdose (Verbatim: adult dose of Harvix to a 19-Month-Old pediatric patient) and extra dose administered (Verbatim: patient received 3 doses of Harvix). The outcome of the adult product administered to child, overdose and extra dose administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 07-JUL-2025 Other HCP reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old) which led to adult product administered to child and overdose and extra dose administered. Also asked if that dose was valid or not. Any side effects need to advise the parents of as well. Upon review two other doses were also given. This case is 1 of 3 cases reported by same reporter.; Sender's Comments: US-GSK-US2025087636:Same reporter/Diffrent patient GSK-US2025087634:Same reporter/Diffrent patient More
2850183 M FL 07/17/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 955E2
Antibody test negative Antibody test negative
doctor did the titer to see how it took, it revealed he didn't take it; This non-serious case w... doctor did the titer to see how it took, it revealed he didn't take it; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in an adult male patient who received MMR (Priorix) (batch number 955E2, expiry date 13-SEP-2026) for prophylaxis. On 02-MAY-2025, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: doctor did the titer to see how it took, it revealed he didn't take it). The outcome of the therapy non-responder 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: 09-JUL-2025 Pharmacist reported that he had an adult patient who got a vaccine, the Priorix back in May and when the doctor did the titer to see how it took. it revealed he didn't take it, and the patient wanted to know if they can get another vaccine. The reporter was trying to look at up in the literature and it did not really address, giving a second dose of this. And as a rule, you can, you know, usually an extra immunization is usually fine, but the reporter couldn't find out spelled out in the literature; no one had specifically asked him/her about this scenario, so, wondered if you that made the product, was there any unforeseen issues with doing that. More
2850184 14 F TX 07/17/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 343DD
Inappropriate schedule of product administration Inappropriate schedule of product administration
Early Dose; This non-serious case was reported by a other health professional via call center repres... Early Dose; 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 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 343DD, expiry date 30-APR-2026) for prophylaxis. Previously administered products included Menveo (first dose was given 3 years ago). On 10-JUL-2025, the patient received the 2nd dose of Menveo. On 10-JUL-2025, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too short (Verbatim: Early Dose). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 10-JUL-2025 The reporter reported that a patient that was fourteen and she received her second Menveo vaccine on the day of reporting. The one prior to that was given three years ago, so, the reporter wanted to know was ok if it was given three years in between but the reporter want to know if it did it need to be repeated at age sixteen like, would the second one count, because it was not 5 years apart. The healthcare professional stated that the first dose was given on the day of reporting and the patient first dose was given 3 years ago. The booster was given in less than recommended of 4 years which led to shortening of vaccination schedule. More
2850185 2 07/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administered adult Havrix to 2-year-old; administered adult Havrix to 2-year-old; This non-serious c... administered adult Havrix to 2-year-old; administered adult Havrix to 2-year-old; 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 2-year-old patient who received HAV (Havrix adult) for prophylaxis. On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: administered adult Havrix to 2-year-old) and overdose (Verbatim: administered adult Havrix to 2-year-old). The outcome of the adult product administered to child and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-OCT-2023 The nurse reported that they administered adult Havrix vaccine to 2-year-old, which led to adult product administered to child and overdose. More
2850186 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
1st shot in 2021; This non-serious case was reported by a other health professional via call center ... 1st shot in 2021; 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 did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in 2021). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st shot in 2021). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 18-JAN-2024 The patient had 1st shot in 2021 and asked if she need to restart series. No other information provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2850187 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient who got 1st dose in May 2021, then 2nd dose in Oct 2023; This non-serious case was reported ... patient who got 1st dose in May 2021, then 2nd dose in Oct 2023; 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 long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in May 2021). In OCT-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient who got 1st dose in May 2021, then 2nd dose in Oct 2023). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 24-APR-2024 The reporter reported that the patient who got 1st dose in May 2021, then 2nd dose in October 2023. The patient thought that she needed to get a new series, but registered pharmacist did not think she needed one. The patient received the 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. More
2850188 KS 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Shingrix third dose administered; This non-serious case was reported by a consumer via sales rep and... Shingrix third dose administered; This non-serious case was reported by a consumer via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 2 doses in 2019). On 14-JUL-2025, the patient received the 3rd dose of Shingrix. On 14-JUL-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix third dose administered). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 14-JUL-2025 The reporter reported that a patient completed 2 doses of Shingrix in 2019 and vaccine coordinator accidentally gave patient 3rd dose of Shingrix today, which led to extra dose administered. More
2850189 1.25 M MI 07/17/2025 HIBV
 SANOFI PASTEUR
 UK169A
Product preparation error Product preparation error
acthib that was reconstituted with sterile water, a diluent from another vaccine, and it was adminis... acthib that was reconstituted with sterile water, a diluent from another vaccine, and it was administered to a patient with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient received HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with sterile water, a diluent from another vaccine, and it was administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine for Immunisation. On 10-Jul-2025, the patient received dose 1 of 0.5 ml suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength, frequency once with lot UK169A and expiry date 28-Feb-2026 via intramuscular route in the right thigh for immunisation that was reconstituted with sterile water, a diluent from another vaccine, and it was administered to a patient with no reported adverse event (product preparation error) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2850190 0.33 M CA 07/17/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK233AC
No adverse event, Product preparation error No adverse event, Product preparation error
reconstituted PENTACEL with a sterile diluent (water) with no reported adverse event; Initial inform... reconstituted PENTACEL with a sterile diluent (water) with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] reconstituted with a sterile diluent (water) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included rotavirus vaccine and pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20), both for Immunisation. On 10-Jul-2025, the patient received Dose 2 of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength, frequency once with lot UK233AC and expiry date 31-Aug-2026 via intramuscular route in the right thigh for Immunization reconstituted with a sterile diluent (water) with no reported adverse event (product preparation error) (Latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2850191 0.33 M CA 07/17/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK233AC
No adverse event, Product preparation error No adverse event, Product preparation error
Medical Assistants reconstituted PENTACEL with a sterile diluent (water) with no adverse event; Init... Medical Assistants reconstituted PENTACEL with a sterile diluent (water) with no adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient for whom medical assistants reconstituted Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile diluent (water) with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 10-Jul-2025, the patient received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine dose 0.5 ml 1x(once) Powder and suspension for suspension for injection (strength standard) lot UK233AC expiry date-31-Aug-2026 via intramuscular route in the right thigh for Immunization and medical assistants reconstituted pentacel with a sterile diluent (water) with no adverse event (product preparation error) (latency same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2850192 17 M CA 07/17/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Y009051
A5AD4
EK7DG
Syncope; Syncope; Syncope Syncope; Syncope; Syncope
Patient was seen for an immunization appointment. After receiving the HPV vaccine and band-aid appl... Patient was seen for an immunization appointment. After receiving the HPV vaccine and band-aid application, patient had a syncopy event that lasted approximately less than 60 seconds. RN was immediately called for assistance. Patient was easily aroused by verbal command. Vitals signs were obtained and observed as follows: BP-78/46, HR- 46, 02-97,T-98.4, Resp-18, Pain-0, Wt-111 . Vital signs were captured every 5 minutes for three cycles. An EMS call was initiated. Upon arrival at approximately, 11:25am, EMS determined patient had a syncopy event, and was stable, however, mom requested patient be taken to the hospital for further evaluation. Patient was transported to Hospita More
2850193 0.5 M OR 07/17/2025 MMRV
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No adverse reactions noted, patient was not due for this vaccine, and it was administered. Patients ... No adverse reactions noted, patient was not due for this vaccine, and it was administered. Patients mother had to be contacted to inform of this, and that patient will be due until age one. Close attention to vaccines will be noted, appropriate time of scanning vaccines will be made, confirm vaccines with other medical staff will also be done and checking for recommended vaccines via database. More
2850194 54 F WI 07/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 EY57A
Syncope Syncope
Syncope after administration of vaccine lasting ~ 30 seconds. No injuries occurred, patient was able... Syncope after administration of vaccine lasting ~ 30 seconds. No injuries occurred, patient was able to walk out of the pharmacy without assistance More
2850195 91 F OR 07/17/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 012M20A
012M20A
002A21A
002A21A
Death, Dyspnoea, Electrocardiogram abnormal, Myocardial infarction, Myocardial i... Death, Dyspnoea, Electrocardiogram abnormal, Myocardial infarction, Myocardial injury; Troponin abnormal; Death, Dyspnoea, Electrocardiogram abnormal, Myocardial infarction, Myocardial injury; Troponin abnormal More
Patient had her initial vaccination on 2-25-2021. She had her second (booster) vaccination on 3-10-... Patient had her initial vaccination on 2-25-2021. She had her second (booster) vaccination on 3-10-2025 at approximately 1:00 pm. By 10:00 pm that evening she was having noticeable difficulty breathing which continued through the night. At approximately 6:00 a.m. on 3-11-2025 she was admitted to ER with an active myocardial infarction. Due to the damage in her heart, the only option for recovery was the insertion of a stent. The operation to insert the stent could not be completed and she had a second MI on 4-25-2021 and died on 4-26-2021. For her age, she was in excellent health and actively cared for both herself and two family members who lived with her. She had no cognitive issues and the only chronic condition she suffered from was atherosclerosis. I am finally reporting this event as I believe that, while she was at clear risk for an MI, the booster shot likely triggered the event, especially when the booster was givien in such close proximity to the original vaccination (14 days). More
✓ ✓
2850196 63 M TN 07/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Unevaluable event Unevaluable event
NO ADVERSE REACTIONS NOTED TO. NO ADVERSE REACTIONS NOTED TO.
2850197 56 F WA 07/17/2025 HEPAB
HEPAB
HEPAB
HEPAB
HEPAB
HEPAB
HEPAB
HEPAB
HEPAB
HEPAB
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 P2443
P2443
P2443
P2443
P2443
P2443
P2443
P2443
P2443
P2443
LN4930
LN4930
LN4930
LN4930
LN4930
LN4930
LN4930
LN4930
LN4930
LN4930
Alanine aminotransferase increased, Asthenia, Basophil count decreased, Basophil... Alanine aminotransferase increased, Asthenia, Basophil count decreased, Basophil percentage decreased, Blood albumin normal; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride increased, Blood creatinine normal; Blood glucose normal, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Blood urea normal; Carbon dioxide decreased, Carbon dioxide normal, Chest X-ray normal, Chest pain, Constipation; Dehydration, Dyspnoea, Eosinophil percentage decreased, Feeling hot, Haematocrit normal; Haemoglobin normal, Hyperhidrosis, Immature granulocyte count, Impaired work ability, Limb discomfort; Lymphocyte count normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal; Monocyte count normal, Monocyte percentage, Nausea, Neutrophil count increased, Neutrophil percentage increased; PCO2, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal; Red cell distribution width normal, Vomiting, White blood cell count increased, pH body fluid; Alanine aminotransferase increased, Asthenia, Basophil count decreased, Basophil percentage decreased, Blood albumin normal; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride increased, Blood creatinine normal; Blood glucose normal, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Blood urea normal; Carbon dioxide decreased, Carbon dioxide normal, Chest X-ray normal, Chest pain, Constipation; Dehydration, Dyspnoea, Eosinophil percentage decreased, Feeling hot, Haematocrit normal; Haemoglobin normal, Hyperhidrosis, Immature granulocyte count, Impaired work ability, Limb discomfort; Lymphocyte count normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal; Monocyte count normal, Monocyte percentage, Nausea, Neutrophil count increased, Neutrophil percentage increased; PCO2, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal; Red cell distribution width normal, Vomiting, White blood cell count increased, pH body fluid More
Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an ho... Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal. More
2850198 43 F OR 07/17/2025 MMR
 MERCK & CO. INC.
 Y010046
Inappropriate schedule of product administration Inappropriate schedule of product administration
MMR vaccine was administered early. 1st dose given 6/17/25. 2nd dose administered 7/8/25. MMR vaccine was administered early. 1st dose given 6/17/25. 2nd dose administered 7/8/25.
2850199 65 M 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster Herpes zoster
Contracted Shingles July 15, 2025. Treating with antivirals. Contracted Shingles July 15, 2025. Treating with antivirals.
2849823 50 VA 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles once afterwards and I now have it again; This serious case ... Suspected vaccination failure; shingles once afterwards and I now have it again; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles once afterwards and I now have it again). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JUL-2025 The patient self-reported this case for himself/herself. The patient had the Shingrix shots when he/she was 50 years old. The patient had shingles once afterwards and he/she now have it again. The patient wanted to know if he/she could receive the Shingrix shots again. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2849824 62 M MI 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Asthenia, Headache, Malaise, Nasal congestion Asthenia, Headache, Malaise, Nasal congestion
Headache; Weakness generalized; slight malaise; Nasal congestion; This non-serious case was reported... Headache; Weakness generalized; slight malaise; Nasal congestion; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on 27-JAN-2025, for tolerance of 1st dose of Shingrix, refer case US2025083753). On 23-JUN-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), weakness generalized (Verbatim: Weakness generalized), malaise (Verbatim: slight malaise) and nasal congestion (Verbatim: Nasal congestion). Rechallenge with Shingrix was positive. The outcome of the headache, weakness generalized, malaise and nasal congestion were resolved. It was unknown if the reporter considered the headache, weakness generalized, malaise and nasal congestion to be related to Shingrix. It was unknown if the company considered the headache, weakness generalized, malaise and nasal congestion to be related to Shingrix. Linked case(s) involving the same patient: US2025083753 Additional Information: GSK Receipt Date: 03-JUL-2025 The patient received Shingrix shot and he experienced slight malaise/weakness, headache, and some nasal congestion. These side effects were very minor compared to first Shingrix shot. These events resolved.; Sender's Comments: US-GSK-US2025083753:same patient/2nd dose More
2849825 CO 07/16/2025 COVID19
 PFIZER\BIONTECH
Cardiac disorder, Chest discomfort, Dyspnoea, Immune system disorder Cardiac disorder, Chest discomfort, Dyspnoea, Immune system disorder
chest, breathing and heart problems from a weakened immune system; chest, breathing and heart proble... chest, breathing and heart problems from a weakened immune system; chest, breathing and heart problems from a weakened immune system; chest, breathing and heart problems from a weakened immune system; my immune system was destroyed two years ago; This is a spontaneous report received from a Consumer or other non HCP. A patient in their 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autistic" (unspecified if ongoing); "flea bite" (unspecified if ongoing), notes: severely sick from being covered in flea bites; "severely sick" (unspecified if ongoing), notes: severely sick from being covered in flea bites; "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, batch/lot: FP7137, anatomical location: arm), administration date: Dec2022, for COVID-19 immunization, reaction(s): "Allergy", "Feeling sick", "Feeling sick"; Bnt162b2 (dose 2, batch/lot: FR2583, anatomical location: arm), administration date: 2023, for COVID-19 immunization, reaction(s): "Arthritis", "Autoimmune disorder", "Cardiac disorder NOS", "Decreased immune responsiveness", "Dyspnoea", "Fatigue extreme", "Allergic reaction", "Illness", "Activities of daily living impaired", "Muscle stiffness", "Myalgia", "Near death experience", "Cancer", "Ache", "Scar". The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2023, outcome "unknown", described as "my immune system was destroyed two years ago"; CHEST DISCOMFORT (non-serious), DYSPNOEA (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "chest, breathing and heart problems from a weakened immune system". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218909 Same patient, different vaccine dose and different event;US-PFIZER INC-202300218333 Same patient, different vaccine dose and different event; More
2849841 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Urticaria Urticaria
Hive reaction; This non-serious case was reported by a consumer and described the occurrence of hive... Hive reaction; This non-serious case was reported by a consumer and described the occurrence of hives 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 hives (Verbatim: Hive reaction). The outcome of the hives was not reported. It was unknown if the reporter considered the hives to be related to Shingrix. It was unknown if the company considered the hives to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2025 The Shingrix vaccine gave a hive reaction on the first dose, so he/she chose to skip the second dose. More
2849887 6 M TX 07/16/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
No symptoms reported at the time of the call/No additional AE; HBP called to report an inadvertent c... No symptoms reported at the time of the call/No additional AE; HBP called to report an inadvertent concomitant administration of VARIVAX and PROQUAD (in place of MMR II). Caller reported that a 6 year old male patient was administered VARIVAX and PROQUAD today, 6/25/2025. No symptoms reported at the time of the; PROQUAD (in place of MMR II); This spontaneous report was received from a medical assistant and refers to a(n) 6-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Jun-2025, the patient was inadvertent vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (formulation, lot #, expiration date, exact dose, route of administration and anatomical location were not reported); and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), formulation: injection 0.5 mL (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was administered in place of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (MMR II) (wrong vaccine administered). No symptoms reported at the time of the call (no adverse event). More
2849888 10 M MA 07/16/2025 HPV9
 MERCK & CO. INC.
Head injury, Loss of consciousness, Syncope Head injury, Loss of consciousness, Syncope
a 10 year old male patient was receiving his second dose of GARDASIL 9 on unknown date and had synco... a 10 year old male patient was receiving his second dose of GARDASIL 9 on unknown date and had syncope and passed out; a 10 year old male patient was receiving his second dose of GARDASIL 9 on unknown date and had syncope and passed out; Bump on the head; This spontaneous report was received from a Nurse referring to a 10-year-old male patient. The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) administered by Health Professional as prophylaxis (dose, route of administration, lot #, and expiration date were not reported). On an unknown date, the patient had syncope and passed out (syncope, loss of consciousness). He fell and hit his head and went to the emergency department (ER) (head injury). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown. Upon internal review, the events of syncope and loss of consciousness were determined to be medically significant. Lot # is being requested and will be submitted if received. More
2849889 17 AZ 07/16/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Incomplete course of vaccination; Incomplete course of vaccination Incomplete course of vaccination; Incomplete course of vaccination
HCP reporting missed dose for GARDASIL-9. A 32-year-old patient had 2 doses of GARDASIL-9 when they ... HCP reporting missed dose for GARDASIL-9. A 32-year-old patient had 2 doses of GARDASIL-9 when they were 17 years old and has not had their final dose. HCP did not provide any other information as they rushed to end the call. No additional AE/No PQC.; This spontaneous report was received from an other health professional and refers to a 32-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as when the patient was 17 years old), the patient was vaccinated with 2 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis and had not had the final dose (Inappropriate schedule of product administration). Additional information is not expected. More
2849890 F GA 07/16/2025 PNC21
 MERCK & CO. INC.
 Z004301
Cellulitis, Fatigue, Injection site reaction, Pyrexia Cellulitis, Fatigue, Injection site reaction, Pyrexia
cellulitis; injection site reaction; This spontaneous report was received from a Physician and refer... cellulitis; injection site reaction; This spontaneous report was received from a Physician and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-Jul-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Z004301, expiration date: 07-Sep-2026), dose was not provided for prophylaxis. On 07-Jul-2025, the patient experienced injection site reaction site with fever and fatigue. Patient was admitted to the hospital with cellulitis. At the reporting time, the outcome of cellulitis and injection site reaction was unknown. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of cellulitis and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of injection site reaction and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. More
✓
2849891 WI 07/16/2025 HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.

Underdose; Underdose Underdose; Underdose
no additional AE; HCP reports pediatric (0.5ml) dose of RECOMBIVAX HB was inadvertently given to an ... no additional AE; HCP reports pediatric (0.5ml) dose of RECOMBIVAX HB was inadvertently given to an adult patient today 07/15/2025.; This spontaneous report has been received from a medical assistant and refers to an adult (exact age was not provided) patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On an unknown date in June 2025, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) suspension for injection, 1 ml (adult dose) (route of administration, anatomical location, lot# and expiry date were not provided), for prophylaxis. On 15-JUL-2025, the patient was inadvertently vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB), 0.5 ml (pediatric dose) (Accidental underdose). No additional adverse event was provided. Lot# is being requested and will be submitted if received. More
2849892 61 M MI 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza like illness, Injection site pain, Therapeutic response unexpected Influenza like illness, Injection site pain, Therapeutic response unexpected
soreness of injected arm; Sinus infection; flu-like symptoms; Unexpected therapeutic benefit; This n... soreness of injected arm; Sinus infection; flu-like symptoms; Unexpected therapeutic benefit; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On 27-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness of injected arm), sinus infection (Verbatim: Sinus infection), influenza-like symptoms (Verbatim: flu-like symptoms) and unexpected therapeutic effect (Verbatim: Unexpected therapeutic benefit). The outcome of the injection site pain, sinus infection and influenza-like symptoms were resolved and the outcome of the unexpected therapeutic effect was not applicable. It was unknown if the reporter considered the injection site pain, sinus infection and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the injection site pain, sinus infection and influenza-like symptoms to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR089300 Additional Information: GSK Receipt Date: 03-JUL-2025 The reporter was the patient. He had an unexpected benefit. He did not want to disclose, at this time, what the specific condition was that he had in his background that the Shingrix had a positive effect on it. He said this condition is a condition that occurs world-wide. Shingrix shot 1 on 27 Jan 2025, he experienced a typical headache, soreness of injected arm, general weakness, flu-like symptoms, light cough, runny nose. These events were more intense than he expected. All of these events resolved/came to an end but then he developed a sinus infection. He had never had a sinus infection before. He was prescribed an antibiotic and it resolved.; Sender's Comments: US-GSK-US2025AMR089300:2nd dose More
2849893 99 M KS 07/16/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
patient was administered only the adjuvant; patient was administered only the adjuvant; This non-ser... patient was administered only the adjuvant; patient was administered only the adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 99-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 08-JUL-2025, the patient received Arexvy. On 08-JUL-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered only the adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient was administered only the adjuvant). On 08-JUL-2025, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-JUL-2025 The Health Care Professional (Pharmacist) called to report that a patient was administered only the adjuvant of Arexvy vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered More
2849894 M SC 07/16/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; He states that he developed shingles about 2-3 months ago; This serio... Suspected vaccination failure; He states that he developed shingles about 2-3 months ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure and blood cholesterol increased. Concomitant products included lisinopril, atorvastatin and rivaroxaban (Xarelto). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: He states that he developed shingles about 2-3 months ago). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 09-JUL-2025 The patient who received 2 doses of shingrix in 2019 and he developed shingles about 2 to 3 months ago. This case was considered as suspected vaccination failure as details regarding 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 details regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2849895 CA 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant wit... nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen; nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 09-JUL-2025, the patient received Shingrix. On 09-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen) and inappropriate dose of vaccine administered (Verbatim: nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 09-JUL-2025 The pharmacist received a call from an unknown nursing supervisor who stated that a facility nurse gave a dose of just the adjuvant portion of the Shingrix vaccine today. The nurse realized that she did not reconstitute adjuvant with the antigen and then administered another dose of antigen and adjuvant which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. More
2849896 NY 07/16/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Discomfort, Herpes zoster, Pain, Pruritus, Vaccination failure; Discomfort, Herp... Discomfort, Herpes zoster, Pain, Pruritus, Vaccination failure; Discomfort, Herpes zoster, Pain, Pruritus, Vaccination failure More
Suspected Vaccination failure; I have shingles; This serious case was reported by a consumer via cal... Suspected Vaccination failure; I have shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 92-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (had the chicken pox at age 3). Concurrent medical conditions included chickenpox (having chicken pox). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles). The patient was treated with aciclovir (Acyclovir) and lidocaine. The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 09-JUL-2025 Last year (in 2024) the patient had the 2 vaccinations for shingles. Now at the age of 92 patient had shingles with the pain itches discomfort and fin for its treatment which consists of a very expensive ointment and an oral tablet. The ointment Acyclovir 5 percent, 500 milligrams, antihistamine levocetir 50 milligrams and lidocaine patch for the pain. After 89 years and having chicken pox patient would have chanced not get the shingles. But with all your propaganda on getting vaccinated patient got the pain, the itch, the suffered the high cost. Patient felt the GlaxoSmithKline company should take some responsibility for this patient took advantage the big push to get the 2 injections only for your product to fail. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2849897 07/16/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
Me down for a week or better; This non-serious case was reported by a consumer via interactive digit... Me down for a week or better; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced unwell (Verbatim: Me down for a week or better). The outcome of the unwell was resolved. It was unknown if the reporter considered the unwell to be related to RSV vaccine. It was unknown if the company considered the unwell to be related to RSV vaccine. Additional Information: GSK Receipt Date: 03-JUL-2025 This case was reported by a consumer via interactive digital media. The patient took the vaccine it laid down for a week or better. More
2849898 07/16/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Ear pain, Herpes zoster, Pain, Pain in jaw, Stomatitis; Vaccination failure Ear pain, Herpes zoster, Pain, Pain in jaw, Stomatitis; Vaccination failure
suspected vaccination Failure; developed Shingles in the last few days on head and face; This seriou... suspected vaccination Failure; developed Shingles in the last few days on head and face; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. In JUL-2025, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles in the last few days on head and face). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine last year (2024) and just developed shingles in the last few days from reporting. The shingles was not severe but on head and face. The sores were around mouth making it hard to eat and drink, shooting pains in jaw to ear and beyond. Started medication one day prior to the reporting date (07-July-2025). The patient stated hoping it clears up quickly and did not get in ear or eye. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix. More
2849899 F 07/16/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
COVID-19 COVID-19
They both got Covid after the shot; This non-serious case was reported by a consumer via interactive... They both got Covid after the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced covid-19 (Verbatim: They both got Covid after the shot). The outcome of the covid-19 was not reported. It was unknown if the reporter considered the covid-19 to be related to RSV vaccine. It was unknown if the company considered the covid-19 to be related to RSV vaccine. Additional Information: GSK Receipt Date: 09-JUL-2025 This case was reported by a consumer via interactive digital media. It was reported that because of their Jobs their two daughters, they need to get the shot plus the news was saying if you get the shot you won't get Covid. They both got covid after the shot. This case is linked with case US2025AMR088613 from the same reporter for different patient.; Sender's Comments: US-GSK-US2025AMR088613:Same reporter, different patient More
2849900 F 07/16/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
COVID-19 COVID-19
got covid after the shot; This non-serious case was reported by a consumer via interactive digital m... got covid after the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced covid-19 (Verbatim: got covid after the shot). The outcome of the covid-19 was not reported. It was unknown if the reporter considered the covid-19 to be related to RSV vaccine. It was unknown if the company considered the covid-19 to be related to RSV vaccine. Additional Information: GSK receipt date: 09-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter told two daughters that, because of their jobs, they needed to get the shot. Additionally, the news was saying that if you got the shot, you would not get COVID. The reporter questioned, well, guess what. They both got COVID after getting the shot. This case had been linked with US2025AMR088612, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR088612:Same reporter More
2849901 07/16/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Neuralgia, Vaccination failure; Herpes zoster, Neuralgia, Vaccina... Herpes zoster, Neuralgia, Vaccination failure; Herpes zoster, Neuralgia, Vaccination failure More
Suspected vaccination failure; had the first dose of shots they came out with; they are back on / 2 ... Suspected vaccination failure; had the first dose of shots they came out with; they are back on / 2 cases back to back; years later I went back for the two part shots; 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), shingles (Verbatim: had the first dose of shots they came out with), shingles (Verbatim: they are back on / 2 cases back to back) and drug dose administration interval too long (Verbatim: years later I went back for the two part shots). The outcome of the vaccination failure, shingles and shingles were not reported and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the vaccination failure, shingles 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 and shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The reporter can always tell when mine are coming. They follow that same nerve pain & it is such awful pain. The patient had the first dose of shots they came out with. That didn't work so years later I went back for the two part shots which led to drug dose administration interval too long. They actually did work for 5 years but now they are back on 2 cases back to back. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2) More
2849902 F 07/16/2025 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; still get shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; still get shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 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: still get shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 09-JUL-2025 This case was reported by a patient via interactive digital media. The patient said trust her that the Shingles shots did not stop from getting shingles. The patient had both Shingles shots and still get shingles. The vaccines were not what they were cracked up to be and reporter was just stating their experience. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with US2025AMR089380, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). US-GSK-US2025AMR089380:Same reporter, different patient More
2849903 M 07/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter said trust her that the Shingles shots did not stop from getting shingles. Reporter's husband got the shot, and he has a bad case of the shingles. The vaccines were not what they were cracked up to be and reporter was just stating their experience. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with US2025AMR089374, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR089374:Same reporter, different patient More
2849904 07/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Had the vaccine, but still got them twice; This serious case was repo... Suspected vaccination failure; Had the vaccine, but still got them twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had the vaccine, but still got them twice). 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: 09-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine, but still got them twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2849905 82 M CA 07/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2443
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient received Twinrix 3rd dose earlier than recommended for the standard dosing schedule.; This n... patient received Twinrix 3rd dose earlier than recommended for the standard dosing schedule.; 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 82-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) 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). On 08-MAY-2025, the patient received the 3rd dose of Twinrix. On 08-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: patient received Twinrix 3rd dose earlier than recommended for the standard dosing schedule.). 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: 07-JUL-2025 The pharmacist reported that an adult patient received Twinrix 3rd dose earlier than recommended for the standard dosing schedule. Twinrix first dose was on 07th March 2025, Twinrix second dose was on 12th April 2025 and Twinrix third dose was on 08th May 2025 which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter. More
2849906 61 M KY 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Herpes zoster, Swelling Erythema, Herpes zoster, Swelling
Shingles outbreak.; Swelling; Arm redness; This non-serious case was reported by a nurse via call ce... Shingles outbreak.; Swelling; Arm redness; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-JUN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak.), swelling (Verbatim: Swelling) and erythema of extremities (Verbatim: Arm redness). The outcome of the shingles, swelling and erythema of extremities were unknown. It was unknown if the reporter considered the shingles, swelling and erythema of extremities to be related to Shingrix. It was unknown if the company considered the shingles, swelling and erythema of extremities to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2025 The nurse practitioner called to inform that a patient with some mild shingles symptoms and wanted to beat the shingles symptoms and got the 1st dose of Shingrix on 30th June 2025. The reporter mentioned that after getting Shingrix, patient had swelling and arm redness and shingles symptoms. No further details provided. This case US2025086143 was reported by same reporter.; Sender's Comments: US-GSK-US2025086143:Same reporter different patient More
2849907 07/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
inadvertent administration of the vaccine after a temperature excursion (below freezing); This non-s... inadvertent administration of the vaccine after a temperature excursion (below freezing); 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 DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertent administration of the vaccine after a temperature excursion (below freezing)). 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: 09-JUL-2025 The nurse reported that a patient had been administered a Boostrix vaccine after transport (from nine ante meridiem until nine fifteen ante meridiem) when the temperature was around twenty-seven degrees Fahrenheit and had dropped to negative five point five degrees Fahrenheit which led to, incorrect storage of drug. The reporter mentioned that no vaccination date, vaccine details, or patient demographics details were obtained or specified by the anonymous healthcare provider during the call. More
2849908 07/16/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
Arexvy - Expired dose; This non-serious case was reported by a nurse via call center representative ... Arexvy - Expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Arexvy - Expired dose). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 10-JUL-2025 The nurse reported that a patient received an Arexvy vaccine and they noticed that one of the vials was expired, which led to expired vaccine used. The medical information specialist contacted the nurse, via phone, in order to get more information about this event. The nurse mentioned that one of the vials was expired (not mentioned if it was the lyophilized vial or the vial with the diluent). More
2849909 F VA 07/16/2025 COVID19
 MODERNA
 048221A/048621A
Near death experience, Urticaria chronic Near death experience, Urticaria chronic
I think I am dying from this vaccine; experiencing "hives" since June 2024 / Chronic spont... I think I am dying from this vaccine; experiencing "hives" since June 2024 / Chronic spontaneous hives; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 048221A/048621A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Apr-2025, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In June 2024, the patient experienced URTICARIA CHRONIC (experiencing "hives" since June 2024 / Chronic spontaneous hives). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) (seriousness criterion medically significant). The patient was treated with Prednisone for Hives, at an unspecified dose and frequency. At the time of the report, NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) outcome was unknown and URTICARIA CHRONIC (experiencing "hives" since June 2024 / Chronic spontaneous hives) had not resolved. Concomitant medications were not reported. The reporter shared that patient had reached out to multiple specialists, Oncologist, Rheumatologist, and Allergist. The reporter shared that antihistamines and prednisone did not help to treat the hives. The reporter mentioned that her dermatologist, allergist, rheumatologist, and family doctor said that patient had chronic spontaneous hives. The reporter added that patient had received the vaccine shots except for year, 2025. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2022-516527 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
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