🏥 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 💀 🏥 🚑 ♿ ⚠️
2860235 09/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles and had the vaccine, both were fun but were necessary. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860236 F 09/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Exposure during pregnancy, Herpes zoster, Vaccination failure Exposure during pregnancy, Herpes zoster, Vaccination failure
suspected vaccination failure; Shingles; Vaccine exposure to pregnancy; This serious prospective pre... suspected vaccination failure; Shingles; Vaccine exposure to pregnancy; This serious prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included nerve pain (took medication for the nerve pain for years). 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), shingles (Verbatim: Shingles) and vaccine exposure during pregnancy (Verbatim: Vaccine exposure to pregnancy). The outcome of the vaccination failure and shingles were not reported and the outcome of the vaccine exposure during pregnancy was not applicable. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be related to Shingles vaccine. Pregnancy exposure: Pregnancy Exposure (Shingles vaccine): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 07-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles 3 different times. Also had the shingles shot, which did not prevent shingles, but makes the episode not as bad as the first time. Took medication for the nerve pain for year. The patient was pregnant when using the product which led to Vaccine exposure during pregnancy. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2860237 09/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Wheezing Wheezing
wheezing in my throat; This non-serious case was reported by a consumer via interactive digital medi... wheezing in my throat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of wheezing 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 wheezing (Verbatim: wheezing in my throat). The outcome of the wheezing was not reported. It was unknown if the reporter considered the wheezing to be related to Arexvy. It was unknown if the company considered the wheezing to be related to Arexvy. Additional Information: GSK Receipt Date: 09-SEP-2025 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient thought he/she was being silly with the wheezing in throat and this site made him/her realize just how it was. The patient mentioned he/she was going to ask doctor about it. More
2860238 F 09/22/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Bedridden, Herpes zoster, Vaccination failure; Herpes zoster, Mobility decreased... Bedridden, Herpes zoster, Vaccination failure; Herpes zoster, Mobility decreased, Vaccination failure; Bedridden, Herpes zoster, Vaccination failure; Herpes zoster, Mobility decreased, Vaccination failure; Bedridden, Herpes zoster, Vaccination failure; Herpes zoster, Mobility decreased, Vaccination failure; Bedridden, Herpes zoster, Vaccination failure; Herpes zoster, Mobility decreased, Vaccination failure More
Suspected vaccination failure; Still get the breakout; Its horrible and puts me into bed; This serio... Suspected vaccination failure; Still get the breakout; Its horrible and puts me into bed; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd 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), shingles (Verbatim: Still get the breakout) and bedridden (Verbatim: Its horrible and puts me into bed). The outcome of the vaccination failure, shingles and bedridden were not reported. It was unknown if the reporter considered the vaccination failure, shingles and bedridden 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 and bedridden to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 This case was reported by a patient via interactive digital media. Consumer reported that shingles shot doesn't always help. She had all the shots and still get the breakout. Reporter mentioned it was horrible & it was put in bed. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Case US2025AMR117657 was identified as follow-up to case US2025AMR117700. Case US2025AMR117657 was deleted due to being created in error. All future correspondence will be submitted to case US2025AMR117700.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix (1st and 2nd ), in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860239 M 09/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... 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 adult male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (4 times). 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). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 This case was reported by a patient via interactive digital media. The had shingles 4 times and it took this long and got the shot. Then patient got it one more time it was been a year now and so far so good. He was lucky that pain and rashes were not near as bad as some of his friends. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a adult male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860240 F 09/22/2025 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; Still got shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; Still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd 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: Still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 08-SEP-2025, 10-SEP-2025 and 11-SEP-2025 This case was reported by a patient via interactive digital media. The patient had two of them, still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix(1st and 2nd), in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860241 F 09/22/2025 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; Outbreak of shingles; This serious case was reported by a nurse via s... Suspected Vaccination failure; Outbreak of shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Outbreak of shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 15-SEP-2025 The patient's age was approximately 70-year-old The reporter reported that the patient has taken both doses of Shingrix and she was seen in the office (on the reporting day) for an outbreak of shingles. It was unknown how long it has been since she completed the 2-dose series of Shingrix. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix (1st and 2nd), in a elderly female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860242 M 09/22/2025 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; shingles on one side of his torso; This serious case was reported by ... suspected vaccination failure; shingles on one side of his torso; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on one side of his torso). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 17-SEP-2025 The patient has taken both doses of Shingrix. Even though he took both doses of Shingrix, he developed a mild case of shingles on one side of his torso. It was unknown how long it has been since he completed the 2 dose series 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: A case of Vaccination failure, an unknown time after receiving Shingrix and Shingrix, in a 60-year-old male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2860243 09/22/2025 VARZOS
 UNKNOWN MANUFACTURER
Product preparation issue Product preparation issue
Administration without reconstitution.; This non-serious case was reported by a other health profess... Administration without reconstitution.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient received Shingles vaccine. After receiving Shingles vaccine, the patient experienced inappropriate reconstitution technique (Verbatim: Administration without reconstitution.). The outcome of the inappropriate reconstitution technique was not applicable. Additional Information: GSK Receipt Date: 08-SEP-2025 The reporter (healthcare professional) mentioned that shingles vaccination dose was administered using just one vial and not both of them which led to inappropriate reconstitution technique. More
2860244 MI 09/22/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product storage error Product storage error
Product storage error; This non-serious case was reported by a other health professional via call ce... Product storage error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients 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 incorrect storage of drug (Verbatim: Product storage error). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-SEP-2025 The reporter requested for the stability data for Engerix-B stored at 46.4 Fahrenheit for 30 minutes. The excursion occurred on 08-AUG-2025, so reporter was sure that patients had been administered based on the date of the excursion. The lot and expiry dates were unknown. More
2860245 1 M AZ 09/22/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Twinrix under 18 years of age administration.; This non-serious case was reported by a other health ... Twinrix under 18 years of age administration.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. On 05-SEP-2025, the patient received Twinrix. On 05-SEP-2025, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Twinrix under 18 years of age administration.). 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: 10-SEP-2025 The reporter wanted to get safety information on the administration of Twinrix in five patients below 18 years of age which led to inappropriate age at vaccine administration. This was one of the five cases reported by same reporter.; Sender's Comments: US-GSK-US2025116668:SAME REPORTER US-GSK-US2025116676:same reporter US-GSK-US2025116673:same reporter US-GSK-US2025116674:same reporter More
2860246 47 M PA 09/22/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 3J9G4
Expired product administered Expired product administered
administration of an expired dose of Havrix to a patient; This non-serious case was reported by a nu... administration of an expired dose of Havrix to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis. The patient's past medical history included liver transplant. On 08-SEP-2025, the patient received Havrix. On 08-SEP-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administration of an expired dose of Havrix to a patient). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-SEP-2025 The reporter called to inform about the administration of an expired dose of Havrix to a patient, which led to expired vaccine used. According to reporter, the patient received the dose because he was a recent liver transplant recipient. More
2860247 78 F 09/22/2025 COVID19
 MODERNA
COVID-19 COVID-19
they both had mild cases of COVID last summer after a cruise; This spontaneous case was reported by ... they both had mild cases of COVID last summer after a cruise; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (they both had mild cases of COVID last summer after a cruise) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced COVID-19 (they both had mild cases of COVID last summer after a cruise). At the time of the report, COVID-19 (they both had mild cases of COVID last summer after a cruise) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. The patient had always got Moderna COVID-19 vaccines since they were first released. She had mild case of COVID last summer after a cruise. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789425 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2025: Live follow-up received: Reporter email address and Reference numbers added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789425:Husband case, Same Report More
2860248 F 09/22/2025 COVID19
 MODERNA
Skin exfoliation Skin exfoliation
her feet significantly peeled; This spontaneous case was reported by a consumer and describes the oc... her feet significantly peeled; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (her feet significantly peeled) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In April 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In April 2025, the patient experienced SKIN EXFOLIATION (her feet significantly peeled). At the time of the report, SKIN EXFOLIATION (her feet significantly peeled) outcome was unknown. No concomitant medication was reported. It was reported that after last vaccine in Apr-2025 patient feet were significantly peeled. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not provided. No treatment medication was reported. Reporter did not allow further contact More
2860249 NY 09/22/2025 TDAP
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
temp excursion with maximum temp reached: 60�F, minimum temp reached: 49�F for duration: 89 hr, ... temp excursion with maximum temp reached: 60�F, minimum temp reached: 49�F for duration: 89 hr, and was administered post excursion with no reported adverse event; Initial information received on 16-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who administered Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] post excursion with maximum temp reached: 60� Fahrenheit, minimum temperature reached: 49�Fahrenheit for duration: 89 hr, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for immunization, post excursion with maximum temperature reached: 60�Fahrenheit minimum temp reached: 49�Fahrenheit for duration: 89 hour, with no reported adverse event (poor quality product administered) (latency: same day). Reportedly, human error was not involved, Reason: Fridge not working an d product was used. Information on the batch number was requested corresponding to the one at time of event occurrence. 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
2860260 4 M CA 09/22/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.

Arthralgia, Condition aggravated, Contusion, Epistaxis, Fatigue; Immune thromboc... Arthralgia, Condition aggravated, Contusion, Epistaxis, Fatigue; Immune thrombocytopenia, Immunoglobulin therapy More
Nose bleeds , bruising , fatigue , joint pain then went to er got diagnosed with Immune thrombocytop... Nose bleeds , bruising , fatigue , joint pain then went to er got diagnosed with Immune thrombocytopenic purpura . Had to get 2 rounds of IVIG More
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2860261 35 F CA 09/22/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Chills, Fatigue, Myalgia Arthralgia, Chills, Fatigue, Myalgia
Fatigue, muscle pain, joint pain, chills within first 12 hours. Then, reoccurring fever and chills b... Fatigue, muscle pain, joint pain, chills within first 12 hours. Then, reoccurring fever and chills began within 24 hours. Symptoms lasted for total of 48 hrs. More
2860262 19 M 09/22/2025 JEV1
 INTERCELL AG
 JEV23J01E
Abdominal pain upper, Dizziness, Vomiting Abdominal pain upper, Dizziness, Vomiting
light-headedness, vomiting x1 and stomachache around 30 minutes after immunizations. light-headedness, vomiting x1 and stomachache around 30 minutes after immunizations.
2860263 16 M MP 09/22/2025 FLU3
MNQ
 SEQIRUS, INC.
SANOFI PASTEUR
 AX4604C
U8558BA
Balance disorder, Dizziness, Fall, Syncope; Balance disorder, Dizziness, Fall, S... Balance disorder, Dizziness, Fall, Syncope; Balance disorder, Dizziness, Fall, Syncope More
Post-Vaccination Syncopal Episode After receiving vaccinations, patient reported feeling lightheade... Post-Vaccination Syncopal Episode After receiving vaccinations, patient reported feeling lightheaded and was observed leaning against the wall. Patient began to lose balance and fall backward but was caught by nurse and safely supported to prevent injury. Assisted to a chair for monitoring. VS at 1447: O2 sat: 98% HR: 50 bpm BP #1: 86/61 mmHg BP #2(Taken 10 minutes after BP #1): 98/69 mmHg Temp: 97.2�F Patient stated he had only eaten one donut today. Provided with 2 Rice Krispies treats and water. Patient is an active basketball player and was advised to refrain from physical activity for the remainder of the day. Patient monitored and tolerated event well. No signs of distress or ongoing symptoms at time of discharge. Left clinic ambulatory with mother, stating he felt well. More
2860264 25 M NM 09/22/2025 COVID19
COVID19
 JANSSEN
JANSSEN
 1821186
1821186
Chest pain, Dyspnoea, Eosinophilic oesophagitis, Fatigue, Laboratory test; Migra... Chest pain, Dyspnoea, Eosinophilic oesophagitis, Fatigue, Laboratory test; Migraine, Palpitations, Supraventricular extrasystoles, Surgery, Ventricular extrasystoles More
Diagnosed Severe case of EOE, heart palpitations and pvc/pacs, fatigue, chest pain, stabbing migrai... Diagnosed Severe case of EOE, heart palpitations and pvc/pacs, fatigue, chest pain, stabbing migraines, shortness of breath all starting in 2022 More
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2860268 F 09/22/2025 PPV
RSV
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Pneumonia, Respiratory syncytial virus infection, Vaccination failure; Pneumonia... Pneumonia, Respiratory syncytial virus infection, Vaccination failure; Pneumonia, Respiratory syncytial virus infection, Vaccination failure More
Suspected vaccination Failure; pneumonia; RSV infection; This serious case was reported by a consume... Suspected vaccination Failure; pneumonia; RSV infection; 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. On an unknown date, the patient received Arexvy and Pneumococcal vaccine. On an unknown date, an unknown time after receiving Arexvy and not applicable after receiving Pneumococcal vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure) (serious criteria GSK medically significant), pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV infection). The outcome of the vaccination failure was not reported and the outcome of the pneumonia and respiratory syncytial virus infection were not resolved. The reporter considered the vaccination failure, pneumonia and respiratory syncytial virus infection to be related to Arexvy. It was unknown if the reporter considered the pneumonia and respiratory syncytial virus infection to be related to Pneumococcal vaccine. The company considered the vaccination failure and pneumonia to be unrelated to Arexvy. The company considered the respiratory syncytial virus infection to be related to Arexvy. It was unknown if the company considered the pneumonia and respiratory syncytial virus infection to be related to Pneumococcal vaccine. Additional Information: GSK Receipt Date: 23-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned she been vaccinated for Respiratory syncytial virus and Pneumonia but still got both. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Respiratory syncytial virus and laboratory confirmation regarding Respiratory syncytial virus were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Pneumonia, unknown time after receiving Arexvy in a female patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2860269 09/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination Failure; the reactivation of virus in my body; This serious case was reported... Suspected vaccination Failure; the reactivation of virus in my body; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 55-year-old patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included herpes zoster. Concurrent medical conditions included spinal fusion (spinal conditions and fusions that have affected the nerve area). On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: the reactivation of virus in my body). The outcome of the vaccination failure and herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the herpes zoster to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 15-SEP-2025 This case was reported by a patient via interactive digital media. Patient was 55 and had spinal conditions and fusions that affected the nerve area, and may have triggered the reactivation of a virus in his/her body. It was so scary. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for herpes zoster and laboratory confirmation regarding herpes zoster were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix in a 55-year-old patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2860270 1 F GA 09/22/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 Z9Y95
Product preparation issue Product preparation issue
mistakenly given the vaccine without diluent; mistakenly given the vaccine without diluent; This non... mistakenly given the vaccine without diluent; mistakenly given the vaccine without diluent; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old female patient who received Hib (Hiberix) (batch number Z9Y95, expiry date 20-OCT-2026) for prophylaxis. On 27-AUG-2025, the patient received Hiberix. On 27-AUG-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: mistakenly given the vaccine without diluent) and inappropriate dose of vaccine administered (Verbatim: mistakenly given the vaccine without diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-AUG-2025 Three patients who were mistakenly given the vaccine without diluent they were given the diluent. This was 1 out of 3 linked cases, reported by same reporter different patients.; Sender's Comments: US-GSK-US2025111045:Same reporter, Different patient US-GSK-US2025111066:Same reporter, Different patient More
2860271 09/22/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 3043160
3043160
Balance disorder, Deafness unilateral, Gait disturbance, Nausea, Vertigo; Vision... Balance disorder, Deafness unilateral, Gait disturbance, Nausea, Vertigo; Vision blurred; Balance disorder, Deafness unilateral, Gait disturbance, Nausea, Vertigo; Vision blurred More
Loss of hearing in one ear/deafness in one ear); Blurred vision; Extreme vertigo/vertigo so bad; Nau... Loss of hearing in one ear/deafness in one ear); Blurred vision; Extreme vertigo/vertigo so bad; Nausea/sickwith nausea/became very nauseated); Difficulty walking/could not walk across the room/Barely able to Walk; Balance issues/unbalanced; Initial information received on 10-Sep-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional). This case involves an unknown age and unknown gender patient who experienced loss of hearing in one ear/deafness in one ear), difficulty walking/could not walk across the room/barely able to walk, balance issues/unbalanced, blurred vision, extreme vertigo/vertigo so bad and nausea/sick with nausea/became very nauseated) after receiving Spikevax 2024-2025 Formula [COVID-19 vaccine MRNA OMICRON (JN.1) Moderna] and Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity, Sulphur and Penicillin. Concomitant medications included Metoprolol Tartrate for Product used for unknown indication; and Levothyroxine sodium (Synthroid) for Product used for unknown indication. On 20-Sep-2024, the patient received a dose of 0.5ml of suspect Spikevax 2024-2025 Formula [Covid-19 Vaccine Mrna Omicron (Jn.1) Moderna] not produced by Sanofi Pasteur (lot 3043160 and expiry date-06-Feb-2025) via intramuscular route in unknown administration site for COVID-19 prophylaxis. On 20-Sep-2024, the patient received a dose of 1 DF (dosage form) suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date in 2024 the patient developed balance issues/unbalanced (balance disorder) (unknown latency). On 21-SEP-2024 the patient developed difficulty walking/could not walk across the room/barely able to walk (gait disturbance) (latency-1 day). On 23-Sep-2024 the patient developed loss of hearing in one ear/deafness in one ear) (deafness unilateral), blurred vision (vision blurred), extreme vertigo/vertigo so bad (vertigo) and nausea/sick with nausea/became very nauseated) (nausea) (latency-3 days). Action taken was not applicable. An unknown corrective treatment was received for all the events. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness Criteria- The patient was hospitalized for all the events. The patient was discharged on 30-Sep-2024 (hospitalization for 7 days). The event of Deafness unilateral is considered as medically significant.; Sender's Comments: Sanofi Company Comment dated 19-Sep-2025: This case involves an unknown age and unknown gender patient who experienced loss of hearing in one ear/deafness in one ear), difficulty walking/could not walk across the room/barely able to walk, balance issues/unbalanced, blurred vision, extreme vertigo/vertigo so bad and nausea/sick with nausea/became very nauseated) after receiving Spikevax 2024-2025 Formula [COVID-19 vaccine MRNA OMICRON (JN.1) Moderna] and Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. Furthermore, patient information regarding medical history, clinical course excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
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2860288 14 M TX 09/22/2025 HPV9
 MERCK & CO. INC.
 Y015179
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; TE for GARDASIL 9; This spontaneous report was received from a registered medical... no adverse event; TE for GARDASIL 9; This spontaneous report was received from a registered medical assistant and refers to a 14-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 25-Aug-2025, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Y015179, expiration date: 28-Jan-2027) 0.5 mL (0.5mL / once) for prophylaxis. The vaccine underwent a temperature excursion of 47.3 F for 50 minutes and 20 seconds on 08-JUL-2025 and 46.4 F for 25 minutes and 50 seconds on 20-AUG-2025. No additional adverse event was reported. More
2860289 VA 09/22/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Z009076
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
administering PROQUAD and VARIVAX after experiencing a temperature excursion; no adverse event; This... administering PROQUAD and VARIVAX after experiencing a temperature excursion; no adverse event; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, lot #Z009076, expiration date: 15-Nov-2026 (strength, dose, route and site of administration not provided) for prophylaxis, which was reconstituted with sterile diluent (strength, dose, formulation, route and site of administration, lot # and expiration date not provided). The vaccine was administered after a temperature excursion (TE) at -13.4 degree Celsius (C) for 9 hours and 32 minutes, with a previous TE at -12.9 degree C for 2 hours and 22 minutes (product storage error). No additional adverse event was reported for the patient (no adverse event). No additional information provided. This is one of several reports received from the same reporter. More
2860290 VA 09/22/2025 UNK
VARCEL
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
Z008197
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional information provided. No additional AE; Medical Assistant calling to report administer... No additional information provided. No additional AE; Medical Assistant calling to report administering VARIVAX after experiencing a temperature excursion.; This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly storage dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Z008197 [which has been verified to be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 30-APR-2027, administered for prophylaxis (strength, dosage, vaccination schedule, route and anatomical site of administration were not provided). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported). The vaccine was administered after a temperature excursion (TE) at -13.4 degree Celsius (C) for 9 hours and 32 minutes, with a previous TE at -12.9 degree C for 2 hours and 22 minutes (Product storage error). No additional information provided (No adverse event). This is one of several reports received from the same reporter. More
2860291 M MN 09/22/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
a 20 year old male patient who received his first dose of GARDASIL 9 "a year ago" but did ... a 20 year old male patient who received his first dose of GARDASIL 9 "a year ago" but did not come back for the second dose at the recommended dosing interval and is now back in office to receive his second dose today.; No other AE; This spontaneous report was received from a Pharmacist and refers to a 20-year-old male patient. The patient's medical history, concurrent condition, concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL (lot # and expiration date were not reported) for prophylaxis. It was reported that this patient who received his first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) "a year ago" but did not come back for the second dose at the recommended dosing interval and was now back in office to receive his second dose "today" (Inappropriate schedule of vaccine administered). No other adverse event. More
2860292 14 F CA 09/22/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013407
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
HCP reported that a patient had a delay in receiving a second dose of GARDASIL 9.; no additional AE;... HCP reported that a patient had a delay in receiving a second dose of GARDASIL 9.; no additional AE; This spontaneous report was received from a nurse practitioner on 18-Sep-2025, referring to a currently 15-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Apr-2024 (when the patient was 14 years old), the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL, (lot # and expiration date were not reported) as prophylaxis. On 20-Aug-2025, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y013407, expiration date: 01-Feb-2027), 0.5 ml as prophylaxis. She had a delay in receiving the second dose. There was approximately 16 months in between her first and second dose (Inappropriate schedule of product administration). No symptoms reported. No additional AE (no adverse event). More
2860293 09/22/2025 HEP
SMALLMNK
 DYNAVAX TECHNOLOGIES CORPORATION
BAVARIAN NORDIC

Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Received JYNNEOS instead of HEPLISAV-B; Initial report received on 08-Aug-2025. A consumer reported... Received JYNNEOS instead of HEPLISAV-B; Initial report received on 08-Aug-2025. A consumer reported that a patient (age and gender not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received JYNNEOS instead of HEPLISAV-B as the second dose. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 08-Aug-2025, after receiving HEPLISAV-B, the patient presented to the pharmacy for the second dose of HEPLISAV-B. The patient asked the pharmacy technician if they had the monkey pox vaccine and received JYNNEOS intramuscularly (lot number, expiration date, and site not provided) in error. On 08-Aug-2025, approximately 1 hour after receiving JYNNEOS instead of HEPLISAV-B, the patient received a call from the pharmacy informing the patient of the pharmacy's error. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2860294 F NC 09/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
5 1/2 Weeks Since I had the First Dose of HEPLISAV-B; Initial report received on 27-Aug-2025. A pha... 5 1/2 Weeks Since I had the First Dose of HEPLISAV-B; Initial report received on 27-Aug-2025. A pharmacist reported that she, a 58-year-old female, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization five and a half weeks ago and has not had the second dose. No medical history or concomitant medications were reported. In approximately Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, and site not available)] intramuscularly. On 27-Aug-2025, five and a half weeks after receiving HEPLISAV-B, the patient had not received the second dose of HEPLISAV-B yet. No other information was available per the reporter. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2860295 F NC 09/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
5 1/2 Weeks Since the First Dose of HEPLISAV-B; Initial report received on 27-Aug-2025. A pharmacis... 5 1/2 Weeks Since the First Dose of HEPLISAV-B; Initial report received on 27-Aug-2025. A pharmacist reported that a female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization five and a half weeks ago and has not had the second dose. No medical history, including no known drug allergies, or concomitant medications were reported. In Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, and site not available)] intramuscularly. On 27-Aug-2025, five and a half weeks after receiving HEPLISAV-B, the patient had not received the second dose of HEPLISAV-B. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2860296 74 F MD 09/22/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Blister, Ileus; Blister, Computerised tomogram kidney, Gastrointestinal disorder... Blister, Ileus; Blister, Computerised tomogram kidney, Gastrointestinal disorder, Ileus; Blister, Ileus; Blister, Computerised tomogram kidney, Gastrointestinal disorder, Ileus More
Ileus; Blisters; This serious case was reported by a consumer via call center representative and des... Ileus; Blisters; This serious case was reported by a consumer via call center representative and described the occurrence of ileus in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included rheumatoid arthritis (Rheumatoid arthritis) and sjogren's syndrome (Sjogren's syndrome). Previously administered products included Shingrix (received 1st dose on an unknown date). Concomitant products included botulinum toxin type a (Botox). On 30-AUG-2025, the patient received the 2nd dose of Shingrix (left arm). On 30-AUG-2025, less than a day after receiving Shingrix, the patient experienced blister (Verbatim: Blisters). On 02-SEP-2025, the patient experienced ileus (Verbatim: Ileus) (serious criteria GSK medically significant). The outcome of the ileus was not resolved and the outcome of the blister was resolving. It was unknown if the reporter considered the ileus and blister to be related to Shingrix. The company considered the ileus to be related to Shingrix. It was unknown if the company considered the blister to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 The reporter was a patient who received her second dose of Shingrix on 30th August 2025. The reporter stated that she developed blisters the night after receiving the vaccine on her right leg and left arm. The reporter stated that three days after the vaccine she went to the emergency department and was diagnosed with an ileus. The reporter stated her small intestines stopped moving and she was now on a light diet. The reporter stated that her immune system was low due to her other illness.; Sender's Comments: A case of Ileus, three days after receiving Shingrix vaccine, in a 74-year-old female subject. Report is consistent with causal relation to the vaccine product, considering plausible time to onset. More
2860297 F GA 09/22/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
provided DDAP instead of TDAP; provided DDAP instead of TDAP; This non-serious case was reported by ... provided DDAP instead of TDAP; provided DDAP instead of TDAP; This non-serious case was reported by other health professional and described the occurrence of wrong vaccine administered in adult female patient who received DTPa (Infanrix) (batch number 5KR3R) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On 22-AUG-2025, the patient received the 1st dose of Infanrix (right deltoid). The patient did not receive Tdap Vaccine. On 22-AUG-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: provided DDAP instead of TDAP) and adult use of a child product (Verbatim: provided DDAP instead of TDAP). The outcome of the wrong vaccine administered, and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-AUG-2025 It was a mistake, provided DTAP instead of TdAP. More
2860298 F 09/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
a sore arm for 2 days; This non-serious case was reported by a consumer via interactive digital medi... a sore arm for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: a sore arm for 2 days). The outcome of the pain in arm was resolved (duration 2 days). 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. Linked case(s) involving the same patient: US2025AMR110684 Additional Information: GSK Receipt Date: 23-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter reported that she got the vaccine last year. The reporter mentioned better to safe than sorry and different insurance providers both had covered it. No side effects for either of them except a sore arm for 2 days. This case has been linked withUS2025AMR110684, reported by the same reporter. More
2860299 09/22/2025 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 75-year-old patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included systemic lupus erythematosus. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster 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 Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 07-SEP-2025 This case was reported by a consumer via interactive digital media. The patient got shingles from time to time. The patient was of 75 years and had lupus. The patient stated that it was very helpful. Though the patient had the shingles they usually affected an area. The patient was taking water exercise in public pool and asked if it could spread them to others. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Herpes Zoster vaccine, in a 75-year-old patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2860300 09/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Respiratory syncytial virus test positive, Vaccination failure Respiratory syncytial virus test positive, Vaccination failure
Suspected vaccination failure; I tested positive for RSV; This serious case was reported by a consum... Suspected vaccination failure; I tested positive for RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On 18-AUG-2025, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: I tested positive for RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK Receipt Date: 07-SEP-2025 The patient was vaccinated on 14 December. The patient tested positive for respiratory syncytial virus (RSV) on 18-Aug-2025. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Arexvy, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860301 09/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; got the shingles right after the shot; This serious case was reported... Suspected vaccination failure; got the shingles right after the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles right after the shot). 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-SEP-2025 This case was reported by a patient via interactive digital media. The reporter stated that he/she took a chance and got the shingles right after the shot. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860302 09/22/2025 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; shingles; This serious case was reported by a consumer via call cente... Suspected vaccination failure; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 15-SEP-2025 This case was reported by a patient via interactive digital media. The patient had both doses of the Shingrix vaccine a few years ago and now have a mild breakthrough case of shingles The patient enquired if they should revaccinate. This case was considered as suspected vaccination failure as details time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingrix (dose 1 and dose 2), in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860303 09/22/2025 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 got the shingles it does not work for everyone; This serious ca... Suspected vaccination failure; still got the shingles it does not work for everyone; 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: still got the shingles it does not work for everyone). 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: 13-SEP-2025 This case was reported by a patient via interactive digital media. The patient got the shots the 2nd dose a year ago and still got the shingles. The patient mentioned it does not work for everyone. This case was considered as suspected vaccination failure as details time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine (dose 1 and dose 2), in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860304 M VA 09/22/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Syncope, Tooth fracture Syncope, Tooth fracture
patient fainted; chipped his tooth; This serious case was reported by a other health professional vi... patient fainted; chipped his tooth; This serious case was reported by a other health professional via sales rep and described the occurrence of faint in a male patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced faint (Verbatim: patient fainted) (serious criteria GSK medically significant) and chipped tooth (Verbatim: chipped his tooth). The outcome of the faint and chipped tooth were not reported. It was unknown if the reporter considered the faint and chipped tooth to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the faint to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the chipped tooth to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-SEP-2025 Healthcare professional said that patient fainted and chipped his tooth, had to go to hospital.; Sender's Comments: A case of Syncope, an unknown time after receiving Bexsero and Bexsero Pre-Filled Syringe Device, in a male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow-up information has been sought. More
2860305 09/22/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I still Got shingles; This serious case was reported by a consumer vi... Suspected vaccination failure; I still Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still Got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 18-SEP-2025 This case was reported by a patient via interactive digital media. Patient had two injections with Shingrix and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix (1st and 2nd), in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860306 F 09/22/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 GE974
Incorrect route of product administration Incorrect route of product administration
A female patient received an IM dose of Priorix instead of SC.; received at 28 years of age; This no... A female patient received an IM dose of Priorix instead of SC.; received at 28 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 28-year-old female patient who received MMR (Priorix) (batch number GE974, expiry date 01-DEC-2026) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A female patient received an IM dose of Priorix instead of SC.) and inappropriate age at vaccine administration (Verbatim: received at 28 years of age). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-AUG-2025 The health care professional reported that a 28 years old female patient received Priorix vaccine intramuscular instead of subcutaneous, which led to subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration . The reporter was ask did it need a revaccination and what did have to do next. More
2860307 M IL 09/22/2025 TDAP
 UNKNOWN MANUFACTURER
Incomplete course of vaccination Incomplete course of vaccination
missed vaccine series; This non-serious case was reported by a other health professional via call ce... missed vaccine series; 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 male patient who received DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced incomplete course of vaccination (Verbatim: missed vaccine series). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-AUG-2025 The reporter reported that a practice administrator called on behalf of the doctor to get guidance on the administration of Boostrix to a 9-year-old male patient. The patient missed the vaccine series of the DTaP vaccine when he was 5-year-old. The reporter asked can it be administered to the patient since the PI mentions it is for 10 years and older and HepB vaccine series was administered as scheduled. More
2860308 0.08 M GA 09/22/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 Z9Y95
Product preparation issue Product preparation issue
mistakenly given the vaccine without diluent; mistakenly given the vaccine without diluent; This non... mistakenly given the vaccine without diluent; mistakenly given the vaccine without diluent; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 1-month-old male patient who received Hib (Hiberix) (batch number Z9Y95, expiry date 20-OCT-2026) for prophylaxis. On 27-AUG-2025, the patient received Hiberix. On 27-AUG-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: mistakenly given the vaccine without diluent) and inappropriate dose of vaccine administered (Verbatim: mistakenly given the vaccine without diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-AUG-2025 Three patients who were mistakenly given the vaccine without diluent they were given the diluent. This was 1 of 3 linked cases, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025111058:Same reporter, Different patient US-GSK-US2025111066:Same reporter, Different patient More
2860309 37 M DC 09/22/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 7KD5B
Product storage error Product storage error
Vaccine administration after temperature excursion; This non-serious case was reported by a other he... Vaccine administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 37-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7KD5B, expiry date 14-JUN-2027) for prophylaxis. On 04-AUG-2025, the patient received Boostrix. On 04-AUG-2025, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date:29-AUG-2025 This case is 1 of 3 cases reported by same reporter.; Sender's Comments: GSK-US2025111575:same reporter, different patient GSK-US2025111574:same reporter, different patient More
2860310 VA 09/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This no... 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient received Shingrix. After receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 11-SEP-2025 Reporter called to report a temperature excursion involving Shingrix vaccines. The reporter stated that the vaccines were exposed to a temperature of 32.8?degree C for 93 hours, with no prior excursions reported. During the call, the healthcare professional inquired about the stability of Boostrix and Shingrix following the excursion. They also mentioned that 6 doses of Boostrix and 4 doses of Shingrix had already been administered to 10 different patients after the temperature deviation. They asked whether revaccination would be necessary for the affected individuals. This case is 1 of 6 cases reported by same reporter.; Sender's Comments: US-GSK-US2025117354:same reporter US-GSK-US2025117369:same reporter, Different patient US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117367:same reporter, different patient US-GSK-US2025117361:same reporter, different patient US-GSK-US2025117369:same reporter, different patient US-GSK-US2025117358:same reporter More
2860311 M 09/22/2025 COVID19-2
 MODERNA
Death Death
found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (... found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetic. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on 25-Dec-2022 The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient got the booster shot found dead in Christmas morning. Treatment drug was not reported. Company comment: This is a spontaneous case regarding a male patient of an unknown age, with concurrent medical condition of diabetes, who died after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). The event Death (seriousness criteria death and medically significant) occurred on an unknown latency from vaccination. The cause of death was not reported. It is unknown if an autopsy was performed. According to the report, patient received the booster shot and was found dead. No further details were disclosed. Concurrent medical condition of diabetes remains a confounding factor. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-692839, US-MODERNATX, INC.-MOD-2022-692969 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Upon internal review significant correction was performed on 01-Sep-2025 to update IB listedness, event onset date added, and Reference type updated from E2B Company Number to E2B Report Duplicate.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-692839:Master case US-MODERNATX, INC.-MOD-2022-692969:same reporter; Reported Cause(s) of Death: unknown cause of death More
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2860312 71 M CA 09/22/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Arthralgia, Arthritis, Brain fog, Condition aggravated, Decreased activity; Depr... Arthralgia, Arthritis, Brain fog, Condition aggravated, Decreased activity; Depressed level of consciousness, Disturbance in attention, Fatigue, Headache, Lethargy; Loss of personal independence in daily activities More
lethargic; started to feel a little bit of arthritis in his hands which he always has but was gettin... lethargic; started to feel a little bit of arthritis in his hands which he always has but was getting worse; getting a low-grade headache (annoying); more body aches in my other joints - knees and shoulders; 'fuzzy' feeling in my head not concentrating or alert as normal; Tired; Doesn�t want to do nothing; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION ('fuzzy' feeling in my head not concentrating or alert as normal), LETHARGY (lethargic), ARTHRITIS (started to feel a little bit of arthritis in his hands which he always has but was getting worse), DECREASED ACTIVITY (Doesn�t want to do nothing) and HEADACHE (getting a low-grade headache (annoying)) in a 71-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hand arthritis. On 10-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 11-Sep-2025, the patient experienced DISTURBANCE IN ATTENTION ('fuzzy' feeling in my head not concentrating or alert as normal), ARTHRITIS (started to feel a little bit of arthritis in his hands which he always has but was getting worse), HEADACHE (getting a low-grade headache (annoying)) and ARTHRALGIA (more body aches in my other joints - knees and shoulders). On 12-Sep-2025, the patient experienced LETHARGY (lethargic). In September 2025, the patient experienced DECREASED ACTIVITY (Doesn�t want to do nothing) and FATIGUE (Tired). On 12-Sep-2025, HEADACHE (getting a low-grade headache (annoying)) and ARTHRALGIA (more body aches in my other joints - knees and shoulders) had resolved. At the time of the report, DISTURBANCE IN ATTENTION ('fuzzy' feeling in my head not concentrating or alert as normal), DECREASED ACTIVITY (Doesn�t want to do nothing) and FATIGUE (Tired) outcome was unknown and LETHARGY (lethargic) and ARTHRITIS (started to feel a little bit of arthritis in his hands which he always has but was getting worse) had not resolved. No concomitant medications were reported. The patient received vaccine on 10-Sep-2025 around 5 o'clock in the evening. It made him sick for a day, he was fine on the 10th, no problems until the middle of the day on 11-Sep-2025, he started to get a 'fuzzy' feeling in my head not concentrating or alert as normal. Then he started to feel a little bit of arthritis in his hands, which he always had but was getting worse and later in the day around 4 or 5 o'clock more body aches in his other joints - knees and shoulders. He never got a real strong headache, but his head was tired and did not feel sharp (was not sharp and alert). He got a low-grade headache (annoying) and did not have a temperature. Skipped class too and went to bed early. In Friday morning, he was still achy in hands and joints, and now just kind of tired and did not want to do anything but no fever, no headache and pretty much all the joint pain was gone. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789410 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789410:Wife case More
2860313 70 F CA 09/22/2025 COVID19
 MODERNA
Influenza like illness Influenza like illness
flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ... flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved. No concomitant medication was reported. Following her most recent vaccination in 2024, the patient experienced flu-like symptoms for nearly a week but did not experience difficulty walking. No pain was reported during any of these events. The patient had such a bad reaction and was over 65. The patient had a reaction every time. The patient got the Moderna vaccine, and she had it 3 or 4 times. The last time she took it, the reaction was pretty intense. There were no lab data/results available. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. No treatment medication was reported. Reporter causality was not reported. This case was linked to MOD-2025-789436 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2025: Live follow-up received: Reference id added. More
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