🏥 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 💀 🏥 🚑 ♿ ⚠️
2865221 53 F NY 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center repre... Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 16 Oct 2021). On 05-DEC-2024, the patient received the 2nd dose of Shingrix. On 05-DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 01-OCT-2025 The pharmacist asked how to proceed after a patient received a late second dose of Shingrix. Lot numbers and expiration dates of both doses unknown by the healthcare professional given that they were administered in another facility. The batch number was not provided upon follow- up with the reporter More
2865222 F NY 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
got shot 1 of Shingrix on an unspecified date in October 2024 and shot 2 on 08-OCT-2025 today on the... got shot 1 of Shingrix on an unspecified date in October 2024 and shot 2 on 08-OCT-2025 today on the day of reporting; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in OCT-2024). On 08-OCT-2025, the patient received the 2nd dose of Shingrix. On 08-OCT-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: got shot 1 of Shingrix on an unspecified date in October 2024 and shot 2 on 08-OCT-2025 today on the day of reporting). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 08-OCT-2025 The patient self-reported this case for herself. The batch number was not provided, and unable to contact the reporter. More
2865223 F MI 10/13/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 3255P
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
A 5 weeks old female patient received a wrong dose of Havrix instead of a HepB vaccine.; A 5 weeks o... A 5 weeks old female patient received a wrong dose of Havrix instead of a HepB vaccine.; A 5 weeks old female patient received a wrong dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-week-old female patient who received HAV (Havrix) (batch number 3255P, expiry date 01-FEB-2027) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. On 08-OCT-2025, the patient received Havrix. On an unknown date, the patient received Hepatitis B vaccine. On 08-OCT-2025, an unknown time after receiving Havrix and not applicable after receiving Hepatitis B vaccine, the patient experienced wrong vaccine administered (Verbatim: A 5 weeks old female patient received a wrong dose of Havrix instead of a HepB vaccine.) and inappropriate age at vaccine administration (Verbatim: A 5 weeks old female patient received a wrong dose of Havrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-OCT-2025 The medical assistant called to report the administration of Havrix to a 5 weeks old patient. They were intended to administer a HepB vaccine, but the patient received a wrong dose of Havrix instead. The reporter asked what they having to do next. More
2865224 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Accident Accident
today I feel achy; like I have a fever; This non-serious case was reported by a consumer via interac... today I feel achy; like I have a fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 18-SEP-2025, the patient received the 1st dose of Shingrix. On 19-SEP-2025, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: today I feel achy) and fever (Verbatim: like I have a fever). The outcome of the pain and fever were not resolved. It was unknown if the reporter considered the pain and fever to be related to Shingrix. It was unknown if the company considered the pain and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 19-SEP-2025 This case was reported by a patient via interactive digital media. The patient wanted to know could he/she take Ibuprofen or would that make the vaccine less effective. The batch number was not provided, and unable to contact the reporter. More
2865226 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Swelling of eyelid Herpes zoster, Swelling of eyelid
I got one shot then had the shingles one time. Went from my eyelid to my hairline. It was so bad. M... I got one shot then had the shingles one time. Went from my eyelid to my hairline. It was so bad. My eye was swollen horribly.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: I got one shot then had the shingles one time. Went from my eyelid to my hairline. It was so bad. My eye was swollen horribly.). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date:29-SEP-2025 The batch number was not provided, and we are unable to contact the reporter. More
2865227 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
forgot to get second dose; This non-serious case was reported by a consumer via interactive digital ... forgot to get second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to get second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 29-SEP-2025 The batch number was not provided, and we are unable to contact the reporter. More
2865228 10/13/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Computerised tomogram head normal, Eye pain, Headache, Herpes zoster, Neck pain;... Computerised tomogram head normal, Eye pain, Headache, Herpes zoster, Neck pain; Transient ischaemic attack, Vaccination failure More
Suspected vaccination failure; was having mini strokes; This is the 4th time with shingles/sharp pai... Suspected vaccination failure; was having mini strokes; This is the 4th time with shingles/sharp pain going from right side of head to neck and eye; 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. Family history included ophthalmic herpes zoster (mother went blind with shingles in her eye). 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), ministroke (Verbatim: was having mini strokes) (serious criteria GSK medically significant) and shingles (Verbatim: This is the 4th time with shingles/sharp pain going from right side of head to neck and eye). The outcome of the vaccination failure, ministroke and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ministroke and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ministroke 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: 05-OCT-2025 This case was reported by a patient via interactive digital media. The patient said that this was the 4th time with shingles, and he/she had all the Shingles shots and had no breaking out this time, but sharp pains going from right side of his/her head to neck and eye. The physician assistant (PA) gave the patient CT of entire head and was negative and they gave medication. The patient was going to his/her ophthalmologist tomorrow to check the eyes. The patient thought maybe he/she was having mini strokes. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Transient ischaemic attack , an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2865229 75 F GA 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 354M3
Product preparation issue Product preparation issue
Antigen powder prepared with unknown diluent; This non-serious case was reported by a nurse via call... Antigen powder prepared with unknown diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis. On 15-SEP-2025, the patient received the 1st dose of Shingrix. On 15-SEP-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Antigen powder prepared with unknown diluent). The outcome of the wrong solution used in drug reconstitution was not applicable. Additional Information: GSK Receipt Date: 24-SEP-2025 Registered Nurse reported that they were not 100 percent sure what happened, but they had a patient come in for Shingrix on September 15th 2025. After the patient left and they were doing inventory, they realized that they had an extra dose of adjuvant and not a dose of antigen. Somehow the patient only received the antigen vial, but do not know the Nurse who administered the vaccine cannot remember if she reconstituted with a different diluent or what happened, maybe diluent of Measles Mumps and Rubella vaccine they have in the counter, but that is just a thought, they have no idea. More
2865230 M IA 10/13/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 G79C4
Expired product administered Expired product administered
A nurse reported that a n infant patient received an expired dose of Havrix; This non-serious case w... A nurse reported that a n infant patient received an expired dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-month-old male patient who received HAV (Havrix) (batch number G79C4, expiry date 20-SEP-2025) for prophylaxis. On 24-SEP-2025, the patient received Havrix. On 24-SEP-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: A nurse reported that a n infant patient received an expired dose of Havrix). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 24 SEP 2025 A nurse reported that on the day of reporting, an infant patient received an expired dose of Havrix. The reporter asked if this dose was valid or not. More
2865231 11 M IL 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9C75Y
Wrong product administered Wrong product administered
a nurse called to report that an 11-year-old male patient received a SHINGRIX shot instead of MENVEO... a nurse called to report that an 11-year-old male patient received a SHINGRIX shot instead of MENVEO; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Herpes zoster (Shingrix) (batch number 9C75Y, expiry date 02-MAY-2027) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. Additional patient notes included Patient is not immunocompromised. On 24-SEP-2025, the patient received the 1st dose of Shingrix. The patient did not receive Menveo. On 24-SEP-2025, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: a nurse called to report that an 11-year-old male patient received a SHINGRIX shot instead of MENVEO). The outcome of the wrong vaccine administered was not applicable. Additional Information: GSK Receipt Date: 25-SEP-2025 A nurse called to report that an 11-year-old male patient received a Shingrix shot instead of Menveo. The vaccine was administered on 24 September 2025, and nurse called to know how to proceed. More
2865232 26 F CA 10/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 JB4K2
Underdose Underdose
Inadvertent administration of a pediatric dose to an adult patient; Underdose; This non-serious case... Inadvertent administration of a pediatric dose to an adult patient; Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 26-year-old female patient who received HBV (Engerix B pediatric) (batch number JB4K2, expiry date 23-JAN-2027) for prophylaxis. On 19-SEP-2025, the patient received Engerix B pediatric. On 19-SEP-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Inadvertent administration of a pediatric dose to an adult patient) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 26-SEP-2025 Licensed practical nurse calls to report the inadvertent administration of a pediatric dose to an adult patient and to request further guidance on this topic. The reporter consented to follow up. More
2865233 52 M NC 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 274YD
Expired product administered Expired product administered
we discovered that the vaccine expired 10 days before; This non-serious case was reported by a other... we discovered that the vaccine expired 10 days before; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 274YD, expiry date 15-SEP-2025) for prophylaxis. On 26-SEP-2025, the patient received Shingrix. On 26-SEP-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: we discovered that the vaccine expired 10 days before). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 26-SEP-2025 Paramedic called and reported the Shingrix vaccine expired 10 days before and was administered. The reporter consented to follow up. More
2865234 38 F TN 10/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 47XP4
Underdose Underdose
Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered; Maladmini... Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered; Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 38-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. Previously administered products included Engerix B (received first dose of Engerix B on an unknown date) and Engerix B (received 2nd dose of Engerix B on an unknown date). On 29-SEP-2025, the patient received the 3rd dose of Engerix B pediatric. On 29-SEP-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered) and adult use of a child product (Verbatim: Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered). The outcome of the underdose and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-SEP-2025 The registered pharmacist called to ask about vaccination schedule advise after the maladministration of a pediatric dose on an adult patient. This was intended to be the third dose on this patient vaccination schedule. More
2865235 NY 10/13/2025 HEPA
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Product storage error; Product storage error Product storage error; Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by the other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included HAV (Havrix) for prophylaxis. On an unknown date, the patient received Boostrix and Havrix. On an unknown date, an unknown time after receiving Boostrix and Havrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-SEP-2025 There was a temperature excursion of Boostrix and Havrix as 31.8 degree Fahrenheit for 1.5 hours. The reporter said that She was not sure and needed to check if the vaccines were administered. The batch number was not provided upon follow- up with the reporter. More
2865237 F NJ 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late 2nd dose; This non-serious case was reported by a other health professional via call center rep... Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 2020). In APR-2025, the patient received the 2nd dose of Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt date: 02-OCT-2025 Patient stated got 1 shot of Shingrix in 2020 and forgot to get a second. She then got a second shot in April of this year 2025. Does she need another i know it says to not restart the schedule, but it's been 5 years. The HCP did not provide the specific dates for the vaccines, only said 1st dose in 2020 and 2nd dose in Apr 2025. The batch number was not provided and a request for this information has been made. More
2865239 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix missed second dose; This non-serious case was reported by a pharmacist via call center repr... Shingrix missed second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 6 years ago). The patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix missed second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 03-OCT-2025 Till the date of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. A pharmacist inquired if she should restart the Shingrix series. More
2865240 F CA 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 94J5E
Inappropriate schedule of product administration Inappropriate schedule of product administration
Less than recommended interval; This non-serious case was reported by a pharmacist via call center r... Less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 94J5E, expiry date 02-MAY-2027) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 10-SEP-2025, the patient received the 2nd dose of Shingrix. On 10-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Less than recommended interval). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK receipt date: 06-OCT-2025 On 26-AUG-2025, The patient received 1st dose of Shingrix (batch number 342XP and expiry date 28-APR-2027). The patient received 2nd dose of Shingrix at lesser than the recommended interval which led to shortening of vaccination schedule. More
2865241 57 F FL 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3T74X
Extra dose administered Extra dose administered
female patient got a third dose of SHINGRIX in the same day; This non-serious case was reported by a... female patient got a third dose of SHINGRIX in the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 3T74X, expiry date 28-APR-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose in AUG-2023). On 06-OCT-2025, the patient received the 3rd dose of Shingrix. On 06-OCT-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: female patient got a third dose of SHINGRIX in the same day). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 06-OCT-2025 The patient received 3rd dose of Shingrix, which led to extra dose administered. The patient got the full vaccine series back in August 2023 and the pharmacist wanted to know if there were some safety concerns to take care of for the patient. More
2865242 0.5 F IL 10/13/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration to a 6 MO; 1st patient's Dtap vaccine; This non-serious case was reported by a n... Administration to a 6 MO; 1st patient's Dtap vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B) for prophylaxis. On 08-OCT-2025, the patient received the 1st dose of Kinrix. On 08-OCT-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to a 6 MO) and inappropriate schedule of vaccine administered (Verbatim: 1st patient's Dtap vaccine). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-OCT-2025 The registered nurse called and reported that a 6-month-old patient received Kinrix The Vaccine Administration Facility is the same as Primary Reporter", During the call, the HCP informed that they would call back due to their report was not clear about the patient being 6 month or 5 month. The health care professional informed to my coworker that this was the 1st patient's Dtap vaccine. More
2865243 M FL 10/13/2025 COVID19
 MODERNA
Malaise Malaise
felt sort of crummy the next day; This spontaneous case was reported by a consumer and describes the... felt sort of crummy the next day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sort of crummy the next day) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sort of crummy the next day). At the time of the report, MALAISE (felt sort of crummy the next day) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medications were not reported. Patient never had any problems with Moderna vaccines in the past; except he felt sort of crummy the next day and it was just for a day. Patient started taking Moderna shots when they first came out, in 2021. Patient has had 8 Moderna covid shots. Treatment information was not reported. This case was linked to MOD-2025-789982 (Patient Link). More
2865244 71 M FL 10/13/2025 COVID19
 MODERNA
 3043823
Malaise Malaise
feeling lousy for a day; This spontaneous case was reported by a consumer and describes the occurren... feeling lousy for a day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling lousy for a day) in a 71-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043823) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Mar-2025, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In 2025, the patient experienced MALAISE (feeling lousy for a day). In 2025, MALAISE (feeling lousy for a day) had resolved. No concomitant medication was reported. The patient had been taking Moderna COVID vaccines since they first came out, in 2021. He never had any problems with his Moderna vaccines in the past; except he felt sort of crummy the next day. It was just for a day. He had 8 Moderna covid shots. Every time he got a Moderna shot, he did not plan on doing much the next day, and then the next day after that he was fine again. By crummy - he meant not congested, he just felt sort of "blah", he just did feel that well. His only adverse effect was feeling lousy for a day. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789986, MOD-2025-789989 (Patient Link). More
2865245 F FL 10/13/2025 COVID19
 MODERNA
Atrial flutter, COVID-19 Atrial flutter, COVID-19
Covid; a-flutter; This spontaneous case was reported by a consumer and describes the occurrence of A... Covid; a-flutter; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (a-flutter) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In July 2025, the patient experienced ATRIAL FLUTTER (a-flutter) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (Covid). The patient was treated with Apixaban (Eliquis) in 2025 for Atrial flutter, at an unspecified dose and frequency. In 2025, ATRIAL FLUTTER (a-flutter) had resolved. At the time of the report, COVID-19 (Covid) had resolved with sequelae. No concomitant medication was reported. Patient got Covid after receiving vaccine. Specific dates were not provided. Patient was diagnosed with a-flutter in Jul-2025 and placed on Eliquis. It was unknown if the patient experienced any additional symptoms/events. Causality not reported. Reporter did not allow further contact; Reporter's Comments: Atrial flutter was assessed as not related to suspected vaccine due to lack of temporal plausibility. COVID-19 infection was assessed as confounding factor. Missing information regarding medical history and concomitant medications preclude proper medical assessment. The benefit-risk relationship of product is not affected by this report. More
2865247 64 F AZ 10/13/2025 FLU3
 SANOFI PASTEUR
 U8874AA
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
medication error due to administration of FLUZONE HD to a 64 years old patient with no reported adve... medication error due to administration of FLUZONE HD to a 64 years old patient with no reported adverse event; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years old female patient who administered to Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Sep-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8874AA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in the left deltoid for Influenza and was administerted to a 64 years old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, pharmacist mentioned that they have given Fluzone Hd, the day before the patient turned 65 and wanted to check if anything needed to be done. 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
2865248 IL 10/13/2025 YF
 SANOFI PASTEUR
 UK337AA
No adverse event, Product preparation error No adverse event, Product preparation error
yf-vax may have been administered incorrectly using sterile water as a diluent instead of the saline... yf-vax may have been administered incorrectly using sterile water as a diluent instead of the saline diluent, with no reported adverse event; Initial information received on 07-Oct-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 received Yellow Fever Vaccine - [YF-VAX] using sterile water as a diluent instead of the saline diluent, 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 Yellow Fever Vaccine - US Solution for injection (lot UK337AA and expiry date-Nov-2026) via unknown route in unknown administration site for Immunization using sterile water as a diluent instead of the saline diluent, with no reported adverse event (product preparation error) (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2865250 0.5 M MI 10/13/2025 FLU3
 SANOFI PASTEUR
 U8881CA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
patient received fluzone 3 days before turning 6 months with no reported ae; Initial information rec... patient received fluzone 3 days before turning 6 months with no reported ae; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 180 days old male patient who received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] 3 days before turning 6 months with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection dose 0.5 ml 1x (once) (Strength = standard) lot U8881CA expiry date-30-Jun-2026 via unknown route in the left thigh for immunization, 3 days before turning 6 months with no reported ae (product administered to patient of inappropriate age) (latency same day). Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2865251 4 M ID 10/13/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max tempera... fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], post excursion with maximum temperature reached: 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U8827AA, expiry date:30-Jun-2026, frequency: once, strength :standard via unknown route in the left arm for Immunization, post excursion were exposed with maximum temperature reached: 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event (product storage error). Reportedly, human error was involved: reason for excursion refrigerator temperature knob was accidentality turned down. The extended stability data didn't cover the excursion. 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
2865252 0.58 M ID 10/13/2025 FLU3
 SANOFI PASTEUR
 U8827AA
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max tempera... Fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, human error involve with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old male patient who had Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] (unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, human error involve with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received a dose (0.5ml) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (unopened); Suspension for injection (lot U8827AA with expiry date 30-JUN-2026) via unknown route in the right thigh for Immunization; refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, human error involve with no reported adverse event (product storage error) (latency: same day). Reportedly: refrigerator temperature knob was accidentality turned downmix temperature reached: 25.7F DEGREES Duration: 4 hours and 17 minutes Previous Excursion? No Human error? Administered post-excursion? Yes Does extended stability data cover the excursion? NOT 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
2865253 8 M ID 10/13/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
Temperature excursion negative disposition with human error,refrigerator temperature knob was accide... Temperature excursion negative disposition with human error,refrigerator temperature knob was accidentality turned down with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 years old male patient received Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] that had a negative disposition with human error, refrigerator temperature knob was accidentality turned down with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received a 0.5ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection standard strength, frequency once (lot U8827AA and expiry date-30-Jun-2026) via unknown route in the left arm for Immunization had a temperature excursion negative disposition with human error, refrigerator temperature knob was accidentality turned down with no reported adverse event (product storage error). Reportedly- extended stability data does not cover the excursion, human error was involved (refrigerator temperature knob was accidentality turned down), The product was administered. 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
2865255 94 F NJ 10/13/2025 UNK
 UNKNOWN MANUFACTURER
 407242
Bradykinesia, Dizziness, Heart rate increased, Malaise, Palpitations Bradykinesia, Dizziness, Heart rate increased, Malaise, Palpitations
A little slower than usual; Heart beating so fast; Palpitation; Dizziness; Felt lightheaded; Feeling... A little slower than usual; Heart beating so fast; Palpitation; Dizziness; Felt lightheaded; Feeling ill; This spontaneous case, initially received on 29-Sep-2025, was reported by a non health professional and concerns an elderly female patient. Drug history included Fluad. Concomitant medication: refer to appropriate report section. It also included Vitamins, glaucoma eye drops. Administration of company suspect drug: On 26-Sep-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease., Dose regimen: 0.5 units no reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: 407242. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Sep-2025, the patient experienced Heart beating so fast (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Palpitation (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Dizziness (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Felt lightheaded (outcome: Recovering / Resolving, stop date: 27-Sep-2025), Feeling ill (outcome: Recovering / Resolving, stop date: 27-Sep-2025). On an unknown date, the patient experienced A little slower than usual (outcome: Not Reported). Consumer called to report an adverse reaction for Fluad on behalf of their mother. Consumer stated they were calling to report an adverse reaction for Fluad for their mother. The mother had rapid heartbeat, palpitation, dizziness. Consumer stated they probably would not have called if it was a one-time thing. Consumer stated if it was a bad day or whatever, they gave her some electrolytes after when she was feeling ill. Consumer stated they had this shot last year, they had the Fluad shot, and they had it before, and she had it before, no adverse reactions, but last year they thought they were going to die after they had it, that's how bad the reaction was, their heart was beating so fast, it was so lightheaded. The mother did not have the extant pains too much, she did take Tylenol and it helped. Consumer stated they took Tylenol too, but they felt like they had a full flu, she did not have that, but they were wondering why they were getting cardiac adverse events here. The mother had it for years and she never had a problem before. Consumer stated they did not report it last year because they just thought that was them, but since their mother also had the adverse event this year, they were thinking something was definitely with the shot. Outcome of event: Patient was feeling better now, but a little slower than she usually is Fluad (TIV) action taken: Not Applicable Treatment medication: Tylenol, electrolytes and liquids Reporter's assessment: The primary reporter (consumer) assessed the events Dizziness, Feeling ill, Felt lightheaded, Heart beating so fast, Palpitation related to the administration of Fluad (TIV) and non-serious. The primary reporter (consumer) did not provide the seriousness and causality for the event A little slower than usual.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes More
2865266 38 F CA 10/13/2025 COVID19
HEPAB
HPV9
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 NA0589
2553x
Z006890
Discomfort, Erythema of eyelid, Eyelid oedema, Swelling of eyelid; Discomfort, E... Discomfort, Erythema of eyelid, Eyelid oedema, Swelling of eyelid; Discomfort, Erythema of eyelid, Eyelid oedema, Swelling of eyelid; Discomfort, Erythema of eyelid, Eyelid oedema, Swelling of eyelid More
Moderate bilateral edema, swelling and redness of the upper eyelid and undereyes. Occurred the next ... Moderate bilateral edema, swelling and redness of the upper eyelid and undereyes. Occurred the next morning after vaccination at 5pm the previous day, has not resolved at this time at 8:30pm. This reaction also occurred during previous COVID vaccinations with the Moderna vaccine, with the initial series in April of 2021 and May of 2021 and a booster in January of 2022. I do have under-eye dermal filler and am unsure if that is playing a role, but this reaction has been consistent and predictable. In the past it has resolved without incident after a few weeks, although it s uncomfortable. So I didn t think to report at that time. I have no other symptoms of any kind of allergic reaction and have no known allergies. I can?t know if the other vaccines played a role, I?m going off of my history but I do know this reaction does not occur with the flu vaccine. More
2865269 M 10/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected Vaccination failure; got it anyway 2 yrs ago. He still has terrible pain; still has terrib... Suspected Vaccination failure; got it anyway 2 yrs ago. He still has terrible pain; still has terrible pain; 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 (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), shingles (Verbatim: got it anyway 2 yrs ago. He still has terrible pain) and pain (Verbatim: still has terrible pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the pain was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-SEP-2025 This case was reported by a patient's wife via interactive digital media. The patient had the shingles shot but the patient got it anyway 2 yrs ago. He still had terrible pain. Three doctors have told him it will never go away. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, 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
2865271 0.58 M CA 10/13/2025 FLU3
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
early administration of the second FLUZONE NP dose, gave a flu shot to a child who was supposed to c... early administration of the second FLUZONE NP dose, gave a flu shot to a child who was supposed to come back in 4 weeks for the second shot but came back at the 3-week mark with no reported adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old male patient who received early administration of the second INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] dose, gave a flu shot to a child who was supposed to come back in 4 weeks for the second shot but came back at the 3-week mark with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination ( Immunization). On 15-Sep-2025 Patient received Dose 1 of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE, Suspension for injection (dose, strength, route, lot, expiry, administration site: Unknown) for influenza. On 03-Oct-2025, the patient received a Dose 2, 0.5 ml of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UT8836NA and expiry 30-Jun-2026) (strength: unknown), early administration of the second fluzone np dose, gave who was supposed to come back in 4 weeks for the second shot but came back at the 3-week mark with no reported adverse event (inappropriate schedule of product administration) (latency same day) via intramuscular route in the right thigh for influenza. 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
2865317 CA 10/13/2025 HPV9
 MERCK & CO. INC.
 Y018297
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
a patient received their first dose of GARDASIL 9 when they were 8 years old and 11 months.; No addi... a patient received their first dose of GARDASIL 9 when they were 8 years old and 11 months.; No additional AEs reported.; This spontaneous report was received from a medical assistant and refers to 8 years old and 11 months patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, at the age of 8 years and 11 months, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration and anatomical location were not reported, lot number Y018297 which was verified to be valid, expiration date established on 13-FEB-2027) for prophylaxis (Product administered to patient of inappropriate age), there was no adverse event reported (No adverse event). More
2865318 11 M NM 10/13/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9KB9G
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
DTap given to patient instead of Tdap booster; This non-serious case was reported by a nurse via sal... DTap given to patient instead of Tdap booster; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9KB9G) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On 29-JUL-2025, the patient received the 6th dose of Infanrix (intramuscular, left deltoid). The patient did not receive Tdap Vaccine. On 29-JUL-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: DTap given to patient instead of Tdap booster). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt date:17-SEP-2025 The patient was meant to be administered of the DTap given to patient instead of Tdap was by mistake, which led to wrong vaccine administered. More
2865319 75 F CA 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ft95n
Neuralgia, Pain Neuralgia, Pain
nerve pain that went from her waist to ankles; burning pain; This non-serious case was reported by a... nerve pain that went from her waist to ankles; burning pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number ft95n) for prophylaxis. On 01-AUG-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nerve pain (Verbatim: nerve pain that went from her waist to ankles) and pain burning (Verbatim: burning pain). The outcome of the nerve pain was unknown and the outcome of the pain burning was not reported. It was unknown if the reporter considered the nerve pain and pain burning to be related to Shingrix. It was unknown if the company considered the nerve pain and pain burning to be related to Shingrix. Additional Information: GSK Receipt Date: 18-SEP-2025 Pharmacist reported that after a first dose, a patient experienced nerve pain that went from her waist to ankles. It was a burning pain. More
2865320 66 F CA 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect dose administered Incorrect dose administered
Incomplete dose administered/received half a dose of Shingrix instead of the full dose; This non-ser... Incomplete dose administered/received half a dose of Shingrix instead of the full dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In JUN-2025, the patient received Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete dose administered/received half a dose of Shingrix instead of the full dose). The outcome of the incomplete dose administered was not applicable. Additional Information: GSK receipt date: 24-SEP-2025 Physician stated that patient received half a dose of Shingrix instead of the full dose, she did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine. Also stated that dates of administration were between 23 JUN 2025 to 27 JUN 2025. The batch number was not provided and a request for this information has been made. This case is one of the linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025122813:Same reporter/Different patient US-GSK-US2025122806:Same reporter/Different patient US-GSK-US2025122805:Same reporter/Different patient US-GSK-US2025122804:Same reporter/Different patient More
2865321 F TX 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received Shingrix first dose back in 2023; This non-serious case was reported by a pharmacist via ca... received Shingrix first dose back in 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 13-SEP-2023 having batch number X9KC7 and expiry date 25-OCT-2024). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received Shingrix first dose back in 2023). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 30-SEP-2025 This case is linked with US2025125456, reported by same reporter.; Sender's Comments: US-GSK-US2025125456: More
2865322 51 F CA 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Eye pain, Post herpetic neuralgia, Pruritus, Skin lesion Eye pain, Post herpetic neuralgia, Pruritus, Skin lesion
raised lesions; Pain eye; Itching; postherpetic neuralgia; This non-serious case was reported by a c... raised lesions; Pain eye; Itching; postherpetic neuralgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included ophthalmic herpes zoster (Herpes zoster ophthalmicus). On 22-AUG-2025, the patient received the 1st dose of Shingrix. In AUG-2025, an unknown time after receiving Shingrix, the patient experienced post herpetic neuralgia (Verbatim: postherpetic neuralgia) and pruritus (Verbatim: Itching). In SEP-2025, the patient experienced skin lesion (Verbatim: raised lesions) and eye pain (Verbatim: Pain eye). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the post herpetic neuralgia, skin lesion, eye pain and pruritus were resolving. It was unknown if the reporter considered the post herpetic neuralgia, skin lesion, eye pain and pruritus to be related to Shingrix. It was unknown if the company considered the post herpetic neuralgia, skin lesion, eye pain and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 01-OCT-2025 The patient reported that she was expecting to have a reaction to the Shingrix dose due to her history of Herpes Zoster Ophthalmicas, first diagnosed in August of 2022. The patient received her Shingrix dose 1 on 22nd August 2025. The patient experienced postherpetic neuralgia and itching shortly after the vaccination was received, and two weeks later noticed raised lesions. The patient had medicated the outbreak with Valtrex and she stated that it had not exacerbated and was slowly resolving. More
2865324 F VA 10/13/2025 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; she had one-sided, mild shingles two or three times; This serious cas... Suspected vaccination failure; she had one-sided, mild shingles two or three times; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old 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 (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she had one-sided, mild shingles two or three times). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 06-OCT-2025 The patient had one-sided, mild shingles two or three times, after receiving the two dose Shingrix vaccine. The patient stated these reoccurrences happened 3 or 4 years after receiving the two dose Shingrix series. The patient stated that she got a bump or two that starts like a mosquito bite, was annoying, that did not go away right away, but stays and stays. The patient stated it was a minor eruption that she experienced, and she knew that she would need to slow down and watch stress. The patient did not have any dates, lot/expiry for either Shingrix dose, and states both doses were probably administered in her left arm. The batch number was not provided and a request for this information has been made. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving Shingrix and Shingrix, in an 81-year-old female 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
2865325 M NJ 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Missed dose; This non-serious case was reported by a consumer via call center representative and des... Missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 30-MAR-2025). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-OCT-2025 The reporter reported that the patient had his first Shingrix dose on 30th March 2025 and had not yet had his second dose. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The batch number was not provided, and we are unable to contact the reporter. More
2865326 M NJ 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never came back for his second dose; This non-serious case was reported by a pharmacist via call cen... never came back for his second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 16-DEC-2024 given intramuscularly). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: never came back for his second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-OCT-2025 A pharmacist calling on behalf of a male patient who never came back for his second dose of vaccine. The batch number was not provided upon follow- up with the reporter. More
2865328 71 M CA 10/13/2025 COVID19
 PFIZER\BIONTECH
Swollen tongue Swollen tongue
swollen tongue, it's happened after other covid shots as well, Moderna & Pfizer swollen tongue, it's happened after other covid shots as well, Moderna & Pfizer
2865329 40 F PA 10/13/2025 COVID19
 MODERNA
Pyrexia, Rash Pyrexia, Rash
Rash , fever Rash , fever
2865330 22 F OK 10/13/2025 FLU3
 SANOFI PASTEUR
 UT8873JA
Chills, Dyspnoea, Headache, Nasal congestion, Pain Chills, Dyspnoea, Headache, Nasal congestion, Pain
Body aches , headache , chills, stuffy nose / SOB Body aches , headache , chills, stuffy nose / SOB
2865331 10 M IN 10/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 MY9547
U8823DA
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No adverse events reported. No adverse events reported.
2865334 40 F FL 10/13/2025 FLU3
HEP
HPV9
TDAP
 SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 TFAA2530
946908
Z010824
H4K3S
Abscess limb, Erythema, Induration, Swelling; Abscess limb, Erythema, Induration... Abscess limb, Erythema, Induration, Swelling; Abscess limb, Erythema, Induration, Swelling; Abscess limb, Erythema, Induration, Swelling; Abscess limb, Erythema, Induration, Swelling More
Patient states she experienced swelling, redness, and firmess starting a day after vaccination. Pos... Patient states she experienced swelling, redness, and firmess starting a day after vaccination. Post vaccine induration is still on left arm that appears as a small abscess. Patient is seeing Dr. to assess the abcess and for next step depending on Doctor's recommendations. More
2865335 72 F MI 10/13/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 27lr2
27lr2
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Nausea; Peripheral swelling More
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ... Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: redness at injection site-Severe, Systemic: Nausea-Mild, Additional Details: the patient's left arm was swelled next day after vaccines administration. she visited urgent care on 10/02/2025, the prescribed her antibiotic. we recommended that she can take benadryl too More
2865336 68 M NC 10/13/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Brain fog, Confusional state, Dizziness, Dyspnoea, Peripheral swelling Brain fog, Confusional state, Dizziness, Dyspnoea, Peripheral swelling
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / L... Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Difficulty breathing (asthma like), swelling of the lower extremities (edema), brain fog, Other Vaccines: VaccineTypeBrand: Fluzone High-Dose Flu; Manufacturer: Sanofi; LotNumber: UT8829BA; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN More
2865337 69 F TX 10/13/2025 FLUA4
 SEQIRUS, INC.
 407244
Arthralgia, Injection site pain, Joint injury, Tenderness Arthralgia, Injection site pain, Joint injury, Tenderness
Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Se... Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Pt said shoulder pain for 2 days, started by the end of day she recieved her vaccine. She feels better now, just tender. Wondering if technician administed too high. Rph looked at camera footage and could not verify if it was given too high, everything looked corrected on camera. More
2865338 25 F MA 10/13/2025 COVID19
 UNKNOWN MANUFACTURER
 8146367
Syncope, Unresponsive to stimuli Syncope, Unresponsive to stimuli
Systemic: Fainting / Unresponsive-Severe Systemic: Fainting / Unresponsive-Severe
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