🏥 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 💀 🏥 🚑 ♿ ⚠️
2825864 72 F 02/11/2025 RSV
 PFIZER\WYETH
 hm9854
Extra dose administered Extra dose administered
duplicate vaccine given duplicate vaccine given
2825865 51 F WA 02/11/2025 COVID19
 PFIZER\BIONTECH
 F58757
Autoimmune hepatitis, Protein total increased Autoimmune hepatitis, Protein total increased
Following Pfizer her protein levels started to rise and then she was diagnosed with autoimmune hepat... Following Pfizer her protein levels started to rise and then she was diagnosed with autoimmune hepatitis More
2825866 57 F OK 02/11/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Amnesia, Apathy, Arthralgia, Arthritis, Brain fog; Chest discomfort, Dyspnoea, G... Amnesia, Apathy, Arthralgia, Arthritis, Brain fog; Chest discomfort, Dyspnoea, General physical health deterioration, Osteoarthritis, Pain; Rhinorrhoea, Skin mass, Vision blurred More
Chronic runny nose, crippling arthritis, pain in joints, brain fog, memory loss, lack of motivation,... Chronic runny nose, crippling arthritis, pain in joints, brain fog, memory loss, lack of motivation, growths appearing with pain on multiple locations, blurred vision, osteoarthritis, health determination has occurred at rapid speed since being vaccinated. Shortness of breath, unable to carry item with little weight feels like an elephant is sitting on my chest. More
✓
2825867 53 F FL 02/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 m4b34
Extra dose administered Extra dose administered
Patient submitted to receive her second dose a week after her first. This was flagged in our corpora... Patient submitted to receive her second dose a week after her first. This was flagged in our corporate system and I was notified to verify the patient's records to determine if she received the first dose. Upon investigation on state shots, it was determined the patient received 3 doses of hepA/hepB (twinrix) back in 2012 and 2013 to complete the series. The dose she recently received on 2/7/25 was a revaccination that the guidelines do not recommend at this time. More
2825868 86 F FL 02/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient experienced no adverse effects but received a second dose of vaccine when only one dose is r... Patient experienced no adverse effects but received a second dose of vaccine when only one dose is required More
2825869 62 M CA 02/11/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LG5577
MC7HK
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Patient had Boostrix and Prevnar 20 on 02/04/2025 on his left deltoid . Patient called and informed ... Patient had Boostrix and Prevnar 20 on 02/04/2025 on his left deltoid . Patient called and informed us that he had big redness and swelling on his arm since 02/05 and it spreading more each day, today after 7 days the redness is round 8 inches, some pain but mostly redness and itching around the area. We informed his MD. MD order steroid medication for him to help with the symptoms. Patient picked up his medication on 02/11/25 and we advised patient to contact us or his MD within 3 days if the condition doesnt improve or get worse. More
2825870 60 M FL 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7ZM55
Extra dose administered, No adverse event Extra dose administered, No adverse event
PATIENT RECEIVED A TOTAL OF 4 SHINGRIX SHOTS (FIRST IN 2020 AT PHARMACY, SECOND, THIRD AND FOURTH AT... PATIENT RECEIVED A TOTAL OF 4 SHINGRIX SHOTS (FIRST IN 2020 AT PHARMACY, SECOND, THIRD AND FOURTH AT DIFFERENT PHARMACY IN 2022, 2023 AND NOW 2025) PATIENT AND PRESCRIBER WERE NOTIFIED IMMEDIATELY AND THUS FAR PATIENT EXPERIENCING NO ILL-EFFECT (5 HOURS POST VACCINE) More
2825871 21 F 02/11/2025 JEV1
 INTERCELL AG
 JEV22H64E
Extra dose administered, No adverse event Extra dose administered, No adverse event
PATIENT WAS ADMINISTERED AN ADDITIONAL DOSE OF JEV INSTEAD OF THE INTENDED VACCINE OF HPV. NO REACTI... PATIENT WAS ADMINISTERED AN ADDITIONAL DOSE OF JEV INSTEAD OF THE INTENDED VACCINE OF HPV. NO REACTIONS ACCURED More
2825872 1.08 M VT 02/11/2025 VARCEL
 MERCK & CO. INC.
Injection site vesicles, Scar Injection site vesicles, Scar
Blisters in 2? by 1? area where varicella vaccine was given. Still a scare on his leg. Blisters in 2? by 1? area where varicella vaccine was given. Still a scare on his leg.
2825879 0.5 F CA 02/11/2025 DTPPVHBHPB
FLU3
PNC15
RV5
 MSP VACCINE COMPANY
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U7374BA
UT8415NA
Y010035
Y011481
Eye swelling; Eye swelling; Eye swelling; Eye swelling Eye swelling; Eye swelling; Eye swelling; Eye swelling
Left eye swelling when woke at 5 am the following morning, which resolved. Mother had photo of eye. ... Left eye swelling when woke at 5 am the following morning, which resolved. Mother had photo of eye. Swelling resolved that day, no rash, no cough More
2825408 F 02/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 5RK5T
Eczema Eczema
Eczema Rash; This non-serious case was reported by a consumer and described the occurrence of eczema... Eczema Rash; This non-serious case was reported by a consumer and described the occurrence of eczematous rash in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 5RK5T, expiry date 16-APR-2026) for prophylaxis. On 04-MAR-2024, the patient received the 1st dose of Shingles vaccine. On 02-APR-2024, 29 days after receiving Shingles vaccine, the patient experienced eczematous rash (Verbatim: Eczema Rash). The outcome of the eczematous rash was not resolved. It was unknown if the reporter considered the eczematous rash to be related to Shingles vaccine. It was unknown if the company considered the eczematous rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 Patient was the reporter. Concomitant medication included multiple daily medications for multiple purpose. The symptoms were treated. More
2825409 U CA 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation error Product preparation error
Vaccine incorrect diluent used; Vaccine incorrect diluent used; This non-serious case was reported b... Vaccine incorrect diluent used; Vaccine incorrect diluent used; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vaccine incorrect diluent used) and inappropriate dose of vaccine administered (Verbatim: Vaccine incorrect diluent used). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 16-JAN-2025 The nurse reported that the patient received Shingrix vaccine with incorrect diluent used, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case is linked with US2023AMR151817, reported by same reporter.; Sender's Comments: US-GSK-US2023AMR151817:same reporter More
2825410 U 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
sick; This non-serious case was reported by a consumer and described the occurrence of sickness in a... sick; This non-serious case was reported by a consumer and described the occurrence of sickness 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 sickness (Verbatim: sick). The outcome of the sickness was resolved (duration 1 month). It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter reported that a patient had the first shot of Shingrix a few years ago when dealing with immune issues and experienced severely sick for a month after the vaccine. The reporter said that it was one of the vaccines that is a live virus make sure immune system can handle it. More
2825411 M 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Back pain Back pain
back pain; This non-serious case was reported by a physician via sales rep and described the occurre... back pain; This non-serious case was reported by a physician via sales rep and described the occurrence of back pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included Age: more than 50 years. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced back pain (Verbatim: back pain). The outcome of the back pain was not reported. It was unknown if the reporter considered the back pain to be related to Shingrix. It was unknown if the company considered the back pain to be related to Shingrix. Additional Information: GSK Receipt Date: 03-FEB-2025 A patient received the second dose of Shingrix and experienced back pain which messed up his back. More
2825412 5 M DC 02/10/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 25ZH4
Expired product administered Expired product administered
administered a dose of Kinrix which was expired on 27th Oct, 2024; This non-serious case was reporte... administered a dose of Kinrix which was expired on 27th Oct, 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis. On 14-JAN-2025, the patient received Kinrix. On 14-JAN-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Kinrix which was expired on 27th Oct, 2024). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 14-JAN-2025 Other HCP reported that administered a dose of Kinrix to a 5 year old male patient on 14th Jan, 2025 which had an expiration date of 27th Oct, 2024, which led to expired product used. The vaccines were quarantined in the back of the fridge but apparently the staff member did not notice the sign. At the time of reporting, a repeat dose has not been administered. More
2825413 M WI 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Pain in extremity Pain in extremity
arm soreness; This non-serious case was reported by a consumer via call center representative and de... arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm soreness). The outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 16-JAN-2025 Patient reported arm soreness after receiving Shingrix. More
2825414 F IA 02/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 HR4RB
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 34 months old female patient received an adult dose of Havrix; A 34 months old female patient rece... A 34 months old female patient received an adult dose of Havrix; A 34 months old female patient received an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 34-month-old female patient who received HAV (Havrix adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis. On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: A 34 months old female patient received an adult dose of Havrix) and overdose (Verbatim: A 34 months old female patient received an adult dose of Havrix). The outcome of the adult product administered to child and overdose were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-JAN-2025 A registered nurse called to report that they administered an adult dose of Havrix to a 34 months old female patient, which led to adult product administered to child and overdose. And enquiring whether this dose count as valid. More
2825415 F TX 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Did not receive 2nd dose; This non-serious case was reported by a pharmacist via call center represe... Did not receive 2nd 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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received 1st dose on 16-FEB-2023). 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: Did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK receipt date: 17-JAN-2025 Other HCP reported that a 71 years old female patient received a dose of Shingrix and now the patient wanted to get the second dose, which led to incomplete course of vaccination. Reporter asked the patient needs to repeat the series or not. This case is linked with US2020058338 reported by same reporter.; Sender's Comments: US-GSK-US2020058338:same reporter More
2825416 17 M IN 02/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVA982A
Expired product administered Expired product administered
received a Menveo that was expired by few months; This non-serious case was reported by a physician ... received a Menveo that was expired by few months; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA982A, expiry date 31-OCT-2024) for prophylaxis. On 20-JAN-2025, the patient received Menveo. On 20-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received a Menveo that was expired by few months). The outcome of the expired vaccine used was unknown. Additional Information: GSK receipt date: 14-JAN-2025 Physician reported that a child yesterday that received a Menveo that was expired by few months, which led to expired vaccine used. More
2825417 66 M GA 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 D5AP5
Product administered to patient of inappropriate age, Product preparation issue Product administered to patient of inappropriate age, Product preparation issue
patient was administered 2 vials of adjuvant and no powder (Antigen); patient was administered 2 via... patient was administered 2 vials of adjuvant and no powder (Antigen); patient was administered 2 vials of adjuvant and no powder (Antigen); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number D5AP5, expiry date 31-AUG-2026) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered 2 vials of adjuvant and no powder (Antigen)) and inappropriate dose of vaccine administered (Verbatim: patient was administered 2 vials of adjuvant and no powder (Antigen)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 21-JAN-2025 The pharmacist reported that the patient was administered 2 vials of adjuvant and no powder (Antigen) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. There had been no complaints of any effects. More
2825418 77 M AZ 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5A4H7
Rash, Rash pruritic Rash, Rash pruritic
skin rash all over his body and itching; This non-serious case was reported by a consumer via call c... skin rash all over his body and itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a elderly male patient who received Herpes zoster (Shingrix) (batch number 5A4H7, expiry date 31-OCT-2026) for prophylaxis. On 01-NOV-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced itchy rash (Verbatim: skin rash all over his body and itching). The outcome of the itchy rash was not resolved. It was unknown if the reporter considered the itchy rash to be related to Shingrix. It was unknown if the company considered the itchy rash to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2025 The patient received Shingrix and within a couple of days of receiving the second dose, he had a skin rash all over his body and itching. The patient reported that he continued to have the rash and itching today (date of reporting), but not as severe. More
2825419 22 M NC 02/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMAA989A
Expired product administered Expired product administered
patient received an expired dose of Menveo; This non-serious case was reported by a pharmacist via c... patient received an expired dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA989A, expiry date 30-NOV-2024) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Menveo). The outcome of the expired vaccine used was unknown. Additional Information: GSK receipt date: 21-JAN-2025 Other HCP reported that they administered an expired dose of Menveo (2 vial), the powder portion expired on 30th Nov, 2024, which led to expired product used. Reporter asked that they have to revaccinate the patient. More
2825420 74 F TX 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 BP74J
Extra dose administered Extra dose administered
3rd dose administered; This non-serious case was reported by a pharmacist via call center representa... 3rd dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number BP74J, expiry date 15-NOV-2026) for prophylaxis. Previously administered products included Shingrix (1st dose on 24th Dec, 2019), Shingrix (2nd dose on 27th Feb, 2020) and Zostavax. On 18-JAN-2025, the patient received the 3rd dose of Shingrix. On 18-JAN-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered). The outcome of the extra dose administered was unknown. Additional Information: GSK receipt date: 22-JAN-2025 Other HCP reported that a patient got a 3rd dose of Shingrix. According to reporter on 24th Dec, 2019, the patient received the 1st dose of Shingrix. Then, on 27th Feb, 2020 the patient received the 2nd dose of Shingrix. After that, on 18th Jan, 2025 the patient received the 3rd dose of Shingrix, which led to extra dose administered. More
2825421 M CA 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not receive 2nd dose of shingrix; This non-serious case was reported by a pharmacist via call ce... did not receive 2nd dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient got 1st Zoster, Shingrix vaccine, on Oct 2020). 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: did not receive 2nd dose of shingrix). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK receipt date: 22-JAN-2025 Physician reported that a patient got his 1st Zoster, Shingrix vaccine, on Oct 2020, this was almost 4 and a half years later. Reporter asked was he ok to get another one or does he needs to start the series all over again. Till the time of reporting patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination. More
2825422 U MO 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
COVID-19, Incomplete course of vaccination COVID-19, Incomplete course of vaccination
got off schedule with their 2nd dose due to COVID; This non-serious case was reported by a physician... got off schedule with their 2nd dose due to COVID; This non-serious case was reported by a physician via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patients received their first dose during COVID 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 social problem (Verbatim: got off schedule with their 2nd dose due to COVID). The outcome of the social problem was unknown. Additional Information: GSK Receipt Date: 31-JAN-2025 Reporter stated that 3 patients got their 1st Shingrix dose during COVID and got off schedule with their 2nd dose due to that, she then stated it was 1 or 2 patients. More
2825423 32 F IN 02/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 55M72
Expired product administered Expired product administered
administered an expired dose of Havrix; This non-serious case was reported by a nurse via call cente... administered 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 32-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis. On 08-JAN-2025, the patient received Havrix. On 08-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Havrix). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 Nurse reported a patient was administered an expired dose of Havrix, which led expired vaccine used. The reporter consented to follow up. More
2825424 4 M OR 02/10/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Incorrect route of product administration Incorrect route of product administration
Kinrix SC instead of IM; This non-serious case was reported by a nurse via call center representativ... Kinrix SC instead of IM; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. On 03-FEB-2025, the patient received Kinrix (subcutaneous). On 03-FEB-2025, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Kinrix SC instead of IM). The outcome of the intramuscular formulation administered by other route was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-FEB-2025 Registered nurse reported that a male patient received by error Kinrix subcutaneously instead of Intramuscular which led intramuscular formulation administered by other route. The reporter consented to follow up. More
2825425 U NJ 02/10/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Maladministration of Hiberix Diluent portion alone; administered the syringe diluent only; This non-... Maladministration of Hiberix Diluent portion alone; administered the syringe diluent only; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of Hiberix Diluent portion alone) and inappropriate dose of vaccine administered (Verbatim: administered the syringe diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter had a staff person that administered the syringe diluent only, that was saline, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asking was there any waiting period or should they just bring them back in for proper administration. The reporter could not find any guidance online specifically, but obvious sense of logic would say that it's not valid and no waiting period needed. More
2825426 17 M VA 02/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 PZT72S
Expired product administered Expired product administered
Maladministration after the expiration date; This non-serious case was reported by a nurse via call ... Maladministration after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HBV (Engerix B) (batch number PZT72S, expiry date 15-DEC-2024) for prophylaxis. On 03-FEB-2025, the patient received Engerix B. On 03-FEB-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration after the expiration date). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-FEB-2025 Registered Nurse called mentioning that they gave an ENGERIX-B dose today, after the vaccine expired on 15th December 2024 which led to expired vaccine use. Registered Nurse wanted advise on this situation. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further detail was obtained in this call. More
2825427 51 F OH 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74NC9
Injection site erythema, Injection site induration, Injection site mass, Injecti... Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Product preparation issue More
hard knot at injection site; Injection site hard knot; swelling at injection site; redness at inject... hard knot at injection site; Injection site hard knot; swelling at injection site; redness at injection site; mistakenly administered Shingrix adjuvant only; mistakenly administered Shingrix adjuvant only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis. On 28-JAN-2025, the patient received the 1st dose of Shingrix. On 28-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: mistakenly administered Shingrix adjuvant only) and inappropriate preparation of medication (Verbatim: mistakenly administered Shingrix adjuvant only). On 30-JAN-2025, the patient experienced injection site mass (Verbatim: hard knot at injection site), injection site induration (Verbatim: Injection site hard knot), injection site swelling (Verbatim: swelling at injection site) and injection site erythema (Verbatim: redness at injection site). The outcome of the injection site mass, injection site induration and injection site swelling were not resolved and the outcome of the injection site erythema, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the injection site mass, injection site induration, injection site swelling and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site mass, injection site induration, injection site swelling and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The pharmacy technician mistakenly administered Shingrix adjuvant only, without reconstitution to the patient, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The error was discovered two days later. The patient returned to the pharmacy on 30 January 2025 with injection site redness, swelling, and a hard knot. The vaccine administration facility was the same as primary reporter. Nothing else was reported. The case was linked with case US2019160501, reported by the same reporter.; Sender's Comments: US-GSK-US2019160501:same reporter More
2825428 F TX 02/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 HR4RB
Product storage error Product storage error
A 46 years old female patient received a dose of Havrix after a temperature excursion.; This non-ser... A 46 years old female patient received a dose of Havrix after a 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 46-year-old female patient who received HAV (Havrix) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis. On 02-JAN-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: A 46 years old female patient received a dose of Havrix after a temperature excursion.). The outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-FEB-2025 The health care professional reported that a patient got vaccinated with Havrix after a temperature excursion, which led to incorrect storage of drug. The health care professional would like to know if the patient needs to be revaccinated. More
2825429 U IL 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
ended getting 3rd dose in 2/25; This non-serious case was reported by a other health professional vi... ended getting 3rd dose in 2/25; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in March 2024) and Shingrix (received 2nd dose of Shingrix vaccine in May 2024). In FEB-2025, the patient received the 3rd dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: ended getting 3rd dose in 2/25). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter reported that the patient received three doses of shingrix. Two doses two months apart in march 2024 and May 2024 patient was not sure if they got the second dose. Patient received 3rd dose in February 2025, after dose given after some research turned out patient got 2nd dose and wasn't reported, which led to extra dose administered. The Vaccine Administration Facility is the same as Primary Reporter. More
2825430 M 02/10/2025 VARZOS
 UNKNOWN MANUFACTURER
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose; This non-serious case was reported by a consumer via call center representative an... Late second dose; 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (Patient received first dose in April 2024). On 04-FEB-2025, the patient received the 2nd dose of Shingles vaccine. On 04-FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 05-FEB-2025 Patient reported about the shingles vaccine, stated that he had second one, and the pharmacy told him that it was ok, as patient received first one on Apr 2024, but he was not able to get 2nd one until the day before reporting, so it was longer than 6 months. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2825431 F IL 02/10/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient received 2 doses of Twinrix, one in April and one in May of 2010; This non-serious case was ... patient received 2 doses of Twinrix, one in April and one in May of 2010; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HAB (Twinrix adult) for prophylaxis. Previously administered products included Twinrix (received 1st dose in April 2010) and Twinrix (received 2nd dose in May 2010). On an unknown date, the patient received the 3rd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: patient received 2 doses of Twinrix, one in April and one in May of 2010). The outcome of the incomplete course of vaccination was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-FEB-2025 The pharmacist reported a patient received 2 doses of Twinrix, one in April and one in May of 2010. The pharmacist did not have lot or expiration date of product. The pharmacist stated that he believed it was administered at MD office. Till the time of reporting, the patient did not receive 3rd dose of Twinrix vaccine which led to incomplete course of vaccination. More
2825435 62 F CA 02/10/2025 COVID19
 MODERNA
 1
Biopsy skin abnormal, Cutaneous T-cell lymphoma, Rash Biopsy skin abnormal, Cutaneous T-cell lymphoma, Rash
A skin rash started on the patient's torso a week after receiving vaccine. The rash persiste... A skin rash started on the patient's torso a week after receiving vaccine. The rash persisted and never went away. It is now biopsied and the diagnosis is Mycosis Fungoides a form of Cutaneous Lymphoma More
2825438 70 M CA 02/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Bursitis Bursitis
Bursitis was reported as worsened; This non-serious case was reported by a physician via sales rep a... Bursitis was reported as worsened; This non-serious case was reported by a physician via sales rep and described the occurrence of bursitis in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 27-NOV-2024, the patient received the 1st dose of Arexvy (left arm). On 27-NOV-2024, less than a day after receiving Arexvy, the patient experienced bursitis (Verbatim: Bursitis was reported as worsened). The outcome of the bursitis was not resolved. The reporter considered the bursitis to be related to Arexvy. The company considered the bursitis to be related to Arexvy. Additional Information: GSK Receipt Date: 03-FEB-2025 The patient received Arexvy vaccine and experienced bursitis.; Sender's Comments: US-GSK-US2023145295:same reporter US-GSK-US2023056053:same reporter US-GSK-US2021AMR103016:same reporter US-GSK-US2020AMR210194:same reporter US-GSK-US2020AMR210190:same reporter US-GLAXOSMITHKLINE-US2020AMR089276:same reporter US-GLAXOSMITHKLINE-US2020AMR083961:same reporter More
2825439 U AL 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
administered the Shingrix vaccine but only gave the dilute; administered the Shingrix vaccine but on... administered the Shingrix vaccine but only gave the dilute; administered the Shingrix vaccine but only gave the dilute; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered the Shingrix vaccine but only gave the dilute) and inappropriate dose of vaccine administered (Verbatim: administered the Shingrix vaccine but only gave the dilute). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 13-JAN-2025 The reporter had a nurse that administered the Shingrix vaccine but only gave the dilute which led to inappropriate preparation on medication and inappropriate dose of vaccine administered. The reporter was trying to find out if any of these lot numbers was the dilute TJ534, 745JK, 946580 and LG5577. The reporter was trying to narrow it down so the patient could receive the complete vaccine just not the dilute. More
2825440 U 02/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Facial pain, Herpes zoster, Malaise, Mobility decreased, Swelling face Facial pain, Herpes zoster, Malaise, Mobility decreased, Swelling face
I had shingles; This non-serious case was reported by a consumer via interactive digital media and d... I had shingles; 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 (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (shingles on the side of my face). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I had shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient had shingles on the side of the face just had the first shot, 2 weeks later the patient woke up side of the face hurt like hell swollen went to the doctor she took one look and she said that the patient had shingles had to be in the room for a month and couldn't get out of bed sick as the patient could be but they can not tell that the patient had it and don't want it anymore but the patient was told that you can get it again. More
2825441 1.58 F MI 02/10/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4S5YG
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
4th dose of FluLaval administered; 3rd dose of FluLaval administered; This non-serious case was repo... 4th dose of FluLaval administered; 3rd dose of FluLaval administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 19-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4S5YG, expiry date 30-JUN-2025) for prophylaxis. Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. Previously administered products included Flulaval (patient had 1st dose on December 18th, 2023) and Flulaval (patient had 2nd dose on January 20th, 2024). On 12-DEC-2024, the patient received the 4th dose of FluLaval 2024-2025 season. On 09-SEP-2024, the patient received the 3rd dose of FluLaval 2024-2025 season. On 09-SEP-2024, not applicable after receiving FluLaval 2024-2025 season and an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: 3rd dose of FluLaval administered). On 12-DEC-2024, the patient experienced extra dose administered (Verbatim: 4th dose of FluLaval administered). The outcome of the extra dose administered and extra dose administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 13-JAN-2025 The patient received 4 dose of Flulaval which led to extra dose administered. More
2825442 F FL 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
the second dose has not yet been administered; This non-serious case was reported by a pharmacist vi... the second dose has not yet been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 5th April 2022). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: the second dose has not yet been administered). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 21-JAN-2025 The patient never received the second dose of Shingrix. The pharmacist did not have the product lot number/expiration date information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2825443 F CA 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Dose 1 Shingrix was given in 2021 and wants to get her 2nd dose; This non-serious case was reported ... Dose 1 Shingrix was given in 2021 and wants to get her 2nd 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 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021). 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: Dose 1 Shingrix was given in 2021 and wants to get her 2nd dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 The registered pharmacist reported that the patient wanted to get her 2nd dose of Shingrix and the patient asked if she needed to restart Shingrix series since 1st dose was given in 2021. She stated she was told she had to restart by another pharmacy. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2825444 1.25 F IN 02/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 GC3N4
Extra dose administered Extra dose administered
4th dose of Engerix-B was administered to a patient; This non-serious case was reported by a other h... 4th dose of Engerix-B was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 1-year-old female patient who received HBV (Engerix B) (batch number GC3N4, expiry date 04-AUG-2026) for prophylaxis. Previously administered products included Engerix b (received 3 doses on an unknown dates). On 30-JAN-2025, the patient received the 4th dose of Engerix B. On 30-JAN-2025, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: 4th dose of Engerix-B was administered to a patient). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 The certified medical assistant reported that a 4th dose of Engerix-B was administered to a patient, which led to extra dose administered. More
2825447 4 M AL 02/10/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U783BAA
Y013584
Vaccination site erythema, Vaccination site swelling; Vaccination site erythema,... Vaccination site erythema, Vaccination site swelling; Vaccination site erythema, Vaccination site swelling More
The child experienced large amount of swelling and redness at vaccine site on left thigh. Onset 10/1... The child experienced large amount of swelling and redness at vaccine site on left thigh. Onset 10/18/2024, 1 day after 4 year shots. He was seen at local ER on 10/18 due to swelling and pain. Diagnosed with vaccine reaction. Follow-up on 10/21 with me. Swelling started to improve by then ARTHUS Reaction More
✓
2825448 M KY 02/10/2025 RSV
 PFIZER\WYETH
 KD0161
Asthenia, Myalgia Asthenia, Myalgia
Reported Symptoms: 10028411:MYALGIA; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Ot... Reported Symptoms: 10028411:MYALGIA; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: weakness More
2825449 82 M KY 02/10/2025 FLU3
 SANOFI PASTEUR
 UT8470BA
Rash Rash
Reported Symptoms: 10037844:RASH; Narrative: Pt reported rash to primary care provider 2 months afte... Reported Symptoms: 10037844:RASH; Narrative: Pt reported rash to primary care provider 2 months after receiving influenza-HD vaccine. By this time rash had self resolved. Provider flagged pt chart with allergy. Other Relevant HX: Other: RASH More
2825450 31 F OH 02/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LP1776
LP1776
Chills, Confusional state, Erythema, Nausea, Paraesthesia; Pruritus, Pyrexia, Sk... Chills, Confusional state, Erythema, Nausea, Paraesthesia; Pruritus, Pyrexia, Skin warm, Swelling More
Redness, itching, warm, swelling, chills, low grade fever, nausea, confusion, tingling in face, b/l ... Redness, itching, warm, swelling, chills, low grade fever, nausea, confusion, tingling in face, b/l legs, and b/l feet More
2825451 17 M IN 02/10/2025 COVID19
 JANSSEN
 203A21A
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse reactions reported as of 4/16/21. Patient was under age for administration. No adverse reactions reported as of 4/16/21. Patient was under age for administration.
2825452 34 F CO 02/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EK9231
EK9231
Biopsy oesophagus, Biopsy small intestine abnormal, Chest pain, Duodenitis, Dysp... Biopsy oesophagus, Biopsy small intestine abnormal, Chest pain, Duodenitis, Dysphagia; Endoscopy normal, Endoscopy upper gastrointestinal tract, Odynophagia, Swallow study More
On the evening of 1/16, I developed very painful, mid-sternum pain with swallowing anything. This wa... On the evening of 1/16, I developed very painful, mid-sternum pain with swallowing anything. This was severe and noted with every swallow, even just saliva. It was difficult and painful to swallow for 12 hours. Dysphagia continued for 2 months and I was only able to eat softs, high water content foods and liquids. I was unable to eat foods that formed a bolus such as bread, pasta, meat, etc. Eating and drinking took much longer than normal and I had to take very small bites and chew for an extended period of time. This resolved on its own gradually after 2 months and I am now able to eat normally. More
2825453 16 F FL 02/10/2025 HEP
HPV9
IPV
MMRV
TDAP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
 95BJ9
Y007193
W1C741M

U8232AA
Y010184
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Pt given MMRV and VZV vaccine on same day. No adverse reaction while in clinic. Pt given MMRV and VZV vaccine on same day. No adverse reaction while in clinic.
2825481 F 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Seizure Seizure
seizure; This serious case was reported by a consumer and described the occurrence of seizure in a f... seizure; This serious case was reported by a consumer and described the occurrence of seizure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced seizure (Verbatim: seizure) (serious criteria GSK medically significant). The outcome of the seizure was resolved. It was unknown if the reporter considered the seizure to be related to Shingrix. The company considered the seizure to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 03-FEB-2025 Consumer commented that they had a seizure response to the first dose of the Shingrix vaccine. The reporter also mentioned that yes, even people should be cautious, because drugs were tested on rats before. She was personally know (as a woman) that my seizure response to the shingrix vax wasn't reported, as she kept getting text reminders to get the second one.; Sender's Comments: Seizure is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
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