🏥 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 💀 🏥 🚑 ♿ ⚠️
2721756 48 M CA 12/07/2023 FLU4
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2XTD9
2XTD9
Hypoaesthesia, Injection site mass, Mobility decreased, Pain in extremity, Skin ... Hypoaesthesia, Injection site mass, Mobility decreased, Pain in extremity, Skin warm; Asthenia, Injection site pain, Injection site swelling More
ARM NUMBNESS, HARD TIME LIFTING ARM, ARM FEELING HOT, PAINFUL 5-6/10, LUMP AT INJECTION SITE. ARM NUMBNESS, HARD TIME LIFTING ARM, ARM FEELING HOT, PAINFUL 5-6/10, LUMP AT INJECTION SITE.
2857122 44 F NY 09/05/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 330308D
330308D
330308D
Anti-thyroid antibody increased, Antibody test negative, Autoimmune thyroiditis,... Anti-thyroid antibody increased, Antibody test negative, Autoimmune thyroiditis, Blood thyroid stimulating hormone normal, C-reactive protein increased; Impaired work ability, Iron deficiency, Loss of personal independence in daily activities, Pain, Palpitations; Polymyalgia rheumatica, Red blood cell sedimentation rate increased, SARS-CoV-2 antibody test positive, Thyroxine free decreased More
pt has had 3 covid vaccines and has never had covid infection to her knowledge (nucleocapsid antibod... pt has had 3 covid vaccines and has never had covid infection to her knowledge (nucleocapsid antibody is also negative) Spike protein antibody level is very high still nearly 3.5 years after last covid vaccination. She has always been healthy all her life, took no medicines, exercised daily. Diagnosed in March 2025 with polymyalgia rheumatica, autoimmune thyroiditis and iron deficiency of unknown cause. PMR is very rare, nearly unheard of in her age group. Rheumatology confirmed. Patient is now suffering from chronic pain, is on chronic prednisone, thyroid medicine, daily iron and cannot activity like she used to. this has affected her day to day activities and work significantly. She has most recently presented with new palpitations and is being referred to cardiology. Patient feels the 3 MRNA covid vaccines she had in 2021 have contributed to her new health conditions. More
2857123 17 M TX 09/05/2025 MNQ
 SANOFI PASTEUR
 u8124ab
Dizziness, Dyspnoea, Nausea, Syncope Dizziness, Dyspnoea, Nausea, Syncope
The patient was given MenQuadfi. right away, He felt fainted, dizzy, and nausea, and hard to breath.... The patient was given MenQuadfi. right away, He felt fainted, dizzy, and nausea, and hard to breath. 911 was called right away for help. The patient was taken to the hospital for further monitoring. More
2857124 25 F MD 09/05/2025 FLU3
 SEQIRUS, INC.
 407003
Erythema, Inflammation, Pain of skin, Pruritus Erythema, Inflammation, Pain of skin, Pruritus
Inflammation about 2 inches in diameter. Skin read and tender, as well as itchy Inflammation about 2 inches in diameter. Skin read and tender, as well as itchy
2857126 23 M IL 09/05/2025 COVID19
 PFIZER\BIONTECH
 MY9547
Arthralgia, Injection site pain, Migraine Arthralgia, Injection site pain, Migraine
Injection site has been painful and sore since the evening following the injection, also same timeli... Injection site has been painful and sore since the evening following the injection, also same timeline, having joint aches and soreness especially in the knees both are continuing. Migraine began 9:30PM 9/5/25 More
2857199 1.25 F CO 09/05/2025 DTAPIPVHIB
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
 UK342AA
Z006737
Product preparation issue; Product preparation issue Product preparation issue; Product preparation issue
Dtap/Hib/IPV not mixed correctly. Only Dtap/IPV component given. Dtap/Hib/IPV not mixed correctly. Only Dtap/IPV component given.
2856746 F CA 09/04/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 N733B
Wrong product administered Wrong product administered
a patient got a dose of Engerix-B yesterday instead of Twinrix as scheduled.; This non-serious case ... a patient got a dose of Engerix-B yesterday instead of Twinrix as scheduled.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 57-year-old female patient who received HBV (Engerix B) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 04-AUG-2025, the patient received the 1st dose of Engerix B. The patient did not receive the 2nd dose of Twinrix. On 04-AUG-2025, an unknown time after receiving Engerix B, the patient experienced wrong vaccine administered (Verbatim: a patient got a dose of Engerix-B yesterday instead of Twinrix as scheduled.). 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: 05-AUG-2025 The reporter called to report that a patient got a dose of Engerix-B the day before reporting instead of Twinrix as scheduled, which led to wrong vaccine administered. Healthcare professional wanted to know how to proceed for completing the series. 1st Twinrix vaccine was administered on 3rd July 2025. More
2856747 62 F CA 09/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Rash, Skin swelling Erythema, Rash, Skin swelling
Rash on her forearms, on top part of her elbows; Swelling, skin is swollen; Redness, elbows are stil... Rash on her forearms, on top part of her elbows; Swelling, skin is swollen; Redness, elbows are still red; Little pumps going down both forearms; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22-AUG-2025, the patient received the 1st dose of Shingrix (right deltoid). In AUG-2025, less than a week after receiving Shingrix, the patient experienced papular rash on arms (Verbatim: Little pumps going down both forearms). On 23-AUG-2025, the patient experienced rash (Verbatim: Rash on her forearms, on top part of her elbows), swelling (Verbatim: Swelling, skin is swollen) and erythema (Verbatim: Redness, elbows are still red). The outcome of the rash and swelling were unknown and the outcome of the erythema was not resolved and the outcome of the papular rash on arms was not reported. It was unknown if the reporter considered the rash, swelling, erythema and papular rash on arms to be related to Shingrix. It was unknown if the company considered the rash, swelling, erythema and papular rash on arms to be related to Shingrix. Additional Information: GSK Receipt Date: 28-AUG-2025 and 29-AUG-2025 The reporter's (doctor's) wife received last Friday the Shingrix vaccine and the next day she presented rash, swelling and redness in her forearm. The reporter wanted to know if she should get the Second dose. Upon callback the doctor shared that it (rash) was not only on her forearms but on top part of her elbows and skin was swollen. Her elbows were still red. The patient had little bumps going down both forearms. More
2856748 FL 09/04/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Near death experience COVID-19, Drug ineffective, Near death experience
COVID was a mere nuisance; not even as bad as a cold. Without it, I almost died; COVID was a mere nu... COVID was a mere nuisance; not even as bad as a cold. Without it, I almost died; COVID was a mere nuisance; not even as bad as a cold. Without it, I almost died; COVID was a mere nuisance; not even as bad as a cold. Without it, I almost died; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 003110. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID was a mere nuisance; not even as bad as a cold. Without it, I almost died". Clinical course: The patient stated add me to your data on the COVID vaccine. With the Pfizer vaccine, COVID was a mere nuisance; not even as bad as a cold. Without it, I almost died. One night, I had to make a conscious effort whether to fight uphill and survive or to accept the easier path of no more chills, no more fever, no more life. I am an avid marathon runner. I am not of ill health or overweight or sedentary. What I fought would have killed someone of lesser physical stamina. Please keep making the vaccine available. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2856758 12 F AZ 09/04/2025 TDAP
 SANOFI PASTEUR
 U7869AA
Expired product administered, No adverse event Expired product administered, No adverse event
Member was administered Tdap vaccine on 8/28/25. Vaccine expired on 8/18/25. Member tolerated vaccin... Member was administered Tdap vaccine on 8/28/25. Vaccine expired on 8/18/25. Member tolerated vaccine well. No adverse reactions were observed or reported. More
2856759 49 M TX 09/04/2025 COVID19
COVID19
 MODERNA
MODERNA

Blood disorder, Bone pain, Cardiac disorder, Chemotherapy, Chronic myeloid leuka... Blood disorder, Bone pain, Cardiac disorder, Chemotherapy, Chronic myeloid leukaemia; Full blood count, Platelet count increased, White blood cell count increased More
blood disorder, high WBC * PLT taking CML chemo drugs blood disorder, high WBC * PLT taking CML chemo drugs
✓ ✓ ✓
2856760 54 F WA 09/04/2025 FLU3
RSV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8823AA
B5NJ9
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Pain in site where RSV injected, Redness/swelling/heat that was initially about the size of a nickel... Pain in site where RSV injected, Redness/swelling/heat that was initially about the size of a nickel that is increasing in diameter each day. It is now about four times the size or more. It is hard in the area where the redness/swelling is and is also painful to the touch. More
2856761 1.33 M TX 09/04/2025 MMR
 MERCK & CO. INC.
Autism spectrum disorder Autism spectrum disorder
my son was 1.5 yr old when MMR was given and it impacted his brain and became Autistic my son was 1.5 yr old when MMR was given and it impacted his brain and became Autistic
✓
2856767 12 F VA 09/04/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FH443
Wrong product administered Wrong product administered
Bexsero administered instead of MenA vaccine; This non-serious case was reported by a nurse via call... Bexsero administered instead of MenA vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 15-JUL-2025, the patient received Bexsero. The patient did not receive Menveo. On 15-JUL-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero administered instead of MenA vaccine). 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: 06-AUG-2025 and 14-AUG-2025 The reporter called to report that a patient had received the Meningococcal B vaccine (Bexsero) instead of the intended Menveo, which had been scheduled for administration on 15 July 2025, which led to wrong vaccine administered. According to the reporter, the patient had been scheduled to receive a dose of the Menveo vaccine later that same day, on 06 August 2025. The healthcare provider had requested safety information regarding the administration of Menveo on 6th August 2025, after one of her patients had mistakenly received Bexsero instead of Menveo on 15th July 2025. More
2856768 30 F PA 09/04/2025 FLU3
 SANOFI PASTEUR
 UT8792LA
Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
fluzone administered while mother was pregnant with no reported adverse event; Initial information r... fluzone administered while mother was pregnant with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 years old female patient who was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to vaccine at 22 weeks of pregnancy. The date of last menstrual period was reported as 28-Mar-2025. The estimated due date is 28-Dec-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 27-Aug-2025, the pregnant patient received dose 1 of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, (unknown strength) and expiry date Jun-2026 lot number UT8792LA not reported via intramuscular route in unknown administration site for immunization with no reported adverse event (exposure during pregnancy) (Latency Same day). Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. More
2856825 60 M PA 09/04/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
63 year old male vaccinated with Nonavalent HPV vaccine; Literature Article. This literature report... 63 year old male vaccinated with Nonavalent HPV vaccine; Literature Article. This literature report received from the authors above and refers to a(n) 60-year-old male patient. The patient's medical history included Solid organ transplant at his 55 years old. The patient's concurrent conditions included chronic immunosuppression. Concomitant therapies were not reported. On an unknown date (reported as 4 years after the transplant), the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (manufacturer unknown), Injection, a 2 doses scheme (administration route, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). This is one of 4 same literature reports. A copy of the published article is attached as further documentation of the patient's experience. More
2856827 AZ 09/04/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Z003310
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE; HCP calling to report TE PROQUAD administered on 08/13/2025; This spontaneous repo... No additional AE; HCP calling to report TE PROQUAD administered on 08/13/2025; This spontaneous report was received from an other health professional and refers to an patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-AUG-2025, the patient was vaccinated with an improperly storage of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (dose, route of administration and anatomical location were not reported, lot number Z003310, which was verified to be valid, and expiration date on 21-JUL-2026), the vaccine was reconstituted with sterile diluent (Hollister Sterile Diluent), for prophylaxis. The administered dose of the vaccine experienced a temperature excursion -11.7 degrees Celsius for 31 minutes, it was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. More
2856828 60 CA 09/04/2025 MMR
 MERCK & CO. INC.
 X026404
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
No additional AE; HCP calling to report administration of MMR-II with TE on 08/12/2025; This spontan... No additional AE; HCP calling to report administration of MMR-II with TE on 08/12/2025; This spontaneous report was received from a other health professional and refers to a 60-year-old 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 12-AUG-2025, the patient was vaccinated with an improperly storage of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, route of administration, anatomical location were not reported, lot number X026404, which was verified to be valid, expiration date not reported, but upon internal review established on 08-NOV-2025), the vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion 15.1 degrees Fahrenheit for 15 minutes, and previous excursion was 13.5 degrees Fahrenheit, for 1 hour and 30 minutes, it was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. More
2856829 VA 09/04/2025 HEPA
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y018512
Y013565
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
no adverse reactions were experienced after the administered dose; TE occurring on 8/16/2025 and 8/1... no adverse reactions were experienced after the administered dose; TE occurring on 8/16/2025 and 8/17/2025 for GARDASIL-9 and VAQTA that were administered after TE on 8/18/2025. one patient was administered VAQTA & GARDASIL-9;; This spontaneous report was received from an office manager (also reported as "health business professional" [HBP]) concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 16 and 17-Aug-2025, doses of Hepatitis A Vaccine, Inactivated (VAQTA) and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) underwent temperature excursion (TE) of 1.5C degrees Celsius (C) for 2 hours, 24 minutes, 0 seconds, 0.9 C for 5 hours, 14 minutes, 0 seconds with prior excursion of 8.3C for 0 hours, 44 minutes, o seconds (7/8.) On 18-Aug-2025, the patient was vaccinated with improperly stored doses of Hepatitis A Vaccine, Inactivated (VAQTA) injection 25/0.25, batch/lot #Y018512 has been verified to be a valid batch lot number for Hepatitis A Vaccine, Inactivated, expiration date reported and upon internal validation confirmed as 03-Jul-2026, 0.5 mL (dosage regimen, anatomical location and route of administration were not reported); and with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, batch/lot #Y013565 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation confirmed as 01-Feb-2027, 0.5 mL (dosage regimen, anatomical location and route of administration were not reported) (product storage error). Both vaccines were administered as prophylaxis. TE evaluation was communicated as 'supported' during the call. Reporter stated that no adverse reactions were experienced after the administered dose (no adverse event.) This was one of four reports received from the same reporter. More
2856831 M UT 09/04/2025 HEPA
 MERCK & CO. INC.
 S034636
Expired product administered, No adverse event Expired product administered, No adverse event
HCP called to report an expired dose of VAQTA was administered to a patient on 11/17/202.; No additi... HCP called to report an expired dose of VAQTA was administered to a patient on 11/17/202.; No additional AE/No PQC.; This spontaneous report was received from a medical assistant and refers to a 6-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (reported as 17-Nov-202), the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #S034636 with expiration date reported as and upon internal validation confirmed to be 14-Nov-2020) 0.5 mL (route of administration and vaccination site were not reported) administered for prophylaxis. On that day, an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) was administered to the patient (expired product administered). Potency of the dose was supported by the post expiry memo. No symptoms were reported at the time of the call. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). More
2856832 14 M CO 09/04/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9JT4S
Extra dose administered Extra dose administered
gave another dose of Boostrix in his left deltoid 7 days later by mistake; This non-serious case was... gave another dose of Boostrix in his left deltoid 7 days later by mistake; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 14-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9JT4S, expiry date 21-FEB-2027) for prophylaxis. Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX). On 05-AUG-2025, the patient received Boostrix (left deltoid) .5 ml. On 05-AUG-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: gave another dose of Boostrix in his left deltoid 7 days later by mistake). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 07-AUG-2025 The reporter stated that she gave a dose of Boostrix to a patient on 31-JUL-2025 in his right deltoid. Then she gave the patient another dose of Boostrix in his left deltoid 7 days later by mistake which led to extra dose administered. More
2856833 70 F TX 09/04/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Body temperature increased, Fatigue, Headache, Myalgia Body temperature increased, Fatigue, Headache, Myalgia
Headache; Temperature elevation; Myalgia; Fatigue; This non-serious case was reported by a consumer ... Headache; Temperature elevation; Myalgia; Fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of myalgia in a 70-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 05-AUG-2025, the patient received RSV vaccine (left arm). On 05-AUG-2025, less than a day after receiving RSV vaccine, the patient experienced myalgia (Verbatim: Myalgia) and fatigue (Verbatim: Fatigue). On 06-AUG-2025, the patient experienced headache (Verbatim: Headache) and body temperature increased (Verbatim: Temperature elevation). The outcome of the myalgia, fatigue and headache were not resolved and the outcome of the body temperature increased was resolving. It was unknown if the reporter considered the myalgia, fatigue, headache and body temperature increased to be related to RSV vaccine. It was unknown if the company considered the myalgia, fatigue, headache and body temperature increased to be related to RSV vaccine. Additional Information: GSK Receipt Date: 07-AUG-2025 The patient who received a Respiratory Syncytial Virus vaccine at local pharmacy. The patient did not get any paperwork from the pharmacy, and the name and manufacturer of the vaccine could not be verified. After receiving the Respiratory Syncytial Virus vaccine, she experienced myalgia, fatigue, headache, and a temperature elevation of 101.9 degrees Fahrenheit. All symptoms were ongoing, and her temperature has decreased to 99.0 degrees Fahrenheit as of reporting date. More
2856834 60 F NY 09/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site pain, Injection site swelling, Pyrexia Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
her arm, at injection site was red; her arm, at injection site, was swollen; her arm, at injection s... her arm, at injection site was red; her arm, at injection site, was swollen; her arm, at injection site was painful; Slight fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included No other conditions and products were reported. On 18-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 19-JUL-2025, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: her arm, at injection site was red), injection site swelling (Verbatim: her arm, at injection site, was swollen), injection site pain (Verbatim: her arm, at injection site was painful) and fever (Verbatim: Slight fever). The outcome of the injection site erythema was not resolved and the outcome of the injection site swelling, injection site pain and fever were resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and fever to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 08-AUG-2025 The patient reported 24 hours later her arm, at injection site, was swollen, red, painful and she had a slight fever. She stated everything had resolved except for redness and was very concerned about the redness. She stated that she had been examined by her nurse practitioner and who advised her to apply ice to the affected area. However, she did not follow the advice and had not applied ice to the area. She did discuss the matter with the manager at the pharmacy where she received the injection. More
2856835 TX 09/04/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
Bexsero early second dose; This non-serious case was reported by a pharmacist via call center repres... Bexsero early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO). On 11-AUG-2025, the patient received the 2nd dose of Bexsero. On 11-AUG-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Bexsero early second dose). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-AUG-2025 The reporter reported that the clinics gave the second Bexsero dose too soon and first dose was given on May 2025 and then second dose on Monday which led to drug dose administration interval too short. The reporter asked if they should give a third dose, or it was okay. More
2856836 WA 09/04/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Incorrect Route of Administration; This non-serious case was reported by a nurse via call center rep... Incorrect Route of Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. The patient received Priorix (intramuscular). The patient experienced subcutaneous injection formulation administered by other route (Verbatim: Incorrect Route of Administration). The outcome of the subcutaneous injection formulation administered by other route 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: 14-AUG-2025 Nurse reported that Priorix was supposed to be given by subcutaneous route whereas was given by intramuscular route which led to subcutaneous injection formulation administered by other route. Nurse was concerned whether there was something to be watched for. More
2856837 72 F NC 09/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never received her second dose; This non-serious case was reported by a pharmacist via call center r... never received her 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 72-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received her first dose of Shingrix on 31-MAY-2022, expiry date:10 JUL 2023 and batch number: E42J2). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: never received her second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 The pharmacist calling to report that a patient never receive her second dose. The reporter stated that the patient received the first dose of Shingrix at another pharmacy chain and could not supply the route or location of administration from the online records. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. More
2856838 09/04/2025 VARCEL
VARCEL
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 A1234567
A1234567
A1234567
A1234567
Abdominal pain, Abdominal pain upper, Chest pain, Cough, Diarrhoea; Dizziness, D... Abdominal pain, Abdominal pain upper, Chest pain, Cough, Diarrhoea; Dizziness, Dyspepsia, Pyrexia, Vision blurred, Visual acuity reduced; Abdominal pain, Abdominal pain upper, Chest pain, Cough, Diarrhoea; Dizziness, Dyspepsia, Pyrexia, Vision blurred, Visual acuity reduced More
sensation of acid reflux; chest pain; coughing; heartburn; abdominal pain; stomach pain; deteriorati... sensation of acid reflux; chest pain; coughing; heartburn; abdominal pain; stomach pain; deteriorating vision/feels more like vision getting worse than dizzines/things are blurry, harder to see; diarrhea; fever; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of dry cough in a patient who received Herpes zoster (Shingrix) (batch number A1234567, expiry date 20-OCT-2025) for prophylaxis. Co-suspect products included Varicella zoster vaccine live (Varicella vaccine, live) (batch number A1234567, expiry date 20-NOV-2024) for prophylaxis and Immunoglobulin human anti-tetanus (Tetabulin sn) (batch number A1234567, expiry date 20-OCT-2024) for prophylaxis. Concurrent medical conditions included hypertension (5 years duration), renal disease (3 years Duration) and diabetes (1 years duration). On 15-OCT-2024 11:20, the patient received Shingrix (right deltoid), Varicella vaccine, live (right deltoid) and Tetabulin sn (right deltoid). On 15-OCT-2024, less than a day after receiving Shingrix, Varicella vaccine, live and Tetabulin sn, the patient experienced dry cough (Verbatim: coughing), heartburn (Verbatim: heartburn) and chest pain (Verbatim: chest pain). In OCT-2024, the patient experienced abdominal pain (Verbatim: abdominal pain), stomach pain (Verbatim: stomach pain), deterioration of visual acuity (Verbatim: deteriorating vision/feels more like vision getting worse than dizzines/things are blurry, harder to see), diarrhea (Verbatim: diarrhea) and fever (Verbatim: fever). On an unknown date, the patient experienced esophageal acid reflux (Verbatim: sensation of acid reflux). The outcome of the dry cough, abdominal pain, stomach pain and deterioration of visual acuity were not resolved and the outcome of the heartburn, esophageal acid reflux, chest pain, diarrhea and fever were not reported. It was unknown if the reporter considered the dry cough, heartburn, esophageal acid reflux, chest pain, abdominal pain, stomach pain, deterioration of visual acuity, diarrhea and fever to be related to Shingrix, Varicella vaccine, live and Tetabulin sn. It was unknown if the company considered the dry cough, heartburn, esophageal acid reflux, chest pain, abdominal pain, stomach pain, deterioration of visual acuity, diarrhea and fever to be related to Shingrix, Varicella vaccine, live and Tetabulin sn. Additional Information: GSK Receipt Date: 05-AUG-2025 The patient felt like having heartburn because there was sensation of acid reflux coming up, also seemed to have dry cough. Patient had diarrhea and stomach pain they were not sure if it was from diarrhea or a burning feeling in the upper stomach, but it hurt a lot. Patient felt more like vision was getting worse than dizziness, things were blurry and harder to see, patient also had severe fever. As pe the last update patient was experiencing persistent coughing with abdominal pain and stomach pain that seemed to be worsening over time and feeling of progressively deteriorating vision. Patient had no recent vaccination history. More
2856839 09/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nerve injury, Pain Nerve injury, Pain
nerve damage in my feet and legs; This non-serious case was reported by a consumer via interactive ... nerve damage in my feet and legs; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced nerve damage (Verbatim: nerve damage in my feet and legs). The outcome of the nerve damage was not reported. It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine. It was unknown if the company considered the nerve damage to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a Patient via interactive digital media. Patient advised against getting the shingles shot. He/she had received it, and three months later, he/she developed nerve damage in his/her feet and legs. The pain was so severe that shingles would have felt like heaven in comparison. More
2856840 M 09/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
general feeling of unwell; This non-serious case was reported by a consumer via sales rep and descr... general feeling of unwell; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a 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 feeling unwell (Verbatim: general feeling of unwell). The outcome of the feeling unwell was resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 11-AUG-2025 The reporter's husband had received his Shingrix shot and experienced a general feeling of being unwell for about a day.; Sender's Comments: US-GSK-US2025AMR105760:Same reporter More
2856841 09/04/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
Made me truly sick; This non-serious case was reported by a consumer via interactive digital media a... Made me truly sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Made me truly sick). The outcome of the sickness was resolved. It was unknown if the reporter considered the sickness to be related to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK receipt date: 18-AUG-2025 This case was reported by a patient via interactive digital media. Patient stated that nurse came in and gave him/her a shot without asking and didn't ask her what it was. Patient learned a lesson that it was RSV shot. Well patient was over it. Patient advised that never let anyone give a shot without asking what it is. Patient still recommends older. More
2856842 09/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pruritus Pruritus
itchy spots that moves from one area to; This non-serious case was reported by a consumer via intera... itchy spots that moves from one area to; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pruritus (Verbatim: itchy spots that moves from one area to). The outcome of the pruritus was not reported. It was unknown if the reporter considered the pruritus to be related to Herpes Zoster vaccine. It was unknown if the company considered the pruritus to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 16-AUG-2025 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient reported that he/she had itchy spots that moves from one area to other area. More
2856843 09/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles on face; This serious case was reported by a consumer via in... Suspected vaccination failure; Shingles on face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles on face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK receipt date: 20-AUG-2025 This case was reported by a patient via interactive digital media. The patient had vaccines and was dealing with shingles on face now at the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2856844 1 F CA 09/04/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Wrong vaccine; Wrong age; patient got Kinrix as third dose of Polio vaccine and as the fourth dose o... Wrong vaccine; Wrong age; patient got Kinrix as third dose of Polio vaccine and as the fourth dose of DTaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 20-JUN-2026) for prophylaxis. Co-suspect products included Diphtheria vaccine toxoid (Diphtheria) for prophylaxis, Tetanus vaccine for prophylaxis, Pertussis vaccine for prophylaxis and Polio vaccine for prophylaxis. Previously administered products included Diphtheria vaccine (on 26th April 2024 patient received Diphtheria vaccine), Tetanus vaccine (on 5th August 2024 patient received Tetanus vaccine with batch number 7C9NJ), Pertussis vaccine (on 30th January 2025 patient received pertusis vaccine with batch number 9KB9G), Polio vaccine (received 1st dose of vaccine on 26th April 2024) and Polio vaccine (received 2nd dose of vaccine on 5th August 2024 with batch number W1C751M). On 30-JUL-2025, the patient received Kinrix. The patient did not receive Diphtheria, Tetanus vaccine, Pertussis vaccine and Polio vaccine. On 30-JUL-2025, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine), inappropriate age at vaccine administration (Verbatim: Wrong age) and inappropriate schedule of vaccine administered (Verbatim: patient got Kinrix as third dose of Polio vaccine and as the fourth dose of DTaP). The outcome of the wrong vaccine administered, 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: 31-JUL-2025 and 01-AUG-2025 A registered nurse explained that a 17-month-old patient had been scheduled to receive the Diphtheria, Tetanus, and Pertussis vaccine and the Polio vaccine as separate injections. However, instead of administering them separately, the nurse had given Kinrix instead, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient received Kinrix as the third dose of the polio vaccine (instead of the fourth dose as indicated in the prescribing information) and as the fourth dose of DTaP (instead of the fifth dose as indicated in the prescribing information), which led to inappropriate schedule of vaccine administered. More
2856845 1 M IL 09/04/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 x9eps
Extra dose administered Extra dose administered
Pediarix as a 4th dose in the Hep-B series and IPV series; This non-serious case was reported by a n... Pediarix as a 4th dose in the Hep-B series and IPV series; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number x9eps, expiry date 09-FEB-2026) for prophylaxis. Previously administered products included Hepatitis B (received 3rd dose of Hepatitis B on 24-OCT-2024). On 28-JUL-2025, the patient received the 4th dose of Pediarix. On 28-JUL-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Pediarix as a 4th dose in the Hep-B series and IPV series). The outcome of the extra dose 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: 05-AUG-2025 The nurse reported that a 15-month-old baby received Pediarix as a 4th dose. The patient had now 4 IPVs and 4 Hep-B, which led to extra dose administered. More
2856846 1.83 M MI 09/04/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 Z7L7H
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
one year 10 month old male patient with initials empty was accidentally given a TDAP dose, which was... one year 10 month old male patient with initials empty was accidentally given a TDAP dose, which was supposed to be a DTAP dose; 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 22-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 09-AUG-2026) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On 21-JUL-2025, the patient received the 1st dose of Boostrix. The patient did not receive DTaP vaccine. On 21-JUL-2025, an unknown time after receiving Boostrix the patient experienced wrong vaccine administered (Verbatim: one year 10 month old male patient with initials empty was accidentally given a TDAP dose, which was supposed to be a DTAP dose). 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: 05-AUG-2025 The practice manager reported that a patient of inappropriate age was accidentally given a TDAP dose (Boostrix), which was supposed to be a DTAP dose, being the 4th dose in the series, which led to wrong vaccine administered. The reporter wanted to know how to proceed. The Vaccine Administration Facility was the same as primary reporter. More
2856847 F CA 09/04/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 2ME34
Underdose Underdose
44 year old received a pediatric dose of Engerix-B; 44 year old received a pediatric dose of Engerix... 44 year old received a pediatric dose of Engerix-B; 44 year old received a pediatric dose of Engerix-B; 44 year old received a pediatric dose of Engerix-B; 44 year old received a pediatric dose of Engerix-B; 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 44-year-old female patient who received HBV (Engerix B) (batch number 2ME34, expiry date 15-JUL-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 2ME34, expiry date 15-JUL-2026) for prophylaxis. On 05-AUG-2025, the patient received the 3rd dose of Engerix B. On 04-AUG-2025, the patient received the 2nd dose of Engerix B. On 04-AUG-2025, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: 44 year old received a pediatric dose of Engerix-B) and underdose (Verbatim: 44 year old received a pediatric dose of Engerix-B). On 05-AUG-2025, the patient experienced adult use of a child product (Verbatim: 44 year old received a pediatric dose of Engerix-B) and underdose (Verbatim: 44 year old received a pediatric dose of Engerix-B). The outcome of the adult use of a child product, underdose, 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: 05-AUG-2025 A nurse reported that 44 year old patient received a pediatric dose of Engerix-B and then came back on August 5th 2025 and received a second dose of the pediatric presentation of Engerix-B to complete the series at the instruction of a physician. The realization of the second dose was uncovered during the phone call. They stated that the those that were had been given on 4th August 2025 was the patient's second dose in the hepatitis B series and that the one that was given on 5th August 2025 was the 3rd dose., which led to adult use of a child product and underdose. More
2856848 OH 09/04/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Intercepted product storage error Intercepted product storage error
Possible administration of Priorix 8 hours after reconstitution; This non-serious case was reported ... Possible administration of Priorix 8 hours after reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received MMR (Priorix) for prophylaxis. The patient did not receive Priorix. The patient experienced intercepted product storage error (Verbatim: Possible administration of Priorix 8 hours after reconstitution). The outcome of the intercepted product storage error 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: 12-AUG-2025 A healthcare professional contacted GlaxoSmithKline to request data on the administration of Priorix after it had been stored 8 hours after reconstitution. They stated that this did not take place at their site and mentioned that it was only a possibility, not knowing any data on the patient or vaccine administered. More
2856849 F GA 09/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74NC9
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call cente... Inappropriate Schedule of Vaccine; 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 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis. Previously administered products included Shingrix (received first dose on 17 Feb 2023 with lot 943GF). On 20-FEB-2025, the patient received the 2nd dose of Shingrix. On 20-FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 12-AUG-2025 The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. More
2856850 79 M FL 09/04/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
pt received a second dose of arexvy. first in july 2024 and pt requested and received another on 9/2... pt received a second dose of arexvy. first in july 2024 and pt requested and received another on 9/2/25 More
2856851 F CA 09/04/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Incomplete course of vaccination, Liver transplant Incomplete course of vaccination, Liver transplant
liver transplant; This serious case was reported by a pharmacist via call center representative and ... liver transplant; This serious case was reported by a pharmacist via call center representative and described the occurrence of liver transplant in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis. Concurrent medical conditions included liver disorder. On 15-MAY-2025, the patient received Twinrix. On 16-MAY-2025, 1 days after receiving Twinrix, the patient experienced liver transplant (Verbatim: liver transplant) (serious criteria clinically significant/intervention required). The outcome of the liver transplant was not reported. It was unknown if the reporter considered the liver transplant to be related to Twinrix and Twinrix Pre-Filled Syringe Device. The company considered the liver transplant to be unrelated to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-AUG-2025 The pharmacist contacted GlaxoSmithKline to request data about the recommendations after a patient received their first dose of Twinrix and the following day, got a liver transplant and then never got their second dose. The reporter wanted to know if there was any data, including recommendations. The reporter did not have the vaccine details. The vaccine administration facility was the same as primary reporter.; Sender's Comments: A case of Liver transplant, 1 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, in a 65-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative etiology (Concurrent medical conditions included liver disorder). More
2856852 70 M MD 09/04/2025 PNC20
RSV
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX4486
YE232
Blister, Fatigue, Injection site discharge, Injection site reaction; Blister, Fa... Blister, Fatigue, Injection site discharge, Injection site reaction; Blister, Fatigue, Injection site discharge, Injection site reaction More
patient got clear liquid-filled bullae on each one of the 2 injections sites, tiredness patient got clear liquid-filled bullae on each one of the 2 injections sites, tiredness
2856853 5 M OH 09/04/2025 DTAPIPV
DTAPIPV
DTAPIPV
DTAPIPV
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.





Erythema, Influenza virus test, Peripheral swelling, Respiratory syncytial virus... Erythema, Influenza virus test, Peripheral swelling, Respiratory syncytial virus test, SARS-CoV-2 test; Wheezing; Erythema, Influenza virus test, Peripheral swelling, Respiratory syncytial virus test, SARS-CoV-2 test; Wheezing; Erythema, Influenza virus test, Peripheral swelling, Respiratory syncytial virus test, SARS-CoV-2 test; Wheezing More
left arm swelling and redness. school nurse noted wheezing. no wheezing appreciated left arm swelling and redness. school nurse noted wheezing. no wheezing appreciated
2856854 0.25 M OH 09/04/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 5N2AN
Faeces discoloured, Infant irritability, Rash, Rash maculo-papular Faeces discoloured, Infant irritability, Rash, Rash maculo-papular
Black tacky and tarry stools for 3 days starting one day after administration, child also fussy and ... Black tacky and tarry stools for 3 days starting one day after administration, child also fussy and developed maculopapular rash on chest and face More
2856855 0.58 F DE 09/04/2025 DTAPIPVHIB
 SANOFI PASTEUR
Injection site discomfort, Injection site erythema, Injection site swelling, Inj... Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth More
Immediately became red at injection site, redness and swelling continue to grow and now patients ent... Immediately became red at injection site, redness and swelling continue to grow and now patients entire thigh is showing swelling and redness, hot to the touch, uncomfortable for patient, redness becoming rash-like More
2856856 4 M NY 09/04/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 406989
406989
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No symptoms 30 mins after administration, patient was monitored. No symptoms 30 mins after administration, patient was monitored.
2856857 66 F IN 09/04/2025 FLU3
PNC21
RSV
 SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH


Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, L... Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness More
Patient received 3 vaccines on same date. Felt dizzy/ pass out for few seconds recovered quickly. Pa... Patient received 3 vaccines on same date. Felt dizzy/ pass out for few seconds recovered quickly. Patient stated she does not like needle or blood probably caused but felt ok and did not want any further help or evaluation. More
2856858 77 M IA 09/04/2025 COVID19
 MODERNA
 207h23-2A
Death Death
patient passed away patient passed away
✓
2856860 18 F TN 09/04/2025 MNQ
 SANOFI PASTEUR
 U8271AB
Extra dose administered Extra dose administered
A 3rd dose was given due to not looking at record prior to giving vaccine. This dose was not needed A 3rd dose was given due to not looking at record prior to giving vaccine. This dose was not needed
2856861 56 F TX 09/04/2025 COVID19
 PFIZER\BIONTECH
 MD3414
No adverse event No adverse event
There was no adverse reaction. There was no adverse reaction.
2856862 80 M IN 09/04/2025 FLU3
 SANOFI PASTEUR
 U8764DB
Injection site pain, Musculoskeletal stiffness, Neck pain Injection site pain, Musculoskeletal stiffness, Neck pain
Patient reports pain/stiffness in the left side of his neck a few minutes after receiving the vaccin... Patient reports pain/stiffness in the left side of his neck a few minutes after receiving the vaccination. He states that the pain/stiffness still persisted into the following day. No swelling/redness at injection site. Sore at injection site. More
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