🏥 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 💀 🏥 🚑 ♿ ⚠️
2864291 9 F PA 10/08/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 8146743
UT8852JA
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Patient was given Moderna Spikevax 0.5 ml prefilled syringe for ages 12 - 64 years instead of Modern... Patient was given Moderna Spikevax 0.5 ml prefilled syringe for ages 12 - 64 years instead of Moderna Spikevax 0.25 ml prefilled syringe 6mo-11 yo More
2864292 70 F IL 10/08/2025 FLUA4
UNK
 SEQIRUS, INC.
UNKNOWN MANUFACTURER
 407241
ma2505
Anaphylaxis treatment, Dyspnoea, Immediate post-injection reaction, Pharyngeal s... Anaphylaxis treatment, Dyspnoea, Immediate post-injection reaction, Pharyngeal swelling, Speech disorder; Anaphylaxis treatment, Dyspnoea, Immediate post-injection reaction, Pharyngeal swelling, Speech disorder More
Patient received 2 vaccinations, Fluad given first, followed by Prevnar 20. Immediately after Prevn... Patient received 2 vaccinations, Fluad given first, followed by Prevnar 20. Immediately after Prevnar 20 patient was having breathing issues and difficulty speaking. Administering technician immediately summoned pharmacist. Pharmacist assessed patient and patient confirmed difficulty breathing and felt like throat was swelling up. Epinephrine 0.3mg administered in right thigh to patient by pharmacist.. Patient refused to sit and wanted to stand and pharmacist helped make sure she was supported. Withing 2 minutes of administration patient felt that symptoms were improving. EMS arrived and assessed patient for about 20-25 minutes and patient refused any further evaluation. Followed up with patient at 5pm on 10/7 and she said she was feeling better but drowsy since she had self administered benadryl. Informed her that we had talked with her PCP Dr. (withheld name) and informed him of the situation on 10/7. Recommended that she follow up with Dr. (withheld name) with an office visit to reevaluate. Followed up with patient on 10/8 and she reported she was feeling better. No further breathing issues. She does report feeling a little jittery and some minor cold like symptoms which could be side effects of the vaccines. She did state she was seeing per PCP today 10/8 More
2864293 17 F MI 10/08/2025 FLU3
HEP
HPV9
MENB
TDAP
UNK
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
UNKNOWN MANUFACTURER
 U8881DA
9G523
Y018398
MA2480
U8620BA
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
PATIENT RECEIVED HEP B DUE TO ORDER MIX UP, PATIENT WAS INFORMED AND COUNSELED AND GIVEN MCV4 AFTER... PATIENT RECEIVED HEP B DUE TO ORDER MIX UP, PATIENT WAS INFORMED AND COUNSELED AND GIVEN MCV4 AFTER DUE TO HER BEING DUE FOR IT. More
2864294 4 M PA 10/08/2025 COVID19
FLU3
MMR
VARCEL
 MODERNA
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 8146743
UT8852JA
Z005855
Z008197
Incorrect dose administered; Incorrect dose administered; Incorrect dose adminis... Incorrect dose administered; Incorrect dose administered; Incorrect dose administered; Incorrect dose administered More
Moderna Spikevax 0.5 ml prefilled syringe ages 12-64 years was given to patient instead of Moderna S... Moderna Spikevax 0.5 ml prefilled syringe ages 12-64 years was given to patient instead of Moderna Spikevax 0.25 Ml 6mo-11 yo. More
2864295 63 F UT 10/08/2025 PNC21
 MERCK & CO. INC.
 Z006076
Arthralgia, Immediate post-injection reaction Arthralgia, Immediate post-injection reaction
Patient described immediate L shoulder pain after vaccination administered. Patient described immediate L shoulder pain after vaccination administered.
2864296 36 F NC 10/08/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2NG23
Headache, Odynophagia, Pain Headache, Odynophagia, Pain
The patient came in on 10-8-25 and claimed that since she has had her flu shot, she has had a headac... The patient came in on 10-8-25 and claimed that since she has had her flu shot, she has had a headache that has been unresolved with APAP, ice packs, etc. She says she is sore, she feels like she wants to relax all the time, uncomfortable when she swallows. I stated that all there was over the counter was APAP (which she had been taking), ice packs, ibuprofen. And has lasted since the shot until now. I encouraged her to seek out a provider to conduct more observations than what we are able to do at the pharmacy. More
2864297 54 M NC 10/08/2025 PNC21
PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z006889
Z006889
Z006889
Z006889
Blood culture, Chest X-ray, Chills, Computerised tomogram abdomen, Computerised ... Blood culture, Chest X-ray, Chills, Computerised tomogram abdomen, Computerised tomogram head; Dizziness, Full blood count, Immunisation reaction, Influenza virus test, Malaise; Metabolic function test, Pyrexia, Respiratory syncytial virus test, SARS-CoV-2 test, Scan with contrast; Tachycardia More
Malaise, high fever 103, tachycardia, chills, dizziness. Patient was sent to the ER for further wor... Malaise, high fever 103, tachycardia, chills, dizziness. Patient was sent to the ER for further workup as it appeared he may be septic. He was admitted on 10/3 and he was discharged on 10/7. He had a full workup including blood cultures, and he was given IV antibiotics while they were looking for the source of the fever. After the full workup it was completed, it was suspected it was a systemic reaction to the vaccine and he was sent home on Ibuprofen as needed for the fever. More
✓
2864298 1 M TX 10/08/2025 FLU3
HEPA
MMR
PNC20
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 UT8792MA
Y018582
Y019931
LK6653
Z008429
Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash
One week after receiving vaccines he developed fever and rash which led to a doctor's visit. One week after receiving vaccines he developed fever and rash which led to a doctor's visit.
2864299 69 M TX 10/08/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8875AA
U8875AA
Chest pain, Chills, Nausea, Neck pain, Pyrexia; Tremor Chest pain, Chills, Nausea, Neck pain, Pyrexia; Tremor
At 4pm of the same day of imz patient experienced fever, chills, nausea, severe shaking that caused ... At 4pm of the same day of imz patient experienced fever, chills, nausea, severe shaking that caused pain in the neck. Patient went to er to seek care. No localized reaction in the arm. patient was given fluids and kept for observation til 4am. Patient states symptoms went away but had chest pain when he got home that resolved without needing additional care. More
2864300 79 F 10/08/2025 UNK
 UNKNOWN MANUFACTURER
Dizziness, Gait disturbance, Walking aid user Dizziness, Gait disturbance, Walking aid user
Dizzy can't walk without aide. Dizzy can't walk without aide.
2864301 42 F IA 10/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 G2HA7
Arthritis, Injection site erythema, Injection site pruritus, Injection site swel... Arthritis, Injection site erythema, Injection site pruritus, Injection site swelling More
Patient reported raised skin, itching, and redness at the site of administration, and inflammation i... Patient reported raised skin, itching, and redness at the site of administration, and inflammation in the elbow and wrist of the same arm starting about 24 hours after vaccination. Symptoms subsided after a few days, but redness in skin lasted for a week or so. More
2864302 80 M MN 10/08/2025 FLU3
 SEQIRUS, INC.
 407252
Diarrhoea, Extra dose administered, Wrong product administered Diarrhoea, Extra dose administered, Wrong product administered
PATIENT INADVERTENTLY RECEIVED TWO INFLUENZA VACCINES DURING THE 2025-2026 SEASON. ONE GIVEN 9/8/25 ... PATIENT INADVERTENTLY RECEIVED TWO INFLUENZA VACCINES DURING THE 2025-2026 SEASON. ONE GIVEN 9/8/25 AND THE SECOND GIVEN 10/7/25. PATIENT REQUESTED COVID VACCINE AT SECOND VISIT. PATIENT REPORTED SOME DIARRHEA, BUT NO OTHER SYMPTOMS. More
2864303 48 F NC 10/08/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 YF3413B
Eye haemorrhage, Eye pain, Vaccine positive rechallenge Eye haemorrhage, Eye pain, Vaccine positive rechallenge
Broken blood vessels in eye and pain in eye for 2 days - no treatment, spontaneously resolved Broken blood vessels in eye and pain in eye for 2 days - no treatment, spontaneously resolved
2864305 70 F 10/08/2025 COVID19
 MODERNA
 3052734
Electrocardiogram abnormal, Magnetic resonance imaging heart abnormal, Myocardit... Electrocardiogram abnormal, Magnetic resonance imaging heart abnormal, Myocarditis, Troponin increased More
diagnosed with myocarditis by cardiac MRI. Had elevated troponin and EKG changes consistent with lo... diagnosed with myocarditis by cardiac MRI. Had elevated troponin and EKG changes consistent with low voltage but no arrhythmia disturbances. Recovered without intervention More
✓
2864306 66 F MI 10/08/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 4GR2B
Dizziness, Dyspnoea Dizziness, Dyspnoea
Patient was here today for her influenza vaccination. She has had 2 others prior to this without pro... Patient was here today for her influenza vaccination. She has had 2 others prior to this without problems. Today she developed significant shortness of breath. She denied throat swelling but just could not catch her breath and was light headed. She was seen by our NP, supplemental oxygen given via mask. Vitals were stable, 02 sat 99% on supplemental 02. She was given Benadryl 25 mg orally and was feeling better. Her husband was called to pick her up as it was recommended she not drive for the rest of the day. Patient given danger warning signs and if throat swelling, hard to breath again, light headed, needs to give herself an Epipen dose and call EMS. She voiced understanding. More
2864307 64 M 10/08/2025 PNC20
 PFIZER\WYETH
 LG5579
Injection site erythema Injection site erythema
Erythema at site Erythema at site
2864309 82 M FL 10/08/2025 FLU3
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received Fluzone HD on 10/7/25 in error. He had already received this vaccination on 8/9/25.... Patient received Fluzone HD on 10/7/25 in error. He had already received this vaccination on 8/9/25. He reported no adverse events from the extra dose More
2864310 50 M AZ 10/08/2025 PNC21
 MERCK & CO. INC.
 Z005765
Pain, Rash, Skin warm, Swelling Pain, Rash, Skin warm, Swelling
Swelling, rash, pain, hot to the touch Swelling, rash, pain, hot to the touch
2864311 68 M PA 10/08/2025 COVID19
 MODERNA
 3052549
No adverse event, Wrong product administered No adverse event, Wrong product administered
Administration error, no unusual adverse side effects. Pharmacist gave Spikevax instead of mNEXSPIK... Administration error, no unusual adverse side effects. Pharmacist gave Spikevax instead of mNEXSPIKE as requested by patient. More
2864312 67 F VA 10/08/2025 COVID19
 MODERNA
Injection site vesicles Injection site vesicles
I took band-aid and I had a blister I took band-aid and I had a blister
2864313 37 M OH 10/08/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 U8889CA
Z006890
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisi... Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisil 9 and Flu Vaccine. More
2864314 86 M FL 10/08/2025 FLU3
 SANOFI PASTEUR
Extra dose administered, Tremor Extra dose administered, Tremor
The customer received a second dose of the seasonal influenza vaccine approximately one month after ... The customer received a second dose of the seasonal influenza vaccine approximately one month after the initial administration. The duplicate vaccination was reported by the customer's daughter after the patient experienced shakiness on the same day the second dose was administered. More
2864315 82 F OH 10/08/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 U8859AA
Z006890
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisi... Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisil 9 and Flu Vaccine. More
2864316 87 F MN 10/08/2025 FLU3
 SANOFI PASTEUR
 U8800CA
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient came in for walk-in influenza. After patient received one dose of high dose flu vaccine, rec... Patient came in for walk-in influenza. After patient received one dose of high dose flu vaccine, records get checked and realized that patient already received one dose of high dose flu vaccine while patient was in the hospital about a month ago. Patient shows no sign of allergic reactions or symptoms after receiving the vaccine today. More
2864317 82 M OH 10/08/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 U8859AA
Z006890
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisi... Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisil 9 and Flu Vaccine. More
2864319 61 F TX 10/08/2025 PNC21
 MERCK & CO. INC.
 Z006076
Erythema, Influenza like illness, Pain in extremity, Pruritus Erythema, Influenza like illness, Pain in extremity, Pruritus
Left arm pain and flu-like symptoms within 6 HOURSs, which were later resolved after 18 hours. Left ... Left arm pain and flu-like symptoms within 6 HOURSs, which were later resolved after 18 hours. Left arm has remained red and itchy since injection [> 10 days] More
2864322 92 F OH 10/08/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 U8859AA
Z006890
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisi... Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisil 9 and Flu Vaccine. More
2864325 62 M 10/08/2025 FLU3
 SANOFI PASTEUR
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
High dose given to 62 year old. High dose given to 62 year old.
2864326 53 M FL 10/08/2025 UNK
 UNKNOWN MANUFACTURER
 407244
No adverse event, Product administered to patient of inappropriate age, Wrong pa... No adverse event, Product administered to patient of inappropriate age, Wrong patient More
Patient walked into the pharmacy to receive a flu shot, however this was the patients first time at ... Patient walked into the pharmacy to receive a flu shot, however this was the patients first time at the pharmacy and we were not made aware of that, his personal information happened to match up to another patient that we already had in the system but that patient was 65+ while this patient was not, and therefore a flu ad 65+ vaccine was billed and administered to the patient. Patient did not complain about any symptoms or followed up with the pharmacy about experiencing any adverse events. More
2864327 77 F OH 10/08/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 U8859AA
Z006890
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisi... Vaccine ordered for client in home to get Covid-19 Vaccine and Flu Vaccine. Client recieved Gardisil 9 and Flu Vaccine. More
2864328 1.17 M CA 10/08/2025 FLU3
HEPA
MMRV
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 73BN2
42DM9
Z008220
Z008220
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; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
No immediate adverse reaction. Parent very upset understandably that vaccine Hep A given too early ... No immediate adverse reaction. Parent very upset understandably that vaccine Hep A given too early and had not planned on getting VAR and MRR until 4 years old. I assured parent we would do a report to capture the vaccine given at incorrect interval (too early) per our process. More
2864329 76 F FL 10/08/2025 FLU3
RSV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 u8859ca
pk9c5
Contusion, Erythema, Pain, Peripheral swelling; Contusion, Erythema, Pain, Perip... Contusion, Erythema, Pain, Peripheral swelling; Contusion, Erythema, Pain, Peripheral swelling More
Patient called 10/8/25 stating she had black and blue bruising on her arm. The black and blue color... Patient called 10/8/25 stating she had black and blue bruising on her arm. The black and blue color has subsided and now the area has a red circle around it , some swelling and is painful to lift things. She had been to quest for blood draw prior to getting the vaccines and states the site of blood draw was also bruised. She has an appointment with her primary on 10/13/25. More
2864333 57 M AL 10/08/2025 FLU3
 SANOFI PASTEUR
 UT8792NA
Blister rupture, Injection site vesicles Blister rupture, Injection site vesicles
A single blister at the insertion site. Once it popped the skin came off. A single blister at the insertion site. Once it popped the skin came off.
2864376 F WY 10/08/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS

Rash; Rash Rash; Rash
The patient then reported that she "had a weird rash" on her arm in which the vaccines wer... The patient then reported that she "had a weird rash" on her arm in which the vaccines were injected.; This spontaneous report was received from a Nurse and refers to an "older" female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), along with shingles vaccine (manufacturer unknown) (lot #, expiration date, strength, dose number, route of administration, anatomical location not provided) as prophylaxis. On an unknown date, the patient reported that she "had a weird rash" on her arm in which the vaccines were injected. The reporter did not see the rash the patient reported the event by phone, and she did not seek medical assistance. At the reporting time, the outcome of vaccination site rash was unknown. The causal relationship between the event and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), and shingles vaccine (manufacturer unknown) was not reported. More
2864377 IL 10/08/2025 HPV9
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
the patient was administered their first dose of GARDASIL 9 on 10/04/2024 and has not yet been admin... the patient was administered their first dose of GARDASIL 9 on 10/04/2024 and has not yet been administered the second or third doses in the series; No symptoms reported.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-OCT-2024, the patient was vaccinated with 1st dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a total dose of 0.5 mL, administered for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). The patient had not yet been administered 2nd and 3rd dose in the series; vaccine schedule interruption of 11 months was reported (Inappropriate schedule of product administration). No symptoms were reported (No adverse event). Lot# is being requested and will be submitted if received. More
2864379 F NY 10/08/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
Confirmed no symptoms reported and no additional details provided; first dose in 2023/The next dose ... Confirmed no symptoms reported and no additional details provided; first dose in 2023/The next dose was not received per the dosing schedule in the Prescribing Information until 09/28/2925; This spontaneous report was received from a consumer or other non-health professional and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On an unknown date in 2023, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) 1 dosage form, administered as prophylaxis (Lot No., expiration date, strength, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On 28-Sep-2025, the patient was vaccinated with the second dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) 1 dosage form, administered as prophylaxis (Lot No., expiration date, strength, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (inappropriate schedule of product administration). Additionally, it was stated that the patient had not yet received the third dose of the previous mention vaccine. No other adverse event was reported (no adverse event). More
2864381 F IN 10/08/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient Administered Both 1st and 2nd Dose of HEPLISAV-B and She is 17 Years Old; First Dose 12AUG20... Patient Administered Both 1st and 2nd Dose of HEPLISAV-B and She is 17 Years Old; First Dose 12AUG2025 Second Dose 17Sep2025; Initial report received on 17-Sep-2025. A nurse reported that a 17-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 12-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot, expiration date, NDC #, site and route not reported)]. On 17-Sep-2025, 36 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose(lot, expiration date, NDC #, site and route not reported). The patient was 17 years old at the time of administration. No adverse reactions were reported. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2864382 M 10/08/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Malaise Malaise
Feeling Terrible After Receiving Vaccines; Initial report received on 18-Sep-2025. A male patient... Feeling Terrible After Receiving Vaccines; Initial report received on 18-Sep-2025. A male patient, reported that he received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and felt terrible. Medical history included previous vaccination with ENGERIX-B (total of 6 rounds completed) over the last 25 years with no immunity. No concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)]. On an unknown date, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)]. Concomitant vaccines administered included flu vaccine (lot #, expiration date, NDC #, site and route not reported)] and COVID-19 vaccine (lot #, expiration date, NDC #, site and route not reported)]. On an unknown date, after having been vaccinated with HEPLISAV-B, the patient reported feeling terrible after receiving all three vaccines co-administered together. Symptoms were not specified. No additional information is available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2864383 F TX 10/08/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Extra dose administered, Incorrect route of product administration, Pain in extr... Extra dose administered, Incorrect route of product administration, Pain in extremity, Rash More
Received Second Dose of Heplisav-B In May 2025, Received A Third Dose One Day Later; Extra Dose Admi... Received Second Dose of Heplisav-B In May 2025, Received A Third Dose One Day Later; Extra Dose Administered; Arm Soreness; Rash on the Right Arm at Site of Subcutaneous Injection; Received dose 2 Subcutaneously; Initial report received on 25-Sep-2025. A consumer reported that she, a female, received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization subcutaneously one day later she received a third dose intramuscularly, experienced arm soreness after each dose, and developed a rash on the right arm. Medical history included an allergy to sulfa. No concomitant medications were reported. In May 2025, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC # not reported)] subcutaneously in the right arm. The patient had arm soreness and developed a rash on the right arm at the subcutaneous dose site. In May 2025, approximately one day after having with the second dose of HEPLISAV-B, the patient received a third dose of HEPLISAV-B (lot #, expiration date, NDC #, and site not reported)] intramuscularly. The patient had arm soreness after the dose was given. The event of rash on the right arm lasted "a few weeks" and has since resolved. No other information was provided.; Sender's Comments: The company assessed the events as non-serious. More
2864384 M 10/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Guillain-Barre syndrome, Tracheostomy Guillain-Barre syndrome, Tracheostomy
Guillain Barre syndrome; This serious case was reported by a physician via sales rep and described t... Guillain Barre syndrome; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant, clinically significant/intervention required and other: Serious as per reporter). The outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 29-SEP-2025 The Health Care Professional reported that a colleague's dad had gotten Shingrix and developed Guillain Barre syndrome and had a tracheotomy. This in turn had made the rest of the physicians hold off on getting vaccinated. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2864385 75 M PA 10/08/2025 COVID19
COVID19
VARZOS
VARZOS
 PFIZER\BIONTECH
PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Arthralgia, Chills, Discomfort, Extra dose administered, Medication error; Myalg... Arthralgia, Chills, Discomfort, Extra dose administered, Medication error; Myalgia, Pain in extremity; Arthralgia, Chills, Discomfort, Extra dose administered, Medication error; Myalgia, Pain in extremity More
little feeling of shivering, that he was shaking like he felt a chill; he had muscle aches and joint... little feeling of shivering, that he was shaking like he felt a chill; he had muscle aches and joint pain; he had muscle aches and joint pain; his arm hurts still today; his left arm started having minor discomfort after receiving the two vaccines on 17-SEP-2025, which felt a little worse yesterday; Vaccines should be administered at different anatomic sites; he forgot he had received the 2 dose Shingrix vaccine series, and received a third dose on Wednesday,; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included TOZINAMERAN (COMIRNATY) for covid-19 prophylaxis. Previously administered products included shingrix (1st dose received on 24-NOV-2023) and shingrix (2nd dose received on 24-JAN-2024). On 17-SEP-2025, the patient received the 3rd dose of Shingrix (left arm) and COMIRNATY (left arm). On 17-SEP-2025, less than a day after receiving Shingrix and COMIRNATY and less than a day after receiving Shingrix and COMIRNATY, the patient experienced shivering (Verbatim: little feeling of shivering, that he was shaking like he felt a chill), muscle pain (Verbatim: he had muscle aches and joint pain), joint pain (Verbatim: he had muscle aches and joint pain), pain in arm (Verbatim: his arm hurts still today), discomfort (Verbatim: his left arm started having minor discomfort after receiving the two vaccines on 17-SEP-2025, which felt a little worse yesterday), medication error (Verbatim: Vaccines should be administered at different anatomic sites) and extra dose administered (Verbatim: he forgot he had received the 2 dose Shingrix vaccine series, and received a third dose on Wednesday,). The patient was treated with ibuprofen;paracetamol (Advil Dual Action). On 17-SEP-2025, the outcome of the muscle pain and joint pain were resolved. On 18-SEP-2025, the outcome of the shivering was resolved (duration 1 day). The outcome of the pain in arm and discomfort were not resolved and the outcome of the medication error and extra dose administered were not applicable. It was unknown if the reporter considered the shivering, muscle pain, joint pain, pain in arm and discomfort to be related to Shingrix and COMIRNATY. It was unknown if the company considered the shivering, muscle pain, joint pain, pain in arm and discomfort to be related to Shingrix and COMIRNATY. Additional Information: GSK Receipt Date: 19-SEP-2025 The patient forgot he had received the 2 dose Shingrix vaccine series and received a third dose along with Covid-19 vaccine Comirnaty in the same arm, and per CDC recommendations, the vaccines should be administered at different anatomic sites, on Wednesday 17-SEP-2025 from pharmacist. More
2864386 57 F FL 10/08/2025 FLU3
VARZOS
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 UNK
GA99K
Pruritus, Rash vesicular; Pruritus, Rash vesicular Pruritus, Rash vesicular; Pruritus, Rash vesicular
Itch; Blistery bumps on her right shoulder and right front chest; This non-serious case was reported... Itch; Blistery bumps on her right shoulder and right front chest; This non-serious case was reported by a nurse via call center representative and described the occurrence of blister in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number GA99K, expiry date 19-SEP-2026) for prophylaxis. Co-suspect products included Fluconazole (Fluzone) for prophylaxis. The patient's past medical history included shingles (shingles on her right shoulder on 14-AUG-2025 (pre-existing Shingrix)). On 19-SEP-2025, the patient received Shingrix (intramuscular, right deltoid) and Fluzone (left arm). On 20-SEP-2025, 1 days after receiving Shingrix and Fluzone, the patient experienced blister (Verbatim: Blistery bumps on her right shoulder and right front chest). On 22-SEP-2025, the patient experienced pruritus (Verbatim: Itch). The outcome of the blister and pruritus were not resolved. It was unknown if the reporter considered the blister and pruritus to be related to Shingrix. The reporter considered the blister and pruritus to be not reported if related to Fluzone. It was unknown if the company considered the blister and pruritus to be related to Shingrix. The company considered the blister and pruritus to be not reported if related to Fluzone. Additional Information: GSK Receipt Date: 22-SEP-2025 The reporter reported that a female patient received the Shingrix Vaccine on 19th September 2025 in her right deltoid and developed blistery bumps on her right shoulder and right front chest the next day 20th September 2025. These blistery bumps do not hurt, but they itch. The reporter stated that the patient had shingles on her right shoulder on 14th August 2025 (pre-existing Shingrix) and, the reporter told by the that as long as the patient had no symptoms of shingles on 19th September 2025, she could receive Shingrix. The patient did receive the Fluzone Flu Vaccine in her left arm at the same visit 19th September 2025. The reporter had not reported this adverse event yet in VAERS but will and had reported all that was provided about this adverse event. More
2864387 75 M PA 10/08/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Arthralgia, Extra dose administered, Gait disturbance, Influenza like illness, I... Arthralgia, Extra dose administered, Gait disturbance, Influenza like illness, Injection site erythema; Pain in extremity, Sleep disorder More
FOOT PAIN; limping and difficulty staying; Extra dose administered; Red sore area at shoulder inject... FOOT PAIN; limping and difficulty staying; Extra dose administered; Red sore area at shoulder injection site; large red area at the injection site; Flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included peripheral neuropathy (Peripheral neuropathy in feet). Previously administered products included Shingrix (received first dose on 26-OCT-2019) and Shingrix (received second dose on 05-JAN-2020). On 18-SEP-2025, the patient received the 3rd dose of Shingrix. In SEP-2025, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms) and injection site erythema (Verbatim: large red area at the injection site). On 18-SEP-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered) and injection site pain (Verbatim: Red sore area at shoulder injection site). On 20-SEP-2025, the patient experienced foot pain (Verbatim: FOOT PAIN) and limping (Verbatim: limping and difficulty staying). On 22-SEP-2025, the outcome of the injection site pain was resolved (duration 4 days). The outcome of the extra dose administered was not applicable and the outcome of the influenza-like symptoms was resolved (duration 1 day) and the outcome of the injection site erythema was resolved and the outcome of the foot pain and limping were not resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site pain, foot pain and limping to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms, injection site erythema, injection site pain, foot pain and limping to be related to Shingrix. Additional Information: GSK Receipt Date: 20-SEP-2025 and 22-SEP-2025 The patient reported that he accidently received three doses of Shingrix. The first dose was on 26th October 2019 and 05th January 2020 and then mistakenly his doctor gave him another dose last Thursday. The patient had flu like symptoms for a day and a large red area at the injection site, about 5 or so inches in diameter and otherwise he felt fine now. The patient stated he had large sore shoulder which was about the size of his hand that he had since Thursday 18th September 2025 resolved this morning on 22nd September 2025. The extra dose was administered and he also mentioned that he believed the reason why he got an accidental third dose of Shingrix was because the first two doses were given at pharmacy and his regular doctor retired, and this was a new doctor (who evidentially did not have all his immunization records). The patient also stated, he had really bad pain in his foot starting Saturday, he was limping around and this had not resolved. The patient woke up a couple hours early that morning due to the pain and he was not sure if this was due to the vaccine or if it was just a coincidence. The patient asked was it ok to have the three doses and was anything for him to be concerned about and he will of course seek medical help if he have any other symptoms. More
2864388 F AZ 10/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
late dose; This non-serious case was reported by a consumer via call center representative and descr... late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on unknown date 2 or 3 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: late dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 22-SEP-2025 The reporter reported that patient received a single shingles vaccine 2 or 3 years ago. The patient does not know the name of the vaccine and states that she only got one dose. The batch number was not provided, and we are unable to contact the reporter. More
2864393 10/08/2025 FLU4
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product storage error Product storage error
refrigerator going our of range and out Flulaval was in there; This non-serious case was reported b... refrigerator going our of range and out Flulaval was in there; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis. On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: refrigerator going our of range and out Flulaval was in there). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 22-SEP-2025 Patient was looking for information about a refrigerator that went out of temperature range while Flulaval was stored inside. patient needed more details on its stability. More
2864394 M 10/08/2025 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 adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Covid-19 vaccine with an associated reaction of covid-19 (got the covid vaccine and got covid anyways). 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 unknown. 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. The company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK receipt date: 29-SEP-2025, 29-SEP-2025, 30-SEP-2025 This case was reported by a patient via interactive digital media. The patient got shingles on face after receiving the shot and stated that he would never be forced to take a shot again. 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. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a adult male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2864395 10/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 months). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles lasted 3 months and had the vaccine a year earlier. 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. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a adult patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2864396 10/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; got shingles last week; This serious case was reported by a consumer ... Suspected vaccination failure; got shingles last week; 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. In SEP-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles last week). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-SEP-2025 This case was reported by a patient via interactive digital media. The patient said that he/she got the vaccine 3 years ago and got shingles last week (from the date of reporting), so it was not a guarantee. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2864397 66 M 10/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
I got the Shingles; This non-serious case was reported by a consumer via interactive digital media a... I got the Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: I got the Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 05-OCT-2025 This case was reported by a patient via interactive digital media. Patient had the shot at 66 and had never had chicken pox because they had been vaccinated in elementary school to keep our shot records up to date with the health department. At 77, he got shingles. More
2864398 M 10/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Guillain-Barre syndrome, Respiratory syncytial virus infection, Vaccination fail... Guillain-Barre syndrome, Respiratory syncytial virus infection, Vaccination failure More
suspected vaccination failure; Guillain Barre syndrome; RSV; This serious case was reported by a con... suspected vaccination failure; Guillain Barre syndrome; RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 63-year-old male 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 vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). The outcome of the vaccination failure was not reported and the outcome of the guillain barre syndrome and respiratory syncytial virus infection were resolving. It was unknown if the reporter considered the vaccination failure, guillain barre syndrome and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure, guillain barre syndrome and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 30-SEP-2025 This case was reported by a patient via interactive digital media. Reporter stated that it did not end with RSV as their close family member had it and shortly after ended up with Guillain Barre syndrome and he was recovering in an acute rehab facility. The batch number was not provided, and we are unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding time to onset for RSV infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Guillain-Barre syndrome, unknown time after receiving RSV vaccine, in a 63-year-old male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
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