πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2862655 25 F GA 10/01/2025 RSV
 PFIZER\WYETH
 lg9829
Bell's palsy, Delivery, Exposure during pregnancy, Induced labour Bell's palsy, Delivery, Exposure during pregnancy, Induced labour
Patient received vaccine at 36weeks and 2 days on 9/18/2025. Patient experienced symptoms of Bell�... Patient received vaccine at 36weeks and 2 days on 9/18/2025. Patient experienced symptoms of Bell's Palsy starting on 9/25/25. Patient was induced on 9/27/25. Estimated due date was 10/14/25. More
βœ“
2862656 68 F CA 10/01/2025 FLU3
 SANOFI PASTEUR
 U8855AA
Abdominal pain upper, Fatigue, Impaired work ability, Somnolence Abdominal pain upper, Fatigue, Impaired work ability, Somnolence
I had a Covid vaccine reaction to this flu shot. EXTREMELY exhausted. for the remainder of 9/21. Sle... I had a Covid vaccine reaction to this flu shot. EXTREMELY exhausted. for the remainder of 9/21. Slept 10 hrs. that night. Tired to work on 9/22 and could not stay awake. Took two naps and slept another 12 hours that night. Stomach pain. More
2862657 81 F MN 10/01/2025 FLU3
 SANOFI PASTEUR
 U8855AA
Balance disorder, Dizziness, Fatigue, Musculoskeletal stiffness, Pain in extremi... Balance disorder, Dizziness, Fatigue, Musculoskeletal stiffness, Pain in extremity More
Patient is experiencing stiff neck, dizzy, light headed, unsteady, fatigue, losing her balance, an... Patient is experiencing stiff neck, dizzy, light headed, unsteady, fatigue, losing her balance, and arm is sore from the vaccination. Patient does NOT have redness and there is no hotness to the vaccine site. More
2862658 73 M FL 10/01/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 bg5j4
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received two doses. no adverse events noted patient received two doses. no adverse events noted
2862659 50 F MI 10/01/2025 FLU3
RSV
 SEQIRUS, INC.
PFIZER\WYETH

Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Was injected with the Flu vaccine, but did not permit the flu vaccine... Asked for RSV vaccine and n... Was injected with the Flu vaccine, but did not permit the flu vaccine... Asked for RSV vaccine and newest COVID 19 vaccine. Was given (injected) with wrong vaccine... More
2862661 68 F OH 10/01/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0589
U8837CA
Pain, Pain in extremity; Pain, Pain in extremity Pain, Pain in extremity; Pain, Pain in extremity
Patient states there left arm has been sore with radiating pain down the arm since the day after vac... Patient states there left arm has been sore with radiating pain down the arm since the day after vaccination. Patient states pain started as typical soreness, then progressed. Also states that it has been slowly getting better but concerned about length of time. Recommended speaking to PCP or urgent care. More
2862662 82 F 10/01/2025 FLU3
 SANOFI PASTEUR
 u8764bb
Injected limb mobility decreased, Injection site pain, Lethargy, Musculoskeletal... Injected limb mobility decreased, Injection site pain, Lethargy, Musculoskeletal discomfort, Product administered at inappropriate site More
PATIENT REPORTS PAIN AT INJECTION SITE. SORENESS AND DIFFICULTY MOVING ARM. SAYS IT IS TOO CLOSE TO ... PATIENT REPORTS PAIN AT INJECTION SITE. SORENESS AND DIFFICULTY MOVING ARM. SAYS IT IS TOO CLOSE TO THE JOINT. SITE OF INJECTION WAS PAINFUL FOR A COUPLE DAYS AND CAUSED LETHARGY. THEN THERE WAS CONTINUED DISCOMFORT OF THE JOINT AREA. REPORTED AFTER ABOUT A MONTH THAT IT WAS GETTING BETTER AND THAT SHE HAD TO RECEIVE PHYSICAL THERAPY DUE TO THE DISCOMFORT. More
2862663 76 M TN 10/01/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052736
u8875aa
Asthenia, Cough, Nausea, Respiratory tract congestion, Vomiting; Asthenia, Cough... Asthenia, Cough, Nausea, Respiratory tract congestion, Vomiting; Asthenia, Cough, Nausea, Respiratory tract congestion, Vomiting More
patient called the pharmacy today and reported he experienced symptoms within 2-3 hours of receiving... patient called the pharmacy today and reported he experienced symptoms within 2-3 hours of receiving his flu and mnexspike vaccine. Symptoms included nausea, vomiting, cough, congestion and weakness. More
2862664 67 F CA 10/01/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0589
UT8794CA
Asthenia, Chills, Diarrhoea, Injection site pain, Pyrexia; Asthenia, Chills, Dia... Asthenia, Chills, Diarrhoea, Injection site pain, Pyrexia; Asthenia, Chills, Diarrhoea, Injection site pain, Pyrexia More
Patient experienced sorness at the injection site after getting vaccine, and over the next 3 days he... Patient experienced sorness at the injection site after getting vaccine, and over the next 3 days her symptoms progressed to , weakness, fever, chills and diarrhea . Patient informed that her symptoms are getting much better and she has improved alot since today. She was able to eat some soup today, and her diarrhea has improved a lot. More
2862665 60 F VA 10/01/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 MY9550
MY9550
Immediate post-injection reaction, Injection site discolouration, Injection site... Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site pain, Injection site swelling; Injection site warmth More
At time of vaccine admin, patient's deltoid bled immediately - was controlled with cotton swab ... At time of vaccine admin, patient's deltoid bled immediately - was controlled with cotton swab before a band aid was placed on it. Was not bleeding through band aid. Patient reported that when she went home a large welt/raised area with bruising formed and continued to get larger over the course of 2 days. She reported that on the 3rd day, bruising stopped spreading and now looks to be turning blue/brown (indicative of healing). Patient was mainly concerned with how large the bruise was (was ~ 4-6 inches from injection site). More
2862666 64 M WI 10/01/2025 PNC20
PNC20
UNK
UNK
 PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Injection site induration, Injection site pain, Injection site reaction, Injecti... Injection site induration, Injection site pain, Injection site reaction, Injection site warmth, Pallor; Rash erythematous, Type III immune complex mediated reaction; Injection site induration, Injection site pain, Injection site reaction, Injection site warmth, Pallor; Rash erythematous, Type III immune complex mediated reaction More
Hot, tender, red, blanchable, firm rash inferior to injection site, well defined border, spread more... Hot, tender, red, blanchable, firm rash inferior to injection site, well defined border, spread more widely over next 3 days. Gradually cleared with a livedo-like appearance. Treated as an Arthur?s reaction with high dose cetirizine and famotidine on post vaccine day 4. I am a physician and consulted informally with an allergy/immunology colleague. More
2862667 24 F CA 10/01/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Arthralgia, Chills, Decreased appetite, Headache, Myalgia; Nausea, Pyrexia, Vomi... Arthralgia, Chills, Decreased appetite, Headache, Myalgia; Nausea, Pyrexia, Vomiting More
Headaches, fever,chills vomiting,nausea,muscle aches,joint pain,loss of appetite Headaches, fever,chills vomiting,nausea,muscle aches,joint pain,loss of appetite
2862668 72 F PA 10/01/2025 COVID19
 PFIZER\BIONTECH
Muscle spasms, Oedema peripheral, Tenderness Muscle spasms, Oedema peripheral, Tenderness
Muscle cramps L calf, R calf, R foot 16 hrs after injection. R axillary swelling & tenderness (... Muscle cramps L calf, R calf, R foot 16 hrs after injection. R axillary swelling & tenderness (same side as injection). More
2862669 43 F IL 10/01/2025 FLU3
FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 AH264
AH264
AH264
Bradycardia, Dizziness, Electrocardiogram abnormal, Fatigue, Flushing; Full bloo... Bradycardia, Dizziness, Electrocardiogram abnormal, Fatigue, Flushing; Full blood count normal, Headache, Heart rate decreased, Hyperhidrosis, Hypertension; Metabolic function test normal More
Hypertension, dizziness, diaphoresis, bradycardia, fatigue, flushed, and headache. These began withi... Hypertension, dizziness, diaphoresis, bradycardia, fatigue, flushed, and headache. These began within minutes after receiving the vaccine. More
βœ“
2862670 62 F FL 10/01/2025 PNC20
 PFIZER\WYETH
 ma2523
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient previously received Prevnar 20 on 8/13/2024 so the patient was not indicated to receive an a... Patient previously received Prevnar 20 on 8/13/2024 so the patient was not indicated to receive an additional dose. The vaccine was a duplicate so the patient was not eligible to receive dose per CDC/ACIP guidelines. Patient has not reported any adverse events and is in good health. More
2862671 65 M OH 10/01/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Contusion, Limb injury, Thrombosis Contusion, Limb injury, Thrombosis
The patient reports that approximately a week after he received his covid shot this year, he experie... The patient reports that approximately a week after he received his covid shot this year, he experienced a blood clot in his leg. he is due to have knee surgery at the start of 2026 so they are monitoring his leg and did not notice any clots during previous appointments. He did not report any other changes in his life other than receiving his covid and flu shots this year. In past years, he has received the Moderna shot without any issues but received the Pfizer shot this year so the doctor thinks it may be related. He has begun treatment using Eliquis to try to treat/prevent future clots. He also reported that he had bumped his left arm in the days following his shot and it bruised like he was on blood thinners so he thinks it may have affected some clotting. More
2862672 76 F NY 10/01/2025 COVID19
 PFIZER\BIONTECH
 MY9550
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Patient developed redness and swelling around injection site the day after vaccination. Went to urge... Patient developed redness and swelling around injection site the day after vaccination. Went to urgent care and was told by md that it look like infection. More
2862673 41 F MO 10/01/2025 FLU3
 SEQIRUS, INC.
Headache, Lethargy, Malaise Headache, Lethargy, Malaise
Intense headache. lethargy & overall ill feeling within approx 2 hours of a administration. Intense headache. lethargy & overall ill feeling within approx 2 hours of a administration.
2862674 56 F WA 10/01/2025 COVID19
COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
FLU3
COVID19
COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR















Guillain-Barre syndrome, Imaging procedure, Laboratory test, Lumbar puncture; An... Guillain-Barre syndrome, Imaging procedure, Laboratory test, Lumbar puncture; Angiogram, Antibody test, Asthenia, Back pain, Fatigue; Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Nervous system disorder, Paraesthesia; Guillain-Barre syndrome, Imaging procedure, Laboratory test, Lumbar puncture; Angiogram, Antibody test, Asthenia, Back pain, Fatigue; Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Nervous system disorder, Paraesthesia; Guillain-Barre syndrome, Imaging procedure, Laboratory test, Lumbar puncture; Angiogram, Antibody test, Asthenia, Back pain, Fatigue; Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Nervous system disorder, Paraesthesia; Guillain-Barre syndrome, Imaging procedure, Laboratory test, Lumbar puncture; Angiogram, Antibody test, Asthenia, Back pain, Fatigue; Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Nervous system disorder, Paraesthesia More
Guillan-Barre Guillan-Barre
2862675 17 M KY 10/01/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Computerised tomogram head normal, Crying, Head discomfort, Headache, Magnetic r... Computerised tomogram head normal, Crying, Head discomfort, Headache, Magnetic resonance imaging head normal; Screaming More
Evening of 09/30/25 went to bed with mild headache. Woke up around 145 am on 10/1/25 with a headache... Evening of 09/30/25 went to bed with mild headache. Woke up around 145 am on 10/1/25 with a headache that felt like his head was being crushed. Was screaming and crying because he was in so much pain. Went to er and they thought blood clot. Gave heparin and transported to hospital where neurology team and radiologist confirmed no blood clot. Unknown cause of headache. More
2862676 7 M 10/01/2025 FLU3
 SANOFI PASTEUR
 U8848BA
Injection site rash Injection site rash
Localized skin reaction (rash) on injection site Localized skin reaction (rash) on injection site
2862677 25 F TX 10/01/2025 FLU3
 SANOFI PASTEUR
 UT8802MA
Palpitations Palpitations
A few hours after the flu vaccine, I began having heart palpitations. Over two weeks later, I contin... A few hours after the flu vaccine, I began having heart palpitations. Over two weeks later, I continue to have heart palpitations. They occur 1-2 times per day, sometimes more, sometimes it skips a day. Nothing has changed in my routine and my stress levels are consistent. More
2862678 64 M NC 10/01/2025 FLU3
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7CF5M
X2283
Underdose; Underdose Underdose; Underdose
None- Pediatric dose given in error - should have been adult dose None- Pediatric dose given in error - should have been adult dose
2862171 RI 09/30/2025 HPV9
 MERCK & CO. INC.
 Y013768
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE; GARDASIL 9 was inadvertently administered to a 6 mo old; This spontaneous report w... No additional AE; GARDASIL 9 was inadvertently administered to a 6 mo old; This spontaneous report was received from a physician, concerning to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-Sep-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y013768 has been verified to be valid as a pre-filled syringe, expiration date reported and confirmed as 12-Feb-2027) 0.5 mL (route of administration unknown), as prophylaxis. Since the vaccine was administered to a 6-month-old patient, event coded as Product administered to patient of inappropriate age. No additional adverse event (No adverse event). More
2862172 09/30/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Fear, Herpes zoster meningitis, Vaccination failure; Fear, Herpes zoster meningi... Fear, Herpes zoster meningitis, Vaccination failure; Fear, Herpes zoster meningitis, Vaccination failure More
varicella zoster meningitis; Suspected vaccination failure; This serious case was reported by a cons... varicella zoster meningitis; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster meningitis in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced herpes zoster meningitis (Verbatim: varicella zoster meningitis) (serious criteria hospitalization and GSK medically significant) and vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant). The outcome of the herpes zoster meningitis and vaccination failure were not reported. It was unknown if the reporter considered the herpes zoster meningitis and vaccination failure to be related to Shingles vaccine and Shingles vaccine. The company considered the herpes zoster meningitis and vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 24-SEP-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and booster, shortly after the patient turned 50. This past summer, the patient was admitted to the hospital with varicella zoster meningitis and reported that it was scary stuff. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Herpes zoster meningitis and Vaccination failure, More than 2 years after receiving 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a 56-year-old patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
βœ“
2862173 33 F NY 09/30/2025 COVID19
 PFIZER\BIONTECH
 EN6206
Chills, Flushing, Throat tightness Chills, Flushing, Throat tightness
flushing; throat closing sensation; Chills, shivering; This is a spontaneous report received from a ... flushing; throat closing sensation; Chills, shivering; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A 38-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Left bundle branch block Diagnosed Spring" (unspecified if ongoing); "autonomic nervous system dysfunction" (unspecified if ongoing); "high blood cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "hyper triglycerides" (unspecified if ongoing); "borderline obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "colorectal bleeding" (unspecified if ongoing), notes: Has very long 17 year history with colorectal bleeding; "chronic fatigue syndrome" (unspecified if ongoing); "Immunoglobulin G is borderline Might be" (unspecified if ongoing); "allergic to Sulfa drug class antibiotics" (unspecified if ongoing); "anaphylaxis" (unspecified if ongoing); "allergic to contrast dye" (unspecified if ongoing); "feeling faint" (unspecified if ongoing); "nausea" (unspecified if ongoing); "hives" (unspecified if ongoing); "Fainted" (unspecified if ongoing); "full body tremors" (unspecified if ongoing); "breathing problems" (unspecified if ongoing); "muscle spasms" (unspecified if ongoing); "Causes heart rate" (unspecified if ongoing), notes: high likelihood of reaction with SSRIS, MAOIS, SSNRIS Benadryl; "Coughing" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "dairy and kiwi allergy" (unspecified if ongoing); "Mild allergy to Latex" (unspecified if ongoing); "gets rash from adhesive" (unspecified if ongoing); "swelling" (unspecified if ongoing); "redness itching" (unspecified if ongoing); "REDNESS" (unspecified if ongoing); "Allergic to chemicals like chemicals in sunscreen" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "allergic"; Hydromorphone, reaction(s): "serotonin syndrome response"; Acetaminophen; Oxybenzone, reaction(s): "Allergic to chemicals like Oxybenzone". Vaccination history included: Bnt162b2. The following information was reported: FLUSHING (non-serious), outcome "unknown"; THROAT TIGHTNESS (non-serious), outcome "unknown", described as "throat closing sensation"; CHILLS (non-serious), outcome "unknown", described as "Chills, shivering". Additional information: First dose Covid-19 vaccine, Pfizer: 10Mar2021 LOT: EN6206 Second Dose Pfizer: 31Mar2021 LOT: ER8733, would have been left shoulder, upper arm for all Covid vaccines. Always gets vaccines in left arm, other than 1 time, got Covid in left arm, flu shot in right arm. After first dose had mild reaction, after second dose, did not need Epi pen. Was having throat closing sensation. Chills, shivering, flushing were all way more intense, than before allergic Sulfa drug class antibiotics. Had reaction to 1 type sulfa, was mild anaphylaxis, years ago. CT contrast for CAT scans, specifically, 60 percent intravenous radio contrast dye. Had mild reaction, throat closing, rapid heart beat, feeling faint, nausea, hives. Has to be pre medicated in future, if needing contrast. Cephalexin, less specific of allergy, said to avoid, seemed to exacerbate colorectal bleeding, best to avoid for safety. More of intolerance, than allergy. Dilaudid is brand name, generic medication is Hydromorphone, which causes serotonin syndrome response. Fainted, had full body tremors, severe with nausea. Was told to avoid narcotics. Does not know if more allergy than seratonic drug sensitivity. Causes heart rate and breathing problems, muscle spasms, high likelihood of reaction with SSRIS, MAOIS, SSNRIS Benadryl. Would start having rapid coughing, asthma attacks, chest pain, feeling super faint. Acetaminophen, found when reaction with Theraflu formula, powder thing, put with hot water. Had not reaction to any other ingredients separately, other than Acetaminophen. Told by doctor, to avoid Acetaminophen, would have mild anaphylaxis, hives, rash itching dizziness. Has dairy and kiwi allergy. Mild allergy to Latex, not always but, sometimes, gets rash from adhesive pastes, like the pastes used in EEGs, when having sleep study. That pastes causes hives, swelling, redness itching. Allergic to chemicals like Oxybenzone, chemicals in sunscreen. More
2862174 33 F NY 09/30/2025 COVID19
 PFIZER\BIONTECH
 ER8733
Chills, Flushing, Throat tightness Chills, Flushing, Throat tightness
throat closing sensation; Chills, shivering; flushing; This is a spontaneous report received from a ... throat closing sensation; Chills, shivering; flushing; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A 38-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8733) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Left bundle branch block Diagnosed Spring", start date: 2023 (unspecified if ongoing); "autonomic nervous system dysfunction" (unspecified if ongoing); "high blood cholesterol" (unspecified if ongoing); "hyper triglycerides" (unspecified if ongoing); "borderline obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "colorectal bleeding" (unspecified if ongoing), notes: Has very long 17 year history with colorectal bleeding.; "chronic fatigue syndrome" (unspecified if ongoing), notes: due to long covid, over weight, obesity, lung issues, high blood cholesterol; "Immunoglobulin G is borderline Might be" (unspecified if ongoing); "allergic to Sulfa drug class antibiotics" (unspecified if ongoing); "anaphylaxis," (unspecified if ongoing); "allergic to contrast dye" (unspecified if ongoing); "rapid heart beat" (unspecified if ongoing); "feeling faint" (unspecified if ongoing); "nausea" (unspecified if ongoing); "hives" (unspecified if ongoing); "Fainted" (unspecified if ongoing); "full body tremors" (unspecified if ongoing); "nausea" (unspecified if ongoing); "breathing problems" (unspecified if ongoing), notes: high likelihood of reaction with SSRIS, MAOIS, SSNRIS Benadryl; "muscle spasms" (unspecified if ongoing), notes: high likelihood of reaction with SSRIS, MAOIS, SSNRIS Benadryl; "Causes heart rate" (unspecified if ongoing), notes: high likelihood of reaction with SSRIS, MAOIS, SSNRIS Benadryl; "coughing" (unspecified if ongoing); "asthma attacks" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "dairy and kiwi allergy" (unspecified if ongoing); "Mild allergy to Latex" (unspecified if ongoing); "gets rash from adhesive" (unspecified if ongoing); "hives" (unspecified if ongoing); "swelling" (unspecified if ongoing); "redness itching" (unspecified if ongoing); "redness" (unspecified if ongoing); "Allergic to chemicals like chemicals in sunscreen," (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "allergic"; Hydromorphone, reaction(s): "serotonin syndrome response"; Acetaminophen; Oxybenzone, reaction(s): "Allergic to chemicals like Oxybenzone". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot:EN6206), administration date: 10Mar2021, for COVID-19 immunisation. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "throat closing sensation"; CHILLS (non-serious), outcome "unknown", described as "Chills, shivering"; FLUSHING (non-serious), outcome "unknown". Additional information: First dose Covid-19 vaccine, Pfizer: 10Mar2021 LOT: EN6206 Second Dose Pfizer: 31Mar2021 LOT: ER8733, would have been left shoulder, upper arm for all Covid vaccines. Always gets vaccines in left arm, other than 1 time, got Covid in left arm, flu shot in right arm. After first dose had mild reaction, after second dose, did not need Epi pen. Was having throat closing sensation. Chills, shivering, flushing were all way more intense, than before allergic Sulfa drug class antibiotics. Had reaction to 1 type sulfa, was mild anaphylaxis, years ago. CT contrast for CAT scans, specifically, 60 percent intravenous radio contrast dye. Had mild reaction, throat closing, rapid heart beat, feeling faint, nausea, hives. Has to be pre medicated in future, if needing contrast. Cephalexin, less specific of allergy, said to avoid, seemed to exacerbate colorectal bleeding, best to avoid for safety. More of intolerance, than allergy. Dilaudid is brand name, generic medication is Hydromorphone, which causes serotonin syndrome response. Fainted, had full body tremors, severe with nausea. Was told to avoid narcotics. Does not know if more allergy than seratonic drug sensitivity. Causes heart rate and breathing problems, muscle spasms, high likelihood of reaction with SSRIS, MAOIS, SSNRIS Benadryl. Would start having rapid coughing, asthma attacks, chest pain, feeling super faint. Acetaminophen, found when reaction with Theraflu formula, powder thing, put with hot water. Had not reaction to any other ingredients separately, other than Acetaminophen. Told by doctor, to avoid Acetaminophen, would have mild anaphylaxis, hives, rash itching dizziness. Has dairy and kiwi allergy. Mild allergy to Latex, not always but, sometimes, gets rash from adhesive pastes, like the pastes used in EEGs, when having sleep study. That pastes causes hives, swelling, redness itching. Allergic to chemicals like Oxybenzone, chemicals in sunscreen. More
2862175 40 F NC 09/30/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 NA0587
NA0587
Burning sensation, Fatigue, Headache, Hypersomnia, Lymphadenopathy; Pain, Vaccin... Burning sensation, Fatigue, Headache, Hypersomnia, Lymphadenopathy; Pain, Vaccination site bruising, Vaccination site swelling, Vaccination site warmth More
slept most of the day; side effects that night burning up; a bad headache; hurting from her head to ... slept most of the day; side effects that night burning up; a bad headache; hurting from her head to her feet; extremely tired; lymph nodes were swollen; Her arm was hot to the touch where she got the shot, swollen and later bruised; Her arm was hot to the touch where she got the shot, swollen and later bruised; Her arm was hot to the touch where she got the shot, swollen and later bruised; This is a spontaneous report received from an Other HCP. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, single (Lot number: NA0587) at the age of 40 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "ehlers danlos syndrome" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: shrimp pork. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "allergy"; Lyrica, reaction(s): "allergy"; Morphine, reaction(s): "allergy". The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset 11Sep2025, outcome "recovered" (12Sep2025) and all described as "Her arm was hot to the touch where she got the shot, swollen and later bruised"; HEADACHE (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "a bad headache"; FATIGUE (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "extremely tired"; PAIN (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "hurting from her head to her feet"; LYMPHADENOPATHY (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "lymph nodes were swollen"; BURNING SENSATION (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "side effects that night burning up"; HYPERSOMNIA (non-serious) with onset 12Sep2025, outcome "recovered" (12Sep2025), described as "slept most of the day". Therapeutic measures were taken as a result of headache, pain. Additional information: The patient had side effects that night burning up. By the Friday morning she was hurting from her head to her feet. She had a bad headache. She was extremely tired, her lymph nodes were swollen. Her arm was hot to the touch where she got the shot, swollen and later bruised. She called out to work that Friday morning. She took two tylenol arthritis. By that afternoon her headache was gone. She slept most of the day. The patient did not receive any other vaccines on the same date as the vaccine, the patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine, the patient was not taking any other medications within 2 weeks of the event starting. More
2862177 26 M IN 09/30/2025 FLU3
 SANOFI PASTEUR
 TFAA2417
Expired product administered, No adverse event Expired product administered, No adverse event
accidentally giving expired flublok to a patient with no reported adverse event; Initial information... accidentally giving expired flublok to a patient with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 26 years old male patient who was accidentally received with an expired Influenza Trivalent Recombinant Vaccine [Flublok] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants were reported. On 24-Sep-2025, the patient accidentally received an expired 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection, lot TFAA2417, expiry date:31-May-2025, frequency: once, strength :standard, via intramuscular route in the left deltoid for influenza with no reported adverse event (expired product administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2862178 LA 09/30/2025 FLU3
MEN
TDAP
 SANOFI PASTEUR
UNKNOWN MANUFACTURER
SANOFI PASTEUR
 UT8869BA
U7949AA
U8353BA
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 event, Product storage error More
ADACEL, FLUZONE HD, MENQUADFI, Max/low temperature reached: Lowest 7.92C High 10.51 C. Above 8C sinc... ADACEL, FLUZONE HD, MENQUADFI, Max/low temperature reached: Lowest 7.92C High 10.51 C. Above 8C since July 12 with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unspecified number of patient(s) of unknown age and unknown gender patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] were exposed to temperature excursion where max/low temperature reached: lowest 7.92 Celsius high 10.51 Celsius; above 8 Celsius since july 12 with no reported adverse event. The unspecified patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the unspecified number of patient(s) received an unknown dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength- unknown expiry date- MAR-2026 and lot U7949AA) via unknown route in unknown administration site, received an unknown dose of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- unknown expiry date- DEC-2026 and lot U8353BA) via unknown route in unknown administration site and received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- unknown expiry date- JUN-2026 and lot UT8869BA) via unknown route in unknown administration site all for Prophylactic vaccination (Immunization) were exposed to temperature excursion where max/low temperature reached: lowest 7.92 Celsius high 10.51 Celsius; above 8 Celsius since july 12 with no reported adverse event (poor quality product administered) (latency- same day). Reportedly, Reason: Malfunction. Human error: Unknown. The extended stability data did not cover the excursion. The product administered to a patient: Unknown. Caller not knowing if any product was administered post excursion. They stated Possibly. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2862179 56 F IN 09/30/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UT8852JA
Extra dose administered, No adverse event, Wrong product administered; Extra dos... Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered More
accidentally administered with FLUZONE NP twice instead of Prevnar20 with no reported adverse event;... accidentally administered with FLUZONE NP twice instead of Prevnar20 with no reported adverse event; accidentally administered with FLUZONE NP twice instead of Prevnar20 with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 56 years old female patient who accidentally administered with influenza USP trival A-B subvirion NO preservative vaccine [fluzone] twice instead of pneumococcal vaccine conj 20V (CRM197) [Prevnar 20] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Sep-2025, the patient accidentally received 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection of standard strength, frequency once with lot UT8852JA and expiry date 30-JUN-2026 via intramuscular route in the left deltoid for Influenza twice instead of prevnar20 with no reported adverse event (extra dose administered) (wrong product administered) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2862180 72 M CA 09/30/2025 TD
 SANOFI PASTEUR
 U7183AA
Fungal infection, Neck pain, Product colour issue Fungal infection, Neck pain, Product colour issue
experience pain on their neck, on the side where the shot was given; received a Tenivac shot, and ha... experience pain on their neck, on the side where the shot was given; received a Tenivac shot, and has been battling a fungus ever since, which is possibly ringworm infection, fungus was right above their neck; it was a non-preservative vaccine, color of vaccine was a maple color transparent; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 72 years old male patient who received a tenivac shot, and has been battling a fungus ever since, which is possibly ringworm infection, fungus was right above their neck, experience pain on their neck, on the side where the shot was given and it was a non-preservative vaccine, color of vaccine was a maple color transparent after receiving Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Jul-2022, the patient received an unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (lot U7183AA, expiry date 24-Sep-2023, strength standard) via unknown route in the left shoulder for Immunisation and it was a non-preservative vaccine, color of vaccine was a maple color transparent (poor quality product administered) (latency same day). On 16-Jul-2022, the patient received a tenivac shot, and has been battling a fungus ever since, which is possibly ringworm infection, fungus was right above their neck (tinea infection) (latency 2 days) following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult. On an unknown date, the patient experienced pain on their neck, on the side where the shot was given (neck pain) (latency unknown) following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult. Reportedly, the first two years he applied triple ointment cream, Calamine lotion, peroxide, alcohol, and finally apple cider vinegar and that cleared it up. It is now back, and he would like to know what he could do. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events (Tinea infection, Neck pain). At time of reporting, the outcome was Unknown for both the events (Tinea infection, Neck pain). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2862181 63 M MI 09/30/2025 FLU3
 SANOFI PASTEUR
 UT8826LA
Device connection issue, Exposure via skin contact, No adverse event, Underdose Device connection issue, Exposure via skin contact, No adverse event, Underdose
when the injection was being administered the needle was not screwed on all the way and 1/3 of the v... when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event; when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event; when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional). This case involves a 63 year old male patient who received Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] and when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine standard strength, frequency -once, (lot UT8826LA and expiry date-30-Jun-2026) via unknown route in unknown administration site for Immunization when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event (accidental exposure to product), (exposure via skin contact) and (incorrect dose administered) (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2862212 69 F CA 09/30/2025 FLU3
 SANOFI PASTEUR
 U8837CA
Contusion, Erythema, Swelling Contusion, Erythema, Swelling
Per pt, swelling, redness, and bruising occurred the following day. The redness and swelling went a... Per pt, swelling, redness, and bruising occurred the following day. The redness and swelling went away by 9/28/25. The bruise remains, but has gotten better per pt. No pain reported. More
2862213 61 F CA 09/30/2025 COVID19
 MODERNA
Bell's palsy, Laboratory test normal Bell's palsy, Laboratory test normal
Bells Palsy diagnosed in ER 9/30/2025 Bells Palsy diagnosed in ER 9/30/2025
2862222 M 09/30/2025 ANTH
ANTH
 EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS

Burning sensation, Cardiac monitoring, Concussion, General physical health deter... Burning sensation, Cardiac monitoring, Concussion, General physical health deterioration, Head injury; Loss of consciousness, Syncope, Type 1 diabetes mellitus More
Type 1 diabetes; His health had went downhill; He felt like fire had went through his entire body; B... Type 1 diabetes; His health had went downhill; He felt like fire had went through his entire body; Blacked out/Collapsed; Hit his head and got a concussion; Hit his head and got a concussion; Hit his head and got a concussion; This spontaneous case report was received on 22-Sep-2025 from a 30-year-old male patient (Height: 5'9"/175.26 cm and weight: 160 lbs/72.57 kg) "who felt like fire had went through his entire body" (PT: Burning sensation), "blacked out/collapsed" (PT: Loss of consciousness), "hit his head and got a concussion" (PT: Concussion, PT: Fall, PT: Head injury), "type 1 diabetes" (PT: Type 1 diabetes mellitus ), "health had went downhill" (PT: General physical health deterioration) following BioThrax (anthrax vaccine adsorbed) administration. The patient's concomitant medications, concurrent conditions were not reported and patient had allergy to pollen. On an unknown date in 2019, the patient was administered BioThrax (lot number: unknown) for an unknown indication. The patient received BioThrax in 2019 while serving. Following the initial dose, he experienced a severe reaction, collapsed and hooked onto a heart monitor. He described the sensation as "fire running through his entire body," and he subsequently blacked out, hit his head (corrected*) that resulted in a concussion. The consumer received two additional doses of BioThrax, after which he reported a decline in his overall health. In 2021 or early 2022, he was diagnosed with type 1 diabetes. He had reported no other significant medical conditions. The patient took insulin therapy. He administered long-acting insulin once daily (20 units, exact brand unknown) and short-acting insulin (Novolog) based on carbohydrate intake at a ratio of 1 unit per 15-20 grams of carbohydrates. No labs or imaging were reported. The outcome of the reported events was unknown. Company comment: This case is regarding a 30-year-old male patient who blacked out/collapsed (loss of consciousness), felt like fire had went through his entire body (burning sensation), hit his head and got a concussion (concussion, fall, head injury), reported that his health had went downhill (general physical health deterioration) following BioThrax (anthrax vaccine adsorbed) administration. On an unknown date in 2021 or 2022, he was diagnosed with type 1 diabetes. The events of loss of consciousness, concussion, fall, head injury, and Type 1 diabetes mellitus have been assessed as serious (medically significant), while burning sensation and general physical health deterioration is considered non-serious. The events of loss of consciousness and burning sensation have been assessed as possibly related to BioThrax (anthrax vaccine adsorbed) in view of a strong temporal association and the known potential of BioThrax to cause syncope and burning sensation. The events of fall, consequent head injury and concussion were the consequences of the recent loss of consciousness experienced by this patient following BioThrax administration, hence, assessed as possibly related to BioThrax. Moreover, the event of general physical health deterioration has been assessed as related to BioThrax in view of a temporal association and a clear reporter's implication that this event occurred following administration of two additional doses of BioThrax. Considering lack of information regarding the latency, exact onset date, complete medical history, clinical course of the event, treatment provided, concomitant medications, and outcome, the causality of Type 1 diabetes mellitus has been assessed as not related to BioThrax.; Sender's Comments: This case is regarding a 30-year-old male patient who blacked out/collapsed (loss of consciousness), felt like fire had went through his entire body (burning sensation), hit his head and got a concussion (concussion, fall, head injury), reported that his health had went downhill (general physical health deterioration) following BioThrax (anthrax vaccine adsorbed) administration. On an unknown date in 2021 or 2022, he was diagnosed with type 1 diabetes. The events of loss of consciousness, concussion, fall, head injury, and Type 1 diabetes mellitus have been assessed as serious (medically significant), while burning sensation and general physical health deterioration is considered non-serious. The events of loss of consciousness and burning sensation have been assessed as possibly related to BioThrax (anthrax vaccine adsorbed) in view of a strong temporal association and the known potential of BioThrax to cause syncope and burning sensation. The events of fall, consequent head injury and concussion were the consequences of the recent loss of consciousness experienced by this patient following BioThrax administration, hence, assessed as possibly related to BioThrax. Moreover, the event of general physical health deterioration has been assessed as related to BioThrax in view of a temporal association and a clear reporter's implication that this event occurred following administration of two additional doses of BioThrax. Considering lack of information regarding the latency, exact onset date, complete medical history, clinical course of the event, treatment provided, concomitant medications, and outcome, the causality of Type 1 diabetes mellitus has been assessed as not related to BioThrax. More
2862223 09/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pruritus Pruritus
made me itch; This serious case was reported by a consumer via interactive digital media and descri... made me itch; This serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: made me itch) (serious criteria other: Serious as per reporter). The outcome of the pruritus was unknown. It was unknown if the reporter considered the pruritus to be related to Shingrix. The company considered the pruritus to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 This case was reported by a patient via interactive digital media. Patient reported that he/she did not need any more. Patient was not in pain and made him/her itch.; Sender's Comments: A case of Pruritus, an unknown time after receiving Shingrix, 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
2862224 09/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
Pain at injection site; This non-serious case was reported by a consumer via interactive digital med... Pain at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site). The outcome of the injection site pain was not reported. It was unknown if the reporter considered the injection site pain to be related to Arexvy. It was unknown if the company considered the injection site pain to be related to Arexvy. Additional Information: GSK Receipt Date: 07-SEP-2025 This case was reported by a patient via interactive digital media. The patient had everything was all good except the pain at injection site after the Arexvy vaccine. More
2862225 09/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I still got shingles even though I had the shots; This serious case w... Suspected vaccination failure; I still got shingles even though I had the shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still got shingles even though I had the shots). 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: 24-SEP-2025 Consumer reported that still got shingles even though had the shots, but it was a very mild case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, on an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2862226 09/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 24-SEP-2025 This case was reported by a patient via interactive digital media. The patient had a slight case of shingles even after Shingles vaccination. The patient was going to get her/his Covid shot, and the health unit want to get the four-way vaccine which includes measles chicken pox and two others, asked should he/she get that vaccine since she/he must have had chicken pox to get the shingles. The patient stated he/she worried about this and asking to advise. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, on an unknown time after receiving Shingles vaccine, in a 80-year-old patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2862227 72 M OH 09/30/2025 FLU3
 SANOFI PASTEUR
 UT8804CA
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
situation is pre-assessed as a medication error/an inappropriate use due to possible subcutaneous ad... situation is pre-assessed as a medication error/an inappropriate use due to possible subcutaneous administration with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 72 years old male patient who received Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] and experienced a medication error/an inappropriate use due to possible subcutaneous administration with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Tozinameran (Pfizer BioNTech COVID-19 vaccine) for Immunisation. On 25-Sep-2025, the patient received 0.5ml dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine, Suspension for injection in pre-filled syringe, Strength high dose, frequency once, expiry date lot UT8804CA in the right deltoid for immunisation, which was pre-assessed as a medication error/an inappropriate use due to possible subcutaneous administration with no reported adverse event (incorrect route of product administration) (latency Same day). Reportedly, Pharmacist inadvertently used 5/8" needle instead of a 1" for administration of FLUZONE HD in adult patient. He was asking if it is still effective or if it needs to be repeated. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusivey to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2862228 47 F MA 09/30/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Chills, Condition aggravated, Hyperhidrosis, Nausea, Pain; Pyrexia, Tension head... Chills, Condition aggravated, Hyperhidrosis, Nausea, Pain; Pyrexia, Tension headache; Chills, Condition aggravated, Hyperhidrosis, Nausea, Pain; Pyrexia, Tension headache More
Recieved vaccine on friday afternoon. Still having symptoms as of tuesday morning. Symptoms. Fever u... Recieved vaccine on friday afternoon. Still having symptoms as of tuesday morning. Symptoms. Fever up to 102 degrees. Body aches. Chills. Extreme sweating. Nauseated. Severe tension headaches. More
2862233 15 M PA 09/30/2025 MENB
MENB
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
SANOFI PASTEUR
 3R33K
3R33K
U8645AA
U8645AA
Fall, Hyperhidrosis, Loss of consciousness, Pallor, Syncope; Tremor; Fall, Hyper... Fall, Hyperhidrosis, Loss of consciousness, Pallor, Syncope; Tremor; Fall, Hyperhidrosis, Loss of consciousness, Pallor, Syncope; Tremor More
During check out, approx 10 minutes after vaccines were administered, pt had syncopal episode and fe... During check out, approx 10 minutes after vaccines were administered, pt had syncopal episode and fell to the floor. When pt fell, he was shaking, sweaty and pale. The shaking lasted approx. 10 seconds before he regained consciousness. Upon waking he was assessed by clinical staff and Provider. After being assessed and sitting for a few minutes. pt was given water, juice and a cereal bar. He reported he hadn't eaten yet today. He did not his his head when he fell and had no injuries. Patient's father was with him. He rested in the office for another 10 minutes. Before departing, Provider assessed. Pt was responding appropriately and had no further concerns or symptoms. More
2862275 F 09/30/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
a provider had given GARDASIL 9 to a 65 year old female patient; no additional AE; This spontaneous ... a provider had given GARDASIL 9 to a 65 year old female patient; no additional AE; This spontaneous report was received from a consumer or other non-health professional and refers to a 65-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the 65 years old patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9), Suspension for injection (indication, expiration date, and lot # were not reported) (inappropriate age at vaccine administration). No additional adverse event was reported. Lot number is being requested and will be submitted if available. More
2862276 83 F CA 09/30/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site reaction, Rash erythematous Injection site erythema, Injection site reaction, Rash erythematous
a redness rash at the injection site; redness rash at the injection site / a 7x7 section of erythema... a redness rash at the injection site; redness rash at the injection site / a 7x7 section of erythema around the patient's injection site; This spontaneous report was received from a physician and refers to an 83-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included vitamin B12. The patient was not immunocompromised. On 03-SEP-2025, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection, administered on an unspecified arm (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 04-SEP-2025, the patient had a redness rash at the injection site. The health professional directed the patient to take acrivastine (BENADRYL) and the rash was getting better over the weekend. On 08-SEP-2025 (on Monday), the patient reached out to the health professional complaining of the same symptoms. That day, examination showed a 7x7 section of erythema around the patient's injection site. Health professional informed the patient to continue treating symptoms with acrivastine (BENADRYL). At the reporting time, the outcome of the events was unknown (reported as "okay/fine"). Causality assessment was not provided. Lot# is being requested and will be submitted if received. More
2862278 GA 09/30/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z002399
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; Inappropriate schedule of product administration, No adverse event More
no side effects/symptoms; dose 2 on 9/17/2025 and dose 3 on 9/29/2025.; This spontaneous report was ... no side effects/symptoms; dose 2 on 9/17/2025 and dose 3 on 9/29/2025.; This spontaneous report was received from a nurse regarding a 28-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 16-JUL-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 1 dosage form administered as prophylaxis (strength, exact dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On 17-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 (strength, exact dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On 29-SEP-2025 (less than 1 month after the second dose), the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 1 dosage form administered as prophylaxis (lot number reported as Z002399, which has been verified as valid, expiration date reported and validated as 20-FEB-2027) (strength, exact dose, route and anatomical site of administration were not reported) (Inappropriate schedule of product administration). No side effects or symptoms were reported in the patient. Additional information is not expected. More
2862279 12 F SC 09/30/2025 HPVX
HPVX
HPVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Anxiety, Cardiac stress test normal, Depression, Dizziness, Echocardiogram norma... Anxiety, Cardiac stress test normal, Depression, Dizziness, Echocardiogram normal; Electrocardiogram normal, Loss of consciousness, Loss of personal independence in daily activities, Ovarian cyst ruptured, Seizure; Syncope, Synovitis, Vertigo More
anxiety; vertigo; depression; ovarian cyst ruptures; bilateral ankle synovitis; vasovagal syncope; n... anxiety; vertigo; depression; ovarian cyst ruptures; bilateral ankle synovitis; vasovagal syncope; non-epileptic seizures; Information has been received regarding a case in litigation from a Lawyer and refers to a(n) 12-year-old female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-Nov-2022, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), dose number 1, 1 dosage form as prophylaxis (route of administration, lot # and expiration date were not reported). As the months progressed, so did Plaintiff's injuries, as she began seeing multiple physicians and specialists for a variety of complaints.. In December of 2022, she started seeing a Pediatric Nurse Practitioner(PNP), for nonepileptic seizures. In February 2023, she started seeing a health care professional for anxiety and depression. Around the same time, Plaintiff started experiencing dizziness and began passing out. Plaintiff was taken to physician on 13-Feb-2023 and complained that she had experienced dizziness and lightheadness 3 times in the prior week. Physician referred her to Cardiology. On 16-Feb-2023, she was rushed to the Medical Center after passing out at school. On 17-Feb-2023 at Medical Center, Plaintiff was given a cardiovascular exam, electrocardiogram (EKG), echocardiogram and stress test by physician and was diagnosed with vasovagal syncope. In December 30, 2023, she was treated at the hospital for ovarian cyst ruptures. Since February 2024, she has suffered from bilateral ankle synovitis for which she must wear boots. As a result of her post-Gardasil symptoms, Plaintiff had been unable to engage in activities that a normal young person would enjoy. Prior to Plaintiff's Gardasil vaccination, she was an active child who played soccer, participated in recreational cheer, took ballet lessons, and excelled at competitive gymnastics. Plaintiff was in the middle of her cheer season when she received the Gardasil vaccination. After passing out while extended in the air, and developing dizziness, lightheadedness and vertigo, she was forced to quit cheerleading and gymnastics. She was now medically homebound due to her continuing seizures Based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including but not limited to, vasovagal syncope, non-epileptic seizures, anxiety, depression, ovarian cyst ruptures and bilateral ankle synovitis. As a proximate result of the company wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of Gardasil, Plaintiff has suffered and continues to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Plaintiff also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her injuries caused by Gardasil. As a direct and proximate result of her Gardasil-induced injuries, Plaintiff has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. At the reporting time, the patient had not recovered from anxiety, bilateral ankle synovitis, vertigo, non-epileptic seizures, depression, vasovagal syncope and ovarian cyst ruptures. The reporter considered the events to be related to of ovarian cyst ruptures to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine(GARDASIL). The reporter considered the event(s) of anxiety bilateral ankle synovitis, vertigo, non-epileptic seizures, depression, vasovagal syncope and ovarian cyst ruptures to be disabling/incapacitating. More
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2862280 59 F DE 09/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Lack of drug effect; Shingles; This serious case was reported by a consumer via call center represen... Lack of drug effect; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 28-NOV-2020, the patient received the 2nd dose of Shingrix. On 27-SEP-2020, the patient received the 1st dose of Shingrix. In AUG-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 18-SEP-2025 The patient was currently getting over a case of shingles (lack of drug effect) which began approximately 3 weeks ago. The patient had no health concerned and was not taking any medication on a regular basis. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. No further information was obtained/provided; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving 1si dose of Shingrix and 2nd dose of Shingrix, in a 64-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2862281 F 09/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure/ Lack of drug effect; experienced a shingles outbreak 7 weeks ago; Thi... Suspected vaccination failure/ Lack of drug effect; experienced a shingles outbreak 7 weeks ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In AUG-2025, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: experienced a shingles outbreak 7 weeks ago). The outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 24-SEP-2025 The reporter reported that the patient had both Shingrix doses a few years ago (from the date of reporting) and experienced a shingles outbreak 7 weeks ago. The reporter refused to provide any information. She called to ask if the Shingrix series should be repeated in someone who had active shingles. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than a year after receiving 1st and 2nd dose of Shingrix in a female subject. 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
2862283 F 09/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
First shot gave me shingles; This non-serious case was reported by a consumer via interactive digita... First shot gave me shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had them 40 years ago when the patient was only 33 years old). 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: First shot gave me shingles). The outcome of the shingles was resolving. The reporter considered the shingles to be related to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 25-SEP-2025 This case was reported by a patient via interactive digital media. Patient stated that bullshit the shingles was not about people over 50, patient personally had shingles 40 years ago when patient was only 33 years old and the first shot gave shingles to the patient for the second time got told that patient was clueless for said that patient had shingles at 50 years old approximately 10 years later. The patient was contacted and telling that they had discovered that the first shot was causing people to get shingles so the patient had to have the 2 part shots should be thankful that treatment had improved so much, the patient had to have a shot in the middle of my back for 10 days straight, was given medication to paint on it 3 times a day in the dark. The batch number was not provided, and unable to contact the reporter. More
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