🏥 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 💀 🏥 🚑 ♿ ⚠️
2868245 43 F OH 10/24/2025 FLU3
 SEQIRUS, INC.
 406988
Lymphadenopathy, Pain Lymphadenopathy, Pain
Significant right sided axillary lymphadenopathy and pain starting approximately 10 hours after inj... Significant right sided axillary lymphadenopathy and pain starting approximately 10 hours after injection received. Area continued to be painful over the next 24 hours with pain radiating into the right breast area. 48 hours after inferior, pain and lymphadenopathy persists. More
2868246 29 M 10/24/2025 FLU3
 SEQIRUS, INC.
Expired product administered Expired product administered
expired vaccine expired vaccine
2868247 28 M 10/24/2025 FLU3
 SEQIRUS, INC.
Expired product administered Expired product administered
expired vaccine expired vaccine
2868248 10 F OR 10/24/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA4452
TFAA2537
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Gave adult dose of Comirnaty (instead of 5-11yo dose) Gave adult dose of Comirnaty (instead of 5-11yo dose)
2868249 9 M MD 10/24/2025 FLU3
 SANOFI PASTEUR
 u8864BA
Dizziness, Head injury, Hyperhidrosis, Loss of consciousness, Pallor Dizziness, Head injury, Hyperhidrosis, Loss of consciousness, Pallor
Pt received a flu shot. Mom was next for her appointment so he went outside the booth with dad. When... Pt received a flu shot. Mom was next for her appointment so he went outside the booth with dad. When I came back from getting moms shot, the patient was in dads arms. He apparently told dad he was feeling dizzy and leaned against him. Lost consciousness and went over backwards and hit his head. EMS was called. pt had already regained consciousness but was pale and sweaty. Paramedics arrived and took pt to ambulance to get vitals. More
2868251 0.58 F PA 10/24/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052668
UT8817NA
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Patient was mistakenly given the Covid Spikevax dose for patients age 12 years and up. Pt is 7 month... Patient was mistakenly given the Covid Spikevax dose for patients age 12 years and up. Pt is 7 months old. More
2868252 53 F TN 10/24/2025 FLU3
HEP
HEPA
 SEQIRUS, INC.
DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
 AX4143C
946889
Z27PB
Peripheral swelling, Skin tightness, Tongue disorder, Urticaria; Peripheral swel... Peripheral swelling, Skin tightness, Tongue disorder, Urticaria; Peripheral swelling, Skin tightness, Tongue disorder, Urticaria; Peripheral swelling, Skin tightness, Tongue disorder, Urticaria More
Received phone call from patient 2 days after flu vaccine was administered stating that her tongue h... Received phone call from patient 2 days after flu vaccine was administered stating that her tongue had felt "thick" all day. Denied difficulty breathing or swallowing. Also reports hives and swelling down left arm. States skin feels tight when she bends her arm. Pt was going to have a family member take her to a different clinic that she sees for evaluation. Attempted to contact patient to f/u on visit several times and patient did not answer. More
2868253 69 F 10/24/2025 COVID19
 MODERNA
Peripheral swelling, Vaccination site mass, Vaccination site reaction Peripheral swelling, Vaccination site mass, Vaccination site reaction
my arm is still very swollen; It's like a huge lump/just this one area where I got the injectio... my arm is still very swollen; It's like a huge lump/just this one area where I got the injection; I have the Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm is still very swollen), VACCINATION SITE MASS (It's like a huge lump/just this one area where I got the injection) and VACCINATION SITE REACTION (I have the Covid arm) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse effect with INFLUENZA VACCINE. On 03-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. In October 2025, the patient experienced PERIPHERAL SWELLING (my arm is still very swollen), VACCINATION SITE MASS (It's like a huge lump/just this one area where I got the injection) and VACCINATION SITE REACTION (I have the Covid arm). At the time of the report, PERIPHERAL SWELLING (my arm is still very swollen), VACCINATION SITE MASS (It's like a huge lump/just this one area where I got the injection) and VACCINATION SITE REACTION (I have the Covid arm) had not resolved. No relevant medical history. No concomitant medication was reported. Patient had gotten the latest COVID shot, and her arm was still very swollen. It looks like patient was working out with that muscle. This was just very odd. Patient usually have a pretty big reaction. Patient have taken the Moderna every time and this one was much better, the reaction. Patient had the Covid arm. Patient had this still two weeks later. It's like a huge lump. So, it looked like patient was almost like a bodybuilder in a way, and patient was not. Patient was a very tiny little person in just this one area where she got the injection. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Causality was not reported. This case was linked to MOD-2025-790385 (Patient Link). More
2868254 10 M WA 10/24/2025 COVID19
 MODERNA
 3052995
Fatigue, Injection site reaction, Injection site swelling, Injection site warmth Fatigue, Injection site reaction, Injection site swelling, Injection site warmth
Swollen, red, hot area surrounding injection site measuring 8x6cm. Onset was within a few hours of t... Swollen, red, hot area surrounding injection site measuring 8x6cm. Onset was within a few hours of the injection, and has persisted 4 days since. Pt feels fatigued but is not visibly ill. More
2868257 60 M OH 10/24/2025 FLU3
 SEQIRUS, INC.
 407273
Incorrect dose administered Incorrect dose administered
patient was given the fluad for 65 and over but was only 60 at time of vaccination patient was given the fluad for 65 and over but was only 60 at time of vaccination
2868258 74 F MT 10/24/2025 FLU3
FLU3
PNC21
PNC21
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 UT8763HA
UT8763HA
Z009681
Z009681
Arthralgia, Chills, Headache, Injection site erythema, Injection site induration... Arthralgia, Chills, Headache, Injection site erythema, Injection site induration; Injection site warmth; Arthralgia, Chills, Headache, Injection site erythema, Injection site induration; Injection site warmth More
On Tuesday the Capvaxive injection site became hard shortly after administration, patient developed ... On Tuesday the Capvaxive injection site became hard shortly after administration, patient developed chills a couple of hours after immunization which lasted through the night, patient also developed a headache that radiated up both sides of her neck and developed pain in her hip joints, Wednesday she noticed that her left arm was red and hot-the redness spread from the crest of her shoulder almost down to her inner elbow. More
2868259 64 F 10/24/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 ut8770ka
Z009681
Injection site erythema, Injection site inflammation, Injection site swelling, P... Injection site erythema, Injection site inflammation, Injection site swelling, Product administered at inappropriate site, Somnolence; Injection site erythema, Injection site inflammation, Injection site swelling, Product administered at inappropriate site, Somnolence More
Patient reported event via phone, I was unable to visually confirm any of this. Reaction was a lar... Patient reported event via phone, I was unable to visually confirm any of this. Reaction was a large, red bump (~5-6 inch diameter) believed to be centered on injection site. According to the patient, her nurse says the shot was improperly administered "too low" (potentially below the deltoid?) resulting in this reaction. Was given steroids by her doctor to help with inflammation and the bump has begun to shrink since then. She also reported additional sleepiness in the following days. More
2868260 72 F TX 10/24/2025 FLU3
 SEQIRUS, INC.
 407981
Contusion, Skin discolouration Contusion, Skin discolouration
Bruising - large are - purple, pink, red, yellow - extreme discoloration and the area was larger tha... Bruising - large are - purple, pink, red, yellow - extreme discoloration and the area was larger than a softball. It literally wrapped around my arm. Day 11 - area is about the size of a two fifty cent pieces. One is dark purple and the other is purple and red. I have never had a reaction like this, in the past, to a vaccine. More
2868262 CA 10/24/2025 PNC20
 PFIZER\WYETH
 MG7421
Product contamination physical Product contamination physical
nspects before injecting, noticed white foreign body floating in product. This one has white floatin... nspects before injecting, noticed white foreign body floating in product. This one has white floating thing inside syringe, did not dissolve when tried shaking it.; This is a spontaneous report received from a Pharmacist from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MG7421, Expiration Date: 30Sep2026) for immunisation, Device Lot Number: MG7421, Device Expiration Date: 30Sep2026. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "nspects before injecting, noticed white foreign body floating in product. This one has white floating thing inside syringe, did not dissolve when tried shaking it.". Additional information: Calling about the Prevnar 20. This is second dose, not sure if normal, pretty sure is not. Inspects before injecting, noticed white foreign body floating in product. Thought was a one off the last time, but occurred with a second dose as well. Usually inspects before injecting into patient. This one has white floating thing inside the syringe, and did not dissolve when caller tried shaking it. Confirmed this occurred with two Prevnar 20 products. Still floating. Asking if normal or not? Doesn't think normal. Confirmed no patients were administered the two Prevnar 20 products with the concern, caught before injection. Causality for "nspects before injecting, noticed white foreign body floating in product. this one has white floating thing inside syringe, did not dissolve when tried shaking it." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500190009 same reporter/PC, different product lot.; More
2868263 CA 10/24/2025 PNC20
 PFIZER\WYETH
 MA2519
Product contamination physical Product contamination physical
inspects before injecting, noticed white foreign body floating in product. This one has white floati... inspects before injecting, noticed white foreign body floating in product. This one has white floating thing inside syringe, did not dissolve when tried shaking it.; This is a spontaneous report received from a Pharmacist from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MA2519, Expiration Date: Sep2026) for immunisation, Device Lot Number: MA2519, Device Expiration Date: Sep2026. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "inspects before injecting, noticed white foreign body floating in product. This one has white floating thing inside syringe, did not dissolve when tried shaking it.". Additional information: Calling about the Prevnar 20. This is second dose, not sure if normal, pretty sure is not. Inspects before injecting, noticed white foreign body floating in product. Thought was a one off the last time, but occurred with a second dose as well. Usually inspects before injecting into patient. This one has white floating thing inside the syringe, and did not dissolve when caller tried shaking it. Confirmed this occurred with two Prevnar 20 products. Still floating. Asking if normal or not? Doesn't think normal. Confirmed no patients were administered the two Prevnar 20 products with the concern, caught before injection. Causality for "inspects before injecting, noticed white foreign body floating in product. this one has white floating thing inside syringe, did not dissolve when tried shaking it." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500189939 same reporter/PC, different product lot; More
2868265 30 F 10/24/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Body temperature, Fatigue, Nausea, Pain, Pyrexia; Body temperature, Fatigue, Nau... Body temperature, Fatigue, Nausea, Pain, Pyrexia; Body temperature, Fatigue, Nausea, Pain, Pyrexia More
Body aches; Fever of up to 101 lasting more than 24 hours; nausea; fatigue; This is a spontaneous re... Body aches; Fever of up to 101 lasting more than 24 hours; nausea; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 30-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 21Oct2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 21Oct2025 as dose number unknown, single, in right arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "dermatographism" (unspecified if ongoing). Concomitant medication(s) included: NORETHINDRONE [NORETHISTERONE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FAMOTIDINE. Past drug history included: Betadine, reaction(s): "allergy". The following information was reported: PAIN (non-serious) with onset 21Oct2025 at 17:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 21Oct2025 at 17:00, outcome "recovering", described as "Fever of up to 101 lasting more than 24 hours"; FATIGUE (non-serious) with onset 21Oct2025 at 17:00, outcome "recovering"; NAUSEA (non-serious) with onset 21Oct2025 at 17:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, pyrexia, nausea, fatigue. Additional information: Fever of up to 101 lasting more than 24 hours. Body aches, nausea, fatigue. Treatment received for the adverse event with Tylenol. The patient was not received any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. The vaccine was administered at workplace clinic. The patient was taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868266 56 F MA 10/24/2025 COVID19
 PFIZER\BIONTECH
Brain fog, Chills, Headache, Nausea Brain fog, Chills, Headache, Nausea
Headache; chilis; nausea; brain fog; This is a spontaneous report received from a Consumer or other ... Headache; chilis; nausea; brain fog; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 22Oct2025 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE. The following information was reported: HEADACHE (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering"; BRAIN FOG (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering"; CHILLS (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering", described as "chilis"; NAUSEA (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering". Therapeutic measures were not taken as a result of headache, chills, nausea, brain fog. Additional information: Patient didn't received any other vaccines on the same date of the vaccination. Patient didn't received any other vaccines within 4 weeks prior to the vaccination. Patient took other medications within 2 weeks of the event started. Patient mentioned that no allergy to drug. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868267 66 F TX 10/24/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vacci... COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vaccination failure More
I got COVID; I got COVID; This is a spontaneous report received from a Consumer or other non HCP, Pr... I got COVID; I got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2025 as dose number unknown, single for immunisation. The patient's relevant medical history included: "compromised" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing), notes: On blood pressure medicine; "Cancer" (unspecified if ongoing), notes: Cancer treatment right on May of 2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2025, outcome "unknown" and all described as "I got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Upon looking for assistance about her medication Paxlovid, reported that she's very symptomatic". Reporter stated she got the medicine and came on home, and started it. She is so shocked that she got COVID, the first time she had it because she had like six COVID Pfizer vaccines because she is compromised". She took Flu and COVID Vaccine on the 19th of last month, and she was like totally shocked when she tested positive." Because she is just too stressed out now." She feels like she got a terrible cough. She was wearing a mask up until about six months ago because she started Cancer treatment, right on May of 2020. So Oncologist was like, 'don't get COVID.' So every time she was available to take the COVID vaccine and the Booster, she had taken and now she feels bad. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2868268 M CA 10/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID after Pfizer Shot; COVID after Pfizer Shot; This is a spontaneous report and received from Con... COVID after Pfizer Shot; COVID after Pfizer Shot; This is a spontaneous report and received from Consumer or other non HCPs. A 70-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID after Pfizer Shot". Clinical course: During an inbound call for financial assistance the patient stated, looking into some insurance for COVID. He was in the hospital now. He was in a sniff (SNF) unit. After confirming his insurance, he stated, he was in a sniff (SNF) unit so they were going to get the medication here. After confirming that he was currently at the hospital and been prescribed the medication, he replied, yes. It was for the COVID virus, COVID meds. He was taking Pfizer Shot to keep from catching it. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
✓
2868269 M 10/24/2025 COVID19
 PFIZER\BIONTECH
Musculoskeletal disorder Musculoskeletal disorder
they lost function of 3 fingers on right; This is a spontaneous report received from a Consumer or o... they lost function of 3 fingers on right; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious), outcome "not recovered", described as "they lost function of 3 fingers on right". Additional information: During market research interview, reporter (patient) stated they lost function of 3 fingers on right hand after receiving COVID 19 vaccination was reported by the patient's neurologist to Pfizer. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868271 62 F MI 10/24/2025 COVID19
 MODERNA
 8146545
Pain in extremity Pain in extremity
Patient states over 2 weeks post vaccine their arm still aches. They state 2-3/10 on a pain scale. T... Patient states over 2 weeks post vaccine their arm still aches. They state 2-3/10 on a pain scale. The pain comes and goes but it is bothersome. More
2868273 77 M MO 10/24/2025 COVID19
 MODERNA
 3052549
Blood pressure systolic increased Blood pressure systolic increased
2 days after the vaccine, patient started to have elevated blood pressure. Systolic blood pressure h... 2 days after the vaccine, patient started to have elevated blood pressure. Systolic blood pressure has been in the 180's 2 days and 3 days after the vaccine. He reports that he isn't have any other symptoms. He has been in contract with his cardiologist office to see if he needs to be seen but hasn't received a call back yet. More
2868274 72 M GA 10/24/2025 FLU3
 SANOFI PASTEUR
 U8800BA
Axillary mass, Inflammation, Oedema peripheral, Ultrasound scan Axillary mass, Inflammation, Oedema peripheral, Ultrasound scan
One of our patients previously came in and received a flu shot from us on 09/04 and came in saying h... One of our patients previously came in and received a flu shot from us on 09/04 and came in saying he was suffering from complications from that vaccine. Apparently, they (husband and wife) were saying that the pharmacist that administered his vaccine went a little too far back into the shoulder which had led to a reaction at the local site of injection. He showed me his arm and was suffering pretty moderate swelling and inflammation in the armpit area which they claimed was worse after 2 days or so after he got the vaccine. They went to see the doctor and he prescribed steroids to treat the ongoing inflammation which helped with the swelling. More
2868275 85 F SC 10/24/2025 FLU3
PNC21
RSV
 SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 UT8829BA
Z009681
B5NJ9
Pruritus, Urticaria; Pruritus, Urticaria; Pruritus, Urticaria Pruritus, Urticaria; Pruritus, Urticaria; Pruritus, Urticaria
The patient received 3 immunization on 10/23/25 (Capvaxive and Fluzone HD in right arm and Arexvy in... The patient received 3 immunization on 10/23/25 (Capvaxive and Fluzone HD in right arm and Arexvy in left arm which was more red) and on 10/24/25 the patient came to the pharmacy to say and show that she itched, had hives and whelps all over her body(chest, legs,arms) The patient went to her primary care provider and they gave her a steroid injection and Prednisone 10mg tablets to take for 12 days More
2868293 60 F UT 10/24/2025 FLU3
 SEQIRUS, INC.
 AX9142A
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Patient stated that as she received the vaccine she heard a "pop" from the syringe that th... Patient stated that as she received the vaccine she heard a "pop" from the syringe that the administering RN explained was the air bubble that ensures all of the vaccine is delivered. The next morning, Patient noted a red spot that was tender and after closer examination that there were two red spots on the edge of where the band-aid had been placed. After a call to her PCP's nurse line, the thought was that it was a "chemical burn". Denies any allergies to alcohol prep, band-aids, nitrile gloves or hand sanitizer. More
2868294 44 M 10/24/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Extra dose administered, No adverse event Extra dose administered, No adverse event
PT IS DISABLED AND CAME TO VACCINE CLINIC WITH HIS MOTHER. SHE INITIALLY REQUESTED A COVID AND FLU V... PT IS DISABLED AND CAME TO VACCINE CLINIC WITH HIS MOTHER. SHE INITIALLY REQUESTED A COVID AND FLU VACCINE BUT WHEN SHE CAME TO THE ROOM SHE SAID HE ALREADY HAD THE FLU VACCINE AND TO GIVE THE COVID VACCINE. I CHECKED RECORDS AND UPDATED THE RECORD AND THERE WAS NO INDICATION THAT EITHER VACCINE HAD BEEN GIVEN. I ADMINISTERED THE COVID VACCINE. THE MOTHER WANTED TO MAKE SURE HE RECEIVED THE FLU VACCINE BEFORE SHE LEFT SO SHE CALLED THE NURSING HOME. THEY TOLD HER THAT THEY GAVE BOTH VACCINES ~2 WEEKS AGO. NO ADVERSE EVENTS BUT DUPLICATION. More
2868295 27 M 10/24/2025 COVID19
 PFIZER\BIONTECH
 nao589
Head discomfort, Hyperhidrosis, Malaise Head discomfort, Hyperhidrosis, Malaise
pt had total of 3 vaccines: flucelvax, comirnaty, and heplisav B at the in club clinic. After 45 m... pt had total of 3 vaccines: flucelvax, comirnaty, and heplisav B at the in club clinic. After 45 minutes, he said he did not feel right. He felt sweating and his head got heavy. I asked him if he had eaten anything and he said no. After eating a piece of pizza, he said he felt better and he had no more sweating. He wanted to go home. I explained to him if he had any symptoms of rash, hives, generalized itching, shortness of breath, he should go to an emergency room right away More
2868297 56 F 10/24/2025 FLU3
 SEQIRUS, INC.
 407248
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient received Fluad vaccine at age 56 yrs Patient received Fluad vaccine at age 56 yrs
2868298 M 10/24/2025 FLU3
 SEQIRUS, INC.
 407004
Feeling abnormal, Head discomfort, Hyperhidrosis Feeling abnormal, Head discomfort, Hyperhidrosis
pt had total of 3 vaccines: flucelvax, comirnaty, and heplisav B at the in club clinic. After 45 m... pt had total of 3 vaccines: flucelvax, comirnaty, and heplisav B at the in club clinic. After 45 minutes, he said he did not feel right. He felt sweating and his head got heavy. I asked him if he had eaten anything and he said no. After eating a piece of pizza, he said he felt better and he had no more sweating. He wanted to go home. I explained to him if he had any symptoms of rash, hives, generalized itching, shortness of breath, he should go to an emergency room right away More
2868299 4 F OR 10/24/2025 DTAPIPV
FLU3
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5G23D
FH4YR
Z005152
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
At site of Kinrix patient has a 6 x 5.5 cm red, raised, warm area that is tender At site of Kinrix patient has a 6 x 5.5 cm red, raised, warm area that is tender
2868300 75 F FL 10/24/2025 FLU3
 SANOFI PASTEUR
 u8859da
Rash Rash
Increasingly large red/purple rash. Progressively getting larger. Started 10/21 and 10/24 larger alm... Increasingly large red/purple rash. Progressively getting larger. Started 10/21 and 10/24 larger almost to elbow. She has been taking Zyrtec every day and now will elevate arm, ice, and use hydrocortisone cream. Pt told if continues to get worse, will need follow up with MD. More
2868302 67 F TX 10/24/2025 FLU3
 SEQIRUS, INC.
 407268
Cough, Dyspnoea, Musculoskeletal stiffness Cough, Dyspnoea, Musculoskeletal stiffness
Patient was administered vaccine and left the room. Husband received vaccine and left the room. Husb... Patient was administered vaccine and left the room. Husband received vaccine and left the room. Husband then knocked on door less that a minute later and technician altered the pharmacist. Patient complained of back tension and problems breathing including coughing per technician. Pharmacist arrived and patient was having small breathing problems and complained about stiffness in back. Pharmacist administered Epinephrine and called EMS. Patient was feeling better and refused EMS. Advised patient to continue to monitor and call EMS is further issues arise. Patient was observed before she left with husband., More
2868303 70 F TN 10/24/2025 COVID19
 MODERNA
 NA4457
Extra dose administered Extra dose administered
Duplicate Vaccines Duplicate Vaccines
2868307 29 F OH 10/24/2025 UNK
 UNKNOWN MANUFACTURER
Erythema, Fatigue, Injection site pain Erythema, Fatigue, Injection site pain
Red streaks on arm in 3 places, injection site soreness, and fatigue. streaks occurred day of vacci... Red streaks on arm in 3 places, injection site soreness, and fatigue. streaks occurred day of vaccine and resolved after 14 days. Arm soreness a few days which would be expected. Prior have had flu vaccine and no reaction. More
2868309 6 F WI 10/24/2025 FLU3
 SEQIRUS, INC.
Diarrhoea Diarrhoea
Diarrhea Diarrhea
2868310 53 F AL 10/24/2025 FLU3
 SANOFI PASTEUR
 UT8861JA
Erythema, Pain, Skin warm Erythema, Pain, Skin warm
Large red circle approximately 2.5 inches in diameter. Warm to the touch and very painful Large red circle approximately 2.5 inches in diameter. Warm to the touch and very painful
2868311 42 F NY 10/24/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Z007870
Z007870
Back pain, Dysphagia, Erythema, Fatigue, Musculoskeletal stiffness; Nausea, Pain... Back pain, Dysphagia, Erythema, Fatigue, Musculoskeletal stiffness; Nausea, Pain, Pruritus, Syncope More
swallowing and stiff arm, redness, nausea, backaches, faint, excessive exhaustion, and tiredness. Th... swallowing and stiff arm, redness, nausea, backaches, faint, excessive exhaustion, and tiredness. The injection was received on Sunday, 10/19 and as of today, 10/24, I have needed to take pain reliever daily (without it I cannot function), the arm stings , it is slightly itchy, and the redness/stiffness is traveling down my arm and remains red. More
2868449 49 M CA 10/24/2025 FLUX
 SANOFI PASTEUR
 U8863AA
Product storage error Product storage error
On October 23rd, 2025 at approximately 9:50 am I was on my way to retrieve a flu vaccine for patient... On October 23rd, 2025 at approximately 9:50 am I was on my way to retrieve a flu vaccine for patient when I then remembered a unused flu vaccine I pulled out 10/17/25 @ 3:30 for another pt. who did not end up needing it, so I kept the unused flu vaccine in refridgerator. Come Thrusday October 23 2025 I recalled the unuse flu vaccine and was unsure on whether or not the vaccine was still okay to use. I then consulted my supervisor on asking if it were okay to give vaccine after informing her on the whole scenario asking for an OK 10/23. Supervisor said yes so I gave flu. More
2868450 44 F IN 10/24/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2L353
Pruritus, Urticaria Pruritus, Urticaria
30 minutes after flu injection, patient started itching intensely with hives on arms, stomach and le... 30 minutes after flu injection, patient started itching intensely with hives on arms, stomach and legs More
2868451 0.17 F IN 10/24/2025 DTPPVHBHPB
FLU3
PNC20
RV5
 MSP VACCINE COMPANY
SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.



No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Pt was not 6 months when Fluzone was given. Pt was in for 2 month WCC and was given flu vaccine mean... Pt was not 6 months when Fluzone was given. Pt was in for 2 month WCC and was given flu vaccine meant for 6 months and above. No immediate reaction. Parent notified by PCP. More
2699319 AZ 10/23/2025 COVID19
RSV
UNK
UNK
UNK
FLU4
FLU4
FLU4
 PFIZER\BIONTECH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR




U6968AA
U6968AA
U6968AA
Guillain-Barre syndrome, Respiratory failure; Guillain-Barre syndrome, Respirato... Guillain-Barre syndrome, Respiratory failure; Guillain-Barre syndrome, Respiratory failure; Dysstasia, Gait disturbance; Asthenia, Fall, Guillain-Barre syndrome, Intensive care, Loss of personal independence in daily activities; Middle insomnia, Walking aid user, Wheelchair user; Dysstasia, Gait disturbance; Asthenia, Fall, Guillain-Barre syndrome, Intensive care, Loss of personal independence in daily activities; Middle insomnia, Walking aid user, Wheelchair user More
Respiratory failure; Guillain-Barre syndrome; This is a spontaneous report received from a Consumer ... Respiratory failure; Guillain-Barre syndrome; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Oct2023 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, manufacturer unknown, received from 2021 to 2023), administration date: 2021, for Covid-19 Immunization; Influenza vaccine (dose number unknown, manufacturer unknown, received for years), for Immunization. Following the (Withheld) recommendations for Senior Immunizations, the patient received both the new RSV ABRYSVO and COVID-19 COMIRNATY 12+23-24 SDV at his local pharmacy. On 18Oct2023, the patient received SEQIRUS as part of his annual Primary Care visit. About 12 hours later, the patient began to feel "pins and needles" in his feet and went to bed. Around 2:00 AM on 19Oct2023, the patient asked his wife for assistance to go to the bathroom and return to bed since the patient's legs were very weak and tingling. Around 5:00 AM, the patient sat on the side of the bed and again woke his wife because they were "unable to stand". (Withheld) was called, and the patient was transported to his local (Withheld) where the patient was evaluated. The patient was admitted to the Hospital Observation Unit, and during the course of the next few hours, there was steady progression of ascending paralysis, severe back pain, and difficulty breathing. The wife requested a Hospitalist evaluation, and the patient was transferred to the Progressive Care Unit. In the early morning hours of 20Oct2023, a Multidisciplinary Team consisting of a Neurologist, a Pulmonologist, and an ICU Hospitalist were at the bedside and diagnosed Guillain-Barre Syndrome. The patient was immediately transferred to ICU for STAT Plasma Exchange and Respiratory Failure. The patient received 7 plasmapheresis treatments and were placed on High Level BiPAP and a feeding tube. After 13 days in the hospital, the patient was transferred on 02Nov2023 to an Inpatient Rehab Facility where the patient continued to make progress from complete paralysis on arrival to standing and using a wheelchair and walker. The patient was discharged 28Nov2023 to home, where the patient received Home Health Physical Therapy (PT)/ Occupational Therapy (OT) for the next month and continued to improve. The patient considered himself "one of the fortunate" since he was alive 2 years later, walking short distances independently, using a cane for safety, and a walker and motorized scooter as needed. Since the diagnosis of GBS, the patient has continued expanding his knowledge of GBS, ongoing research, and the impact GBS will continue to have on his life. The ongoing Peripheral Neuropathy/Neuropathic Pain and the Intense Fatigue have definitely impacted his life, causing him to adapt his lifestyle to accommodate these long-term deficits. The patient heard about the (Withheld) created in 1986. It was described as a "no-fault" system, meaning you don't need to prove negligence, only that your injury was "more likely than not caused by the vaccine". He researched filing a claim with the (Withheld); however, only the Seasonal Flu Vaccine is covered by the program at this time. The Vaccine Injury Table for Seasonal Influenza Vaccine lists Guillain-Barre Syndrome as an illness, disability, injury, or condition covered. Patient have been advised it would be difficult to prove the GBS was more likely than not caused by the Seasonal Flu Vaccine because the Vaccine Injury Table for Seasonal Flu Vaccine defines the time period for first symptom or magnification of onset or of significant aggravation as 3-42 days (not less than 3 days and not more than 42 days), and his symptoms began 12 hours after the Seasonal Flu Vaccine. COVID-19 Vaccine is not currently on the (Withheld) and has its own claim process (Withheld). These claims have a one-year filing deadline from the date of receiving the countermeasure; the patient received the COVID-19 Vaccine on 11Oct2023 and has missed the filing deadline of 11Oct2024. The RSV Vaccine is not on the (Withheld) and has no avenue to proceed for compensation consideration unless a claim is filed with the Manufacturer. Physicians have documented "vaccine related event" in the patient's Medical Records and Support Letters. Due to the RSV Vaccine and COVID-19 Vaccine on the same date and then Seasonal Influenza HD 7 days later, it has been difficult to identify which of the three vaccines was the trigger. Patient was asking why did this happen to him. What he do know is he received the recommended Senior Flu Vaccine for years without an outcome. He received COVID-19 Vaccines from 2021 to 2023 without an outcome. The patient was diagnosed with GBS 8 days after receiving the RSV Vaccine, and the research shows first symptom typically develops within 1-3 weeks after vaccination. The patient stated that the only thing that changed is he added the recommended RSV Vaccine to his Senior Immunizations. He considered himself as an "Outcome" of a Vaccine Adverse Event. Further outcome analysis of the data and his case should provide insight and potential "Why". His theory is the RSV Vaccine on 11Oct2023 initiated an autoimmune process, then with the addition of COVID-19 and Seasonal Flu Vaccine, activated a pre-sensitized immune system and "more likely than not" the GBS was caused by the RSV Vaccine. Outcome of the events was unknown. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
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2867721 M PA 10/23/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 947931
Arthralgia, Muscle spasms, Myalgia, Paraesthesia Arthralgia, Muscle spasms, Myalgia, Paraesthesia
Arthralgia; Muscle Cramping; Tingling in Fingers and Toes; Myalgia; Initial report received on 17-Se... Arthralgia; Muscle Cramping; Tingling in Fingers and Toes; Myalgia; Initial report received on 17-Sep-2025. A physician reported that a 35-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient experienced paresthesia, myalgia, arthralgia, and muscle cramping. Medical history included an allergy to sulfa drugs. No concomitant medications were reported. On 08-Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number947931, expiration date 15-May-2027and NDC number 43528-0003-05; site not provided)] intramuscularly. On an unknown date, after receiving HEPLISAV-B, the patient experienced paresthesia, myalgia, arthralgia, and muscle cramping. Paresthesia manifested as tingling in fingers and toes with no associated muscle weakness. The patient has not received the second dose. The outcome was not 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
2867722 87 F FL 10/23/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Carpal tunnel syndrome, Catheterisation cardiac abnormal, Computerised tomogram ... Carpal tunnel syndrome, Catheterisation cardiac abnormal, Computerised tomogram heart abnormal, Coronary arterial stent insertion, Coronary artery disease; Electromyogram abnormal, Nerve conduction studies abnormal, Polyneuropathy More
diagnosed with coronary artery disease; Suspected Carpal tunnel; This serious case was reported by ... diagnosed with coronary artery disease; Suspected Carpal tunnel; This serious case was reported by a consumer via call center representative and described the occurrence of coronary artery disease in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of paraesthesia, Flu vaccine, RSV vaccine and COVID-19 vaccine. Concurrent medical conditions included non-hodgkin's lymphoma (patient who was diagnosed in Non-Hodgkin's Lymphoma in 2020). Concomitant products included rituximab (Rituxan). On 20-MAR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced coronary artery disease (Verbatim: diagnosed with coronary artery disease) (serious criteria hospitalization and clinically significant/intervention required) and carpal tunnel syndrome (Verbatim: Suspected Carpal tunnel). The outcome of the coronary artery disease and carpal tunnel syndrome were unknown. It was unknown if the reporter considered the coronary artery disease and carpal tunnel syndrome to be related to Shingrix. The company considered the coronary artery disease to be unrelated to Shingrix. It was unknown if the company considered the carpal tunnel syndrome to be related to Shingrix. Linked case(s) involving the same patient: US2025131746 Additional Information: GSK receipt date: 13-OCT-2025 At her doctor appointment in February, she was told that she had drug induced polyneuropathy. Her cardiologist had her do a CAT scan and she was diagnosed with coronary artery disease. She got a catheterization and stent done on 26-JUN-2025 and was hospitalized. Her neurologist did an EMG and nerve conduction testing and told her she may have carpal tunnel. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of coronary artery disease, unknown time after receiving Shingrix, in a elderly female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
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2867727 M IA 10/23/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 7FY52
Dizziness, Impaired driving ability, Tinnitus Dizziness, Impaired driving ability, Tinnitus
dizziness; ringing in the ears; still does not feel comfortable driving; This non-serious case was ... dizziness; ringing in the ears; still does not feel comfortable driving; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 40-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number 7FY52, expiry date 30-JUN-2026) for prophylaxis. On 01-OCT-2025, the patient received FluLaval 2025-2026 season. In OCT-2025, less than a week after receiving FluLaval 2025-2026 season, the patient experienced dizziness (Verbatim: dizziness), ringing in ears (Verbatim: ringing in the ears) and discomfort (Verbatim: still does not feel comfortable driving). The outcome of the dizziness and ringing in ears were unknown and the outcome of the discomfort was not resolved. It was unknown if the reporter considered the dizziness, ringing in ears and discomfort to be related to FluLaval 2025-2026 season and Flulaval Pre-Filled Syringe Device. It was unknown if the company considered the dizziness, ringing in ears and discomfort to be related to FluLaval 2025-2026 season and Flulaval Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-OCT-2025 A patient experienced dizziness and ringing in the ears after receiving the Flulaval vaccine. The nurse who administered the vaccine submitted a report to VAERS but wondered if they should have been concerned. The reporter stated this was an employee, and they had upcoming employee vaccine clinics. This employee (patient) still did not feel comfortable driving. More
2867729 10/23/2025 FLUX
VARZOS
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
Sore arm; This non-serious case was reported by a consumer via interactive digital media and describ... Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On 13-OCT-2025, the patient received Shingrix and Flu vaccine. On an unknown date, an unknown time after receiving Shingrix and Flu vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix and Flu vaccine. It was unknown if the company considered the pain in arm to be related to Shingrix and Flu vaccine. Additional Information: GSK Receipt Date: 14-OCT-2025 The patient reported that their arms were little sore after receiving Shingrix and flu vaccine the day prior. The batch number was not provided, and we are unable to contact the reporter. This case was reported by a patient via interactive digital media. More
2867732 17 M KS 10/23/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 Z5434
Inappropriate schedule of product administration, Incorrect dose administered Inappropriate schedule of product administration, Incorrect dose administered
Adult dose to a pediatric patient; he got the 1 ml dose instead of the 0.5 mL; Havrix late second do... Adult dose to a pediatric patient; he got the 1 ml dose instead of the 0.5 mL; Havrix late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 17-year-old male patient who received HAV (Havrix adult) (batch number Z5434) for prophylaxis. Previously administered products included Hepatitis A vaccine (First dose was received on 14-Nov-2011 and did not know the brand name of the product). On 22-SEP-2025, the patient received the 2nd dose of Havrix adult 1 ml. On 22-SEP-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose to a pediatric patient), overdose (Verbatim: he got the 1 ml dose instead of the 0.5 mL) and drug dose administration interval too long (Verbatim: Havrix late second dose). The outcome of the adult product administered to child, overdose and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-SEP-2025 After the 2nd Hepatitis A vaccine, the healthcare professional informed that the patient did not have any adverse event. More
2867733 12 M NH 10/23/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9452S
Expired product administered Expired product administered
Administration of expired dose; This non-serious case was reported by a nurse via call center repres... Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received HBV (Engerix B pediatric) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis. On 18-SEP-2025, the patient received Engerix B pediatric. On 18-SEP-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-SEP-2025 The nurse reported that a 12-year-old boy had received a dose of Engerix-B on 18th September 2025, which had expired on 14 September 2025. More
2867734 1 M OH 10/23/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Underage; This non-serious case was reported by a nurse via call center representative and described... Underage; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. On 22-JUL-2025, the patient received the 1st dose of Kinrix. On 22-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-SEP-2025 The nurse reported that a 17-month-old had been administered Kinrix. It had been the child's first dose of DTaP and IPV. More
2867735 33 F VA 10/23/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 4YA34
Exposure during pregnancy, Inappropriate schedule of product administration Exposure during pregnancy, Inappropriate schedule of product administration
Drug Exposure During Pregnancy; Vaccine administered at 19 weeks of pregnancy; This non-serious pros... Drug Exposure During Pregnancy; Vaccine administered at 19 weeks of pregnancy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4YA34, expiry date 05-NOV-2027) for prophylaxis. Previously administered products included Boostrix (1st dose received on 07-SEP-2022, batch number-YR7AA and expiry date-14-APR-2024). On 15-SEP-2025, the patient received the 2nd dose of Boostrix. On 15-SEP-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Vaccine administered at 19 weeks of pregnancy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the inappropriate schedule of vaccine administered and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in second trimester Estimated Delivery/Due date: 12-FEB-2026 Pregnancy Outcome: Pregnancy was ongoing This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-SEP-2025 The patient received Boostrix at 19 weeks of pregnancy. The reporter consented to follow up. More
2867737 19 F TX 10/23/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect dose administered Incorrect dose administered
Adult dose maladministration; Overdose; This non-serious case was reported by a other health profess... Adult dose maladministration; Overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis. On 30-SEP-2025, the patient received the 1st dose of Engerix B adult. On 30-SEP-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Adult dose maladministration) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-OCT-2025 The nurse called to report the mal-administration of an adult dose of Engerix-B to a patient. She wanted to know if there were safety concerns and if the shot was counted as valid or a revaccination was needed. The batch number was not provided upon follow up with the reporter. The reporter consented to follow up. More
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