🏥 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 💀 🏥 🚑 ♿ ⚠️
2825300 4 M GA 02/07/2025 MMRV
 MERCK & CO. INC.
 X020566
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse reaction noted, discovered that the vaccine expired 02/02/2025 No adverse reaction noted, discovered that the vaccine expired 02/02/2025
2825301 1 M WI 02/07/2025 COVID19
FLU3
MMR
PNC20
VARCEL
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 LN6739
5ZG92
X028014
LC1281
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
no known adverse events no known adverse events
2825303 30 M MI 02/07/2025 FLU3
 SEQIRUS, INC.
 391417
Rash Rash
Rash on Neck Rash on Neck
2825304 62 F NH 02/07/2025 PNC20
 PFIZER\WYETH
Chills, Electrocardiogram, Headache, Injection site pain Chills, Electrocardiogram, Headache, Injection site pain
Minor: soreness at injection site. Day after injection, I had chills and a headache. Second day, ... Minor: soreness at injection site. Day after injection, I had chills and a headache. Second day, I woke up during the night experiencing a high heart rate. This continued and concerned me enough to contact my primary physician. My resting heart rate was at times over 100 bpm, which is rare for me. More
2825305 47 M MN 02/07/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL3302
EN6208
FL3197
Death; Death; Death Death; Death; Death
Patient expired on 2/5/2025. Patient expired on 2/5/2025.
✓
2825306 0.33 F TN 02/07/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U7921AA
LC5483
Y003753
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 More
This nurse administered patient a first dose of Rota Teq vaccine when patient was 23 weeks of age. T... This nurse administered patient a first dose of Rota Teq vaccine when patient was 23 weeks of age. This vaccine's first dose should not be administered after patient is over 15 weeks of age. Patient has had no signs/symptoms as a result. More
2825307 12 F TN 02/07/2025 HEPA
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 C24B9
Y004554
Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli
APPROXIMATELY 5 MINUTES AFTER VACCINES WERE ADMINISTERED, PATIENT BECAME NON-RESPONSIVE AND COLOR BE... APPROXIMATELY 5 MINUTES AFTER VACCINES WERE ADMINISTERED, PATIENT BECAME NON-RESPONSIVE AND COLOR BECAME PALE. EPISODE LASTED 1-2, THEN PATIENT WAS ORIENTED TO PERSON PLACE AND TIME More
2825308 1.25 F MI 02/07/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 LH237
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
During a routine inventory, I noticed there was a vial without a syringe of sterile diluent next to ... During a routine inventory, I noticed there was a vial without a syringe of sterile diluent next to it. I left early the day prior and noticed that was when the vaccine was given. I traced vaccine administration back to previous day to patient and Medical Assistant that scanned the vaccine into the chart. More
2825309 61 M NY 02/07/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 023c21a
023c21a
05bc21a
05bc21a
Bladder calculus removal, Calculus bladder, Erectile dysfunction, Laboratory tes... Bladder calculus removal, Calculus bladder, Erectile dysfunction, Laboratory test abnormal, Nephrolithiasis; Prostatectomy, Prostatomegaly, Renal stone removal; Bladder calculus removal, Calculus bladder, Erectile dysfunction, Laboratory test abnormal, Nephrolithiasis; Prostatectomy, Prostatomegaly, Renal stone removal More
BPH (Enlarged prostate), Kidney stone, bladder stone, ED. I did not suspect anything until Decembe... BPH (Enlarged prostate), Kidney stone, bladder stone, ED. I did not suspect anything until December of 2024 after seeing a video on social media that my injury was related to the vaccine. The video Dr. drops a bombshell, claiming that the mRNA COVID "vaccines" were deliberately engineered to harm, disable, and kill, with the ultimate goal of reducing human fertility... made me dig a little deeper. I had to have a surgery to remove the kidney stone, a surgery to remove bladder stones, and in July of 2024 I had to have my prostate removed. Prior to this I had never need or been to a urologist for any reason and I have no family history of kidney stones or prostate issues. I had no reason to suspect these issues were from the vaccine shot until I saw that video. The timeline of all these events make it 100% clear to me that having an enlarged prostate, which caused the kidney stone and bladder stones were caused by the vaccine. I would be glad to go into more detail if needed. More
✓ ✓
2825310 4 M WI 02/07/2025 COVID19
DTAPIPV
FLUN3
MMRV
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
MEDIMMUNE VACCINES, INC.
MERCK & CO. INC.
 LN8272
42Y93
WF2582
Y003880
Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event
No known adverse events No known adverse events
2825311 2 F WI 02/07/2025 COVID19
 PFIZER\BIONTECH
 LN8272
No adverse event No adverse event
no known adverse events reported no known adverse events reported
2825313 4 F WI 02/07/2025 COVID19
 PFIZER\BIONTECH
 LN8272
No adverse event No adverse event
no known adverse event no known adverse event
2825314 11 F NC 02/07/2025 TDAP
 SANOFI PASTEUR
 U8115AA
No adverse event No adverse event
No adverse event noted. No adverse event noted.
2825315 4 M FL 02/07/2025 FLU3
 SEQIRUS, INC.
Rash Rash
Rash, topical aquaphor and hydrocortisone cream Rash, topical aquaphor and hydrocortisone cream
2825316 27 F CO 02/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74NC9
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Vaccine given in error to a 27 year old female. No reported adverse reaction as of time of this repo... Vaccine given in error to a 27 year old female. No reported adverse reaction as of time of this report. More
2825317 41 F CA 02/07/2025 TDAP
TDAP
TDAP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR




Chest X-ray normal, Chills, Decreased appetite, Dizziness, Erythema; Fatigue, Fe... Chest X-ray normal, Chills, Decreased appetite, Dizziness, Erythema; Fatigue, Feeling hot, Fibrin D dimer normal, Full blood count normal, Heart rate increased; Human chorionic gonadotropin normal, Influenza virus test negative, Malaise, Metabolic function test normal, Nasal congestion; Nodule, Pain, Pyrexia, SARS-CoV-2 test negative, Serum sickness-like reaction; Swelling, Urine analysis normal More
Severe Local Reaction - (Swelling, Redness, Pain, Heat, Nodule) doubling in size daily until started... Severe Local Reaction - (Swelling, Redness, Pain, Heat, Nodule) doubling in size daily until started on Allegra/Prednisone. Systemic Reaction - Low grade fever, aches, chills, extreme fatigue/malaise, dizziness, loss of appetite, raise in bpm. Low Fever, Fatigue, Malaise, Dizziness, Loss of appetite and nasal congestion persist (currently at day 12). More
2825318 89 F SC 02/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 JB27A
Circumstance or information capable of leading to medication error, Extra dose a... Circumstance or information capable of leading to medication error, Extra dose administered, Skin warm More
Patient stated that the agency has her birthday wrong and as a result her insurance has the wrong bi... Patient stated that the agency has her birthday wrong and as a result her insurance has the wrong birthday. They have DOB listed it should be different. When we checked our State database for vaccines we used the correct DOB not realizing she had the wrong birthday on her profile. It said she was due for this dose, and when asked the patient stated she had never gotten this vaccine before. She got a dose on 01/18/2024. So she was given a second dose of this vaccine due all of those factors being combined. She has stated her arm was a little warm on the day of the vaccine but as of now she is not experiencing any physical side effects/symptoms. More
2825319 59 F CO 02/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Dysuria, Genital herpes zoster, Herpes zoster, Magnetic resonance imaging spinal... Dysuria, Genital herpes zoster, Herpes zoster, Magnetic resonance imaging spinal abnormal More
shingles was seen on the patient's lower back, right light knee, and right shin; shingles in ad... shingles was seen on the patient's lower back, right light knee, and right shin; shingles in addition to her groin and pelvis; stopped being able to void her bladder; unable to defecate; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included intervertebral disc protrusion (mentioned nerve dissection at L5 and herniated disk at L3, L4, and L5). Concomitant products included methylprednisolone sodium succinate (Methylprednisolone), pregabalin, methocarbamol, ibuprofen and valaciclovir hydrochloride (Valacyclovir). On 26-DEC-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles was seen on the patient's lower back, right light knee, and right shin), genital herpes zoster (Verbatim: shingles in addition to her groin and pelvis), urine output decreased (Verbatim: stopped being able to void her bladder) and decreased stool volume (Verbatim: unable to defecate). The outcome of the shingles and decreased stool volume were unknown and the outcome of the genital herpes zoster was not reported and the outcome of the urine output decreased was resolved. It was unknown if the reporter considered the shingles, genital herpes zoster, urine output decreased and decreased stool volume to be related to Shingrix. It was unknown if the company considered the shingles, genital herpes zoster, urine output decreased and decreased stool volume to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JAN-2025 The reporter was the patient who reported receiving her first dose of Shingrix vaccine on 26th December 2024. On 2nd January 2024 she went to a neurosurgeon for back pain and got an Magnetic resonance imaging which showed a herniated disk at L3, L4, and L5. She also mentioned nerve dissection at L5. It was on this day that disseminated shingles was seen on the patient's lower back, right light knee and right shin it crossed multiple dermatomes. She also experienced pain in the areas of the shingles in addition to her groin and pelvis. She started valacyclovir on 4th January 2024. Recently she stopped being able to void her bladder and unable to defecate. She stopped taking all her medications except for valacyclovir and she was able to urinate and defecate. More
2825320 F 02/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster, Influenza like illness, Rash, Vaccination failure Herpes zoster, Influenza like illness, Rash, Vaccination failure
Suspectd vaccination failure; Recurrent shingles episodes; Flu like symptoms; This serious case was ... Suspectd vaccination failure; Recurrent shingles episodes; Flu like symptoms; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female 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 vaccination failure (Verbatim: Suspectd vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Recurrent shingles episodes) and influenza-like symptoms (Verbatim: Flu like symptoms). The patient was treated with valaciclovir. The outcome of the vaccination failure was not reported and the outcome of the shingles and influenza-like symptoms were unknown. It was unknown if the reporter considered the vaccination failure, shingles and influenza-like symptoms to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and influenza-like symptoms to be related to Shingrix. Additional Information: GSK Receipt Date: 30-JAN-2025 The member of the public called and mentioning that the patient got a Shingrix shot four years ago and since the patient got it, the patient had recurrent rash for several times on body and flu like symptoms as well. The patient had been experiencing recurrent shingles. The patient doctor told that the patient could receive another shot six months after not been experiencing any shingles episode. And also has been giving the patient valaciclovir. The reporter asked could you give any advise, did the patient need to see an infectious disease specialist. The patient demographics were obtained in this call. No specific vaccination date nor vaccine details were provided from the member of the Public end. No other information was obtained in this call. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix . More
2825321 82 F CA 02/07/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7RK7K
N2954
49Y35
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administ... Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure More
Suspected vaccination failure; had shingles; patient that received a third dose of Shingrix on 30-SE... Suspected vaccination failure; had shingles; patient that received a third dose of Shingrix on 30-SEP-2024; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number N2954, expiry date 30-APR-2026) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 49Y35, expiry date 31-OCT-2020) for prophylaxis and Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 31-OCT-2020) for prophylaxis. On 30-SEP-2024, the patient received the 3rd dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, right arm). On 30-SEP-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced extra dose administered (Verbatim: patient that received a third dose of Shingrix on 30-SEP-2024). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles and extra dose administered were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Shingrix. Additional Information: GSK Receipt Date: 31-JAN-2025 The pharmacist reported that the female patient that received a third dose of Shingrix which led to extra dose administered. The pharmacist also states that the patient mentioned that she recently (no specific date was provided) had shingles. No further information was available about the case of shingles. The pharmacist reported all that was provided about this adverse event. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1, Shingrix dose 2 and Shingrix dose 3. More
2825322 U 02/07/2025 COVID19
 JANSSEN
Disability, Multiple allergies, Tinnitus Disability, Multiple allergies, Tinnitus
disabled; chronic ear ringing attacks; food and med allergies; This spontaneous report received from... disabled; chronic ear ringing attacks; food and med allergies; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. On an unspecified date, the patient experienced disabled, chronic ear ringing attacks, and food and med allergies. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of disabled, chronic ear ringing attacks and food and med allergies was not reported. This report was serious (other medically important condition).; Sender's Comments: V0;Disability; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. More
2825323 74 F 02/07/2025 COVID19
 MODERNA
 3043822
COVID-19 COVID-19
got the vaccine in December and now has COVID; This spontaneous case was reported by a patient and d... got the vaccine in December and now has COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got the vaccine in December and now has COVID) in a 74-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: J and j covid-19 Vaccine (Dose 1) in October 2021; for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 2) in April 2022, Moderna covid-19 vaccine (Dose 3) in April 2023, Moderna covid-19 vaccine (Dose 4) in October 2023 and Moderna covid-19 vaccine (Dose 5) in April 2024. Past adverse reactions to the above products included COVID-19 with J and j covid-19 Vaccine; and No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine. On 05-Dec-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 01-Feb-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (got the vaccine in December and now has COVID). At the time of the report, COVID-19 (got the vaccine in December and now has COVID) had not resolved. Concomitant product use was not provided by the reporter. Patient had no other vaccine on the same day as receiving Spikevax. Treatment information was not provided. Reporter causality was not reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2025: Live non-significant follow-up received: reference number added. More
2825324 61 F NJ 02/07/2025 COVID19-2
 MODERNA
 013H22A
Facial paralysis, Small fibre neuropathy Facial paralysis, Small fibre neuropathy
left facial nerve palsy; small fiber peripheral neuropathy; This spontaneous case was reported by a ... left facial nerve palsy; small fiber peripheral neuropathy; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PARALYSIS (left facial nerve palsy) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Unspecified hypothyroidism, Hyperlipidemia, Constipation chronic and Cancer (cancer survivor (2001)) since 2021. On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In November 2022, the patient experienced SMALL FIBRE NEUROPATHY (small fiber peripheral neuropathy). In 2023, the patient experienced FACIAL PARALYSIS (left facial nerve palsy) (seriousness criterion medically significant). The patient was treated with Pregabalin at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (left facial nerve palsy) and SMALL FIBRE NEUROPATHY (small fiber peripheral neuropathy) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as booster. She received the Moderna booster on 27-Oct-2022 and two weeks later between November 15th-20th she developed numbness of the right fifth toe and foot outer border, discomfort of the right lower back area (butt), sciatica like symptoms which kept progressing. It progressed and then developed like burning, numbness, tingling, pain of hands, feet, facial (around the lips/mouth) and all extremities and face. In 2023 reporter was then diagnosed with small fiber peripheral neuropathy. On Mar-2023, neurologist placed reporter on steroids, responded very well to the steroids, got better but after the steroids wore off, it all came back. Now has developed left facial nerve palsy and taking pregabalin (start date Jun or July 2023), did not control symptoms very well, could not tolerate high doses and still symptomatic. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2825325 M NJ 02/07/2025 COVID19
 MODERNA
Abdominal pain upper, Fatigue, Somnolence Abdominal pain upper, Fatigue, Somnolence
stomach ach; drowsiness; fatigue; This spontaneous case was reported by a non-health professional an... stomach ach; drowsiness; fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ach), SOMNOLENCE (drowsiness) and FATIGUE (fatigue) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ach), SOMNOLENCE (drowsiness) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN UPPER (stomach ach), SOMNOLENCE (drowsiness) and FATIGUE (fatigue) had resolved with sequelae. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications provided by the reporter. No treatment medications provided by the reporter. More
2825326 78 M MN 02/07/2025 COVID19
COVID19
COVID19
COVID19
FLUX
FLUX
FLUX
FLUX
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER







Biopsy, Blood creatinine, Blood creatinine abnormal, COVID-19, Computerised tomo... Biopsy, Blood creatinine, Blood creatinine abnormal, COVID-19, Computerised tomogram; Drug ineffective, Fatigue, Feeling abnormal, Haemoglobin, Haemoglobin decreased; Investigation, Laboratory test, Mass, Pathology test, Pollakiuria; Positron emission tomogram, SARS-CoV-2 test, Ultrasound scan, Weight; Biopsy, Blood creatinine, Blood creatinine abnormal, COVID-19, Computerised tomogram; Drug ineffective, Fatigue, Feeling abnormal, Haemoglobin, Haemoglobin decreased; Investigation, Laboratory test, Mass, Pathology test, Pollakiuria; Positron emission tomogram, SARS-CoV-2 test, Ultrasound scan, Weight More
feeling bad; Hemoglobin was 12; he has been through a biopsy of a mass that they found; abnormal cre... feeling bad; Hemoglobin was 12; he has been through a biopsy of a mass that they found; abnormal creatinine; tested 3 times positive; tested 3 times positive; having frequent urination; fatigue; This is a spontaneous report received from a Nurse from medical information team, Program ID. A 78-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 07Oct2024 as dose number unknown, single), in arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Atrial fib" (ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation (ongoing); LOSARTAN taken for hypertension; CHLORTHALIDONE taken for hypertension; LIPITOR. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2020, when the patient was 74 years old, 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; Comirnaty (2023-2024 formula) (DOSE 5 (BOOSTER), SINGLE), administration date: Apr2024, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2024, outcome "not recovered"; POLLAKIURIA (non-serious) with onset 07Nov2024, outcome "not recovered", described as "having frequent urination"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2024, outcome "unknown" and all described as "tested 3 times positive"; BLOOD CREATININE ABNORMAL (non-serious) with onset 26Dec2024, outcome "unknown", described as "abnormal creatinine"; MASS (medically significant) with onset 27Dec2024, outcome "unknown", described as "he has been through a biopsy of a mass that they found"; HAEMOGLOBIN DECREASED (non-serious) with onset Jan2025, outcome "unknown", described as "Hemoglobin was 12"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad". The event "he has been through a biopsy of a mass that they found" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Unknown result; Blood creatinine: (26Dec2024) abnormal; Computerised tomogram: (2024) Unknown results; (unspecified date) Unknown results; Haemoglobin: (Mar2024) down three points; (Jan2025) 12, notes: it is low; test: (27Dec2024) mass; labs: (unspecified date) minimally changed; Pathology test: (unspecified date) Unknown results; Positron emission tomogram: (unspecified date) normal; SARS-CoV-2 test: (Dec2024) Positive; Ultrasound scan: (unspecified date) Unknown results; (2024) Unknown results; Weight: (unspecified date) about 207. Therapeutic measures were not taken as a result of drug ineffective, covid-19, mass, pollakiuria, fatigue, blood creatinine abnormal, haemoglobin decreased. Clinical course: The Pfizer Covid-19 vaccine was given along with a flu vaccine on the same day as her husband started experiencing fatigue more than usual, he's a retired physician. He had shots on 07Oct and a month later began having frequent urination. A week before Christmas (Dec2024), he started having cold symptoms and got tested 3 times for Covid. She's asking if there could have been some assault on his immune system as it's his first time having 2 shots together. Fatigued continued and patient got some lab work done on the 26Dec after this had gone on for a little while and the lab work came back with an abnormal creatinine, hemoglobin was down three points from Mar (2024) of the same year and that began their journey of ultrasound, CAT scan. Trying to investigate what the fatigue and these blood counts were all about. His labs have minimally changed he has been through a biopsy of a mass that they found on the 27Dec following an ultrasound and the CT scan of his abdomen and then but his lab work is what just spoke. It is so crazy and they have done with the biopsy. They have done all the testing, laboratory testing, pathology and they cannot come up with a solid answer with what and they have not seen anything like this. Also, the reporter read some things that it is possible that an individual could have an abnormal PET scan. Her husband's PET scan was normal and the reason she has concern about this is the proximity in time. From the time of these vaccinations to when the patient became feeling bad. Patient was great right until up that time and no issues of any kind. Patient hadn't been sick and then so unusual that these symptoms started a couple of weeks after these vaccines. Reporter further stated, "we are not saying it is from the vaccine. I am just trying to gather information if it could be something that has happened with his immune system response with getting both the Flu vaccine and COVID vaccine together or one or the other or do we have another process going on here and so, he is being seen by doctors, many doctors, he had a biopsy and they cannot get completely to the bottom of this. They said this is the one of the most difficult cases they have ever had to look at and it is been, it will be six weeks on Friday and so, I just decided I told him I am going to call Pfizer and see if there is been other reported incidence of anything like this plus an abnormal PET Scan with sides that light up in both bone."; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded. As there is limited information in the case provided, the causal association between the event mass and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
2825327 F OK 02/07/2025 COVID19
 PFIZER\BIONTECH
Autoimmune disorder, Sjogren's syndrome Autoimmune disorder, Sjogren's syndrome
Sjogrens disease; autoimmune response; This is a spontaneous report received from a Consumer or othe... Sjogrens disease; autoimmune response; This is a spontaneous report received from a Consumer or other non HCP. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number: 1894792, Facility type vaccine: Hospital), administration date: 17Dec2020, when the patient was 27-year-old, for Covid-19 immunisation; Bnt162b2 (Dose 2, single), for Covid-19 immunisation. The patient had no known allergy. The patient did not had other vaccine same date. No other vaccine in four weeks; No other medications in two weeks. The following information was reported: SJOGREN'S SYNDROME (medically significant) with onset 10Oct2022, outcome "not recovered", described as "Sjogrens disease"; AUTOIMMUNE DISORDER (medically significant) with onset 10Oct2022, outcome "not recovered", described as "autoimmune response". Clinical course: Developed Sjogrens disease after getting two doses of Covid shot and booster. No family history of autoimmune disease and no symptoms prior to Covid shot. The patient was wondering with new info that Covid vaccine can cause autoimmune response if she developed Sjogrens due to Covid vaccine. The patient was on chronic medications for autoimmune disease. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2825328 42 F PA 02/07/2025 COVID19
 PFIZER\BIONTECH
 GH9702
Endometrial cancer, Incorrect route of product administration, Vaginal haemorrha... Endometrial cancer, Incorrect route of product administration, Vaginal haemorrhage More
endometrial cancer; vaccine was administered subcutaneous; heavy and abnormal vagina bleeding; This ... endometrial cancer; vaccine was administered subcutaneous; heavy and abnormal vagina bleeding; This is a spontaneous report received from an Other HCP. A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 42 years subcutaneous, in left arm for covid-19 immunisation. The facility where the vaccine was administered was in a Public Health Department and not at a facility. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, batch/lot number EW0150), administration date: 03Apr2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding"; BNT162b2 (dose 2, batch/lot number EW0170), administration date: 24Apr2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding"; BNT162b2 (dose 3, batch/lot number FH8028), administration date: 21Nov2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding". The patient did not receive any other vaccine on the same date as the Pfizer vaccine, was not taking any other medications within 2 weeks prior to the event onset, and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening) with onset Nov2022, outcome "recovered" (Nov2022), described as "heavy and abnormal vagina bleeding"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Nov2022, outcome "unknown", described as "vaccine was administered subcutaneous"; ENDOMETRIAL CANCER (disability, life threatening, medically significant) with onset Mar2024, outcome "unknown". The events "endometrial cancer" and "heavy and abnormal vagina bleeding" required physician office visit. Therapeutic measures were taken as a result of endometrial cancer. Clinical course: The patient experienced heavy and abnormal vagina bleeding within 2-5 days of each dosing and lasted 1-2 days and went away. The patient was diagnosed endometrial cancer in Mar2024. The patient visited an OBGYN. The events were reported as life threatening illness (immediate risk of death from the event) and disability or permanent damage.; Sender's Comments: The events endometrial cancer, and vaginal haemorrhage are conservatively assessed as related to the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500000306 same reporter/patient, different dose;US-PFIZER INC-202500000311 same reporter/patient, different dose;US-PFIZER INC-202500000312 same reporter/patient, different dose; More
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2825329 U 02/07/2025 FLUX
 UNKNOWN MANUFACTURER
Respiratory tract infection Respiratory tract infection
influenza vaccine causes respiratory infections; Initial information received on 04-Feb-2025 regardi... influenza vaccine causes respiratory infections; Initial information received on 04-Feb-2025 regarding an unsolicited valid social media non-serious case received from a patient. This case involves an unknown age / gender patient who experienced respiratory infections after receiving influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient developed respiratory infections (respiratory tract infection) (unknown latency) following the administration of influenza vaccine. Action taken with was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2825330 1.33 F TX 02/07/2025 HIBV
 SANOFI PASTEUR
 UK107AB
No adverse event, Product preparation error No adverse event, Product preparation error
act-hib was reconstituted with a different diluent, only one of the vials was given with no reported... act-hib was reconstituted with a different diluent, only one of the vials was given with no reported adverse event; Initial information received on 04-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 months old female patient who received haemophilus type B (HIB) vaccine [ACT-HIB] was reconstituted with a different diluent, only one of the vials was given 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 pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) for Immunisation; and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix) for Immunisation. On 31-Jan-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 30-SEP-2025 and lot UK107AB) once via intramuscular route in the right vastus lateralis as Immunization was reconstituted with a different diluent, only one of the vials was given with no reported adverse event (product preparation error) (latency- same day). Reportedly, they want to know if the vaccine was still valid or should the patient be revaccinated. Only the lyophilized vaccine was given. 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
2825332 F CT 02/07/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Heplisav-B Given After Starting A Three Dose Hep-B Series; Incomplete Course of Vaccination; Initial... Heplisav-B Given After Starting A Three Dose Hep-B Series; Incomplete Course of Vaccination; Initial report received on 28-Jan-2025. A pharmacist reported that a female (age and race not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after starting a three dose hepatitis B series. The patient has not received the second dose as of date of report. No medical history or concomitant medications were reported. On an unknown date, the patient received an unknown dose of a three-dose hepatitis B vaccine (brand name and lot number not provided). In Oct-2024, after receiving a dose of an unknown three-dose hepatitis B vaccine, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). At the time of report, the patient has not received the second dose or HEPLISAV-B yet. No adverse reactions were reported. The reporter declined to provide further information. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2825333 U WA 02/07/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945660
Inappropriate schedule of product administration Inappropriate schedule of product administration
Received The 2nd Dose on Day 27; Initial report received on 30-Jan-2025. A nurse reported that a ... Received The 2nd Dose on Day 27; Initial report received on 30-Jan-2025. A nurse reported that a patient (age, gender, race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization early. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, route, and site not available)]. On an unknown date, 27 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot #, expiration date, route, and site not available). No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2825334 2 M MN 02/07/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 T9TL9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
accidentally received the adult formulation of Havrix; accidentally received the adult formulation o... accidentally received the adult formulation of Havrix; accidentally received the adult formulation of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis. On 03-FEB-2025, the patient received the 1st dose of Havrix 1440 adult. On 03-FEB-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: accidentally received the adult formulation of Havrix) and accidental overdose (Verbatim: accidentally received the adult formulation of Havrix). The outcome of the adult product administered to child and accidental overdose were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-FEB-2025 Nurse reported that one of their patients who is 2 years old accidentally received the adult formulation of Havrix, which led to adult product administered to child and accidental overdose. More
2825335 M 02/07/2025 COVID19
 PFIZER\BIONTECH
Loss of personal independence in daily activities, Musculoskeletal disorder, Pai... Loss of personal independence in daily activities, Musculoskeletal disorder, Pain in extremity More
pain in his arm; unable to move his arm; had hard time washing his hands, washing his body; This is ... pain in his arm; unable to move his arm; had hard time washing his hands, washing his body; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in his arm"; MUSCULOSKELETAL DISORDER (non-serious), outcome "not recovered", described as "unable to move his arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "had hard time washing his hands, washing his body". Additional information: When clarified if the issue occurred after taking vaccine, transferring agent stated patient mentioned that when he was injected with the Pfizer vaccine, he was unable to move his arm and he was also asking if that's normal but his main concern here was, he was experiencing what he experienced after getting the Pfizer Covid-19 vaccine. Consumer stated with this shot he had a pain in his arm, it began 2-3 years, patient still had it. Consumer stated he had to try somebody come on and help him around the house because he couldn't move his arm okay at the time of reporting. He had hard time washing his hands, washing his body. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2825336 U 02/07/2025 COVID19
 PFIZER\BIONTECH
Feeling abnormal Feeling abnormal
when I took the vaccine, it is very hard for me to perform; This is a spontaneous report received fr... when I took the vaccine, it is very hard for me to perform; This is a spontaneous report received from a Consumer or other non HCP. A 26-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "when I took the vaccine, it is very hard for me to perform". Additional information: Consumer stated, "I want to see if, I have been taking the vaccine and from then somewhere I took it, it is very hard for me to perform. From when I took the vaccine, it is very hard for me to perform." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2825337 F 02/07/2025 COVID19
 PFIZER\BIONTECH
Cyst Cyst
Well the cyst is back; This is a spontaneous report received from a Consumer or other non HCP, Progr... Well the cyst is back; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 55-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes: back in 90's/right when I was out of high school; "I had a cyst on my ovaries" (unspecified if ongoing); "I had a cyst", start date: 1990 (unspecified if ongoing), notes: back in the 1990s when I was 20 I had it taken out. The patient's concomitant medications were not reported. The following information was reported: CYST (non-serious), outcome "unknown", described as "Well the cyst is back". Additional information: The patient called to obtain a copy of their records. Patient stated, "I had surgery back in the 90s. I had a cyst on my ovaries, and the doctor retired. I know I was in the hospital for a little bit." Well, the cyst was back. So I was trying to get my medical records and find out what I took that made it better. I knew I had gotten the COVID vaccine too. I had surgery right when I was out of high school." The agent asked what the name of the medication was, and patient stated, I didn't know who made the Triphase product, but one of them was, of course, Depo." Patient stated again, "I had a cyst back in the 1990s when I was 20; I had it taken out, and it didn't really bother me because the doctor said dont worry about it. Well, now it's back well, something was back. So I was trying to figure out what it was that I took or what they gave me or what they found... Now I had it again, and I was wondering if they actually gave me something for the cyst or if it wasn't for the cyst. I had always had cysts on my ovaries when I was a teenager, so they put me on Triphase to try to control them, like follicular cysts. I got nausea from that when I was younger, and they said Depo Provera because I didn't have to take it every day. I didn't know if, after the surgery, that's what kept them from coming back or even what type of cyst it was. I could not find them, so I was trying to find out what I took. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2825338 51 F ME 02/07/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I got vaccinated for the last COVID shot in October/for Paxlovid/super sick; I got vaccinated for th... I got vaccinated for the last COVID shot in October/for Paxlovid/super sick; I got vaccinated for the last COVID shot in October/for Paxlovid/super sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 52-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got vaccinated for the last COVID shot in October/for Paxlovid/super sick". Clinical courses is as follows: During an inbound call for financial assistance, the patient stated, "I actually just called the pharmacists, and they gave me the number for assistance regarding the COVID medicine." The reason for the call was clarified. As the patient's demographics were gathered, the patient stated, "Bear with me because I'm super sick." While expectations of the call's timeframe were stated, the caller later said, "Okay, take your time as long as I can get assistance with this medication because I really need it." When the caller is told that they could use the program's assistance in the future again only for Paxlovid, the caller stated, "Okay, well, hopefully I don't have to do this again because this is the third time in five years. With vaccines, I'm actually vaccinated; I got vaccinated for the last COVID shot in October. So, I don't know, I haven't had luck with that." The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received. More
2825339 U NY 02/07/2025 COVID19
 PFIZER\BIONTECH
Postural orthostatic tachycardia syndrome Postural orthostatic tachycardia syndrome
diagnosed with pots; This is a spontaneous report received from a Consumer or other non HCP, Program... diagnosed with pots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "diagnosed with pots". Additional information: Patient reported, was recently diagnosed with pots and they were contributing other symptoms that patient was having to the shot but patient was told by someone. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2825340 U 02/07/2025 PNC20
 PFIZER\WYETH
Malaise Malaise
very sick for a long time; This is a spontaneous report received from a Consumer or other non HCP. O... very sick for a long time; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 02742018 (Merck). A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "very sick for a long time". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2825341 36 M IL 02/07/2025 COVID19
TDAP
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 3043333
3zh27
Blood glucose decreased, Dizziness, Unresponsive to stimuli; Blood glucose decre... Blood glucose decreased, Dizziness, Unresponsive to stimuli; Blood glucose decreased, Dizziness, Unresponsive to stimuli More
Pt. had some dizziness and informed us of that. Pt was observed for 15-20 minutes. He was out for 10... Pt. had some dizziness and informed us of that. Pt was observed for 15-20 minutes. He was out for 10-15 seconds and not responsive. Might have had a seizure but came out of it and responded. He was cold to touch and had pulse at that moment. We called EMS and paramedics checked him out and his blood sugar was low. Pt will do follow up at hospital. More
2825342 35 F CA 02/07/2025 COVID19
 MODERNA
Burning sensation, Chest discomfort, Dyspnoea, Immediate post-injection reaction... Burning sensation, Chest discomfort, Dyspnoea, Immediate post-injection reaction, Productive cough More
Right arm immediately began to burn, down my arm, into my hand, back up my arm, into my neck, then m... Right arm immediately began to burn, down my arm, into my hand, back up my arm, into my neck, then my lungs felt like they were filling with fluid. I had a difficult time breathing and began to cough up sputum. I had to sit in tripod position to catch a breath. The pharmacist offered an ambulance and benadryl. More
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2825352 11 M OR 02/07/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Dermatitis acneiform, Nasopharyngitis, Pyrexia, Rash, Rash pruritic Dermatitis acneiform, Nasopharyngitis, Pyrexia, Rash, Rash pruritic
1/24/25, in the evening began experiencing an itchy rash in his armpit area, described by his mother... 1/24/25, in the evening began experiencing an itchy rash in his armpit area, described by his mother as raised, red "pimple-like" and in groups rather than what she would consider to be hives. Sore when popped due to itching. Believing it it be a new brand of deodorant, they washed his clothes and switched back to his usual deodorant but it the rash remained. Rash remained, on 1/27- he experienced fever and "head cold type symptoms" . Rash spread to groin area, not genitals on 2/2/25 and 2/6/25 spread covering abdomen, starting to spread to back and some on upper arms. Has been using corticosteroid cream to treat. no other medications. More
2825353 73 M SD 02/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 AE435
Injection site erythema Injection site erythema
Redness at injection site approximately 2 inches in diameter, no treatment warranted at this time Redness at injection site approximately 2 inches in diameter, no treatment warranted at this time
2825354 59 F VA 02/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 KB2YT
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth More
Redness, itching, soreness, warm to touch around injection site/arm area 4 days after vaccine. Redness, itching, soreness, warm to touch around injection site/arm area 4 days after vaccine.
2825355 10 M AZ 02/07/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LM7786
UT8423NA
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
A pediatric patient was due for Covid and Flu vaccines. Parent signed consent forms for both vaccine... A pediatric patient was due for Covid and Flu vaccines. Parent signed consent forms for both vaccines. The primary care clinic only had inventory for Covid 12+ vaccines. MA administered vaccine and allowed patient to rest in the room for 10 minutes in order to observe any adverse side effects. After patient had left. the MA noticed that the patient was 10 years old, and the incorrect vaccination had been administered. The MA notified the provider as soon as possible and reported the incident to clinic supervisors. More
2825356 17 F NV 02/07/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Extra dose administered, No adverse event Extra dose administered, No adverse event
Gave a second dose of MenACWY-TT while patient already had received previous dose that day, giving t... Gave a second dose of MenACWY-TT while patient already had received previous dose that day, giving two doses within one day. No reactions presented. More
2825357 51 F TX 02/07/2025 FLU3
HEPAB
PNC21
VARZOS
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 UT8506KA
4DS4N
Y013009
M7G39
Dizziness, Feeling hot; Dizziness, Feeling hot; Dizziness, Feeling hot; Dizzines... Dizziness, Feeling hot; Dizziness, Feeling hot; Dizziness, Feeling hot; Dizziness, Feeling hot More
Patient has a history of anxiety, after the last vaccine she felt faint and got overheated. I advise... Patient has a history of anxiety, after the last vaccine she felt faint and got overheated. I advised her to sit for awhile and we gave her some water. She requested some ibuprofen and started feeling better. More
2825359 39 F NM 02/07/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LJ5281
LJ5281
Injection site erythema, Injection site inflammation, Injection site warmth, Pai... Injection site erythema, Injection site inflammation, Injection site warmth, Pain, Pain in extremity; Tenderness More
baseball size erythema on left deltoid with a quarter size darker red/purple spot closer to injectio... baseball size erythema on left deltoid with a quarter size darker red/purple spot closer to injection site. along with redness is inflammation, skin is hot to the touch, and arm pain/tenderness/soreness More
2825360 36 F CO 02/07/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Arthralgia, Fatigue, Malaise, Mental impairment, Myalgia; Nausea, Pyrexia Arthralgia, Fatigue, Malaise, Mental impairment, Myalgia; Nausea, Pyrexia
Fever up to 102F, general malaise, muscle and joint aches, nausea, exhaustion, decrease in mental ac... Fever up to 102F, general malaise, muscle and joint aches, nausea, exhaustion, decrease in mental acuity More
2825361 57 M CA 02/07/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 99Y4J
99Y4J
99Y4J
C-reactive protein increased, Catheterisation cardiac normal, Chest pain, Dyspno... C-reactive protein increased, Catheterisation cardiac normal, Chest pain, Dyspnoea, Echocardiogram abnormal; Ejection fraction normal, Electrocardiogram ST segment elevation, Left ventricular hypertrophy, Leukocytosis, Neck pain; Pain, Pericarditis, Pleuritic pain More
Adverse event: pericarditis Presented to ER with chest pain, radiating to neck, shortness of breath... Adverse event: pericarditis Presented to ER with chest pain, radiating to neck, shortness of breath, EKG showed ST elevation, so STEMI activated for . Cath: normal coronaries. Felt sx-: pleuritic chest pain, mild leukocytosis, CRP 19.3, felt indicative of acute pericarditis , Echo: ? Left Ventricle: Mild concentric hypertrophy present. Normal systolic function with an estimated EF of 60 - 65%. ? Right Ventricle: Right ventricle size is normal. Normal systolic function. ? Normal valve function. More
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2825445 75 F CA 02/07/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Abdominal pain upper, Blindness, Impaired work ability, Malaise, Nausea; Neurolo... Abdominal pain upper, Blindness, Impaired work ability, Malaise, Nausea; Neurological symptom More
Loss of sight in both eyes resulting in loss of job like stroke after 3 day illness stomach crampy ... Loss of sight in both eyes resulting in loss of job like stroke after 3 day illness stomach crampy & naucea (active convulsive) spike protein triggered acid immune response meds hyper sensitive w/ response More
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