πŸ₯ VAERS Vaccine Data Browser

πŸ”’ Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

πŸ“– Help & Search Guide

Column Icons Legend

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

How to Search

πŸ’‘ Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2840306 05/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Discomfort, Herpes zoster, Pain, Vaccination failure Discomfort, Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Had the shot and still got it; Extremely uncomfortable; This serious ... Suspected vaccination failure; Had the shot and still got it; Extremely uncomfortable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had the shot and still got it) and discomfort (Verbatim: Extremely uncomfortable). The outcome of the vaccination failure was not reported and the outcome of the shingles and discomfort were resolved. It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and discomfort to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the shot and still got them. Extremely uncomfortable and painful. Ran its course and so far had not returned. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2840307 M 05/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; this time a lot worse.; This serious case was reported by a consumer ... Suspected vaccination failure; this time a lot worse.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had got a mild case). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: this time a lot worse.). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that her husband had got a mild case then a year or so later got the vaccine and this time a lot worse. He said he did not wish that on his worst enemy. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2840308 36 F NE 05/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
nurse accidentally administered a Priorix vaccine intravenously instead of intramuscularly; This non... nurse accidentally administered a Priorix vaccine intravenously instead of intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 36-year-old female patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intravenous). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: nurse accidentally administered a Priorix vaccine intravenously instead of intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-APR-2025 Pharmacist called to report that a nurse accidentally administered a Priorix vaccine intravenously instead of intramuscularly, which led to subcutaneous injection formulation administered by other route. The reporter wanted to know was there any advice or safety concern on this situation No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2840309 11 M NM 05/09/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 XL223
PJ3RP
Product storage error; Product storage error Product storage error; Product storage error
Administration after temp. excursion; This non-serious case was reported by a other health professio... Administration after temp. excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number XL223) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number PJ3RP) for prophylaxis. On 28-APR-2025, the patient received Menveo and Boostrix. On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temp. excursion). The outcome of the incorrect storage of drug 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: On 29 April 2025, a Primary coordinator/AMAS called to report a temperature excursion. Healthcare professional mentioned that after the temperature excursion, they administered 8 vaccines. This patient received Boostrix and Menveo (1 vial) which led to incorrect storage of drug. The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments: US-GSK-US2025051844:same reporter/different patient US-GSK-US2025051843:same reporter/different patient More
2840310 F 05/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix late second dose; This non-serious case was reported by a nurse via call center representat... Shingrix late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in June 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 29-APR-2025 Nurse practitioner wanted to obtain recommendations on a late second dose of Shingrix (the patient got the first dose in June 2024). Only the month in which the patient got vaccinated, her age and gender was provided. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. More
2840311 M VA 05/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Brain fog, Chills, Hyperhidrosis Brain fog, Chills, Hyperhidrosis
profuse sweats; chills; brain fog; This non-serious case was reported by a pharmacist via call cente... profuse sweats; chills; brain fog; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles). Previously administered products included Acyclovir (received 5 times a day). In APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In APR-2025, an unknown time after receiving Shingrix, the patient experienced sweating (Verbatim: profuse sweats), chills (Verbatim: chills) and brain fog (Verbatim: brain fog). The outcome of the sweating, chills and brain fog were resolved. It was unknown if the reporter considered the sweating, chills and brain fog to be related to Shingrix. It was unknown if the company considered the sweating, chills and brain fog to be related to Shingrix. Additional Information: GSK Receipt Date: 29-APR-2025 The pharmacist stating that he was procrastinated in getting the vaccine. He got shingles early on and thought he had immunity to exposure. He was treated with Acyclovir 5 times a day. He got hist first dose of Shingrix 3 weeks ago. He experienced profuse sweats, chills and brain fog that week up to 2 weeks after. Symptoms were now resolved. He states he had been told that the 2nd dose of Shingrix was worse but he felt the first dose was worse. More
2840312 M MN 05/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix late second has not received the second dose yet; This non-serious case was reported by a p... Shingrix late second has not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 11-APR-2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second has not received the second dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 29-APR-2025 The pharmacist reported that a patient received the first dose of Shingrix on April 11, 2023 and has not received the second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2840313 46 F WI 05/09/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
Accidental administration of Infanrix instead of Boostrix.; This non-serious case was reported by a ... Accidental administration of Infanrix instead of Boostrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 46-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 16-APR-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 16-APR-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Accidental administration of Infanrix instead of Boostrix.). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-MAY-2025 The nurse practitioner called to inform that, a patient accidentally received a dose of Infanrix. According to reporter, the initial intention was to administer a booster dose of Boostrix, which led to wrong vaccine administered. More
2840314 CA 05/09/2025 COVID19
 MODERNA
COVID-19 COVID-19
Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19... Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication information was not provided. The reporter inquired about the necessary steps to be taken following the 7 to 10 days incubation period, and how to know that it was cured, and requested guidance on how to prevent the transmission of the virus and was it necessary to take Tameflu medication for TTT. The patient had been in other country for 35 years. Treatment information was not reported. More
2840315 79 F CA 05/09/2025 COVID19
 MODERNA
Diarrhoea, Vomiting Diarrhoea, Vomiting
Diarrhea like food poisoning; Vomiting; This spontaneous case was reported by a patient and describe... Diarrhea like food poisoning; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea like food poisoning) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-Apr-2025, the patient experienced DIARRHOEA (Diarrhea like food poisoning) and VOMITING (Vomiting). On 26-Apr-2025, DIARRHOEA (Diarrhea like food poisoning) and VOMITING (Vomiting) had resolved. No concomitant medication was reported. During the night after vaccine began with vomiting, then diarrhea. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2840316 F TX 05/09/2025 RSV
 PFIZER\WYETH
Allergy to vaccine, Exposure during pregnancy, Rash, Rash erythematous Allergy to vaccine, Exposure during pregnancy, Rash, Rash erythematous
got a red rash all over body; got a red rash all over body; most likely an allergy to something in t... got a red rash all over body; got a red rash all over body; most likely an allergy to something in the vaccine; This is a spontaneous report received from a Physician from a sales representative. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "got a red rash all over body"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "most likely an allergy to something in the vaccine". It was unknown if therapeutic measures were taken as a result of rash, rash erythematous, allergy to vaccine. Additional information: the patient received rsv vaccine prot.subunit pref 2v and within a few days the patient developed a red rash all over the body. The provider determined that the event was most likely an allergy to something in the vaccine. More
2840317 65 F 05/09/2025 PNC13
 PFIZER\WYETH
Diarrhoea, Headache, Swelling Diarrhoea, Headache, Swelling
headache; diarrhea committing; swelling; This is a spontaneous report received from an Other HCP fro... headache; diarrhea committing; swelling; This is a spontaneous report received from an Other HCP from a sales representative. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 01May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 01May2025, outcome "recovered"; DIARRHOEA (non-serious) with onset May2025, outcome "recovered", described as "diarrhea committing"; SWELLING (non-serious) with onset May2025, outcome "recovered". It was unknown if therapeutic measures were taken as a result of headache, diarrhoea, swelling. Additional information: patient reported headache one hour after administration followed by 3 days of diarrhea committing and swelling. Eventually recovered. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2840318 M 05/09/2025 PNC20
 PFIZER\WYETH
Drug ineffective Drug ineffective
Doesn't work; constantly seeing ineffectiveness; This is a spontaneous report received from a P... Doesn't work; constantly seeing ineffectiveness; This is a spontaneous report received from a Physician. A 3-year-old male patient 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Doesn't work; constantly seeing ineffectiveness".; Sender's Comments: Despite no PREVNAR 20 preventable infection currently provided, the case is conservatively handled as LOE with the suspect vaccine in terms of "Doesn't work; constantly seeing ineffectiveness". More critical information on any infectious condition including pathogen/serotype as a result of 'PREVNAR 20/vaccine ineffectiveness' and vaccination regimen are needed for meaningful causality assessment. More
2840319 F 05/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
the caller mentioned that she had all four Pfizer shots, but she still has COVID; the caller mention... the caller mentioned that she had all four Pfizer shots, but she still has COVID; the caller mentioned that she had all four Pfizer shots, but she still has COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 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 and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the caller mentioned that she had all four Pfizer shots, but she still has COVID". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2840320 73 F CA 05/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID; COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID.... COVID; COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2840321 05/09/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 8080748
8080748
UT8459MA
UT8459MA
Back pain, Diabetic ketoacidosis, Fatigue, Laboratory test, Type 1 diabetes mell... Back pain, Diabetic ketoacidosis, Fatigue, Laboratory test, Type 1 diabetes mellitus; Vomiting; Back pain, Diabetic ketoacidosis, Fatigue, Laboratory test, Type 1 diabetes mellitus; Vomiting More
type 1 diabetes mellitus; Diabetic ketoacidosis; low back pain; excessive vomiting; Fatigue; Initial... type 1 diabetes mellitus; Diabetic ketoacidosis; low back pain; excessive vomiting; Fatigue; Initial information received on 29-Apr-2025 (Live follow-up processed together) regarding an unsolicited valid serious (courtesy) case received from a consumer/non-healthcare professional. This case involves an unknown age and unknown gender patient who had type 1 diabetes mellitus, diabetic ketoacidosis after receiving Elasomeran [Spikevax] and Influenza USP Trival A-B Subvirion no Preservative Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Cleft palate on 13-Jun-2008 and attention deficit hyperactivity disorder on 12-Feb-2020. Concomitant medications included Methylphenidate Hydrochloride (Concerta); Melatonin (Melatonin) and Escitalopram Oxalate (Lexapro) all for attention deficit hyperactivity disorder. On 26-Dec-2024, the patient received 1DF (Dosage form) dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection, lot UT8459MA, for prophylactic vaccination (immunisation) and received 50ug dose of suspect Spikevax, Injection not produced by Sanofi Pasteur lot 8080748 (unknown strength and expiry date) via intramuscular route in unknown administration site for COVID-19 prophylaxis. On 07-Jan-2025 the patient developed fatigue (Latency 12 days). On 08-Jan-2025 the patient developed a non-serious excessive vomiting (vomiting) (Latency 13 days). On 09-Jan-2025 at 02:00 hours, the patient developed low back pain (back pain) and at 03:00 hours, the patient developed type 1 diabetes mellitus and diabetic ketoacidosis (Latency 14 days). Relevant laboratory test results included: Laboratory test - On 09-Jan-2025: [revealed diabetic ketoacidosis] Reportedly, patient was taken to emergency room. Testing revealed DKA (diabetic ketoacidosis) and patient took life flight to health center with concern for brain swelling. Patient received treatment of DKA from 11-Jan-2025 with ongoing type 1 diabetes. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the event (type 1 diabetes mellitus) and (diabetic ketoacidosis), was Unknown for rest of the events. Seriousness criteria: Both event were assessed as medically significant and The patient was hospitalized for both the events. The patient was discharged on 12-Jan-2025 (hospitalization for 3 days).; Sender's Comments: Sanofi Company Comment dated 06-May-2025,This case involves an unknown age and unknown gender patient who had type 1 diabetes mellitus, diabetic ketoacidosis after receiving Elasomeran [Spikevax] and Influenza USP Trival A-B Subvirion no Preservative Vaccine [Fluzone]. Further information regarding tolerance, allergic history, medical history, and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Concomitant medications included Methylphenidate Hydrochloride (Concerta); Melatonin (Melatonin) and Escitalopram Oxalate (Lexapro) all for attention deficit hyperactivity disorder. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
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2840322 70 M MI 05/09/2025 TDAP
 SANOFI PASTEUR
 U8366A
Immunoglobulin therapy, Myasthenia gravis, Product administered to patient of in... Immunoglobulin therapy, Myasthenia gravis, Product administered to patient of inappropriate age More
adacel was administered to a patient above 65 years old; Myasthenia gravis localized in the right ey... adacel was administered to a patient above 65 years old; Myasthenia gravis localized in the right eye; Initial information received on 06-May-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 70 years old male patient who had myasthenia gravis localized in the right eye and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was administered to a patient above 65 years old. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitants: no other vaccines On 06-Feb-2025, the patient received a dose of 0.5 ml once of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection with strength- standard, (lot U8366A, expiry date- 31-Jan-2027) via intramuscular route in the left arm for Immunization, above 65 years old (off label use) (latency- same day). On an unknown date in 2025 the patient developed myasthenia gravis localized in the right eye (Ocular myasthenia) (latency- few days approximately) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. Action taken was not applicable. The patient was given Prednisone and Ig (immunoglobulins) infusions and eye symptoms improved . At time of reporting, the outcome was Recovering / Resolving for the event Ocular myasthenia. Seriousness criteria: The event Ocular myasthenia was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 09-MAY-2025: This case involves a 70 years old male patient who had myasthenia gravis localized in the right eye and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was administered to a patient above 65 years old. Further information regarding allergic history, laboratory investigations, medical history and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
2840323 0.17 NY 05/09/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK307AA
Seizure Seizure
patient had initial dose of pentacel yesterday and ended up in the er overnight with a possible seiz... patient had initial dose of pentacel yesterday and ended up in the er overnight with a possible seizure; Initial information received on 06-May-2025 regarding an unsolicited valid serious case received from an other healthcare professional. This case involves a 2 months old and unknown gender patient where patient had initial dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday and ended up in the er (emergency room) overnight with a possible seizure. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-May-2025, the patient received a dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UK307AA and expiry date- 31-AUG-2026) via unknown route in unknown administration site (strength: not provided) for Immunization. On 05-MAY-2025 the patient had initial dose of pentacel yesterday and ended up in the er overnight with a possible seizure (seizure) (latency- same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. This event was assessed as medically significant. Reportedly, No other vaccines were administered at the time. Product used : Used, First time product used : Yes. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovering / Resolving for the event.; Sender's Comments: Sanofi Company Comment dated 07-May-2025: This case involves a 2 months old and unknown gender patient where patient had initial dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday and ended up in the er (emergency room) overnight with a possible seizure. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine can be denied. More
2840324 25 M CA 05/09/2025 ANTH
TYP
YF
 EMERGENT BIOSOLUTIONS
SANOFI PASTEUR
SANOFI PASTEUR
 300216A
Y2A021M
UK134AA
Pruritus, Urticaria; Pruritus, Urticaria; Pruritus, Urticaria Pruritus, Urticaria; Pruritus, Urticaria; Pruritus, Urticaria
Pt reported to clinic several hours post-vaccine administration c/o Hives and itchiness that started... Pt reported to clinic several hours post-vaccine administration c/o Hives and itchiness that started on inner aspect of L arm that traveled to his L axilla. Pt. "brushed it off" and continued with his workday until he noticed hives to be getting worse and spreading to his trunk, abdomen and R arm/axilla. S/sx of anaphylaxis assessed but where found to be unremarkable and patient to be in stable condition. Pt. denies SOB, difficulty breathing, Tachypnea or cool clammy skin, feelings of impending doom. RN and MD called in to assess patient per protocol and ordered 50mg of Benadryl, PO to be administered. Orders carried out with patient endorsing improvement 30 minutes after Rx administration, skin still showing hives. MD educated patient on ER precautions and encouraged OTC allergy meds to be sought out for symptom management. Pt verbalized agreement to care plan and all education provided by medical staff. Pt left clinic; ambulatory and in stable condition. More
2840325 63 M MT 05/09/2025 YF
YF
MMR
MMR
YF
YF
 SANOFI PASTEUR
SANOFI PASTEUR
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SANOFI PASTEUR
SANOFI PASTEUR
 UK134AA
UK134AA
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
The yellow fever vaccine was administered two weeks after the patient had received the MMR vaccine; ... The yellow fever vaccine was administered two weeks after the patient had received the MMR vaccine; as such, these two live vaccines were not separated by the recommended 4 weeks. When this error was brought to this RN's attention, she reached out to Sanofi, the manufacturer of the Yellow Fever who provided the following guideline: "ACIP guidelines are that live vaccinations should be administered at least 4 weeks apart. In the case that two live vaccines are given less than four weeks apart, the second vaccination should not be counted, and that dose should be repeated at least 4 weeks later." This RN called and spoke with the patient, he denied experiencing any adverse effects from the vaccines. He had a scheduled appointment to return to the health department to receive other vaccines and was amenable to recieve a second Yellow Fever vaccination. More
2840326 1 M CA 05/09/2025 MMR
 MERCK & CO. INC.
 Y014391
Soft tissue foreign body, Syringe issue Soft tissue foreign body, Syringe issue
As MMR was being administered it splashed out. Needle stayed in the patient as I pulled out the syri... As MMR was being administered it splashed out. Needle stayed in the patient as I pulled out the syringe. Needle pulled out of patient intact right away. Patient did not appear to be in any further distress than just the usual reaction to receiving a shot. Provider informed immediately and provider decided the following steps to patient care in accordance with procedure. More
2840331 0.5 M CA 05/09/2025 PNC20
 PFIZER\WYETH
 LX4483
Crying, Needle issue, Soft tissue foreign body Crying, Needle issue, Soft tissue foreign body
I administered the vaccine, as I was pulling out, the needle portion stayed in the patient's th... I administered the vaccine, as I was pulling out, the needle portion stayed in the patient's thigh. Right away I pulled out the needle from the patient intact. The patient was crying from receiving the shot but did not appear to be in distress. Manager and provider made aware of the situation. More
2840332 12 F CA 05/09/2025 MNQ
 SANOFI PASTEUR
 U8494AA
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Redness/ swelling at injection site , warm to the touch. Redness/ swelling at injection site , warm to the touch.
2840333 80 F AZ 05/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Rash, Skin reaction Erythema, Rash, Skin reaction
Patient developed skin reaction in her whole body. Rash/redness to the skin. Patient developed skin reaction in her whole body. Rash/redness to the skin.
2840334 43 F WY 05/09/2025 COVID19
 PFIZER\BIONTECH
Phantosmia Phantosmia
Phantosmia smelling cigarette smoke. Sometimes constant (several hours) sometimes only a few times ... Phantosmia smelling cigarette smoke. Sometimes constant (several hours) sometimes only a few times a day- (6- More
2840335 33 F AZ 05/09/2025 HPV9
 MERCK & CO. INC.
 Y007197
Rash, Rash erythematous Rash, Rash erythematous
PATIENT REPORTED DARK PINK/RED NON-PURULENT, NON-PRURITC RASH ON LEGS ONLY, NOT AT INJECTION SITE. D... PATIENT REPORTED DARK PINK/RED NON-PURULENT, NON-PRURITC RASH ON LEGS ONLY, NOT AT INJECTION SITE. DURATION OF RASH IS UNKNOWN (POSSIBLY 1-2 DAYS) More
2840336 16 M GA 05/09/2025 MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS

Chills, Cough, Dyspnoea, Dysstasia, Headache; Pain, Photophobia Chills, Cough, Dyspnoea, Dysstasia, Headache; Pain, Photophobia
Light sensitivity, headache, body ache, chills, difficulty standing, difficulty breathing, and cough Light sensitivity, headache, body ache, chills, difficulty standing, difficulty breathing, and cough
2839957 41 TN 05/08/2025 MMRV
 MERCK & CO. INC.
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Pharmacist called to report that a 41 year old was supposed to receive both an MMR and VARICELLA vac... Pharmacist called to report that a 41 year old was supposed to receive both an MMR and VARICELLA vaccine but instead was administered PROQUAD. Caller provided the name and address he was calling from and stated it happened at one of their facilities; No patient symptoms had been reported; 41 year old received PROQUAD; This spontaneous report was received from a Pharmacist and refers to a 41-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #, expiration date, strength, route of administration, anatomical location not provided) as prophylaxis; instead of measles, mumps and rubella (MMR) and varicella vaccine as it was supposed to be received (wrong vaccine administered, inappropriate age at vaccine administration). It was stated that no symptoms had been reported. More
2839958 1 PA 05/08/2025 HEPA
 MERCK & CO. INC.
 X025482
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AEs were reported, no further information provided; Field employee called to report a ... No additional AEs were reported, no further information provided; Field employee called to report a patient received an expired VAQTA.; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 16-Apr-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #X025482, expiration date: 12-Apr-2025) (1 dose) for prophylaxis. No additional adverse event was reported. More
2839959 45 F MI 05/08/2025 HPV9
 MERCK & CO. INC.
 1957407
Autoimmune disorder, Biopsy skin abnormal, Pruritus, Skin hyperpigmentation, Vei... Autoimmune disorder, Biopsy skin abnormal, Pruritus, Skin hyperpigmentation, Vein discolouration More
autoimmune response that generates lichen planus; she noted that her veins looked "darker and b... autoimmune response that generates lichen planus; she noted that her veins looked "darker and blue/One week after noticing the vein discoloration/hyperpigmentation showed up all throughout the body/lichen planus pigmentosus; This spontaneous report was received from a consumer, regarding herself, a 46-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Mar-2024, the patient was vaccinated with the first dose of human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose of 0.5 mL, intramuscularly administrated in the left deltoid (lot #1957407 which has been verified to be a valid number, expiration date reported and validated as 23-Jan-2026) as a prophylaxis. On unspecified date in 2024 (reported as about 7 days later), the patient noted that her veins looked darker and blue. On unspecified date (reported as one week after noticing the vein discoloration) she started itching all over her body for a few days. She thought it was just a rash, but then a month later hyperpigmentation showed up all throughout the body. The patient sought medical attention calling the health care professional (HCP). On 03-Dec-2024, the patient went to see the dermatologist and a biopsy was taken from the left deltoid area, which confirmed that there was an induced autoimmune response (autoimmune disorder) that caused lichen planus pigmentosus. The patient was placed on treatment which had been unsuccessful. At the reporting time, the patient had not recovered from the events. The action taken with human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as therapy discontinued. The causal relationship between the events with human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Upon internal review, the event of autoimmune disorder was determined to be medically significant. More
2839960 IL 05/08/2025 HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.

Antiphospholipid syndrome, Autonomic nervous system imbalance; Antiphospholipid ... Antiphospholipid syndrome, Autonomic nervous system imbalance; Antiphospholipid syndrome, Autonomic nervous system imbalance More
Antiphospholipid antibodies/syndrome; Autonomic dysfunction; This initial spontaneous report was rec... Antiphospholipid antibodies/syndrome; Autonomic dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning patient (pt) of a not reported age or gender. Patient's current conditions, medical history and concomitant therapy was not reported. On 27-MAR-2018 and 27-SEP-2018, the pt was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prophylaxis. On an unknown date, the pt experienced Autonomic dysfunction and Antiphospholipid antibodies/syndrome. At the reporting time, the outcome of the events was not provided. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was stated that the lawyer previously filed a petition, however, the lawsuit would remain unfiled during a period while the legal statute of limitations would remain preserved. Upon internal review, the event of Antiphospholipid antibodies/syndrome was determined to be medically significant. More
2839961 GA 05/08/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014436
Y015559
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AEs; Caller reported patient received PROQUAD and VARIVAX at same office visit.; This ... No additional AEs; Caller reported patient received PROQUAD and VARIVAX at same office visit.; This spontaneous report was received from a physician assistant (reported as medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs and allergies were not reported. On 06-May-2025, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA [recombinant Human albumin]) (PROQUAD) injection, 0.5 mL, administered subcutaneously as prophylaxis (Lot No. Y014436 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 22-Feb-2026) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not provided); also with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection 0.5 mL, administered subcutaneously as prophylaxis (Lot No. Y015559 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 16-Sep-2026)(strength, dose number, anatomical location of administration and vaccination scheme frequency were not provided); both doses were reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) administered subcutaneously (Lot No., expiration date and indication were not provided). It was stated that the patient received both doses of previous mentions vaccines at the same office visit (overdose). No additional adverse events were reported (no adverse event). More
2839962 M MN 05/08/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Extra dose administered, No adverse event Extra dose administered, No adverse event
Received HEPLISAV-B and then ENGERIX B; Initial report received on 11-Apr-2025. A nurse reported th... Received HEPLISAV-B and then ENGERIX B; Initial report received on 11-Apr-2025. A nurse reported that a 40-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 21-Feb-2025 and then received ENGERIX-B on 02-Apr-2025. No medical history or concomitant medications were reported. On 21-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 02-Apr-2025, 41 days after having been vaccinated with HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number and expiration date not provided)]. The reporter was inquiring if another dose of HEPLISAV-B was required. No adverse reactions were reported. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2839963 F UT 05/08/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945664
Dyspnoea, Erythema, Pruritus, Urticaria Dyspnoea, Erythema, Pruritus, Urticaria
A Red Face; Shortness of Breath; Itchiness; Hives; Initial report received on 17-Apr-2025. A repo... A Red Face; Shortness of Breath; Itchiness; Hives; Initial report received on 17-Apr-2025. A reporter reported that a 19-year-old female (ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed hives, a red face, itchiness, and shortness of breath. No medical history was reported. No concomitant medications were reported. On 16-Apr-2025, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #945664, expiration date 31-Jan-2027, NDC # 43528-003-01)] intramuscularly in the left deltoid. On an unknown date, after receiving dose 2 of HEPLISAV-B, the patient developed hives, a red face, itchiness, and shortness of breath. No other side effects were reported. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2839964 05/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Seizure Seizure
Had a seizure 6 days after getting the first shot; This serious case was reported by a consumer via ... Had a seizure 6 days after getting the first shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of seizure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced seizure (Verbatim: Had a seizure 6 days after getting the first shot) (serious criteria GSK medically significant). The outcome of the seizure was not reported. It was unknown if the reporter considered the seizure to be related to Shingles vaccine. The company considered the seizure to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 01-MAY-2025 This case was reported by a patient via interactive digital media. The patient had a seizure 6 days after getting the first shot. The patient did not get the 2nd shot. The patient would have gotten it if he/she had not had the seizure. The patient would take his/her chances.; Sender's Comments: Seizure is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2839982 1 M 05/08/2025 HIBV
MEN
MMR
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
Autism spectrum disorder; Autism spectrum disorder; Autism spectrum disorder Autism spectrum disorder; Autism spectrum disorder; Autism spectrum disorder
He was diagnosed with autism not long after his 3rd birthday in 2010; This serious case was reported... He was diagnosed with autism not long after his 3rd birthday in 2010; This serious case was reported by a consumer via interactive digital media and described the occurrence of autism in a 18-year-old male patient who received Hib (Hiberix) for prophylaxis. Co-suspect products included MMR (Priorix) for prophylaxis and Meningococcal vaccine C conj (CRM197) (Meningitec) for prophylaxis. Previously administered products included Infanrix hexa (received 1st dose on 02-MAR-2007 and received Prevenar 7 also on same day), Infanrix hexa (received 2nd dose on 21-MAY-2007 and received Prevenar 7 also on same day) and Infanrix hexa (received 3rd dose on 23-JUL-2007 and received Prevenar 7 also on same day). On 01-FEB-2008, the patient received Hiberix, Priorix and Meningitec. On an unknown date, an unknown time after receiving Hiberix and Priorix, the patient experienced autism (Verbatim: He was diagnosed with autism not long after his 3rd birthday in 2010) (serious criteria GSK medically significant). The outcome of the autism was not resolved. The reporter considered the autism to be related to Hiberix, Priorix and Priorix Pre-Filled Syringe Device. The company considered the autism to be unrelated to Hiberix, Priorix and Priorix 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: 30-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient received 3 doses of Infanrix hexa and Prevnar 7 vaccines in 2007(the first 6 months of his life) and in 2008 vaccinated with Hiberix, Priorix and Meningitec vaccines. The patient recently had to obtain his immunisation records for the agency. The reporter thought what was he/she thought, did not like he/she, so many parents, unless you have a vaccine injured child, or you have been injured by Pharma, carry on blindly believing and never questioning. He was diagnosed with autism not long after his 3rd birthday in 2010, so stopped with all injections after that. Never again. Now reporter was worried sick as he was joining the agency and they are still mandating the messenger ribonucleic acid death shots, not to mention the other jabs that he would need to catch up on. The reporter's general practitioner would not gave him an exemption. Looks like would be drafting a letter of conscientious objection when it was time for his medical assessment . The reporter did not like his chances. All reporter could did was hope that the next intake was after September and pray that did not go back on his word. The reporter considered the autism to be related to Meningitec.; Sender's Comments: Autism spectrum disorder is an unlisted event which is considered unrelated to GSK vaccine Hiberix, Priorix and Priorix PRE-FILLED SYRINGE DEVICE. More
2839993 4 F OK 05/08/2025 DTAPIPVHIB
HEPA
PNC15
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 UK043AA
H3N97
Y010032
Cough, Rhinorrhoea; Cough, Rhinorrhoea; Cough, Rhinorrhoea Cough, Rhinorrhoea; Cough, Rhinorrhoea; Cough, Rhinorrhoea
Pt had runny nose last night with cough by father reported on 5-6-25. Pt had runny nose last night with cough by father reported on 5-6-25.
2839994 45 F MI 05/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 MC7HK
Pain in extremity Pain in extremity
TDAP administered into left deltoid on 01/08/2025. On 02/03/2025, patient notified clinic of left ar... TDAP administered into left deltoid on 01/08/2025. On 02/03/2025, patient notified clinic of left arm pain. Patient denied skin color changes; no fever; no itching; no redness. Patient returned to clinic on 03/03/2025 for an unrelated issues. Patient did not express and reference to the previous left arm pain. On 03/11/2025, patient sent an electronic message to the provider indicating still having left arm pain / soreness. Patient was seen for follow up on 03/20/2025. At that appointment, patient denied numbness, tingling, weakness. Physician ordered a treatment plan of NSAIDs/ice and an ultrasound of the left arm to assist with determining cause/source of pain. Received a phone call on 04/29/2025 to discuss left arm pain. Per patient, she is still experiencing left arm pain although it has markedly improved. Ultrasound was not completed. More
2839995 11 M FL 05/08/2025 FLU3
HPV9
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 495MK
Y012865
U8361AA
LQ494
Syncope; Syncope; Syncope; Syncope Syncope; Syncope; Syncope; Syncope
brief syncope with last vaccine administered (Tdap) immediately recovered when name called. mom beli... brief syncope with last vaccine administered (Tdap) immediately recovered when name called. mom believes he was holding breath. Laid in supine position given H20, vitals stable. More
2839996 57 M IA 05/08/2025 HEP
HEPA
IPV
MMR
MMRV
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y5XYT
Y012054
W1B511M
X019100
Y002374
9YB46
Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event; Unev... Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event; Unevaluable event More
None Known Of None Known Of
2840031 4 F TX 05/08/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Y019173
Injection site induration, Injection site pain, Injection site swelling, Injecti... Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia; Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia More
Mother reported patient "woke this morning she c/o pain to her legs and could not walk. Parent ... Mother reported patient "woke this morning she c/o pain to her legs and could not walk. Parent noted redness/swelling to L thigh. She called the nurse line and was advised to offer medication PRN. Child also had a fever this morning. Parent last offered Motrin 5 hours ago and has noted improvement in pain. Child is now walking Area is still warm, tender, and swollen but improving. No rash" Assessment noted a "tender, indurated about 3-4 cm area surrounding injection site with mild erythema. " More
2840032 60 F WA 05/08/2025 COVID19
 MODERNA
 NDC80777-0110-9
Injection site rash, Pain, Rash, Rash macular, Rash pruritic Injection site rash, Pain, Rash, Rash macular, Rash pruritic
Small itchy rash around injection site that began blotchy and filled in. First started 4-6-2025. On ... Small itchy rash around injection site that began blotchy and filled in. First started 4-6-2025. On 4-7-25 the rash began with hive-like bumps on my chest. It rapidly filled in on my chest and neck, from about below ears and all the way across. Very red and slightly raised. Doesn't respond to anthistimine or Benedryl creme. Slowly spreading around to my back. Not itchy. It stings. More
2840033 0.25 F MI 05/08/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 dn273
Unevaluable event Unevaluable event
n/a n/a
2840034 81 F IL 05/08/2025 COVID19
 MODERNA
Body temperature increased, Hypersomnia Body temperature increased, Hypersomnia
May 7 by 7AM had 100.6 temperature, slept entire day May 7 by 7AM had 100.6 temperature, slept entire day
2840035 82 F NC 05/08/2025 PNC21
TYP
 MERCK & CO. INC.
SANOFI PASTEUR
 UK118AA
Y2A021M
Pain, Pain in extremity; Pain, Pain in extremity Pain, Pain in extremity; Pain, Pain in extremity
Patient developed severe shooting pain in the right arm after vaccination with the yellow fever vacc... Patient developed severe shooting pain in the right arm after vaccination with the yellow fever vaccine. She was seen by physical therapy the day after her travel clinic appointment. No fevers, redness, warmth. Patient reported having been vaccinated with YF vaccination 60 years prior but had no documentation. More
2840036 65 F OK 05/08/2025 PNC20
 PFIZER\WYETH
 LX4482 (EAST TU
Chills, Injection site swelling, Pain, Peripheral swelling, Pruritus Chills, Injection site swelling, Pain, Peripheral swelling, Pruritus
Patient reported symptoms started the next day with chills, arm swelling starting at site of injecti... Patient reported symptoms started the next day with chills, arm swelling starting at site of injection and then involving entire left arm, rash present. Itch and pain present. symptoms continue 5/8/25 More
2840037 5 F FL 05/08/2025 DTAP
DTAP
IPV
IPV
MMR
MMR
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 3CA11C1
3CA11C1
X1D141M
X1D141M
Y014096
Y014096
Lymphadenopathy, Pharyngeal erythema, Pyrexia, Rash, Streptococcus test positive... Lymphadenopathy, Pharyngeal erythema, Pyrexia, Rash, Streptococcus test positive; Tonsillar hypertrophy; Lymphadenopathy, Pharyngeal erythema, Pyrexia, Rash, Streptococcus test positive; Tonsillar hypertrophy; Lymphadenopathy, Pharyngeal erythema, Pyrexia, Rash, Streptococcus test positive; Tonsillar hypertrophy More
She started with rash on face & trunk on 5/1/25- 2 weeks after vaccine given. She was seen in o... She started with rash on face & trunk on 5/1/25- 2 weeks after vaccine given. She was seen in office on 5/2/25 & rash was on face, trunk, arms, groin & thighs. She also had enlarged cervical lymph nodes, enlarged tonsils & red throat. She also had fever 3 days after MMR vaccine (4/21/25) & was seen & tested positive for Strep throat & started on Amoxil. More
2840038 20 F ID 05/08/2025 VARCEL
 MERCK & CO. INC.
 Y017063
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More
Pt reports golf ball sized red slightly raised injection site reaction. Reports it is itchy and hot. Pt reports golf ball sized red slightly raised injection site reaction. Reports it is itchy and hot.
2840039 12 M TX 05/08/2025 MNQ
MNQ
TDAP
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Z92L4
Z92L4
M2G3Z
M2G3Z
Blood creatine phosphokinase increased, Guillain-Barre syndrome, Hypoaesthesia, ... Blood creatine phosphokinase increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture normal; Magnetic resonance imaging spinal abnormal, Muscular weakness; Blood creatine phosphokinase increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture normal; Magnetic resonance imaging spinal abnormal, Muscular weakness More
Patient began to have numbness of feet starting on 4/21/25. this progressed to full Guillain BarrοΏ... Patient began to have numbness of feet starting on 4/21/25. this progressed to full Guillain BarrοΏ½ syndrome with 4 day admission to hospital and 3 rounds of IVIG with good response to treatment. More
βœ“ βœ“
2840041 18 M TN 05/08/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
DD72H
Arthralgia, Dizziness, Ear pain, Headache, Injection site pain; Migraine, Neck p... Arthralgia, Dizziness, Ear pain, Headache, Injection site pain; Migraine, Neck pain, Pain, Pain in extremity, Paraesthesia More
After he got his shots he got light headed afterwards. HIs arm was very tingly. Then about 2-3 hours... After he got his shots he got light headed afterwards. HIs arm was very tingly. Then about 2-3 hours after that it started hurting, up above the where they put the shot in. He thought it was related to the medicine in the shot. Then the pain started migrating down his arm and up his shoulder and neck into his ear. Yesterday it started migrating into his hand. He uses his laptop to do his homework it start a throbbing pulsing pain. The headaches started two to three hours after the shot, then it turned into a very bad migraine. IT went away and he was able to sleep a few hours, he must have rolled in his sleep and the pain started up again, a pulsing pain in his arm. The headaches are mild now. He took tylenol and motrin for the headache. No nausea, no vision change. He had chills and felt hot at first. Not sure if he had a fever. No vomiting, no diarrhea, no cough, no runny nose. The issue is in the left arm. More
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