๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

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

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2863368 16 M KS 10/06/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

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
Administration to 16 YO patient; Administration to 16 YO patient; This non-serious case was reported... Administration to 16 YO patient; Administration to 16 YO patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. On 08-MAY-2025, the patient received the 2nd dose of Twinrix. On 08-APR-2025, the patient received the 1st dose of Twinrix. On 08-APR-2025, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to 16 YO patient). On 08-MAY-2025, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to 16 YO patient). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-SEP-2025 The healthcare professional (HCP) reported that a 16-year-old pediatric patient had received two doses of Twinrix, possibly administered in country. The first dose was given on April 8, 2025, and the second on May 8, 2025. The HCP was seeking guidance on how to complete the Hepatitis A and Hepatitis B vaccination series for the patient. This case was reported as a possible adverse event due to the patient's age and the country in which the vaccine was administered. More
2863369 52 M 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GY559
Expired product administered Expired product administered
received a dose of Shingrix yesterday that expired on 15-Aug-2025; This non-serious case was reporte... received a dose of Shingrix yesterday that expired on 15-Aug-2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number GY559, expiry date 15-AUG-2025) for prophylaxis. On 18-SEP-2025, the patient received Shingrix. On 18-SEP-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: received a dose of Shingrix yesterday that expired on 15-Aug-2025). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 19-SEP-2025 Reporter stated that patient received a dose of Shingrix yesterday that expired on 15-Aug-2025. More
2863370 50 M 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient that received the Shingrix vaccine a Month early; This non-serious case was reported by a ot... Patient that received the Shingrix vaccine a Month early; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number PJ353, expiry date 31-MAR-2027) for prophylaxis. Previously administered products included Shingrix (1st dose received on 20-AUG-2025). Additional patient notes included Patient is not immunocompromised. On 19-SEP-2025, the patient received the 2nd dose of Shingrix. On 19-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Patient that received the Shingrix vaccine a Month early). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 19-SEP-2025 Clinical manager reported a patient received the Shingrix vaccine a month early. More
2863371 F IL 10/06/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 J3952
Incorrect dose administered Incorrect dose administered
Administration of an Engerix-B adult dose to a 4-year-old patient; Administration of an Engerix-B ad... Administration of an Engerix-B adult dose to a 4-year-old patient; Administration of an Engerix-B adult dose to a 4-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 4-year-old female patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis. On 18-SEP-2025, the patient received Engerix B adult. On 18-SEP-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Administration of an Engerix-B adult dose to a 4-year-old patient) and overdose (Verbatim: Administration of an Engerix-B adult dose to a 4-year-old patient). The outcome of the adult product administered to child and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 22-SEP-2025 A healthcare professional reported regarding the administration of an Engerix-B adult dose to a 4-year-old patient and asked for guidance to handle this situation which led to adult product administration to child and overdose. More
2863372 ND 10/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Boostrix use in patients younger than 10 years of age; This non-serious case was reported by a nurse... Boostrix use in patients younger than 10 years of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patients received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patients experienced inappropriate age at vaccine administration (Verbatim: Boostrix use in patients younger than 10 years of age). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 22-Sep-2025 A nurse reported that she had been working in her clinic for several years and they often use Boostrix for catch-up vaccination in patients 7 to 8 year-old. Recently, one of the staff members realized that as per PI of Boostrix, it was approved for patients aged 10 years and older. They wanted clarification about the age indication for Boostrix. No further details provided. More
2863373 15 F CA 10/06/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 32M5G
Expired product administered Expired product administered
we did give an expire vaccine (Engerix-B) to a patient; This non-serious case was reported by a othe... we did give an expire vaccine (Engerix-B) to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-year-old female patient who received HBV (Engerix B) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis. On 23-SEP-2025, the patient received Engerix B. On 23-SEP-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: we did give an expire vaccine (Engerix-B) to a patient). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. More
2863374 F OH 10/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 F9K3L
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
gave the wrong vaccine to a child; Boostrix was administered to a 12-month-old baby/Accidental admin... gave the wrong vaccine to a child; Boostrix was administered to a 12-month-old baby/Accidental administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number F9K3L, expiry date 30-NOV-2027) for prophylaxis. On 25-SEP-2025, the patient received the 1st dose of Boostrix. On 25-SEP-2025, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: gave the wrong vaccine to a child) and inappropriate age at vaccine administration (Verbatim: Boostrix was administered to a 12-month-old baby/Accidental administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. More
2863375 78 M GA 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 H97H2
Extra dose administered Extra dose administered
3rd dose was given in 05-Sep-2025; This non-serious case was reported by a pharmacist via call cente... 3rd dose was given in 05-Sep-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number H97H2) for prophylaxis. Previously administered products included Shingrix (patient received 1 dose of Shingrix in 2021) and Shingrix (patient received 2 dose of Shingrix in 2021). On 05-SEP-2025, the patient received the 3rd dose of Shingrix. On 05-SEP-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose was given in 05-Sep-2025). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 26-SEP-2025 The Vaccine Administration Facility was the same as Primary Reporter. More
2863376 10/06/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Post-acute COVID-19 syndrome; Post-acute COVID-19 syndrome Post-acute COVID-19 syndrome; Post-acute COVID-19 syndrome
long covid; This spontaneous case was reported by a consumer and describes the occurrence of POST-AC... long covid; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long covid) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (long covid). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long covid) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The reporter queried about the availability of Novavax vaccine. Patient had not yet received the Novavax vaccine, because appointment was scheduled for patient to get a vaccine, but the patient wanted to receive only Novavax vaccine. The patient felt grateful to have that option of getting Novavax vaccine because, patient was able to take Pfizer and Moderna vaccines for a while, but then the patient had long Covid. And since the patient got long Covid, it caused some problems for the patient. So, the patient needed to receive Novavax vaccine which would work just fine for the patient. No treatment information was reported. More
2863377 64 M 10/06/2025 COVID19
 MODERNA
Blood test, Myasthenia gravis Blood test, Myasthenia gravis
myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of ... myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (myasthenia gravis) in a 64-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Prostate surgery in September 2024. Previously administered products included for Product used for unknown indication: shingrix in 2016, Pfizer (Dose 1) in 2021, Pfizer (Dose 2) in 2021 and flu shots (flu shots). Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, flu shots and shingrix. Family history included Heart disorder. Concurrent medical conditions included Hypothyroidism. In March 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In June 2025, the patient experienced MYASTHENIA GRAVIS (myasthenia gravis) (seriousness criterion medically significant). The patient was treated with Cefalexin in 2025 at an unspecified dose and frequency and Erythromycin in 2025 at an unspecified dose and frequency. At the time of the report, MYASTHENIA GRAVIS (myasthenia gravis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Blood test: The blood tests confirmed patient probably had it by some number that's supposed to be less than 0.02 when patient's result was like 3.7. No concomitant medications were provided. It was reported that after the surgery in March 2025, it was reported that he experienced an eye droop within the following 6 months and one day at breakfast his eye was half closed. The patient also experienced double vision. At that time the eye doctor treated it for 3 weeks with drops and Cefalexin and then erythromycin ointment for 3 weeks and he was told that these things take time. It was reported that he was told by the ophthalmic assistant that he should visit his primary health care provider in the meantime as he was being evaluated for cataract surgery. He was told that he had ptosis in both eyes. The second primary doctor mentioned it could be neurological. The patient had blood tests at the Clinic which confirmed that he probably had it by some number that's supposed to be less than 0.02 when his result was like 3.7 and then another test that was either positive or negative and he was positive. The patient went to a neurologist, he was diagnosed with myasthenia gravis in June 2025. It was reported that during his 3.5-hour surgery, along with the 3 hours it took him to wake up afterwards, there was at least 2 drugs that could cause myasthenia gravis as well as any kind of strain in the body or crisis. The patient was told that there was a good chance that the myasthenia gravis was caused by general anesthesia. The patient was immunocompromised by the drugs at that point as he had been on steroids for over a year. In February 2025, the patient started on CellCept for myasthenia gravis to get him off of the steroids, it was tapering them, but he was still on them. It was reported that he switched to Moderna from Pfizer when it was figured out that none of them worked the 6 months. It was concluded that patient had to get more than one type of immunity, but the most robust immunity was to start to dissipate after 4 months and then with the Moderna it was after 5 months so it little longer than the Pfizer. The reporter stated it seemed to be what many of the studies had shown anyway. This case was linked to US-MODERNATX, INC.-MOD-2025-789703 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789703:different patient More
2863378 62 M 10/06/2025 COVID19
COVID19
COVID19
 MODERNA
PFIZER\BIONTECH
UNKNOWN MANUFACTURER


Pain in extremity, Prostate cancer; Pain in extremity, Prostate cancer; Pain in ... Pain in extremity, Prostate cancer; Pain in extremity, Prostate cancer; Pain in extremity, Prostate cancer More
prostate cancer; a sore arm; This spontaneous case was reported by a consumer and describes the occu... prostate cancer; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER (prostate cancer) in a 62-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and COVID-19 vaccine for an unknown indication. Previously administered products included for Product used for unknown indication: shingrix in 2016 and flu shots (flu shots). Past adverse reactions to the above products included No adverse effect with flu shots and shingrix. Family history included Heart disorder. Concurrent medical conditions included Hypothyroidism. In 2021, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In 2021, received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of COVID-19 vaccine (unknown route) 1 dosage form. In March 2023, the patient experienced PROSTATE CANCER (prostate cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient was treated with Surgery (had surgery for prostate cancer in September 2024) for Prostate cancer. At the time of the report, PROSTATE CANCER (prostate cancer) outcome was unknown and PAIN IN EXTREMITY (a sore arm) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that the patient experienced a sore arm for a day and that was it after an unspecific COVID vaccine. The Patient was received two doses of Pfizer in Fall 2021 and after that the patient received Moderna COVID-19 vaccine every year afterwards. It was reported that the patient should get vaccines as often as he has heart disease in his family history and has personal issues including hypothyroidism. The Patient had surgery for his prostate cancer in Sep- 2024. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789703 (E2B Linked Report).; Reporter's Comments: Co-suspect Pfizer vaccine is a confounder for the events. Due to lack of biological plausibility, the causality of the event prostate cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789703:Same reporter, different patient More
2863379 M 10/06/2025 COVID19
 MODERNA
Illness, Mobility decreased Illness, Mobility decreased
he has some mobility issues; Sick; This spontaneous case was reported by a consumer and describes th... he has some mobility issues; Sick; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (he has some mobility issues) and ILLNESS (Sick) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (in the past always had Pfizer.). Past adverse reactions to the above products included No adverse effect with Pfizer COVID-19 Vaccine. Concurrent medical conditions included CLL (lymphoma (CLL)) and Mobility decreased. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In August 2024, the patient experienced ILLNESS (Sick). On an unknown date, the patient experienced MOBILITY DECREASED (he has some mobility issues). At the time of the report, MOBILITY DECREASED (he has some mobility issues) was resolving and ILLNESS (Sick) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. Concomitant medication was not provided. It was reported that the patient had been sick in august and had some mobility issues as well as lymphoma (CLL) which he was taking unspecified medication for and was controlled. It was unknown if the patient experienced any additional symptoms or events. This case was linked to US-MODERNATX, INC.-MOD-2025-789702 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789702:Master case More
2863380 69 M OH 10/06/2025 COVID19
 MODERNA
Headache, Influenza like illness Headache, Influenza like illness
flu-like symptoms/a severe headache" described as "kind of a crushing headache that headac... flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice; flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) had resolved. Concomitant medications details were not reported by the reporter. It was reported that patient had Moderna COVID-19 Vaccine in Jun-2021, Jul-2021 and Spring 2022. Patient always had side effects for 36 hours. Treatment medication was not reported by the reporter. This case was linked to MOD-2025-789717 (Patient Link). More
2863381 69 M OH 10/06/2025 COVID19-2
 MODERNA
COVID-19, Headache, Influenza like illness COVID-19, Headache, Influenza like illness
COVID-19; flu-like symptoms/a severe headache" described as "kind of a crushing headache t... COVID-19; flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice; flu like symptoms/achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/achy), COVID-19 (COVID-19) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) had resolved and COVID-19 (COVID-19) outcome was unknown. No concomitant medication was reported. Patient received one dose of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in spring 2023. It was reported that patient always had side effects for 36 hours after each one, he had flu-like symptoms, achy, a severe headache described as kind of a crushing headache that headache kind of feel was felt like his head was in a vice. That would last for like 36 hours and once he hit the 36-hour mark, it was just like somebody flipped the switch, disappeared. No treatment information was provided. This case was linked to MOD-2025-789717 (Patient Link). More
2863382 69 M OH 10/06/2025 COVID19
 MODERNA
COVID-19, Headache, Influenza like illness COVID-19, Headache, Influenza like illness
COVID-19; flu-like symptoms/a severe headache" described as "kind of a crushing headache t... COVID-19; flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice; flu like symptoms/achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/achy), COVID-19 (COVID-19) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/achy), COVID-19 (COVID-19) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms/achy) and HEADACHE (flu-like symptoms/a severe headache" described as "kind of a crushing headache that headache kind of feel like your head feel like it was in a vice) had resolved and COVID-19 (COVID-19) outcome was unknown. Concomitant medications details were not reported by the reporter. It was reported that patient had Moderna COVID-19 Vaccine in fall 2023 and spring 2024. Patient always had side effects for 36 hours. Treatment medication was not reported by the reporter. This case was linked to MOD-2025-789717 (Patient Link). More
2863383 64 F OH 10/06/2025 COVID19-2
 MODERNA
COVID-19 COVID-19
contracted Covid-19 "in the last 2-3 years; This spontaneous case was reported by a consumer an... contracted Covid-19 "in the last 2-3 years; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 "in the last 2-3 years) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (contracted Covid-19 "in the last 2-3 years). At the time of the report, COVID-19 (contracted Covid-19 "in the last 2-3 years) outcome was unknown. No concomitant medication was reported. Patient received the vaccine in approximates Fall of 2022. Patient had received all Moderna Covid vaccines and contracted Covid-19 in the last 2-3 years approximately sometime in 2023. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789717 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789717:female patient case More
2863384 67 F 10/06/2025 COVID19-2
 MODERNA
 AS7145B
Cardiac dysfunction Cardiac dysfunction
heart issues/only 20% of her left bundle was functioning; This spontaneous case was reported by a co... heart issues/only 20% of her left bundle was functioning; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (heart issues/only 20% of her left bundle was functioning) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Dose 1, Lot/Batch Number: 026L20A, Expiration Date: 28JUN2021) on 22-Jan-2021, Spikevax NOS (Dose 2. Lot/Batch Number: 013L20A, Expiration Date: 08JUL2021) on 20-Feb-2021, Spikevax NOS (Dose 3 booster, Lot/Batch Number: 038C21A, Expiration Date: 27OCT2021) on 26-Oct-2021, Spikevax NOS (Dose 4 and Lot/Batch Number: 007M21A) on 02-Apr-2022. Past adverse reactions to the above products included No adverse effect with Spikevax NOS, Spikevax NOS, Spikevax NOS and Spikevax NOS. On 17-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DYSFUNCTION (heart issues/only 20% of her left bundle was functioning) (seriousness criterion medically significant). At the time of the report, CARDIAC DYSFUNCTION (heart issues/only 20% of her left bundle was functioning) had resolved with sequelae. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. The patient was asking about further details regarding mNEXSPIKE for 65 years and older with heart issues when receiving the mNEXSPIKE as she just had gotten an ICD implanted in the chest the meaning of which she did not elaborate, but she shared that she had it since Apr-2023. The patient stated that she should be concerned about getting the product as it is a lower dosage but had precautions for seniors with heart issues. She also desired to get it, having booked an appointment at pharmacy. The patient added she was concerned because she had never had this "heart thing" which she added had just happened. The patient verbalized that she had not realized she had a heart issue, but when she thought she had heartburn, a couple of tests were done and found out that only 20% of her left bundle was functioning. She was then on medicine and a life vest but the condition didn't improve and that was when the cardiologist along with her primary HCP decided that she needed to have the implant but still she feels the same way as before. It was further stated that she was a regular recipient of the COVID-19 vaccines since 2020 except last year because her husband was ill. She added that in Oct-2023, she received both Moderna COVID-19 vaccine with the flu shot on the same day while she was going to a street fair. She recalled that she had not felt well, was very tired, had pain from both shots in both arms, very lethargic and that her arms were killing her. It was reported that the patient was going to her Primary HCP in 2 weeks specifically on 01-Oct-2025 for her annual physical exam. She added that she would have her next dose with Moderna COVID-19 vaccine on a Tuesday afternoon but it was unknown to her yet if it would be Spikevax or mNEXSPIKE hence her calling Moderna. It was also reported that the patient had not received any other brands of Moderna COVID-19 vaccine. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to MOD-2025-789732 (Patient Link).; Reporter's Comments: The event of unspecified cardiac dysfunction, but require ICD implantation, was assessed as not related to suspected vaccine due to nature of reported event. The benefit-risk relationship of product is not affected by this report. More
2863385 67 M MA 10/06/2025 COVID19
 MODERNA
Vaccination site pain Vaccination site pain
Injection site soreness; This spontaneous case was reported by a consumer and describes the occurren... Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 67-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COMIRNATY (First 6 doses). Past adverse reactions to the above products included No adverse effect with COMIRNATY. In December 2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had resolved. No concomitant medication was reported. It was reported that patient had received 8 doses of covid-19 vaccine since 2020, 6 Pfizer doses and 7th dose of Moderna and received 8th dose of Moderna Spikevax 2025-26 on 25-Sep-2025. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-789738 (Patient Link). More
2863386 70 F 10/06/2025 COVID19
 MODERNA
Headache, Somnolence Headache, Somnolence
she's just snoozing all day; she has a bit of a headache and, you know, she's just feeling... she's just snoozing all day; she has a bit of a headache and, you know, she's just feeling kind of blah.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she's just snoozing all day) and HEADACHE (she has a bit of a headache and, you know, she's just feeling kind of blah.) in a 70-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. In September 2025, the patient experienced SOMNOLENCE (she's just snoozing all day) and HEADACHE (she has a bit of a headache and, you know, she's just feeling kind of blah.). At the time of the report, SOMNOLENCE (she's just snoozing all day) and HEADACHE (she has a bit of a headache and, you know, she's just feeling kind of blah.) outcome was unknown. No concomitant medications provided by the reporter. The patient received every Moderna Covid vaccine and latest dose as booster. It was reported that post vaccination patient snoozed all day and it was expected that patient would be fine by tomorrow. The Patient always have that kind of reaction to the COVID shots or, sometimes even after the flu shots. Patient experienced a bit of a headache post vaccination. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789832 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789832:Female patient different patient More
2863387 70 F 10/06/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Somnolence; Somnolence Somnolence; Somnolence
she's just snoozing all day; This spontaneous case was reported by a consumer and describes the... she's just snoozing all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she's just snoozing all day) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (she's just snoozing all day). At the time of the report, SOMNOLENCE (she's just snoozing all day) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. The. The patient received Flue shot as co-suspect on an unknown date for product used for unknown indication. It was reported that post vaccination the patient used to snooze all day. The Patient always have that kind of reaction to the COVID shots or, sometimes even after the flu shots. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789832 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789832:Female patient (different patient) and different suspect More
2863388 61 F NY 10/06/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 17680
17680
Atrophy, Constipation, Gait inability, Headache, Myalgia; Weight increased Atrophy, Constipation, Gait inability, Headache, Myalgia; Weight increased
4/15/21 Couldn't have bowel elimination, gained weight, 2025: january 12, 2025 present- headac... 4/15/21 Couldn't have bowel elimination, gained weight, 2025: january 12, 2025 present- headaches, muscle aches, atrophy, 2/6/25 couldn't poop, using rolator, 3/20/25 received the (withheld) group/ Dr (name withheld) 'Ultimate detox pills w/4x nattokinaise...really helped, discontinued benefiber, still difficult walking but really worked. More
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2863390 49 M 10/06/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2L353
Dry throat, Fatigue, Hypotension, Myalgia, Pyrexia Dry throat, Fatigue, Hypotension, Myalgia, Pyrexia
Within 6 hours of vaccination, I have developed high fever (39.5๏ฟฝC), fatigue, and severe muscle pa... Within 6 hours of vaccination, I have developed high fever (39.5๏ฟฝC), fatigue, and severe muscle pain plus dry throat and low blood pressure. Symptoms persisted for approximately 72 hours. No hospitalization was required, and I have since recovered fully. More
2863391 67 F FL 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3t74x
Injection site erythema, Injection site pain, Injection site pruritus Injection site erythema, Injection site pain, Injection site pruritus
Patient came in Friday 10/3/25 after receiving their shingrix shot on sunday 9/28/25 complaining of ... Patient came in Friday 10/3/25 after receiving their shingrix shot on sunday 9/28/25 complaining of a reaction to their vaccine. Her upper arm was red, itchy and burning. It spread from the spot of injection across her upper arm from her elbow to her shoulder. More
2863392 12 M FL 10/06/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y018389
U8558BA
LX494
Syncope; Syncope; Syncope Syncope; Syncope; Syncope
Patient fainted on his way out the door no head trauma. He was placed in a room gave him some water ... Patient fainted on his way out the door no head trauma. He was placed in a room gave him some water and a snack, he was also fasting that day. He remember everything. Physical exam was negative. He left the office about 30 mins later walking by himself. Oriented to call us back if any concerns or changes. More
2863393 52 F NY 10/06/2025 COVID19
 JANSSEN
 unknown
Acoustic stimulation tests, Rheumatoid arthritis, Tinnitus Acoustic stimulation tests, Rheumatoid arthritis, Tinnitus
Constant Tinnitus since injection. It never stops. It started the night I was vacinated. It has not ... Constant Tinnitus since injection. It never stops. It started the night I was vacinated. It has not let since. Also newly diagnosed Rheumatoid Arthritis 3 years ago. More
2863394 30 F TX 10/06/2025 COVID19
 PFIZER\BIONTECH
Burning sensation, Injection site erythema, Injection site mass, Injection site ... Burning sensation, Injection site erythema, Injection site mass, Injection site pain, Pruritus More
itching, burning all over body where vaccine was injected large baseball sized red lump and it felt ... itching, burning all over body where vaccine was injected large baseball sized red lump and it felt like i was on fire. Was pregnant with first shot and miscarried a few days later. More
2863395 64 M 10/06/2025 FLU3
 SANOFI PASTEUR
 UT8804AA
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
INCORRECTLY GAVE AN HD VACCINE TO A PATIENT LESS THAN 65 YEARS OF AGE THAT DID NOT MEET THE CRITERIA... INCORRECTLY GAVE AN HD VACCINE TO A PATIENT LESS THAN 65 YEARS OF AGE THAT DID NOT MEET THE CRITERIA FOR FLUZONE HD FOR PATIENTS LESS THAN 65 YEARS OLD. More
2863396 52 F VA 10/06/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8817KA
UT8817KA
Arrhythmia, Blood pressure abnormal, Chest X-ray normal, Chest discomfort, Elect... Arrhythmia, Blood pressure abnormal, Chest X-ray normal, Chest discomfort, Electrocardiogram normal; Full blood count normal, Headache, Migraine More
Client woke up with a headache and tightness in chest, went to Urgent Care and after checking vitals... Client woke up with a headache and tightness in chest, went to Urgent Care and after checking vitals, they were concerned with her heart rhythm and blood pressure and sent her to ED. Dr. diagnosed her with a severe migraine from the vaccine. The Dr. could not say for sure that her other symptoms came from the flu shot, but recommended she not take the flu vaccine anymore due to concerns for her heart and blood pressure. More
2863397 39 F PA 10/06/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 37KF3
Dizziness, Headache Dizziness, Headache
Headache dizzy Headache dizzy
2863398 71 M IN 10/06/2025 COVID19
 MODERNA
 3051995
Immediate post-injection reaction, Injection site swelling Immediate post-injection reaction, Injection site swelling
Immediately after injection arm puffed up about the size of a golf ball at the injection site. Per p... Immediately after injection arm puffed up about the size of a golf ball at the injection site. Per patient there was no pain. Visually inspected the site and there was no discoloration or bleeding. More
2863399 4 F MI 10/06/2025 FLU3
 SANOFI PASTEUR
 U8790AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No reaction as of yet No reaction as of yet
2863400 5 F MD 10/06/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.
 3052579
3052579
407799
407799
Injection site pain, Injection site rash, Injection site warmth, Pain, Pyrexia; ... Injection site pain, Injection site rash, Injection site warmth, Pain, Pyrexia; Rash erythematous; Injection site pain, Injection site rash, Injection site warmth, Pain, Pyrexia; Rash erythematous More
Large red rash, around 2x3 inches, on left arm at site of injections. Rash is red with uneven borde... Large red rash, around 2x3 inches, on left arm at site of injections. Rash is red with uneven borders and hot to the touch. Rash/arm is also sore with movement and pressure. Mild fever for about 24 hours post shot. Treated with acetaminophen and ice and marked borders of rash to watch for spread. At approx. 36 hours post injection rash is not as red but has spread about .5 inches further down the arm. More
2863401 51 F SD 10/06/2025 FLU3
 SANOFI PASTEUR
 U8855AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient under the age of 65 received a HD flu vaccine. We have left messages with patient to get aho... Patient under the age of 65 received a HD flu vaccine. We have left messages with patient to get ahold of her, but we have not heard back and we are thinking she lives in assisted living facility. More
2863402 73 F ND 10/06/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 MY9548
407244
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth; Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth More
Patient called pharmacy to report warmth, redness, pain, itching at injection site Patient called pharmacy to report warmth, redness, pain, itching at injection site
2863403 73 F TX 10/06/2025 FLU3
 SEQIRUS, INC.
Dizziness, Tremor Dizziness, Tremor
Patient reported shaking and dizziness the night after she received the Fluad influenza vaccine. The... Patient reported shaking and dizziness the night after she received the Fluad influenza vaccine. The patient reported that the symptoms only lasted that night and that she currently does not have the symptoms More
2863404 11 M MI 10/06/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8438AA
9JT4S
Feeling hot, Vertigo, Vomiting; Feeling hot, Vertigo, Vomiting Feeling hot, Vertigo, Vomiting; Feeling hot, Vertigo, Vomiting
patient woke up the next day feeling like his head was spinning and he vomited 2 times, mom thought ... patient woke up the next day feeling like his head was spinning and he vomited 2 times, mom thought he felt warm but didn't have a thermometer to check - checked on pt this morning per mom it lasted a few hours and he's been normal since More
2863405 74 M FL 10/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 bg5j4
Extra dose administered Extra dose administered
We were notified by a corporate pharmacy that patient has received 2 doses of Arexvy on 10/04/25 and... We were notified by a corporate pharmacy that patient has received 2 doses of Arexvy on 10/04/25 and 01/24/24. More
2863406 0.17 F OH 10/06/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS



Crying, Eye movement disorder, Hemiparesis, Pyrexia, Restlessness; Crying, Eye m... Crying, Eye movement disorder, Hemiparesis, Pyrexia, Restlessness; Crying, Eye movement disorder, Hemiparesis, Pyrexia, Restlessness; Crying, Eye movement disorder, Hemiparesis, Pyrexia, Restlessness; Crying, Eye movement disorder, Hemiparesis, Pyrexia, Restlessness More
Infant started running fever around 8 PM on 05/12/2025. The next morning, the fever was noticably w... Infant started running fever around 8 PM on 05/12/2025. The next morning, the fever was noticably warmer approx 101 F and she was crying. A cool compress was applied to her head. In addition to breast milk, cold formula was given throughout the day. The infant was placed in a tepid/warm bath and allowed to remain until the water cooled. This helped reduce the fever to about 100 F. The fever persisted a second day. The same treatment was provided. The infant was still restless and crying. At 8 PM on 05/14/2025 infant dye-free 1/4 ml ibuprophen was given by mouth, along with 1 oz cold sterilized water. The outcome: a noticable drift in the left eye. Weakness in the left arm and leg. More
2863407 72 M TX 10/06/2025 PNC21
 MERCK & CO. INC.
 Z010761
Chills, Erythema, Injection site rash, Pyrexia, Rash Chills, Erythema, Injection site rash, Pyrexia, Rash
received shot friday at 11, friday evening started running fever, felt bad and had chills. took tyle... received shot friday at 11, friday evening started running fever, felt bad and had chills. took tylenol when tylenol wore off would run fever again. rash on arm around injection site and down arm. fever subsided on sunday. arm still red but no pain or itching More
2863408 60 F RI 10/06/2025 COVID19
 PFIZER\BIONTECH
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
This pharmacy gave me a covid vaccine when I asked for TDaP. I had a covid vaccine on September 29 ... This pharmacy gave me a covid vaccine when I asked for TDaP. I had a covid vaccine on September 29 2025 (2 weeks prior) More
2863409 56 F GA 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55KB9
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Redness, swelling, hot sensation in right deltoid. Apply ice to rea and rest. If symptoms worsen, go... Redness, swelling, hot sensation in right deltoid. Apply ice to rea and rest. If symptoms worsen, go to ER. More
2863410 80 M IA 10/06/2025 COVID19
 MODERNA
 3042648
Death Death
resident passed away resident passed away
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2863412 61 F NH 10/06/2025 FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.


Abdominal pain upper, Arthralgia, Asthenia, Bone pain, Chills; Diarrhoea, Feelin... Abdominal pain upper, Arthralgia, Asthenia, Bone pain, Chills; Diarrhoea, Feeling cold, Immediate post-injection reaction, Impaired work ability, Pain; Palpitations, Peripheral coldness, Tremor, Vomiting More
Immediately felt weak. Two hours later I was in bed shivering incessantly and hard, with freezing fe... Immediately felt weak. Two hours later I was in bed shivering incessantly and hard, with freezing feet as if they were on ice. I had aches and pain across my entire body and my heart was racing. Heavy socks didn't help. I had socks and parka on with multiple blankets for 24 hours. I did not take my temp. Didnt think of it. I finally took 2 Advil at 5:30pm and it took 2 hours almost for them to kick in and take edge off of the shaking but the aches in my joints and bones were still there. Then at 12:30 the shaking and freezing began again and I took another two advil. It took about an hour and half for them to kick in. I slept until 9am next day and took day off from work. I woke up and felt aching and joint pain but the shaking stopped. However at about 10:30 I has severe gastro pain. It was so painful that I vomited from the pain. Diareha. Ate little for that day and had aches and pains the following day but no shivering. Still very cold with sweaters on even with 80 degree temp outside. The next day after that better but still total body aches and pains. Generally cold. During the shivering I was worried about my heart condition because my heart was racing. Never had a reaction to a vax in my life like this. I took every covid vax and booster and never had a problem. I have been vax'd many times for flu and this never happened. I worry about what shot I was given. It was truly a bad experience. I will NEVER take this again. More
2863414 31 F FL 10/06/2025 COVID19
FLU3
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 MY9547
39R9B
Anxiety, Dizziness, Loss of consciousness, Nausea; Anxiety, Dizziness, Loss of c... Anxiety, Dizziness, Loss of consciousness, Nausea; Anxiety, Dizziness, Loss of consciousness, Nausea More
About five minutes after receiving the vaccine the patient started to feel light headed and moved fr... About five minutes after receiving the vaccine the patient started to feel light headed and moved from a chair to the ground. While laying on the ground the patient passed out (fainted). After less than a minute the patient woke up and reported feeling anxious, nauseas, and light headed. Patient's boyfriend reported she has a history of panic attacks and sat with her for about 20 minutes while she regained her strength and bearing. Pharmacist asked her multiple times if she would like medical attention and she declined. More
2863415 39 F NC 10/06/2025 FLU3
 SANOFI PASTEUR
 UT8792KA
Dizziness, Pruritus, Throat irritation, Throat tightness Dizziness, Pruritus, Throat irritation, Throat tightness
Concerns of allergic reaction. This occurred about 30 minutes prior to ED visit. Shortly afterward... Concerns of allergic reaction. This occurred about 30 minutes prior to ED visit. Shortly afterward she complained of generalized pruritus, lightheadedness, and throat feels tight and itchy. No GI symptoms. No chest pain or shortness of breath, but has used her inhaler. No rash. More
2863419 39 M OH 10/06/2025 FLU3
 SEQIRUS, INC.
 ax4603a
Injection site pain Injection site pain
Pain at the site of injection and also an inch to the right of injections Pain at the site of injection and also an inch to the right of injections
2863421 0.33 F MI 10/06/2025 DTAPIPVHIB
PNC20
RV5
 SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.
 UK356 aa
MA2502
2096664
Pyrexia, Rash, Swelling face; Pyrexia, Rash, Swelling face; Pyrexia, Rash, Swell... Pyrexia, Rash, Swelling face; Pyrexia, Rash, Swelling face; Pyrexia, Rash, Swelling face More
rash and fever and swelling (face was swollen) rash and fever and swelling (face was swollen)
2863422 34 F 10/06/2025 RSV
 PFIZER\WYETH
Extra dose administered, Maternal exposure before pregnancy Extra dose administered, Maternal exposure before pregnancy
Patient received a second dose of Abrysvo prior to a second pregnancy. Patient received a second dose of Abrysvo prior to a second pregnancy.
2863423 30 F GA 10/06/2025 FLU3
 SANOFI PASTEUR
 u8832da
Injection site reaction, Injection site warmth, Rash erythematous Injection site reaction, Injection site warmth, Rash erythematous
Px received the vaccine Saturday 10/4/25. She said a few hours later she noted a red rash at the inj... Px received the vaccine Saturday 10/4/25. She said a few hours later she noted a red rash at the injection site and it felt hot to the touch. By Monday 10/6/25, she complained that the rash had grown larger in diameter and still felt hot to the touch. I asked if she had any other symptoms. She said she did not. I advised her how to treat the site, and monitor for further signs/symptoms, and to seek medical help if it did get worse. More
2863424 77 M IN 10/06/2025 FLU3
 SEQIRUS, INC.
 407242
Injected limb mobility decreased, Pain in extremity Injected limb mobility decreased, Pain in extremity
LEFT ARM HURTS AND CAN'T LIFT UP VERY HIGH SINCE ADMINISTRATION LEFT ARM HURTS AND CAN'T LIFT UP VERY HIGH SINCE ADMINISTRATION
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