🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2857017 F 09/05/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Pruritus, Vaccination failure; Herpes zoster, Pain, Pruritu... Herpes zoster, Pain, Pruritus, Vaccination failure; Herpes zoster, Pain, Pruritus, Vaccination failure More
Suspected vaccination failure; Shingles/pain/itching; This serious case was reported by a consumer v... Suspected vaccination failure; Shingles/pain/itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/pain/itching). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. The company considered the shingles to be possibly related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated that it was early, but the pain and itching were relatively mild. The patient's physician said the vaccine was only 90 percent effective but might be accounts for patient's mild reaction. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine(1st and 2nd dose), in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2857018 M TX 09/05/2025 HEPA
MMR
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Incomplete course of vaccination; Incomplete course of vaccination Incomplete course of vaccination; Incomplete course of vaccination
MMR 2nd missing dose/HepA 2nd missing dose; This non-serious case was reported by a other health pro... MMR 2nd missing dose/HepA 2nd missing dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 5-year-old male patient who did not receive Hepatitis A vaccine for prophylaxis. Co-suspect products included MMR (MMR vaccine) for prophylaxis. Previously administered products included Hepatitis A (received first dose on an unknown date), MMR (received first dose on an unknown date), varicella (received first dose on an unknown date), Infanrix (received 3 doses on an unknown date), Haemophilus influenzae type B (received 3 doses on an unknown date) and inactivated polio vaccine (received 3 doses on an unknown date). The patient did not receive the 2nd dose of Hepatitis A vaccine and the 2nd dose of MMR vaccine. The patient experienced incomplete course of vaccination (Verbatim: MMR 2nd missing dose/HepA 2nd missing dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 06-AUG-2025 The reporter wanted to know if she could give a catch up Kinrix, instead of Infanrix, to a 5-year-old patient as a fourth dose in the diphtheria, tetanus and pertussis immunization series. She mentioned that the patient was missing Hepatitis A (2nd dose), diphtheria, tetanus and pertussis (4th and 5th dose), Haemophilus influenzae type B (4th dose), measles, mumps, and rubella (2nd dose), varicella (2nd dose) and inactivated polio vaccine (4th dose). Till the time of reporting the patient did not receive the second dose of Hepatitis A and measles, mumps, and rubella, which led to incomplete course of vaccination. More
2857019 11 F AZ 09/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Wrong product administered Wrong product administered
Bexsero instead of MCV4 vaccines at 11-year-old visit; This non-serious case was reported by a physi... Bexsero instead of MCV4 vaccines at 11-year-old visit; This non-serious case was reported by a physician via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero. The patient did not receive Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero instead of MCV4 vaccines at 11-year-old visit). 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: 06-AUG-2025 and 07-AUG-2025 The patient received Bexsero instead of MCV4 (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) at her visit, which led to wrong vaccine administered. The reporter knew it was approved down to 10 years and not harmful but wanted to know would this count as her 1st dose. The reporter further asked was this ok to just get 2nd dose at 16 years of age or does she need 2 more doses 16 to18 years of age. More
2857020 11 F NY 09/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 ZH7SN
Wrong product administered Wrong product administered
administered the MenB (Bexsero) vaccine to an 11-year-old patient instead of the intended MenACWY (M... administered the MenB (Bexsero) vaccine to an 11-year-old patient instead of the intended MenACWY (Menveo) vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ZH7SN) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 07-AUG-2025, the patient received the 1st dose of Bexsero. The patient did not receive Menveo. On 07-AUG-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: administered the MenB (Bexsero) vaccine to an 11-year-old patient instead of the intended MenACWY (Menveo) vaccine). 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: 07-AUG-2025 The reporter reported administered the MenB (Bexsero) vaccine to a patient and it was supposed to be the MenACWY (Menveo) vaccine, which led to wrong vaccine administered. The Vaccine Administration Facility was the same as the Primary Reporter. More
2857021 2 M MO 09/05/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 BH57H
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administered a dose of Kinrix to a patient who is 3 years old/ HCP was not sure if it was Kinrix or ... administered a dose of Kinrix to a patient who is 3 years old/ HCP was not sure if it was Kinrix or a dose of Infanrix; 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 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number BH57H, expiry date 07-JUL-2026) for prophylaxis. Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (INFANRIX). On 08-APR-2025, the patient received Kinrix. On 08-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a dose of Kinrix to a patient who is 3 years old/ HCP was not sure if it was Kinrix or a dose of Infanrix). 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: 15-AUG-2025 A registered nurse called to report that they administered a dose of Kinrix to a patient who was 3 years old, which led to an inappropriate age at vaccine administration. Patient did not experience any adverse event. HCP (health care professional) was not sure if it was Kinrix or a dose of Infanrix the vaccine that was administered to the patient. The reporter wanted to know was this a valid dose. More
2857022 F 09/05/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
received Dtap instead of Tdap; This non-serious case was reported by a physician via call center rep... received Dtap instead of Tdap; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 9-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Infanrix and did not receive Tdap Vaccine. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: received Dtap instead of Tdap). 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: 19-AUG-2025 Patient received Infanrix instead of Tdap for catch-up series, which led to wrong vaccine administered. The reporter asked if the dose was valid or if they should administer Tdap. The reporter mentioned that the vaccine was administered a couple of months ago (no date provided). More
2857023 OH 09/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late second dose; This non-serious case was reported by a pharmacist via call center representative ... Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patients received 1st dose of vaccine between AUG-2023 and AUG-2024). On an unknown date, the patients did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 Pharmacist called to report that might be like five patients over 65 years of age, between male and female that were administered with a first dose of Shingrix vaccine between AUG-2023 and AUG-2024. The reporter wanted to know do they need to revaccinate or restart the vaccination schedule, was there any percentage drop on effectiveness. No specific vaccination date or details, patient demographics and further information were provided. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.; Sender's Comments: US-GSK-US2025109347:same reporter, different patient US-GSK-US2025109352:same reporter, different patient More
2857024 M MT 09/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 J32PB
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
the administration of the Shingrix adjuvant alone; the administration of the Shingrix adjuvant alone... the administration of the Shingrix adjuvant alone; the administration of the Shingrix adjuvant alone; the patient received vaccine at around age of 40; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 40-year-old male patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the administration of the Shingrix adjuvant alone), inappropriate dose of vaccine administered (Verbatim: the administration of the Shingrix adjuvant alone) and inappropriate age at vaccine administration (Verbatim: the patient received vaccine at around age of 40). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were not applicable. Additional Information: GSK Receipt Date:28-AUG-2025 Pharmacist reported that wanted to get information regarding the administration of the Shingrix adjuvant alone. The patient was administration of the Shingrix adjuvant alone around at age of 40 years, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered, and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. More
2857025 29 F 09/05/2025 CHIK
 VALNEVA USA, INC.
Arthralgia, Fatigue, Lymphadenopathy, Malaise, Myalgia Arthralgia, Fatigue, Lymphadenopathy, Malaise, Myalgia
The following information was received from a consumer on 25 Aug 2025. A 29-year-old female vaccine... The following information was received from a consumer on 25 Aug 2025. A 29-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number not reported) on 08 Aug 2025. The vaccinee experienced prolonged chikungunya-like symptoms for up to almost a month after vaccination. She had strong side effects, including fatigue, muscle/joint pains and aches and fever-like feelings (without a fever) for three weeks following the vaccination. Over two and a half weeks after the vaccination she developed an extremely swollen and painful lymph node above her collarbone wich made it hard to sleep, move her head or do normal activities. The outcome was reported as recovered.; Sender's Comments: The company assessed the non-serious events of prolonged chikungunya-like symptoms, fatigue, myalgia, arthralgia, fever-like feeling, and lymphadenopathy as possibly related to IXCHIQ vaccine administration, based on temporal association, the known safety profile, and clinical plausibility. These reported events, including longer lasting symptoms, are already included in the IXCHIQ reference safety information and are consistent with chikungunya like adverse reactions described in the label and in clinical trials. More
2857026 40 F VA 09/05/2025 CHIK
 VALNEVA USA, INC.
Arthralgia, Body temperature increased, Headache, Heart rate increased, Neck pai... Arthralgia, Body temperature increased, Headache, Heart rate increased, Neck pain More
The following information was received from a consumer on 25 Aug 2025. A 40-year-old female vaccine... The following information was received from a consumer on 25 Aug 2025. A 40-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number not reported) on 21 Aug 2025. She started having some moderate neck/shoulder pain and mild headache on 24 Aug 2025 and had an elevated temperature (about two degrees Fahrenheit) and an elevated resting heart rate (about 10 beats per minute higher than what is normal for her). The patient went for a challenging run on Sunday (24 Aug 2025) which may have put some additional stress on her body that contributed to the symptoms. The patient was reportedly in excellent health otherwise. She still had the headache and neck pain the morning of this report.; Sender's Comments: The company assessed the non-serious listed events of arthralgia, headache and body temperature increased, and the unlisted events of neck pain and heart rate increased as possibly related to IXCHIQ vaccine administration due to temporal association and clinical plausibility. The events occurred 3 days after vaccination in an otherwise healthy patient and may be consistent with post-vaccination systemic reactions or chikungunya-like adverse reactions. Of note, although the patient experienced neck pain and headache along with increased body temperature, no other meningitis-like symptoms were reported to suggest a neurological involvement in this case. Furthermore, the patient's reported physical exercise on the day of the symptoms' onset may be a possible contributory factor in the events' occurrence. All of the reported symptoms, are already included in the IXCHIQ reference safety information and are consistent with chikungunya like adverse reactions described in the label and in clinical trials. More
2857027 F 09/05/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

COVID-19; COVID-19 COVID-19; COVID-19
She has had COVID and got very, very sick from it once before; This spontaneous case was reported by... She has had COVID and got very, very sick from it once before; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She has had COVID and got very, very sick from it once before) in an adult 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. Concurrent medical conditions included Asthma, Multiple allergies (allergies due to asthma) and Bronchitis (frequent bronchitis). 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 COVID-19 (She has had COVID and got very, very sick from it once before). At the time of the report, COVID-19 (She has had COVID and got very, very sick from it once before) outcome was unknown. Upon internal review on 03-Sep-2025, it was determined that the patient did not experience any adverse event after receiving SPIKEVAX 2024-2025 PFS vaccine as the patient nowhere stated that she got COVID-19 due to the recent vaccination. Therefore, only one case MOD-2025-788981 (US-MODERNATX-MOC20250828000018) with suspect SPIKEVAX NOS will be retained in the database as it was reported that "she had gotten all her shots with Moderna". Hence all information from duplicate case MOD-2025-788965 (US-MODERNATX-MOC20250828000018) was added and merged with the retained case MOD-2025-788981 (US-MODERNATX-MOC20250828000018). The case MOD-2025-788965 (US-MODERNATX-MOC20250828000018) will be deleted from the safety database. It was unclear if patient turned 64 years in July or would turn 64 this August and then it was reported that she was 2 months into her 64th year. No concomitant medication was reported. It was reported that the patient had received her flu shot and COVID-19 shot last fall, and she had received all her shots with Moderna. Patient had COVID and got very, very sick from it once before. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. More
2857028 71 F 09/05/2025 COVID19
 MODERNA
Malignant neoplasm progression Malignant neoplasm progression
Indolent lymphoma/started progressing in Summer of 2024; This spontaneous case was reported by a con... Indolent lymphoma/started progressing in Summer of 2024; This spontaneous case was reported by a consumer and describes the occurrence of MALIGNANT NEOPLASM PROGRESSION (Indolent lymphoma/started progressing in Summer of 2024) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Kidney cancer and Renal surgery (Kidney cancer treated surgically). Concurrent medical conditions included Lymphoma (Indolent lymphoma) since 2020. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2024, the patient experienced MALIGNANT NEOPLASM PROGRESSION (Indolent lymphoma/started progressing in Summer of 2024) (seriousness criterion medically significant). At the time of the report, MALIGNANT NEOPLASM PROGRESSION (Indolent lymphoma/started progressing in Summer of 2024) was resolving. Concomitant medication use information was not provided by reporter. In 2020, the patient was diagnosed with indolent lymphoma, and the physicians took the decision to watch and wait. It started progressing in the summer of 2024, and the treatment started in December and finished chemotherapy in April 2025. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Past medical history of Kidney cancer, concurrent medical condition Lymphoma are contributors for the event. Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2857029 91 M FL 09/05/2025 COVID19
 MODERNA
 3043823
Asthenia, Dizziness, Fall Asthenia, Dizziness, Fall
has been weak for the last 8 month; fell over 3 times; he became dizzy; This spontaneous case was re... has been weak for the last 8 month; fell over 3 times; he became dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (has been weak for the last 8 month), FALL (fell over 3 times) and DIZZINESS (he became dizzy) in a 91-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043823) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 12-Jan-2025, the patient experienced ASTHENIA (has been weak for the last 8 month), FALL (fell over 3 times) and DIZZINESS (he became dizzy). At the time of the report, ASTHENIA (has been weak for the last 8 month), FALL (fell over 3 times) and DIZZINESS (he became dizzy) had not resolved. No concomitant medications provided by the reporter. It was reported that patient received vaccination on 10-Jan-2025 and two days later on 12-Jan-2025 patient experienced dizzy, fell over 3 times, and has been weak for the last 8 month and it did not want to go away. The patient was an active individual in great shape. The patient had a doctor's appointment on 03-Sep-2025. It was unknown if the patient experienced any additional symptoms or events. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2025: Live non-significant follow-up received in which case narrative was updated. More
2857030 80 M 09/05/2025 COVID19
COVID19
 MODERNA
MODERNA
 2071123-29 (or
2071123-29 (or
Cardiac disorder, Dysphagia, Eye pruritus, Feeling hot, Illness; Pain in extremi... Cardiac disorder, Dysphagia, Eye pruritus, Feeling hot, Illness; Pain in extremity, Pruritus, Rash More
had a big rash across the chest above and below the breasts and under the arms; arm soreness; swallo... had a big rash across the chest above and below the breasts and under the arms; arm soreness; swallowing; warm; a little bit sick that evening; I got itching in the eyes and the head; I got itching in the eyes and the head; heart surgery took place on 30OCT2024; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart surgery took place on 30OCT2024) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 2071123-29 (or 207H23-29 )) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (The patient had 7 previous Moderna injections). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. On 15-Jul-2024, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2024, the patient experienced CARDIAC DISORDER (heart surgery took place on 30OCT2024) (seriousness criterion medically significant). On 15-Jul-2024, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DYSPHAGIA (swallowing), FEELING HOT (warm), ILLNESS (a little bit sick that evening) and PAIN IN EXTREMITY (arm soreness). In July 2024, the patient experienced PRURITUS (I got itching in the eyes and the head) and EYE PRURITUS (I got itching in the eyes and the head). On 18-Jul-2024, the patient experienced RASH (had a big rash across the chest above and below the breasts and under the arms). In 2024, CARDIAC DISORDER (heart surgery took place on 30OCT2024) had resolved. In July 2024, PRURITUS (I got itching in the eyes and the head), EYE PRURITUS (I got itching in the eyes and the head) and RASH (had a big rash across the chest above and below the breasts and under the arms) had resolved. On 17-Jul-2024, DYSPHAGIA (swallowing), FEELING HOT (warm), ILLNESS (a little bit sick that evening) and PAIN IN EXTREMITY (arm soreness) had resolved. No concomitant medication was reported. The patient had no vaccines in the past 4 weeks. On 15-Jul-2024 patient had 8th vaccine and had some side effects including arm soreness and swallowing, and that wasn't a big deal, and warm and a little bit sick that evening and it was no big deal, but the next, it felt better on the 17-Jul-2024, but on the 18-Jul-2024, he took a shower and had a big rash across the chest above and below the breasts and under the arms and that lasted a couple of days. And as that started diminishing, he got itching in the eyes and the head and that lasted a day or two. Those were just a few days, and he had heart surgery in the intervening period. The heart surgery took place on 30-Oct-2024. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789062 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789062:Invalid case for multiple people More
2857031 M 09/05/2025 COVID19
 UNKNOWN MANUFACTURER
Pericardial effusion, Pleural effusion Pericardial effusion, Pleural effusion
pleuropericardial effusions following mRNA COVID-19 vaccination; pleuropericardial effusions followi... pleuropericardial effusions following mRNA COVID-19 vaccination; pleuropericardial effusions following mRNA COVID-19 vaccination; This is a literature report for the following literature source(s). A 78-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDIAL EFFUSION (medically significant), PLEURAL EFFUSION (medically significant), outcome "recovered" and all described as "pleuropericardial effusions following mRNA COVID-19 vaccination". Therapeutic measures were taken as a result of pericardial effusion, pleural effusion. Clinical course: Several case reports have described pleuropericardial effusions following mRNA COVID-19 vaccination. Patient who developed unilateral pleural effusion without identifiable infection or malignancy. All resolved with anti-inflammatory therapy and supportive care, supporting an inflammatory rather than infectious or neoplastic etiology.; Sender's Comments: Although it is difficult to establish temporal association between the reported events pericardial effusion and pleural effusion and suspect drug BNT162B2 based on the limited information provided in the case, the causal association between the Reported events and the suspect drug cannot be excluded as there is no concrete evidence available to eliminate the causal association. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate More
2857032 80 CO 09/05/2025 FLU3
 SANOFI PASTEUR
Fatigue Fatigue
fatigue; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case... fatigue; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 80 years old and unknown gender patient who had fatigue after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in the end of 2024, the patient received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunziation). Information on the batch number could not be requested corresponding to the one at time of event occurrence. On an unknown date the patient had fatigue (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2857033 F MO 09/05/2025 MEN
 UNKNOWN MANUFACTURER
 U8573AA
Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
given menquadfi to a pregnant patient with no reported adverse event; Initial information received o... given menquadfi to a pregnant patient with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age pregnant female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 02-Sep-2025, the pregnant patient was given unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (lot U8573AA; Expiration Date :30-Sep-2028; Strength not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (exposure during pregnancy) (latency: same day). Reportedly they did not knowthat the patient was pregnant when the vaccine was administered. After the vaccine was given, they ran a pregnancy test when the patient already left, and it turned out positive (patient was pregnant). Relevant prenatal testing after exposure was not reported. Relevant laboratory test results included: Pregnancy test - On 02-Sep-2025: Positive Action taken: Not applicable. Additionally, at time of reporting, the outcome of the pregnancy was unknown. More
2857034 21 F KY 09/05/2025 DTAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 4CA03C2
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
as an adult patient received DAPTACEL instead of ADACEL with no reported adverse event; as an adult ... as an adult patient received DAPTACEL instead of ADACEL with no reported adverse event; as an adult patient received DAPTACEL instead of ADACEL with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 years old female patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Sep-2025, the patient received 0.5 ml of diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with strength- standard (expiry date- 29-OCT-2026 and lot 4CA03C2) via unknown route in the left deltoid (arm) once for Immunization instead of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot not reported) with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency- same day). Information on the batch number was requested for Adacel corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2857035 60 F MI 09/05/2025 FLU3
 SANOFI PASTEUR
 U88308A
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
inappropriate use due to administration of a vaccine intended for 65+ to a 60 year old with no repor... inappropriate use due to administration of a vaccine intended for 65+ to a 60 year old with no reported adverse event; Initial information received on 03-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 60 years old female patient to whom administration of a Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] intended for 65+ to a 60 year old with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Sep-2025, the 60 years old female patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength: unknown, expiry date: 01-jun-2026 and lot U88308A) via unknown route in the right deltoid for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2857036 17 M IN 09/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Wrong product administered Wrong product administered
The wrong vaccine was administered. Should have been MCV required for senior year of high school as ... The wrong vaccine was administered. Should have been MCV required for senior year of high school as discussed. He was given MenB wrongfully. More
2857037 4 F AL 09/05/2025 MMR
MMR
MMR
TDAP
TDAP
TDAP
VARCEL
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.








Injection site discolouration, Injection site erythema, Injection site mass, Inj... Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site rash, Injection site swelling, Injection site warmth, Rash, Rash erythematous; Rash maculo-papular; Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site rash, Injection site swelling, Injection site warmth, Rash, Rash erythematous; Rash maculo-papular; Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site rash, Injection site swelling, Injection site warmth, Rash, Rash erythematous; Rash maculo-papular More
Developed red, swollen, hot to the touch lump where vaccine was given on left thigh one day after in... Developed red, swollen, hot to the touch lump where vaccine was given on left thigh one day after injection. It continued to grow outside the line drawn around it for monitoring for 4 more days. It was itchy and painful for the child. Cold compresses, over the counter hydrocortisone 1% cream, and colloidal oatmeal soaks were the treatment. It began to resolve about 5-7 days after injection but even 3 weeks out the child has a dark, bruise like, discoloration where the redness was. Approximately 10 days after injection the child had a red, maculopapular rash along her left thigh and buttocks that lasted for approximately 1 week. No fever seen. Treatment was the same as mentioned above. More
2857038 4 F 09/05/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Redness and warmth to deltoid area where injection was given. Redness and warmth to deltoid area where injection was given.
2857039 66 F PA 09/05/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4753C
4753C
Erythema, Feeling cold, Injection site cellulitis, Peripheral swelling, Pruritus... Erythema, Feeling cold, Injection site cellulitis, Peripheral swelling, Pruritus; Skin discolouration, Tremor More
pt says she woke up cold and shaking. These symptoms continued all day and night. She took some Tyle... pt says she woke up cold and shaking. These symptoms continued all day and night. She took some Tylenol and went to sleep. When she woke up her arm was very red, swollen and itchy. It started spreading. She went to Urgent Care. She was diagnosed with cellulitis at injection site and was given Keflex antibiotics. She was told use cortisone cream for the itching and go to the ER if it got worse. The antibiotics are helping but she is still itching. The skin is still dark but seems to be going away. More
2857040 13 F ME 09/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 k7jy3
Inappropriate schedule of product administration Inappropriate schedule of product administration
Men B given too soon- no symptoms documented Men B given too soon- no symptoms documented
2857041 1 M GA 09/05/2025 VARCEL
 MERCK & CO. INC.
 90716
Fatigue, Irritability, Pyrexia, Wrong product administered Fatigue, Irritability, Pyrexia, Wrong product administered
PATIENT WAS SUPPOSED TO GET THE HIB VACCINE BUT WAS GIVEN THE VARICELLA VACCINE IN ERROR AND WAS NOT... PATIENT WAS SUPPOSED TO GET THE HIB VACCINE BUT WAS GIVEN THE VARICELLA VACCINE IN ERROR AND WAS NOT DOCUMENTED CORRRECTLY. DOCTORS OFFICE WAS NOTIFIED AND HAS NOT CORRECTED THIS ERROR. PATIENT HAD A FEVER OF 101 FOR 2 DAYS AFTER THE VACCINE. HE ASLO WAS FATIGUED AND VERY IRRATABLE. FOR THE FOLLOWING THREE DAYS AFTER THE VACCINE. More
2857042 18 M OH 09/05/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 47ks7
u8508aa
Syncope; Syncope Syncope; Syncope
Patient was told to sit after vaccines were given which he did for 20 minutes after sitting got up t... Patient was told to sit after vaccines were given which he did for 20 minutes after sitting got up to leave walked out to the lobby and asked for water where he then fainted More
2857043 4 M CT 09/05/2025 MMRV
 MERCK & CO. INC.
 Z007579
Pyrexia, Rash, Varicella Pyrexia, Rash, Varicella
Widespread varicella rash one week post event, fever Widespread varicella rash one week post event, fever
2857044 16 F 09/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 EY57A
Incorrect dose administered, Wrong product administered Incorrect dose administered, Wrong product administered
Misread label and administered HAV instead of HEAV, adult vs pediatric dose of Hepatitis A to a mino... Misread label and administered HAV instead of HEAV, adult vs pediatric dose of Hepatitis A to a minor. More
2857045 12 F VA 09/05/2025 UNK
 UNKNOWN MANUFACTURER
Pain, Swelling Pain, Swelling
Swelling and pain. Swelling and pain.
2857046 1.25 F AL 09/05/2025 HIBV
IPV
 SANOFI PASTEUR
SANOFI PASTEUR
 UK166AB
Y1A212M
Pallor, Rash, Rash macular; Pallor, Rash, Rash macular Pallor, Rash, Rash macular; Pallor, Rash, Rash macular
diffuse red, macular, blanching rash seen on trunk and extremities. No swelling or tenderness at are... diffuse red, macular, blanching rash seen on trunk and extremities. No swelling or tenderness at area of injection sites. More
2857047 17 F OH 09/05/2025 MNQ
 SANOFI PASTEUR
 U8645AA
Confusional state, Hypotonia, Seizure like phenomena, Tremor, Unresponsive to st... Confusional state, Hypotonia, Seizure like phenomena, Tremor, Unresponsive to stimuli More
Patient experienced seizure-like activity immediately after injection. Noted to slump down in chair... Patient experienced seizure-like activity immediately after injection. Noted to slump down in chair and have generalized tremors with blank stare and unresponsive to verbal stimuli briefly. Initial confusion when arousing. EMS contacted and upon their arrival patient had returned to baseline and EMS and father was in agreeance that transport was not necessary. Father reports this morning that patient has been fine following episode. More
2857048 25 F MO 09/05/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Urticaria Urticaria
Hives, being managed with topical antihistamines Hives, being managed with topical antihistamines
2857049 64 F 09/05/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 GH9697
GH9697
Blood test normal, Electromyogram abnormal, Facial paralysis, Familial amyloidos... Blood test normal, Electromyogram abnormal, Facial paralysis, Familial amyloidosis, Genetic testing; Magnetic resonance imaging head normal, Muscle contractions involuntary, Muscle twitching More
By 1PM same day as injection, I experienced muscle twitching of my right lower facial muscles (arou... By 1PM same day as injection, I experienced muscle twitching of my right lower facial muscles (around mouth). This continued intermittently for the rest of the afternoon. By 6pm I experienced paralysis of the lower right side of my face; the left moved as normal. Over the next 3-6 months, I gradually lost the ability to move the left side also. I now have very little movement of my lower face, which causes difficulties with eating and occasionally talking. As a result of this facial paralysis and after multiple medical tests, I learned that I have a genetic disorder that includes a predisposition to lower motor neuron disorders, which I did not realized that I had. I already has some forehead paralysis, but until this event, no MD could tell me why. More
2857050 66 F SC 09/05/2025 FLU3
FLU3
HEP
HEP
 SANOFI PASTEUR
SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
 U874BB
U874BB
946907
946907
Dizziness, Fatigue, Hypersomnia, Loss of personal independence in daily activiti... Dizziness, Fatigue, Hypersomnia, Loss of personal independence in daily activities, Muscular weakness; Pain; Dizziness, Fatigue, Hypersomnia, Loss of personal independence in daily activities, Muscular weakness; Pain More
Muscle weakness, light headed, all over body ache and very tried, unable to function. I never had a ... Muscle weakness, light headed, all over body ache and very tried, unable to function. I never had a bad reaction to any of the vaccines given, up until now. I slept most of the day yesterday and today, Have not seen my primary care physician, but will notify her of the incident. More
2857051 0.5 M IN 09/05/2025 DTAPIPVHIB
DTAPIPVHIB
PNC20
PNC20
RV1
RV1
DTAPIPVHIB
DTAPIPVHIB
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
 UK194AA
UK194AA
hn5980
hn5980
32PF3
32PF3
UK194AA
UK194AA
Product preparation issue; No adverse event, Product preparation issue; Product ... Product preparation issue; No adverse event, Product preparation issue; Product preparation issue; No adverse event, Product preparation issue; Product preparation issue; No adverse event, Product preparation issue; Product preparation issue; No adverse event, Product preparation issue More
none noted, there was in incorrect administration of DTaP: wrong components have been mixed: 1) Pent... none noted, there was in incorrect administration of DTaP: wrong components have been mixed: 1) Pentacel component 1 of 2 (NDC 49281-561-01, lot UK194AA, exp 2026/03) + ActHIB component 1 of 2 (NDC 49281-547-58, lot UK169AB, exp 2026/02) More
2857052 66 F FL 09/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 xa53y
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
The patient complains of increased swelling and redness at the injection site. She was advised of th... The patient complains of increased swelling and redness at the injection site. She was advised of the reactions to expect and advised to seek medical care. She subsequently went to the hospital to seek care on 9/4/25 More
2857053 71 M FL 09/05/2025 FLU3
HEPAB
RSV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8764BB
P2443
JB27A
Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
Patient received extra dose of Arexvy. Should only receive one per lifetime. Patient received extra dose of Arexvy. Should only receive one per lifetime.
2857054 76 F CA 09/05/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Bone pain, Burning sensation, Chills, Dizziness, Headache; Malaise, Nausea, Vomi... Bone pain, Burning sensation, Chills, Dizziness, Headache; Malaise, Nausea, Vomiting More
Woke up at 0600 feeling extremely dizzy and had nausea and vomiting. As morning progressed felt like... Woke up at 0600 feeling extremely dizzy and had nausea and vomiting. As morning progressed felt like my body was burning from inside out. Developed 100.2 temperature with chills. Every bone in my body ached. I had a headache and felt like there were waves in my head. Was ill to the point I thought I was dying. Thought about going to ER. More
2857055 5 M MA 09/05/2025 DTAPIPV
 SANOFI PASTEUR
 U8383AB
Arthralgia, Rash, Skin warm Arthralgia, Rash, Skin warm
large > 10 cm rash warm area and joint pain large > 10 cm rash warm area and joint pain
2857056 58 F FL 09/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75g27
Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus
Patient reported 3 days after vaccine she developed swelling , redness and itching. She showed me he... Patient reported 3 days after vaccine she developed swelling , redness and itching. She showed me her arm and there was noticeable swelling and redness generalized on her arm. Patient did not want to seek emergency treatment, because not having difficulty breathing. Has been taking Benadryl and hydrocortisone. It does appear to be resolving. More
2857057 43 M 09/05/2025 FLU3
 SANOFI PASTEUR
Lip swelling Lip swelling
AFter half an hr of vaccine adminstration, pt felt that his lips were swelling from one side. we gav... AFter half an hr of vaccine adminstration, pt felt that his lips were swelling from one side. we gave him benadryl and it went away More
2857058 61 M LA 09/05/2025 FLU3
 SANOFI PASTEUR
 UT8817KA
Urticaria Urticaria
Hives Hives
2857059 22 F NY 09/05/2025 HEPA
HEPA
MNQ
MNQ
TDAP
TDAP
TYP
TYP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
 EY57A
EY57A
U8562AA
U8562AA
793PT
793PT
Y2A04P1
Y2A04P1
Chills, Hyperhidrosis, Hyporesponsive to stimuli, Loss of consciousness, Musculo... Chills, Hyperhidrosis, Hyporesponsive to stimuli, Loss of consciousness, Musculoskeletal stiffness; Nausea, Pallor; Chills, Hyperhidrosis, Hyporesponsive to stimuli, Loss of consciousness, Musculoskeletal stiffness; Nausea, Pallor; Chills, Hyperhidrosis, Hyporesponsive to stimuli, Loss of consciousness, Musculoskeletal stiffness; Nausea, Pallor; Chills, Hyperhidrosis, Hyporesponsive to stimuli, Loss of consciousness, Musculoskeletal stiffness; Nausea, Pallor More
Patient attempted to pass out become very stiff then relaxed. She was very pale, nausea and sweaty. ... Patient attempted to pass out become very stiff then relaxed. She was very pale, nausea and sweaty. She then began to shiver. She was talking to this nurse then became minimally responsive again. Cold compresses applied to back of the neck and bilateral wrist. When she became more responsive this nurse laid her down on the bed. She was given cold water to drink. She became much more responsive when she laid down and her color returned to baseline. Paramedic from EMS office did come down to see Patient. More
2857060 1.58 M TN 09/05/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
NONE NONE
2857061 3 M CO 09/05/2025 DTAPIPV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 52D72
Y009430
Z004246
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Incorrect vaccines given. No adverse event. Incorrect vaccines given. No adverse event.
2857062 1.25 F TN 09/05/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
none none
2857063 5 M CO 09/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 22GP3
No adverse event, Wrong product administered No adverse event, Wrong product administered
Incorrect vaccines given. No adverse event. Incorrect vaccines given. No adverse event.
2857064 80 M NY 09/05/2025 RSV
 PFIZER\WYETH
 ln5489
Hypotension, Paralysis Hypotension, Paralysis
paralyzed for 3 hours and low blood pressure paralyzed for 3 hours and low blood pressure
2857065 9 M WA 09/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 H3N97
Abdominal discomfort, Eye pain, Loss of consciousness Abdominal discomfort, Eye pain, Loss of consciousness
Patient had brief loss of consciousness, stomach upset, and eye pain. Patient was evaluated by nursi... Patient had brief loss of consciousness, stomach upset, and eye pain. Patient was evaluated by nursing staff and given juice and crackers. Patient was monitored for 15 additional minutes after incident. More
2857066 11 F OR 09/05/2025 MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8508AA
U8508AA
EB499
EB499
Dyspnoea, Nausea, Pallor, Photophobia, Skin burning sensation; Tremor, Visual im... Dyspnoea, Nausea, Pallor, Photophobia, Skin burning sensation; Tremor, Visual impairment; Dyspnoea, Nausea, Pallor, Photophobia, Skin burning sensation; Tremor, Visual impairment More
APPROXIMATELY 3 MINUTES AFTER VACCINE PATIENT REPORTED SYMPTOMS OF DARKENING VISION, SHAKING, NAUSEA... APPROXIMATELY 3 MINUTES AFTER VACCINE PATIENT REPORTED SYMPTOMS OF DARKENING VISION, SHAKING, NAUSEA, LIGHT SENSITIVITY, FACIAL PALLOR, BURNING SENSATION OF THE NOSE, INCREASED WORK OF BREATHING. More
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