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
2859875 37 M TX 09/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Headache, Injection site swelling, Irritability, Malaise, Myalgia; Pyrexia, SARS... Headache, Injection site swelling, Irritability, Malaise, Myalgia; Pyrexia, SARS-CoV-2 test negative More
fever, headache, irritability, general malaise, muscle soreness, injection site swelling fever, headache, irritability, general malaise, muscle soreness, injection site swelling
2859876 35 M CO 09/18/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 Fc3181
Fc3181
Fc3181
Cardiac stress test, Cardiovascular symptom, Chest pain, Dizziness, Dyspnoea; Ec... Cardiac stress test, Cardiovascular symptom, Chest pain, Dizziness, Dyspnoea; Echocardiogram, Electrocardiogram, Heart rate increased, Muscle spasms, Myocardial necrosis marker; Tunnel vision More
Erratic heart rate, heart attack like symptoms. Dizziness, tunnel vision cramping in arm. Heart rate... Erratic heart rate, heart attack like symptoms. Dizziness, tunnel vision cramping in arm. Heart rate into the 150s while resting. Chest pain labored breathing. More
2859895 34 M UT 09/18/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH



Chest discomfort, Chest pain, Chills, Gastrooesophageal reflux disease, Insomnia... Chest discomfort, Chest pain, Chills, Gastrooesophageal reflux disease, Insomnia; Pyrexia, Rhinitis, Seizure; Chest discomfort, Chest pain, Chills, Gastrooesophageal reflux disease, Insomnia; Pyrexia, Rhinitis, Seizure More
Chills, muscle convulsions the night of first injection followed by fever the next day. Periodic and... Chills, muscle convulsions the night of first injection followed by fever the next day. Periodic and unusual chest tightness started after the vaccine More
2859896 25 M UT 09/18/2025 COVID19
 JANSSEN
Deep vein thrombosis Deep vein thrombosis
DVT in both legs DVT in both legs
โœ“
2859897 33 F FL 09/18/2025 COVID19
COVID19
 MODERNA
MODERNA

Abortion spontaneous, Maternal exposure before pregnancy; Abortion spontaneous, ... Abortion spontaneous, Maternal exposure before pregnancy; Abortion spontaneous, Maternal exposure before pregnancy More
I had back to back miscarriages following my forced Covid vaccination. My first miscarriage was in N... I had back to back miscarriages following my forced Covid vaccination. My first miscarriage was in November of 2021 and then again in March 2022. This is following a totally normal healthy pregnancy and successful delivery. More
2859898 34 F FL 09/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood test, COVID-19, CREST syndrome, Cardiomegaly, Echocardiogram abnormal; Hea... Blood test, COVID-19, CREST syndrome, Cardiomegaly, Echocardiogram abnormal; Heavy menstrual bleeding, Malaise, Mobility decreased More
I couldn?t stop bleeding with menstrual cycle. They had to give me hormone pills and everything to t... I couldn?t stop bleeding with menstrual cycle. They had to give me hormone pills and everything to try to stop me from bleeding because I was bleeding so heavily when I didn?t have a period to begin with also had to go to the emergency room because the shot gave me such a bad reaction, barely being able to breathe, and then I got Covid with that second shot. I literally felt like I was dying. I stayed in the bed for three weeks then in March 2023 I got diagnosed with CREST syndrome. My heart walls are also swollen like enlarged when I had an echogram done in 2024. More
2859899 32 M MD 09/18/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 025A21A
025A21A
025A21A
025A21A
Abdominal discomfort, Arthralgia, Asthenia, Body temperature increased, Brain fo... Abdominal discomfort, Arthralgia, Asthenia, Body temperature increased, Brain fog; Chills, Disturbance in attention, Dyspnoea, Fatigue, Headache; Injection site discomfort, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling; Memory impairment, Myalgia, Nausea More
Elevated body temperature and episodes of shivering (Fever & chills) Ongoing lack of energy or ... Elevated body temperature and episodes of shivering (Fever & chills) Ongoing lack of energy or exhaustion (Fatigue) Persistent or recurring head pain (Headaches) Aches in muscles and stiffness or soreness in joints (Muscle & joint pain) Tenderness, discomfort, or swelling where the shot was given (Pain & swelling at the injection site) Feeling nauseous or experiencing an upset stomach (Nausea) Visible redness or irritation around the injection area (Redness at injection site) Difficulty breathing or feeling short of breath (Shortness of breath) Mental cloudiness, forgetfulness, or difficulty concentrating (Brain fog) Lasting or recurring exhaustion that doesn?t improve with rest (Persistent fatigue & tiredness) More
2859900 27 F 09/18/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR

Chest pain, Occipital neuralgia, Pain of skin; Chest pain, Occipital neuralgia, ... Chest pain, Occipital neuralgia, Pain of skin; Chest pain, Occipital neuralgia, Pain of skin More
Occipital neuralgia for 2 days, very painful patch scalp on top of head whenever hair moves . Chest... Occipital neuralgia for 2 days, very painful patch scalp on top of head whenever hair moves . Chest pain continueing daily 2 weeks post vaccine still. More
2859902 24 M GA 09/18/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA



Antiphospholipid syndrome, Autonomic nervous system imbalance, Blood pressure fl... Antiphospholipid syndrome, Autonomic nervous system imbalance, Blood pressure fluctuation, Brain fog, Chest pain; Coagulopathy, Dizziness, Dyspnoea, Generalised tonic-clonic seizure, Head discomfort; Heart rate decreased, Heart rate increased, Inflammation, Laboratory test, Lyme disease; Mast cell activation syndrome, Palpitations More
Mast cell activation syndrome, lupus anticoagulant blood clotting disorder, anti phospholipid blood ... Mast cell activation syndrome, lupus anticoagulant blood clotting disorder, anti phospholipid blood clotting disorder, chronic lymes disease. Symptoms include while having episodes full body convulsions/ dizziness/ high and low blood pressure sever brain fog/ pressure in head / severe inflammation throughout entire body/ height heart rate then will bottom out/ shortness of breath/ chest pain/ heart palpitations More
โœ“ โœ“ โœ“
2859903 42 M OR 09/18/2025 COVID19
 MODERNA
Blood pressure fluctuation, Dizziness, Hypertension, Palpitations Blood pressure fluctuation, Dizziness, Hypertension, Palpitations
Blood pressure fluctuation. High blood pressure lasting 18 months. Heart palpitations. Light headine... Blood pressure fluctuation. High blood pressure lasting 18 months. Heart palpitations. Light headiness More
2859904 30 M DE 09/18/2025 COVID19
 MODERNA
 014B22A
Bronchospasm, Cough, Heart rate increased, Laboratory test normal, Total lung ca... Bronchospasm, Cough, Heart rate increased, Laboratory test normal, Total lung capacity normal More
Exercised induced bronchitis. Any heart rate elevation caused intense coughing fits. Exercised induced bronchitis. Any heart rate elevation caused intense coughing fits.
2859263 AR 09/17/2025 HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No adverse effects were reported; RECOMBIVAX HB 15 days late / First dose was given on 7/22/2025 and... No adverse effects were reported; RECOMBIVAX HB 15 days late / First dose was given on 7/22/2025 and the second dose was administered on 9/8/2025; This spontaneous report was received from a pharmacist and refers to an 18-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-Jul-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB),, dose number 1, (lot # and expiration date were not reported). On 08-Sep-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), dose number 2, (lot # and expiration date were not reported) as a prophylaxis. However, the 2 dose was 15 days late (inappropriate schedule of vaccine administrated). No adverse effects were reported. More
2859264 OR 09/17/2025 MMRV
 MERCK & CO. INC.
 Y004545
Expired product administered, No adverse event Expired product administered, No adverse event
no patient symptoms have been reported; Specialist transferred medical assistant who called to repor... no patient symptoms have been reported; Specialist transferred medical assistant who called to report an expired dose of PROQUAD was inadvertently administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 08-Sep-2025, the patient received an expiry dose of with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y004545, expiration date: 19-Aug-2025) diluted with sterile diluent (indication, expiration date, and lot # were not reported) for prophylaxis (Expired product administered). No patient symptoms reported. More
2859265 13 F VA 09/17/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Barium swallow normal, Computerised tomogram normal, Dysarthria, Dysphagia, Magn... Barium swallow normal, Computerised tomogram normal, Dysarthria, Dysphagia, Magnetic resonance imaging normal; Tremor More
she experienced slurred speech; Tongue tremors; trouble swallowing; Having hard time eating; This sp... she experienced slurred speech; Tongue tremors; trouble swallowing; Having hard time eating; This spontaneous report was received from a consumer concerning a 13-year-old female patient. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions were not provided. Concomitant medications included Propanolol. On 28-AUG-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), administered by Intravenous (not otherwise specified) route in Left Arm (strength, lot # and expiration date were not reported) as prophylaxis. On that same day after the second dose (reported as ''5 hours after''), she experienced slurred speech, trouble swallowing and tongue tremors. Consumer advised she took her daughter to and then she gave it couple more days and called her neurologist and then she took her to the emergency room (ER) and she was admitted on 03-SEP-2025 and the patient was hospitalized for a day and half after receiving the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9)vaccine . On unspecified date in September 2025, while in the hospital they did labs a magnetic resonance imaging (MRI), computerized tomography (CT) and swallow test and all of the tests came back normal. Consumer advised her daughters side effects were getting worst and her speech was still slurred and now she was having a hard time eating and she was having problems swallowing her spit. At the reporting time, she had not recovered from the events. The causality between Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) and all the events was not reported. Lot # is being requested and will be submitted if received. More
โœ“
2859266 F 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Loss of personal independence in daily activities, Malaise Loss of personal independence in daily activities, Malaise
Malaise; This non-serious case was reported by a physician via sales rep and described the occurrenc... Malaise; This non-serious case was reported by a physician via sales rep and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (First dose was received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On 30-AUG-2025, an unknown time after receiving Shingrix, the patient experienced malaise (Verbatim: Malaise). On 01-SEP-2025, the outcome of the malaise was resolved (duration 2 days). The reporter considered the malaise to be related to Shingrix. The company considered the malaise to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 HCP reported that the patient experienced malaise following the 2nd dose of Shingrix. The malaise had lasted 3 days over Labor Day weekend. It was not too bad, but it had ruined her weekend because she could not do anything. The patient did not have any issues with the first dose. More
2859267 F CA 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received the first dose of Shingrix more than 1 year ago and did not complete the series.; This non-... received the first dose of Shingrix more than 1 year ago and did not complete the series.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine more than a year ago). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: received the first dose of Shingrix more than 1 year ago and did not complete the series.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 08-SEP-2025 A female patient got their first dose of Shingrix more than a year ago. The reporter wanted to know if the patient can receive the second dose, if she need to restart the series. More
2859268 09/17/2025 COVID19
 NOVAVAX
 6024MF025
Chills, Headache, Nausea, Pain, Pyrexia Chills, Headache, Nausea, Pain, Pyrexia
Debilitating chills; Fever; Head & body ache; Head & body ache; Nausea; This non serious ini... Debilitating chills; Fever; Head & body ache; Head & body ache; Nausea; This non serious initial spontaneous safety report was reported by a Consumer or other non-health professional and concerns an individual of an unspecified age and sex who experienced DEBILITATING CHILLS, FEVER, HEAD & BODY ACHE, HEAD & BODY ACHE and NAUSEA on an unknown date after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on unknown day. At the time of the report, the outcome of the Chills, Pyrexia, Headache, Pain, Nausea was Unknown. Based on internal review on 24-Sep-2024, it was determined that for case 2024-NVX-GB-00497, the country of incidence was captured incorrectly in the structured field. Therefore, this case 2024-NVX-US-00599 has been created with the correct country of incidence. 2024-NVX-GB-00497 will be invalidated. On 02-Sep-2025, significant information was received from a consumer via social media monitoring (Resolver No. 00367183): The following medical history was reported: pancreatic and kidney transplant, and a transplant recipient. The patient's past therapy included five doses of unspecified COVID-19 vaccines. On 11-Mar-2025, the patient received 12th dose of Novavax vaccine (Therapy #two).; Sender's Comments: This individual of an unspecified age and sex experienced Chills, Pyrexia, Headache, Pain and Nausea after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Chills, Pyrexia, Headache, Pain, Nausea was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Chills, Pyrexia, Headache, Pain and Nausea is considered Possible. More
2859269 33 F PA 09/17/2025 FLU3
 SANOFI PASTEUR
 UT8792LA
Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
pregnant patient recived FLUZONE with no reported adverse event; Initial information received on 08-... pregnant patient recived FLUZONE with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 33 years old female pregnant patient who was received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at unknown gestation period. The date of last menstrual period was reported as 24-Jul-2025. The estimated due date is 01-May-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies. On an unknown date in 2025, the patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date- 30-JUN-2026 and lot UT8792LA) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (same day latency). Reportedly, the patient did not receive any treatment for infertility. The patient did not experience any adverse events. There were no relevant prenatal testing after exposure. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. More
2859270 30 F PA 09/17/2025 FLU3
 SANOFI PASTEUR
Headache Headache
Headache is non stop, from the second I wake up until the moment I go to sleep. It gets worse every ... Headache is non stop, from the second I wake up until the moment I go to sleep. It gets worse every day; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non healthcare professional). This case involves a 30 years old female patient who had headache which was non stop, from the second she woke up until the moment she went to sleep, it got worse every day after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Aug-2025, the patient received 1mL (1Total) of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site fro Annual flu shot (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On 28-Aug-2025, the patient developed headache is non stop, from the second i wake up until the moment i go to sleep. it gets worse every day (headache) (latency same day)following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved. Action taken was not applicable. An unknown corrective treatment was received for the event (Headache). At time of reporting, the outcome was Not Recovered / Not Resolved for the event (Headache). More
2859271 63 F CA 09/17/2025 UNK
 UNKNOWN MANUFACTURER
 TFAA2504
Injection site haemorrhage Injection site haemorrhage
felt that it was very moist, with more than just blood; Initial information received on 08-Sep-2025 ... felt that it was very moist, with more than just blood; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old female patient who had felt that it was very moist, with more than just blood after receiving Influenza Trivalent Recombinant Vaccine [flublok TIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included covid-19 vaccine or Immunisation. On 07-Sep-2025, the patient received unknown dose of suspect influenza trivalent recombinant vaccine Solution for injection of standard strength, frequency once with lot TFAA2504 and expiry date 30-APR-2026 via intramuscular route in the left deltoid for Influenza. On 07-Sep-2025 the patient developed a non-serious felt that it was very moist, with more than just blood (vaccination site haemorrhage) (Latency same day) following the administration of influenza trivalent recombinant vaccine. Reportedly, The reporter stated that this weekend one of their interns administered flublok to a customer. The customer went home and took off the bandage and she felt that it was very moist, with more than just blood. The pharmacist spoke to the intern, and the intern said that nothing went wrong when he administered it. All of the liquid went in, and it was administered correctly. The needle was screwed onto the syringe properly and the syringe was put all the way in. There was no issue with the flublok syringe. Action taken was not applicable. It was not reported if the patient received corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2859272 71 F TX 09/17/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Abdominal discomfort, Chills, Decreased appetite, Diarrhoea, Erythema; Headache,... Abdominal discomfort, Chills, Decreased appetite, Diarrhoea, Erythema; Headache, Influenza, Pyrexia, Rhinorrhoea More
had a runny nose; stomach is still a little "upset" but she hasn't done anything; her... had a runny nose; stomach is still a little "upset" but she hasn't done anything; her arm was maroon for a couple of days after the administration; felt like she's had the flu.; has had a decreased appetite; has had a headache in the back and front of her head on and off since she received FLUZONE HD; had a fever, but noted that she has not taken her temperature to confirm fever; chills on and off since the administration; noted "uncontrollable diarrhea" that started the day after she received FLUZONE HD; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 71 years old female patient who had a runny nose, stomach is still a little upset but she hasn't done anything, has had a decreased appetite, has had a headache in the back and front of her head on and off since she received fluzone hd, had a fever, but noted that she has not taken her temperature to confirm fever, chills on and off since the administration, noted uncontrollable diarrhea that started the day , her arm was maroon for a couple of days and felt like she's had the flu after the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's past medical history included Sinus disorder. At the time of the event, the patient had ongoing Multiple sclerosis and Hypothyroidism. Patient had also given herself MS (Multiple sclerosis) shots in that arm about 6-7 years ago (capture in history), but she has stopped receiving the MS shots. On 25-Aug-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, (lot number, expiry date and strength not reported) via intramuscular route in the left arm for immunisation. On 25-Aug-2025 the patient had a runny nose (rhinorrhoea), stomach is still a little "upset" but she hasn't done anything (abdominal discomfort), has had a decreased appetite (decreased appetite), had a headache in the back and front of her head on and off since she received fluzone hd (headache), had a fever, but noted that she has not taken her temperature to confirm fever (pyrexia), noted "uncontrollable diarrhea that started the day after she received fluzone hd (diarrhoea), her arm was maroon for a couple of days after the administration (skin discolouration) and felt like she's had the flu (influenza like illness) (latency: same day). Reportedly, She described how she was in bed for a week, has had a decreased appetite and has felt like she's had the flu. Caller is concerned to take FLUZONE HD next time. The patient felt like she had to get the flu shot in order to be around her dad, who is 96 years old. She is 71 years old. Caller also feels like she needs to get the COVID vaccine before seeing her dad, but it was not available at the time she received FLUZONE HD. Caller wasn't sure if she should call her PCP [Primary Care Physician] or MS [Medical Specialist] doctor in regards to her symptoms and to discuss whether she should receive a COVID vaccine. Caller does not want to have the same reaction to the COVID vaccine that she had to FLUZONE HD. Action taken was not applicable. The patient was treated with Loperamide hydrochloride (Imodium) for Diarrhoea and abdominal discomfort. It was not reported if the patient received a corrective treatment for rest of the events. At time of reporting, the outcome was Recovering / Resolving for the Rhinorrhoea was Recovered / Resolved on 28-Aug-2025 for the event Diarrhoea and was Unknown for rest all the events. More
2859273 8 M NV 09/17/2025 DTAP
 SANOFI PASTEUR
 3CA55C1
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 to age group outside PI recommendations; Initial information... inappropriate use due to administration to age group outside PI recommendations; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 8 years old male patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], which was outside Prescribing Information (PI) recommendations, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine inact 3v (Vero) (Ipol); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Varicella zoster vaccine live (Varicella zoster vaccine live) all for Immunisation. On 05-Sep-2025, the patient received 0.5ml (dose 5) (once) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, Strength Standard, lot 3CA55C1 and expiry date 31-Aug-2026 via intramuscular route in the right vastus lateralis for immunisation, which was outside PI recommendations, with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). 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
2859274 1.25 F NJ 09/17/2025 FLU3
 SANOFI PASTEUR
 UT8779NA
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
vaccine was administered subcutaneously instead of intramuscularly with no reported adverse event; I... vaccine was administered subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who received influenza USP TRIVAL A-B SUBVIRION no preservative vaccine [Fluzone] subcutaneously instead of intramuscularly with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) for Immunisation. On 09-Sep-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B SUBVIRION no preservative vaccine Suspension for injection with standard strength (expiry date- 30-JUN-2026 and lot UT8779NA) once via subcutaneous route in the right thigh instead of intramuscular route with no reported adverse event (incorrect route of product administration) (latency- same day). Reportedly, care coordinator is inquiring about the effectiveness of FLUZONE NP that was administered to a 15-month-old patient using a 5g needle which is smaller than the usual 1-inch needle. The care coordinator also mentioned that since a smaller needle was used, they are assuming that the vaccine was administered subcutaneously instead of intramuscularly. 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
2859275 M MN 09/17/2025 IPV
 SANOFI PASTEUR
 W1B511M
Expired product administered, No adverse event Expired product administered, No adverse event
administered an ipol vaccine that was 3 days beyond the expiration date with no reported ae; Initial... administered an ipol vaccine that was 3 days beyond the expiration date with no reported ae; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves an unknown age male patient to whom administered an IPV (Vero) [IPOL] that was 3 days beyond the expiration date with no reported ae (adverse event) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine) And Pneumococcal Vaccine Conj 21v (Crm197) for Immunisation. On 11-Sep-2025, the patient received a 0.5 ml 1x (once) dose of suspect IPV (VERO) Suspension for injection (strength: unknown, expiry date: 08-Sep-2025 and lot W1B511M) via intramuscular route in unknown administration site as prophylactic vaccination (immunization) and that was 3 days beyond the expiration date with no reported ae (expired product administered) (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
2859276 12 M TX 09/17/2025 MEN
 UNKNOWN MANUFACTURER
 U8573AA
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event, Underdose More
did not get his full dose of MENQUADFI/it was only 0.03 mL that remained and which the patient did n... did not get his full dose of MENQUADFI/it was only 0.03 mL that remained and which the patient did not receive, with no reported adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old male patient who did not get his full dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]/it was only 0.03 ml that remained and which the patient did not receive, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation; HPV vaccine VLP rL1 4v (yeast) (Gardasil) for Immunisation; and Influenza vaccine (Fluzone) for Immunisation. On 11-Sep-2025, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (lot U8573AA, with unknown strength and expiry) via intramuscular route in the arm nos (not otherwise specified) as immunization, the patient drew back or flinched at the last second and did not get the full 0.5 mL dose. Physician stated that the patient received most of the dose, it was only 0.03 mL that remained and which the patient did not receive, with no reported adverse event (incorrect dose administered) (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
2859277 59 M MN 09/17/2025 IPV
 SANOFI PASTEUR
 W1B511M
Expired product administered, No adverse event Expired product administered, No adverse event
an inappropriate use due to administration of an expired vaccine to a patient with no reported adver... an inappropriate use due to administration of an expired vaccine to a patient with no reported adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 59 years old male patient who had an inappropriate use due to administration of an expired IPV (VERO) [IPOL] to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis b vaccine for Immunisation; Pneumococcal vaccine for Immunisation; Diphtheria vaccine toxoid, Pertussis vaccine, Tetanus vaccine toxoid (Diphtheria tetanus pertussis vaccine) for Immunisation; and Varicella zoster vaccine (Varicella vacc.) for Immunisation. On 11-Sep-2025, the patient received an expired 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot W1B511M, Expiry: 08-Sep-2025) (Strength: standard and Frequency: once ) via intramuscular route in the left arm as Immunization with no reported adverse event (expired product administered) (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
2859278 74 F NY 09/17/2025 FLU3
 SANOFI PASTEUR
 66S150
No adverse event, Underdose No adverse event, Underdose
stated that she noted that after the after the needle was pulled out of her arm, the liquid was comi... stated that she noted that after the after the needle was pulled out of her arm, the liquid was coming out of the syringe with no reported ae; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74 years old female patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] and noted that after the needle was pulled out of her arm, the liquid was coming out of the syringe with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE for Immunisation. On 11-Sep-2025, the patient received an unknown dose of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- unknown, expiry date- 30-JUN-2026 and lot 66S150) via unknown route in the left arm for Immunization and noted that after the after the needle was pulled out of her arm, the liquid was coming out of the syringe with no reported adverse event (incorrect dose administered) (latency- same day). Reportedly, caller stated that the customer was not sure if she received the full dose and the caller would like to know if the customer could receive another dose. Clear location of the leakage was unknown. The reporter stated that their cameras do not show the area of the pharmacy where the vaccines are administered, and thus details are limited. The leakage occurred after the needle was removed from the patient's arm. The patient informed the reporter that it was a fair amount dripping from the syringe. 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
2859300 62 F SC 09/17/2025 COVID19
 MODERNA
Burning sensation, Nerve injury, Ventricular extrasystoles Burning sensation, Nerve injury, Ventricular extrasystoles
Set my left side on fire, still have nerve damage. Caused heart arrhythmia PVCs Set my left side on fire, still have nerve damage. Caused heart arrhythmia PVCs
2859303 09/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspeceted vaccination failure; I got it again last week; This serious case was reported by a consum... Suspeceted vaccination failure; I got it again last week; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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. In SEP-2025, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got it again last week). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 11-SEP-2025 This case was reported by a patient via interactive digital media. Patient got both the shots last year when patient got 1 painful shingle. And patient got it again last week. Again 1 shingle and it hurts. The shot did not make sure wont get it. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, between 1 and 2 years after receiving Shingles vaccine (dose 1 and dose 2), in a 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
2859304 64 F 09/17/2025 COVID19
 MODERNA
Hypersensitivity Hypersensitivity
Caller has received a Moderna COVID-19 vaccine before that sickness/She said it was not a sickness p... Caller has received a Moderna COVID-19 vaccine before that sickness/She said it was not a sickness per say, it was an allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Caller has received a Moderna COVID-19 vaccine before that sickness/She said it was not a sickness per say, it was an allergy) in a 64-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Transplant. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Immunocompromised and Multiple sclerosis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Caller has received a Moderna COVID-19 vaccine before that sickness/She said it was not a sickness per say, it was an allergy). At the time of the report, HYPERSENSITIVITY (Caller has received a Moderna COVID-19 vaccine before that sickness/She said it was not a sickness per say, it was an allergy) had resolved. She and her husband were both immunocompromised, 65 and older. She got Spikevax and husband got mNEXSPIKE. She was on immune suppressants. Her health did not change. The transplant occurred before receiving Moderna COVID-19 vaccines. She travelled a lot, and she had no immunity, no immune system, and she got sick when she went travelling, and she did not want to get COVID. She got sick a couple months ago. She received a Moderna COVID-19 vaccine before that sickness. She said it was not a sickness per say, it was an allergy, it wasn't anything. She did not have a Moderna vaccine for a year. It had nothing to do with Moderna at all, it had nothing to do with her, it was an allergy type of thing. It had nothing to do with any vaccine or anything like that. She lived in an allergy prone area. No treatment medication was reported. Reporter did not allow further contact More
2859305 32 F PA 09/17/2025 FLU3
 SANOFI PASTEUR
 UT8792LA
Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
pregnant women received fluzone vaccine with no reported adverse event; Initial information received... pregnant women received fluzone vaccine with no reported adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 32 years old pregnant female patient who was exposed to vaccine Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 17 weeks of pregnancy. The date of last menstrual period was reported as 11-May-2025. The estimated due date is 15-Feb-2026. 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 10-Sep-2025, the pregnant patient received a dose 1 of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8792LA, expiry date- 30-JUN-2025) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation), with no reported adverse event (exposure during pregnancy) (latency- same day). Reportedly, the patient did not experience any adverse events. Relevant prenatal testing after exposure was not reported. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. More
2859360 19 M GA 09/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946065
Pruritus, Urticaria Pruritus, Urticaria
Diffuse hives, itching Diffuse hives, itching
2859362 54 F 09/17/2025 UNK
 UNKNOWN MANUFACTURER
Cardiac arrest Cardiac arrest
cardiac arrest 10 minutes post vaccine administration, not consistent with an anaphylactic reaction cardiac arrest 10 minutes post vaccine administration, not consistent with an anaphylactic reaction
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2859363 77 F NJ 09/17/2025 FLU3
FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8837AA
U8837AA
Fluzone HD 65+0
Fluzone HD 65+0
Pruritus, Rash erythematous, Rash papular, Skin warm; Pain in extremity, Skin wa... Pruritus, Rash erythematous, Rash papular, Skin warm; Pain in extremity, Skin warm, Swelling; Pruritus, Rash erythematous, Rash papular, Skin warm; Pain in extremity, Skin warm, Swelling More
Red raised rash, warm to touch, itchy Red raised rash, warm to touch, itchy
2859364 66 F MI 09/17/2025 TD
 SANOFI PASTEUR
 U8511AA
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received Td earlier than her due date per provider. Patient received Td earlier than her due date per provider.
2859365 11 M 09/17/2025 MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8600AA
U8600AA
U8670BA
U8670BA
Altered state of consciousness, Fall, Fatigue, Hyperhidrosis, Malaise; Nausea; A... Altered state of consciousness, Fall, Fatigue, Hyperhidrosis, Malaise; Nausea; Altered state of consciousness, Fall, Fatigue, Hyperhidrosis, Malaise; Nausea More
Patient presented to office today 9/16/25 for nurse visit for an Adacel and Meningitis vaccine. Pati... Patient presented to office today 9/16/25 for nurse visit for an Adacel and Meningitis vaccine. Patient was sitting on the table in room 16, both vaccines given in right deltoid and writer had patient wait a few minutes. Upon checkout at the front desk, PSA came back and alerted nursing staff patient was not feeling well. Writer went out to waiting room to see dad holding patient as he was falling down. Patient did not hurt any body part upon falling. Writer and RN assisted patient down and onto his side, eventually onto his back. Patient stated he felt like he had a dream and did not know what happened. Patient stated he was tired a little and was nauseated and sweaty. Pillow brought for under his head, ice pack for back of his neck and water. Pulse ox applied which read HR 68 and not thready, and O2 100%. Apple Juice, water and fruit snacks brought out to patient and when he was feeling better, he was brought back to room 16, laid down on the table pillow under his head with icepack for neck and pillows to elevate legs. Dr was present, listened to his heart and breathing. BP checked at 1605 108/72, HR 83, O2 99%. Patient given the rest of Apple Juice and fruit snacks and laid down for another 10 minutes. Rechecked BP again at 1615 BP 106/70, HR 78, O2 100%. Spoke with Dr, she stated have him sit up another 10 minutes, have some water and he can be discharged home. Patient waited the 10 minutes and then stood up slowly, writer observed, no dizziness, per patient and he stated he felt fine. Per Dr, no soccer practice tonight, dad understood and agreed. Advised dad to call with any issues or concerns. More
2859366 37 M MI 09/17/2025 HEP
 MERCK & CO. INC.
 Y006509
Extra dose administered Extra dose administered
Received an extra dose of Hep B Received an extra dose of Hep B
2859367 4 M CA 09/17/2025 DTAP
DTAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Condition aggravated, Eczema, Eczema herpeticum, Loss of personal independence i... Condition aggravated, Eczema, Eczema herpeticum, Loss of personal independence in daily activities, Staphylococcal infection; Urticaria More
It first started as hives. I contacted the doctor and he said that it?s a minor allergic reaction. I... It first started as hives. I contacted the doctor and he said that it?s a minor allergic reaction. It kept spreading until it got out of control after few weeks. We went to hospital they said it was eczema flare up . They never wanted to admit that it?s the vaccine. From age 4 till this day my son has been suffering , we had to home school him because his whole skin was covered with severe eczema, he had numerous infections since then including eczema herpeticum and staph , he took so many. Antibiotics, antihistamines, antiviral and several other medications and creams . It was a nightmare and I was never allowed to report it back then. No doctor wanted to admit it was the vaccine except a couple who were afraid to lose their license and didn?t want to publicly say it More
2859369 M 09/17/2025 DTAP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
 JF7DM
UK231AA
LP4946
Accident at work, Injury associated with device; Accident at work, Injury associ... Accident at work, Injury associated with device; Accident at work, Injury associated with device; Accident at work, Injury associated with device More
After administering medication, MA noticed she stuck herself with needle After administering medication, MA noticed she stuck herself with needle
2859370 53 F IA 09/17/2025 COVID19
 MODERNA
 3046734
Expired product administered, No adverse event Expired product administered, No adverse event
Expired Dose given. No other adverse effects noted. Expired Dose given. No other adverse effects noted.
2859371 32 F CO 09/17/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 7L3ST
Exposure during pregnancy, No adverse event, Product use issue, Wrong product ad... Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered More
Pt is 32 wk and 2 days EDD 11/10/25, medical assistant administered Arexvy vaccine instead of Abrysv... Pt is 32 wk and 2 days EDD 11/10/25, medical assistant administered Arexvy vaccine instead of Abrysvo. No adverse reaction reported on patient's behalf. More
2859372 12 M MI 09/17/2025 MMR
 MERCK & CO. INC.
 Y009430
No adverse event, Wrong product administered No adverse event, Wrong product administered
No reported adverse events noted. No follow up treatment was needed. Parent was contacted and offere... No reported adverse events noted. No follow up treatment was needed. Parent was contacted and offered a visit to administer correct vaccine. More
2859373 66 F AR 09/17/2025 COVID19
 MODERNA
 3031419
COVID-19 COVID-19
hospitalized with COVID hospitalized with COVID
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2859374 37 M PA 09/17/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR

Urticaria; Urticaria Urticaria; Urticaria
Broke out in hives in left arm (moderate) and right arm (mild) so I took 50 MG liquid gel benadryl Broke out in hives in left arm (moderate) and right arm (mild) so I took 50 MG liquid gel benadryl
2859375 13 M MI 09/17/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 UT8770NA
Y007197
Hyperhidrosis, Loss of consciousness, Pallor, Syncope; Hyperhidrosis, Loss of co... Hyperhidrosis, Loss of consciousness, Pallor, Syncope; Hyperhidrosis, Loss of consciousness, Pallor, Syncope More
Syncope within 2 minutes of second injection being adminsitered. Inflluenza adminsitered first and ... Syncope within 2 minutes of second injection being adminsitered. Inflluenza adminsitered first and HPV adminsitered second. Patient becamse pale, broke out into a sweat and had a witnessed loss of consciousness. No fall as Provider able to recognize symptoms and assist patient to laying position. LOC last approx 3-5 seconds. More
2859376 63 F AZ 09/17/2025 FLU3
PNC21
 SEQIRUS, INC.
MERCK & CO. INC.

Arthralgia, Muscular weakness, Nausea, Pain in extremity; Arthralgia, Muscular w... Arthralgia, Muscular weakness, Nausea, Pain in extremity; Arthralgia, Muscular weakness, Nausea, Pain in extremity More
Severe pain in the shoulder and arm. Weakness in the arm and nausea Severe pain in the shoulder and arm. Weakness in the arm and nausea
2859377 82 M NH 09/17/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8837DA
U8837DA
Chills, Pyrexia, Tremor; Chills, Pyrexia, Tremor Chills, Pyrexia, Tremor; Chills, Pyrexia, Tremor
Sever chills and shaking followed by fever of 101.5 Lasting a couple of hours Sever chills and shaking followed by fever of 101.5 Lasting a couple of hours
2859378 21 M MD 09/17/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0196
EW0196
Arrhythmia, Death, Dizziness, Dyspnoea, Influenza like illness; Myocardial fibro... Arrhythmia, Death, Dizziness, Dyspnoea, Influenza like illness; Myocardial fibrosis, Palpitations More
flu like symptoms initially, shortness of breath, heart palpitations, dizziness, arrhythmia, death f... flu like symptoms initially, shortness of breath, heart palpitations, dizziness, arrhythmia, death from fatal arrhythmia due to heart scarring More
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2859379 33 M WI 09/17/2025 IPV
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y1A212M
37R35
Hyperhidrosis, Hypotension, Loss of consciousness, Pallor, Tremor; Hyperhidrosis... Hyperhidrosis, Hypotension, Loss of consciousness, Pallor, Tremor; Hyperhidrosis, Hypotension, Loss of consciousness, Pallor, Tremor More
+Pallor, +Diaphoretic, +Hypotensive, +Tremors, +Unconscious (approximately 1-minute). +Pallor, +Diaphoretic, +Hypotensive, +Tremors, +Unconscious (approximately 1-minute).
2859380 50 F VT 09/17/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9JT4S
Asthenia, Fatigue, Headache, Injected limb mobility decreased, Injection site pa... Asthenia, Fatigue, Headache, Injected limb mobility decreased, Injection site pain More
Symptoms of headache, overall weakness and fatigue. This continued for 12 days. Sore site of inject... Symptoms of headache, overall weakness and fatigue. This continued for 12 days. Sore site of injection limiting flexion of shoulder to 100 degrees. Painful deltoid continued for about a week. More
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