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
2821875 U 01/20/2025 RSV
RSV
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
UNK
Cough, Decreased appetite, Diarrhoea, Pain, Somnolence; Weight decreased Cough, Decreased appetite, Diarrhoea, Pain, Somnolence; Weight decreased
body pain; coughing; weight loss 12 lbs in 6 days; uncontrolled mucus diarrhea; stopped eating; Slee... body pain; coughing; weight loss 12 lbs in 6 days; uncontrolled mucus diarrhea; stopped eating; Sleeping; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced general body pain (Verbatim: body pain), cough (Verbatim: coughing), weight loss (Verbatim: weight loss 12 lbs in 6 days), mucous diarrhea (Verbatim: uncontrolled mucus diarrhea), appetite absent (Verbatim: stopped eating) and sleepiness (Verbatim: Sleeping). The outcome of the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness were not reported. It was unknown if the reporter considered the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness to be related to Arexvy. It was unknown if the company considered the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness to be related to Arexvy. Additional Information: GSK Receipt Date: 25-DEC-2024 This case was reported by a patient via interactive digital media. The patient experienced body pain, coughing, sleeping , stopped eating, weight loss 12 lbs in 6 days, uncontrolled mucus diarrhea. The follow-up could not be possible as no contact details were available. More
2821876 U 01/20/2025 VARZOS
VARZOS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNK
UNK
Oral herpes zoster, Pain, Vaccination failure; Oral herpes zoster, Pain, Vaccina... Oral herpes zoster, Pain, Vaccination failure; Oral herpes zoster, Pain, Vaccination failure More
Suspected vaccination failure; Oral Shingles; This serious case was reported by a consumer via inter... Suspected vaccination failure; Oral Shingles; 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. 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 oral herpes zoster (Verbatim: Oral Shingles). The outcome of the vaccination failure and oral herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and oral herpes zoster 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 oral herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 06-JAN-2025 This case was reported by a patient via interactive digital media. The patient received 2 series shot of Shingles vaccine and experienced oral shingles. The patient had worse pain ever. This case was considered as suspected vaccination failure as details regarding time to onset for oral herpes zoster and laboratory confirmation regarding oral herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine( 1st dose) and Shingles vaccine (2nd dose) More
2821877 U 01/20/2025 VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
UNK
Herpes zoster, Impaired work ability, Ophthalmic herpes zoster, Pain, Pruritus; ... Herpes zoster, Impaired work ability, Ophthalmic herpes zoster, Pain, Pruritus; Vaccination failure, Visual impairment More
Suspected vaccination failure; Shingles in eye; Shingles in face; This serious case was reported by ... Suspected vaccination failure; Shingles in eye; Shingles in face; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles in face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix. Additional Information: GSK receipt date: 07-JAN-2025 Patient stated that he/she got the vaccine 4 years ago. And, diagnosed with shingles in the left side of face and eye in early December. At the time of reporting rash was gone, but pain, itch, and impaired vision still very present. Also reported that out of work at least through the end of January when he/she meet with the eye specialist next. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting. This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2821878 68 M CA 01/20/2025 FLU3
GLAXOSMITHKLINE BIOLOGICALS
37NR4
Wrong product administered Wrong product administered
Fluarix was given to a 68 year old, instead of Fluad; This non-serious case was reported by a other ... Fluarix was given to a 68 year old, instead of Fluad; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 68-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 37NR4, expiry date 30-JUN-2025) for prophylaxis. Co-suspect products included Influenza vaccine inact sAg 3v (Fluad) for prophylaxis. On 09-DEC-2024, the patient received the 1st dose of Fluarix 2024-2025 season. On an unknown date, the patient did not receive Fluad. On 09-DEC-2024, immediately after receiving Fluarix 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: Fluarix was given to a 68 year old, instead of Fluad). The outcome of the wrong vaccine administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-DEC-2024 The other health professional reported that one of their members administered a Flu, the normal Fluarix, to a 68 year old male patient, just wanted to see what was GlaxoSmithKline's recommendations on that. The other health professional reported that Fluarix was given to a 68 year old patient, instead of Fluad which led to wrong vaccine administered. Consented The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of 7 linked cases, reported by same reporter.; Sender's Comments: US-GSK-US2024092435:same reporter US-GSK-US2024043628:same reporter US-GSK-US2024043626:same reporter US-GSK-US2024043624:same reporter US-GSK-US2024043623:same reporter US-GSK-US2024043622:same reporter More
2821879 F TN 01/20/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
4H79Y
Incorrect route of product administration, Pain in extremity, Product administer... Incorrect route of product administration, Pain in extremity, Product administered at inappropriate site More
Shingrix - Route of administration.; Shingrix - Sore arm; This non-serious case was reported by a ph... Shingrix - Route of administration.; Shingrix - Sore arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H79Y, expiry date 13-NOV-2026) for prophylaxis. On 17-DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Shingrix - Sore arm). On 17-DEC-2024, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix - Route of administration.). The outcome of the pain in arm and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 23-DEC-2024 A pharmacist mentioned they administered a Shingrix vaccine to a patient in the upper arm but they are not sure if the vaccine was administered intramuscular in the deltoid. The pharmacist said that the vaccine was administered in the shoulder for sure. The patient had sore arm. The reporter was ask if this dose valid or patient should be revaccinated. The patient received vaccine other than intramuscular, which led to intramuscular formulation administered by other route. More
2821880 57 F TX 01/20/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
B4942
Inappropriate schedule of product administration Inappropriate schedule of product administration
she had her first dose approximately 4 years ago and did not return for a second dose until today; T... she had her first dose approximately 4 years ago and did not return for a second dose until today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number B4942, expiry date 06-APR-2026) for prophylaxis. Previously administered products included Shingrix (first dose received approximately 4 years ago). On 02-JAN-2025, the patient received the 2nd dose of Shingrix. On 02-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: she had her first dose approximately 4 years ago and did not return for a second dose until today). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 02-JAN-2025 The reporter stated patient came in to pharmacy on the day of reporting for her second Shingrix dose. The patient reported she had her first dose approximately 4 years ago and did not return for a second dose until today. The first dose was not at the same pharmacy, so the reporter did not knew exact date of first dose. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up but did not provide email or fax, so use postal. The patient received second dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2821881 25 F IL 01/20/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
A4P5G
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
35 weeks pregnant patient, was given the Arexvy; Unapproved Age; This non-serious prospective pregna... 35 weeks pregnant patient, was given the Arexvy; Unapproved Age; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A4P5G, expiry date 12-OCT-2025) for prophylaxis. On 08-JAN-2025, the patient received the 1st dose of Arexvy. On 08-JAN-2025, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: Unapproved Age). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 35 weeks pregnant patient, was given the Arexvy). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown. Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 09-JAN-2025 The nurse reported that patient at their facility was a 35 weeks pregnant patient, was given the Arexvy immunization by mistake and he/she wonder what kind of information GlaxoSmithKline had regarding that. The patient was 25 years old and nurse mentioned that she was born which led to drug use in unapproved population. More
2821882 68 U NC 01/20/2025 DTAP
GLAXOSMITHKLINE BIOLOGICALS

Product administered to patient of inappropriate age Product administered to patient of inappropriate age
accidentally administered Infanrix to a 68 year old patient; This non-serious case was reported by a... accidentally administered Infanrix to a 68 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 68-year-old patient who received DTPa (Infanrix) for prophylaxis. On 09-JAN-2025, the patient received Infanrix. On 09-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally administered Infanrix to a 68 year old patient). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JAN-2025 The pharmacist reported that they accidentally administered Infanrix to patient of an inappropriate age, which led to inappropriate age at vaccine administration. More
2821883 51 F CA 01/20/2025 VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Blood pressure decreased, Chills, Decreased appetite, Dehydration, Dizziness; He... Blood pressure decreased, Chills, Decreased appetite, Dehydration, Dizziness; Headache, Myalgia, Pyrexia, Syncope More
Fainting; Dizziness; Low BP; loss of appetite; Headache; Shivering; Fever; Muscle pain; Dehydrated; ... Fainting; Dizziness; Low BP; loss of appetite; Headache; Shivering; Fever; Muscle pain; Dehydrated; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 06-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 08-JAN-2025, 2 days after receiving Shingrix, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant), dizziness (Verbatim: Dizziness), blood pressure decreased (Verbatim: Low BP), appetite lost (Verbatim: loss of appetite), headache (Verbatim: Headache), shivering (Verbatim: Shivering), fever (Verbatim: Fever), muscle pain (Verbatim: Muscle pain) and dehydration (Verbatim: Dehydrated). The outcome of the fainting, dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration were not resolved. It was unknown if the reporter considered the fainting, dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration to be related to Shingrix. The company considered the fainting to be unrelated to Shingrix. It was unknown if the company considered the dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JAN-2025 The patient self reported the case. Patient called on the day of reporting with the following complaints, dehydration, muscle pain, shivering, headache, fever, loss of appetite, dizziness, blood pressure low, and fainting. All of these complaints were ongoing. Patient was actually at a urgent care to receive IV fluids for her dehydration. The reporter consented to follow up.; Sender's Comments: Syncope is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2821885 M MI 01/20/2025 COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH


Hyperhidrosis, Labyrinthitis, Loss of consciousness, Vertigo, Vestibular neuroni... Hyperhidrosis, Labyrinthitis, Loss of consciousness, Vertigo, Vestibular neuronitis; Vomiting More
vetibular neuritis; throw up until pass out; labyrinthitis; the room would spin; sweaty; throw up un... vetibular neuritis; throw up until pass out; labyrinthitis; the room would spin; sweaty; throw up until pass out; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant), 4 weeks after the suspect product(s) administration, outcome "recovered", described as "vetibular neuritis"; LOSS OF CONSCIOUSNESS (medically significant), VOMITING (non-serious), outcome "unknown" and all described as "throw up until pass out"; LABYRINTHITIS (non-serious), 4 weeks after the suspect product(s) administration, outcome "recovered"; VERTIGO (non-serious), outcome "unknown", described as "the room would spin"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweaty". Clinical details: the patient asked if there have been reports of labyrinthitis/vetibular neuritis after a Pfizer covid booster. He developed this 4 weeks after the vax, took nearly a year to resolve. He mentions that he wound up in a situation where the room would spin, he'd get very sweaty and he'll throw up until he pass out. Caller adds that he was on steroids for almost a year and he found one article linking this but there was a very small number of cases. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2821886 U HI 01/20/2025 RSV
PFIZER\WYETH

Foetal exposure during pregnancy, Premature baby Foetal exposure during pregnancy, Premature baby
Preterm birth. Due date 13Feb2025.; This is a spontaneous report received from a Physician from a sa... Preterm birth. Due date 13Feb2025.; This is a spontaneous report received from a Physician from a sales representative. A neonate patient born to a 33-year-old mother who, while pregnant received RSV Vaccine Prot. Subunit Pref 2v (ABRYSVO) on 04Jan2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. A neonate patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), administration details for the mother: not provided, on 04Jan2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The mother of the patient was 33 years old at the time of vaccination. The mother is expected to deliver a baby(s) on 13Feb2025. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE BABY (non-serious) with outcome "unknown", described as "Preterm birth. Due date 13Feb2025. Delivery date ". The baby was delivered premature. Therapeutic measures were not taken as a result of premature baby. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2821887 U 01/20/2025 COVID19
PFIZER\BIONTECH

Arrhythmia Arrhythmia
heart arrhythmia; This is a spontaneous report received from a Consumer or other non HCP from Licens... heart arrhythmia; This is a spontaneous report received from a Consumer or other non HCP from License Party. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "not recovered", described as "heart arrhythmia". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. BNT162b2 is under agreement with BIONTECH SE. More
2821888 43 F 01/20/2025 COVID19
FLU3
UNKNOWN MANUFACTURER
SANOFI PASTEUR


Condition aggravated, Dizziness postural, Heart rate increased, Postural orthost... Condition aggravated, Dizziness postural, Heart rate increased, Postural orthostatic tachycardia syndrome; Condition aggravated, Dizziness postural, Heart rate increased, Postural orthostatic tachycardia syndrome More
Heart rate increased; Postural orthostatic tachycardia syndrome; Condition aggravated; Dizziness pos... Heart rate increased; Postural orthostatic tachycardia syndrome; Condition aggravated; Dizziness postural; Initial information received on 13-Jan-2025 regarding an unsolicited valid serious courtesy case received from a consumer. This case involves a 43 years old female patient who experienced heart rate increased, postural orthostatic tachycardia syndrome, condition aggravated and dizziness postural after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and Covid-19 Vaccine Prot. Subunit (Nvx Cov 2373) (Novavax Covid-19 Vaccine). The patient's past medical history included Ehlers-Danlos syndrome, Complex regional pain syndrome, Postural orthostatic tachycardia syndrome, Mast cell activation syndrome and Migraine. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Erenumab aooe (Aimovig); Buprenorphine (Butrans); Metoclopramide (Reglan); Duloxetine hydrochloride (Cymbalta); Mirtazapine; Doxepin (Doxepin); and Gabapentin. On 11-Nov-2024, the patient received a unknown dose of suspect Novavax Covid-19 Vaccine not produced by Sanofi Pasteur injection (strength: 0.5 ml, expiry date and lot number not reported for both suspects) via intramuscular route in unknown administration site as COVID-19 immunization; On the same day, the patient received a unknown dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection via intramuscular route in unknown administration site as prophylactic vaccination (immunization). There will be no information available on the batch number and expiration date corresponding to the one at time of event occurrence. On 12-Nov-2024 the patient developed heart rate increased, postural orthostatic tachycardia syndrome, condition aggravated and dizziness postural (latency: 1 day). These events were leading to disability. Action taken: not applicable. It was not reported if the patient received a corrective treatment for all events. At time of reporting, the outcome was Not Recovered / Not Resolved for all events.; Sender's Comments: Sanofi company comment dated on 16-Jan-2025: This case involves a 43 years old female patient who experienced heart rate increased, postural orthostatic tachycardia syndrome, condition aggravated and dizziness postural after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and Covid-19 Vaccine Prot. Subunit (Nvx Cov 2373) (Novavax Covid-19 Vaccine). Further information regarding tolerance medical history or family history, concurrent condition and concomitant medication laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed. More
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2821889 U NY 01/20/2025 TDAP
SANOFI PASTEUR
2CA94C1
No adverse event, Product storage error No adverse event, Product storage error
This situation is pre-assessed as a medication error/an inappropriate use due to administration of A... This situation is pre-assessed as a medication error/an inappropriate use due to administration of ADACEL post-excursion. with no reported adverse event; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an this situation is pre-assessed as a medication error/an inappropriate use due to administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] post-excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. On an unknown date, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) lot 2CA94C1, Expiry date: 31-AUG-2025, strength was unknown via unknown route in unknown administration site for prophylactic vaccination (Immunization) and this situation is pre-assessed as a medication error/an inappropriate use due to administration of adacel post-excursion with no reported adverse event (poor quality product administered) (latency; same day). 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
2821890 U 01/20/2025 FLU4
SANOFI PASTEUR

Multiple use of single-use product, Wrong technique in product usage process Multiple use of single-use product, Wrong technique in product usage process
the physician is initially giving half doses of HD Fluzone and having the patient return a week lat... the physician is initially giving half doses of HD Fluzone and having the patient return a week later for the second half with no reported AE; storing the opened product for a week before re-administration with no reported AE; Initial and live follow-up information received on 19-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an elderly unknown gender patient who received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and it was reported that the physician is initially giving half doses of hd fluzone and having the patient return a week later for the second half with no reported ae (adverse event) and storing the opened product for a week before re-administration with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, injection (dose, strength, route: unknown) lot number not reported in unknown administration site as Immunization . On an unknown date the physician is initially giving half doses of hd fluzone and having the patient return a week later for the second half with no reported ae (incorrect dose administered) and storing the opened product for a week before re-administration with no reported ae (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The reporter stated the nurse would like to know what dose should the patients received for the second FLUZONE HD injection. Should the patients receive another half dose, a whole dose or what dose should they receive. She statesdthat she has found multiple practices in which HCPs were administering half-doses of FLUZONE HIGH-DOSE QUADRIVELENT. Reasons provided were either that the patient had an egg allergy (in which case she advises FLUBLOK), or that the practitioner felt that the high-dose is just too much so they wanted to break it into 2 doses. (In which case she advises not using the high-dose). She stated that when she has informed practitioners of underdose information, some of them have declined to change their practice. 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. Based on data previously received, the following information [age group was captured as Elderly along with case classification as valid] has been amended. More
2821891 16 M OR 01/20/2025 UNK
UNKNOWN MANUFACTURER
TFAA2406
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
16 year-old boy was administered flublok in error with no reported adverse event; Initial informatio... 16 year-old boy was administered flublok in error with no reported adverse event; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 16 years old male patient who was administered with influenza trivalent recombinant vaccine [Flublok TIV] in error with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in January 2025, the patient received an unknown dose of influenza trivalent recombinant vaccine Solution for injection (strength- unknown, expiry date 31-MAY-2025 and lot TFAA2406) via unknown route in unknown administration site as Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Reportedly, pharmacist stated that they had checked on him by telephone every day for 5 days and there had been no adverse reactions reported. Patient did not receive any other vaccines concomitantly. 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
2821892 1.33 M TX 01/20/2025 DTAPIPVHIB
SANOFI PASTEUR
UK109AA
Extra dose administered, No adverse event Extra dose administered, No adverse event
a patient, who completed his Pentacel series in nov 2024, was given an extra dose of Pentacel yester... a patient, who completed his Pentacel series in nov 2024, was given an extra dose of Pentacel yesterday by mistake with no reported adverse event; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves, a 16 months old male patient who completed his Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] series in Nov-2024, was given an extra dose of pentacel yesterday by mistake 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 Rotavirus Vaccine and PCV-20 for Immunisation. On 14-Jan-2025, the patient who completed his Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (once) (lot UK109AA) (unknown strength, expiry date) via intramuscular route in the right thigh for prophylactic vaccination series in Nov-2024, was given an extra dose of Pentacel yesterday by mistake with no reported adverse event (extra dose administered) (latency-same day). Reportedly, The error happened when the medical assistant (MA) became confused because the patient and his brother had the same date of birth except for the year. The affected patient actually only needed an MMRV vaccine yesterday. However, yesterday the MA was looking at the ''m-track'' record for the patient's brother without realizing it was not the correct patient. The patient's brother, born in 2024, did need Pentacel, PCV- 20, and rotavirus. The patient, born in 2023, only needed MMRV. Therefore, it was the Pentacel, PCV-20, and rotavirus vaccines that were administered in error yesterday as extra doses to patient. 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
2821893 F 01/20/2025 UNK
UNKNOWN MANUFACTURER
No batch number
Influenza Influenza
Infected with influenza virus; This spontaneous case, initially received on 06-Jan-2025, was reporte... Infected with influenza virus; This spontaneous case, initially received on 06-Jan-2025, was reported by a non-health professional and concerns an adult female patient. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for active immunization, (FLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine) Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: No batch number available and would be requested with follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Infected with influenza virus (Medically Significant, outcome: Unknown). Patient got infected with influenza virus following seasonal influenza vaccination Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed the event as non-serious and did not provide the causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. The case lacks information regarding the strain of influenza with which the patient was diagnosed, clinical presentation, time frame between vaccination and diagnosis of influenza, detailed investigations (swab and blood culture, immunological tests), hence assessed as related. More
2821900 1.58 F GA 01/20/2025 MMR
VARCEL
MERCK & CO. INC.
MERCK & CO. INC.
X019100
Y005922
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 reaction; MMR II and Varicella vaccine administered on the same day; This spontaneous rep... No adverse reaction; MMR II and Varicella vaccine administered on the same day; This spontaneous report was received from Licensed practical nurse and refers to a 19-month-old female. The patient has no pre-existing allergies, birth defects of medical conditions nor illness at the time of vaccination. No adverse events following a prior vaccination.Concomitant medications included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). On 08-AUG-2024, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #Y005922, expiration date: 13-MAR-2026, administered subcutaneously in the right arm; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #X019100, expiration date: 16-JUL-2025, administered subcutaneously in the left arm (Inappropriate schedule of vaccine administration). Both vaccines for prophylaxis. It was reported that during the day of the vaccine administration, there was a power loss for approximately 2 hours; however, the vaccines were moved to another refrigerator and freeze before they reached the excursion point. All safety guidelines were followed, and the vaccines were safe and kept the temperature range. The patient had not adverse reaction. This is one of several reports from the same source.; Sender's Comments: US-009507513-2501USA004794: More
2821901 U 01/20/2025 COVID19
PFIZER\BIONTECH

Thrombosis Thrombosis
blood clots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A ... blood clots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 58-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "several surgeries" (unspecified if ongoing), notes: I'm 58 years old had several surgeries. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2821902 7 F MO 01/20/2025 COVID19
MODERNA

Epistaxis, Pyrexia Epistaxis, Pyrexia
Fever of 102.2 on 1/18, fever of 104 on 1/19, nosebleed on 1/20 Fever of 102.2 on 1/18, fever of 104 on 1/19, nosebleed on 1/20
2821903 60 F MI 01/20/2025 PNC21
MERCK & CO. INC.
y013009
Discomfort, Rash, Rash erythematous Discomfort, Rash, Rash erythematous
Pt received a Capvaxive vaccine on 11/21. She did not have any issues until 11/27, when she started ... Pt received a Capvaxive vaccine on 11/21. She did not have any issues until 11/27, when she started to develop small, red rash-like bumps on both arms. They slowly got worse and covered both arms, from hands to upper arm, and within a couple days started to resolve on their own. She did not have any other reaction. She did not report to dr or hospital, and did not take any OTC medicine to make rash go away. It was "uncomfortable", but was gone within a couple days. More
2821904 50 F CA 01/20/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
58160-08253-11
Injection site reaction, Injection site warmth, Rash macular Injection site reaction, Injection site warmth, Rash macular
8 am of 1/20/25 (approximately two and a half days after injection) , splotchy redness in the upper ... 8 am of 1/20/25 (approximately two and a half days after injection) , splotchy redness in the upper left arm in the area of the injection site. Hotter than surrounding area. Has stayed that way through the day. Called the pharmacist to discuss. Pharmacist suggested filling out this form. More
2821905 52 F NC 01/20/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS

Chills, Headache, Injection site pain, Nausea Chills, Headache, Injection site pain, Nausea
Sore arm at the injection site started the day of the vaccine. Pain gone within 24 hours. Headache... Sore arm at the injection site started the day of the vaccine. Pain gone within 24 hours. Headache, nausea, and chills the day after the vaccine from 8am - 3pm. More
2821921 78 M FL 01/20/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
255T2
Extra dose administered, No adverse event Extra dose administered, No adverse event
The patient had no issues with the second shot. The patient had no issues with the second shot.
2821922 53 F WV 01/20/2025 COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH


Asthenia, Condition aggravated, Fatigue, Migraine, Nausea; Palpitations, Vertigo Asthenia, Condition aggravated, Fatigue, Migraine, Nausea; Palpitations, Vertigo
Sever migraine, nausea, heart palpitations, weak, fatigue, vertigo Sever migraine, nausea, heart palpitations, weak, fatigue, vertigo
2821923 84 M FL 01/20/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS

Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received a second dose of Arexvy on advice of the dr. patient had NO adverse effects at the ... patient received a second dose of Arexvy on advice of the dr. patient had NO adverse effects at the time of vaccination More
2821924 79 F FL 01/20/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS

Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received a second dose of Arexvy on advice of the dr. patient had NO adverse effects at the ... patient received a second dose of Arexvy on advice of the dr. patient had NO adverse effects at the time of vaccination More
2821925 4 F NY 01/20/2025 DTAP
GLAXOSMITHKLINE BIOLOGICALS
9kB9G
Injection site erythema, Injection site induration, Injection site swelling, Typ... Injection site erythema, Injection site induration, Injection site swelling, Type III immune complex mediated reaction More
Developed substantial redness, induration, and swelling at injection site, measuring 9.5cm x 8.5cm. ... Developed substantial redness, induration, and swelling at injection site, measuring 9.5cm x 8.5cm. Parents sent several photos over the weekend. Seen in office 1/20, at which point there was central clearing. No fevers. Walking and playing normally, felt to represent Arthus reaction. More
2821926 72 F NY 01/20/2025 PNC20
PFIZER\WYETH

Rash, Rash pruritic Rash, Rash pruritic
Itchy rash on arm that received the vaccine on 3rd day after vaccine. Itchy rash on arm that received the vaccine on 3rd day after vaccine.
2821927 1.25 M MO 01/20/2025 DTAPIPVHIB
DTAPIPVHIB
SANOFI PASTEUR
SANOFI PASTEUR
UK112AA
UK112AA
Balance disorder, Diet refusal, Dizziness, Erythema multiforme, Fatigue; Gait di... Balance disorder, Diet refusal, Dizziness, Erythema multiforme, Fatigue; Gait disturbance, Pruritus, Pyrexia, Rash, Swelling of eyelid More
Two days after his vaccine he started developing a full body rash diagnosed as erythema multiform a... Two days after his vaccine he started developing a full body rash diagnosed as erythema multiform at urgent care. It progressed for a week. Days 5, 6 and 7 after had the worst symptoms. His eyes were almost swelled shut, 103 fever, rash on the bottoms of his feet made it difficult to walk, exhaustion, wouldn?t eat or drink, and he was unsteady/dizzy. We were told to him motrin as needed to keel him comfortable and give Zyrtecs for swelling and itchiness More
2821937 0.75 F PA 01/20/2025 FLU3
HEP
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
UT8468JA
9452S
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
none none
2821938 1 M PA 01/20/2025 FLU3
HEPA
SANOFI PASTEUR
MERCK & CO. INC.
U8518CA
Y012054
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
None None
2821939 0.75 F PA 01/20/2025 FLU3
SANOFI PASTEUR
UT8475JA
Unevaluable event Unevaluable event
none none
2821940 0.75 F PA 01/20/2025 HEP
MERCK & CO. INC.
X027728
Reaction to previous exposure to any vaccine Reaction to previous exposure to any vaccine
none none
2821941 1.58 F PA 01/20/2025 HEPA
MERCK & CO. INC.
X026666
Unevaluable event Unevaluable event
none none
2821942 0.67 F PA 01/20/2025 HEP
MERCK & CO. INC.
Y009551
Unevaluable event Unevaluable event
none none
2821943 1 F PA 01/20/2025 FLU3
HEPA
SANOFI PASTEUR
MERCK & CO. INC.
U8518CA
Y012054
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
None None
2821702 7 M CO 01/19/2025 IPV
MMRV
TDAP
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
W1C831M
Y014436
U8252AA
Fall, Head injury, Somnolence; Fall, Head injury, Somnolence; Fall, Head injury,... Fall, Head injury, Somnolence; Fall, Head injury, Somnolence; Fall, Head injury, Somnolence More
Patient came into clinic for vaccine only appointment. He tolerated the vaccines well and then, when... Patient came into clinic for vaccine only appointment. He tolerated the vaccines well and then, when leaving, he fell by the elevator and hit the side of his head. He was groggy, but responsive. Observed closely in clinic and vital signs remained stable. Patient needed no other assistive care. More
2821703 52 M TX 01/19/2025 COVID19
PFIZER\BIONTECH

Rash, Rash pruritic Rash, Rash pruritic
The vaccine is listed in my insurance as: COMIRNATY 2024-25 (Rx #: 000007490038) I had no immediate ... The vaccine is listed in my insurance as: COMIRNATY 2024-25 (Rx #: 000007490038) I had no immediate reaction to the vaccine on Dec 1, but after a week or two I started getting itchy rashes over large parts of my torso. These have spread from one part to another part of my body, mostly on my upper half. As one area returns to normal, the rash spreads to another area. As of right now, the affected area is my breasts and buttocks, though the rash seems to be subsiding somewhat in those areas. I have experienced some level of rash each time I take a COVID vaccine, but the reaction this year is far worse, covering a larger area, and has lasted noticeably longer than previous years. At this point I intend to discontinue any future COVID vaccinations unless a safer alternative can be found. More
2821704 54 F MD 01/19/2025 COVID19
MODERNA
046B21A
Fatigue, Malaise Fatigue, Malaise
I did get tired and didn't feel well. Did report. I did get tired and didn't feel well. Did report.
2821705 70 F OH 01/19/2025 FLU3
SANOFI PASTEUR
UT8409AB
Mobility decreased, Pain Mobility decreased, Pain
SHE SAYS SHE CAN'T LIFT ARM AND HAS SEVERE PAIN FROM VACCCINATION ON 11/24. SHE SAID SHE WILL B... SHE SAYS SHE CAN'T LIFT ARM AND HAS SEVERE PAIN FROM VACCCINATION ON 11/24. SHE SAID SHE WILL BE GETTING PHYSICAL THERAPY DUE TO INCIDENT. More
2821706 67 F ME 01/19/2025 FLU3
SEQIRUS, INC.

Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More
My upper left arm is very red and swollen. It's bit itchy as well and warm to the touch. I'... My upper left arm is very red and swollen. It's bit itchy as well and warm to the touch. I've never had a reaction to a flu shot before and feel this should be jnoted More
2821707 54 F MD 01/19/2025 COVID19
COVID19
MODERNA
MODERNA
AU3918E
AU3918E
Axillary pain, Cardiac failure congestive, Computerised tomogram heart abnormal,... Axillary pain, Cardiac failure congestive, Computerised tomogram heart abnormal, Coronary arterial stent insertion, Mammogram; Myocardial infarction, Scan with contrast abnormal, Ultrasound breast normal More
Heart Attack- 2 Stents. First issue was pain under left arm in breast area. radiology did Mammo, th... Heart Attack- 2 Stents. First issue was pain under left arm in breast area. radiology did Mammo, then Mamo sonogram, was negative but no other referral or indication. This was Jan 12 or approx. Feb 24 went to hospital with similar pains. Sent home. Next day went to hospital, Admitted and tested for 4 days. On 5 day, heart scan with contrast revealed congestive heart failure l. Surgery performed March 1 . released March 3. More
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2821708 75 F OH 01/19/2025 RSV
RSV
PFIZER\WYETH
PFIZER\WYETH


Arthralgia, Arthropathy, Fall, Induration, Joint swelling; Peripheral swelling Arthralgia, Arthropathy, Fall, Induration, Joint swelling; Peripheral swelling
Swelling, hardness, and pain in left shoulder where vaccination was given. When I got up the next m... Swelling, hardness, and pain in left shoulder where vaccination was given. When I got up the next morning, my entire left leg, ankle, and foot were swollen and they are still swollen six weeks later. I have had two total left knee replacements, with the revision surgery requiring a titanium rod to be placed inside the entire left femur in 2018 at the main campus of the Clinic. Since receiving the RSV vaccination, I have nearly fallen several times because of my left knee . More
2821709 32 F OR 01/19/2025 COVID19
COVID19
FLU3
FLU3
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
lm7786
lm7786
tfaa2442
tfaa2442
Amnesia, Blood glucose, Dizziness, Fall, Head injury; Hyperhidrosis, Syncope, Tr... Amnesia, Blood glucose, Dizziness, Fall, Head injury; Hyperhidrosis, Syncope, Tremor, Vision blurred; Amnesia, Blood glucose, Dizziness, Fall, Head injury; Hyperhidrosis, Syncope, Tremor, Vision blurred More
fainted about a min after getting the shots. Fell hit her head. Was awake but can't remember f... fainted about a min after getting the shots. Fell hit her head. Was awake but can't remember fainting from chair to floor. Took about 15-20 minutes to recover. Was given water and evaluated by paramedic. Has another dizzy and shaking spell after returned to chair from fall before paramedic arrived. Lasted a min or so, lots of sweating and blurry vision. Hands shaking but not any other sign that would indicate seizure versus recovery from syncope event. patient left on own accord, when friend arrived to take them home and monitor. More
2821710 78 M 01/19/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
255T2
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient had previously received the dose on 12/03/23 and received a shot again on 01/18/25. Health a... Patient had previously received the dose on 12/03/23 and received a shot again on 01/18/25. Health agency recommendations is just one dose and complete. He was not experiencing any side effects as of 01/19/25. Patient was educated on possible side effects. More
2821711 64 M MO 01/19/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
54A7M
Extra dose administered Extra dose administered
Patient received two doses of RSV vaccine. First dose was 12/19/2023 and second dose was 1/19/2025. ... Patient received two doses of RSV vaccine. First dose was 12/19/2023 and second dose was 1/19/2025. First dose was discovered after pt was administered the second dose and it was reported into the vaccine database. Patient states first dose would have been given at this pharmacy (no record here) or the dr's clinic. More
2821712 63 F FL 01/19/2025 UNK
UNKNOWN MANUFACTURER
52z52
Extra dose administered, Pain, Pain in extremity Extra dose administered, Pain, Pain in extremity
Pt received the RSV vaccine in 2023 and again on 1/18/25. Followed up with pt and she said she felt ... Pt received the RSV vaccine in 2023 and again on 1/18/25. Followed up with pt and she said she felt like she was hit by a truck last night and her arm was sore. She stated that she is doing okay now More
2821713 84 F FL 01/19/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
5TP73
Extra dose administered, No adverse event Extra dose administered, No adverse event
Second dose of RSV was administered inappropriately. Patient did not suffer from any adverse effects... Second dose of RSV was administered inappropriately. Patient did not suffer from any adverse effects. More