🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2819110 1.17 F PA 01/02/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 32M5G
Extra dose administered Extra dose administered
patient received by accident a fourth dose of Engerix-B instead of a Hepatitis A vaccine; patient re... patient received by accident a fourth dose of Engerix-B instead of a Hepatitis A vaccine; patient received by accident a fourth dose of Engerix-B; 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 14-month-old female patient who received HBV (Engerix B) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis. On 03-DEC-2024, the patient received the 4th dose of Engerix B. On an unknown date, the patient received Hepatitis A vaccine. On 03-DEC-2024, an unknown time after receiving Engerix B and not applicable after receiving Hepatitis A vaccine, the patient experienced wrong vaccine administered (Verbatim: patient received by accident a fourth dose of Engerix-B instead of a Hepatitis A vaccine) and extra dose administered (Verbatim: patient received by accident a fourth dose of Engerix-B). The outcome of the wrong vaccine administered and extra dose administered were 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: 03-DEC-2024 Healthcare Provider explained that a 14 month old patient received by accident a fourth dose of Engerix-B instead of a Hepatitis A vaccine that they needed, which led to Wrong vaccine administered and Extra dose administered. Reporter consented to follow up. More
2819111 75 F CT 01/02/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Dry skin, Headache, Herpes zoster, Injection site pain, Pyrexia; Skin discoloura... Dry skin, Headache, Herpes zoster, Injection site pain, Pyrexia; Skin discolouration More
dry spot; shingles; 5 tiny white spots; sore at the injection site; mild fever; headache; This non-s... dry spot; shingles; 5 tiny white spots; sore at the injection site; mild fever; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 24-NOV-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 meq/kg. On 25-NOV-2024, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: sore at the injection site), fever (Verbatim: mild fever) and headache (Verbatim: headache). On 03-DEC-2024, the patient experienced skin discoloration (Verbatim: 5 tiny white spots). On an unknown date, the patient experienced dry skin (Verbatim: dry spot) and shingles (Verbatim: shingles). On 27-NOV-2024, the outcome of the injection site pain, fever and headache were resolved. The outcome of the skin discoloration was not resolved and the outcome of the dry skin and shingles were not reported. It was unknown if the reporter considered the injection site pain, fever, headache, skin discoloration, dry skin and shingles to be related to Shingrix. It was unknown if the company considered the injection site pain, fever, headache, skin discoloration, dry skin and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 03-DEC-2024 The patient's arm was sore at the injection site, she had a mild fever, and headache. The reporter reported her physical therapist noticed about 5 white spots around a scar from a back surgery she had 6 months ago that goes vertically along her spine. The therapist said there was also a dry spot on the scar on her back. The therapist said it could be shingles since she just had the vaccine last week. Referenced Shingrix was a non-live vaccine. The reporter did not consent to follow-up. More
2819112 40 F 01/02/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 T3H32
Extra dose administered Extra dose administered
vaccine expired on 12/1/2024 and was given to a patient; This non-serious case was reported by a oth... vaccine expired on 12/1/2024 and was given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received MMR (Priorix) (batch number T3H32, expiry date 01-DEC-2024) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: vaccine expired on 12/1/2024 and was given to a patient). The outcome of the expired vaccine used 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: 04-DEC-2024 The reporter reported vaccine expired was given to a patient, which led to expired vaccine used. The reporter asked what if any adverse reaction could that have. The reporter just need to know if the shelf life was longer on this vaccine then the expiration date. The date of vaccine administration was not provided, reporter disconnected chat prior to completing safety information. More
2819113 40 F MO 01/02/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 T3H32
Expired product administered, Product administered to patient of inappropriate a... Expired product administered, Product administered to patient of inappropriate age More
Priorix - Administration after expiration date; 40 year old patient; This non-serious case was repor... Priorix - Administration after expiration date; 40 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received MMR (Priorix) (batch number T3H32, expiry date 01-DEC-2024) for prophylaxis. On 04-DEC-2024, the patient received Priorix. On 04-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Priorix - Administration after expiration date) and inappropriate age at vaccine administration (Verbatim: 40 year old patient). The outcome of the expired vaccine used and inappropriate age at vaccine administration were 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: 04-DEC-2024 Medical assistant mentioned that a 40-year-old patient received a Priorix dose on the day of reporting that expired, which led to which led to inappropriate age at vaccine administration and expired vaccine used. The medical assistant asked if the shelf life was longer than the expiration date. More
2819114 U NY 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
box of Shingrix and one of their staff put it in the freezer for 12 hours where it was exposed to 5F... box of Shingrix and one of their staff put it in the freezer for 12 hours where it was exposed to 5F; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: box of Shingrix and one of their staff put it in the freezer for 12 hours where it was exposed to 5F). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK Receipt Date: 06-DEC-2024 The pharmacist stated they received a box of Shingrix and one of their staff put it in the freezer for 12 hours where it was exposed to 5 F and they were wondering if there was any chance of saving it. When asked, pharmacist stated there was no reason given as to why it was placed in the freezer which led to incorrect storage of drug. More
2819115 62 F NC 01/02/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2553X
Inappropriate schedule of product administration Inappropriate schedule of product administration
didn't come in for the second until 23-Sep-2024; This non-serious case was reported by a pharma... didn't come in for the second until 23-Sep-2024; 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 62-year-old female patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 09-SEP-2020). On 23-SEP-2024, the patient received the 2nd dose of Twinrix. On 23-SEP-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: didn't come in for the second until 23-Sep-2024). The outcome of the drug dose administration interval too long 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: 06-DEC-2024 The pharmacist reported that a patient started the Twinrix series on 09th September 2020 and did not came in for the second until 23th September 2024. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2819116 26 M IL 01/02/2025 MMR
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
9594A
Incorrect route of product administration, Product administered to patient of in... Incorrect route of product administration, Product administered to patient of inappropriate age; Incorrect route of product administration, Product administered to patient of inappropriate age More
26 years old patient; it actually was given Intramuscularly; 26 years old patient; This non-serious ... 26 years old patient; it actually was given Intramuscularly; 26 years old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old male patient who received MMR (Priorix) for prophylaxis. Co-suspect products included MMR (Priorix) (batch number 9594A) for prophylaxis. On 06-DEC-2024, the patient received the 2nd dose of Priorix (subcutaneous). On 23-OCT-2024, the patient received the 1st dose of Priorix (intramuscular). On 23-OCT-2024, not applicable after receiving Priorix and an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: it actually was given Intramuscularly) and inappropriate age at vaccine administration (Verbatim: 26 years old patient). On 06-DEC-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: 26 years old patient). The outcome of the inappropriate age at vaccine administration, subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were 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: 06-DEC-2024 and 07-DEC-2024 The other health professional reported that they had a 26 years old patient for their very first dose of Priorix which led to inappropriate age at vaccine administration. The Priorix was given intramuscularly which led to subcutaneous injection formulation administered by other route, so the other health professional think from what he/she know, GlaxoSmithKline know, Priorix was usually given subcutaneous and then, so on the day of reporting, the patient got their Second dose which was given subcutaneous, the right way which led to inappropriate age at vaccine administration. The other health professional asked that first dose given in October, would that be valid. More
2819117 73 F IL 01/02/2025 PPV
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Pneumonia; Pneumonia Pneumonia; Pneumonia
pneumonia; This serious case was reported by a consumer via call center representative and described... pneumonia; This serious case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 73-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. Concurrent medical conditions included emphysema and chronic obstructive pulmonary disease. In NOV-2023, the patient received RSV vaccine. On an unknown date, the patient received PNEUMOCOCCAL VACCINE. On 01-NOV-2023, an unknown time after receiving RSV vaccine, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria hospitalization and GSK medically significant). The outcome of the pneumonia was unknown. It was unknown if the reporter considered the pneumonia to be related to RSV vaccine. The company considered the pneumonia to be unrelated to RSV vaccine. Linked case(s) involving the same patient: US2024AMR160812 Additional Information: GSK Receipt Date: 18-DEC-2024 The patient received her RSV vaccination in November 2023, but she did not know which manufacturer's product it was. She reported that she was hospitalized last month with pneumonia despite having had her pneumonia vaccination several years ago. Did not consent to follow-up. Emergency room visit was required. The patient initially provided consent to contact her HCP but later revoked that consent, stating that they were too busy for that. This case was linked with case US2024AMR160812 for the same patient.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine. US-GSK-US2024AMR160812:Same patient More
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2819118 56 F 01/02/2025 COVID19
 MODERNA
Dermatitis atopic, Drug ineffective, Vaccination site erythema, Vaccination site... Dermatitis atopic, Drug ineffective, Vaccination site erythema, Vaccination site pain More
Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic);... Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic); Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic); Localized redness and pain at injection site; Localized redness and pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Localized redness and pain at injection site), VACCINATION SITE PAIN (Localized redness and pain at injection site), DERMATITIS ATOPIC (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) and DRUG INEFFECTIVE (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product Dupilumab (Dupixent) for Atopic dermatitis. Concurrent medical conditions included Atopic dermatitis. In June 2020, the patient started Dupilumab (Dupixent) (Subcutaneous use) 300 milligram. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Localized redness and pain at injection site) and VACCINATION SITE PAIN (Localized redness and pain at injection site). On an unknown date, the patient experienced DERMATITIS ATOPIC (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) and DRUG INEFFECTIVE (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)). At the time of the report, VACCINATION SITE ERYTHEMA (Localized redness and pain at injection site), VACCINATION SITE PAIN (Localized redness and pain at injection site), DERMATITIS ATOPIC (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) and DRUG INEFFECTIVE (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not reported. On 31-Mar-2021, patient had injection site pain and erythema while still being on Dupilumab therapy. Patient also reported that the medication stopped working and experienced dermatitis flare. No action was taken for the events of injection site erythema and injection site pain. Treatment medication was not reported.; Reporter's Comments: Company comment: The events of dermatitis atopic and drug ineffective are assessed as not related as reported for dupilimab therapy which was used for atopic dermatitis. The benefit-risk relationship of product is not affected by this report. More
2819119 79 F 01/02/2025 COVID19
 MODERNA
Hepatic function abnormal Hepatic function abnormal
liver dysfunction; This spontaneous case was reported by a physician and describes the occurrence of... liver dysfunction; This spontaneous case was reported by a physician and describes the occurrence of HEPATIC FUNCTION ABNORMAL (liver dysfunction) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Dec-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 26-Dec-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced HEPATIC FUNCTION ABNORMAL (liver dysfunction). At the time of the report, HEPATIC FUNCTION ABNORMAL (liver dysfunction) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient was administered the vaccine 23rd December 2024 and 3 days later had liver dysfunction. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact More
2819120 79 F MA 01/02/2025 COVID19
 MODERNA
Chromaturia, Fatigue, Pain in extremity, Pyrexia Chromaturia, Fatigue, Pain in extremity, Pyrexia
pain legs; dark urine; fever; fatigue; This spontaneous case was reported by a patient and describes... pain legs; dark urine; fever; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain legs), CHROMATURIA (dark urine), PYREXIA (fever) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. CLL, breast cancer,colon cancer. Previously administered products included for Product used for unknown indication: Rsv on 27-Nov-2024 and Flu on 11-Dec-2024. Past adverse reactions to the above products included No adverse effect with Flu and Rsv. Concurrent medical conditions included CLL, Breast cancer and Colon cancer. On 27-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 27-Dec-2024, the patient experienced PAIN IN EXTREMITY (pain legs), CHROMATURIA (dark urine), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with Paracetamol (Acetaminophen) at an unspecified dose and frequency. On 31-Dec-2024, PAIN IN EXTREMITY (pain legs), CHROMATURIA (dark urine), PYREXIA (fever) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. It was unknown if the patient experienced any additional symptoms or events. There were no lab data or results were available. Reporter causality was not reported. More
2819121 F 01/02/2025 COVID19
 PFIZER\BIONTECH
Sinusitis Sinusitis
Sinus infection; This is a spontaneous report received from a Nurse from medical information team, P... Sinus infection; This is a spontaneous report received from a Nurse from medical information team, Program ID:. A 71-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic and react to all IV antibiotics" (unspecified if ongoing); "Anaphylaxis" (unspecified if ongoing), notes: 3 times in the past when she was much younger like when she was 19 years old and in her early 20s; "out cold after a few drops" (unspecified if ongoing); "might have been a fluke" (unspecified if ongoing), notes: when I was younger but don't get anything unless I have to; "COVID-19", start date: 2019 (unspecified if ongoing), notes: mild case of COVID twice/ First case of COVID was before the vaccines; "COVID-19" (unspecified if ongoing), notes: The second COVID case was mild and was like a bad cold that lasted for about a week. The patient's concomitant medications were not reported. Past drug history included: Penicillin iv, notes: For some reason, she do not react to and can tolerate and use penicillin IV; Gentamicin for infected ovarian cyst, reaction(s): "anaphylaxis", notes: manufacturer unknown to reporter; Epipen . Vaccination history included: Johnson and johnson covid 19 vaccine (Johnson and Johnson vaccine), administration date: 2020, for COVID-19 immunisation, reaction(s): "pain in joints and was so sore ". The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "Sinus infection". Additional Information: The patient just wants to know if it has preservatives before she gets Prevnar-20 because she was allergic to some preservatives. She doesn't know the specific preservative. Her pharmacist says to come on in and that she can get it but right now she was dealing with a sinus infection so won't do anything until she was better. "The patient allergic and react to all IV antibiotics, except penicillin IV. For some reason, she does not react to and can tolerate and use penicillin IV. The patient had an infected ovarian cyst and was given and reacted to gentamicin (manufacturer unknown to reporter) and another IV antibiotic (name unknown) so stopped taking any antibiotics IV since patient went into anaphylaxis, suddenly you are breathing and then you are not, so it is not very pleasant at all. She was out cold after a few drops. She can take oral antibiotics but not IV antibiotics. She knows it was not the bacteriostatic sterile water since that was used with penicillin IV. It has to be some bizarre ingredient that was used when packaging the IV antibiotics that was not in the penicillin IV. She was not really sure what was allergic to. Patient went into anaphylaxis 3 times in the past when she was much younger, like when she was 19 years old and in her early 20s. It might have been a fluke when she was younger but don't get anything unless she has to. Patient have gotten anything since except the COVID 19 vaccines recently and she took all of them. Luckily, she did not react to that. She usually reacts almost immediately, literally within seconds. Patient had an epi pen in one hand but no reaction to the COVID shots and she had taken 7 of them already. She had a mild case of COVID twice. First case of COVID was before the vaccines in 2019. Then she got the COVID vaccine (first one was Johnson and Johnson vaccine) and then she had another mild case of COVID again about 2 years later (dates unknown in relation to the COVID 19 vaccine). The second COVID case was mild and was like a bad cold that lasted for about a week. Johnson and Johnson Covid 19 vaccine was the first one She got in 2020 but had horrible side effects like pain in joints and was so sore for 24 hours she wanted to cry, so she never got Johnson and Johnson again. Then thereafter, she alternated between either Pfizer or Moderna in 2021 and thereafter and got them when they said she could take them. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2819122 51 M CO 01/02/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Anger, Anxiety, Depression; Anger, Anxiety, Depression Anger, Anxiety, Depression; Anger, Anxiety, Depression
Depression; anxiety; anger; This is a spontaneous report received from a Consumer or other non HCP. ... Depression; anxiety; anger; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Oct2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 23Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEPRESSION (non-serious) with onset 06Nov2024, outcome "recovered" (17Dec2024); ANGER (non-serious) with onset 06Nov2024, outcome "recovered" (17Dec2024); ANXIETY (non-serious) with onset 06Nov2024, outcome "recovered" (17Dec2024). Therapeutic measures were not taken as a result of depression, anxiety, anger. Additional Information: Patient didn't receive any other vaccines within 4 weeks PRIOR to the suspect vaccine. Patient had no known allergies. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2819130 4 U WA 01/02/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y009588
y007955
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AEs were reported; Medical assistant reported that a 4 year old patient only supposed ... No additional AEs were reported; Medical assistant reported that a 4 year old patient only supposed to receive PROQUAD but the patient also inadvertently received VARIVAX on the same day. No additional AEs were reported. No further information provided. No PQC.; This spontaneous report was received from medical assistant referring to a 4-year-old patient. The patient's medical history, previous drug reactions or allergies and concomitant therapies were not reported. On 16-DEC-2024, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHa) lot number reported as y009588 have been verified to be valid, expiration date: 17-NOV-2024; but also inadvertently received (accidental overdose) one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number y007955 have been verified to be valid, expiration date: 17-APR-2026; both vaccines for prophylaxis (strengths, routes of administration and anatomical locations were not provided). No additional AEs were reported. More
2819131 42 F IL 01/02/2025 COVID19
 PFIZER\BIONTECH
 LM7786
Gastrointestinal disorder, Muscle spasms, Muscle twitching Gastrointestinal disorder, Muscle spasms, Muscle twitching
whole body muscle spasms/tummy muscle spasms; muscle twitching; Digestive issues; This is a spontane... whole body muscle spasms/tummy muscle spasms; muscle twitching; Digestive issues; This is a spontaneous report received from a Consumer or other non HCP. A 42-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Oct2024 at 18:30 as dose 1, single (Lot number: LM7786) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: FLULAVAL taken for immunisation, on 18Oct2024 as dose number unknown, single. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 22Nov2024 at 08:00, outcome "not recovered", described as "Digestive issues"; MUSCLE TWITCHING (non-serious) with onset 22Nov2024 at 08:00, outcome "not recovered"; MUSCLE SPASMS (non-serious) with onset 22Nov2024 at 08:00, outcome "not recovered", described as "whole body muscle spasms/tummy muscle spasms". Therapeutic measures were taken as a result of muscle spasms, muscle twitching, gastrointestinal disorder. Additional information: past drug allergy was no. Facility vaccine was administered pharmacy or Drug Store. Patient was not taking any other medications within 2 weeks of the event starting. On 22Nov2024, 08:00, the patient had whole body muscle spasms and muscle twitching starting, digestive issues, tummy muscle spasms. Treatment received for the adverse events Endoscopy, colonoscopy, number of visits to facility. More
2819132 M TX 01/02/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase... Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Investigation, Iron binding capacity total; Iron overload, Magnetic resonance elastography, Magnetic resonance imaging heart, Serum ferritin, Transferrin saturation; Ultrasound abdomen More
Iron Overload; This is a literature report for the following literature source(s). A 48-year-old ma... Iron Overload; This is a literature report for the following literature source(s). A 48-year-old male 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: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 20; 19; 16; 25; 25; 24; Aspartate aminotransferase: 24; 23; 20; 19; 23; 19; Blood alkaline phosphatase: 53; 52; 51; 49; 47; 53; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 155; 161; 162; 145; 139; 170; Magnetic resonance elastography: Normal; Magnetic resonance imaging heart: normal; Serum ferritin: 541; 519; 548; 530; 506; 457; Transferrin saturation: 66; 56; 47; 55; 45; 33; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Based on current available information, event Iron overload is more likely due to the patient's underlying or intercurrent condition is unrelated to suspect drug The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
2819133 U 01/02/2025 COVID19
 PFIZER\BIONTECH
Pain Pain
still have a sore, aching; This is a spontaneous report received from a Consumer or other non HCP fr... still have a sore, aching; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Dec2024 as dose 1, 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: PAIN (non-serious) with onset Dec2024, outcome "not recovered", described as "still have a sore, aching". Additional information: Patient had not yet received a bill for the office visit the morning after the vaccination received on 02Dec2024. When patient do, and patient assume patient would. It was asked would patient be able to be reimbursed. Also asked to keep in mind that as of this writing (report), patient still have a sore, aching. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2819134 M 01/02/2025 COVID19
 PFIZER\BIONTECH
Chills, Illness, Pyrexia, Vaccination site pain Chills, Illness, Pyrexia, Vaccination site pain
got seriously sick; fever; chills; pain at the injection site; This is a spontaneous report received... got seriously sick; fever; chills; pain at the injection site; This is a spontaneous report received from an Other HCP, Program ID. A 46-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got seriously sick"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819135 F 01/02/2025 COVID19
 PFIZER\BIONTECH
Vaccination site rash Vaccination site rash
she experienced a red rash at the injection site that was about the size of a grapefruit; This is a ... she experienced a red rash at the injection site that was about the size of a grapefruit; This is a spontaneous report received from an Other HCP, Program ID. A 41-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Nov2023, outcome "unknown", described as "she experienced a red rash at the injection site that was about the size of a grapefruit". Additional information: The patient reported that when they received the vaccine last year, they had a really bad reaction. The patient stated she experienced a red rash at the injection site that was about the size of a grapefruit. No further information was provided. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819136 65 F 01/02/2025 PNC20
 PFIZER\WYETH
Pyrexia Pyrexia
high fever; This is a spontaneous report received from an Other HCP, Program ID. A 65-year-old fema... high fever; This is a spontaneous report received from an Other HCP, Program ID. A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jul2023 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) at the age of 65 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "high fever". Additional information: Patient reported that whenever she gets the vaccine, she runs a high fever. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2819137 M 01/02/2025 COVID19
 PFIZER\BIONTECH
Chest pain, Cough Chest pain, Cough
chest pain; bad cough; This is a spontaneous report received from an Other HCP, Program ID. A 71-ye... chest pain; bad cough; This is a spontaneous report received from an Other HCP, Program ID. A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "bad cough". Additional information: Patients wife reported that the last time the patient received a vaccine he had chest pain and a bad cough that lasted for two months. The information on the batch/lot number for BNT162b2 omi xbb.1.5, pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2819138 F CT 01/02/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Alanine aminotransferase, Antimitochondrial antibody, Antinuclear antibody, Aspa... Alanine aminotransferase, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase, Autoimmune hepatitis; Bilirubin conjugated, Biopsy liver, Blood alkaline phosphatase, Blood bilirubin, Investigation; Ultrasound abdomen More
Acute Autoimmune Hepatitis After COVID-19 Vaccine; This is a literature report for the following lit... Acute Autoimmune Hepatitis After COVID-19 Vaccine; This is a literature report for the following literature source(s). The author presented a rare case of autoimmune hepatitis (AIH) following COVID-19 vaccination, highlighting emerging concerns about vaccine-induced autoimmune diseases. A 57-year-old woman with no significant medical history presented with jaundice and excessive fatigue for 2 weeks. She denied recent travel, medications, or alcohol use but had received a booster dose of the Pfizer COVID-19 vaccine just before the onset of symptoms. Examination showed scleral icterus. Blood work revealed elevated levels of bilirubin, AST, ALT, and ALP. Abdominal ultrasound showed a hepatic echotexture with a "starry sky" appearance, consistent with acute hepatitis. More workup revealed a positive ANA screen with a 1:1280 titer and cytoplasmic pattern. Antimitochondrial antibody was positive. Liver biopsy showed multiple portal tracts expanded by plasma cell-predominant inflammatory infiltrate with severe interface activity. The remaining hepatic parenchyma showed extensive lobular disarray with multiacinar collapse, apoptotic hepatocytes, and ceroid-containing macrophages. Overall, the findings are consistent with acute AIH. She was subsequently given IV methylprednisolone 40 mg daily, resulting in marked improvement (Alanine Aminotransferase (ALT): 21, notes: Day-30; 479, notes: Day 7; 725, notes: Day 4; 805, notes: Day 3 steroid started; 834, notes: Day 2; 950, notes: Day 1; Aspartate Aminotransferase (AST): 16, notes: Day-30; 385, notes: Day 7; 595, notes: Day 4; 830, notes: Day 3 steroid started; 844, notes: Day 2; 903, notes: Day 1; bilirubin direct: 0.4, notes: Day -30; 3.8, notes: Day 7; 8.6, notes: Day-1; Alkaline Phosphatase (ALP): 65, notes: Day-30; 171, notes: Day 7; 216, notes: Day 4; 204, notes: Day 3 steroid started; 210, notes: Day 2; 242, notes: Day 1; bilirubin, total: 1.2, notes: Day-30; 7.0, notes: Day 7; 13.2, notes: Day 4; 13.0, notes: Day 3 steroid started; 11.2, notes: Day 2; 10.7, notes: Day 1). She was discharged with oral steroids and scheduled for hepatology follow-up. Discussion: The presence of ceroid-containing macrophages and lobular disarray/hepatocytic necrosis, along with recent immunization, raises suspicion for drug-induced autoimmune hepatitis. AIH cases following COVID-19 vaccination range from 27 to 82 years of age, mostly in females, and occur after any vaccine dose. The time of symptom onset from vaccination varies from 1 day to 1 month, with jaundice occurring in nearly all cases. Abnormal LFTs are common, but normal results do not exclude AIH. Possible mechanisms include molecular mimicry, adjuvants, epitope spreading, bystander activation, X chromosome factors, and skeptical hepatotropism of SARS-CoV-2. Steroid therapy, with or without azathioprine, shows favorable outcomes. The key question is whether subsequent COVID-19 vaccine doses are safe when immune hepatitis develops post-vaccination.; Sender's Comments: Based on the implied temporal association, a causal relationship between suspect drug and the reported event autoimmune hepatitis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
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2819139 F 01/02/2025 PNC20
 PFIZER\WYETH
Pain in extremity Pain in extremity
arm hurt a lot afterwards; This is a spontaneous report received from an Other HCP, Program ID. A 5... arm hurt a lot afterwards; This is a spontaneous report received from an Other HCP, Program ID. A 55-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2024 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "unknown", described as "arm hurt a lot afterwards". Additional information: Patient reported the last time they received a vaccine their arm hurt a lot afterwards. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2819140 74 F 01/02/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
getting really sick; This is a spontaneous report received from an Other HCP, Program ID. A 75-year... getting really sick; This is a spontaneous report received from an Other HCP, Program ID. A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 74 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "getting really sick". Additional information: Patient reported that when they got the vaccine last year they ended up getting really sick. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819141 F 01/02/2025 COVID19
 PFIZER\BIONTECH
Feeling abnormal Feeling abnormal
feel bad afterwards; This is a spontaneous report received from an Other HCP, Program ID. A 73-year... feel bad afterwards; This is a spontaneous report received from an Other HCP, Program ID. A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (strength: 0.5ML, Dose: 0.5ml, Frequency: once,Route: intramuscularly), administration date: May2023, for immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2023, outcome "unknown", described as "feel bad afterwards". Additional information: patient reported that when she gets the covid vaccine they make her feel bad afterwards. More
2819142 M 01/02/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity Pain in extremity
severe pain in his arm; This is a spontaneous report received from an Other HCP, Program ID. A 76-y... severe pain in his arm; This is a spontaneous report received from an Other HCP, Program ID. A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "unknown", described as "severe pain in his arm". Additional information: The patient reported experiencing severe pain in his arm after receiving the last vaccine. He stated that the pain didn't start right away; it took about six months for the symptoms to appear, but they lasted for a very long time. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819143 72 F 01/02/2025 COVID19
 PFIZER\BIONTECH
Influenza like illness, Nasopharyngitis Influenza like illness, Nasopharyngitis
cold; flu like symptoms; This is a spontaneous report received from an Other HCP, Program ID. A 72-... cold; flu like symptoms; This is a spontaneous report received from an Other HCP, Program ID. A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2023, outcome "unknown", described as "flu like symptoms"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". Additional information: Patient reports that she was currently experiencing a cold and would like to wait until after new year's before getting the next covid shot. unknown when cold first started. patient also states that for 24 hours after receiving the vaccine she experiences flu like symptoms. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819144 F 01/02/2025 PNC20
 PFIZER\WYETH
Chills, Malaise, Pyrexia Chills, Malaise, Pyrexia
Fever; Chills; Feeling sick; This is a spontaneous report received from an Other HCP, Program ID: . ... Fever; Chills; Feeling sick; This is a spontaneous report received from an Other HCP, Program ID: . A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, 0.5 ml, single (Batch/Lot number: unknown) intramuscular for pneumococcal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Jun2023, 2 days after the suspect product(s) administration, outcome "unknown"; MALAISE (non-serious) with onset Jun2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Feeling sick"; PYREXIA (non-serious) with onset Jun2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Fever". Additional Information: The ent reports after getting the vaccine for approximately 2 days after getting a fever, chills, and feeling sick. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2819145 41 M 01/02/2025 COVID19
 PFIZER\BIONTECH
Headache Headache
bad headaches; This is a spontaneous report received from an Other HCP, Program ID. A 41-year-old m... bad headaches; This is a spontaneous report received from an Other HCP, Program ID. A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 41 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2023, outcome "unknown", described as "bad headaches". Additional information: Patient reported that he always has a reaction when he gets a covid-19 vaccine. Patient stated he gets really bad headaches when he gets the vaccine. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819146 70 M 01/02/2025 PNC20
 PFIZER\WYETH
Cough Cough
cough; This is a spontaneous report received from an Other HCP, Program ID. A 70-year-old male pati... cough; This is a spontaneous report received from an Other HCP, Program ID. A 70-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) at the age of 70 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of cough. Additional information: Patient reported the last time they got a vaccine they had a really bad reaction. They ended up going to an urgent care and obtained a prescription for a Medrol dose pack and Tessalon pearls to help with their cough that lasted for almost a month. No further information provided. Lot number and expiration date was unknown. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2819147 M TX 01/02/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Blood alkali... Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Blood iron; Hepatic enzyme, Investigation, Iron binding capacity total, Iron overload, Serum ferritin; Transferrin saturation, Ultrasound abdomen More
Iron Overload; This is a literature report for the following literature source(s). A 48-year-old ma... Iron Overload; This is a literature report for the following literature source(s). A 48-year-old male 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: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 26; 24; 18; 16; 23; 26; Aspartate aminotransferase: 21; 22; 17; 17; 22; 22; Biopsy liver: 30 %, notes: hepatocyte iron deposition without significant fibrosis or Kupffer cell involvement; Blood alkaline phosphatase: 65; 64; 55; 59; 75; 73; Blood iron (normal high range 2): 2.3 mg/g; Hepatic enzyme: normal; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 145; 173; 156; 177; 157; 141; Serum ferritin: elevated; 572.8; 528; 479; 502; 618; 662; Transferrin saturation: elevated; 55 %; 33 %; 21 %; 20 %; 21 %; 43 %; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Reported event Iron overload is assessed as unrelated to suspect drug but most likely due to intercurrent condition or illness. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
2819148 F 01/02/2025 COVID19
 PFIZER\BIONTECH
Influenza like illness Influenza like illness
flu-like symptoms such as chills; This is a spontaneous report received from an Other HCP, Program I... flu-like symptoms such as chills; This is a spontaneous report received from an Other HCP, Program ID. An 85-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1 (toppac), 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms such as chills". Additional Information: The patient reports that they get sick with the vaccine sometimes. She reports that she experienced flu-like symptoms such as chills. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819149 63 F 01/02/2025 PNC20
 PFIZER\WYETH
Asthenia Asthenia
weakness; This is a spontaneous report received from an Other HCP, Program ID. A 63-year-old female... weakness; This is a spontaneous report received from an Other HCP, Program ID. A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) at the age of 63 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2024, outcome "unknown", described as "weakness". Additional information: Patient reported that the last time she received the vaccine she had a horrible reaction. Patient reported weakness to the point to where all she can do was lay in bed. No further information provided. Lot number and expiration date was unknown. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2819150 M 01/02/2025 COVID19
 PFIZER\BIONTECH
Malaise, Pain, Pyrexia Malaise, Pain, Pyrexia
body aches; a low grade fever; just in general did not feel good; This is a spontaneous report recei... body aches; a low grade fever; just in general did not feel good; This is a spontaneous report received from an Other HCP, Program ID. A 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "a low grade fever"; MALAISE (non-serious), outcome "unknown", described as "just in general did not feel good". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819151 F 01/02/2025 FLUX
 UNKNOWN MANUFACTURER
Cough Cough
coughing my head off for over a week; Initial information received on 27-Dec-2024 regarding an unsol... coughing my head off for over a week; Initial information received on 27-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a patient. This case involves Adult female patient who experienced coughing her head off for over a week after receiving influenza vaccine. 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 influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). On an unknown date the patient developed coughing my head off for over a week (cough) (unknown latency) following the administration of influenza vaccine. Reportedly, patient had the flu shot, but it wasn't any good. Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (coughing my head off for over a week). At time of reporting, the outcome was Unknown for the event coughing my head off for over a week. More
2819152 M 01/02/2025 FLUX
 UNKNOWN MANUFACTURER
COVID-19 COVID-19
had covid twice in last 40 days after the vaccine; Initial information received on 30-Dec-2024 regar... had covid twice in last 40 days after the vaccine; Initial information received on 30-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a patient. This case involves Adult male patient who had covid twice in last 40 days after receiving influenza vaccine. 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 influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). On an unknown date the patient had covid twice in last 40 days after the vaccine (covid-19) (unknown latency) following the administration of influenza vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2819154 57 F PA 01/02/2025 PNC20
 PFIZER\WYETH
 LG5579
Cellulitis Cellulitis
CELLULITIS CELLULITIS
2819155 66 F TX 01/02/2025 FLU3
 SEQIRUS, INC.
 388482
Injected limb mobility decreased, Pain in extremity Injected limb mobility decreased, Pain in extremity
Patient called the pharmacy today (1/2/25) to report that the flu shot they were given on 10/01/24 w... Patient called the pharmacy today (1/2/25) to report that the flu shot they were given on 10/01/24 was still sore and giving her issues raising her arm in the air at times. Patient reported that they went to see their NP who told them the shot might have hit the muscle. Informed the patient that since this is an intramuscular shot it is supposed to hit the muscle, but that we would report the reaction accordingly. Encouraged patient to follow up with us and inform of us any changed or possible improvements but that we would report the reaction to VAERs. More
2819179 25 M WA 01/02/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Allergy test, Asthenia, Cold sweat, Nausea, Pruritus; Rash, Throat irritation, U... Allergy test, Asthenia, Cold sweat, Nausea, Pruritus; Rash, Throat irritation, Urticaria More
After having the vaccine, had hives over the whole body, hands and feet were extremely itchy, nausea... After having the vaccine, had hives over the whole body, hands and feet were extremely itchy, nausea, burning in throat, weakness, cold sweats, rash around eyes. Took Benadryl seemed to make it better. More
2819180 6 F OR 01/02/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered, No adverse event Expired product administered, No adverse event
Pt was in Clinic for a Well child check, pt was offered to received 1st dose of Covid vaccine series... Pt was in Clinic for a Well child check, pt was offered to received 1st dose of Covid vaccine series, Parent of child approved. Pt received vaccine and took well, no adverse reactions. This writer then found out vaccine was non-viable per Pfizer recommendations. Vaccine was viable until 12/05/2024., vaccine was given 12/13/24. Vial of vaccine expired on 12/2025. More
2819181 51 F MA 01/02/2025 COVID19
 PFIZER\BIONTECH
 Unknown
Feeling of body temperature change, Malaise, Nausea Feeling of body temperature change, Malaise, Nausea
I ate dinner with my family at 6:15 and was the only person in my family who suddenly became extreme... I ate dinner with my family at 6:15 and was the only person in my family who suddenly became extremely nauseous around 7:05 and was getting sick by 7:10. Prior to that I was burning up and now I?m freezing. More
2819182 U 01/02/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered, No adverse event Expired product administered, No adverse event
Pt came in for a Well child check, pt was offered first covid vaccine, pt took vaccine well and had ... Pt came in for a Well child check, pt was offered first covid vaccine, pt took vaccine well and had no adverse reactions. Vaccine was given on a non-viable date per Pfizer recommendations. More
2819183 70 F TN 01/02/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UT84773CA
LG5579
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient received Prevnar 20 Vaccine last year. Patient did not disclose this information to me at th... Patient received Prevnar 20 Vaccine last year. Patient did not disclose this information to me at the time of today's visit. I called the patient and discussed this information and patient is aware that she does not need to get Prevnar 20 vaccine annually. More
2819184 18 M CA 01/02/2025 COVID19
FLU3
IPV
TDAP
 PFIZER\BIONTECH
SEQIRUS, INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 LN0588
AW1696A
W1B511M
235D2
Blood glucose decreased, Head injury, Hypotension, Syncope; Blood glucose decrea... Blood glucose decreased, Head injury, Hypotension, Syncope; Blood glucose decreased, Head injury, Hypotension, Syncope; Blood glucose decreased, Head injury, Hypotension, Syncope; Blood glucose decreased, Head injury, Hypotension, Syncope More
Patient received 4 vaccines : Polio, Afluria, Comirnaty, Boostrix . After receiving all 4, he got up... Patient received 4 vaccines : Polio, Afluria, Comirnaty, Boostrix . After receiving all 4, he got up and stand up while waiting for his brother to get his. About a few minutes after, he fainted and hit his head against the wall . We called EMS but his mom said he should be fine. We still stayed on the phone with the medical dispatcher to wait for advice and help. The paramedics came to check him out and gave him NaCl fluids since his blood pressure and blood sugar were low. He was taken to the hospital to get medical attention by the paramedics. More
2819185 0.25 M MT 01/02/2025 RSV
 PFIZER\WYETH
 HL9687
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
There were no adverse affects. This was found upon inventory of vaccines. There were no adverse affects. This was found upon inventory of vaccines.
2819186 81 M TN 01/02/2025 FLU3
RSV
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 388488
52z52
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Received second dose of arexvy. First dose was 01/2024 Received second dose of arexvy. First dose was 01/2024
2819187 70 F TN 01/02/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UT8473CA
LG5579
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient received Prevnar 20 Vaccine last year in 2023. Patient did not disclose this information to ... Patient received Prevnar 20 Vaccine last year in 2023. Patient did not disclose this information to me at the time of today's visit. Patient came to the visit wanting pneumonia and influenza vaccine. I called the patient and discussed this information and patient is aware that she does not need to get Prevnar 20 vaccine annually. Patient verbalized understanding. More
2819188 82 F TN 01/02/2025 FLU3
RSV
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 388488
52z52
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Received 2nd dose of Arexvy. First dose was 01/2024 Received 2nd dose of Arexvy. First dose was 01/2024
2819189 19 M IN 01/02/2025 COVID19
 PFIZER\BIONTECH
 VT8514KA
Underdose Underdose
Covid age 5-11 years given to patient instead of the adult dose by, FNP-C Covid age 5-11 years given to patient instead of the adult dose by, FNP-C
2819190 19 M IN 01/02/2025 COVID19
 PFIZER\BIONTECH
 VT8514KA
Underdose Underdose
Covid 5-11 years given to patient instead of adult dose by, FNP-C. Covid 5-11 years given to patient instead of adult dose by, FNP-C.
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