🏥 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 💀 🏥 🚑 ♿ ⚠️
2820663 16 M KS 01/13/2025 FLU3
MENB
 GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
 J245K
EN939
Product storage error; Product storage error Product storage error; Product storage error
Vaccine deemed not stable due to temperature excursion Vaccine deemed not stable due to temperature excursion
2820664 11 M CA 01/13/2025 DTAP
 SANOFI PASTEUR
Adverse reaction Adverse reaction
Patient received Tdap vaccine on 01/10/25 and the next day developed a reaction to vaccine on his ri... Patient received Tdap vaccine on 01/10/25 and the next day developed a reaction to vaccine on his right arm. Per physician in office patient developed a possible reaction to Tdap vaccine. Advised to take Ibuprofen 600mg every 8hrs and Benadryl 25mg as needed every 8hrs. More
2820665 5 M KS 01/13/2025 DTAPIPV
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5H95B
J245K
Product storage error; Product storage error Product storage error; Product storage error
Vaccine deemed not stable due to temperature excursion Vaccine deemed not stable due to temperature excursion
2820666 67 F TN 01/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 7GF79
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
DOSAGE WAS GIVEN TO PT ABOVE APPROVED AGE FOR THIS VACCINE DOSAGE WAS GIVEN TO PT ABOVE APPROVED AGE FOR THIS VACCINE
2820667 59 F IA 01/13/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 TK3YE
TK3YE
Circumstance or information capable of leading to medication error, Haematoma, I... Circumstance or information capable of leading to medication error, Haematoma, Injection site pain, Moaning, Pain; Pain in extremity, Swelling More
11/4/2024: Employee presented to EHS for influenza vaccination. Given Influenza VIS to review. Risks... 11/4/2024: Employee presented to EHS for influenza vaccination. Given Influenza VIS to review. Risks section of vaccine pointed out. EE agreed to proceed with immunization. After selecting the site, requested by the employee, II recall, the employee moved away from me after inserting the needle, IM, left deltoid area, using Z-trach technique. At this time, the EE began moaning, moving away from me as the serum was injected, stating, ?It hurts?. I apologized for the pain felt with the injection and placed a Band-Aid over the site after the serum was injected and withdrawing the needle. Vaccination information documented per standard processes including name, lot number, time, location and technique.11/20/2024: Manager initially reported the injury on behalf of the employee, stating, "After receiving the flu shot, her arm was sore, developed a hematoma and swelling. When at work, the area becomes sore, painful with movement, then when off improves, recurring when back to work. 11/19/2024: She spoke with one of the hospitalists while on duty (night shift) who advised she be seen". She has finished her assignment and wishes to return home, clarifying if this is considered a work-related injury and if she should see someone out of network or in network location. It was explained that since this is a WC claim, that in/out of network does not apply. I advised him that the EE needs to complete a incident report. 1235: EE presented to EHS to review injury reporting processes. More
2820688 1.25 M MT 01/13/2025 HEPA
MMR
VARCEL
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.


Extra dose administered, Product administered to patient of inappropriate age, W... Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered; Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered; Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered More
No additional AE.; Indicate at which point in the process the medication error occurred: Preparation... No additional AE.; Indicate at which point in the process the medication error occurred: Preparation for administration / administration; Patient received varicella vaccine 12-SEP-2024 / Patient came in on 13-DEC-2024 for varicella and MMR was accidentally administered; Regulatory Authority called on behalf of HCP and reported a patient who inadvertently received a third dose of MMR-II. Dates of administration unknown and patient demographics unknown by reporter. No additional information was known by reporter. No additional AE/PQC.; Patient received 2 MMR vaccines on 18-JUL-2015 and on 08-AUG-2024 (Age 10); This spontaneous report was received from a nurse via company representative regarding to a patient of unknown age and gender. The patient's medical history, concomitant therapies, dug reactions or allergies were not reported. On an unspecified dates, the patient was inadvertently vaccinated with 3 doses of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) injection, (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis (extra dose administered). No additional information was known by reporter. No additional adverse event (AE)/product quality complaint (PQC). Lot # is being requested and will be submitted if received. This is a non-valid case due to lack of patient's identifiers. Follow-up information has been received from the nurse on 30-DEC-2024. This spontaneous report was no longer considered as non-valid as patient's identifiers were provided, referring to a 10-year-old male patient (Product administered to patient of inappropriate age). On 08-JUL-2015 and on 08-AUG-2024, the patient was vaccinated with a first and second doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), respectively. On 12-SEP-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (Manufacturer unknown) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecifies date, the patient was vaccinated with other suspect therapies hepatitis a vaccine (Other manufacturer) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 13-DEC-2024, the patient went for an additional dose of varicella virus vaccine live (oka/merck) (Manufacturer unknown) but instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was accidentally administered (Extra dose administered and wrong product administered) subcutaneous (SQ) injection, lot # Y008284 (Lot number [Y008284] is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live [M-M-R II]). The medication error occurred at the point of process of preparation for administration (Product preparation issue) and administration. The vaccine was not available for return/evaluation and the operator of vaccine was a trained healthcare professional. No adverse events occurred to patient. More
2820689 U VA 01/13/2025 PPV
 MERCK & CO. INC.
 X014729
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event; HCP called to report expired dose of PNEUMOVAX 23 was administered to a patient on... No adverse event; HCP called to report expired dose of PNEUMOVAX 23 was administered to a patient on 08JAN2025. Product expiration date was 22NOV2024. No temperature excursions reported. No symptoms reported. Consent to correspond was granted. See related case 0273; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 08-JAN-2025, the patient was vaccinated with expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), formulation: injection, lot # X014729, expiration date: 22-NOV-2024, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (no adverse event). More
2820690 F 01/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Dyspnoea, Guillain-Barre syndrome, Motor dysfunction Dyspnoea, Guillain-Barre syndrome, Motor dysfunction
hospital for diagnosed as Guillain Barre syndrome; This serious case was reported by a consumer via ... hospital for diagnosed as Guillain Barre syndrome; This serious case was reported by a consumer via sales rep and described the occurrence of guillain barre syndrome in a elderly female 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 guillain barre syndrome (Verbatim: hospital for diagnosed as Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was resolving. The reporter considered the guillain barre syndrome to be related to Arexvy. The company considered the guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK receipt date: 05-JAN-2025 The reporter reported that they heard this second hand from his/her mother, who was a second cousin to the patient the Arexvy vaccine given approximately three months ago. The dates for diagnosed as guillain barre syndrome after being hospitalized was unknown. The reporter reported that the dates when patient was in hospital for diagnosed as guillain barre syndrome after being hospitalized it was unspecified. The reporter reported that the dose number and expiry date of Arexvy vaccine were unknown. The reporter mentioned that the patient was hospitalized with motor issues and difficulty breathing and had been diagnosed as guillain barre syndrome. The reporter believed this was associated to the RSV vaccination but, it was not clear if this was GlaxoSmithKline RSV vaccine or competitor.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy. More
✓
2820691 99 F MA 01/13/2025 FLU4
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site urticaria Injection site urticaria
Hives right arm near injection site; This non-serious case was reported by a other health profession... Hives right arm near injection site; This non-serious case was reported by a other health professional and described the occurrence of injection site hives in a 99-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (expiry date 30-JUN-2025) for prophylaxis. On 12-NOV-2024, the patient received FluLaval Quadrivalent 2024-2025 season (right arm) .5 ml. On 12-NOV-2024, less than a day after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced injection site hives (Verbatim: Hives right arm near injection site). The outcome of the injection site hives was resolved. It was unknown if the reporter considered the injection site hives to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. It was unknown if the company considered the injection site hives to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. 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 patient experienced hives right arm near injection site. More
2820692 M PA 01/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Lymph node pain, Lymphadenitis, Lymphadenopathy, Skin warm Lymph node pain, Lymphadenitis, Lymphadenopathy, Skin warm
Lymphadenitis acute/ Lymphadenitis under the right side armpit; This serious case was reported by a ... Lymphadenitis acute/ Lymphadenitis under the right side armpit; This serious case was reported by a consumer and described the occurrence of acute lymphadenitis in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypertension (Patient is being treated with Amlodipine). Concomitant products included amlodipine. On 27-DEC-2024 17:00, the patient received the 1st dose of Shingrix (right arm). On 29-DEC-2024 09:00, 2 days after receiving Shingrix, the patient experienced acute lymphadenitis (Verbatim: Lymphadenitis acute/ Lymphadenitis under the right side armpit) (serious criteria clinically significant/intervention required). The outcome of the acute lymphadenitis was not resolved. It was unknown if the reporter considered the acute lymphadenitis to be related to Shingrix. The company considered the acute lymphadenitis to be unrelated to Shingrix. Additional Information: GSK receipt date: 29-DEC-2024 The patient received first dose of Shingrix vaccine on 27 December 2024. The patient experienced lymphadenitis under the right side armpit, which was the same arm as the site of injection on 29 December 2024. The affected lymph nodes was enlarged to approximately 1 inch by 2 inch it felt warm and was tender to touch. On a 1-10 pain scale, the patient described pain at number 2 when physical examination was performed.; Sender's Comments: Lymphadenitis is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2820693 U 01/13/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; second time I have had shingles; This serious case was reported by a ... Suspected vaccination failure; second time I have had 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 shingles (Verbatim: second time I have had shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 31-DEC-2024 The case was received from the patient via interactive digital media. The patient had the shingle shot last year both parts. The patient reported that this was the second time he/she had shingles the shot does not work. It cost the patient 120.00. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles 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
2820694 U 01/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine several years ago and now had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles 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 regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2820695 U NY 01/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
given second Hep B vaccine today inadvertently given 8 days sooner than scheduled 1 month; This non-... given second Hep B vaccine today inadvertently given 8 days sooner than scheduled 1 month; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 16-DEC-2024, the patient received the 2nd dose of Engerix B. On 16-DEC-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: given second Hep B vaccine today inadvertently given 8 days sooner than scheduled 1 month). The outcome of the drug dose administration interval too short 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: 16-DEC-2024 The reporter reported that patient received second Engerix B vaccine inadvertently 8 days sooner than scheduled 1 month out from the initial dose which led to shortening of vaccine schedule. More
2820696 U 01/13/2025 COVID19
 JANSSEN
Off label use Off label use
vaccine being used to avoid inflammation; This spontaneous report received from a patient concerned ... vaccine being used to avoid inflammation; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's concurrent conditions included: inflammation. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for inflammation. The product was associated with off label use. (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine being used to avoid inflammation. ( Dose number in series 1) The action taken with janssen covid-19 vaccine was not reported. The outcome of vaccine being used to avoid inflammation was not reported. This report was non-serious. More
2820697 U CA 01/13/2025 COVID19
 JANSSEN
Headache Headache
UNRELENTING HEADACHES; This spontaneous report received from a health care professional concerned a ... UNRELENTING HEADACHES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on 2021, for covid-19 prophylaxis. Additional dosage information included: Dose Series:1. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced unrelenting headaches. HCP was a neurologist called stating that HCP sees a patient for headaches. According to the HCP, the patient has daily, unrelenting headaches (Dose series: 1) after getting the J&J Covid vaccine about 3years ago. HCP stated that HCP has tried many different medications for the patient's headache treatment. The action taken for janssen covid-19 vaccine is not applicable. The patient had not recovered from unrelenting headaches. This report was non-serious. More
2820698 U 01/13/2025 COVID19
 JANSSEN
Ophthalmic herpes simplex, Ophthalmic herpes zoster Ophthalmic herpes simplex, Ophthalmic herpes zoster
Herpes zoster ophthalmic; Herpes Simplex Ophthalmicus; This solicited report received from a physici... Herpes zoster ophthalmic; Herpes Simplex Ophthalmicus; This solicited report received from a physician by COV19VAC-NONCOMP: Jansen COVID 19 Non Company Solicited Study. This report was referenced in literature: and concerned a patient of unspecified age and sex (subject number and site number were not reported). The patient's height and weight were not reported. Age at time of vaccination was unknown. Aim- The aim of this study was to evaluate the cases of herpes simplex and zoster ophthalmicus after SARS-CoV-2 vaccination and assess the clinical presentations in patients. The aim of this study was to evaluate the cases osimplex and zoster No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covd-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Additional dosage information included: dose series 1. The batch number was not reported. The company is unable to perform follow up. Method- A retrospective analysis of cases reported to the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS) between December 11, 2020, and July1, 2022. Patients diagnosed with herpes simplex ophthalmicus (HSO) and herpes zoster ophthalmicus (HZO) after vaccination withBNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.-COV2.S (Janssen) were included in the study. We performed adescriptive analysis of patient demographics, history, and ophthalmic and systemic clinical presentations. The correlations between vaccine type and continuous variables were assessed by the one-way analysis of variance test. In addition, we used the Pearsonx2test to assess the association between 3 vaccines and categorical variables. A post hoc analysis was performed between HSO and HZO onset intervals after vaccination, dose, and vaccine type. The 30-day risk analysis was also performed for HSO and HZO onset postvaccination using the reverse Kaplan-Meier analysis. Result- A total of 1180 cases of HZO (983, 83.30%) and HSO (180,15.25%) were reported. The mean age of patients with HZO and HSO was 59.02619.05 and 52.68617.83 years, respectively. Most of the cases of HZO (795, 80.87%) and HSO (131, 72.78%) were reported inpatients who received BNT162b2. In the cohort, 63.28% and 65.56%diagnosed with HZO and HSO were women. About one third of HZO(36.52%) and HSO (35.56%) cases were reported after the first dose. More than half of the cases of HZO (61.34%) and HSO (64.45%) were reported within the first 2 weeks after vaccination. The estimated crude reporting rate (per million doses) in the United States was 0.25, 0.22,and 0.47 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The onset interval for HZO was significantly shorter in patients who received BNT162b2 (20.51656.20 days, P= 0.030) compared with patients who received mRNA-1273 (36.566108.67 days) andAd26.COV2.S (39.66660.15 days) vaccines. The 30-day risk analysis showed a significantly higher risk of HZO after BNT162b2than the other 2 vaccines (P= 0.011). No concomitant medications were reported. On an unspecified date, the patient experienced herpes zoster ophthalmic (dose series 1) and herpes simplex ophthalmicus (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of herpes zoster ophthalmic and herpes simplex ophthalmicus was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and herpes zoster ophthalmic and herpes simplex ophthalmicus as related. Company causality between covid-19 vaccine ad26.cov2.s and herpes zoster ophthalmic and herpes simplex ophthalmicus was not related. Conclusion- The low crude reporting rate suggests that HZO and HSO after SARS-CoV-2 vaccination occur rarely. This study provides insights into the possible temporal association between reported HSO and HZO after SARS-CoV-2 vaccines; however, further investigations are required to delineate the possible underlying immunological mechanisms. This report was serious (other medically important condition).; Sender's Comments: V0-Ophthalmic herpes zoster, Ophthalmic herpes simplex. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY (Diabetes). Therefore, this event is considered inconsistent with vaccine administration. More
2820699 M 01/13/2025 COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
MODERNA
MODERNA



Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, H... Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, Heart rate, Hypertension; Oxygen saturation, Pyrexia, Vaccination site pain; Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, Heart rate, Hypertension; Oxygen saturation, Pyrexia, Vaccination site pain More
fever for "18 hours" on the 7th day after he got the vaccine; hypertension/systolic blood ... fever for "18 hours" on the 7th day after he got the vaccine; hypertension/systolic blood pressure went as high as 198 mmHg andhis diastolic blood pressure went as high as 95mmHg; little sting in the arm; This spontaneous report received from a patient concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's concurrent conditions included: hypertension. The patient was previously treated with rsv vaccine for product used for unknown indication and moderna covid-19 vaccine for covid-19 prophylaxis. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Additional dosage information included: dose series 1. Non-company products included: spikevax (form of admin not reported, route of admin not reported, batch number not reported) dose and frequency not reported, administered on 01-Oct-2024 to end date not provided, for covid-19 prophylaxis. Additional dosage information included: dose series 2. Concomitant medications included: lisinopril for hypertension. On 01-Oct-2024, the patient experienced hypertension/systolic blood pressure went as high as 198 mmhg andhis diastolic blood pressure went as high as 95mmhg and little sting in the arm. On 07-Oct-2024, the patient experienced fever for "18 hours" on the 7th day after he got the vaccine. dose series 2. On an unspecified date, laboratory data included: systolic blood pressure (NR: not provided) as high as 198 mmHg, diastolic blood pressure (NR: not provided) as high as 95mmHg, blood pressure (NR: not provided) at 130 to 140 mmHg, heart rate (NR: not provided) never exceeded 95bpm, and oxygen saturation (NR: not provided) from 95 to 97. The action taken with janssen covid-19 vaccine and spikevax was not applicable. The patient recovered from hypertension/systolic blood pressure went as high as 198 mmhg andhis diastolic blood pressure went as high as 95mmhg on Oct-2024. The patient recovered from little sting in the arm and fever for "18 hours" on the 7th day after he got the vaccine on an unspecified date. This report was serious (other medically important condition).; Sender's Comments: V0: Hypertension. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. More
2820700 M 01/13/2025 COVID19
 JANSSEN
 Unknown
Death Death
DEATH; This spontaneous report received from a consumer concerned a male patient of unspecified age.... DEATH; This spontaneous report received from a consumer concerned a male patient of unspecified age.(via social media). The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced death. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. It was unknown if an autopsy was performed. Reported cause of death was unknown cause of death. The patient died on an unspecified date. This report was serious (death).; Sender's Comments: V0; Death; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death More
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2820702 82 F 01/13/2025 COVID19-2
 MODERNA
COVID-19 COVID-19
COvID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (... COvID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COvID-19) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The patient's past medical history included Head injury. Concurrent medical conditions included Immunocompromised, Chronic kidney disease stage 3, Lung scarring, Scleroderma (bleed internally all the time in stomach and have to keep on getting iron infusions) and Heart disorder (was in really bad physical shape and heart was not good either.). On 29-Sep-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On 10-Apr-2023, received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) dosage was changed to 1 dosage form. In June 2023, the patient experienced COVID-19 (COvID-19). At the time of the report, COVID-19 (COvID-19) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported post vaccination events. This case was linked to US-MODERNATX, INC.-MOD-2025-781009, US-MODERNATX, INC.-MOD-2025-781011, US-MODERNATX, INC.-MOD-2025-781010 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781009:SPIKEVAX 2023-2024 US-MODERNATX, INC.-MOD-2025-781011:Spikevax NOS US-MODERNATX, INC.-MOD-2025-781010:SPIKEVAX 2024-2025 PFS More
2820703 F 01/13/2025 COVID19
 MODERNA
COVID-19 COVID-19
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (... COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The patient's past medical history included Head injury (she had "5 closed head injuries"), Kidney disorder (she has "stage 3 kidney disease), Lung scarring (scar tissue forming on my lungs), Scleroderma (scleroderma, bleed internally all the time in my stomach from scleroderma and have to keep on getting iron infusions), Heart disorder (heart is "not good either"), COVID-19 (she first contracted with COVID-19 in June 2023) in June 2023 and COVID-19 (she first contracted with COVID-19 in June 2023 and in the "early part of 2024, about March or April) in 2024. On 25-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2024, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medications include iron infusions. It was reported that the last infection in November was the worst and she experienced hard time breathing and her throat is closing up like she was getting an allergic reaction to it, her chest hurt, and heart rate went high. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-781010, US-MODERNATX, INC.-MOD-2025-781011, US-MODERNATX, INC.-MOD-2025-781012 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781010:Same report for different Product US-MODERNATX, INC.-MOD-2025-781011:Same report for different Product (SPIKEVAX NOS) US-MODERNATX, INC.-MOD-2025-781012:Same report for different Product (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) More
2820705 76 F 01/13/2025 COVID19
COVID19
 MODERNA
MODERNA

Alopecia, Blister, Fatigue, Inflammation, Pruritus; Rash erythematous Alopecia, Blister, Fatigue, Inflammation, Pruritus; Rash erythematous
itching; feeling completely exhausted; She is from head to toe, red with a rash; her hands are blist... itching; feeling completely exhausted; She is from head to toe, red with a rash; her hands are blistering and same with her feet; inflammation; she lost about 60% of her hair; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair), PRURITUS (itching) and RASH ERYTHEMATOUS (She is from head to toe, red with a rash) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu in September 2024. Past adverse reactions to the above products included No adverse event with Flu. On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 06-Oct-2024, the patient experienced BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair) and RASH ERYTHEMATOUS (She is from head to toe, red with a rash). On an unknown date, the patient experienced PRURITUS (itching) and FATIGUE (feeling completely exhausted). At the time of the report, BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair), PRURITUS (itching), RASH ERYTHEMATOUS (She is from head to toe, red with a rash) and FATIGUE (feeling completely exhausted) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 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. They had been to a dermatologist, but They need to go to another step further. patient expressed feeling completely exhausted after 3 months. It was unknown if the patient experienced any additional symptoms/events. she was using creams for itching. There were no lab data/results available. Specific treatment drugs not provided. More
2820707 M 01/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Heart rate, Interchange of vaccine products, SARS-Co... COVID-19, Drug ineffective, Heart rate, Interchange of vaccine products, SARS-CoV-2 test More
Tested positive on PCR for SARS-CoV-2; Tested positive on PCR for SARS-CoV-2; Interchange of vaccine... Tested positive on PCR for SARS-CoV-2; Tested positive on PCR for SARS-CoV-2; Interchange of vaccine products; This is a literature report for the following literature source: . A 51-year-old male patient received BNT162b2 (COMIRNATY), in Apr2021 as dose 1, single and in May2021 as dose 2, single for COVID-19 immunisation; elasomeran (SPIKEVAX), in Nov2021 as dose 3 (booster), single) and in Aug2022 as dose 4 (booster), single) for COVID-19 immunisation. The patient's relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. In, a 51-year-old man with a medical history notable only for tinnitus tested positive on PCR for SARS-CoV-2. He had previously received four doses of SARS-CoV-2 vaccines (Comirnaty in Apr2021 and May2021, Spikevax in Nov2021 and Aug2022), most proximally three weeks prior to COVID-19 symptom onset. His acute COVID symptoms included mild cough, fatigue, severe brain fog, heart rate variability, symptoms of paresthesia (skin crawling sensations and tingling in the back), visual snow and mild warping visual distortions, and loss of smell and taste. He began a 5-day course of nirmatrelvir/ritonavir the same day he tested positive (and within 1 day of experiencing COVID-19 symptoms), during which he experienced improvement in some symptoms. After completing the 5-day course, he tested negative on day five, then experienced rebound symptoms, testing positive again 2-3 days after his last nirmatrelvir/ritonavir dose. The likely variant of COVID-19 was Omicron.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. Consider also the possible contributory effect of interchange of vaccine products in the vaccine efficacy. More
2820708 F 01/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID-19 infection, confirmed by rapid antigen test; drug ineffective; This is a literature report f... COVID-19 infection, confirmed by rapid antigen test; drug ineffective; This is a literature report for the following literature source(s). A 34-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), in Nov2021 as dose 1, single and in Oct2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID-19 infection, confirmed by rapid antigen test"; DRUG INEFFECTIVE (medically significant), outcome "unknown". It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: In November 2021, a 34-year-old-woman developed symptoms consistent with a COVID-19 infection, confirmed by rapid antigen test. She had previously received two doses of the Comirnaty SARS-CoV-2 vaccine in October and November 2021.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported events Covid 19 and Drug ineffective cannot be ruled out. More
2820709 F 01/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID-19 infection/likely variant: omicron; COVID-19 infection/likely variant: omicron; This is a li... COVID-19 infection/likely variant: omicron; COVID-19 infection/likely variant: omicron; This is a literature report for the following literature source(s). A 45-year-old female patient received BNT162b2 (COMIRNATY), in May2021 as dose 1, single and in Jul2021 as dose 2, single for covid-19 immunisation; elasomeran (SPIKEVAX), in Jan2022 as dose 3 (booster), single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19 infection/likely variant: omicron". Clinical course: In January 2022, a 45-year-old woman developed symptoms of a COVID-19 infection. Her Long COVID symptoms included fatigue, breathing difficulties, and severe chest pain diagnosed as costochondritis. Over the first eight weeks of her illness, her Long COVID symptoms worsened and she experienced severe weight loss and migraines. Since that time, clinicians diagnosed her with chronic pericarditis, POTS, cardiac fibrosis, ME/CFS, and possible MCAS. Before her illness, she had received two doses of the Comirnaty vaccine (May and July 2021) and a dose of the Spikevax vaccine in January 2022 (immediately prior to her diagnosis).; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500003572 Same patient, different drug;US-PFIZER INC-PV202500004992 Same Patient / Different Drug; More
2820710 F 01/13/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chronic fatigue syndrome, Fibrosis, Interchange of vaccine products, Mast cell a... Chronic fatigue syndrome, Fibrosis, Interchange of vaccine products, Mast cell activation syndrome, Pericarditis; Postural orthostatic tachycardia syndrome More
chronic pericarditis; Mast Cell Activation Syndrome; cardiac fibrosis; Postural orthostatic tachycar... chronic pericarditis; Mast Cell Activation Syndrome; cardiac fibrosis; Postural orthostatic tachycardia syndrome; Myalgic encephalomyelitis/chronic fatigue syndrome; Interchange of vaccine products; This is a literature report for the following literature source(s). A 45-year-old female patient received BNT162b2 (COMIRNATY), in May2021 as dose 1, single and in Jul2021 as dose 2, single for covid-19 immunisation; elasomeran (SPIKEVAX), in Jan2022 as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jan2022, outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown", described as "chronic pericarditis"; MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown"; FIBROSIS (non-serious), outcome "unknown", described as "cardiac fibrosis"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown"; CHRONIC FATIGUE SYNDROME (non-serious), outcome "unknown", described as "Myalgic encephalomyelitis/chronic fatigue syndrome". Clinical course: In January 2022, a 45-year-old woman developed symptoms of a COVID-19 infection. Her Long COVID symptoms included fatigue, breathing difficulties, and severe chest pain diagnosed as costochondritis. Over the first eight weeks of her illness, her Long COVID symptoms worsened and she experienced severe weight loss and migraines. Since that time, clinicians diagnosed her with chronic pericarditis, POTS, cardiac fibrosis, ME/CFS, and possible MCAS. Before her illness, she had received two doses of the Comirnaty vaccine (May and July 2021) and a dose of the Spikevax vaccine in January 2022 (immediately prior to her diagnosis). She received an additional dose of the Spikevax vaccine in September 2022.; Sender's Comments: Although it is difficult to establish temporal association between the reported events PERICARDITIS, MAST CELL ACTIVATION SYNDROME and suspect drug based on the limited information provided in the case, the causal association between the Reported events and the suspect drug cannot be excluded as there is no concrete evidence available to eliminate the causal association The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500003569 Same article, different patient;US-PFIZER INC-202500003572 Same patient, different dose; More
2820711 F 01/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19 infection; COVID-19 infection; This is a literature report for the following literature sou... COVID-19 infection; COVID-19 infection; This is a literature report for the following literature source(s). A 55-year-old transgender person assigned female at birth developed symptoms of a clinically confirmed COVID-19infection in March 2020 and a reinfection in March 2021 (confirmed by PCR test). Before his illness, he had been diagnosed with Neuromyelitis Optica Spectrum Disorder (2011), ME/CFS (diagnosed in 2017, but began earlier), fibromyalgia, and psoriasis. Following his first COVID-19 infection, he developed tachycardia, brain fog, and mild cognitive symptoms. After his second COVID-19 infection, he developed MCAS symptoms, including frequent, mild-to-moderate sinus congestion, flushing, and throat swelling in relation to many foods. Currently, his Long COVID symptoms include brain fog, difficulty with word finding, MCAS symptoms, sensitivity to histamines, and intermittent PEM. He received one dose of the Spikevax vaccine in February 2021, two doses of the Jcovden vaccine in July and October 2021, a Comirnaty bivalent booster in October 2022, and one primary series dose of the Nuvaxovid vaccine in April 2023. In December 2022, he took a 7.5 day course of nirmatrelvir/ritonavir during a third COVID-19 infection (confirmed by at-home molecular Lucira test and multiple rapid antigen tests). At the time, he was taking cromolyn sodium, ketitofen, low-dose naltrexone, metoprolol succinate XL, rosuvastatin, nortriptyline, modafinil, finasteride, loratadine, valacyclovir, famotidine, and nitrofurantoin daily; testosterone cypionate weekly; leuprolide quarterly; and Zofran and clonazepam as needed. His daily supplements included Deplin (algal oil), cranberry extract, laxin forte, vision optimizer blend, biotin, ubiquinol, alpha-lipoic acid, probiotics, fish oil, flaxseed oil, quercetin, vitamin C, acetyl-l-carnitine, milk thistle, P5P, calcium, skullcap and passionflower tinctures, and DAO and digestive enzymes. He also received twice-weekly injections of glutathione and methylcobalamin. During his acute COVID infection, he also took melatonin and high dose Vitamin C powder. After this course of nirmatrelvir/ritonavir, he experienced several days with no fatigue or notable pain, although his fatigue and pain then returned to his pre-infection baseline within 2-3 weeks. This pattern resembled his experience with his first COVID infection, in which he experienced improvements in his fatigue and chronic pain during the ten days of initial infection, while also experiencing intermittent low-grade fevers. At that time, as his fevers subsided, his fatigue and pain returned.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported events Covid 19 and Drug ineffective cannot be ruled out. More
2820713 42 F CA 01/13/2025 COVID19
 PFIZER\BIONTECH
 EL1283
Brain fog, Headache, Memory impairment Brain fog, Headache, Memory impairment
Severe headache; memory fog/brain fog; short term memory got real bad; This is a spontaneous report ... Severe headache; memory fog/brain fog; short term memory got real bad; This is a spontaneous report received from an Other HCP. A 42-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 2, single (Lot number: EL1283) at the age of 42 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (disability) with onset 11Jan2021, outcome "not recovered", described as "Severe headache"; BRAIN FOG (disability) with onset 11Jan2021, outcome "recovering", described as "memory fog/brain fog"; MEMORY IMPAIRMENT (disability) with onset 11Jan2021, outcome "not recovered", described as "short term memory got real bad". Therapeutic measures were not taken as a result of headache, brain fog, memory impairment. More
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2820720 F 01/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
developed COVID-19 symptoms. The infection was confirmed via rapid antigen test; developed COVID-19 ... developed COVID-19 symptoms. The infection was confirmed via rapid antigen test; developed COVID-19 symptoms. The infection was confirmed via rapid antigen test; This is a literature report for the following literature source(s). A 25-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), in Apr2021 as dose 1, single and in Nov2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2023, outcome "unknown" and all described as "developed COVID-19 symptoms. The infection was confirmed via rapid antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: infection confirmed. It was unknown if therapeutic measures were taken as a result of covid-19. Additional information: Patient given a 15-day course of Paxlovid as part of a study to see if it would improve her Long COVID symptoms. According to the media article, the patient reported experiencing significant improvement in symptoms. Case report: In May2022, a previously healthy25-year-old woman with a medical history notable only for mild seasonal allergies developed COVID-19 symptoms. The infection was confirmed via rapid antigen test. She had previously received the primary two-shot series of the COVID-19 vaccine(Comirnaty) in April2021 and a Comirnaty booster in November2021. Initially, her Long COVID symptoms were primarily gastrointestinal, including lack of appetite, bloating, weight loss and new food intolerances. Over the next few months, she developed additional symptoms, including fatigue, PEM, exercise intolerance, brainfog, headaches, noise and light sensitivity, and joint pain. In November and December2022, she was treated for small intestinal bacterial overgrowth with two courses of rifaximin, which did not lead to sustained improvement; specifically, after the first course in November, her gastrointestinal symptoms improved for two days before returning top rerifaximin baseline and after these cond course in December, there was no improvement. In January2023, she began a 10-day course of nirmatrelvir/ritonavir outside of the context of an acute COVID-19infection. At the time, she was taking loratadine and a multivitamin. On day4, she experienced a severe "crash" characterized by increased fatigue, headache, brainfog, sound and light sensitivity, and difficulty remaining upright, walking and balancing. Approximately one month later, she had recovered from the initial crash and her fatigue and PEM had lessened meaningfully; she also experienced limited improvement in brainfog and headaches. In late February and March 2023, she switched from loratadine to fexofenadine and famotidine. In April and May2023, the fatigue, PEM, brainfog, and headache benefits dissipated and her symptoms returned to her pre-nirmaltrevir/ritonavir baseline, and she began taking quercetin, low-dosenaltrexone, and a pro-biotic. As of July2023, she was experiencing some improvements in symptoms,was slowly reintroducing foodsnot tolerated earlier in her disease course, and added gentle swimming multiple times per week with out PEM. She also began a 3-month course of valacyclovir with celecoxib, given the irantiviral and anti-inflammatory properties, respectively, but observed no benefits.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500004609 Same patient, different drug and events; More
2820721 M 01/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome COVID-19, Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome
SARS-CoV-2 infections; SARS-CoV-2 infections; SARS-CoV-2 infections; Long COVID symptoms arose; This... SARS-CoV-2 infections; SARS-CoV-2 infections; SARS-CoV-2 infections; Long COVID symptoms arose; This is a literature report for the following literature source(s). A 29-year-old male patient received BNT162b2 (COMIRNATY), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "SARS-CoV-2 infections"; DISEASE RECURRENCE (medically significant) with onset Jul2022, outcome "recovered", described as "SARS-CoV-2 infections"; POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2022, outcome "unknown", described as "Long COVID symptoms arose". Therapeutic measures were taken as a result of post-acute covid-19 syndrome which included nirmatrelvir/ritonavir. Clinical course: A 29-year-old man had clinically confirmed SARS-CoV-2 infections in May2022 and Jul2022. His symptoms appeared to resolve fully after his first infection. After his second infection, his acute symptoms resolve after three weeks, at which time his Long COVID symptoms arose. His Long COVID symptoms include extreme fatigue, PEM, tachycardia, POTS, persistent headache, brain fog, chest pain and shortness of breath on exertion, and unrefreshing sleep; he met the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) diagnostic criteria. Since the onset of his Long COVID symptoms, he also developed constipation, chilblains, atopic dermatitis on his face, and paresthesia. His abnormal test results include high cholesterol and prominent Virchow spaces on a brain MRI. Before his initial infection, he had received three doses of the Comirnaty vaccine (Mar2021, Apr2021, and Nov2021). He received an additional dose of the Spikevax vaccine in Oct2022. In May2023, he began a 15-day course of nirmatrelvir/ritonavir outside of the context of an acute COVID-19 infection. Concomitant medications included finasteride, amphetamine/dextroamphetamine salts, bupropion, atenolol, midodrine, Vitamin D3, and famotidine. Approximately six days into the course, he noticed slight ("~10%") improvement in his fatigue and brain fog. These improvements were sustained and increased to "~20%" by the end of the course. His 15 days on nirmatrelvir/ritonavir also coincided with the longest number of consecutive days (15) without any worsening of symptoms (e.g., a crash). However, two days after the final nirmatrelvir/ritonavir dose, he experienced a PEM crash, which included a sore burning sensation in his arms, poor sleep, headache, fatigue, and brain fog so intense that sitting, moving, and talking was difficult. He returned to his pre-nirmatrelvir/ritonavir Long COVID baseline within five days. He has remained at his pre-nirmatrelvir/ritonavir Long COVID baseline in the subsequent months.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19, and disease recurrence) with the suspect product BNT162B2 cannot be fully excluded. Based on known disease pathophysiology, the event post-acute COVID-19 syndrome is assessed as not related to the suspect product, and more likely a consequence or complication of the CoVID-19 infection.,Linked Report(s) : US-PFIZER INC-202500004798 Same patient, different dose; More
2820722 79 F 01/13/2025 PNC20
 PFIZER\WYETH
Asthenia, Headache, Malaise, Restlessness, Somnolence Asthenia, Headache, Malaise, Restlessness, Somnolence
Today she was feeling like sleeping, she just does not feel right.; feel lousy; had a feeling of unr... Today she was feeling like sleeping, she just does not feel right.; feel lousy; had a feeling of unrest; Feeling of no energy; Headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 79-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 07Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 08Jan2025, outcome "not recovered", described as "Today she was feeling like sleeping, she just does not feel right."; ASTHENIA (non-serious) with onset Jan2025, outcome "not recovered", described as "Feeling of no energy"; HEADACHE (non-serious) with onset Jan2025, outcome "not recovered"; MALAISE (non-serious) with onset Jan2025, outcome "not recovered", described as "feel lousy"; RESTLESSNESS (non-serious) with onset Jan2025, outcome "unknown", described as "had a feeling of unrest". Additional information: The patient stated that how if experiencing like no energy or headache, how long before that goes away. Patent stated in one or two days, she was going to be feeling herself, then. She is on her own then. She just have to wait until it runs out. She felt very good before that and now she feels lousy, it doesn't matter, she just have to wait. She received dose of Prevnar 20 yesterday (07Jan2025) and now is feeling drowsy. She is calling reporting side effects. After transfer reporter clarified she was not drowsy. She clarified she has a feeling of no energy and a headache. Before she got the shot she was full of energy and doing things. Today (08Jan2025) she is feeling like sleeping, she just does not feel right. Difficult to understand caller, as she sounds muffled. Sounded like she stated had a feeling of unrest. Attempted to clarify statement, but she would not clarify further. Patient called and stated, "yesterday around 11:00 she had a prevnar 20 injection before that she was feeling fine today she feels lousy." More
2820724 M 01/13/2025 RSV
 PFIZER\WYETH
Guillain-Barre syndrome Guillain-Barre syndrome
Guillian Barre SYNDROME; This is a spontaneous report received from a Consumer or other non HCP. An... Guillian Barre SYNDROME; This is a spontaneous report received from a Consumer or other non HCP. An adult male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization), outcome "not recovered", described as "Guillian Barre SYNDROME". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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2820725 14 M AK 01/13/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FE3594
FE3594
Blood creatine phosphokinase, Blood creatine phosphokinase MB, Body height, Echo... Blood creatine phosphokinase, Blood creatine phosphokinase MB, Body height, Echocardiogram, Electrocardiogram; Laboratory test, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin I, Weight More
diagnosed the myocarditis; This is a spontaneous report received from a Physician from medical infor... diagnosed the myocarditis; This is a spontaneous report received from a Physician from medical information team. A 14-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Lot number: FE3594) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 20Jan2022, outcome "recovered", described as "diagnosed the myocarditis". The patient was hospitalized for myocarditis (start date: 20Jan2022, discharge date: 21Jan2022, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: (Jan2022) 564 pg/mL; Blood creatine phosphokinase MB: (Jan2022) 27.4 ng/ml; Body height: (unspecified date) 63.5, notes: inch 5 feet 3.5 inches; Echocardiogram: (Feb2022) Unknown results; Electrocardiogram: (Jan2022) inverted T waves and ST depression; testing: (unspecified date) diagnosed the myocarditis; N-terminal prohormone brain natriuretic peptide: (Jan2022) 242 pg/mL; Troponin I: (Jan2022) 9913 ng/L, notes: very elevated; Weight: (unspecified date) 183 lbs. Therapeutic measures were taken as a result of myocarditis, the patient was treated with Ibuprofen.; Sender's Comments: Given the compatible time association, the reasonable possibility that the event myocarditis is related to BNT162b2 (BNT162B2) administration cannot be excluded. This case will be reassessed should additional information become available. 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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2820726 F 01/13/2025 COVID19
 PFIZER\BIONTECH
Ageusia, Anosmia, Cough, Fatigue, Sneezing Ageusia, Anosmia, Cough, Fatigue, Sneezing
wet sneezes; coughing; tired; loss of taste and smell; loss of taste and smell; This is a spontaneou... wet sneezes; coughing; tired; loss of taste and smell; loss of taste and smell; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A female patient received BNT162b2 (COMIRNATY), on 23Jan2021 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: SNEEZING (non-serious), outcome "unknown", described as "wet sneezes"; COUGH (non-serious), outcome "unknown", described as "coughing"; FATIGUE (non-serious), outcome "unknown", described as "tired"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "loss of taste and smell". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2820727 M 01/13/2025 RSV
 UNKNOWN MANUFACTURER
Drug ineffective, Respiratory syncytial virus infection Drug ineffective, Respiratory syncytial virus infection
Then my husband and I contracted RSV in December 2024; Then my husband and I contracted RSV in Decem... Then my husband and I contracted RSV in December 2024; Then my husband and I contracted RSV in December 2024; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset Dec2024, outcome "unknown" and all described as "Then my husband and I contracted RSV in December 2024". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500004123 same reporter/event, different patient/dose; More
2820732 F 01/13/2025 RSV
 PFIZER\WYETH
Exposure during pregnancy, Inappropriate schedule of product administration, Sti... Exposure during pregnancy, Inappropriate schedule of product administration, Stillbirth More
had a stillbirth two days after vaccination; This is a spontaneous report received from a Physician.... had a stillbirth two days after vaccination; This is a spontaneous report received from a Physician. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STILLBIRTH (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "had a stillbirth two days after vaccination". The pregnancy resulted in still birth. Clinical course: The physician was informed that a pregnant patient who received the RSV vaccine had a stillbirth two days after vaccination. The patient received the vaccine at 37 weeks, outside the recommended window. The physician did not clarify if the patient had indeed received the Pfizer Abrysvo RSV Pref vaccine, simply stating that she had "received the RSV vaccine". Patient was a late entry into prenatal care. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: The pregnant patient who received the RSV vaccine had a stillbirth two days after vaccination. Currently available data are insufficient to establish or exclude a causal relationship between stillbirth and ABRYSVO. More epidemiologic data and cumulative safety reports collected post marketing use are needed to indicate if there is the potential causal link between the vaccination and the event occurrence. 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
2820733 F 01/13/2025 COVID19
 PFIZER\BIONTECH
 HF9300
Cardiomyopathy, Hypothyroidism Cardiomyopathy, Hypothyroidism
Hypothyroidism; Cardiomyopathy; This is a spontaneous report received from an Other HCP. A 46-year-... Hypothyroidism; Cardiomyopathy; This is a spontaneous report received from an Other HCP. A 46-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Lot number: HF9300) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose - Pfizer, lot number: EWO0170), administration date: 29Jul2021, for Covid-19 immunization; BNT162b2 (2nd dose - Pfizer, Lot number EWO169), administration date: 19Aug2021, for Covid-19 immunization; BNT162b2 (3rd dose - Pfizer, Lot number: FM0698), administration date: 25Feb2022, for Covid-19 immunization. The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown"; CARDIOMYOPATHY (medically significant), outcome "unknown". Clinical course: recent diagnosis of hypothyroidism & cardiomyopathy.; Sender's Comments: There is not a reasonable possibility that the reported events hypothyroidism and cardiomyopathy was related to the suspect product event most likely due to patient underlying contributory factors. 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
2820735 F 01/13/2025 RSV
 UNKNOWN MANUFACTURER
Drug ineffective, Respiratory syncytial virus infection Drug ineffective, Respiratory syncytial virus infection
Then my husband and I contracted RSV in December 2024; Then my husband and I contracted RSV in Decem... Then my husband and I contracted RSV in December 2024; Then my husband and I contracted RSV in December 2024; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset Dec2024, outcome "unknown" and all described as "Then my husband and I contracted RSV in December 2024". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500005918 same reporter/event, different patient/dose; More
2820736 M 01/13/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Body temperature, Chills, Hypersensitivity, Pyrexia Arthralgia, Body temperature, Chills, Hypersensitivity, Pyrexia
patient is concerned that covid vaccine sensitized his immune system and made him allergic to the me... patient is concerned that covid vaccine sensitized his immune system and made him allergic to the medication; Chills; low grade fever; knee hurl no matter if he was sitting or walking/ongoing; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA335342 (Sanofi), US-SA-2024SA345149 (Sanofi), 2024SA345149 (Sanofi). A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; hylan g-f 20 (SYNVISC ONE), since 2021) for osteoarthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovering"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "knee hurl no matter if he was sitting or walking/ongoing"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "low grade fever"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "recovered", described as "patient is concerned that covid vaccine sensitized his immune system and made him allergic to the medication". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for hylan g-f 20 was unknown. Additional information: Initial information received on 13Nov2024 regarding an unsolicited valid non-serious case received from the patient. This case is linked to US-SA-2024SA345149 (Multiple devices used in same patient (case for left knee)). This case involves an unknown age male patient who was concerned that covid vaccine sensitized his immune system and made him allergic to the medication and his knee hurt no matter if he was sitting or walking/ ongoing pain issues with his knee, after being treated with Covid-19 Vaccine and after the use of medical device HYLAN G-F 20, Sodium Hyaluronate [Synvisc One]. The patient's past medical history, concomitant medications, vaccination(s) and family history were not provided. In 2021, the patient received Synvisc One (HYLAN G-F 20, Sodium Hyaluronate) Injection in the right knee (strength: 48 mg/6ml) once (with unknown dose, route) and in the left knee (strength: 48 mg/6ml) once (with unknown dose, route, frequency) for Osteoarthritis. On an unknown date, the patient received covid-19 vaccine (with unknown formulation , strength, dose, route and frequency) for Immunisation. In 2021 the patient developed a non-serious event "patient is concerned that covid vaccine sensitized his immune system and made him allergic to the medication" (hypersensitivity) (Latency: same day) following the first dose intake (unknown batch number and expiry date) after starting use of HYLAN G-F 20 and sodium and (unknown latency) of Covid-19 Vaccine. In 2021 the patient developed a non-serious event "chills" (Latency: same day) following the first dose intake (unknown batch number and expiry date) after starting use of HYLAN G-F 20 and sodium and (unknown latency) of covid-19 vaccine. In 2021 the patient developed a non-serious event "low grade fever"(pyrexia) (Latency: same day) following the first dose intake (unknown batch number and expiry date) after starting use of HYLAN G-F 20 and sodium and (unknown latency) of Covid-19 Vaccine. In 2021 the patient developed a non-serious event "knee hurt no matter if he was sitting or walking/ongoing pain issues with his knee" (injection site joint pain) (Latency: same day) following the first dose intake (unknown batch number and expiry dale) after starting use of HYLANG-F 20 and sodium and (unknown latency) of covid-19 vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "Consumer of Synvisc One states in 2021, he had Synvisc One installed in both of his knees. Later in the evening, he developed symptoms which were chills and low grade fever which persisted for about a month and both knees hurt no matter if he was sitting or walking. He is concerned that the COVID vaccine sensitized his immune system and made him allergic to the medication. He reports ongoing pain issues with his knees. Caller inquires is it safe to try the product after again after 3 years however is concerned that if he's allergic the symptoms will be more severe. No further information provided by the reporter. He also added that his general practitioner doctor mentioned that there's a plastic material that is used in plastic surgery (not synvisc) that they're seeing that is causing allergic reactions." Action taken with Synvisc one and Covid-19 Vaccine was not applicable. Corrective treatment: not reported for both the events. Outcome: recovered on an unknown date for hypersensitivity and not recovered for injection site pain. A Product Technical Complaint (PTC) was initiated on 13Nov2024 for Synvisc One (lot/batch number: unknown) with Regulatory Authority number: Complaint-051245. The PTC stated: Based on the complaint from intake team, there is no quality related effect that would attribute to a malfunction a death or serious injury. Sanofi Global Pharmacovigilance and Epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. The product lot number was not provided. A batch record review is not possible. Based on the lack of information, no assessment is possible. It is the requirement 10 review all finished batch records for specification conformance prior lo re lease. Any out of specification result is identified and mitigated through the Nonconforming Material or Product process. Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a CAPA (Corrective and Preventive Actions) is required. The final investigation was completed on 20Nov2024 with summarized conclusion as No assessment possible. Additional information received on 14Nov2024 from patient: No significant information received. Clinical course updated and text amended accordingly. Additional information was received on 20Nov2024 from quality department: PTC number, details and results were added. Text was amended. Evaluation in light of similar events in the past. Sanofi assessment: non serious, causal: Yes, Case Listedness: Listed. BNT162B2 is under agreement with BIONTECH SE. More
2820737 F 01/13/2025 COVID19
 PFIZER\BIONTECH
Allergy to vaccine, Rash Allergy to vaccine, Rash
small rash on leg above ankle; a new allergy to covid vaccine; This is a spontaneous report received... small rash on leg above ankle; a new allergy to covid vaccine; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA277231 (Sanofi). A 72-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), in Jun2024 (ongoing) as 300 mg qow (every other day)) subcutaneous for nasal polyps. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2024, outcome "unknown", described as "a new allergy to covid vaccine"; RASH (non-serious) with onset 2024, outcome "unknown", described as "small rash on leg above ankle". The action taken for dupilumab was dosage not changed. Additional information: Initial information received on 24Sep2024 (by Sanofi) regarding an unsolicited valid non-serious case received from a patient. In 2024 the patient developed the non-serious events (unknown latency) following the first dose intake of DUPILUMAB and of COVID-19 vaccine. Additional information was received on 20Nov2024 (by Sanofi) from the patient. Event of allergy to vaccine along with co-suspect COVID-19 VACCINE were added. Batch/lot number is not provided, and it cannot be obtained. More
2820738 1 F TX 01/13/2025 HEPA
HEPA
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y012054
Y012054
Y014306
Y014306
Cyanosis, Electroencephalogram normal, Influenza A virus test negative, Influenz... Cyanosis, Electroencephalogram normal, Influenza A virus test negative, Influenza B virus test negative, Irritability; SARS-CoV-2 test negative, Seizure, Streptococcus test negative, Vomiting, White blood cell count normal; Cyanosis, Electroencephalogram normal, Influenza A virus test negative, Influenza B virus test negative, Irritability; SARS-CoV-2 test negative, Seizure, Streptococcus test negative, Vomiting, White blood cell count normal More
My Daughter received her MMR Vaccine on 12/2/2024 and on 12/11/2024 she began acting "fussy&quo... My Daughter received her MMR Vaccine on 12/2/2024 and on 12/11/2024 she began acting "fussy" at about 1200. Pt was afebrile until approx. 1945 when she was found with emesis around her mouth, cyanotic, and seizing. She was taken to the ER. Her seizure lasted approx. 15 min. and required IV Ativan to stop. her O2 was 55% and HR was 218 upon arrive. She was flown to hospital. All test results were negative. She did not have elevated WBC's and no source was found. Her EEG was negative and has since made a full recovery with no symptoms of the event More
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2820739 74 M AZ 01/13/2025 RSV
 PFIZER\WYETH
 LG9827
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient stated that he had never had a RSV vaccine. Patient stated that he had attempted to have one... Patient stated that he had never had a RSV vaccine. Patient stated that he had attempted to have one at our facility in the past but was not able to due to insurance issues. After the patient had left while going through his chart to add the vaccine it was discovered that he had a previous RSV vaccine two years ago here. Patient had no adverse effects at the visit and left the clinic in stable condition. Patient was notified about the issue, patient again stated "I did not have an RSV vaccine two years ago today was the first one". Advised patient of records on file and that provider would be making a report of the incident. More
2820740 17 F TX 01/13/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 52N4s
Chills, Dizziness, Fatigue, Pain, Vertigo Chills, Dizziness, Fatigue, Pain, Vertigo
Patient had chills, dizziness, vertigo 2 hours after vaccine given. B/P lower at time of recheck, al... Patient had chills, dizziness, vertigo 2 hours after vaccine given. B/P lower at time of recheck, all other vital signs ok. B/P went up after drinking fluids, pt tired, achy More
2820741 61 M CA 01/13/2025 TYP
 BERNA BIOTECH, LTD.
 3004045
Expired product administered, No adverse event Expired product administered, No adverse event
Patient took one expired dose of Vivotif capsules. Patient reported no side effects or adverse event... Patient took one expired dose of Vivotif capsules. Patient reported no side effects or adverse events. The patient was provided non expired vaccine capsules and completed the course with no complications. More
2820742 29 F MA 01/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LM7786
U8440AA
Nausea, Pallor; Nausea, Pallor Nausea, Pallor; Nausea, Pallor
Patient received both Pfizer covid and Flublok vaccinations in her left arm. After vaccinations were... Patient received both Pfizer covid and Flublok vaccinations in her left arm. After vaccinations were given, I stayed with the patient for five minutes, while I provided the same two vaccinations to her friend. She seemed fine and was speaking with us and did not report any issues. After I finished giving them the vaccines, I confirmed they were okay and went to help a customer at the register because I was working alone. Her friend knocked on the door and asked for a bag for her friend to use if she had to vomit. I saw the patient, and she was sitting in the chair leaning back and was very pale. I told her friend to stay close to her and keep an eye so that she would not fall if she fainted, and I got her some water and a piece of candy. She did not tell me that she fainted, but her mother came into the store two days later to thank me for being there for her when she fainted. I kept a close eye on her and offered to check her blood pressure, which she declined. Once she ate the candy, pretzels and drank some water her coloring came back and she felt fine. She stayed in the vaccine room for 10 minutes or so before leaving while I checked on her in between customers at Will Call. She was shopping in the store after for about 30 minutes and told me she was feeling much better. Her mom said she usually faints when she gives blood. More
2820743 38 F IL 01/13/2025 RSV
 PFIZER\WYETH
 LN5463
Urticaria Urticaria
Hives from chest down to ankles including arms/hands. Hives from chest down to ankles including arms/hands.
2820750 62 F OR 01/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 BP74J
Arthralgia, Dyspnoea, Injection site erythema, Injection site swelling, Ocular d... Arthralgia, Dyspnoea, Injection site erythema, Injection site swelling, Ocular discomfort More
Patient reported to pharmacy two days after receiving shingrix vaccine with swelling and redness of ... Patient reported to pharmacy two days after receiving shingrix vaccine with swelling and redness of the injection site, shoulder pain, trouble breathing in the morning, and left eye discomfort More
2820751 51 F FL 01/13/2025 COVID19
 MODERNA
Flushing, Urticaria Flushing, Urticaria
Facial flushing and Hives was given po 25 mg of benadryl Facial flushing and Hives was given po 25 mg of benadryl
✓
2820752 64 F TX 01/13/2025 PNC20
RSV
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 lc1281
7l3st
Dyspnoea, Pyrexia, Respiratory tract congestion; Dyspnoea, Pyrexia, Respiratory ... Dyspnoea, Pyrexia, Respiratory tract congestion; Dyspnoea, Pyrexia, Respiratory tract congestion More
pt received the vaccine on 1/6/25 and had shortness of breath, congestion and fever the next day. S... pt received the vaccine on 1/6/25 and had shortness of breath, congestion and fever the next day. She was not tested for the influenza, but was prescribed albuterol and benzonatate. More
2820753 78 F GA 01/13/2025 COVID19
 PFIZER\BIONTECH
 ln0589
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
patient came in on 01/09/2025 for a covid shot. received shot. The store cooperate contacted pharmac... patient came in on 01/09/2025 for a covid shot. received shot. The store cooperate contacted pharmacy on 1/10/2025 that patient had received the same type covid shot on 11/25/2024. They were given to close together and pharmacist did not catch that she did not need another shot and patient did not remember getting the first shot. We notified the patient and she said she did not have any reaction other than the typical sore arm but the corporate office wanted us to report it. More
2820754 75 M AL 01/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pt Rec'd 2nd dose of Arexvy. No Adr from 2nd dose were noted by patient. Pt Rec'd 2nd dose of Arexvy. No Adr from 2nd dose were noted by patient.
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