๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2851055 1.5 F MO 07/24/2025 HEPA
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH

Serum sickness; Serum sickness Serum sickness; Serum sickness
serum sickness serum sickness
2851056 0.5 M 07/24/2025 HIBV
 MERCK & CO. INC.
 Y005248
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse reaction. Patient received an extra dose of Pedvaxhib at the 6 month well check. Patien... No adverse reaction. Patient received an extra dose of Pedvaxhib at the 6 month well check. Patient had already received 1st and 2nd dose at 2 month and 4 month well check. Pt was not due for booster dose until 12-15 months of age. More
2851057 75 F VA 07/24/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 ln4930
5a4xg
Injection site erythema, Injection site pain, Injection site warmth; Injection s... Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth More
redness, warm, soreness around the right arm beneath the injection sites. home treatment. presented... redness, warm, soreness around the right arm beneath the injection sites. home treatment. presented to pharmacy 7 days post vaccination. pt reported symptoms to be improving. counseled to apply ice to area, rotate tylenol and ibuprofen and seek additional care if condition worsens or does not improve More
2851058 32 M CA 07/24/2025 COVID19
 MODERNA
Allergy test, Pruritus, Urticaria Allergy test, Pruritus, Urticaria
I received a COVID-19 booster shot on July 8, 2022, in preparation for international work travel. Ap... I received a COVID-19 booster shot on July 8, 2022, in preparation for international work travel. Approximately two weeks later, on July 22, 2022, I began experiencing a severe allergic reaction characterized by hives and intense itching. The hives would appear in random locations?such as my forearms, neck, back, legs, and palms?and move unpredictably across different areas of my body. The itching was severe enough to cause skin damage from scratching and rubbing. I initially tried over-the-counter Benadryl, which provided symptom relief, but the drowsiness made it unsuitable for use during work hours. I then began using Allerease (OTC fexofenadine), which I purchased on the military base. This medication effectively controlled the symptoms; however, missing a single dose caused the hives and itching to return immediately. This condition has persisted for approximately three years. Since August 2022, I have taken fexofenadine daily, rarely missing a dose, due to the recurrence of symptoms upon interruption. The reaction has significantly impacted my daily comfort and quality of life. Two coworkers also received the booster shot. One received the same vaccine batch on the same day, at the same location, by the same nurse, and developed similar symptoms. The other coworker, vaccinated on a different day, did not experience any adverse effects. Upon returning from travel, I consulted my primary care physician, who: Prescribed a 90-day supply of fexofenadine with multiple refills which I have renewed multiple times Provided a VAERS form and instructed me to fill it out and return it Ordered allergy testing I was told I would be contacted regarding my VAERS submission, but I have not received any follow-up. I was also informed the reaction could be either a vaccine-related adverse event or a dust allergy, though no definitive diagnosis has been made. To this day, I remain dependent on daily antihistamines to control the ongoing symptoms. More
2851059 15 M NH 07/24/2025 COVID19
 MODERNA
 3046979
Underdose Underdose
MA inadvertently gave a dose of 0.25 ml of the covid 19 vaccine (6m-11y) instead of 0.5 ml of the co... MA inadvertently gave a dose of 0.25 ml of the covid 19 vaccine (6m-11y) instead of 0.5 ml of the covid vaccine 12y and older (Spikevax) More
2851060 40 F IL 07/24/2025 DTAPIPV
 SANOFI PASTEUR
 U7908AB
No adverse event, Underdose No adverse event, Underdose
Pt received Pediatric dose vs Adult dose. No adverse side effects noted. Pt received Pediatric dose vs Adult dose. No adverse side effects noted.
2851061 VA 07/24/2025 VARCEL
 MERCK & CO. INC.
 Z004455
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; HCP reporting that a patient received a dose of improperly stored VARIVAX.; This s... No adverse event; HCP reporting that a patient received a dose of improperly stored VARIVAX.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies were not reported. On an unknown date, the vaccine Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Z004455, expiration date: 13-Feb-2027) 0.5 mL (0.5mL), and the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). Both were temperature excursion to 52.2 degrees Fahrenheit for unknown time. The previous temperature excursion was N/A. On 26-Jun-2025, this vaccine was vaccinated to the patient for prophylaxis (strength, and route of administration were not provided) (Product storage error). No symptoms or side effects were reported by HCP. No other information reported by HCP. Consent to contact HCP was given. No additional adverse event. More
2851062 2 M MA 07/24/2025 HPV9
 MERCK & CO. INC.
 Y012776
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
n/a n/a
2851063 5 F TX 07/24/2025 DTAPIPV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 4L454
Y013171
Z003882
Peripheral swelling, Rash; Peripheral swelling, Rash; Peripheral swelling, Rash Peripheral swelling, Rash; Peripheral swelling, Rash; Peripheral swelling, Rash
Rash and other nonspecific skin eruption. Bump and rash on left leg. Rash and other nonspecific skin eruption. Bump and rash on left leg.
2851064 12 F CA 07/24/2025 TDAP
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
 U8618AA
Y071063
Musculoskeletal stiffness, Syncope; Musculoskeletal stiffness, Syncope Musculoskeletal stiffness, Syncope; Musculoskeletal stiffness, Syncope
Pt had syncope episode right after varivax administration. Pt regained consciousness within 10 secon... Pt had syncope episode right after varivax administration. Pt regained consciousness within 10 seconds, then fainted again with muscle stiffness, RPH suspected seizure, hence 911 was called and paramedics assessed the pt. More
2851065 57 F IA 07/24/2025 DT
DT
 SANOFI PASTEUR
SANOFI PASTEUR
 U8492BA
U8492BA
Abdominal discomfort, Blood iron, Burning sensation, C-reactive protein, Full bl... Abdominal discomfort, Blood iron, Burning sensation, C-reactive protein, Full blood count; Metabolic function test, Red blood cell sedimentation rate, Serum ferritin, Vitamin B12 More
Patient reported no symptoms of pain or concern the day of vaccine. Patient reported symptoms of bur... Patient reported no symptoms of pain or concern the day of vaccine. Patient reported symptoms of burning to feet, groin area and fingertips to bilateral upper and lower extremities within two days after receiving vaccine. More
2851066 0.5 F 07/24/2025 HIBV
 MERCK & CO. INC.
 Y005248
Extra dose administered, Injection site erythema, Injection site swelling, Local... Extra dose administered, Injection site erythema, Injection site swelling, Local reaction More
Patient received an extra Pedvaxhib at 6 month well check. Patient had already received a Pedvaxhib... Patient received an extra Pedvaxhib at 6 month well check. Patient had already received a Pedvaxhib dose at 2 month and 4 month well check. Patient was not due for booster until 12 month of age. Parent reported redness and swelling at the injection site. Localized reaction. More
2851067 60 F NY 07/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5a4xg
Mass, Swelling Mass, Swelling
Pain that lasted 6 days. Lump, swollen Pain that lasted 6 days. Lump, swollen
2851068 12 M IN 07/24/2025 HPV9
 MERCK & CO. INC.
 Z007847
Blister, Limb discomfort Blister, Limb discomfort
Developed discomfort over LT arm and fingers. Blisters over fingers, LT 5th finger and middle finger... Developed discomfort over LT arm and fingers. Blisters over fingers, LT 5th finger and middle fingers- developed 7/22/2025. No fever, vomiting or diarrhea. More
2851069 67 F CA 07/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 957d4
No adverse event, Product preparation issue No adverse event, Product preparation issue
There is no adverse event, this is just report that pharmacist only administered diluent to patient,... There is no adverse event, this is just report that pharmacist only administered diluent to patient, pharmacist did not mix vaccine prior to administration. More
2851070 11 M WA 07/24/2025 HPV9
MNQ
TD
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Z0025580
U8370AA
U8252AA
Chest pain, Rash; Chest pain, Rash; Chest pain, Rash Chest pain, Rash; Chest pain, Rash; Chest pain, Rash
Mother mentioned when bringing in the daughter in at 1:00 pm this afternoon, that she wanted to ment... Mother mentioned when bringing in the daughter in at 1:00 pm this afternoon, that she wanted to mention that the Patient upon getting in the car was complaining of rash on chest and pain in chest, this was around 10:30 this morning, after mom told MA the MA went to the covering provider and was told to tell him mom to give him an antihistamine Zyrtec and then informed Dr. of the incident and he agreed with provider recommendation More
2851071 7 M MO 07/24/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8209CB
Z007851
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
n/a n/a
2851073 F 07/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Arexvy administered to pregnant women; healthcare system decided to switch from Arexvy to Abrysvo du... Arexvy administered to pregnant women; healthcare system decided to switch from Arexvy to Abrysvo due to some instances where Arexvy was administered to pregnant women; This non-serious prospective pregnancy case was reported by a other health professional via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to pregnant women) and product use in unapproved population (Verbatim: healthcare system decided to switch from Arexvy to Abrysvo due to some instances where Arexvy was administered to pregnant women). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 16-JUL-2025 The health care professional reported that the Arexvy vaccine administered to pregnant women, which led to vaccine exposure during pregnancy and contraindicated product administered. The healthcare system decided to switch from Arexvy to Abrysvo due to some instances where Arexvy was administered to pregnant women. She had no other details about these administrations. More
2851074 F NC 07/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via... Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in May 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter was the patient. The patient received her first Shingrix dose in May 2023, she forgot to receive her second dose. Nothing else was reported. Till the time of reporting, the patient did not receive 3rd dose of Shingrix vaccine, which led to incomplete course of vaccination. More
2851075 11 M IL 07/24/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 55N34
Wrong product administered Wrong product administered
patient received Bexsero inadvertently, the patient was supposed to receive Menveo; This non-serious... patient received Bexsero inadvertently, the patient was supposed to receive Menveo; This non-serious case was reported by a nurse and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 55N34, expiry date 30-SEP-2027) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 17-JUL-2025, the patient received Bexsero. The patient did not receive Menveo. On 17-JUL-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient received Bexsero inadvertently, the patient was supposed to receive Menveo). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-JUL-2025 The reporter stated that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo, which led to wrong vaccine administered. More
2851076 F 07/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
vaccine not administered within time frame specified in PI; This non-serious case was reported by a ... vaccine not administered within time frame specified in PI; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: vaccine not administered within time frame specified in PI). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 18-JUL-2025 The consumer stated that the second dose of Shingrix had not been administered within the 2 to 6 month time frame. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2851077 F 07/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Patient got shingles after receiving immunization; This serious case ... Suspected vaccination failure; Patient got shingles after receiving immunization; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient got shingles after receiving immunization). 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 Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 18-JUL-2025 Patient got shingles after receiving immunization. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2851078 CA 07/24/2025 HEP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9K34M
H4279
Hypotonia, Immediate post-injection reaction, Syncope; Hypotonia, Immediate post... Hypotonia, Immediate post-injection reaction, Syncope; Hypotonia, Immediate post-injection reaction, Syncope More
fainted seconds after receiving the vaccines; very limp; This serious case was reported by a pharmac... fainted seconds after receiving the vaccines; very limp; This serious case was reported by a pharmacist via other manufacturer and described the occurrence of fainting in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4279, expiry date 30-AUG-2027) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 9K34M, expiry date 05-SEP-2025) for prophylaxis. On an unknown date, the patient received Boostrix .5 ml and Engerix B .5 ml. On an unknown date, an unknown time after receiving Boostrix and Engerix B, the patient experienced fainting (Verbatim: fainted seconds after receiving the vaccines) (serious criteria GSK medically significant) and limping (Verbatim: very limp). The outcome of the fainting and limping were not reported. It was unknown if the reporter considered the fainting and limping to be related to Boostrix and Engerix B. The company considered the fainting to be unrelated to Boostrix and Engerix B. It was unknown if the company considered the limping to be related to Boostrix and Engerix B. Additional Information: GSK Receipt Date: 14-JUL-2025 A pharmacist had called and reported an adverse event for Boostrix and Engerix. The healthcare professional had stated that a patient had come in to receive vaccines and had expressed nervousness and had been scared to receive an injection. The pharmacist had left the patient in the room with another pharmacist, but shortly after leaving the room, the healthcare professional (HCP) had heard a scream. The other pharmacist, who had been left in the room with the patient, had opened the door and requested assistance because the patient had fainted seconds after receiving the vaccines Boostrix and Engerix. The HCP had called an ambulance, and the patient had woken up upon arrival of the emergency personnel and had been able to answer questions but had appeared very limp. The patient had been transported to the hospital due to fainting, and the HCP had been unable to provide any additional details or information during the call.; Sender's Comments: A case of Syncope, after receiving Boostrix and Engerix B , in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2851079 07/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Rash, Vaccination failure Herpes zoster, Rash, Vaccination failure
Suspected vaccination failure; got shingles anyway; This serious case was reported by a consumer via... Suspected vaccination failure; got shingles anyway; 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: got shingles anyway). 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. 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: 12-JUL-2025 This case was reported by a patient via interactive digital media. The patient received Shingles shots and got shingles anyway, but a very mild case. The patient had no pain, no itching, just a rash. The patient stated probably would have been much worse without the shots.; 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 Shingles vaccine. More
2851080 F 07/24/2025 HEP
HIBV
HIBV
PNC13
TDAP
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
UNKNOWN MANUFACTURER
PFIZER\WYETH
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
Paralysis; Paralysis; Paralysis; Paralysis; Paralysis Paralysis; Paralysis; Paralysis; Paralysis; Paralysis
had like a type of palsy after vaccinations; This serious case was reported by a consumer via other ... had like a type of palsy after vaccinations; This serious case was reported by a consumer via other manufacturer and described the occurrence of paralysis in a 15-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis, Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for prophylaxis and HIB vaccine conj (tet tox) (Act hib) for prophylaxis. On an unknown date, the patient received DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib. On an unknown date, an unknown time after receiving DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib, the patient experienced paralysis (Verbatim: had like a type of palsy after vaccinations) (serious criteria GSK medically significant and other: Medically Significant). The outcome of the paralysis was unknown. The reporter considered the paralysis to be related to DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib. The company considered the paralysis to be unrelated to DTPa vaccine, Hepatitis B vaccine and Hib vaccine. The company considered the paralysis to be related to Prevnar 13 and Act hib. Additional Information: GSK receipt date: 15-JUL-2025 The reporter reported that the patient who experienced a reaction that resembled a type of palsy after receiving the pneumococcal vaccine CONJ 13V (CR M 197) Prevnar 13, hepatitis B vaccine, HIB (PRP/T) Vaccine (ACT-HIB), and Diphtheria toxoid, Pertussis acellular, Tetanus toxoid vaccine (DTaP). The patient's past medical history, medical treatments, vaccinations, and family history were not provided. The patient received an unknown dose of the suspect HIB (PRP/T) vaccine (powder and solvent for solution for injection), an unknown dose of hepatitis B vaccine produced by an unknown manufacturer via an unknown route and administration site, an unknown dose of Prevnar 13 not produced by Sanofi Pasteur via an unknown route and administration site, and an unknown dose of DTaP not produced by Sanofi Pasteur (formulation not reported) (strength, expiry date, and lot number not reported for all) via an unknown route and administration site, all for immunization. The reporter reported that on an unknown date, the patient developed a reaction that resembled a type of palsy (paralysis) with unknown latency. The patient was followed by an allergist, who suspected that an egg or animal component might have caused the episode. The caller was unable to clarify the palsy further, including its location on the body. It was not reported whether the patient received corrective treatment for the event. At the time of reporting, the outcome was unknown for the event.; Sender's Comments: A case of Paralysis, an unknown time after receiving DTPa vaccine, Hepatitis B vaccine and Hib vaccine, in a 15-month-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2851081 07/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JUL-2025 This case was reported by a consumer via interactive digital media. The patient took Shingrix and 2 months later got Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming 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,and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix . More
2851082 07/24/2025 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; got it 3 months after my 2nd shot; This serious case was reported by ... Suspected Vaccination failure; got it 3 months after my 2nd shot; 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: got it 3 months after my 2nd shot). 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: 20-JUL-2025 This case was reported by a patient via interactive digital media. Reporter took the 2 vaccines and got it 3 months after his/her 2nd shot. Patient honestly was in shock. Right after vaccinations seemed weird to patient. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). More
2851083 07/24/2025 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; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). 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: 18-JUL-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine, 2 shots and still got shingles and stated that vaccine is only 91 percent effective. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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 Shingles vaccine (1st dose) and Shingles vaccine (2nd dose) More
2851084 4 F GA 07/24/2025 DTAPHEPBIP
DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 X9EP5
7D2Y4
Erythema, Pain; Erythema, Pain Erythema, Pain; Erythema, Pain
localized reaction of redness; localized reaction of pain; gave a patient a Kinrix and a Pediarix at... localized reaction of redness; localized reaction of pain; gave a patient a Kinrix and a Pediarix at the same time; were the 3rd dose of Kinrix and 4th dose of Pediarix of the patient in the DTap series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP5, expiry date 09-MAR-2026) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. On 06-NOV-2024, the patient received the 4th dose of Pediarix and the 3rd dose of Kinrix. On 06-NOV-2024, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: gave a patient a Kinrix and a Pediarix at the same time) and inappropriate schedule of drug administration (Verbatim: were the 3rd dose of Kinrix and 4th dose of Pediarix of the patient in the DTap series). On an unknown date, the patient experienced localized erythema (Verbatim: localized reaction of redness) and pain localized (Verbatim: localized reaction of pain). The outcome of the localized erythema and pain localized were resolved and the outcome of the overdose and inappropriate schedule of drug administration were unknown. It was unknown if the reporter considered the localized erythema and pain localized to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. It was unknown if the company considered the localized erythema and pain localized to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix 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: 06-NOV-2024 and 23-DEC-2024 The medical assistant reported that they gave a patient a Kinrix and a Pediarix at the same time and according to reporter, the doses were the 3rd and 4th doses of the patient in the DTap series, which led to overdose and inappropriate schedule of drug administration. The patient may had more localized reaction of redness or pain but that patient would be fine and no follow-up was needed. The Vaccine Administration Facility was the same as Primary Reporter More
2851085 66 M CA 07/24/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2334
Incorrect route of product administration Incorrect route of product administration
Twinrix subcutaneous administration; This non-serious case was reported by a other health professio... Twinrix subcutaneous administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 66-year-old male patient who received HAB (Twinrix) (batch number P2334, expiry date 18-SEP-2027) for prophylaxis. On 10-JUL-2025, the patient received Twinrix (unknown arm). On 10-JUL-2025, an unknown time after receiving Twinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Twinrix subcutaneous administration). The outcome of the intramuscular formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-JUL-2025 The health care provider wanted to know how to proceed after a patient had received Twinrix administered subcutaneously, instead of intramuscularly, with a rather long needle in the arm, which led to Intramuscular formulation administered by other route. More
2851086 PA 07/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 57H54
Product storage error Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number 57H54, expiry date 31-JAN-2026) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 14-JUL-2025 The Licensed Practical Nurse reported that the Menveo 1-vial vaccine had been through a temperature excursion for 78 cumulative hours and reached a temperature was high as 55.8-degree Fahrenheit which led to incorrect storage of drug. The reporter did not mention that a patient was involved but she confused the stability data of the Menveo 1-vial presentation with the stability data of the Menveo 2-vial presentation, thinking that the vaccine Menveo was still stable More
2851087 F NY 07/24/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received a 1st dose of Engerix-B 2 months ago, she is late for her second dose/missed dose; This non... received a 1st dose of Engerix-B 2 months ago, she is late for her second dose/missed dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who did not receive HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (received 1st dose on 7th May 2025, Batch number: 4BX39 and Expiry date: 29-JUL-2027). On an unknown date, the patient did not receive the 2nd dose of Engerix B. The patient experienced incomplete course of vaccination (Verbatim: received a 1st dose of Engerix-B 2 months ago, she is late for her second dose/missed dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:17-JUL-2025 The reporter called to know how to proceed for a second late dose of Engerix-B. Patient was coming on 17th July 2025 to receive her second dose. The reporter wanted to know when they could administer the third dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination. More
2851088 M 07/24/2025 COVID19
 MODERNA
Fall, Foaming at mouth, Head injury Fall, Foaming at mouth, Head injury
8 hours later, patient was on the floor in his bedroom/and he fell; hit his head; foaming at the mou... 8 hours later, patient was on the floor in his bedroom/and he fell; hit his head; foaming at the mouth; This spontaneous case was reported by a consumer and describes the occurrence of FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth). At the time of the report, FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth) outcome was unknown. No concomitant medication was reported. The patient had taken their second Moderna shots. 8 hours later, he was on the floor in his bedroom, foaming at the mouth, and he fell and hit his head. Then rushed to the hospital. Battery test was performed, and they saw nothing. He never went back for another shot. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 24-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:Master case More
2851089 F NY 07/24/2025 COVID19
 UNKNOWN MANUFACTURER
 5683_MF012
COVID-19, Fatigue, Influenza like illness, SARS-CoV-2 test, Vaccination failure COVID-19, Fatigue, Influenza like illness, SARS-CoV-2 test, Vaccination failure
I had extreme fatigue; Flu like run down mild, very mild symptoms; Got Covid in 21SEP2024; Got Covid... I had extreme fatigue; Flu like run down mild, very mild symptoms; Got Covid in 21SEP2024; Got Covid in 21SEP2024; This serious initial Spontaneous report was received by Novavax on 16-May-2025 from a Consumer or other non-health professional via Novavax Medical Information (MI number NOV25- 00329). A 65-year-old Female was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)(Intramuscular) (LOT: 5683_MF012) on 26-Oct-2023. The following medical history was reported: COVID (on 04-Apr-2022 and 10-Feb-2023). No concomitant medications were reported. On 26-Oct-2024, the same day after vaccination the patient "Got Covid in 21SEP2024" (Vaccination failure) (Serious: Other Medically Important Condition) (COVID-19). On 21-Sep-2024, 332 days after vaccination, the patient "Got Covid in 21SEP2024" (COVID-19). On an unspecified date after vaccination the patient experienced extreme fatigue (Fatigue), and Flu like run down mild, very mild symptoms (Influenza like illness). On an unspecified date after vaccination the patient experienced I had extreme fatigue(Fatigue), and Flu like run down mild, very mild symptoms(Influenza like illness). Treatment included Paxlovid (nirmatrelvir/ritonavir). Relevant lab tests included: COVID-19 TEST (Result: Positive, Test Date: 04-Apr-2022), COVID-19 TEST (Result: Positive, Test Date: 10-Feb-2023) and COVID-19 TEST (Result: Positive, Test Date: 21-Sep-2024). At the time of reporting, the event outcome of Vaccination failure was Recovered/Resolved while the event outcome of Fatigue, Influenza like illness, and COVID-19 was Unknown.; Sender's Comments: This 65-year-old Female experienced Fatigue, Influenza like illness, Vaccination failure and COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Vaccination failure was reported as serious. The events COVID-19, Fatigue, and Influenza like illness were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Vaccination failure, COVID-19, Fatigue and Influenza like illness is considered Possible. More
2851090 56 F 07/24/2025 COVID19
COVID19
COVID19
 NOVAVAX
NOVAVAX
NOVAVAX
 6024MF014A
6024MF014A
6024MF014A
Breakthrough COVID-19, Condition aggravated, Discomfort, Fatigue, Joint range of... Breakthrough COVID-19, Condition aggravated, Discomfort, Fatigue, Joint range of motion decreased; Joint swelling, Joint warmth, Nasopharyngitis, Pain, Pyrexia; SARS-CoV-2 test, Sensitive skin, Vaccination failure More
I had a second flare in May; Right knee swelled; Right knee...was hot; Right knee...I could not bend... I had a second flare in May; Right knee swelled; Right knee...was hot; Right knee...I could not bend it; I had CPPD flare; Fever; Cold-like symptoms; Uncomfortable; I got COVID after getting vaccinated with Novavax's COVID vaccine; Extreme fatigue/Extremely tired; Achiness all over; Skin sensitivity; Your vaccine did not work; This serious initial Spontaneous safety report was received by Novavax via web portal (Adverse Event Submission No.US-1000000501-NVAX) on 09-Jun-2025 from a Consumer or other non-health professional. A 56-year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (Intramuscular) (Lot number was not provided in the report.) on 26-Oct-2024. The following medical history was reported: COUGH VARIANT ASTHMA. No concomitant medications were reported. On 26-Oct-2024, 1 Day after vaccination, the patient reported "Your vaccine did not work"(Vaccination failure)(Serious: Other Medically Important Condition), On 24-Dec-2024, 60 Day after vaccination the patient reported "I got COVID after getting vaccinated with Novavax's COVID vaccine" (Breakthrough COVID-19). Treatment included Paxlovid. On unknown date in Dec-2024, after vaccination the patient reported "I was a week in bed" (Adverse event). Relevant lab tests included: COVID-19 RAPID POC TEST (Result: Positive, Test Date: 24-Dec-2024) and COVID-19 RAPID POC TEST (Result: Positive, Test Date: 21-Jun-2022). At the time of reporting, the event outcome of Vaccination failure was Recovered/Resolved on 26-Oct-2024, Adverse event was Unknown and Breakthrough COVID-19 was Recovering/Resolving. Few discrepancies were identified in the source document: For the event of vaccination failure, event onset date was captured as the date of vaccine administration and event cessation was captured to match the event start date with an outcome of recovered/resolved as it is a special situation, Other Medically Important Condition event. The reporter indicated that the Novavax vaccine was administered as a booster dose; however, it was also stated that only one COVID-19 vaccination dose has been received to date. On 18-Jun-2025, significant information was received from consumer via a query response with the following updates: CPPD (Pseudogout) (Calcium Pyrophosphate Dihydrate deposition disease) and Severe Osteoarthritis were added to patient's medical history. Patient's past therapy was updated with 2 administrations of Pfizer Covid-19 vaccines (reported as full course) followed by Moderna Covid-19 vaccine booster. Novavax vaccine therapy start and end dates were updated from 26-Oct-2024 to 07-Oct-2024, and lot number 6024MF014A was reported with an expiration date of 31-Oct-2024. The onset and cessation dates of the event Vaccination failure were updated from 26-Oct-2024 to 07-Oct-2024. The following events were added: On unspecified date in Dec-2024, the patient experienced "Extreme fatigue/Extremely tired" (Fatigue), "Achiness all over" (Pain), "Skin sensitivity" (Sensitive skin), "Fever" (Pyrexia), "Cold-like symptoms" (Nasopharyngitis), "Uncomfortable" (Discomfort). On 05-Jan-2025, the patient experienced "Right knee swelled" (Joint swelling), "Right knee... was hot" (Joint warmth), "Right knee... I could not bend it" (Joint range of motion decreased), and "I had CPPD flare" (Condition aggravated). On an unspecified date in May-2025, the patient experienced "I had a second flare in May" (Condition aggravated). At the time of reporting, the outcome of the events Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated (second flare) was Unknown. The outcome of the event Condition aggravated (first flare) was Recovered/Resolved (on an unknown date). Discrepancies were identified in the source document: For the event of vaccination failure, event onset date was captured as the date of vaccine administration and event cessation was captured to match the event start date with an outcome of recovered/resolved as it is a special situation, Other Medically Important Condition event. The outcome of the event "I had CPPD flare" (Condition aggravated) was not reported but was captured as Recovered/Resolved due to reported second episode of the same event. On 28-Jun-2025, significant information was received from consumer via a query response with the following updates: Primary physician was added as another reporter. Patient's date of birth was added. The following medical history was added: Bursitis of the shoulders (left+right). The previously reported patient's medical history was updated: CPPD: the start date was updated from unknown to 05-Jan-2025, severe osteoarthritis onset date was updated from unknown to 2015 (reported as: "started 10 years ago"), cough variant asthma was updated from continuing to No and the onset was updated from unknown to 2015. The previously reported patient's past therapies were updated: Comirnaty (previously reported as Pfizer vaccine) with the therapy start and stop date on 02-Apr-2021 for the first dose (Lot number: EW0150, left arm), 23-Apr-2021 for the second dose (Lot number: EW0171, left arm), and 29-Nov-2021 for the booster dose (Lot number: FH8030, right arm). Moderna vaccine was updated to Spikevax (Lot number: 013H22A, right arm) with the therapy start and stop date on 05-Nov-2022. The following details were updated for the reported events: The onset dates of the following events were updated from an unspecified date in Dec-2024 to 25-Dec-2024: Fever (PT: Pyrexia), Cold-like symptoms (PT: Nasopharyngitis), Uncomfortable (PT: Discomfort). The outcome of the event Right knee swelled (PT: Joint swelling) was Recovering/Resolving. The outcome of the events "Right knee๏ฟฝwas hot" (PT: Joint warmth), "Right knee๏ฟฝI could not bend it" (PT: Joint range of motion decreased) was Recovered/Resolved with Sequelae, on an unknown date. The outcome of the event Skin sensitivity (PT: Sensitive skin) was Recovered/Resolved on an unknown date. The outcome of the event Fever (PT: Pyrexia) was Recovered/Resolved on 29-Dec-2024. The outcome of the events Cold-like symptoms (PT: Nasopharyngitis) and Uncomfortable (PT: Discomfort) were Recovered/Resolved on 03-Jan-2025. The outcome of the events of "I got COVID after getting vaccinated with Novavax COVID vaccine" (PT: Breakthrough COVID-19)" was Recovered/resolved on 04-Jan-2025, "I had a second flare in May (PT: Condition aggravated) was Recovered/Resolved on 15-Jun-2025. The cessation date for the event of "I had CPPD flare" (PT: Condition aggravated) (first flare) was updated to 20-Jan-2025.; Sender's Comments: This 56 year-old Female experienced Vaccination failure, Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Breakthrough COVID-19, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated and Condition aggravated after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Vaccination failure was reported as serious. The events Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Breakthrough COVID-19, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated and Condition aggravated were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Vaccination failure is considered Related, and the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Fatigue, Pain, Sensitive skin, Pyrexia, Nasopharyngitis, Discomfort, Breakthrough COVID-19, Joint swelling, Joint warmth, Joint range of motion decreased, Condition aggravated and Condition aggravated is considered Possible. More
2851091 M MI 07/24/2025 COVID19
 PFIZER\BIONTECH
Myocarditis Myocarditis
myocarditis; This is a spontaneous report received from a Consumer or other non HCP. A male patient... myocarditis; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (death, medically significant), outcome "fatal". It was unknown if therapeutic measures were taken as a result of myocarditis. The patient date of death was unknown. Reported cause of death: "myocarditis". It was not reported if an autopsy was performed. Additional information: It is Unknown if other vaccine same date, if other vaccine in four weeks, if other medications in two weeks. Covid vaccine caused myocarditis and death. AE resulted in: Patient died. if autopsy performed: Unknown. If treatment received: Unknown. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: myocarditis More
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2851092 F TX 07/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old... covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing); "kidney" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; OXYBUTYNIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient had just expressed that they did take the vaccine, the Pfizer shots (Clarified as Pfizer Covid-19 Vaccine) and have taken the medication (clarified as Paxlovid) before. When probed to clarify if patient had covid again after getting the medication and vaccine, transferring agent stated, "Yes." Age adverse event(s) started: Consumer stated, "I am 69. When I had it before it was last year, I was 67. I am 69 now, 67."(Age at the time of AE was not clarified appropriately. Hence, not captured in tab). Consumer is being prescribed to Paxlovid again. Consumer stated, "I did not take the vaccine earlier, I took the vaccine after I completed the pack and went back to work. I took the vaccine during the Covid. During the covid, I did take the Pfizer vaccine." Consumer stated, "The only other thing that they gave is cough syrup, that's it." Other medical conditions and concomitant medication: patient took take a cholesterol and kidney pill. Indication: patient tested positive. One of the kids at her daycare took the test on Thursday and they call me back on Friday and told her tested positive and that they were sending a prescription for the cough syrup and the Pfizer pack. When probed to clarify if consumer had not taken the Covid-19 shot before, consumer stated, "Yes, I have. I had it in my right arm. I take it when they first start giving the shot. I have had it one time at the 'first of' year at the pharmacy where I am going to pick my medication. The other vaccine that I took was the Flu Vaccine (Unspecified Flu Vaccine).(pending clarification). More
2851093 93 M MA 07/24/2025 COVID19
 PFIZER\BIONTECH
 HGU677
Fall, Wrist fracture Fall, Wrist fracture
The previous year on 19Oct2023, the Dad had unfortunately fallen and broken his wrist; The previous ... The previous year on 19Oct2023, the Dad had unfortunately fallen and broken his wrist; The previous year on 19Oct2023, the Dad had unfortunately fallen and broken his wrist; This is a spontaneous report received from a Consumer or other non HCP. A 93-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Lot number: HGU677) at the age of 93 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Blood sugar (Type II diabetes)" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Blood Flow" (unspecified if ongoing); "Blood pressure regulation (Hypertension)" (unspecified if ongoing); "Constipation (preventative)" (unspecified if ongoing), notes: Avoid constipation; "Bullous pemphigoid (skin condition)" (unspecified if ongoing); "Prevent fungus from recurring in large toe and nails" (unspecified if ongoing); "intermittent skin breakdown on buttock" (unspecified if ongoing); "Scalp psoriasis" (unspecified if ongoing); "facial dermatitis" (unspecified if ongoing); "yeast in groin areas/prevent recurrence of yeast in groing areas" (unspecified if ongoing); "Maintain bone strength" (unspecified if ongoing); "Probably to maintain sufficient Vit.D levels" (unspecified if ongoing); "Skin breakdown" (unspecified if ongoing); "Alzheimer's disease", start date: 2020 (unspecified if ongoing), notes: his dementia had presumably progressed since the fall of 2023.; "Vascular Dementia", start date: 2020 (unspecified if ongoing); "Bladder Cancer" (unspecified if ongoing), notes: Many years ago and In remission as of May2021; "Redness" (unspecified if ongoing); "Prostate cancer", start date: 1999, stop date: 1999, notes: Resolved with surgery; "Significant Hearing loss", start date: Mar2023 (unspecified if ongoing), notes: hearing test in Mar2023. He was deemed a candidate for hearing aids.; "Hyperlipidemia" (unspecified if ongoing); "weakness" (unspecified if ongoing); "Disease Of thyroid gland" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing), notes: Occasional: Irritated eyes; "Appendectomy" (unspecified if ongoing); "Bladder surgery" (unspecified if ongoing); "Colectomy" (unspecified if ongoing); "Hernia repair" (unspecified if ongoing); "Phacoemulsification Aspiration with IOL Implant", start date: 25Apr2018 (unspecified if ongoing), notes: Right, Location: DFD OR; Service: Ophthalmology; "Phacoemulsification Aspiration with IOL Implant", start date: 23May2018 (unspecified if ongoing), notes: Left, Location: DFD OR; Service: Ophthalmology; "itching" (unspecified if ongoing); "rash" (unspecified if ongoing); "former smoker" (unspecified if ongoing), notes: Tobacco comments: Quit in 1995; "cerebral amyloid angiopathy" (unspecified if ongoing); "Moderata cerebral atrophy", start date: 14Oct2020 (unspecified if ongoing), notes: Ventricular syalam normal. No hydrocephalus. normal vascular flow voids present.; "Hypokalemia" (unspecified if ongoing); "metastatic cancer", start date: 2018 (unspecified if ongoing), notes: dementia and evidence of metastatic cancer (2018) emanating from the bladder.; "dementia", start date: 2018 (unspecified if ongoing); "Prostate surgery" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Bladder wall tumor" (unspecified if ongoing). The patient's family history included: "cancer" (unspecified if ongoing), notes: Sister, brother. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol; TRADJENTA oral taken for type 2 diabetes mellitus; LEVOTHYROXINE SODIUM taken for hypothyroidism; LEVOTHYROXINE SODIUM taken for hypothyroidism; ASPIRIN [ACETYLSALICYLIC ACID] oral taken for thrombosis; NORVASC taken for hypertension; GERI KOT taken for constipation; CLEARLAX [MACROGOL 3350] taken for constipation; DUPIXENT subcutaneous taken for pemphigoid; TERBINAFINE taken for fungal infection; AQUAPHOR [MINERAL WAX;PARAFFIN, LIQUID;PETROLATUM;WOOL ALCOHOLS] taken for skin disorder; KETOCONAZOLE taken for psoriasis; CLOBETASOL PROPIONATE taken for psoriasis; KETOCONAZOLE taken for dermatitis; MICONAZOLE NITRATE taken for fungal infection; MENTHOL taken for fungal infection, erythema; CALCIUM CITRATE WITH VITAMIN D3 taken for bone disorder; VITAMIN D3 taken for vitamin d deficiency; AMLODIPINE; ZOFRAN [ONDANSETRON] intravenous; NIZORAL topical; NIZORAL; SYNTHROID oral; POLYETHYLENE GLYCOL 3350 oral; SENOKOT; ZOCOR oral; NORVASC; GLUTOSE; DEXTROSE intravenous; GLUCAGON intramuscular; GLUCOSE oral; SYNTHROID oral; PRINIVIL oral; MILK OF MAGNESIA oral; MENTHOL;ZINC OXIDE topical; MICOTIN [MICONAZOLE NITRATE] topical; ATIVAN. The patient also took other concomitant therapy. Past drug history included: Amoxicillin, start date: Jul2020, stop date: 03Oct2021, for H. Pylori infection, notes: for 2 weeks. Dose: 875 mg Unit: 1 tablet Frequency: 3x per day; Levofloxacin, start date: Jul2020, stop date: 03Oct2021, for H. Pylori infection, notes: Unit 1 tablet Frequency: 1x per day; Omeprazole dr, start date: Jul2020, stop date: 03Oct2021, for H. Pylori infection, notes: Dose: 40 mg Unit 1 capsule Frequency: 2x per day; Culturelle ultimate strength probiotic, start date: Jul2020, stop date: 03Oct2021, for H. Pylori infection, notes: Dose: 20 billion CFUs Unit 1 capsule Frequency: 1x per day; Tecentriq, reaction(s): "bullous pemphigoid", notes: developed bullous pemphigoid in 2028 and discontinued. Vaccination history included: BNT162b2 (DOSE 1, Location: Upper arm, lot number:EN6200 or EN5318), administration date: 05Feb2021, when the patient was 91-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, Location: Upper arm, lot number: EN6200 or EN6700), administration date: 04Mar2021, when the patient was 91-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), Location: Upper arm , Lot# FE3592), administration date: 25Sep2021, when the patient was 91-year-old, for Covid-19 Immunization; moderna COVID-19 vaccination (DOSE 4 (BOOSTER), SINGLE), administration date: 31Mar2022, when the patient was 92-year-old, for Covid-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose: 5, Location: Upper arm, Lot# GJ5342), administration date: 23Sep2022, when the patient was 92-year-old, for Covid-19 Immunization; moderna COVID-19 vaccination (DOSE 6 (BOOSTER), SINGLE), administration date: 23May2023, when the patient was 93-year-old, for Covid-19 Immunization. The following information was reported: WRIST FRACTURE (medically significant), FALL (medically significant) all with onset 19Oct2023, outcome "unknown" and all described as "The previous year on 19Oct2023, the Dad had unfortunately fallen and broken his wrist".Clinical course: The previous year on 19Oct2023, the dad had unfortunately fallen and broken his wrist. Since then, the siblings and reporter had cared for the Dad 24/7. Reported lived with him and cared for him the vast majority of the time. And helped him with a variety of his Activities of Dally living. This included walking with him to and from the bathroom. As they walked, reporter held the back of his belt with his left hand, and gave him light hand to hold. This was a technique we had learned from a visiting occupational therapist, who had come to the house in 2023 to help us after the fall. Since the fall reporter had also assisted the Dad in the bathroom, cleaning him, changing his disposable brief as needed. etc. It was not unusual for them to get up during the overnight hours so he could use the toilet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500126283 same patient, different dose and event ; More
2851095 F GA 07/24/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Biopsy skin, COVID-19, Drug ineffective, Eosinophil count, Magnetic resonance im... Biopsy skin, COVID-19, Drug ineffective, Eosinophil count, Magnetic resonance imaging; Physical examination; Biopsy skin, COVID-19, Drug ineffective, Eosinophil count, Magnetic resonance imaging; Physical examination More
Eosinophilic fasciitis following COVID-19; Eosinophilic fasciitis following COVID-19; The initial ca... Eosinophilic fasciitis following COVID-19; Eosinophilic fasciitis following COVID-19; The initial case was missing the following minimum criteria: [ICH-unspecified product]. Upon receipt of follow-up information on (18Jul2025), this case now contains all required information to be considered valid. This is a literature report. A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single and as dose 2, single for immunisation. The patient's relevant medical history included: "comprising gastroesophageal dysmotility" (unspecified if ongoing), notes: necessitating total parenteral nutrition; "intestinal dysmotility" (unspecified if ongoing), notes: necessitating total parenteral nutrition; "total parenteral nutrition" (ongoing), notes: no recent alterations in her total parenteral nutrition formulations; "rectal adenocarcinoma" (unspecified if ongoing); "primary hyperparathyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Melanoma" (unspecified if ongoing); "paresthesia" (unspecified if ongoing); "edema" (unspecified if ongoing); "progressive induration of the extremities with restricted motion" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 3 weeks after the suspect product(s) administration, outcome "unknown" and all described as "Eosinophilic fasciitis following COVID-19"; EOSINOPHILIC FASCIITIS (medically significant), 2 months after the suspect product(s) administration, outcome "recovering", described as "Eosinophilic fasciitis following COVID-19". The patient underwent the following laboratory tests and procedures: Biopsy skin: moderate, mixed inflammatory infiltrate affecting, notes: affecting the fascia and skeletal muscle, with associated edema; Eosinophil count (0-0.36): 0.71 x10 3/mm3, notes: 10%; Magnetic resonance imaging: fascial enhancement without involvement of the, notes: subcutaneous fat or musculature; Physical examination: plaque formation and stiffness affecting the hips, notes: pelvic girdle, lower thoracic back, bilateral proximal thighs, distal legs, and forearms, with a positive "groove sign". Therapeutic measures were taken as a result of eosinophilic fasciitis. A woman, with a complex medical history comprising gastroesophageal and intestinal dysmotility necessitating total parenteral nutrition, rectal adenocarcinoma, primary hyperparathyroidism, osteoporosis, and melanoma, developed eosinophilia (10%, 0.71 [0.00 e 0.36 3 103/ _L]), paresthesia, edema, progressive induration of the extremities with restricted motion, and low-grade fever with progressive weight loss 2 months after contracting SARS-CoV-2. She reported no recent alterations in her total parenteral nutrition formulations. Physical examination showed plaque formation and stiffness affecting the hips, pelvic girdle, lower thoracic back, bilateral proximal thighs, distal legs, and forearms, with a positive "groove sign". A skin biopsy revealed a moderate, mixed inflammatory infiltrate affecting the fascia and skeletal muscle, with associated edema. Magnetic resonance imaging findings showed fascial enhancement without involvement of the subcutaneous fat or musculature. The patient was diagnosed with EF and received prednisone 10 mg per day with concurrent methotrexate at 10 mg per week. Six weeks later, dupilumab was introduced at a weekly subcutaneous dose of 300 mg, and prednisone and methotrexate doses were then tapered. The patient reported a significant reduction in edema and substantial improvement in range of motion. DISCUSSION: The etiology of EF is complex, with many factors potentially influencing its development. Although some triggers have been identified, the complete pathophysiologic landscape remains elusive. None of the 3 patients described in this case series had a history of preceding exercise, gadolinium exposure within 6 months of EF onset, comorbid Raynaud phenomenon, or symptoms compatible with lichen sclerosis. A noticeable pattern from our case series is the temporal correlation between onset of EF and COVID-19, spanning weeks to several months postinfection. Although this association could be coincidental, the incidence of such a rare disorder post-SARS-CoV-2 infection in 3 separate cases suggests a relationship worthy of further investigation. Moreover, there have been documented cases of EF emerging after administration of SARS-CoV-2 vaccination. Although it may be argued that these symptoms following SARS-CoV-2 vaccination or infection could potentially represent an exacerbation of preexisting conditions, there are cases where individuals without prior conditions have also developed EF. This offers a compelling clue regarding the potential association between EF and COVID-19. In the 3 cases outlined above, each patient exhibited mild COVID-19 symptoms and did not require hospitalization. Patient 3 received the Pfizer bivalent booster 3 weeks before COVID-19 and the onset of EF symptoms occurred 2 months after. For patient 3, pinpointing the clear trigger for EF would be complex, given the close interval between her SARS-CoV-2 vaccination and subsequent infection. The mechanisms by which SARS-CoV-2 might catalyze the onset of EF are multifarious, potentially encompassing direct viral-induced effects, immune dysregulation, and molecular mimicry. Direct effects of the virus could initiate local tissue damage and inflammation, instigating a cascade of immune responses that eventually manifest as fibrotic alterations, characteristic of EF. Furthermore, the severe systemic inflammatory response, commonly referred to as cytokine storm, that often accompanies COVID-19 could potentially disrupt the finely balanced immune regulation and tolerance mechanisms, leading to an autoimmune reaction. The principle of molecular mimicry posits an additional mechanism through which EF could be triggered. This principle describes a situation where the immune response, although targeting viral proteins, may inadvertently affect self-antigens in the fascia that share antigenic structures with these proteins, leading to an autoimmune reaction. Viruses, including SARS-CoV-2, are known to induce significant immune dysregulation, resulting in heightened inflammatory responses and imbalances in various immune cell regulations. This disruption could potentially compromise immune tolerance to self-antigens, setting the stage for the emergence of autoimmune conditions such as EF. Lastly, the concepts of bystander activation and epitope spreading, where a robust immune response to a viral infection inadvertently activates autoreactive immune cells or exposes previously concealed self-antigens, are plausible. Further research is necessary to solidify these hypotheses and elucidate the precise mechanisms underpinning the association between COVID-19 and EF. The mechanisms underlying the onset of EF often involve immune dysregulation, marked by eosinophilia. Intriguingly, in hospitalized patients with COVID-19, eosinopenia has emerged as a notable observation. Interpretations of its significance differ among studies, many of which are region-specific. Authors found a pronounced decrease in eosinophil counts among patients with severe COVID-19 symptoms, hinting that eosinopenia could be associated with increased disease severity. The underlying causes of eosinopenia are still debated and could be multifaceted. The possible triggers range from interruptions in the eosinophil life cycle, apoptosis triggered by type 1 interferon during the acute phase of the infection, eosinophil consumption due to their antiviral activities, to reflection of host immune exhaustion. Notably, the use of corticosteroids, one of the main drugs utilized in the treatment of severe COVID-19, could play a role in the development of eosinopenia. As patients approached discharge, eosinophil counts generally normalized, indicating that a rebound in these counts might correlate with a patient's clinical improvement. This resurgence in eosinophil activity during recovery prompts speculation regarding its potential role in predisposing individuals to conditions such as EF. Although the link between SARS-CoV-2 vaccination and EF has previously been described, to our knowledge, this case series is the first report of the potential association between COVID-19 and EF. A larger patient cohort and a more exhaustive molecular study are necessary to confirm a temporal relationship between EF and COVID-19.; 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, BNT162B2 OMI BA.4-5 cannot be fully excluded. More
2851096 M NC 07/24/2025 HIBV
 SANOFI PASTEUR
Epilepsy Epilepsy
epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case re... epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case linked to US-SA-2025SA209519, US-SA-2025SA209950 and US-SA-2025SA209519 This case involves a 5 months old male patient who had epilepsy after receiving HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel), Polio vaccine inact 3v (Vero) (Ipol) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) all for prophylactic vaccination (Immunisation). On an unknown date in 2017, the patient received an unknown dose (dose 1) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date, the patient received an unknown dose (dose 2) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On 18-Sep-2018, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot U1915AA, strength: standard and frequency: once) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation). On an unknown date in Nov-2017, the patient developed epilepsy (Latency: few days to few months approxmately) following the administration of (dose 1) of suspect HIB (PRP/T) vaccine [ACT-HIB]. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. Seriousness criteria: This event was assessed as medically significant; Sender's Comments: Sanofi company comment dated 23-Jul-2025: This case involves a 5 months old male patient who had epilepsy after receiving HIB (PRP/T) vaccine [ACT-HIB]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed US-SA-2025SA209519:pentacel US-SA-2025SA209950:ipol US-SA-2025SA209519:daptacel More
2851097 M NC 07/24/2025 IPV
 SANOFI PASTEUR
Epilepsy Epilepsy
epilepsy after taking ipol; Initial information received on 18-Jul-2025 regarding an unsolicited val... epilepsy after taking ipol; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case was linked to US-SA-2025SA209387 (master case). This case involves a 5 months old male patient who had epilepsy after receiving IPV (Vero) [Ipol]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Epilepsy in Nov-2017 from 4 months age. Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel); Hib Vaccine Conj (Tet Tox) (Act Hib) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) all for Immunisation. On an unknown date in 2017, The patient also received (dose 1) of suspect IPV (Vero), Suspension for injection unknown strength and expiry date), lot number not reported via unknown route in unknown administration site for immunisation. On an unknown date, The patient also received (dose 2) of suspect IPV (Vero), Suspension for injection unknown strength and expiry date), lot number not reported via unknown route in unknown administration site for immunisation . On 21-Jun-2021, the patient received 0.5ml (Dose 3) of suspect IPV (Vero) (once) Suspension for injection, lot RIG101M (unknown strength and expiry date) via subcutaneous route in left arm for immunisation. On an unknown date in Nov-2017, the patient developed epilepsy after taking ipol (epilepsy) (Latency Few day to months approximately) following the first dose administration of IPol. Reportedly, Patient had epilepsy after taking Pentacel. Patient has been epileptic since he's 4 months old and it lasted "forever". They first noticed it since Nov-2017. Some epileptic episodes were noted when he was given with these vaccines. The patient is on treatment since he's 4 months old. He tried different drugs but caller declined to provide as they're "not really pertinent Action taken was not applicable. An unknown corrective treatment was received for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 23-Jul-2025,This case involves a 5 month old male patient who had epilepsy after receiving IPV (Vero) [Ipol]. Further information regarding tolerance, allergic history, medical history and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. Furthermore, Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel); Hib Vaccine Conj (Tet Tox) (Act Hib) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) all for Immunisation could be the confounding factor for the event US-SA-2025SA209387:IPOL US-SA-2025SA209519:IPOL More
2851098 23 IL 07/24/2025 RAB
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
second dose was supposed to be given on the 7th day, but there was a delay, and the patient was admi... second dose was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule with no reported adverse evenf; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 23 years old and unknown gender patient who had second dose of Rabies (Hdc) Vaccine [Imovax Rabies] was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and second dose was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule with no reported adverse event (inappropriate schedule of product administration) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, a patient was supposed to receive a 3-dose series of IMOVAX. Their second dose was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851099 2 F IL 07/24/2025 HIBV
 SANOFI PASTEUR
 UK151AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
inappropriate use due to reconstituting the ACTHIB powder with a sterile water solution not included... inappropriate use due to reconstituting the ACTHIB powder with a sterile water solution not included in the packaging and the dose was administered to a patient with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 2 years old female patient where reporter reported inappropriate use due to reconstituting the HIB (PRP/T) Vaccine [ACT-HIB] powder with a sterile water solution not included in the packaging and the dose was administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Jul-2025, the patient received 0.5 ml dose 4 of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength- standard) (batch number- UK151AA and expiry date- 30-SEP-2025) via intramuscular route in the left thigh for immunization and inappropriate use due to reconstituting the acthib powder with a sterile water solution not included in the packaging and the dose was administered to a patient with no reported adverse event (Single component of a two-component product administered) (latency- same day). Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851100 0.92 F CA 07/24/2025 HIBV
 SANOFI PASTEUR
 UK201AC
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event, Underdose More
partial dose of ACTHIB due to patient moving during injection with no reported adverse event; Initia... partial dose of ACTHIB due to patient moving during injection with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 months old female patient who received partial dose of HIB (PRP/T) vaccine [ACT-HIB] due to patient moving during injection with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (Pneumococcal 20) for Immunisation. On an unknown date, the patient received a partial dose 4 of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 30-APR-2026 and lot UK201AC) via intramuscular route in the right thigh for Immunization due to patient moving during injection with no reported adverse event (incorrect dose administered) (same day latency). Reportedly, the reporter asked what was appropriate follow up. What was the time she could take another Act-HIB. No side effect. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851101 NM 07/24/2025 TYP
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
inappropriate use due to nurse administered TYPHIM VI to a patient 9 months early with no reported a... inappropriate use due to nurse administered TYPHIM VI to a patient 9 months early with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient with inappropriate use due to nurse administered Typhoid Vi Polysaccharide Vaccine [Typhim Vi]9 months early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in March 2024, the patient received a Dose 1 of suspect Typhoid Vi Polysaccharide Vaccine Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On 21-Jul-2025 he/she again received Dose 2 of same vaccine with an unknown batch number via unknown route in unknown administration site, inappropriate use due to nurse administered typhim vi to a patient 9 months early with no reported adverse event (inappropriate schedule of product administration) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Reportedly, the patient had already gotten the vaccine in Mar-2024 and the nurse administered it yesterday instead of waiting until Mar-2026 Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851102 35 F TX 07/24/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Burning sensation, Dizziness, Hypoaesthesia, Immediate post-injection reaction, ... Burning sensation, Dizziness, Hypoaesthesia, Immediate post-injection reaction, Nausea; Pain, Paraesthesia More
Immediate nausea, pain, dizziness. Persistent paresthesias in arm - burning, numbness, tingling. Immediate nausea, pain, dizziness. Persistent paresthesias in arm - burning, numbness, tingling.
2851103 4 F CA 07/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 YN2X2
Erythema, Skin lesion Erythema, Skin lesion
6x6cm erythematous lesion to the thigh 6x6cm erythematous lesion to the thigh
2851104 74 F MS 07/24/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LC5485
N77J2
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
Patient stated that she just had a sore arm for two days after the vaccine. Patient stated that she just had a sore arm for two days after the vaccine.
2851105 16 M TX 07/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 L5229
No adverse event, Wrong product administered No adverse event, Wrong product administered
The patient arrived for his 16-year vaccines and was missing his MCV and HPV vaccines. Accompanied b... The patient arrived for his 16-year vaccines and was missing his MCV and HPV vaccines. Accompanied by his 11-year-old sister, who was receiving her 11-year vaccines TDAP, HPV, and MCV the patient was administered TDAP, HPV, and MCV as well. We identified the error the following day, but it s important to note that there have been no adverse reactions reported in the patient More
2851123 61 F IN 07/24/2025 PNC21
RSV
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 z005765
XA53Y
Bacterial infection, Erythema, Skin warm; Bacterial infection, Erythema, Skin wa... Bacterial infection, Erythema, Skin warm; Bacterial infection, Erythema, Skin warm More
Patient complained of large area that was red, hot to touch on the deltoid area. She saw her doctor ... Patient complained of large area that was red, hot to touch on the deltoid area. She saw her doctor for it and was diagnosed with bacterial infection. She was prescribed Cephalexin and felt much better and improved. More
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