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
2864579 63 F SC 10/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 342XP
342XP
Dysgeusia, Feeling abnormal, Feeling hot, Headache, Rash; Rash erythematous, Ten... Dysgeusia, Feeling abnormal, Feeling hot, Headache, Rash; Rash erythematous, Tenderness More
Injected arm is tender to the touch; Rash on arm red and hot; Rash on arm red and hot; Rash on arm r... Injected arm is tender to the touch; Rash on arm red and hot; Rash on arm red and hot; Rash on arm red and hot; Metallic taste in mouth after Shingrix vaccine; Low grade headache; Head felt fuzzy/did not feel like self; This non-serious case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 342XP, expiry date 28-APR-2027) for prophylaxis. Concurrent medical conditions included thyroid disorder and hormone replacement therapy. Concomitant products included thyroid, progesterone and estradiol. On 12-SEP-2025 12:30, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 12-SEP-2025, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: Low grade headache) and fuzzy head (Verbatim: Head felt fuzzy/did not feel like self). On 12-SEP-2025 13:30, the patient experienced taste metallic (Verbatim: Metallic taste in mouth after Shingrix vaccine). On 19-SEP-2025, the patient experienced rash (Verbatim: Rash on arm red and hot), erythema of extremities (Verbatim: Rash on arm red and hot) and extremities hot feeling of (Verbatim: Rash on arm red and hot). On an unknown date, the patient experienced tenderness (Verbatim: Injected arm is tender to the touch). On 12-SEP-2025 19:00, the outcome of the taste metallic was resolved (duration 5 hrs 30 min). On 13-SEP-2025, the outcome of the headache and fuzzy head were resolved (duration 1 day). The outcome of the tenderness was not resolved and the outcome of the rash, erythema of extremities and extremities hot feeling of were not reported. It was unknown if the reporter considered the taste metallic, tenderness, headache, fuzzy head, rash, erythema of extremities and extremities hot feeling of to be related to Shingrix. It was unknown if the company considered the taste metallic, tenderness, headache, fuzzy head, rash, erythema of extremities and extremities hot feeling of to be related to Shingrix. Additional Information: GSK Receipt Date: 15-SEP-2025 and 19-SEP-2025 The same day after receiving Shingrix, the patient states she had a low grade headache, did not feel like herself and head felt fuzzy. These lasted until the next day, when she woke up, she felt fine. Patient called back to report an additional adverse event. She states that, she has developed a rash on her arm that was red and hot. It looks like a bee bite and was about 6 inches by 3 inches wide. More
2864581 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
first one made me pretty sick too; This non-serious case was reported by a consumer via interactive ... first one made me pretty sick too; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: first one made me pretty sick too). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK receipt date: 28-SEP-2025 The patient reported case for himself or herself. The batch number was not provided, and we are unable to contact the reporter. The patient never got the second one, but patient wish to take it. More
2864582 F 10/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via in... Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an adult female 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 the shingles). The outcome of the vaccination failure was not reported, and the outcome of the shingles was unknown. 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: 01-OCT-2025 This case was reported by a patient via interactive digital media. The patient got the shingles even though the patient had shot. It was ever painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2864583 10/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Product administered to patient of inappropriate age, Vaccination... Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure More
Suspected vaccination failure; Very slight case of the shingles; patient got shots at 48; This serio... Suspected vaccination failure; Very slight case of the shingles; patient got shots at 48; 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), shingles (Verbatim: Very slight case of the shingles) and inappropriate age at vaccine administration (Verbatim: patient got shots at 48). The outcome of the vaccination failure and shingles were not reported and the outcome of the inappropriate age at vaccine administration was not applicable. 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: 02-OCT-2025 This case was reported by a patient via interactive digital media. Patient had a very slight case of shingles. Patient caught it really very early and they took care of it when patient was 48 and did the shingles shot because patient had heard horror stories. Patient indicated that it was worth taking a risk. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2864584 1 PA 10/09/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 5EF45
Extra dose administered, Product preparation issue Extra dose administered, Product preparation issue
Flulaval was used as the diluent to reconstitute Merck and MMR II and Varivax vaccine; Flulaval was ... Flulaval was used as the diluent to reconstitute Merck and MMR II and Varivax vaccine; Flulaval was used as the diluent to reconstitute Merck and MMR II and Varivax vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-month-old patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number 5EF45, expiry date 09-JUN-2026) for prophylaxis. On 08-SEP-2025, the patient received FluLaval 2025-2026 season. On 08-SEP-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced inappropriate preparation of medication (Verbatim: Flulaval was used as the diluent to reconstitute Merck and MMR II and Varivax vaccine) and inappropriate dose of vaccine administered (Verbatim: Flulaval was used as the diluent to reconstitute Merck and MMR II and Varivax vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 09-SEP-2025 The registered nurse reported that Flulaval was mistakenly used as the diluent to reconstitute Merck's MMR II and Varivax vaccines. Due to this reconstitution error, the patient inadvertently received two doses of Flulaval. More
2864585 VA 10/09/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
Boostrix vaccines after a temperature excursion./The medication fridge had an excursion (32 degrees ... Boostrix vaccines after a temperature excursion./The medication fridge had an excursion (32 degrees Celsius) that was outside of allowable limits; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix vaccines after a temperature excursion./The medication fridge had an excursion (32 degrees Celsius) that was outside of allowable limits). The outcome of the incorrect storage of drug 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: 11-SEP-2025 Reporter called to report a temperature excursion involving Boostrix and Shingrix vaccines. The Reporter stated that the vaccines were exposed to a temperature of 32.8?๏ฟฝC for 93 hours, with no prior excursions reported. During the call, the HCP inquired about the stability of Boostrix and Shingrix following the excursion. They also mentioned that 6 doses of Boostrix and 4 doses of Shingrix had already been administered to 10 different patients after the temperature deviation. They asked whether revaccination would be necessary for the affected individuals. Follow up information received on 22-SEP-2025 There were no adverse events noted. The medication fridge had an excursion (32 degrees Celsius) that was outside of allowable limits. No adverse events were noted by the patients. Summary of changes: The primary reporter details and narrative were updated.; Sender's Comments: GSK-US2025117354:same reporter US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117361:same reporter US-GSK-US2025117358:same reporter US-GSK-US2025117367:same reporter, different patient US-GSK-US2025117369:same reporter More
2864586 M 10/09/2025 DTAP
TDAP
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS

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
Potential TDaP second shot administration under 10 years of age; Potential DTaP administration after... Potential TDaP second shot administration under 10 years of age; Potential DTaP administration after 6 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Boostrix and DTaP vaccine. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving DTaP vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: Potential TDaP second shot administration under 10 years of age) and inappropriate age at vaccine administration (Verbatim: Potential DTaP administration after 6 years of age). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were 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: 15-SEP-2025 A Health Care Provider wanted to know if she could administer Boostrix to an 8-year-old patient that was doing the catch up for the DTaP. The patient only had 1 DTap over 1 year ago and also a TDaP last year. No dates of vaccination nor vaccine's brand names of these last were mentioned, still the adverse event was created for TDaP administration below 10 years of age and the potential administration of the DTaP after the 6 years of age, as well as the potential administration of Boostrix before 10. The Health Care Provider refused to provide any adverse event details (except for the gender). Transfer to second line was attempted, but there were not available agents at the time, so escalation was offered but the Health Care Provider declined it. More
2864588 12 M NY 10/09/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 37F34
Extra dose administered Extra dose administered
Received 2 doses; This non-serious case was reported by a nurse via call center representative and d... Received 2 doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 37F34, expiry date 24-OCT-2027) for prophylaxis. Previously administered products included Boostrix (received 1st dose in 12-JUL-2024). On 25-SEP-2025, the patient received the 2nd dose of Boostrix. On 25-SEP-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Received 2 doses ). The outcome of the extra dose 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: 25-SEP-2025 The nurse reported that she had a student that gave the Boostrix vaccine to, and he actually, already had one on 12-JUL-2024, which led to extra dose administered. So it was not due to another one yet. More
2864589 72 M 10/09/2025 COVID19
COVID19
 MODERNA
MODERNA

Body temperature, Chills, Fatigue, Pyrexia, Tremor; Vaccination site pain Body temperature, Chills, Fatigue, Pyrexia, Tremor; Vaccination site pain
Body tremors; developed fever (101๏ฟฝF); Chills; Fatigue; a sore shoulder or sore injection site; Th... Body tremors; developed fever (101๏ฟฝF); Chills; Fatigue; a sore shoulder or sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body tremors), VACCINATION SITE PAIN (a sore shoulder or sore injection site), PYREXIA (developed fever (101๏ฟฝF)), FATIGUE (Fatigue) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (The patient had 9 Moderna shots since the COVID disease hit.). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. On 17-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, the patient experienced VACCINATION SITE PAIN (a sore shoulder or sore injection site) and FATIGUE (Fatigue). On 26-Sep-2025, the patient experienced TREMOR (Body tremors), PYREXIA (developed fever (101๏ฟฝF)) and CHILLS (Chills). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. In September 2025, TREMOR (Body tremors), VACCINATION SITE PAIN (a sore shoulder or sore injection site), PYREXIA (developed fever (101๏ฟฝF)), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F. No concomitant medications were reported. After the shot, the patient experienced common side effects like injection site pain and fatigue, which resolved quickly. The patient had mild side effects but then did not have any other side effects, nine days after the shot (26-Sep-2025), developed fever (101๏ฟฝF), chills, and body tremors, lasting less than 24 hours. By the next morning, on 27-Sep-2025, everything was gone, and he was fine. The side effects were pretty uneventful, regular side effects, but this was the first time that they gotten something really weird, had a fever and chills 9 days after was a little weird. The patient reported feeling fine with no lingering side effects. This case was linked to US-MODERNATX, INC.-MOD-2025-789766 (E2B Linked Report). This case was linked to MOD-2021-296625 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2025: Live non-significant follow-up received included: Event information, narrative was updated and reference ID added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789766:Patient brother case (Reporter) -Spikevax LP.8.1 PFS More
2864590 68 F NC 10/09/2025 COVID19
 MODERNA
Influenza like illness Influenza like illness
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ... Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Sulfa, Naproxen sodium and Doxycycline. Past adverse reactions to the above products included Allergy with Doxycycline, Naproxen sodium and Sulfa. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic, Allergy to NSAIDs and Urinary tract disorder NOS. Concomitant products included Mirabegron (Myrbetriq) from 01-Jan-2024 to an unknown date for Urinary tract disorder NOS. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Patient experienced similar event from the moderna vaccine not from Pfizer. The event did not cause the patient to seek medical care. There were not any other factors that could have led to the adverse event. No treatment information was reported. This case was linked to MOD-2025-789469 (Patient Link). More
2864591 75 F 10/09/2025 COVID19-2
COVID19-2
 MODERNA
MODERNA

Ear discomfort, Fatigue, Palpitations, Pyrexia, Upper-airway cough syndrome; Vac... Ear discomfort, Fatigue, Palpitations, Pyrexia, Upper-airway cough syndrome; Vaccination site pain More
A little pounding of the heart/Heart pounding; Ear pressure/Pressure in ear; Post nasal drip a littl... A little pounding of the heart/Heart pounding; Ear pressure/Pressure in ear; Post nasal drip a little bit/A little bit of post-nasal drip; Fever; Tiredness; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (A little pounding of the heart/Heart pounding), EAR DISCOMFORT (Ear pressure/Pressure in ear), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip a little bit/A little bit of post-nasal drip), PYREXIA (Fever) and FATIGUE (Tiredness) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eye, Seasonal allergy (sometimes seasonal allergy), GERD (GERD which sometimes irritates the lungs a little bit), Irritable bowel syndrome, Asthma (asthma types but unspecified) and Allergy (Some allergies). Concomitant products included Ciclosporin (Restasis) for Dry eyes. In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (A little pounding of the heart/Heart pounding), EAR DISCOMFORT (Ear pressure/Pressure in ear), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip a little bit/A little bit of post-nasal drip), PYREXIA (Fever), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, PALPITATIONS (A little pounding of the heart/Heart pounding), EAR DISCOMFORT (Ear pressure/Pressure in ear), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip a little bit/A little bit of post-nasal drip), PYREXIA (Fever), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. The current age of the patient was reported as 79-year-old. The patient was pretty healthy. The patient always received Moderna vaccines. She clarified that she never received two vaccines at once and said that she did not even get the flu vaccine because she always waited 2 weeks in between. The only side effects patient had experienced were fever, tiredness, heart pounding, pressure in her ears and a little bit of post-nasal drip, and pain at the injection site. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to MOD-2025-786055 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2025: Live follow up received is non-significant. Reporter's phone number was added, allergy was added, reference number was added. More
2864592 71 F NC 10/09/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Eructation, Hiccups; Eructation, Hiccups Eructation, Hiccups; Eructation, Hiccups
hiccup all the time; belch - burping; This spontaneous case was reported by a consumer and describes... hiccup all the time; belch - burping; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (hiccup all the time) and ERUCTATION (belch - burping) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Concurrent medical conditions included Heart disease, unspecified (diagnosed prior to ever having received a Covid vaccine). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced HICCUPS (hiccup all the time) and ERUCTATION (belch - burping). At the time of the report, HICCUPS (hiccup all the time) and ERUCTATION (belch - burping) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that patient received total of 6 Moderna Covid vaccines since 2021, but exact dates were not available at the time of the reporting. The patient received last dose as Spikevax vaccination on Nov-2024. It was reported that the patient had noticing hiccupping and belching more frequently since the patient had Moderna Covid vaccines. The patient used to have hiccups all the time and the patient also experienced belch-burping. The symptoms lasted for the year, but they continued after a year. The patient did not notice when the symptoms started, the patient informed that it had been years. The patient used to wait for two weeks in between flu shot and our COVID shot. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter. This case was linked to MOD-2025-789935, MOD-2025-789957 (Patient Link). More
2864593 79 M 10/09/2025 COVID19
 MODERNA
Body temperature, Chills, Pyrexia, Vaccination site pain Body temperature, Chills, Pyrexia, Vaccination site pain
sore shoulder or sore injection site; very very bad chills; Fever of 101๏ฟฝF; This spontaneous case ... sore shoulder or sore injection site; very very bad chills; Fever of 101๏ฟฝF; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore shoulder or sore injection site), CHILLS (very very bad chills) and PYREXIA (Fever of 101๏ฟฝF) in a 79-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (patient had 9 Moderna shots in his arm from the beginning of the pandemic). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. On 17-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 26-Sep-2025, the patient experienced VACCINATION SITE PAIN (sore shoulder or sore injection site), CHILLS (very very bad chills) and PYREXIA (Fever of 101๏ฟฝF). On 27-Sep-2025, VACCINATION SITE PAIN (sore shoulder or sore injection site), CHILLS (very very bad chills) and PYREXIA (Fever of 101๏ฟฝF) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2025, Body temperature: 101 F (just under 102 fever). No concomitant medications were reported. The site of vaccine administration was reported as 'shoulder'. The patient had no other side effects since then; it could be a delayed reaction even though it was 9 days later. This strain of SARS was a pretty bad strain so his body may have taken a few days to react to it. After suspect administration, 9 days later he came down with chills, eventually within a couple of hours of getting the chills, developed just under 102 fevers. That lasted until 27-Sep-2025. They said that they had had 9 Moderna shots since the COVID disease began. Both of them had only taken Moderna shots. Most of the shots had been pretty uneventful, with regular side effects, but it was the first time one of them had experienced little weird effects. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789768 (E2B Linked Report). This case was linked to MOD-2021-015968 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2025: Live-significant follow-up received with narrative: Event information was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789768:Patient brother case (Spikevax LP.8.1 PFS) More
2864594 F 10/09/2025 COVID19
 MODERNA
COVID-19 COVID-19
Have an acquaintance who had the COVID vaccine who went on a trip and caught COVID; This spontaneous... Have an acquaintance who had the COVID vaccine who went on a trip and caught COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Have an acquaintance who had the COVID vaccine who went on a trip and caught COVID) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2025, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2025, the patient experienced COVID-19 (Have an acquaintance who had the COVID vaccine who went on a trip and caught COVID). At the time of the report, COVID-19 (Have an acquaintance who had the COVID vaccine who went on a trip and caught COVID) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication use information was not provided by reporter. The patient received a COVID vaccine, went on a trip, and caught COVID, even though the patient had just gotten the vaccine maybe 2 weeks before. The reporter did not know if the patient got a Moderna COVID-19 vaccine or another COVID-19 vaccine. The reporter knew that the patient got the COVID vaccine, got it like few weeks before. It was unknown if the patient experienced any additional symptoms or events. Treatment medication use information was not provided by reporter. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2025: Live follow up received that contains non-significant information includes reference numbers were added. More
2864595 F 10/09/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

COVID-19, Hallucination; COVID-19, Hallucination COVID-19, Hallucination; COVID-19, Hallucination
severe hallucinations; she got Covid about 2 years ago; This spontaneous case was reported by a cons... severe hallucinations; she got Covid about 2 years ago; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (severe hallucinations) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Respiratory disorder. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Intramuscular use) 1 dosage form. On an unknown date, received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 (she got Covid about 2 years ago). On an unknown date, the patient experienced HALLUCINATION (severe hallucinations) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in 2023 at an unspecified dose and frequency. In 2023, COVID-19 (she got Covid about 2 years ago) had resolved. At the time of the report, HALLUCINATION (severe hallucinations) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that patient had always Moderna vaccine but 2 times she took Pfizer dose vaccination. However, both times she had a reaction. It was reported that the Patient had severe hallucinations. When the patient slept, she used to see images in her brain. This was very disturbing for her. It was reported that patient got COVID about 2 years ago after having multiple vaccines. Patient had COVID for 3 weeks though she had treatment medication of Paxlovid. It was interpreted that she got COVID because she always had Moderna vaccines and had gotten Pfizer which was premature. The Patient unable to take penicillin but it was not explained the reason. It was unknown if the patient experienced any additional symptoms or events.; Reporter's Comments: Company comment: The benefit-risk relationship of the product is not affected by this report. More
2864596 55 F HI 10/09/2025 COVID19
COVID19
FLUX
FLUX
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Abdominal pain, Blister, Deafness, Diarrhoea, Ear discomfort; Headache, Pain, Py... Abdominal pain, Blister, Deafness, Diarrhoea, Ear discomfort; Headache, Pain, Pyrexia; Abdominal pain, Blister, Deafness, Diarrhoea, Ear discomfort; Headache, Pain, Pyrexia More
Hearing loss; Raised blisters on left arm; Abdominal cramps; Fever; Headache; Clogged feeling in the... Hearing loss; Raised blisters on left arm; Abdominal cramps; Fever; Headache; Clogged feeling in the left ear; Body aches; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss), BLISTER (Raised blisters on left arm), ABDOMINAL PAIN (Abdominal cramps), PYREXIA (Fever) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 29-Sep-2025, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), BLISTER (Raised blisters on left arm) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal cramps) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), EAR DISCOMFORT (Clogged feeling in the left ear), PAIN (Body aches) and DIARRHOEA (Severe diarrhea). At the time of the report, DEAFNESS (Hearing loss), BLISTER (Raised blisters on left arm), ABDOMINAL PAIN (Abdominal cramps), PYREXIA (Fever), HEADACHE (Headache), EAR DISCOMFORT (Clogged feeling in the left ear), PAIN (Body aches) and DIARRHOEA (Severe diarrhea) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. Patient had no medical history, concomitant disease or risk factor. There were no lab data or results available. Patient did not experience any additional symptoms or events. Treatment information was not reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2864597 76 F 10/09/2025 COVID19
COVID19
 MODERNA
MODERNA

Allergy to vaccine, Chills, Decreased appetite, Fatigue, Feeding disorder; Heada... Allergy to vaccine, Chills, Decreased appetite, Fatigue, Feeding disorder; Headache, Increased need for sleep, Pain, Pyrexia More
painful; lack of appetite; she sleeps the entire time; she can't eat; mI'm allergic to som... painful; lack of appetite; she sleeps the entire time; she can't eat; mI'm allergic to something in the vaccine; fever; chills; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (painful), DECREASED APPETITE (lack of appetite), INCREASED NEED FOR SLEEP (she sleeps the entire time), FEEDING DISORDER (she can't eat) and ALLERGY TO VACCINE (mI'm allergic to something in the vaccine) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (painful), DECREASED APPETITE (lack of appetite), INCREASED NEED FOR SLEEP (she sleeps the entire time), FEEDING DISORDER (she can't eat), ALLERGY TO VACCINE (mI'm allergic to something in the vaccine), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (tired). At the time of the report, PAIN (painful), DECREASED APPETITE (lack of appetite), INCREASED NEED FOR SLEEP (she sleeps the entire time), FEEDING DISORDER (she can't eat), ALLERGY TO VACCINE (mI'm allergic to something in the vaccine), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (tired) had resolved. Concomitant medication was not provided. It was reported that the patient had received the Moderna shot for COVID many times and had always experienced the same severe reaction. The patient wanted to find out more about the specific reaction that she experienced with the Moderna COVID-19 vaccine. She stated that she had spoken to many people who had received the vaccine, but no one had experienced the same thing as she did. The patient wanted to find out why she reacted differently from others and described them as very severe, lasting for about two days before subsiding. She went to CVS to receive the Moderna COVID-19 vaccine and had received around 8 or 10 vaccines at that point. She mentioned that the lot number of the vaccine did not matter as she experienced the same reaction every time. It was reported that if the patient received the COVID shot at 10am in the morning, she began developing severe side effects by 2pm. She had experienced every side effect listed by Moderna including headache, lack of appetite, tiredness, chills, fever and more. It was stated that the symptoms were so severe that she decided not to receive the vaccine again, but the patient had to receive, and it lasted exactly for 48 hours. It was reported that by 2pm on the second day, it was completely gone. However, during the reaction she could not get out of bed, was unable to eat, slept most of the time and it was painful and had chills. She felt as if she was allergic to something in the vaccine and wanted to speak to someone about that. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Reporter did not allow further contact More
2864598 70 F NY 10/09/2025 COVID19
 MODERNA
 024M20A
Fatigue Fatigue
just sleeping a little later, was just a little tired; This spontaneous case was reported by a consu... just sleeping a little later, was just a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (just sleeping a little later, was just a little tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In February 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (just sleeping a little later, was just a little tired). At the time of the report, FATIGUE (just sleeping a little later, was just a little tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that the patient was healthy, and she had all the Moderna shots over the years of the boosters for COVID and got her flu shot on 03-Oct-2025 and figure she get the COVID booster in a few weeks. It was stated that she never had a reaction other than back in 2020 when they first came out and was tired the next day or something but never had a reaction to the shot and only had Moderna. It was the first, that was when it was the 2 dose one. It was stated that it was the first dose, but patient thought everyone was very anxious then because all were expecting it, it had just come out, and people clear their calendars for a day or two after just remember just sleeping a little later. I was just a little tired. That was for the first dose, that was when it was a two dose and clarified date of administration of 14-Feb-2021 with second dose received 14-Mar-2021. It was stated that she got it and then a few weeks later got the second dose. She was fine and then ever since then, she had it every year. It was added, in 2024, she got one in the fall of 2023 and then did get it again because they were going to (withheld country) and they came out, Moderna said seniors should get maybe a second dose five-six months later and because they were going out of the country, she did get it. So that one year, she did get it, then got it last Oct-2024 and she will be getting it again this October, one of these [Spikevax or mNEXSPIKE], so she had gotten it every year. Administration dates of Oct-2021, Apr-2022 and stated, whenever offered and told to get it she got it, and everything was Moderna. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2864599 10/09/2025 COVID19
 MODERNA
Illness, Seizure Illness, Seizure
seizure syndrome/had a seizure; ill; This spontaneous case was reported by a consumer and describes ... seizure syndrome/had a seizure; ill; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure syndrome/had a seizure) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. On 05-Oct-2025, the patient experienced SEIZURE (seizure syndrome/had a seizure) (seriousness criterion medically significant) and ILLNESS (ill). At the time of the report, SEIZURE (seizure syndrome/had a seizure) and ILLNESS (ill) outcome was unknown. No concomitant medications were reported. On 06-Oct-2025, it was reported that the patient had Moderna vaccination three days ago. Post vaccination, patient was ill for two days afterwards. It was reported that the patient had a seizure at the end of day two, post vaccination. The patient had no idea about the seizure, and the patient was not sure exactly how it evolved. All the past Covid vaccines received by the patient were mRNA vaccines, and the patient had no trouble after receiving them. It was interpreted that perhaps the problem was that patient was now diagnosed with seizure syndrome or perhaps the patient's body did not like the vaccine. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2864600 F 10/09/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
COVID symptoms/ sore throat and cough; This spontaneous case was reported by a consumer and describe... COVID symptoms/ sore throat and cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms/ sore throat and cough) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced COVID-19 (COVID symptoms/ sore throat and cough). At the time of the report, COVID-19 (COVID symptoms/ sore throat and cough) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2025, SARS-CoV-2 test: confirmed. No concomitant medication was reported. The patient had COVID symptoms, including a sore throat and cough. She had received the COVID vaccine on 16-Sep-2025 and contracted COVID a week later, confirmed after taking a COVID test on Saturday. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality not provided. More
2864601 M 10/09/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ... Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) 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 dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. No concomitant medication was reported. Patient and his wife had been receiving the Moderna vaccine since 2020. They were older and have received the Moderna vaccine for COVID-19. Patient always used Moderna and had COVID-19 once. His wife did not had COVID-19, but they had great success with Moderna. They would like to continue with the Moderna vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality not provided. More
2864603 75 F 10/09/2025 COVID19
 MODERNA
Post-acute COVID-19 syndrome Post-acute COVID-19 syndrome
she has had some long COVID effects; This spontaneous case was reported by a consumer and describes ... she has had some long COVID effects; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (she has had some long COVID effects) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu shot; for COVID-19 prophylaxis: Spikevax NOS (Previous 3 doses). Past adverse reactions to the above products included No adverse effect with Flu shot and Spikevax NOS. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) .5 milliliter. On an unknown date, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to .5 milliliter. In 2023, the patient experienced POST-ACUTE COVID-19 SYNDROME (she has had some long COVID effects). At the time of the report, POST-ACUTE COVID-19 SYNDROME (she has had some long COVID effects) outcome was unknown. No concomitant medication was reported. The patient was not planning to originally get the regular COVID vaccine, but since there was a new one, a lower dose for seniors, she was willing to try it. She was very petite and had chronic fatigue after her last two COVID boosters. She wasn't going to have one this year, but she felt anxious about not having one, because she had all 5 priors. All of her Covid vaccines prior to that with no side effects. But last year and the year before, she had some long COVID effects, and she wasn't going to get one at all. But since there was one that's like 1/5 the dose of the regular, she's going to try. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact More
2864604 28 F MO 10/09/2025 FLUN3
FLUN3
 MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
 Yh3387C
Yh3387C
Chest pain, Chills, Cough, Lethargy, Oropharyngeal pain; Pyrexia, Streptococcus ... Chest pain, Chills, Cough, Lethargy, Oropharyngeal pain; Pyrexia, Streptococcus test positive More
First day after vaccine, sore throat emerged. Second day after vaccine, cough and lethargy began. Th... First day after vaccine, sore throat emerged. Second day after vaccine, cough and lethargy began. Third day after vaccine, fever, chills and worsening cough with chest pain. Fourth day after vaccine, emergency room visit due to worsening above symptoms. More
2864606 62 F GA 10/09/2025 FLU3
 SANOFI PASTEUR
 UT8829BA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was given high dose flu despite not being 65+ years of age; clinician was unclear about age ... Patient was given high dose flu despite not being 65+ years of age; clinician was unclear about age parameters. Patient is expected to experience no adverse effects. More
2864607 70 F AZ 10/09/2025 FLU3
 SANOFI PASTEUR
 2025-2026
Rash, Rash pruritic, Urticaria Rash, Rash pruritic, Urticaria
Severe itching rash and hives cover my whole body top of my scalp to the bottom of my feet. started ... Severe itching rash and hives cover my whole body top of my scalp to the bottom of my feet. started at 3:00am went to Urgent care at 8:40am was prescribed Prednisone 20mg tablets for 3 days used Benadryl Allergy pill 25mg Cortizone .10 spray, Cortizone.10 cream , Aloe Vera gel had two hours of relief but itching returned. this is the second day More
2864608 63 M TN 10/09/2025 FLU3
 SANOFI PASTEUR
 u8855ca
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient reported no adverse effects from receiving the high dose vaccine Patient reported no adverse effects from receiving the high dose vaccine
2864609 30 F MD 10/09/2025 RSV
 PFIZER\WYETH
Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered
Currently pregnant with baby #2, received RSV vaccine at 33 weeks 1 day pregnant. This was the secon... Currently pregnant with baby #2, received RSV vaccine at 33 weeks 1 day pregnant. This was the second RSV vaccine I received- I received the first RSV vaccine during my first pregnancy in November 2023. Had extreme fatigue and nausea. Was not made aware I shouldn't have the RSV vaccine twice. More
2864610 28 F NY 10/09/2025 FLU3
FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8863CA
U8863CA
U8863CA
U8863CA
Arthralgia, Product administered at inappropriate site; Arthralgia; Arthralgia, ... Arthralgia, Product administered at inappropriate site; Arthralgia; Arthralgia, Product administered at inappropriate site; Arthralgia More
Reports left shoulder pain started day after flu shot 9/17/25 Patient reports that injection was hi... Reports left shoulder pain started day after flu shot 9/17/25 Patient reports that injection was high in the shoulder and the band aid was placed on the deltoid but closer to AC joint This was only injection in that arm, no prrevious vaccinations this season Denies increased warmth, erythema, edema to the shoulder or itching Denies injury/trauma No previous shoulder injuries She is left handed Incomplete relief with Tylenol Denies radiculopathy, decreased grip strenth More
2864611 6 F NY 10/09/2025 COVID19
 MODERNA
 3052784
Extra dose administered Extra dose administered
Gathering all the information from everyone involved, It was a busy time of day and we had an inexpe... Gathering all the information from everyone involved, It was a busy time of day and we had an inexperienced technician input the data at data entry. I am still wondering why there wasn't a "hard-Stop" when the moderna12+ was billed. It was then verified by (name withheld). She told me she was under the impression she was giving the flu shot. The flu shot was given to this family by myself back at the end of August. Spoke with the mother and she recalls talking about the covid vaccine with (name withheld). Not sure why this didn't draw up any red flags. The vaccine was apparently given to the mother and both daughters. The vaccine was the covid-19 moderna 12+ for the six year old More
2864612 8 F 10/09/2025 COVID19
 MODERNA
 3052784
Extra dose administered Extra dose administered
Gathering all the information from everyone involved, It was a busy time of day and we had an inexpe... Gathering all the information from everyone involved, It was a busy time of day and we had an inexperienced technician input the data at data entry. I am still wondering why there wasn't a "hard-Stop" when the moderna12+ was billed. It was then verified by (name withheld). She told me she was under the impression she was giving the flu shot. The flu shot was given to this family by myself back at the end of August. Spoke with the mother and she recalls talking about the covid vaccine with (name withheld). Not sure why this didn't draw up any red flags. The vaccine was apparently given to the mother and both daughters. The vaccine was the covid-19 moderna 12+ for the eight year old More
2864613 50 F KY 10/09/2025 PNC21
 MERCK & CO. INC.
 z009681
Erythema, Peripheral swelling Erythema, Peripheral swelling
patient experience redness and swelling of upper arm down to elbow, no pain , no itching patient experience redness and swelling of upper arm down to elbow, no pain , no itching
2864614 31 F MA 10/09/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Headache, Mobility decreased, Pain, Pain in extremity, Paraesthesia; Sleep disor... Headache, Mobility decreased, Pain, Pain in extremity, Paraesthesia; Sleep disorder More
Got the flu vaccine 10/8/2025 at 11:15 am. Got home from work at 4:00 pm. Dog jumped on me and I rea... Got the flu vaccine 10/8/2025 at 11:15 am. Got home from work at 4:00 pm. Dog jumped on me and I realized my arm really hurt. 7 out of 10 pain scale. Was unable to sleep on my left arm the night of 10/8/2025. Woke up at 4:30 am 10/9/2025, showered and got dressed. Unable to lift my arm above counter height. Tinglingly sensation in my left arm and hand. Went to the Clinic nurse [name withheld] at 8:20 am. She tested my strength in my left versus right arm. Hurt to squeeze her hand with my left hand. Have a 7 out of 10 headache in the back of my head. Took two ibuprofen. Nurse also gave me an icepack to keep on my arm for 20 minutes. More
2864615 79 F OK 10/09/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 Comirnaty 12+ (
Echocardiogram, Electrocardiogram, Pericarditis, Scan myocardial perfusion; Echo... Echocardiogram, Electrocardiogram, Pericarditis, Scan myocardial perfusion; Echocardiogram, Electrocardiogram, Pericarditis, Scan myocardial perfusion More
Pericarditis. Hospitalized Pericarditis. Hospitalized
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2864616 44 F IL 10/09/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 AH2G4
Injected limb mobility decreased, Injection site pain, Ultrasound scan normal, X... Injected limb mobility decreased, Injection site pain, Ultrasound scan normal, X-ray normal More
Left upper arm pain for 3 weeks with limited range of motion of left shoulder, Left upper arm pain for 3 weeks with limited range of motion of left shoulder,
2864617 67 F MI 10/09/2025 COVID19
 MODERNA
 3051995
Abdominal discomfort, Chills, Diarrhoea, Headache, Pain Abdominal discomfort, Chills, Diarrhoea, Headache, Pain
Patient stated that 2 hours after administration she felt sick to her stomach (which has continued ... Patient stated that 2 hours after administration she felt sick to her stomach (which has continued daily since), aches and pains, chills, headache and watery diarrhea. She states that starting today 10//9/25 it is starting to subside. More
2864619 21 M OH 10/09/2025 FLU3
 SANOFI PASTEUR
 U8837CA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Received High Dose prior to 65. Client notified. No adverse reactions expressed or noted. Received High Dose prior to 65. Client notified. No adverse reactions expressed or noted.
2864620 21 F FL 10/09/2025 HPV9
 MERCK & CO. INC.
 Z005469
Injection site erythema, Injection site inflammation, Injection site pruritus, I... Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling More
Patient stated at about 8-10 hours after vaccination, she started experiencing itchiness, inflammati... Patient stated at about 8-10 hours after vaccination, she started experiencing itchiness, inflammation, redness and swelling in her left deltoid where the vaccination was administered. No fever or shortness of breath reported. More
2864622 16 F MO 10/09/2025 FLU3
MENB
 GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
 D5H4Y
47KS7
Concussion, Fall, Head injury, Syncope; Concussion, Fall, Head injury, Syncope Concussion, Fall, Head injury, Syncope; Concussion, Fall, Head injury, Syncope
Almost immediately after receiving both vaccines, the patient experienced syncope. She fell from the... Almost immediately after receiving both vaccines, the patient experienced syncope. She fell from the examination table to the floor, striking her head and experiencing a concussion. More
2864623 47 M NY 10/09/2025 FLU3
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
LP2G2
Expired product administered; Expired product administered Expired product administered; Expired product administered
Boostrix Immunization given to pt was expired Boostrix Immunization given to pt was expired
2864624 70 M 10/09/2025 COVID19
 MODERNA
Emotional distress, Somnolence Emotional distress, Somnolence
drowsiness; feeling "put down"; This spontaneous case was reported by a consumer and descr... drowsiness; feeling "put down"; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness) and EMOTIONAL DISTRESS (feeling "put down") in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (drowsiness) and EMOTIONAL DISTRESS (feeling "put down"). At the time of the report, SOMNOLENCE (drowsiness) and EMOTIONAL DISTRESS (feeling "put down") outcome was unknown. No concomitant medication was reported. The patient believed vaccines prevented him from having severe reactions to it and kept him out of the hospital. The patient had adverse reactions to the first four Moderna vaccines, experiencing drowsiness and feeling "put down" by the vaccine. After switching to Pfizer for three doses, they experienced no reactions. Last year, they received Spikevax instead of Pfizer and had no reaction. This year, the patient was uncertain about the vaccine. it was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. No causality provided More
2864625 57 M NC 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 C9X3R
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
The patient didn't experience any side effects other than a sore arm. It was discovered after ... The patient didn't experience any side effects other than a sore arm. It was discovered after the fact that the dose that the patient received on 10/02/2025 was his 3rd dose. His 2nd dose was administered on 06/01/2023 but didn't automatically transmit to the database due to a typing error at the billing of the dose. Since the 2nd dose wasn't seen in database, it was recommended that the patient receive a dose. The patient was thankful that we called and made him aware. The pharmacy also manually updated database to reflect all the doses that he had be given. More
2864626 0.17 F OK 10/09/2025 FLU3
 SANOFI PASTEUR
 UT8802MA
No adverse event, Wrong product administered No adverse event, Wrong product administered
INFLUENZA GIVEN BY MISTAKE SHOULD HAVE BEYFORTUS. NO ADVERSE REACTION NOTED AT THIS TIME INFLUENZA GIVEN BY MISTAKE SHOULD HAVE BEYFORTUS. NO ADVERSE REACTION NOTED AT THIS TIME
2864627 87 M WI 10/09/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0738
UT8781AA
Dyspnoea, Fatigue; Dyspnoea, Fatigue Dyspnoea, Fatigue; Dyspnoea, Fatigue
Patient experienced extreme fatigue and shortness of breath about 24 hours after vaccinations, whic... Patient experienced extreme fatigue and shortness of breath about 24 hours after vaccinations, which prompted a trip to the emergency room and subsequent hospitalization. Patient appears to have experienced an acute exacerbation of CHF (my words, not the patient's or the patient's cardiologist's words) based on symptoms reported and follow-up medication changes. Symptom management is still ongoing as of this report, though the patient is being managed outpatient now. More
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2864628 16 F NC 10/09/2025 MENB
MNQ
 PFIZER\WYETH
SANOFI PASTEUR

Pharyngeal paraesthesia, Urticaria; Pharyngeal paraesthesia, Urticaria Pharyngeal paraesthesia, Urticaria; Pharyngeal paraesthesia, Urticaria
Hives on legs and arms, tingling sensation in throat. Hives on limbs came an hour or two before thro... Hives on legs and arms, tingling sensation in throat. Hives on limbs came an hour or two before throat began to tingle. After two doses of Benadryl, all symptoms dissipated. More
2864631 79 M FL 10/09/2025 PNC20
 PFIZER\WYETH
 LP4948
Extra dose administered Extra dose administered
Patient received one dose of Prevnar 20. Patient had already had one dose of Prevnar 20 on 12/13/202... Patient received one dose of Prevnar 20. Patient had already had one dose of Prevnar 20 on 12/13/2023. Vaccine was inappropriately administered. Patient did not report any adverse events from receiving the vaccine. More
2864632 12 F MI 10/09/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 4GR2B
Flushing, Nausea, Pyrexia Flushing, Nausea, Pyrexia
Patient presented to Flu clinic yesterday for her Flu vaccine. Due to patient's complex medical... Patient presented to Flu clinic yesterday for her Flu vaccine. Due to patient's complex medical history and multiple food allergies, our Doctor at the clinic reviewed patient's chart and history. Risks discussed with mom and patient about receiving a Flu vaccine with an egg allergy. Mother and patient were offered to have pt present to health department for egg-free vaccine. Mom declined. Mom reports that pt has received the normal flu vaccine every year with no difficulty. Mom and pt stated that they understand these risks and agree to take the flu vaccine. Dr. approved the vaccine to be given. Pt monitored for 15 minutes with no reaction. The next morning, mother called office to inform us that pt woke up with a fever of 99.5 - 101.5 and is feeling nauseous/flushed, denies body aches and there is no rash or redness at site. Pt was not sick yesterday. I told mom to give ibuprofen or Tylenol for fever, and make sure she stays hydrated and sticks to bland diet for now. May give Benadryl if needed. Mom is going to continue to monitor and will keep us updated if her symptoms change or worsen. I told mom that patient should probably only get the egg-free vaccine moving forward due to risk of reaction related to her being immunocompromised and having multiple allergies. A VARS report will be submitted. More
2864633 68 F MO 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9c75y
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
injection site swelling and redness that lasted several days injection site swelling and redness that lasted several days
2864634 1 F TX 10/09/2025 FLU3
FLU3
HEPA
HEPA
MMR
MMR
VARCEL
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UT8858LA
UT8858LA
Z005472
Z005472
Z005856
Z005856
Z008428
Z008428
Hypoxia, Intensive care, Respiratory depression, Respiratory viral panel, Seizur... Hypoxia, Intensive care, Respiratory depression, Respiratory viral panel, Seizure; Status epilepticus; Hypoxia, Intensive care, Respiratory depression, Respiratory viral panel, Seizure; Status epilepticus; Hypoxia, Intensive care, Respiratory depression, Respiratory viral panel, Seizure; Status epilepticus; Hypoxia, Intensive care, Respiratory depression, Respiratory viral panel, Seizure; Status epilepticus More
12 month old histroy of newly diagnosed seizure disorder last month who presented to the ER followin... 12 month old histroy of newly diagnosed seizure disorder last month who presented to the ER following a one-time brief and self resolving seizure at home but without returning to baseline. Experienced 3 additional seizures in the (withheld name) ER. Some hypoxemia following one of the seizures due to respiratory depression. Admitted PICU for break through seizures in status epilepticus for neurologic monitoring. More
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2864635 71 F FL 10/09/2025 FLU3
 SANOFI PASTEUR
 U8764BB
Chills, Headache, Pruritus, Pyrexia, Swelling Chills, Headache, Pruritus, Pyrexia, Swelling
PT JUST CALLED STATING SHE HAD ITCHING, SWELLING, FEVER/CHILLS, AND HEADACHE FOLLOWING THIS VACCINE PT JUST CALLED STATING SHE HAD ITCHING, SWELLING, FEVER/CHILLS, AND HEADACHE FOLLOWING THIS VACCINE
2864636 22 F VT 10/09/2025 FLU3
 SEQIRUS, INC.
 AX4606A
Feeling hot, Hypoaesthesia, Paraesthesia, Pruritus Feeling hot, Hypoaesthesia, Paraesthesia, Pruritus
within 30 minutes of receiving vaccine in L Deltoid, patient developed left sided facial numbness/ti... within 30 minutes of receiving vaccine in L Deltoid, patient developed left sided facial numbness/tingling/ and face feeling hot/itchy. lasted approximately 8 hours and then resolved. More
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