🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2859496 17 M KS 09/17/2025 IPV
 SANOFI PASTEUR
 W1B511M
Expired product administered, No adverse event Expired product administered, No adverse event
vaccine was given today for a patient but it already expired three days ago with no reported AE; Ini... vaccine was given today for a patient but it already expired three days ago with no reported AE; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient to whom was given IPV (Vero) [IPOL] today for a patient but it already expired three days ago with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation. On 11-Sep-2025, the patient received a 0.5 ml (dose 2) of suspect IPV (Vero) Suspension for injection (strength: standard, Frequency: Once, lot W1B511M and expiry date: 08-Sep-2025) via intramuscular route in the left deltoid. as immunization and vaccine was given today for a patient but it already expired three days ago with no reported ae (expired 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
2859497 0.17 F NH 09/17/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK224AC
No adverse event, Product preparation issue No adverse event, Product preparation issue
powdered component (Hib) was given with a saline solution, instead of the liquid component (DTaP-IPV... powdered component (Hib) was given with a saline solution, instead of the liquid component (DTaP-IPV) that came with it with no reported Adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2-month-old female patient and is reported powdered component (hib) was given with a saline solution, instead of the liquid component (dtap-ipv) that came with diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 7v (CRM197) (Prevnar); Hepatitis b vaccine (Hepatitis b); and Rotavirus vaccine live oral 1v (Rotarix) all for Immunisation. On 19-Aug-2025, the patient received a 0.5 ml dose (dose 1) of suspect Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection of lot UK224AC and expiry date: 31-Jul-2026 frequency: once, strength; standard via intramuscular route in the left thigh for immunization and powdered component (hib) was given with a saline solution, instead of the liquid component (dtap-ipv) that came with it with no reported adverse event (product preparation error) (latency: on same day) Reportedly, She said that PENTACEL comes in 2 vials. She said that they receive pre-filled saline diluent to reconstitute a Varicella vaccine and that was used to reconstitute the Hib component in this situation. She said that she talked to the immunization program in their state and she was told that the vaccine is not counted because it was not reconstituted with the liquid component that came with it. Thus, they're planning to revaccinate the child. She asked if they need to be concerned for the patient. She is wondering if they need to contact the parent of the patient and educate them if there's an increased risk for the child since the vaccine is invalid. 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
2859498 11 M IN 09/17/2025 DTAP
 SANOFI PASTEUR
 3CA11C1
No adverse event, Wrong product administered No adverse event, Wrong product administered
inadvertently administered Daptacel instead of Adacel to an otherwise fully vaccinated 11 year old m... inadvertently administered Daptacel instead of Adacel to an otherwise fully vaccinated 11 year old male patient with no adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who was inadvertently administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation. On 12-Sep-2025, the patient received dose 2 with dosage 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection (lot 3CA11C1, Expiry Date: 31-Dec-2025) (Frequency: once, Strength: Standard) via intramuscular route in left deltoid as immunization instead of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot number and expiry unknown) with no adverse event (wrong 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 More
2859499 71 F CO 09/17/2025 FLU3
 SANOFI PASTEUR
 U8527BA
Expired product administered, No adverse event Expired product administered, No adverse event
a patient accidentally received expired Fluzone HD that was from last year with no adverse event; In... a patient accidentally received expired Fluzone HD that was from last year with no adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 71 years old female patient who accidentally received expired Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] that was from last year with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2025, the patient received expired 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8527BA, expiry date 30-Jun-2025, strength high dose) via intramuscular route in the left deltoid for Influenza immunization and accidentally received expired fluzone hd that was from last year with no adverse event (expired product administered) (latency same day). Reportedly, they wanted to know if the patient still needed to get this year's flu shot or not. 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
2859500 F OH 09/17/2025 UNK
 UNKNOWN MANUFACTURER
 AX4606A
Device connection issue, Injury associated with device Device connection issue, Injury associated with device
Pricked by needle; Luer-lock system not tightening properly/defect occurred; This spontaneous case, ... Pricked by needle; Luer-lock system not tightening properly/defect occurred; This spontaneous case, initially received on 10-Sep-2025, was reported by a health professional and concerns a female patient. Administration of company suspect drug: On an unknown date, the patient received Afluria (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: AX4606A. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Sep-2025, the patient experienced Pricked by needle (outcome: Unknown), Luer-lock system not tightening properly/defect occurred (outcome: Unknown). The nurse reported that the treatment measures were taken associated with event as called worker's department and patient had blood work and confirmed that there were four or five, defective units may had more units they're tightened down a bit more no to see if that doesn't happen anymore and patient informed nurse confirmed that a total of 8 units had this issue and all vaccine hubs were loose and they have to tighten all of them all 100 boxes have the same lot and patient confirmed that was able to apply a full dose by nurse and confirmed Luer-lock system was not tightened, it spins and pops off and product was stored in original box with blister package Afluria (TIV) action taken: Not Applicable Reporter's assessment: The reporter (nurse) consider events as non-serious and causality assessment was not provided.; Reporter's Comments: The causality of events assessed as not related due to event nature (special situation) More
2859511 76 F TX 09/17/2025 COVID19
 PFIZER\BIONTECH
Blood test, Chills, Headache, Pain, Pyrexia Blood test, Chills, Headache, Pain, Pyrexia
Body aches; Chills; Fever; Headache; This is a spontaneous report received from a Consumer or other ... Body aches; Chills; Fever; Headache; This is a spontaneous report received from a Consumer or other non HCP. A 76-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "AFib" (ongoing); "Aortic valve replacement" (ongoing); "cardiac disease", start date: Jun1949 (unspecified if ongoing), notes: congenital; "thyroid was removed" (unspecified if ongoing), notes: years ago. Concomitant medication(s) included: SOTALOL taken for atrial fibrillation (ongoing); AMLODIPINE (ongoing); WARFARIN (ongoing); LEVOTHYROXINE taken for thyroidectomy (ongoing). Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025), described as "Body aches"; CHILLS (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025); PYREXIA (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025), described as "Fever"; HEADACHE (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, chills, pyrexia, headache. Additional Information: Consumer stated, Well, couple of weeks ago, she got her updated COVID vaccine, and she had never had side effects with that vaccine ever at all, but she just wanted to let you all know that with this particular one. She did had chills and fever and body aches and a headache and it was pretty miserable for 24 hours and so, she was just reported side effects the name of the COVID vaccine she got was the she guess, Comirnaty and she mean, it only last for 24 hours but she had never had side effects from any vaccine she had received and she had received her COVID vaccine ever since they were available and she had received her covered vaccine ever since they were available and she know this one was, this one is for the more for the updated version of COVID and so she was just, she was just letting you all know. It's kind of an FYI. Yes, reporter does have cardiac disease. She do not had to specify it was congenital, She had the, recently been suffering from AFib. She had an aortic valve replacement. The list kind of goes on and so. Consumer stated, she was on Sotalol. She was taking amlodipine. She was taking Warfarin. She also don't had a thyroid, so she take levothyroxine. She was taking Sotalol, amlodipine, Warfarin and because her thyroid was removed years ago, She take levothyroxine. Its Sotalol, it's for the AFib that she was battling. Patient was on Sotalol. She was taking amlodipine. She was taking Warfarin. She also don't have a thyroid, so she take levothyroxine. She was taking Sotalol, amlodipine, Warfarin and because her thyroid was removed years ago, She take levothyroxine. Its Sotalol, it was for the AFib that she was battling. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2859512 F 09/17/2025 COVID19
 UNKNOWN MANUFACTURER
Fatigue, Headache, Nasopharyngitis Fatigue, Headache, Nasopharyngitis
headache; fatigue; cold-like symptoms; This is a spontaneous report received from a Pharmacist from ... headache; fatigue; cold-like symptoms; This is a spontaneous report received from a Pharmacist from a sales representative. A female patient (unknown if pregnant) received BNT162b2 omicron (lp.8.1) (COVID-19 VACCINE OMICRON LP.8.1-MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Sep2025 as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 12Sep2025, outcome "unknown", described as "cold-like symptoms"; FATIGUE (non-serious) with onset 12Sep2025, outcome "unknown"; HEADACHE (non-serious) with onset 12Sep2025, outcome "unknown". It was unknown if therapeutic measures were taken as a result of headache, fatigue, nasopharyngitis. Additional information: HCP reported feeling headache, fatigue, and cold-like symptoms after getting the Covid vaccine and flu vaccine. It is unknown if vaccine was Pfizer product. Unknown if patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which they are reporting. Unknown if patient taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859514 M 09/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
just tested positive for Covid on 2 old tests; just tested positive for Covid on 2 old tests; This i... just tested positive for Covid on 2 old tests; just tested positive for Covid on 2 old tests; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2025, outcome "unknown" and all described as "just tested positive for Covid on 2 old tests". Clinical course: the patient (reporter's husband) just tested positive for Covid on 2 old tests plus he is going thru radiation treatments for Cancer he wants to know if he can trust the tests. He had a Covid vaccination about a week ago. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2859515 F GA 09/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I have COVID; I have COVID; This is a spontaneous report received from a Consumer or other non HCP. ... I have COVID; I have COVID; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 IMMUNISATION, reaction(s): "COVID-19", "DRUG INEFFECTIVE"; Bnt162b2 (6 BOOSTER DOSES), for COVID-19 IMMUNISATION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID". The event "i have covid" required physician office visit. Clinical Course: The patient stated, "I just went to senior medical center, and I have COVID, and she prescribed Paxcovid. I used Pfizer for all of my booster shots. When asked to repeat herself, stated, "No, no, I just said I had Pfizer for all of my booster shots." When asked if they had Pfizer booster shots before, (withheld) stated, "Oh, yes." When asked if they had COVID previously, (withheld) stated, "I had COVID I didn't have it during the epidemic time in 2021 and all that, but I had it later. I went somewhere and I got it, and I only had what you called a mild case, and I took Paxcovid then, and they gave it to me. "After asking if she remembers when she last took Paxlovid, stated, "Uh, no, I don't know when I got it, but I have, I have a shot book that tells me all my medication-boosters and everything that I got from Pfizer." When confirming if she had the booter shots, stated, "Six of them. "When asked to clarify if she had the 6 boosters, (withheld) stated, "I think so, I had every time I was supposed to get one, I got it." When asked if she got the booster shots but not COVID, stated, "I never got COVID except for the one time that I said back a couple of years ago. Not during the big time or anything, but I have had COVID the one time." The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2859516 CA 09/17/2025 COVID19
 PFIZER\BIONTECH
Oropharyngeal pain Oropharyngeal pain
sore throat; This is a spontaneous report received from a Nurse from medical information team. A pa... sore throat; This is a spontaneous report received from a Nurse from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: Sore throat ever reported as a side effect of the COVID-19 vaccine? I know it could come from COVID itself, but I was wondering if the vaccine could have caused it. More
2859517 F 09/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP. A fem... got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got Covid". The caller inquired about obtaining financial assistance for Paxlovid for their spouse, who is covered under Medicare. Despite getting vaccinated for Pfizer Covid 19 she stills got Covid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859518 3 M NV 09/17/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2H259
Expired product administered, No adverse event Expired product administered, No adverse event
Expired vaccine given by accident ( vaccine expired 6/11/2025) , patient has no side effects I spoke... Expired vaccine given by accident ( vaccine expired 6/11/2025) , patient has no side effects I spoke to dad today More
2859519 65 F WA 09/17/2025 FLU3
 SANOFI PASTEUR
 U8830DA
Angioedema Angioedema
Pt describes feeling angioedema in upper airway, lips, face and eyelids starting several hours after... Pt describes feeling angioedema in upper airway, lips, face and eyelids starting several hours after the injections. She is a nurse and took benadryl, waited a couple of hours and the edema subsided. She did not see a doctor. More
2859520 73 F 09/17/2025 COVID19
 PFIZER\BIONTECH
Eye irritation, Injection site erythema, Injection site pain, Injection site pru... Eye irritation, Injection site erythema, Injection site pain, Injection site pruritus More
Local injection site reaction including redness, burning and itching continuing for 4 days beyond da... Local injection site reaction including redness, burning and itching continuing for 4 days beyond date of vaccination More
2859521 39 M TX 09/17/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 153E21A
153E21A
153E21A
153E21A
051E21A
051E21A
051E21A
051E21A
Autonomic nervous system imbalance, Biopsy, Blindness, Blister, Blood test; Corn... Autonomic nervous system imbalance, Biopsy, Blindness, Blister, Blood test; Corneal transplant, Death, Dehydration, Diagnostic procedure, Diarrhoea; Laboratory test, Necrotising fasciitis, Postural orthostatic tachycardia syndrome, Renal impairment, Skin lesion; Vision blurred, Weight decreased; Autonomic nervous system imbalance, Biopsy, Blindness, Blister, Blood test; Corneal transplant, Death, Dehydration, Diagnostic procedure, Diarrhoea; Laboratory test, Necrotising fasciitis, Postural orthostatic tachycardia syndrome, Renal impairment, Skin lesion; Vision blurred, Weight decreased More
After COVID vaccination 8/20/21 and 9/10/2021 patient's vision became extremely blurry resultin... After COVID vaccination 8/20/21 and 9/10/2021 patient's vision became extremely blurry resulting in eventual legal blindness in both eyes cornea transplant etc; Chronic diarrhea resulting in extreme weight loss, from 250 down to 122 lbs, dehydration, kidney malfunction; Blistering lesions over abdomen lower extremities and hands Patient was in the hospital for 7 months with dysautonomia POTS necrotizing fasciitis Patient expired 04/29/2025 at home after being discharged from long term acute care hosp Hundreds of blood tests Numerous biopsies and diagnostic testing starting Oct 2021 Please see attached information More
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2859522 21 F FL 09/17/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 036A21A
036A21A
036A21A
036A21A
027B21A
027B21A
027B21A
027B21A
Biopsy skin, Cardiomegaly, Cerebrovascular accident, Chest pain, Computerised to... Biopsy skin, Cardiomegaly, Cerebrovascular accident, Chest pain, Computerised tomogram; Dizziness, Dyspnoea, Headache, Hypoaesthesia, Laboratory test; Magnetic resonance imaging, Myocardial infarction, Nausea, Neuropathy peripheral, Paraesthesia; Pulmonary function test, Sinus node dysfunction, Tachycardia, X-ray; Biopsy skin, Cardiomegaly, Cerebrovascular accident, Chest pain, Computerised tomogram; Dizziness, Dyspnoea, Headache, Hypoaesthesia, Laboratory test; Magnetic resonance imaging, Myocardial infarction, Nausea, Neuropathy peripheral, Paraesthesia; Pulmonary function test, Sinus node dysfunction, Tachycardia, X-ray More
SOB, chest pain, dizziness, tachycardia, headache, nausea, numbness, tingling. Multiple heart attack... SOB, chest pain, dizziness, tachycardia, headache, nausea, numbness, tingling. Multiple heart attacks. Stroke. Sick sinus syndrome. Cardiomegaly. Enlarged heart. Neuropathy. Etc More
✓ ✓
2859534 48 M NH 09/17/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EM9809
EM9809
EN6205
EN6205
Angina pectoris, Atrial fibrillation, Cardiac ablation, Chest pain, Condition ag... Angina pectoris, Atrial fibrillation, Cardiac ablation, Chest pain, Condition aggravated; Laboratory test; Angina pectoris, Atrial fibrillation, Cardiac ablation, Chest pain, Condition aggravated; Laboratory test More
Have had issues over the last 3-4 years with heart. Have had to have metoprolol dosage upped. Got ... Have had issues over the last 3-4 years with heart. Have had to have metoprolol dosage upped. Got AFIB and was recommended an ablation to fix. Still have recurring chest pain since, but AFIB was fixed with ablation procedure. Currently seeing cardiologist for heart and chest pain. More
✓
2859535 40 M FL 09/17/2025 FLU3
HEP
IPV
MMR
TDAP
VARCEL
 SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.





Blood pressure decreased, Dizziness, Syncope; Blood pressure decreased, Dizzines... Blood pressure decreased, Dizziness, Syncope; Blood pressure decreased, Dizziness, Syncope; Blood pressure decreased, Dizziness, Syncope; Blood pressure decreased, Dizziness, Syncope; Blood pressure decreased, Dizziness, Syncope; Blood pressure decreased, Dizziness, Syncope More
Patient said they were afraid of needles . After receiving the last vaccine he said he was going to ... Patient said they were afraid of needles . After receiving the last vaccine he said he was going to pass out. He fainted briefly and had a drop in blood pressure. He said that happens to him anytime he gets scared. More
2859536 83 M TX 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 HM9N5
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Patient came in today for a flu vaccine and reported that he has had arm and shoulder pain ever sinc... Patient came in today for a flu vaccine and reported that he has had arm and shoulder pain ever since receiving his covid vaccine in April More
2859537 15 F CA 09/17/2025 HPV9
HPV9
MNQ
MNQ
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Y013818
Y013818
U8574AA
U8574AA
Loss of consciousness, Loss of personal independence in daily activities, Nausea... Loss of consciousness, Loss of personal independence in daily activities, Nausea, Pallor, Paraesthesia; Vomiting; Loss of consciousness, Loss of personal independence in daily activities, Nausea, Pallor, Paraesthesia; Vomiting More
Pt received the HPV and Meningococcal vaccine on 9/17/25 at 0935. Administered by MA. At 0939- The ... Pt received the HPV and Meningococcal vaccine on 9/17/25 at 0935. Administered by MA. At 0939- The patient's mother was heard screaming out from exam room . MD- Dr., RN and MA staff entered the room to assess pt. Per Mother of patient at bedside pt became pale and briefly lost consciousness. Patient explains that she remembers speaking to the nurse and then awakening to see staff surrounding her. Upon entering the room, the pt was observed to be alert, AxO 4, respirations even. Pt voiced that she felt nauseous. To prevent aspiration pt was positioned in sitting position and emesis bag provided. Pt endorsed that she was very anxious prior to vaccine administration, and had not eaten or drank prior to her appointment. Initial set of VS recorded at 0940 were stable - BP- 99/67, HR 82, SPO2- 99%, RR 20, 0/10 pain. She reported feeling "tingles" in her bilateral arms. Pt encouraged to take slow deep breaths, assured of safety, cup of water offered ( encouraged to take slow, small sips). At 0943- the pt was seen vomiting into emesis bag. Post episode pt stated that she felt slight better and no longer felt tingles, radial pulses intact and even. Vital recheck done at 0950- VSS BP 98/70, HR 78, SPO2- 97%, RR- 16, 0/10 pain. Pt observed for another 10 minutes. 1000- Pt stated that she was feeling better, school absence note generated for today. ED precautions offered to pt and mother at bedside. If pt were to experience feeling dizzy, lightheaded, generally unwell, or experiences another episode of LOC to immediately seem emergency medical services. Pt and mother verbalized understanding. Pt was offered apple juice which she tolerated well and was sent home, steady gait observed while leaving. Per MD, d/t presenting symptoms and factors such as anxiety and lack of food or drink prior to vaccine administration- a syncopal episode is suspected. More
2859538 14 F WA 09/17/2025 MMRV
 MERCK & CO. INC.
 z005152
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
None reported None reported
2859539 37 F TX 09/17/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
 203A21A
203A21A
203A21A
203A21A
203A21A
Amenorrhoea, Autonomic neuropathy, Biopsy skin abnormal, Chest pain, Connective ... Amenorrhoea, Autonomic neuropathy, Biopsy skin abnormal, Chest pain, Connective tissue disorder; Epistaxis, Fatigue, Hyperthyroidism, Immunoglobulin therapy, Infertility female; Iodine uptake abnormal, Laboratory test abnormal, Postural orthostatic tachycardia syndrome, Raynaud's phenomenon, Sjogren's syndrome; Small fibre neuropathy, Syncope, Thyroglobulin present, Tilt table test positive, Tryptase increased; Vaginal haemorrhage More
Within three weeks after the vaccine I ended up in the ER with profuse nose bleeding and heavy vagin... Within three weeks after the vaccine I ended up in the ER with profuse nose bleeding and heavy vaginal bleeding (not my cylcle) that last for 10 days. Shortly. after this I started developing concerning symptoms-Chest pain, syncope, fatigue, and I no longer had periods after this episode. I was diganosed with thyroid toxicosis. Currently my diagnoses are not POTS- pyridostigmine TID; Autonomic Neurapthy- Ubrey/Neurtech; Small Fiber Neuropathy-Gabapentin; Systemic Sjorgens-IVIG & Hydroxychlorquine; Amenorrhea; infertility; Connective Tissue disorder; Potential MCAS (under testing now)- Hydroxyzine. More
✓
2859540 35 M AL 09/17/2025 COVID19
 MODERNA
 008C21A
Chest pain, Dizziness, Muscle spasms, Pyrexia Chest pain, Dizziness, Muscle spasms, Pyrexia
High fever, muscle cramps, chest pain, dizziness. All symptoms lasted approximately 48 hours. High fever, muscle cramps, chest pain, dizziness. All symptoms lasted approximately 48 hours.
2859541 77 F MN 09/17/2025 COVID19
COVID19
UNK
UNK
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

MY9550
MY9550
Chills, Headache, Heart rate increased, Hypertension, Nausea; Supraventricular t... Chills, Headache, Heart rate increased, Hypertension, Nausea; Supraventricular tachycardia; Chills, Headache, Heart rate increased, Hypertension, Nausea; Supraventricular tachycardia More
12 hours later: I woke up with chills, nausea, bad headache, high blood pressure for which I took ex... 12 hours later: I woke up with chills, nausea, bad headache, high blood pressure for which I took extra lisinopril, and a faster heart beat, for which I took 5 mg propranolol. I developed SVT 2 days after receiving the Fall 2024 Covid vaccine. I do not need a daily beta blocker. I take Propranolol in small doses as needed. I may have gone to a hospital if I didn't have the Lisinopril and Propranolol at home. Note: I've received all the previous Covid vaccinations in the years offered. These adverse effects were the worst I've ever had; therefore, I am reporting them. More
2859542 40 M AL 09/17/2025 COVID19
 JANSSEN
Atrial fibrillation, Cardiac ablation, Cardiac dysfunction Atrial fibrillation, Cardiac ablation, Cardiac dysfunction
Developed A-Fib requiring an Ablation on my heart. Heart only operates at 50% capacity now Developed A-Fib requiring an Ablation on my heart. Heart only operates at 50% capacity now
✓ ✓ ✓
2859543 1 F IA 09/17/2025 FLU3
MMR
PNC20
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.



Pyrexia, Seizure; Pyrexia, Seizure; Pyrexia, Seizure; Pyrexia, Seizure Pyrexia, Seizure; Pyrexia, Seizure; Pyrexia, Seizure; Pyrexia, Seizure
She experienced 2 minute long seizure and was found to have fever of 102. Seizure stopped, she was e... She experienced 2 minute long seizure and was found to have fever of 102. Seizure stopped, she was evaluated in emergency department with no immediate complications and discharged home More
2859556 6 F OH 09/17/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 Y49B2
Z003309
Injection site erythema, Injection site warmth; Injection site erythema, Injecti... Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth More
Redness, warmth on entire deltoid left Redness, warmth on entire deltoid left
2856631 1.08 M 09/16/2025 MMR
 UNKNOWN MANUFACTURER
Condition aggravated, Dermatitis atopic Condition aggravated, Dermatitis atopic
flare up of symptoms most likely due to the dryness during the flight; This spontaneous report was r... flare up of symptoms most likely due to the dryness during the flight; This spontaneous report was received from a consumer or other non health professional (reported as patient's guardian) via other company on 27-Aug-2025 and refers to a 1-year-old male patient. The patient's medical history and concomitant therapies were not reported. As concurrent conditions were reported atopic dermatitis. On 07-Feb-2025, the patient who developed flare up of symptoms was intentionally prescribed and started therapy with Dupixent (Dupilumab) Solution for injection 200 mg once (strength: 200 mg) as loading dose followed by 200 mg every month subcutaneously since Mar-2025 for atopic dermatitis, unspecified, other atopic dermatitis via pre-filled pen with no adverse event (lot # and expiration date were not reported). In April 2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date unknown). At the same time, the patient also administered Dupixent (Dupilumab). In 2025, the patient experienced flare up of symptoms of symptoms most likely due to the dryness during the flight in the travelling (dermatitis atopic) following the first dose intake of Dupixent (Dupilumab and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine. Unspecified topical was received as treatment for dermatitis atopic, which helped flare. Status of reported flare up not provided. Unknown if prescriber was aware. At the reporting time, the outcome of the event was unknown. The action taken with sterile diluent and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was reported as not applicable. The action taken with Dupixent (Dupilumab) was reported as unknown. The causal relationship between the event and all suspect drugs and vaccine was not reported. Lot# is being requested and will be submitted if received. It has been determined that case safety report UID NUMBER US-009507513-2324240 is a duplicate of case safety report UID NUMBER US-009507513-2323993. Therefore, case safety report UID NUMBER US-009507513-2324240 is being deleted from our files and the cases are consolidated into case safety report UID NUMBER US-009507513-2323993. More
2858488 F 09/16/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Myalgia, Pyrexia, SARS-CoV-2 test COVID-19, Myalgia, Pyrexia, SARS-CoV-2 test
COVID-19; muscle pain; mild fever; This is a spontaneous report received from a Consumer or other no... COVID-19; muscle pain; mild fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 56-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2024, outcome "unknown", described as "mild fever"; MYALGIA (non-serious) with onset 2024, outcome "unknown", described as "muscle pain"; COVID-19 (non-serious) with onset 30Aug2025, outcome "recovered" (09Sep2025). The event "covid-19" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: Caller (Patient) dialed in to inquire about Comirnaty. She had COVID-19 last week, starting with a fever on 30Aug2025, and tested positive for COVID-19 on 01Sep2025. She went to urgent care and was prescribed Paxlovid, and she is fine now. Caller is wondering if she can receive the regular booster shot today. She took the last course of Paxlovid, with her last dose on Friday (05Sep2025). She has an appointment today with (withheld) and wants to know if she can receive it or if she has to wait. Caller clarified that the vaccine she's referring to is Comirnaty. It's been a year and a half since she got the vaccine, and she got COVID-19, so she wants to update her vaccine. Caller said that there's a question about her health, and she put yes. It has a list, and one says overweight. She is 210 lbs and thinks that's probably overweight, so she just clicked it and got it. She takes thyroid medicine for her thyroid, but it was nothing serious. She's wondering if maybe because she clicked it, she got approved for the vaccine. They tested for COVID-19 yesterday, and it came out negative, but she wants to get the booster shot because she read on Paxlovid that a patient can get a rebound. She wants to get the vaccine so she doesn't get the rebound. The only person she talked to was a pharmacist from (withheld), and she was advised to get the vaccine after 2 weeks. PMI mentioned about experiencing some side effects like muscle pain of mild fever from previous Covid-19 vaccines received as a common side effect, caller agreed and said she had those. PMI wasn't able to clarify because it was inaudible at the time of the call and was only noted during documentation post-call. Caller was wondering if she develops some immunity after taking Paxlovid. She wanted to get the vaccine because she read the pamphlet, and it says you don't get immunity with Paxlovid like you do if it ran its course, so she wants to get the vaccine so she has good immunity against it. Caller was thankful for Paxlovid. She's glad that Pfizer has the medication. They were out of town when they got it and had to isolate, so they took it and it got them better faster. Her husband took Paxlovid too. Caller asked what is the difference between Comirnaty and the regular Pfizer vaccine? Are they just the same?. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859030 09/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Guillain-Barre syndrome, Neuropathy peripheral Guillain-Barre syndrome, Neuropathy peripheral
got Guillain-Barre; This serious case was reported by a consumer via interactive digital media and d... got Guillain-Barre; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: got Guillain-Barre) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 08-SEP-2025 This case was reported by a patient via (Shingles) interactive digital media. Reporter reported that vaccines destroying adult lives also. Patient now having extreme problems with peripheral neuropathy and other conditions.; Sender's Comments: A case of Guillain-Barre syndrome, on an unknown date after receiving the 1st dose of Shingrix, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2859031 79 M NC 09/16/2025 UNK
 UNKNOWN MANUFACTURER
 3052549
Fatigue, Vaccination site pain Fatigue, Vaccination site pain
he had some fatigue/little bit tired; mild tenderness at the vaccination site; This spontaneous case... he had some fatigue/little bit tired; mild tenderness at the vaccination site; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (he had some fatigue/little bit tired) and VACCINATION SITE PAIN (mild tenderness at the vaccination site) in a 79-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (dose 12) in March 2025, SPIKEVAX 2024-2025 PFS (dose 12) in March 2025, Spikevax NOS (previous 11 doses) and Spikevax NOS (previous 11 doses). Past adverse reactions to the above products included Fatigue with SPIKEVAX 2024-2025 PFS; and Vaccination site tenderness with SPIKEVAX 2024-2025 PFS, Spikevax NOS and Spikevax NOS. On 02-Sep-2025, the patient received thirteenth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 50 microgram. In 2025, the patient experienced FATIGUE (he had some fatigue/little bit tired) and VACCINATION SITE PAIN (mild tenderness at the vaccination site). At the time of the report, FATIGUE (he had some fatigue/little bit tired) and VACCINATION SITE PAIN (mild tenderness at the vaccination site) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had some fatigue and mild tenderness at the vaccination site. His doctor did not want to prescribe him the vaccine for unknown reasons (even though he was already 69 years old, and he had 12 doses of Covid vaccines in the past with similar side effects) and he finally got vaccinated. He did not have an immunization card or any other numbers pertaining to the LOT and was unable to find out what the lot number was. He went to the pharmacist and collected the exact lot number. The patient was between various places that morning, and he was a little bit tired. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789115, MOD-2025-789158 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2025: Live follow-up received: Age, lot number and event verbatim were updated and references added. On 09-Sep-2025: Live follow-up received: Reporter's details and reference numbers were added. Dose and unit updated. More
2859032 F FL 09/16/2025 UNK
 UNKNOWN MANUFACTURER
 3052549
Chills, Pyrexia Chills, Pyrexia
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYRE... fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 microgram. On 07-Sep-2025, the patient experienced PYREXIA (fever) and CHILLS (chills). On 08-Sep-2025, PYREXIA (fever) and CHILLS (chills) had resolved. No concomitant medication was reported. The patient had fever and chills, which did not occur until about 12 hours following the injection. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. Reporter did not allow further contact More
2859033 F FL 09/16/2025 UNK
 UNKNOWN MANUFACTURER
Rash Rash
she developed a rash in the abdomen and around the broad-line; This spontaneous case was reported by... she developed a rash in the abdomen and around the broad-line; This spontaneous case was reported by a consumer and describes the occurrence of RASH (she developed a rash in the abdomen and around the broad-line) 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 04-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 06-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced RASH (she developed a rash in the abdomen and around the broad-line). On 07-Sep-2025, RASH (she developed a rash in the abdomen and around the broad-line) had resolved. No concomitant medication was reported. The patient was vaccinated with Spikevax on 4-Sep-2025 and on 6-Sep-2025, she developed a rash in the abdomen and around the broad-line. The rash disappeared on the 7-Sep-2025. The patient did not experience any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2025: Live non-significant follow-up received with narrative and reference ID added More
2859034 87 M NH 09/16/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Balance disorder, Chest pain, Cough, Disorientation, Pain; Painful respiration Balance disorder, Chest pain, Cough, Disorientation, Pain; Painful respiration
It was pain to what seemed to be skeletal structure, and it was severe pain/was in very, very severe... It was pain to what seemed to be skeletal structure, and it was severe pain/was in very, very severe pain; have no sense of balance; whole thing disoriented; it hurt to cough; it hurt to cough and to take a deep breath; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (It was pain to what seemed to be skeletal structure, and it was severe pain/was in very, very severe pain), BALANCE DISORDER (have no sense of balance), DISORIENTATION (whole thing disoriented), COUGH (it hurt to cough) and HYPERVENTILATION (it hurt to cough and to take a deep breath) in an 87-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes (taking insulin, product name unspecified). Concomitant products included Insulin porcine (Insulin) for Diabetes. On 06-Sep-2025 at 12:15 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (It was pain to what seemed to be skeletal structure, and it was severe pain/was in very, very severe pain), BALANCE DISORDER (have no sense of balance), DISORIENTATION (whole thing disoriented), COUGH (it hurt to cough) and HYPERVENTILATION (it hurt to cough and to take a deep breath). The patient was treated with Ibuprofen (Advil) for Skeletal pain, at a dose of popped 3 Advil; Ibuprofen (Advil) for Skeletal pain, at a dose of popped a couple of Advil; Ibuprofen (Advil) for Skeletal pain, at a dose of popped more Advil and Ibuprofen (Advil) for Skeletal pain, at a dose of popped more Advil. At the time of the report, BONE PAIN (It was pain to what seemed to be skeletal structure, and it was severe pain/was in very, very severe pain), BALANCE DISORDER (have no sense of balance), DISORIENTATION (whole thing disoriented), COUGH (it hurt to cough) and HYPERVENTILATION (it hurt to cough and to take a deep breath) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. It was reported that, the patient did not know the product name. Patient had an incredible thing, never felt this bad in all his life. Patient got the vaccination and when got to his home, he was in very severe pain and the pain was such the whole thing that disoriented him, and he was not a disoriented kind of person. He was old but was very organized. Patient was very self-sufficient and was incredibly screwed up. He had no sense of balance, and he put himself to sleep. Starting at about 4 o'clock and got fit for sleep and again, his normal reaction would have been, with pain, to pop some Advil and he didn't do that for hours later, that he popped 3 Advil and that alleviated the pain, didn't made it disappear, but it certainly alleviated it and he got tip toe sleep all night. Unfortunately, he went to local professional football game, which he had been doing for 35 years, and it was very weird what he was left with. Patient popped up a couple of Advil probably 6 doses of Advil total and still had pain. This pain was at the level of like his clavicle and it hurt him to cough and to take a deep breath and he was so screwed up that, that night, He was a diabetic and didn't take any insulin and didn't take any medications. He took no medication which was so unusual for him. Patient was anal when it came to this stuff and still had this when he came home from a football game at night. He didn't eat, but had some tailgating at the game, nothing stupendous, just some stuff nothing heavy, and he consciously ate something because he didn't want to take insulin on an empty stomach. He went into a coma. So, he consciously ate something and gave himself a normal shot of insulin and popped more Advil. And then in the morning of 08-Sep-2025, he didn't feel anything, popped more Advil and was normal on everything, didn't feel any pain. Patient's whole mental processes was affected because not taking insulin was like he had been a diabetic for 9 million years and his A1C was very controlled. It was stated that he was fine now. He had had so many of these shots before. Previous administration dates were unknown. He was under the care of a cardiologist. More
2859035 1.33 F TN 09/16/2025 DTAP
HIBV
MENB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 JP227
BS59L
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
None at this time. Just wrong vaccine given at visit. None at this time. Just wrong vaccine given at visit.
2859036 4 F MA 09/16/2025 DTAPIPV
DTAPIPV
DTAPIPV
FLU3
FLU3
FLU3
MMRV
MMRV
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 U8623AA
U8623AA
U8623AA
406987
406987
406987
Z010379
Z010379
Z010379
Aspartate aminotransferase increased, Blood creatine phosphokinase increased, C-... Aspartate aminotransferase increased, Blood creatine phosphokinase increased, C-reactive protein increased, Chromaturia, Crying; Injection site erythema, Leukocytosis, Pain, Red blood cell sedimentation rate increased, Renal function test normal; Respiratory viral panel, Tremor, Urine analysis abnormal, Viral test negative, White blood cell count increased; Aspartate aminotransferase increased, Blood creatine phosphokinase increased, C-reactive protein increased, Chromaturia, Crying; Injection site erythema, Leukocytosis, Pain, Red blood cell sedimentation rate increased, Renal function test normal; Respiratory viral panel, Tremor, Urine analysis abnormal, Viral test negative, White blood cell count increased; Aspartate aminotransferase increased, Blood creatine phosphokinase increased, C-reactive protein increased, Chromaturia, Crying; Injection site erythema, Leukocytosis, Pain, Red blood cell sedimentation rate increased, Renal function test normal; Respiratory viral panel, Tremor, Urine analysis abnormal, Viral test negative, White blood cell count increased More
Patient woke during the night crying, shaking and pain - given Tylenol and went to ER - arrived at E... Patient woke during the night crying, shaking and pain - given Tylenol and went to ER - arrived at ER just before midnight on 9/10/2025 - she left at 1:08am on 9/11/25 without being seen as symptoms had resolved - she went back to ER on 9/11/25 at 7:27pm due to pink tinged urine - she had erythemia on left arm- denied any other symptoms - she was was admitted for observation due to lab work - she was given 1.5 liter of saline - she was started on Amoxil for positive u/a but discontinued once culture came back with multiple flora - More
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2859113 19 F PA 09/16/2025 FLU3
 SANOFI PASTEUR
 U8800DA
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Given high dose influenza vaccine for 65+ in error. No symptoms or adverse reactions. Given high dose influenza vaccine for 65+ in error. No symptoms or adverse reactions.
2859114 23 F PA 09/16/2025 FLU3
 SANOFI PASTEUR
Exposure during pregnancy, Incorrect dose administered, No adverse event Exposure during pregnancy, Incorrect dose administered, No adverse event
received Fluzone highdose in error at ~ 19 wks GA. no adverse reactions. received Fluzone highdose in error at ~ 19 wks GA. no adverse reactions.
2859116 18 F VA 09/16/2025 TD
 SANOFI PASTEUR
 2CA91C1
Expired product administered, No adverse event Expired product administered, No adverse event
The TD vaccine was administered with an expired date of 7/04/25. No symptom. The TD vaccine was administered with an expired date of 7/04/25. No symptom.
2859117 16 F 09/16/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 9N424
Z92L4
Injection site induration, Injection site pain; Injection site induration, Injec... Injection site induration, Injection site pain; Injection site induration, Injection site pain More
Hard spot where the injection was given, painful. Hard spot where the injection was given, painful.
2859118 64 M MO 09/16/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 006d21a
006d21a
052E21A
052E21A
Asthenia, Blood pressure abnormal, Brain fog, Death, Dizziness; Head injury, Los... Asthenia, Blood pressure abnormal, Brain fog, Death, Dizziness; Head injury, Loss of consciousness, Pyrexia, Road traffic accident, Syncope; Asthenia, Blood pressure abnormal, Brain fog, Death, Dizziness; Head injury, Loss of consciousness, Pyrexia, Road traffic accident, Syncope More
After first and second shot my father was ill with fever, loss of energy and mental clarity on both ... After first and second shot my father was ill with fever, loss of energy and mental clarity on both occasions for more than three days. He developed blood pressure issues over time and had fainting episodes. He died September 30th 2025 after loosing consciousness while driving a vehicle. There was a medical examination due to the accident and it was determined that he had lost consciousness and then suffered a head injury which ultimately caused is death. More
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2859119 18 M MO 09/16/2025 MENB
MENB
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 2G3S9
2G3S9
Z453D
Z453D
Injection site pruritus, Injection site rash, Injection site warmth, Rash, Rash ... Injection site pruritus, Injection site rash, Injection site warmth, Rash, Rash erythematous; Urticaria; Injection site pruritus, Injection site rash, Injection site warmth, Rash, Rash erythematous; Urticaria More
vaccines given at 4:19 pm. By4:27 pm client had developed at rash at vaccine sites and the sites we... vaccines given at 4:19 pm. By4:27 pm client had developed at rash at vaccine sites and the sites were itching. Client had a 4 inch circular red and warm rash at vaccine site (left arm, Men B) and a 1.5 inch (MCV right arm) and rash/hives on upper arms and chest. rash did improve within 30 minutes and the itching did subside. Client did take a Benadryl when he arrived home around 530 pm and by 6:15 pm the rash did go away. More
2859120 0.08 M PA 09/16/2025 HIBV
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Vaccine was given to a 5 week old. No reaction at this time noted. Vaccine was given to a 5 week old. No reaction at this time noted.
2859121 31 M FL 09/16/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
 204A21A
204A21A
204A21A
Ataxia, Chest pain, Computerised tomogram head, Dyspnoea, Echocardiogram; Electr... Ataxia, Chest pain, Computerised tomogram head, Dyspnoea, Echocardiogram; Electroencephalogram, Electromyogram, Loss of consciousness, Magnetic resonance imaging head, Postural orthostatic tachycardia syndrome; Tachycardia, Tilt table test positive, Tremor More
I initially developed some tremors in the left arm and hand about 2 weeks after the shot, late Augus... I initially developed some tremors in the left arm and hand about 2 weeks after the shot, late August or early September 2021. Went to the ER within a week of increased severity of the tremors in the left hand and arm, due to shortness of breath and chest pains. ER noted short tachycardia events but deemed to not be a heart attack and sent home after about 8 hours of observation. Tremors started to be experienced across more muscles in the body. Early December of 2021, I exhibited what appeared to be a partial seizure, losing fine control of all limbs, tongue and mouth. Started developing more tremors frequently across my entire body, numbering hundreds of events a day. During a PT test in April 2022, I completed the fitness exam run with only 100BPM heartrate and was blacking out from lack of oxygen. Approximately 15 minutes after completion well resting and recovering, my heart rate jumped to over 150BPM. Was put on a medical profile to prevent further injury or possible death from physical activity due to the nature of my tremors and uncontrolled heartrate. I have been seen by multiple neurologists and cardiologists, with inconclusive results other than a positive POTS diagnosis within the last year. Neurology had tried various medications: Depakote, Flexeril and Lamictal as a source of relief which were either ineffective or caused severe exhaustion. Clonazepam 1MG has shown to reduce the tremor events to between 15 and 50 a day. More
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2859123 58 F GA 09/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Patient had localized reaction at vaccine site. Had a painful red circle (approximately 4 inches in ... Patient had localized reaction at vaccine site. Had a painful red circle (approximately 4 inches in diameter) around the injection site with no other signs or symptoms according to patient. More
2859124 3 M AL 09/16/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 93H32
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
The patient was given the combination vaccine Kinrix for his 3rd dose of both dtap and polio. This v... The patient was given the combination vaccine Kinrix for his 3rd dose of both dtap and polio. This vaccine is to be used for ages 4-6 years and he is 3 years of age. More
2859125 49 M WI 09/16/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 MB599
No adverse event, Wrong technique in product usage process No adverse event, Wrong technique in product usage process
Pulled pediatric dose which was 0.5ml. Gave two of same lot number to equal 1.0ml adult dose. NO A... Pulled pediatric dose which was 0.5ml. Gave two of same lot number to equal 1.0ml adult dose. NO ADVERSE REACTIONS. More
2859126 14 M GA 09/16/2025 MMRV
 MERCK & CO. INC.
 Z007213
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No allergic reaction noted, no symptoms or signs. The patient was given ProQuad off label. Patient&... No allergic reaction noted, no symptoms or signs. The patient was given ProQuad off label. Patient's mother was informed, she stated that her child is doing great, no issues noted. More
2859127 76 F NC 09/16/2025 COVID19
 MODERNA
 unknown
Dizziness Dizziness
Woke w/ dizziness starting 3 1/2 days after injection. Better by mid-afternoon, but still not back ... Woke w/ dizziness starting 3 1/2 days after injection. Better by mid-afternoon, but still not back to normal. More
2859128 16 M GA 09/16/2025 MMRV
 MERCK & CO. INC.
 Z007213
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No allergic reaction noted, no symptoms or signs. The patient was given ProQuad off label. Patient&... No allergic reaction noted, no symptoms or signs. The patient was given ProQuad off label. Patient's mother was informed, she stated that her child is doing great, no issues noted. More
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