🏥 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 💀 🏥 🚑 ♿ ⚠️
2864699 76 M FL 10/09/2025 COVID19
 NOVAVAX
 6315MF001C
Rash, Rash macular Rash, Rash macular
PATIENT STATES THAT HE RECEIVED THE VACCINE YESTERDAY AND TODAY A BLOTCHY RASH APPEARED ON HIS STOMA... PATIENT STATES THAT HE RECEIVED THE VACCINE YESTERDAY AND TODAY A BLOTCHY RASH APPEARED ON HIS STOMACH. AFTER A FEW HOURS, THE RASH HAD SPREAD A LITTLE ON HIS LEFT SIDE. PATIENT APPLIED HYDROCORTISONE 1% CREAM TO HELP THE RASH INITIALLY. NO MENTION OF ITCHING OR PAIN. More
2864700 76 F FL 10/09/2025 FLU3
 SANOFI PASTEUR
 UT8781DA
Dizziness, Head injury, Syncope, Unresponsive to stimuli Dizziness, Head injury, Syncope, Unresponsive to stimuli
After receiving her vaccination, the patient shopped around the grocery store for about 10 minutes, ... After receiving her vaccination, the patient shopped around the grocery store for about 10 minutes, then fainted while she was checking out her groceries at a self-checkout kiosk. She fell backward and hit her head on the floor. She was unresponsive for 30 to 40 seconds. EMS was called and took her via ambulance to the ER. More
2864701 70 M OR 10/09/2025 FLU3
 SANOFI PASTEUR
 ut8794ca
Extra dose administered, Wrong patient Extra dose administered, Wrong patient
pt given flu shot in error, was meant for another pt. this pt had already received his flu shot this... pt given flu shot in error, was meant for another pt. this pt had already received his flu shot this season More
2864702 19 F AL 10/09/2025 HPV9
 MERCK & CO. INC.
 2002580
Blindness transient, Malaise, Pallor Blindness transient, Malaise, Pallor
While patient in clinic after HPV was given approximately 5minutes post injection , patient states &... While patient in clinic after HPV was given approximately 5minutes post injection , patient states " Nurse, I don't feel good." Patient was pale and states she couldn't see. She was talking to staff, she had not had anything to eat today. Asked if she wanted something to drink. blood pressure obtained 98/60. She tolerated her Coke and was able to walk to Exam room 2 and staff assisted her the bed and elevated her feet for better blood flow. Damp cloth provided. She rested for approximately 10 more minutes. Stated she was feeling much better. Blood pressure rechecked before leaving. No distress noted assisted patient to waiting room for check out. More
2864703 62 M GA 10/09/2025 FLU3
 SANOFI PASTEUR
 UT8781BA
Incorrect dose administered Incorrect dose administered
High dose flu vaccine given to 62 year old flu vaccine. High dose flu vaccine recommended for 65 yea... High dose flu vaccine given to 62 year old flu vaccine. High dose flu vaccine recommended for 65 years and older. Vaccine given outside of recommended age. More
2864704 74 F PA 10/09/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR

Tinnitus; Tinnitus Tinnitus; Tinnitus
Ringing in both ears! Ringing in both ears!
2864706 79 M AL 10/09/2025 COVID19
 PFIZER\BIONTECH
 my9547
Pain, Pain in extremity Pain, Pain in extremity
Patient said after receiving the COVID-19 vaccine, his arm started hurting. He described it as '... Patient said after receiving the COVID-19 vaccine, his arm started hurting. He described it as 'tennis elbow' pain. He said the pain shot down to his elbow. He later went to the chiropractor thinking he will need an adjustment. More
2864707 9 M GA 10/09/2025 FLU3
 SANOFI PASTEUR
 UT8861JA
Erythema, Peripheral swelling Erythema, Peripheral swelling
After injection patient's arm noted with redness and swelling. After injection patient's arm noted with redness and swelling.
2864708 26 F CO 10/09/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 8146545
AX4604A
Rash erythematous, Rash papular, Rash pruritic; Rash erythematous, Rash papular,... Rash erythematous, Rash papular, Rash pruritic; Rash erythematous, Rash papular, Rash pruritic More
Approximately 15 minutes after injection, patient presented to pharmacy with a red, raised, itching ... Approximately 15 minutes after injection, patient presented to pharmacy with a red, raised, itching rash. RPh attempted to administer 25 mg of liquid benadryl which was refused by the patient for fear of sedation. Patient agreed to take 12. mg of liquid benadryl at 12:07 pm. Patient was monitored until 12:37 pm at which point the rash had resolved. patient was contacted via phone at 2:13 pm and reported her symptoms have resolved. RPh counseled patient to go to the ED if symptoms persist or worsen More
2864709 13 M 10/09/2025 FLU3
 SEQIRUS, INC.
 do not know bra
Rash Rash
full body rash full body rash
2864711 0.67 M ME 10/09/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 3052579
2T543
Urticaria; Urticaria Urticaria; Urticaria
About 30 minutes after receiving both vaccines he started scratching his head, mom noticed that he w... About 30 minutes after receiving both vaccines he started scratching his head, mom noticed that he was starting to develop hives. Starting on his head, neck and his chest. He was brought back to the office, given a dose of Benadryl and monitored by PCP for about 45 minutes. Hives were going down, and baby was playing when they left the office More
2864712 75 F NY 10/09/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 407269
407269
Back pain, Blood glucose, Chest discomfort, Chest pain, Dizziness; Dysphagia, Dy... Back pain, Blood glucose, Chest discomfort, Chest pain, Dizziness; Dysphagia, Dyspnoea, Flushing More
5 minutes after receiving vaccine the patient started to experience back pain, chest pain and tightn... 5 minutes after receiving vaccine the patient started to experience back pain, chest pain and tightness, dizziness, flushed face, trouble breathing and trouble swallowing. EMS was called. RPh gave dose of chewable aspirin 81 mg to patient. Patient was assessed by paramedics who took patients vitals, measured blood sugar, and asked further questions to patient. Patient declined being transported to the hospital stating they wanted to go home. More
2864713 57 M 10/09/2025 FLU3
 SANOFI PASTEUR
Erythema, Pruritus Erythema, Pruritus
itching and redness 3 days after vaccine itching and redness 3 days after vaccine
2864714 35 F CO 10/09/2025 FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 99h9a
99h9a
99h9a
99H9A
99H9A
99H9A
Injection site haemorrhage, Injection site pain, Pain in extremity; Hypoaesthesi... Injection site haemorrhage, Injection site pain, Pain in extremity; Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Muscle spasms, Muscular weakness; Paraesthesia; Injection site haemorrhage, Injection site pain, Pain in extremity; Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Muscle spasms, Muscular weakness; Paraesthesia More
Patient reports pain down her arm at the time of the vaccine. Reports felt like she hit the bone. Wh... Patient reports pain down her arm at the time of the vaccine. Reports felt like she hit the bone. When needle removed she bled. More
2864715 0.33 M OK 10/09/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 TC47K
Y018168
1X4486
EX434
Injection site erythema, Injection site induration; Injection site erythema, Inj... Injection site erythema, Injection site induration; Injection site erythema, Injection site induration; Injection site erythema, Injection site induration; Injection site erythema, Injection site induration More
Pt had redness/induration on L thigh most likely from DTaP given this week. Gave conservative measu... Pt had redness/induration on L thigh most likely from DTaP given this week. Gave conservative measure instructions and watchful waiting. More
2864716 54 F CO 10/09/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052034
U8832CA
Conjunctival haemorrhage, Pyrexia; Conjunctival haemorrhage, Pyrexia Conjunctival haemorrhage, Pyrexia; Conjunctival haemorrhage, Pyrexia
Patient called on 10/9/25 asking about the side effects of the Covid vaccine. Patient stated that sh... Patient called on 10/9/25 asking about the side effects of the Covid vaccine. Patient stated that she received the Covid vaccine and is experiencing subconjunctival hematoma and wanted to know if this was one of the side effects. Patient also stated that she has a history of subconjunctival hematoma but it hasn't been this bad. She did also experience a fever post vaccine but no longer has and the hematoma is not affecting her vision. More
2864717 16 F ND 10/09/2025 MENB
 PFIZER\WYETH
 LL0641
Rash, Urticaria Rash, Urticaria
On 9/21/2025 patient's mother contacted me through My Chart indicating child developed hive r... On 9/21/2025 patient's mother contacted me through My Chart indicating child developed hive rash to both of her legs after receiving the Meningococcal vaccine. Rash resolved on it's own after a few days. Just wanted to make sure reaction to Meningococcal Vaccine was mentioned. More
2864718 37 M ID 10/09/2025 FLU3
 SANOFI PASTEUR
 U8366AA
Blood pressure increased, Chills, Headache Blood pressure increased, Chills, Headache
chills, elevated blood pressure (139/100) and pulse 133, temperature 99.4 degrees F, severe headache chills, elevated blood pressure (139/100) and pulse 133, temperature 99.4 degrees F, severe headache
2864719 2 M WI 10/09/2025 FLU3
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 F4A7R
Z005472
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Received 3rd dose of Hep A (Vaqta) today. Has previously received Hep A 9/23/24 and 3/20/25. Received 3rd dose of Hep A (Vaqta) today. Has previously received Hep A 9/23/24 and 3/20/25.
2864720 51 M TX 10/09/2025 HEPAB
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 AZ2A3
72R4G
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Third twinrix vaccination dose was given a month after 2nd twinrix vaccination dose. Third twinrix vaccination dose was given a month after 2nd twinrix vaccination dose.
2864721 78 F TX 10/09/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Ageusia, Asthenia, Chills, Circulatory collapse, Decreased appetite; Dizziness, ... Ageusia, Asthenia, Chills, Circulatory collapse, Decreased appetite; Dizziness, Fatigue, Headache, Hyperhidrosis, Nausea; Pyrexia More
collapsed and had to crawl to the bathroom; taste was completely gone; Chills; woke up and was soake... collapsed and had to crawl to the bathroom; taste was completely gone; Chills; woke up and was soaked with sweat; had no appetite whatsoever; weak; bad fever; splitting headache; got sick to her stomach; dizzy; very tired; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Sep2025 at 17:00 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "allergy to Oral Sulfa drugs" (unspecified if ongoing), notes: she gets heart flutters if ingested.; "Seasonal Allergies" (ongoing), notes: Does not take anything for her seasonal allergies.; "Arthritis in her knees" (ongoing), notes: Takes Bayer back and body in the evening for her knees.; "slightly dehydrated" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation, on 25Sep2025 as dose number unknown, 0.5 ml single; CAPTOPRIL taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); SIMVASTATIN taken for blood cholesterol increased (ongoing); MIRALAX taken for constipation (ongoing). The patient also took other concomitant therapy. Vaccination history included: Pfizer covid vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "chills"; Moderna covid vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "chills". The following information was reported: CHILLS (non-serious) with onset 2025, outcome "unknown"; PYREXIA (non-serious) with onset 2025, outcome "unknown", described as "bad fever"; CIRCULATORY COLLAPSE (medically significant) with onset 2025, outcome "unknown", described as "collapsed and had to crawl to the bathroom"; DIZZINESS (non-serious) with onset 2025, outcome "unknown", described as "dizzy"; NAUSEA (non-serious) with onset 2025, outcome "unknown", described as "got sick to her stomach"; DECREASED APPETITE (non-serious) with onset 2025, outcome "unknown", described as "had no appetite whatsoever"; HEADACHE (non-serious) with onset 2025, outcome "recovered", described as "splitting headache"; AGEUSIA (non-serious) with onset 2025, outcome "recovered", described as "taste was completely gone"; FATIGUE (non-serious) with onset 2025, outcome "unknown", described as "very tired"; ASTHENIA (non-serious) with onset 2025, outcome "unknown", described as "weak"; HYPERHIDROSIS (non-serious) with onset 2025, outcome "unknown", described as "woke up and was soaked with sweat". Therapeutic measures were taken as a result of pyrexia, headache. Clinical course: Caller was a consumer called about the medication Comirnaty and said that it is for 65 years and older. She thought about filing something with the government, but it did not seem the right thing to do. She got the flu vaccine and the Comirnaty vaccine on Thursday around midday. Usually after she gets the vaccines, she has had Pfizer covid vaccines and including Moderna covid vaccines. She usually gets the chills that last a couple of hours and then everything is fine. She got the Comirnaty vaccine around noon and at about 5pm she started getting the chills, but by 9 they were turning into really bad chills that seemed to be a bad fever. She went to bed early and let it go. She must have been running a bad fever and it broke in the middle of the night and she woke up and she was soaked with sweat. When she woke up, she had a splitting headache and she was completely weak and collapsed and had to crawl to the bathroom, and that had never happened before. She got sick to her stomach, but no throwing up. She managed to take some aspirin and crawl back to bed and go to sleep. In the morning it seemed as if the fever had broken, but she had no appetite whatsoever. She forced herself to eat breakfast, but could taste anything, her taste was completely gone. It was odd. She was very tired and very weak, but she got through the day. In the evening, she got the chills again and said that the headache had not gone away. She switched to Excedrin and the headache started to go away. She went to make dinner to see if her taste was coming back, but every time she stood up, after 4-5 minutes, she would feel weak like she was going to collapse. It was like she was not stable. Once she sat down it would go away, but once she stood back up it would come back after a few minutes. She stated she was not exactly dizzy, but she guesses it could be categorized as dizzy. She slept all night and she felt better and said that she is starting to lose track of time. The headache was not entirely gone, but the headache is gone today. She does not feel up to par, she does not feel bad, but not like she normally would. She feels tired and she got a full night sleep. Her taste came back and does not know why it went away. She is back to her usual breakfast routine. She is extremely healthy 78-year-old. She takes high blood pressure medication and cholesterol medication. She has no preexisting conditions. If this happens to someone with a preexisting condition it would be bad. That is why she is calling. Someone she talked to had heard that other people had adverse reactions to the Comirnaty vaccine. She has taken a Pfizer covid vaccine before and this never happened before. There is something in the vaccine that needs to be looked at. She will need to report this to the doctor as part of her health routine. Caller added that she has been on a diet for the last year to lose certain number of pounds. Medical conditions: She is slightly dehydrated and her doctor told her to eat more protein. Lost almost no weight since Jan. Stated that since she was taking in more protein she became constipated and was on Miralax and said that probably made her more dehydrated. Other than being sick as a dog, it was not like she was going to die or anything. She considered that she has been dieting for so long that it could be related to weight loss and then taking Miralax with a diuretic that made her more dehydrated than she was before. She is concerned about other people with preexisting conditions this could affect. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine reported as none. Did any AE require a visit to the Emergency Room or Physician's Office reported as No. Treatment received for the adverse event included: Aspirin and Excedrin. Only thing that ever happened after receiving the previous Covid vaccines was she got the chills after a couple of hours, and then after a couple of hours the chills would go away and then everything would be fine. More
2864722 F DE 10/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Investigation COVID-19, Drug ineffective, Investigation
we've gotten all their shots and still, we've had COVID like, four times in the last, I do... we've gotten all their shots and still, we've had COVID like, four times in the last, I don't know, year and a half, her 5th; we've gotten all their shots and still, we've had COVID like, four times in the last, I don't know, year and a half, her 5th; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 81-year-old 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 included: "Covid-19" (unspecified if ongoing), notes: we've had COVID like, four times in the last, I don't know, year and a half, her 5th. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN. We've gotten all their shots), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "we've gotten all their shots and still, we've had COVID like, four times in the last, I don't know, year and a half, her 5th". The patient underwent the following laboratory tests and procedures: rapid test: Unknown results; she's bad again; better and perfect. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: During an inbound call for financial assistance, the reporter stated that her wife is 81, and his 76 and they had COVID and they've gotten all their shots and still, they had COVID, like four times in the last, year and half, her 5th. He added, "we're otherwise in good health". Later on, he stated, " she got her last prescription, it was two weeks ago, took them all, felt better and the thing is, I just did another test, she's bad again". The reporter then added, "one interesting thing about COVID, or about Paxlovid, is you basically feel better very quickly compared to anything other than getting penicillin for us". When asked who the financial assistance was for, he stated, " well she's the one that's sick right now. We both took it like two weeks ago, but she's, she was better and perfect, and now she's bad and the rapid test is". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2864723 M DE 10/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
we've gotten all their shots and still, we've had COVID like, four times in the last, I do... we've gotten all their shots and still, we've had COVID like, four times in the last, I don't know, year and a half; we've gotten all their shots and still, we've had COVID like, four times in the last, I don't know, year and a half; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 76-year-old male 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 included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we've gotten all their shots and still, we've had COVID like, four times in the last, I don't know, year and a half". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Additional information: During an inbound call for financial assistance, the reporter stated that her wife is 81, and his 76 and they had COVID and they've gotten all their shots and still, they had COVID, like four times in the last, year and half, her 5th. He added, we're otherwise in good health. Later on, he stated, she got her last prescription, it was two weeks ago, took'em all, felt better and the thing is, just did another test, she's bad again. The reporter then added, one interesting thing about COVID, or about Paxlovid, is you basically feel better very quickly compared to anything other than getting penicillin for us. When asked who the financial assistance was for, he stated, well she's the one that's sick right now. We both took it like two weeks ago, but she's, she was better and perfect, and now she's bad and the rapid test. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2864724 55 F 10/09/2025 COVID19
 PFIZER\BIONTECH
Gastrooesophageal reflux disease, Nausea, Vomiting Gastrooesophageal reflux disease, Nausea, Vomiting
nausea; reflux; vomiting; This is a spontaneous report received from a Consumer or other non HCP. A... nausea; reflux; vomiting; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Oct2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "portal hypertension" (unspecified if ongoing); "liver NRH" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; CARVEDILOL; BRIMONIDINE; BIMATOPROST. Past drug history included: No, reaction(s): "Hypersensitivity". The following information was reported: NAUSEA (non-serious) with onset 05Oct2025 at 14:00, outcome "recovered"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 05Oct2025 at 14:00, outcome "recovered", described as "reflux"; VOMITING (non-serious) with onset 05Oct2025 at 14:00, outcome "recovered". Therapeutic measures were not taken as a result of nausea, gastrooesophageal reflux disease, vomiting. Additional information: The patient received the Comirnaty vaccine at a doctor office or urgent care facility. No other vaccines were administered on the same day or within the prior four weeks. The patient was taking other medications within two weeks of the event. Approximately 25 hours after vaccination, she experienced nausea, reflux, and two episodes of vomiting. The batch/lot number was not available to the reporter at the time of report completion. The event was documented on 06 October 2025. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2864725 67 M CA 10/09/2025 COVID19
 PFIZER\BIONTECH
 AS7144B
Arthralgia, Fatigue, Pyrexia Arthralgia, Fatigue, Pyrexia
Fever beginning at 6:00 PM, peaking at 100.3.; Achy joints; Feeling tired; This is a spontaneous rep... Fever beginning at 6:00 PM, peaking at 100.3.; Achy joints; Feeling tired; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Oct2025 at 10:45 as dose 1, single (Lot number: AS7144B) at the age of 67 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "CLL" (unspecified if ongoing). Concomitant medication(s) included: IMBRUVICA, start date: 28Jul2023; AMLODIPINE, start date: 21Jan2022; BACTRIM, start date: 05Sep2024. The following information was reported: ARTHRALGIA (non-serious) with onset 06Oct2025 at 18:00, outcome "not recovered", described as "Achy joints"; FATIGUE (non-serious) with onset 06Oct2025 at 18:00, outcome "not recovered", described as "Feeling tired"; PYREXIA (non-serious) with onset 06Oct2025 at 18:00, outcome "not recovered", described as "Fever beginning at 6:00 PM, peaking at 100.3.". Therapeutic measures were not taken as a result of pyrexia, arthralgia, fatigue. Additional information: Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting: No. Did the patient receive any other vaccines within 4 weeks prior to the vaccine for which you are reporting: No. Was the patient taking any other medications within 2 weeks of the event starting: Yes. Reported Event: Fever beginning at 6:00 PM, peaking at 100.3, achy joints and feeling tired. More
2864726 57 M NE 10/09/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Abdominal discomfort, Arthralgia, Diarrhoea, Fatigue, Joint swelling; Myalgia, P... Abdominal discomfort, Arthralgia, Diarrhoea, Fatigue, Joint swelling; Myalgia, Pain, Peripheral swelling, Swelling face, Vaccination site pruritus More
pain; stomach discomfort; swollen joints; swollen feet; swollen face; Extreme fatigue; itching at si... pain; stomach discomfort; swollen joints; swollen feet; swollen face; Extreme fatigue; itching at site; muscle pain; joint pain; diarrhea; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 03Oct2025 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "Extreme fatigue"; DIARRHOEA (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "diarrhea"; VACCINATION SITE PRURITUS (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "itching at site"; ARTHRALGIA (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "joint pain"; MYALGIA (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "muscle pain"; PAIN (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025); ABDOMINAL DISCOMFORT (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "stomach discomfort"; SWELLING FACE (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "swollen face"; PERIPHERAL SWELLING (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "swollen feet"; JOINT SWELLING (non-serious) with onset 03Oct2025 at 16:30, outcome "recovered" (06Oct2025), described as "swollen joints". Therapeutic measures were not taken as a result of pain, abdominal discomfort, joint swelling, peripheral swelling, swelling face, fatigue, vaccination site pruritus, myalgia, arthralgia, diarrhoea. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2864727 51 F 10/09/2025 COVID19
FLUX
PNC13
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
PFIZER\WYETH


Pain in extremity, Pruritus, Rash macular; Pain in extremity, Pruritus, Rash mac... Pain in extremity, Pruritus, Rash macular; Pain in extremity, Pruritus, Rash macular; Pain in extremity, Pruritus, Rash macular More
Massive red spot on arm with pain and itching; Massive red spot on arm with pain and itching; Massiv... Massive red spot on arm with pain and itching; Massive red spot on arm with pain and itching; Massive red spot on arm with pain and itching; This is a spontaneous report received from a consumer. A 51-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13), on 04Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in arm for immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2025 as dose number unknown, single for immunisation. The patient's relevant medical history included: "Allergy to sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious), PAIN IN EXTREMITY (non-serious), PRURITUS (non-serious) all with onset Oct2025, outcome "not recovered" and all described as "Massive red spot on arm with pain and itching". Therapeutic measures were not taken as a result of rash macular, pain in extremity, pruritus. Additional Information: The facility where vaccine was administered was in a pharmacy or drugstore. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. The patient did not receive any other vaccines within 4 weeks prior to the suspect vaccines. The patient received Comirnaty, Prevnar (reported as Prevnar 23; pending clarification), and Influenza Vaccines. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2864728 F TX 10/09/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Chills; Chills Chills; Chills
usually gets the chills that last a couple of hours and then everything is fine; This is a spontaneo... usually gets the chills that last a couple of hours and then everything is fine; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 0.3 ml single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Seasonal Allergies" (ongoing), notes: Does not take anything for her seasonal allergies; "Arthritis in her knees" (ongoing), notes: Takes Bayer back and body in the evening for her knees; "high blood pressure" (unspecified if ongoing); "constipation" (unspecified if ongoing); "allergies to oral sulfa drugs" (unspecified if ongoing), notes: gets heart flutter when ingested; "heart flutter" (unspecified if ongoing). Concomitant medication(s) included: CAPTOPRIL taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension; SIMVASTATIN taken for hypertension. The following information was reported: CHILLS (non-serious), outcome "recovering", described as "usually gets the chills that last a couple of hours and then everything is fine". Additional information: She thought about filing something with the government, but it did not seem the right thing to do. Usually after she gets the vaccines, she has had Pfizer covid vaccines and including Moderna covid vaccines. She usually gets the chills that last a couple of hours and then everything is fine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2864729 F ME 10/09/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP... feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 9, 0.3 ml single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 2; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 3; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 4; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 5; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 6; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 7; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 8; in left arm), for covid-19 immunization, reaction(s): "With previous doses would feel crummy". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "feel crummy for a day or two". Additional information: With previous doses would feel crummy for a day or two, as people do after any immunization. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2864730 PA 10/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
received my newest Covid vaccine about 6 weeks ago. This week I got Covid; received my newest Covid ... received my newest Covid vaccine about 6 weeks ago. This week I got Covid; received my newest Covid vaccine about 6 weeks ago. This week I got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 75-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Aug2025 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "received my newest Covid vaccine about 6 weeks ago. This week I got Covid". Clinical course: patient received newest Covid vaccine about 6 weeks ago and this week got Covid and called doctor who prescribed Paxlovid because of the age and medical conditions that have. Because the patient was too sick, patient sent a friend to get the medication and was charged #504 out of pocket. When looked on the internet, it said it was free to seniors. Patient have worked hard the whole life and live on social security and little savings. Patient have 65 and they verified this price. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2864731 F 10/09/2025 COVID19
 PFIZER\BIONTECH
Fatigue Fatigue
feeling a little fatigued and tired from getting the vaccines; This is a spontaneous report received... feeling a little fatigued and tired from getting the vaccines; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA275248, AE-021060. A 72-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), from 19Aug2025 to 19Aug2025 at 300 mg single (300 mg, single (qow)), subcutaneous for neurodermatitis; influenza vaccine (FLU [INFLUENZA VACCINE]), in 2025 as dose 1, single for prophylaxis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2025, outcome "unknown", described as "feeling a little fatigued and tired from getting the vaccines". The action taken for dupilumab was unknown. Additional Information: It was reported that patient was feeling a little fatigued and tired from getting the vaccines while being treated with dupilumab delivered Via Single dose pre-filled pen, flu shot and COVID-19 vaccine. The patients past medical history, medical treatrnent(s), vaccination(s) and family history were not provided. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was not reported if the patient received corrective treatment. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2864732 10/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
they got a Covid vaccine two weeks ago but diagnosed with covid; they got a Covid vaccine two weeks ... they got a Covid vaccine two weeks ago but diagnosed with covid; they got a Covid vaccine two weeks ago but diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2025, outcome "unknown" and all described as "they got a Covid vaccine two weeks ago but diagnosed with covid". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The caller and their spouse, both recently diagnosed with COVID-19, sought financial assistance for a prescribed Paxlovid medication due to its high cost. The agent informed the caller about a Pfizer program that could potentially provide assistance based on their insurance coverage and eligibility. Created Manual AE form because the caller mentioned they got a Covid vaccine two weeks ago but diagnosed with covid and prescribed Paxlovid medication. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2864733 10/09/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Asthenia, Chills, Pyrexia, Tremor; Asthenia, Chills, Pyrexia, Tremor Asthenia, Chills, Pyrexia, Tremor; Asthenia, Chills, Pyrexia, Tremor
shaking; incapacitated; chills; fever; This is a spontaneous report received from a Consumer or othe... shaking; incapacitated; chills; fever; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789857. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as 1 df, single intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (experienced side effects every time for about 9 hours after the injection), for covid-19 immunization, reaction(s): "side effects"; Bnt162b2 (Dose number unknown, Pfizer COVID-19 vaccines. Patient experienced side effects every time for about 9 hours after the injection.), for covid-19 immunization, reaction(s): "side effects". The following information was reported: TREMOR (non-serious), outcome "recovered with sequelae", described as "shaking"; ASTHENIA (non-serious), outcome "recovered", described as "incapacitated"; CHILLS (non-serious), outcome "recovered with sequelae"; PYREXIA (non-serious), outcome "recovered with sequelae", described as "fever". Additional information: This case describes the occurrence of TREMOR (shaking), ASTHENIA (incapacitated), CHILLS (chills) and PYREXIA (fever) in a patient who received SPIKEVAX NOS (SPIKEVAX NOS) and Pfizer BioNTech COVID-19 vaccine. The patient had previously taken Moderna and Pfizer COVID-19 vaccines and experienced side effects every time for about 9 hours after the injection. The patient experienced chills, fever, shaking, and was incapacitated for at least a day and a half, sometimes up to 2 to 3 days. Then it would resolve all by itself. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Batch/lot number is not provided, and it cannot be obtained. More
2864734 10/09/2025 COVID19
COVID19
COVID19
 JANSSEN
MODERNA
PFIZER\BIONTECH


Organ failure; Organ failure; Organ failure Organ failure; Organ failure; Organ failure
Organ failure; This is a spontaneous report received from a Consumer or other non HCP. Other Case id... Organ failure; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789655 (MODERNA). A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (ongoing), notes: Current Condition: Diabetes mellitus. There were no concomitant medications. The following information was reported: ORGAN FAILURE (death), outcome "fatal". The patient date of death was 08Feb2022. Reported cause of death: "All organs shut down/Due to the vaccination, whole body went down [Organ failure]". It was not reported if an autopsy was performed. Clinical course: On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and dose of COVID-19 vaccine NRVV Ad26 (withheld) (Janssen COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORGAN FAILURE (All organs shut down/Due to the vaccination, whole body went down) (seriousness criterion death). The patient died on 08Feb2022. The reported cause of death was all organs shut down/due to the vaccination, whole body went down. It was unknown if an autopsy was performed. No concomitant medications were reported. It was reported that, the patient was diabetic. got vaccinated and all organs shut down, and died, on 08Feb2022. Due to the vaccination, whole body went down. No treatment information was provided. Reporter Comment: Patient's condition of diabetes mellitus and co-suspect products Tozinameran and Janssen COVID-19 vaccines remail as confounding factors. The benefit-risk relationship of the product was not affected by this report. Batch/lot number is not provided, and it cannot be obtained.; Reporter's Comments: Patient's condition of diabetes mellitus and co-suspect products Tozinameran and Janssen COVID-19 vaccines remail as confounding factors. The benefit-risk relationship of the product was not affected by this report.; Reported Cause(s) of Death: All organs shut down/Due to the vaccination, whole body went down [Organ failure] More
✓
2864737 10/09/2025 YF
 SANOFI PASTEUR
No adverse event, Product preparation error No adverse event, Product preparation error
error made in the diluent of the YF-VAX, instead of sodium chloride, the provider used sterile water... error made in the diluent of the YF-VAX, instead of sodium chloride, the provider used sterile water with no reported adverse event; Initial information received on 06-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient with unknown age and gender and an error was made in the diluent of the Yellow Fever Vaccine [Yf-Vax], instead of sodium chloride, the provider used sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine, Solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and error made in the diluent of the yf-vax, instead of sodium chloride, the provider used sterile water with no reported adverse event (product preparation error). Reportedly, she wanted to know if there was a need to revaccinate and If yes, what interval did the patient need to wait. 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
2864739 41 F WA 10/09/2025 FLU3
 SANOFI PASTEUR
 U8863CA
Arthralgia, Pain Arthralgia, Pain
Received vaccine on 9/30/25 and has continuous shoulder pain until present. Per Workforce Member fee... Received vaccine on 9/30/25 and has continuous shoulder pain until present. Per Workforce Member feels "most pain when lifting arm above my shoulder or if lifting or pushing or pulling with this arm." More
2864740 74 F TX 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3E27G
Malaise, Pain in extremity, Peripheral swelling, Pruritus Malaise, Pain in extremity, Peripheral swelling, Pruritus
Patient reported a sore arm with itchiness and a few small bumps. Patient described feeling under th... Patient reported a sore arm with itchiness and a few small bumps. Patient described feeling under the weather but is feeling a little better. More
2864741 35 F OH 10/09/2025 UNK
 UNKNOWN MANUFACTURER
Oral mucosal blistering, Urticaria Oral mucosal blistering, Urticaria
HIVES, ORAL BLISTERS HIVES, ORAL BLISTERS
2864742 31 M CA 10/09/2025 FLU3
 SANOFI PASTEUR
 U8848BA
Suicide attempt Suicide attempt
Attempted Suicide Attempted Suicide
✓
2864743 36 F OR 10/09/2025 FLU3
 SANOFI PASTEUR
Arthralgia, Exposure during pregnancy, Product administered at inappropriate sit... Arthralgia, Exposure during pregnancy, Product administered at inappropriate site More
She is 9 weeks pregnant. She rec'd the flu vaccine in her right deltoid. States she felt like t... She is 9 weeks pregnant. She rec'd the flu vaccine in her right deltoid. States she felt like the shot was given a little too high. (She is an RN). Within 3 hours, she started feeling pain in her right shoulder. States pain has continued with movement for the last two weeks. More
2864744 45 F PR 10/09/2025 HPV9
 MERCK & CO. INC.
 Z002399
Dizziness, Feeling hot, Hyperhidrosis, Nausea Dizziness, Feeling hot, Hyperhidrosis, Nausea
PATIENT STATED PRESENTES DIZZINESS, NAUSEAS, FEELING A SENSE OF HEAT IN THE BODY AND SWEATING THAT S... PATIENT STATED PRESENTES DIZZINESS, NAUSEAS, FEELING A SENSE OF HEAT IN THE BODY AND SWEATING THAT STARTED AT 2PM AND LASTED A FEW HOURS SHE DID NOT TOOK ANY MEDICATION FOR SYMPTOMS AND SYMPTOMS DISAPEAR AFTER A FEW HOURS NO OTHER SYMPTOMS REMAIN. SHE WAS ORIENTED TO MONITOR FOR ANY SIDE EFFECT AND TO GO TO MD IF ANY OF THEM ARE BOTHERSOME OR PERSISTENT More
2864762 64 F NV 10/09/2025 FLU3
 SEQIRUS, INC.
 409413
Injection site haemorrhage, Injection site swelling Injection site haemorrhage, Injection site swelling
Customer c/o of bleeding at the time of event and after shot, arm swelled up with a bump. Patient t... Customer c/o of bleeding at the time of event and after shot, arm swelled up with a bump. Patient took Tylenol and applied ice to site, states reaction is better now. Customer c/o of Immunizer hitting a vein. More
2864763 53 F FL 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3T74X
Injected limb mobility decreased, Injection site erythema, Injection site pain, ... Injected limb mobility decreased, Injection site erythema, Injection site pain, Joint injury, X-ray limb abnormal More
Patient stated on Sunday at 2 pm she felt right arm pain from top of shoulder to biceps. She could n... Patient stated on Sunday at 2 pm she felt right arm pain from top of shoulder to biceps. She could not lift her arm. She said the top of her shoulder was bright red. She saw her doctor the following Wednesday and he gave her a steroid pack and on Thursday, she got a cortisone shot. She said she now feels 85% better. They did an x-ray to determine if there was a pocket caused by injection and they concluded there was. More
2864765 75 F MD 10/09/2025 COVID19
 PFIZER\BIONTECH
 00069-2528-10
Chills, Fatigue, Pyrexia Chills, Fatigue, Pyrexia
Fatigue, chills, shivering, fever in evening and over night Fatigue, chills, shivering, fever in evening and over night
2864767 65 M MO 10/09/2025 COVID19
 MODERNA
 3052087
Dizziness, Hyperhidrosis, Loss of consciousness, Malaise, Somnolence Dizziness, Hyperhidrosis, Loss of consciousness, Malaise, Somnolence
Patient had vaccine, no history of dizziness or fainting prior to today. Was standing up by his car... Patient had vaccine, no history of dizziness or fainting prior to today. Was standing up by his cart talking to me for about 10 minutes after the shot doing totally fine. After about 10 minutes he told me he wasn't feel very good, was experiencing dizziness and lightheadedness, starting to sweat. I had him sit down in the chair and brought the table in front of him to put his arms on and lay his head down. We brought ice packs to put on his neck and had cool water available to drink. He said he had eaten full breakfast that morning. Within 2 minutes he had passed out completely, we called 911 and kept cool pack on him which I tried to wake him by gently shaking his arm and rubbing back of neck. He came to within a minute and was very groggy, within another minute he was talking and sitting up, covered in sweat. Over next several minutes while waiting for EMS to arrive he drank some cool water and let me take his BP twice, 5 minutes apart. Readings were 123/81 & pules of 56, then 133/84 & pulse of 53. EMS arrived and took over, checking his blood sugar (175) and doing quick readings on his heart with sensors which I heard showed nothing out of ordinary. They recommended he go be seen (offering to take him to the hospital) and patient said he would consider seeing his Dr at some point but felt fine. I visited with him for a few more minutes before he left to go do some shopping saying he felt completely fine. I called him tonight around 6pm to follow up but had to leave a voice mail. More
2864768 62 F IN 10/09/2025 COVID19
FLU3
RSV
 MODERNA
SANOFI PASTEUR
PFIZER\WYETH
 3052736
U8823BA
MF2147
Abdominal discomfort, Balance disorder, Vertigo; Abdominal discomfort, Balance d... Abdominal discomfort, Balance disorder, Vertigo; Abdominal discomfort, Balance disorder, Vertigo; Abdominal discomfort, Balance disorder, Vertigo More
Severe vertigo starting 9/22/25 at 3 am which is still currently present after 2 weeks, upset stomac... Severe vertigo starting 9/22/25 at 3 am which is still currently present after 2 weeks, upset stomach and her balance is still off. Patient did receive three vaccines at this one visit - Mnexspike, Abrysvo, and Flublok. More
2864769 58 F AZ 10/09/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8790BA
Z003579
Erythema, Pain in extremity, Peripheral swelling, Skin warm; Erythema, Pain in e... Erythema, Pain in extremity, Peripheral swelling, Skin warm; Erythema, Pain in extremity, Peripheral swelling, Skin warm More
Patient presented at the pharmacy 2 days post vaccination with a swollen and red left arm. Patient d... Patient presented at the pharmacy 2 days post vaccination with a swollen and red left arm. Patient described it as warm to the touch and painful. Symptoms had improved since the prior day per patient recollection. Counseled patient to seek medication attention at approximately 12:45pm on 10/9/25 due to the spreading redness, swelling, and heated area. Patient saw her provider the same day and was prescribed cephalexin and prednisone for the reaction on 10/9/25. More
2864770 63 M ND 10/09/2025 FLU3
 SEQIRUS, INC.
 407248
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Incorrect dose of flu vaccine given to patient. Due to patients age, patient should have received Fl... Incorrect dose of flu vaccine given to patient. Due to patients age, patient should have received Flucelvax. No adverse side effects noted. More
2864771 59 M ND 10/09/2025 FLU3
 SEQIRUS, INC.
 407248
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Incorrect dose of flu vaccine given to patient. Due to patients age, patient should have received Fl... Incorrect dose of flu vaccine given to patient. Due to patients age, patient should have received Flucelvax. No adverse side effects noted. More
2864772 58 F GA 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7523j
Extra dose administered Extra dose administered
patient received vaccine before 2 months (9/11- 10/08) patient received vaccine before 2 months (9/11- 10/08)
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