🏥 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 💀 🏥 🚑 ♿ ⚠️
2871903 3 F 11/10/2025 FLU3
 SEQIRUS, INC.
 948401
Circumstance or information capable of leading to medication error, Scratch Circumstance or information capable of leading to medication error, Scratch
Patient moved during vaccine administration and was scratched by needle. Patient moved during vaccine administration and was scratched by needle.
2871904 30 F WA 11/10/2025 COVID19
 MODERNA
 3052581
Condition aggravated, Electrocardiogram, Laboratory test, Tachycardia Condition aggravated, Electrocardiogram, Laboratory test, Tachycardia
Tachycardic. Tachycardic.
2871905 56 F NY 11/10/2025 FLU3
 SEQIRUS, INC.
 AX6151A
Computerised tomogram, Dysphagia, Endoscopy Computerised tomogram, Dysphagia, Endoscopy
Dysphagia Dysphagia
2871906 64 M AL 11/10/2025 FLU3
 SEQIRUS, INC.
 409412
Pain in extremity Pain in extremity
Vaccine administered on 09/30/25. Patient came into store on 11/8/25 and reported that his arm was s... Vaccine administered on 09/30/25. Patient came into store on 11/8/25 and reported that his arm was still hurting after receiving the injection. More
2871907 63 M PA 11/10/2025 COVID19
COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
FLU3
 MODERNA
MODERNA
MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 3052086
3052086
3052086
3052086
U8823CA
U8823CA
U8823CA
U8823CA
Adenovirus test negative, Astrovirus test, Bacterial test negative, Clostridium ... Adenovirus test negative, Astrovirus test, Bacterial test negative, Clostridium test negative, Escherichia test negative; Giardia test negative, Helicobacter test negative, Intensive care, Myocarditis, Norovirus test; Parasitic test negative, Rotavirus test negative, Salmonella test negative, Sapovirus test, Septic shock; Viral test negative, Yersinia test negative; Adenovirus test negative, Astrovirus test, Bacterial test negative, Clostridium test negative, Escherichia test negative; Giardia test negative, Helicobacter test negative, Intensive care, Myocarditis, Norovirus test; Parasitic test negative, Rotavirus test negative, Salmonella test negative, Sapovirus test, Septic shock; Viral test negative, Yersinia test negative More
Myocarditis / Septic Shock / Treated in ER and CVICU / Records are available Myocarditis / Septic Shock / Treated in ER and CVICU / Records are available
✓ ✓
2871909 84 M WI 11/10/2025 COVID19
 PFIZER\BIONTECH
 MY9547
Fatigue, Muscular weakness, Urinary incontinence Fatigue, Muscular weakness, Urinary incontinence
Patient reported that the day after the immunization and for the following week he experienced fatig... Patient reported that the day after the immunization and for the following week he experienced fatigue, muscle weakness, and urinary incontinence. Symptoms resolved by the time the patient reported to us. More
2871910 82 M VA 11/10/2025 FLU3
 SANOFI PASTEUR
 U8874BA
Urticaria Urticaria
Reported breaking out in hives within 24 hours after receiving the vaccine. Patient also stated tha... Reported breaking out in hives within 24 hours after receiving the vaccine. Patient also stated that he's allergic to peaches but only the skin, had eaten canned peaches within a couples hours from receiving the flu vaccines. Have asked if he had eaten this brand of canned peaches and stated that he had and didn't experienced any allergic reactions before. More
2871913 76 F MA 11/10/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 na0739
407242
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
At the time of the vaccine clinic on 11/06/25 patient signed immunization form requesting to get the... At the time of the vaccine clinic on 11/06/25 patient signed immunization form requesting to get the flu and COVID vaccine for 2025-2026 season. Patient needed an interpreter and her son helped translate. She was asked when was the last time she received vaccines and she reported that she did not remember but that it was last year. When billing flu vaccine, it was evident that patient has received the flu vaccine at pharmacy on 11/03/25. Therefore, patient received two doses of flu vaccine, Patient was called on 11/10/25 and she reports that she is doing fine, no side effects. Patient's PCP was called to report that patient received two doses of flu shot More
2871914 79 F NJ 11/10/2025 COVID19
 MODERNA
 8081260
Injection site pain Injection site pain
patient reports pain in arm at site of visit patient reports pain in arm at site of visit
2871915 42 F NC 11/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 ES4H5
Rash Rash
Patient developed extensive rash on torse, face and arms within a few minutes of vaccine administrat... Patient developed extensive rash on torse, face and arms within a few minutes of vaccine administration. Patient was given 4 mg of Dexamethasone IM, which resolved her symptoms. More
2871916 65 M CA 11/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Chronic kidney disease, Coagulopathy, Vena cava filter insertion COVID-19, Chronic kidney disease, Coagulopathy, Vena cava filter insertion
Blood clotting Blood Disorder/ Cronic Kidney Failure Cronic Kidney Damage . Heart Filter Installati... Blood clotting Blood Disorder/ Cronic Kidney Failure Cronic Kidney Damage . Heart Filter Installation to Block Blood clot entry14 Hospital stays To clear out clots and for COVID New variant and old COVID 19 Illnes More
✓ ✓ ✓
2871919 1.08 F MI 11/10/2025 FLU3
HEPA
HIBV
MMR
PNC20
VARCEL
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 UT8802MA
273H3
Z003040
Y020517
MA2484
Z01437
Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrex... Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash More
Patient received one year vaccines including flu on 10/23/25. Mother states a couple dates after vac... Patient received one year vaccines including flu on 10/23/25. Mother states a couple dates after vaccines patient started getting a rash all over her body. Arms, legs, stomach and back. Mother states that she used lotion and warm baths and rash started to go away. 2 weeks later, 11/6/25, mother states rash came back with fever. Has now had rash for a week and it will not go away. Was seen today 11/10/25 by provider. And was assessed by Immunization Specialist. Informed mother that this rash is common with an MMR vaccine. Contacted health dep't as well for further instructions. More
2871920 67 F MD 11/10/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 018B21A
018B21A
017C21A
017C21A
Balance disorder, Chest scan, Cough, Laryngoscopy, Lower respiratory tract infec... Balance disorder, Chest scan, Cough, Laryngoscopy, Lower respiratory tract infection; Ventilation/perfusion scan; Balance disorder, Chest scan, Cough, Laryngoscopy, Lower respiratory tract infection; Ventilation/perfusion scan More
Within a couple of weeks, i loss all balance & equilibrium. Went to an Ear, Nose, throat docto... Within a couple of weeks, i loss all balance & equilibrium. Went to an Ear, Nose, throat doctor after my Internist (who said it would just go away). My E,N T doctor put me on prednisone for one month, and eventually I became normal. A year later, I go a normal chest cold/cough, June of 2022. I've been coughing ever since. More
2871922 62 F FL 11/10/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 na4452
u8864ca
Blister, Erythema, Pruritus, Rash; Blister, Erythema, Pruritus, Rash Blister, Erythema, Pruritus, Rash; Blister, Erythema, Pruritus, Rash
Rash, blisters, bright red skin, itching. Rash, blisters, bright red skin, itching.
2871923 37 F NE 11/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 73BN2
Headache, Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia Headache, Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia
I received my flu shot on 10/28/25. I experienced the soreness to the right arm and a headache that ... I received my flu shot on 10/28/25. I experienced the soreness to the right arm and a headache that evening when going to bed.The headache was better the next day,I just felt like my whole body ached still. The soreness to my right arm went away after about 4-5 days. I still feel like my right side of the body is somewhat more tight/stiff, I feel mild pain when extending out my right leg and I also feel intermittent tingling especially in my right foot More
2871924 83 M GA 11/10/2025 COVID19
 PFIZER\BIONTECH
Middle ear effusion, Tinnitus Middle ear effusion, Tinnitus
At mid morning of November 7 I noticed that sounds were very tinny and unusual in my right ear. I w... At mid morning of November 7 I noticed that sounds were very tinny and unusual in my right ear. I wear hearing aids and had them in at that time. I took out my aids from my right ear and could hardly hear any sounds or voices. I thought that I had impacted ear wax and began applying ear drops and then flushing the right ear. I continued with that until the evening of November 8. More
2871925 82 M 11/10/2025 COVID19
FLU3
RSV
 MODERNA
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS


Mental status changes, Metabolic encephalopathy, Pyrexia; Mental status changes,... Mental status changes, Metabolic encephalopathy, Pyrexia; Mental status changes, Metabolic encephalopathy, Pyrexia; Mental status changes, Metabolic encephalopathy, Pyrexia More
fever, mental status changes, metabolic encephalopathy fever, mental status changes, metabolic encephalopathy
✓
2871926 75 F NC 11/10/2025 COVID19
 MODERNA
 3053669
Pruritus, Rash, Swelling, Swelling face Pruritus, Rash, Swelling, Swelling face
patient states day after receiving shot started with itching and puffiness in face and forehead. thi... patient states day after receiving shot started with itching and puffiness in face and forehead. this progressed to move down the body. she states had overall rash and severe itching. she has been taking benadryl and using cortisone cream otc. More
2871928 73 F IN 11/10/2025 COVID19
COVID19
 MODERNA
MODERNA
 3053777
3053777
Dizziness, Dysstasia, Fatigue, Memory impairment, Syncope; Vomiting Dizziness, Dysstasia, Fatigue, Memory impairment, Syncope; Vomiting
Patient did not report any reactions at the time of the immunization. She is reporting that later th... Patient did not report any reactions at the time of the immunization. She is reporting that later that night (around dinnertime) she started to feel really tired and lightheaded. She stated that she laid down in bed at that time. At some point she had tried to get up and fainted and was out for around 4 hours. she stated she had to call EMS to help her get back up. She also reported vomiting when the EMS was present. EMS helped her back up and must have thought vital wise she was ok since she was not taken to the hospital. She stated that she continued to feel very tired and dizzy the remainder of the night into the next morning. She has continued to have memory issues still as of 11/10/25...She has never had this reaction before to the covid vaccine but that was the only thing new that she had done that day. More
2871929 26 F 11/10/2025 FLU3
 SEQIRUS, INC.
 407257
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
high dose flu vaccine indicated for 65 years and older given to a 26-year-old female inappropriately high dose flu vaccine indicated for 65 years and older given to a 26-year-old female inappropriately
2871930 85 F OH 11/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 NA4459
NA4459
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
The patient was inadvertently given 2 doses of the Pfizer Comirnaty at the same visit. The patient w... The patient was inadvertently given 2 doses of the Pfizer Comirnaty at the same visit. The patient was due for their anual Flu vaccination and Covid vaccination, they came to the office with their husband, who was also due for the same vaccines. The nurse went into the room with 2 Covid Vaccines and 2 Flu High Dose vaccines. The nurse accidently gave the patient in question 2 Covid vaccines instead of 1 Flu High Dose and 1 COVID. The patient was informed of the error. The patient was not vaccinated for the flu following 2 doses of the Comirnaty. The patient showed no signs or symptoms after 30 minute. The patient took the news well, and went home after observation. More
2871931 68 F VA 11/10/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 3052734
3052734
3052734
3052734
Atrial fibrillation, Blood thyroid stimulating hormone, Chills, Differential whi... Atrial fibrillation, Blood thyroid stimulating hormone, Chills, Differential white blood cell count, Diplopia; Electrocardiogram, Fatigue, Full blood count, Headache, Hepatic function abnormal; Hyperhidrosis, Metabolic function test, Pain, Tachycardia, Troponin I; Urine analysis More
Within 24 hrs - chills, sweating, body aches, headache. Within 48 hours - fatique, sweating, double ... Within 24 hrs - chills, sweating, body aches, headache. Within 48 hours - fatique, sweating, double vision. Within 72 hours - excessive sweating, tachycardia diagnosed as Afib with RVR. More
2871932 24 M ID 11/10/2025 COVID19
 PFIZER\BIONTECH
 NA4457
Excessive eye blinking, Loss of consciousness, Musculoskeletal stiffness, Seizur... Excessive eye blinking, Loss of consciousness, Musculoskeletal stiffness, Seizure More
My technician gave the patient the vaccine in the vaccine room. He called me and said that patient w... My technician gave the patient the vaccine in the vaccine room. He called me and said that patient was having a seizure after the Covid vaccine. I get to the vaccine room within 10 seconds but patient already regain conscious. The patient stand up and was okay but his mom was in the room with him at the time said that he had a seizure and took to a near by hospital to have him check out. (S/S: My technician described patient was tensed up straighten all his hands and legs the eyes were blinking rapidly. More
2871933 50 M TX 11/10/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 407004
407004
Injected limb mobility decreased, Injection site pain, Limb injury, Pain, Pain i... Injected limb mobility decreased, Injection site pain, Limb injury, Pain, Pain in extremity; Peripheral swelling More
Presents to clinic for initial visit for left shoulder injury that occurred on 10/29/25. Complaints ... Presents to clinic for initial visit for left shoulder injury that occurred on 10/29/25. Complaints of pain and inability to move L.arm. Employee received his flu vaccine on 10/29/25 and reports on the Friday, 10/31, around 11:00 he started to have soreness to the left arm at the site of injection. He reports by Saturday morning 11/1 he was unable to really move/lift his left arm. Today, he reports pain as 7.5-8/10 sharp with movement. If he is just sitting and resting he reports pain as 1-2/10 aching/sore. Aggravating factors are flexion, abduction, reaching back to scratch his back or get his wallet. He denies any numbness, tingling, loss of sensation. Denies any weakness. He does endorse some swelling to left hand. Follow-up visit 6 days later had significant improvement, with full range of motion and minor pain. More
2871934 45 F MT 11/10/2025 COVID19
 PFIZER\BIONTECH
 na0739
Peripheral swelling, Swelling Peripheral swelling, Swelling
Patient called stating that after receiving vaccination 3 days ago that her arm has become more swol... Patient called stating that after receiving vaccination 3 days ago that her arm has become more swollen and that the swelling has spread to her side of torso towards her left breast. Pt stated having had pain and swelling with previous vaccinations but has never spread or lasted longer than 24 hours. Pt advised to seek medical attention if swelling continues. More
2871935 27 F MD 11/10/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 33cm4
33cm4
Feeling hot, Hypoaesthesia, Immediate post-injection reaction, Injection site pa... Feeling hot, Hypoaesthesia, Immediate post-injection reaction, Injection site paraesthesia, Injection site warmth; Pain in extremity, Paraesthesia More
immediate rush of warmth and tingling coming from injection site all the way down to my hand as soon... immediate rush of warmth and tingling coming from injection site all the way down to my hand as soon as shot was given. Continued pain, tingling, numbness and warmth in entire arm without ceasing. More
2871936 56 M TX 11/10/2025 FLU3
 SEQIRUS, INC.
 407004
Injected limb mobility decreased, Pain, Pain in extremity Injected limb mobility decreased, Pain, Pain in extremity
Employee presents to clinic for initial evaluation for work injury that occurred 10/28/25. Employee ... Employee presents to clinic for initial evaluation for work injury that occurred 10/28/25. Employee works as a CRNA and received his flu vaccine to left deltoid on 10/28/25. He reports at first he noticed nothing but about two days ago his arm became sore and then this morning he had severe pain with movement and limited ROM. He reports pain as 8-9/10 with movement. He can?t really describe the pain but says it?s like a pulling and pressure. If he is just resting he has no pain. He denies fever, chills, numbness, tingling, radiation, or weakness. He denies any history of left shoulder injury or any injury since flu vaccine. Aggravating factors are movement and alleviating factors are rest. No swelling noted. No redness or bruising noted. Good grip strength. Symptoms were relieved within 1 week by follow-up visit. More
2871937 39 F 11/10/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 3052834
3052834
AH2G4
AH2G4
Ear swelling, Headache, Injection site erythema, Oedema peripheral, Rash; Swelli... Ear swelling, Headache, Injection site erythema, Oedema peripheral, Rash; Swelling, Swelling face; Ear swelling, Headache, Injection site erythema, Oedema peripheral, Rash; Swelling, Swelling face More
Vaccine was administered. Around 7 pm, pt started experiencing symptoms. Redness at the injection si... Vaccine was administered. Around 7 pm, pt started experiencing symptoms. Redness at the injection sight. Swelling over her face, neck, ears and armpit. No swelling in the mouth, but rash all over her face, instead her mouth. Also had a headache the following morning. No treatment was given. More
2871938 52 F IL 11/10/2025 COVID19
FLU3
VARZOS
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 NA0739
P394K
G2HA7
Cellulitis; Cellulitis; Cellulitis Cellulitis; Cellulitis; Cellulitis
PATIENT REPORTED HAVING DEVELOPED CELLULITIS THE DAY AFTER RECEIVING HER VACCINES. PATIENT HAS HAD S... PATIENT REPORTED HAVING DEVELOPED CELLULITIS THE DAY AFTER RECEIVING HER VACCINES. PATIENT HAS HAD SIMILAR VACCINES IN THE PAST WITH NO ADVERSE REACTIONS REPORTED. SHE WAS PRESCRIBED AN ANTIBIOTIC PER THE PATIENT. More
2871939 41 F CA 11/10/2025 COVID19
 PFIZER\BIONTECH
Headache, Lymphadenopathy, Neuralgia, Pain Headache, Lymphadenopathy, Neuralgia, Pain
Lymph node swelling on right side of neck with sharp nerve pain and headache lasting 5 days on the r... Lymph node swelling on right side of neck with sharp nerve pain and headache lasting 5 days on the right side of my head. Sharp and shooting. Not relieved by anything but ibuprofen taken around the clock. More
2871941 8 F AZ 11/10/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA4452
410514
Head injury, Syncope; Head injury, Syncope Head injury, Syncope; Head injury, Syncope
AFTER WAITING ABOUT 5 MINUTES POST VACCINATION, PATIENT AND HER FATHER STOOD UP AND BEGAN LEAVING T... AFTER WAITING ABOUT 5 MINUTES POST VACCINATION, PATIENT AND HER FATHER STOOD UP AND BEGAN LEAVING THE VACCINATION ROOM. AFTER TAKING A FEW STEPS, PATIENT'S LEGS BUCKLED AND SHE FAINTED FOR A FEW MOMENTS (APPROXIMATELY 10 SECONDS). PATIENT HIT HER FOREHEAD SLIGHTLY WHEN GOING DOWN . PATIENT WAS THEN LAID DOWN ON THE FLOOR, AND LEGS WERE RAISED UNTIL SHE SEEMED RECOVERED ENOUGH TO SIT AGAIN. A BOTTLE OF WATER WAS PROVIDED TO AID HYDRATION. PATIENT AND HER FATHER, GRANDMOTHER THEN WAITED ANOTHER APPROXIMATELY 5 MINUTES AND LEFT. PHARMACY STAFF EXPLAINED THEY SHOULD SIT FOR AT LEAST ANOTHER 15 MINUTES BEFORE THEY SHOULD LEAVE. FATHER PREFERRED NOT TO WAIT SO THEY LEFT. More
2871942 2 M MD 11/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 409413
409413
Electrocardiogram normal, Electroencephalogram normal, Full blood count normal, ... Electrocardiogram normal, Electroencephalogram normal, Full blood count normal, Gaze palsy, Generalised tonic-clonic seizure; Hypotonia, Metabolic function test normal, Unresponsive to stimuli More
Patient had a generalized tonic-clonic seizure 3 hours after vaccine administration. No fever, no ap... Patient had a generalized tonic-clonic seizure 3 hours after vaccine administration. No fever, no apnea, no cyanosis. Event lasted 60 seconds. A second seizure with eye rolling, limp body, unresponsiveness x 90 seconds. More
✓
2871943 73 F TX 11/10/2025 FLU3
 SEQIRUS, INC.
 407981
Injection site pain, Pain Injection site pain, Pain
The patient is experiencing pain at injection site since the injection. The patient describes the p... The patient is experiencing pain at injection site since the injection. The patient describes the pain as dull aching pain. More
2871944 10 M MT 11/10/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA4457
UT8861KA
Injection site pain, Oedema peripheral, Product administered to patient of inapp... Injection site pain, Oedema peripheral, Product administered to patient of inappropriate age, Tenderness; Injection site pain, Oedema peripheral, Product administered to patient of inappropriate age, Tenderness More
A vaccine administration error occurred; patient received a vaccine approved for age 12 and older in... A vaccine administration error occurred; patient received a vaccine approved for age 12 and older instead of the age-appropriate 5-11 y.o. vaccine. Patient reports experiencing a sore arm at the injection site and arm pit tenderness & swelling. Post-vaccination side effects were mild and resolved without need for intervention. More
2871945 3 F CA 11/10/2025 FLU3
 SANOFI PASTEUR
 U8883AA
Injection site urticaria, Urticaria Injection site urticaria, Urticaria
Returned about 1.5 hrs after getting flu vaccine due to having hives. On exam had them at injection ... Returned about 1.5 hrs after getting flu vaccine due to having hives. On exam had them at injection site and upper back. No SOB, no lip swelling, no N/V. Vitals checked and wnl. Given diphenhydramine and observed for an additional 1.5 hrs. Hives resolved. Vitals recheck and wnl. DC home w precautions for calling 911 if any symptoms besides hives. Cetirizine rx'd to give if return. Has had the flu vax x3 before today so may have just been coincidence, however as at injection site need to assume it was from the vaccine. More
2871946 62 F OH 11/10/2025 FLU3
FLU3
VARZOS
VARZOS
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Chills, Fatigue, Injection site erythema, Injection site pain, Injection site sw... Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling; Nausea, Pain, Rash; Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling; Nausea, Pain, Rash More
12 hours after vaccine, patient developed fatigue, body aches, chills, and nausea, those symptoms re... 12 hours after vaccine, patient developed fatigue, body aches, chills, and nausea, those symptoms resolved. Rash started ~ 24 hours after vaccine. Pain, redness, and swelling noted to left upper arm. More
2871947 12 F ND 11/10/2025 HPV9
 MERCK & CO. INC.
Condition aggravated, Epilepsy, Eyelid myoclonus Condition aggravated, Epilepsy, Eyelid myoclonus
Epilepsy with Eyelid Myoclonia. Epilepsy with Eyelid Myoclonia.
✓ ✓
2871948 0.5 F WA 11/10/2025 COVID19
FLU3
PNC20
RSV
RV5
VARCEL
 MODERNA
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 3052859
UT8802NA
LX2496
AZ240045
2051965
Y013350
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
Pt should have received the Vaxelis Combo (Dtap, Hib, Hep B, Polio) but Varivax (Varicella) was give... Pt should have received the Vaxelis Combo (Dtap, Hib, Hep B, Polio) but Varivax (Varicella) was given by mistake. There were no symptoms exhibited. More
2871950 65 M PA 11/10/2025 FLU3
 SANOFI PASTEUR
Diarrhoea Diarrhoea
30 minutes after having the vaccine, he started having diarrhea and still has it. 30 minutes after having the vaccine, he started having diarrhea and still has it.
2871951 51 M 11/10/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3051995
Chills, Hyperhidrosis, Myalgia, Polymyalgia rheumatica, Red blood cell sedimenta... Chills, Hyperhidrosis, Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate; Chills, Hyperhidrosis, Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate More
polymyalgia, rheumatica-like reactions; that was PMR; severe myalgia; drenching sweats; shaking chil... polymyalgia, rheumatica-like reactions; that was PMR; severe myalgia; drenching sweats; shaking chills; This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia, rheumatica-like reactions; that was PMR), MYALGIA (severe myalgia), HYPERHIDROSIS (drenching sweats) and CHILLS (shaking chills) in a 51-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3051995) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3051995) for COVID-19 prophylaxis and non-company co-suspect product included Influenza vaccine (Fluzone) for an unknown indication. No Medical History information was reported. On 21-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 10 microgram and dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Oct-2025, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia, rheumatica-like reactions; that was PMR) (seriousness criterion medically significant). 22-Oct-2025, the patient experienced MYALGIA (severe myalgia) (seriousness criterion medically significant), HYPERHIDROSIS (drenching sweats) (seriousness criterion medically significant) and CHILLS (shaking chills) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia, rheumatica-like reactions; that was PMR), MYALGIA (severe myalgia), HYPERHIDROSIS (drenching sweats) and CHILLS (shaking chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate: 117, a sed rate of over 100, that was PMR. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were reported. The 51-year-old male, healthy came in for annual physical exam and travels a lot for work, so he wanted to get both his flu shot and COVID and he received the mnexspike on 21-Oct-2025, and he also received a flu shot. 24 hours later, he had severe myalgia, drenching sweats, and shaking chills. It persisted for 10 days, and his labs were through the roof and his sed rate was 117. He might have polymyalgia, rheumatica-like reactions. The rheumatology and infectious disease involved seeing if need to put him on steroids. The myalgias were common, but myalgia to this extent with drenching sweat and a sed rate of over 100, that was PMR. The symptoms were severe. The patient travels a lot. He wanted to update it cause his last one was a year prior, and he's an international traveler and felt like he was exposed a lot, so he opted to take it. It was reported that the patient was in the office (for vaccine administration) for middle of the day and then it was the following evening (when symptoms showed up). They had persisted for these 10 days and symptoms were ongoing. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: Flu vaccine remains as a co-suspect vaccine. The benefit-risk relationship of product is not affected by this report. More
2871953 65 F WV 11/10/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052133
U8855BA
Injection site erythema, Injection site swelling; Injection site erythema, Injec... Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling More
Significant erythema and swelling of left upper arm, vaccine site appears to be mid upper arm, not d... Significant erythema and swelling of left upper arm, vaccine site appears to be mid upper arm, not deltoid. More
2871954 1.25 F WA 11/10/2025 COVID19
FLU3
HIBV
TDAP
 MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 3052859
UT8802NA
UK328AA
u8620aa
Product administered to patient of inappropriate age, Wrong product administered... Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
Tdap was given instead of the Dtap that was needed. Dtap Lot# 3CA55C1, daptacel, date given: 11/03/2... Tdap was given instead of the Dtap that was needed. Dtap Lot# 3CA55C1, daptacel, date given: 11/03/2025, IM, Left Thigh More
2871955 78 F 11/10/2025 COVID19
COVID19
 MODERNA
MODERNA

Chills, Clostridium test, Erythema, Feeling hot, Headache; Malaise, Myalgia, Swe... Chills, Clostridium test, Erythema, Feeling hot, Headache; Malaise, Myalgia, Swelling More
Feeling lousy/Feel cruddy; Stay red, hot, and swollen for a full week; Stay red, hot, and swollen fo... Feeling lousy/Feel cruddy; Stay red, hot, and swollen for a full week; Stay red, hot, and swollen for a full week; Stay red, hot, and swollen for a full week; Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling lousy/Feel cruddy), ERYTHEMA (Stay red, hot, and swollen for a full week), FEELING HOT (Stay red, hot, and swollen for a full week), SWELLING (Stay red, hot, and swollen for a full week) and MYALGIA (Body aches) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Anaphylactic shock, COVID-19, Thyroid tumor, Diarrhea (bad diarrhea), Clostridium difficile infection, Fall in 2023, Hives (The patient had massive hives after she was placed with Flagyl again), Knee replacement (left knee) in 2004, Shoulder arthroplasty (The patient other shoulder had surgery two years ago due to a really painful fall in 2023 leading to shredded biceps. The part of her bicep had to be cut off and reattached, with rotator cuff straps that was not attached, and the other one is torn - she had a torn rotator cuff on the left arm. Apparently, the patient worn them out. I did not know what to say. The patient asked the doctor; do we just have a certain amount of time that we get to have good muscles and then they start deteriorating.) in 2023, Gallbladder removal (gall bladder was removed 5 years ago before COVID) in 2020, Hysterectomy, Thyroidectomy partial (quarter of her thyroid was taken out 30 years ago) in 1990 and Knee replacement (right knee) in 2012. Previously administered products included for Clostridium difficile infection: FLAGYL [METRONIDAZOLE] (It was reported that arthritis which felt like every bone in her hands and her feet was shattering again making it incredibly painful and then reiterated that this happened very, very fast due to a reaction with Flagyl making her hesitant to put anything into her body and added it was double whammy from then. The patient had massive hives after she was placed with Flagyl again), FLAGYL [METRONIDAZOLE] (It was reported that arthritis which felt like every bone in her hands and her feet was shattering again making it incredibly painful and then reiterated that this happened very and very fast due to a reaction with Flagyl making her hesitant to put anything into her body and added it was double whammy from then. The patient had massive hives after she was placed with Flagyl again). Past adverse reactions to the above products included Hives with FLAGYL [METRONIDAZOLE]; and Rheumatoid arthritis with FLAGYL [METRONIDAZOLE]. Concurrent medical conditions included Rheumatoid arthritis (The patient was more a little sensitive when she got her arthritis that was so intense which has been a lifelong battle stating it was extremely painful. She described her arthritis which felt like every bone in her hands and her feet was shattering over and over making it incredibly painful and then reiterated that this happened very, very fast due to a reaction with Flagyl making her hesitant to put anything into her body and added it was double whammy from then.) and Hypothyroidism (The patient "low thyroid" due to a benign tumor on her thyroid. She added that a quarter of her thyroid was taken out 30 years ago and it happened in 1990 when she had the said surgery in the thyroid but couldn't really remember. She takes thyroid supplement because her thyroid test did not come as high as it should.). Concomitant products included INFLUENZA VACCINE for an unknown indication. On 18-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced MALAISE (Feeling lousy/Feel cruddy), ERYTHEMA (Stay red, hot, and swollen for a full week), FEELING HOT (Stay red, hot, and swollen for a full week), SWELLING (Stay red, hot, and swollen for a full week), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). In 2025, MALAISE (Feeling lousy/Feel cruddy), ERYTHEMA (Stay red, hot, and swollen for a full week), FEELING HOT (Stay red, hot, and swollen for a full week), SWELLING (Stay red, hot, and swollen for a full week), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Clostridium test: (Positive) Clostridium difficile test. Patient was on thyroid supplement. It was reported that the patient was consistently received Moderna vaccines. It was reported that post vaccination symptom of caused her to stay red, hot, and swollen for a full week. She had a headache and body aches as well as other reactions. It was reported that the symptoms were listed as normal. The patient did not vomit but had chills and just feeling lousy. It was also reported that the patient wonders if the dose was doubled up or something referred as to why she experienced reactions which lasted for a week and which also made her feel cruddy. No treatment medications provided by the reporter. This case was linked to MOD-2025-790871 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2025: Live non-significant follow-up received in which new reference number was added. On 03-Nov-2025: Live non-significant follow-up received in which case narrative was updated and new reference number was added. More
2871956 93 F 11/10/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Motion sickness, Nausea, Pyrexia; Motion sickness, Nausea, Pyrexia Motion sickness, Nausea, Pyrexia; Motion sickness, Nausea, Pyrexia
motion; extreme nausea; fever; This is a spontaneous report received from a Consumer or other non HC... motion; extreme nausea; fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 93-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 02Nov2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 02Nov2025 at 15:00 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunisation series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious) with onset 02Nov2025 at 15:00, outcome "unknown", described as "extreme nausea"; PYREXIA (non-serious) with onset 02Nov2025 at 15:00, outcome "unknown", described as "fever"; MOTION SICKNESS (non-serious) with onset 02Nov2025 at 15:00, outcome "unknown", described as "motion". Additional information: It was reported that patient got the covid 19 shot last sunday, what she was calling about was that she had the shot at the afternoon around 3 o'clock and the symptoms she had was extreme nausea especially any movement even lifting a finger would make her nauseous and feel like she was going to throw up and that went on for 6 hours, when she thought that she was free with it, it was the next day. She wondered if there was a connection like she have with the covid the nausea was terrible she never did throw up, she did feel like she have a fever and she was just try not to move or even think about it. She was concerned if does that sound like what could be considered problems with the fact that she got the flu shot at the same time. She don't considered it adverse she consider it somewhat normal reaction a lot of people don't have reaction, some people do. only thing that bothered her so much was the motion, it's terrible effect and if she haven't have that she wouldn't have felt anything more than. She don't usually react to such things. a lot of the time if you think you're going to be sick you will be she said. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2871957 11/10/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Vaccination site pain; Vaccination site pain Vaccination site pain; Vaccination site pain
arm hurt a lot after taking a flu shot and a covid shot the next day; This is a spontaneous report r... arm hurt a lot after taking a flu shot and a covid shot the next day; 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)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), 1 day after the suspect product(s) administration, outcome "unknown", described as "arm hurt a lot after taking a flu shot and a covid shot the next day". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2871958 F 11/10/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Diarrhoea Diarrhoea
Persistent sudden bursts of very loose bowel movements to diarrhea to today (11/6/25) and perhaps be... Persistent sudden bursts of very loose bowel movements to diarrhea to today (11/6/25) and perhaps beyond; This is a spontaneous report received from a Consumer or other non HCP. A female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Sep2025 as dose 1, single (Lot number: NA0589), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "cholesterol high" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 30Oct2025, outcome "not recovered", described as "Persistent sudden bursts of very loose bowel movements to diarrhea to today (11/6/25) and perhaps beyond". Therapeutic measures were not taken as a result of diarrhoea. Additional information: It was reported that Persistent sudden bursts of very loose bowel movements to diarrhea to today (06Nov25) and perhaps beyond. the patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting, the patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting, the patient was taking other medications within 2 weeks of the event starting. More
2871960 57 F 11/10/2025 COVID19
 PFIZER\BIONTECH
Vaccination site erythema Vaccination site erythema
The injection site turned red for about two weeks and then brownish; This is a spontaneous report re... The injection site turned red for about two weeks and then brownish; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Oct2025 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: "Celiac disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Only allergic to dust, mold and perfumes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; FLUOXETINE; CETIRIZINE; SHINGRIX taken for immunisation, on 17Sep2025 as dose 2, single. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 06Oct2025 at 18:00, outcome "recovered with sequelae" (21Oct2025), described as "The injection site turned red for about two weeks and then brownish". Therapeutic measures were not taken as a result of vaccination site erythema. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional Information: The patient stated that the injection site turned red for about two weeks and then brownish. It was still discolored. The site was round and about two inches in diameter. When it was red, it was warm to touch. The patient did not had any meds for it. More
2871961 M GA 11/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID after Pfizer Shots; COVID after Pfizer Shots; This is a spontaneous report and received from C... COVID after Pfizer Shots; COVID after Pfizer Shots; This is a spontaneous report and received from Consumer or other non HCPs, Program ID: . A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Mar2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "aneurysms" (unspecified if ongoing); "heart stents and in my brain" (unspecified if ongoing); "heart stents and in my brain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 6, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 7, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer Shots".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500131177 same reporter/event; different patient/product; More
2871962 11/10/2025 COVID19
 PFIZER\BIONTECH
Dyspnoea Dyspnoea
shortness of breath; This is a spontaneous report received from a Consumer or other non HCP and an O... shortness of breath; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): MOD-2025-790763 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 14Nov2022 as dose 4(booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3(BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". Additional information: It was mentioned that patient received four doses of the Pfizer COVID-19 vaccine, with the most recent dose administered on November 14, 2022. Since then, has been experiencing shortness of breath for approximately a year and a half. The seeking information regarding potential long-term side effects associated with the Pfizer COVID-19 vaccine. It was unknown if the patient experienced any additional symptoms/events. Batch/lot number is not provided, and it cannot be obtained. More
2871963 11/10/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
Provide better vaccines that would not make me very sick/very bad reaction to the Covid vaccine; Thi... Provide better vaccines that would not make me very sick/very bad reaction to the Covid vaccine; 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)), 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: ILLNESS (non-serious), outcome "unknown", described as "Provide better vaccines that would not make me very sick/very bad reaction to the Covid vaccine". Additional information: It was reported that patient had very bad reaction to COVID vaccine and asking to provide better vaccine that would not make them feel sick. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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