🏥 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 💀 🏥 🚑 ♿ ⚠️
2869641 74 F NY 10/30/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 49281-0125
00006-4347
Cough, Pyrexia, Wheezing; Cough, Pyrexia, Wheezing Cough, Pyrexia, Wheezing; Cough, Pyrexia, Wheezing
4 hrs after shots @ 1pm 10/19/25 @ 5pm 10/19/25 102.4 fever x3 day with cough + wheezing. Fever took... 4 hrs after shots @ 1pm 10/19/25 @ 5pm 10/19/25 102.4 fever x3 day with cough + wheezing. Fever took 3 days to subside, wheezing present 10/25/25 - 6 days post injection! No more vax for me More
2869650 74 F CA 10/30/2025 FLU3
 SEQIRUS, INC.
 407256
Anaphylaxis treatment, Hemiparesis, Hypoaesthesia, Pain Anaphylaxis treatment, Hemiparesis, Hypoaesthesia, Pain
PT HAD PAIN LEFT SIDED WEAKNESSA/NUMBNESS. ADMINISTERED EPIPEN. PATIENT RESTED UNTIL SYMPTOMS SUBSID... PT HAD PAIN LEFT SIDED WEAKNESSA/NUMBNESS. ADMINISTERED EPIPEN. PATIENT RESTED UNTIL SYMPTOMS SUBSIDED AND SON PICKED UP PATIENT. ADVISED WITH ER PRECAUTIONS. More
2869651 45 F CO 10/30/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P394R
P394R
Dry skin, Ear inflammation, Ear swelling, Erythema, Hypoacusis; Paranasal sinus ... Dry skin, Ear inflammation, Ear swelling, Erythema, Hypoacusis; Paranasal sinus discomfort, Rash, Skin warm, Swelling face More
At the time of her Influenza immunization, she was experiencing mild eczema symptoms on her neck. O... At the time of her Influenza immunization, she was experiencing mild eczema symptoms on her neck. On 10/18 at approximately 12pm she noticed that she was having some facial swelling below her eyes with a rash below her right eye, both ears were red and dry skin was noted. On 10/20 she woke with facial swelling, rash to the both sides of her face-the right was more apparent, both ears were puffy with a rash. She went to her provider who prescribed 0.025% Triamcinolone cream to apply to the affected areas. She applied the steroid cream to the affected areas and was having improvement. On 10/25 both checks had started swelling again, her right ear was inflamed; these sites were ?hot.? She returned to her provider, at this visit the eczema had resolved but swollen checks, sinus pressure, right ear swelling with hearing difficulty were present. Her provider dispensed 100mg doxycycline to be taken twice daily in addition to a probiotic. The swelling was resolving. On 10/28 a new rash was observed on her forearms. On 10/30 she observed a baseball sized rash near her left shoulder blade. She stopped using the triamcinolone cream on 10/25 and has started using Aveno Hydrocortisone on 10/25. She started taking Allegra routinely on 10/20 and using her NetiPot nasal rinse device. She has been intermittently taking Benedryl and Mucinex since 10/19. She is planning on pursuing additional care through Workman?s Comp as of 10/30/25 5:00pm. More
2869652 70 F VA 10/30/2025 UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 3053648
3053648
UT8829BA
UT8829BA
Contusion, Eye swelling, Face injury, Loss of consciousness, Nausea; Pyrexia, Vi... Contusion, Eye swelling, Face injury, Loss of consciousness, Nausea; Pyrexia, Visual impairment; Contusion, Eye swelling, Face injury, Loss of consciousness, Nausea; Pyrexia, Visual impairment More
Woke next morning feeling feverish and nauseated, moved to kitchen where began to see a gray lace li... Woke next morning feeling feverish and nauseated, moved to kitchen where began to see a gray lace like pattern over my visual field and without further warning passed out. Came to on the floor having hit face without any attempt to fend or catch oneself. No memory of even starting to go down. Moved to living room where blacked out again within feet of the couch - not even a visual field warning the second time; just suddenly discovered myself on the floor with my face crushed into the rug. I crawled onto the couch where I remained for two hours before attempting to get fluid and food which I did, managed the bathroom, then spent the rest of the day until about 8 or 9 PM sleeping off and on but remaining prone on the couch. The feverish and nauseated feelings abated after initially resting and eating (respectively) but I had a splitting headache which moderate aspirin did not seem to help. I cannot with certainty assign the headache to whatever caused the two black outs within minutes because hitting my face caused extremely large lumps and dark bruising on my forehead and cheek bone and closing one eye. The headache was lighter by the next morning and absent at this time (10/30/2025) 7:00 PM. I would like to add that the only time I have fainted in the past was when I was 18 when I fainted once. More
2869653 45 F NJ 10/30/2025 FLU3
 SANOFI PASTEUR
 U8847BA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient did not have any adverse event after the vaccination administration. Patient did not have any adverse event after the vaccination administration.
2869654 64 M WA 10/30/2025 FLU3
 SANOFI PASTEUR
 U8764AB
Fatigue, Nausea, Product administered to patient of inappropriate age Fatigue, Nausea, Product administered to patient of inappropriate age
64 year old male was administered high dose flu licensed for 65 yrs of age and older. Typical influe... 64 year old male was administered high dose flu licensed for 65 yrs of age and older. Typical influenza vaccine side effects of nausea and fatigue occurred the evening of administration and resolved after the following day. No treatment needed. More
2869657 54 F 10/30/2025 COVID19
 PFIZER\BIONTECH
Injection site erythema, Injection site mass, Injection site swelling, Pain in e... Injection site erythema, Injection site mass, Injection site swelling, Pain in extremity More
ARM WAS SORE THE EVENING OF RECEIVING THE VACCINE, BUT NEXT DAY WAS MORE SORE AND GREW A KNOT. THERE... ARM WAS SORE THE EVENING OF RECEIVING THE VACCINE, BUT NEXT DAY WAS MORE SORE AND GREW A KNOT. THERE WAS REDNESS AND SWOLLEN HORIZONTALLY ON THE UPPER ARM AROUND INJECTION SITE AND ABOVE/BELOW IT "THE SIZE OF A TENNIS BALL". STAYED RED FOR 8-9 DAYS BUT DECREASED SINCE THEN. More
2869660 36 F WI 10/30/2025 FLU3
 SANOFI PASTEUR
Urticaria Urticaria
At 6 pm started with generalize urticarial rash on arms, legs, abdomen, back, and hands. Treated at ... At 6 pm started with generalize urticarial rash on arms, legs, abdomen, back, and hands. Treated at home with single dose Claritin and doxylamine before bed. Symptoms worsened with further spreading and intensifying rash. Took another dose of Claritin in the morning without relief. Was ultimately prescribed and took prednisone to take at 8am the following morning. Symptoms are still current active, but improving More
2869661 71 F CA 10/30/2025 FLU3
 SANOFI PASTEUR
 u8800ba
Rash Rash
This patient came to pharmacy today and stated she developed rash on the back of her arm (not near t... This patient came to pharmacy today and stated she developed rash on the back of her arm (not near the injection site) after getting the flu vaccine on 10/10/25. It's gone now. More
2869662 69 F PA 10/30/2025 FLU3
 SANOFI PASTEUR
 U8862BA
Extra dose administered Extra dose administered
Patient received a second flu shot this season. She did not realize she already received the flu vac... Patient received a second flu shot this season. She did not realize she already received the flu vaccine at another pharmacy. More
2869663 72 F WI 10/30/2025 COVID19
 MODERNA
 3052035
Back pain, Injection site pain, Pain Back pain, Injection site pain, Pain
THE PATIENT CAME INTO THE PHARMACY AT 3 PM ON 10/30/2025 TO REPORT THAT SHE IS HAVING BACK PAIN/LOW... THE PATIENT CAME INTO THE PHARMACY AT 3 PM ON 10/30/2025 TO REPORT THAT SHE IS HAVING BACK PAIN/LOWER BACK PAIN. BACK PAIN WITH BENDING AND AND BACK PAIN WITH WALKING. SHE ALSO REPORTED THAT SHE HAD SOME PAIN AROUND THE COVID VACCINE AREA ON SJHOULDER FOR A FEW DAYS BUT IT WENT AWAY. SHE WANT ED TO DISCUSS IF THE COVID SHT THAT SHE GOT ON 10/25/25COULD CAUSE BACK PAIN. I DISCUSSED COVID MNEXSPIKE SIDE EFFECTS WITH HER AND SHE SAID IF CONTINUES OR GETS WORSE SHE MAY SEE A PROVIDER. I ASKED HER TO LET ME/PHARMACY KNOW HOW SHE IS DOING. More
2869664 66 F MA 10/30/2025 COVID19
COVID19
 MODERNA
MODERNA
 3051995
3051995
Diarrhoea, Fatigue, Injection site pain, Malaise, Migraine; Nausea, Pyrexia Diarrhoea, Fatigue, Injection site pain, Malaise, Migraine; Nausea, Pyrexia
Migraine, nausea, malaise, fatigue, mild fever, diarrhea, injection site pain. Symptoms lasted 24 h... Migraine, nausea, malaise, fatigue, mild fever, diarrhea, injection site pain. Symptoms lasted 24 hours. Diarrhea lasted 48 hours. Took pain reliever, Tums and antidiarrheal medication. Slept for six hours then up for 20 minutes then back to bed for nine hours. More
2869665 95 F NE 10/30/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA4457
407981
Accidental exposure to product, Injury associated with device; Accidental exposu... Accidental exposure to product, Injury associated with device; Accidental exposure to product, Injury associated with device More
Needlestick - pharmacist intern pricked her finger after administering the vaccine to the patient Needlestick - pharmacist intern pricked her finger after administering the vaccine to the patient
2869666 71 M 10/30/2025 FLU3
 SANOFI PASTEUR
 U8862BA
Extra dose administered Extra dose administered
Patient presented to the pharmacy and asked for a flu shot. It was discovered at the time of billing... Patient presented to the pharmacy and asked for a flu shot. It was discovered at the time of billing that patient already received a flu shot this season. More
2869668 18 F IA 10/30/2025 COVID19
COVID19
FLU3
FLU3
MENB
MENB
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
 3052732
3052732
ut8861ja
ut8861ja
mf2128
mf2128
Asthenia, Blood glucose normal, Loss of consciousness, Pallor, Somnolence; Synco... Asthenia, Blood glucose normal, Loss of consciousness, Pallor, Somnolence; Syncope, Visual impairment; Asthenia, Blood glucose normal, Loss of consciousness, Pallor, Somnolence; Syncope, Visual impairment; Asthenia, Blood glucose normal, Loss of consciousness, Pallor, Somnolence; Syncope, Visual impairment More
After receiving third vaccine Trumenba patient became weak, had a fainting/blacking out spell and be... After receiving third vaccine Trumenba patient became weak, had a fainting/blacking out spell and became very pale. Patient would awake and answer questions then close eyes and become very sleepy for about 10 minutes. Patient also said her vision was going in and out for 10 minutes after the administration. EMT services were called and patient had normal vital signs and blood glucose. Patient started feeling better 20 minutes after vaccine administration and color returned to skin. More
2869669 13 M IL 10/30/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 AX4142A
AX4142A
Dizziness, Hyperhidrosis, Nausea, Pallor, Presyncope; Syncope Dizziness, Hyperhidrosis, Nausea, Pallor, Presyncope; Syncope
Pt experienced a delayed vasovagal response to Afluria (annual flu shot) on 10/30/2025. Pt came to t... Pt experienced a delayed vasovagal response to Afluria (annual flu shot) on 10/30/2025. Pt came to the pharmacy on 10/30/25 with his mother and brother to get their annual flu vaccines. Vaccine was administered sometime between 3:48 and 4pm. Pharmacy staff was notified by front end that a customer was having a reaction to the flu shot between 4-4:30pm. I went to the front of the store with pharmacy tech. The pt started having a reaction after shopping a little bit and checking out at the registers at the store. We found the patient sitting on the floor at the front of the store. He was pale, felt faint, light headed, nauseated/had a queezy feeling in his stomach, sweating. The mom said that he was collapsing by the registers and that she had to hold him up to walk [from the registers to the wall where he was sitting is my understanding]. The patient also reported hearing 'static' and he did NOT lose consciousness at any time. He remained alert and was able to verbalize his symptoms, which were negative for itching and also negative for any swelling in the mouth/throat. We called 911 and the paramedics arrived per mom's request. While waiting for the paramedics, I checked the patient's blood pressure which was 90/70 and temperature 99.6 F. I offered the patient water, he didn't want anything to drink and I also offered him a chair. Before the paramedics arrived the patient said his symptoms were improving and that he was feeling better. When the paramedics arrived, they checked the patient's vitals. His oxygen and blood pressure were normal and the patient was feeling better. The paramedics did not advise transport, mom agreed that she did not want the patient transported to the hospital. Pt was advised to rest and drink plenty of fluids and to call 911 if the symptoms recurred/his condition worsened. I also advised the mom to have the patient sit for 15-30 minutes after receiving any vaccinations in the future. Per mom, the pt had never had any reactions to any vaccinations in the past. More
2869670 0.5 F DC 10/30/2025 COVID19
COVID19
DTPPVHBHPB
DTPPVHBHPB
FLU3
FLU3
PNC20
PNC20
RV5
RV5
 MODERNA
MODERNA
MSP VACCINE COMPANY
MSP VACCINE COMPANY
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 3053238
3053238
U7836AA
U7836AA
U8889CA
U8889CA
LN4932
LN4932
Y009789
Y009789
Cyanosis, Eye movement disorder, Immediate post-injection reaction, Paralysis, R... Cyanosis, Eye movement disorder, Immediate post-injection reaction, Paralysis, Respiratory arrest; Unresponsive to stimuli; Cyanosis, Eye movement disorder, Immediate post-injection reaction, Paralysis, Respiratory arrest; Unresponsive to stimuli; Cyanosis, Eye movement disorder, Immediate post-injection reaction, Paralysis, Respiratory arrest; Unresponsive to stimuli; Cyanosis, Eye movement disorder, Immediate post-injection reaction, Paralysis, Respiratory arrest; Unresponsive to stimuli; Cyanosis, Eye movement disorder, Immediate post-injection reaction, Paralysis, Respiratory arrest; Unresponsive to stimuli More
Pt became unresponsive, turned blue and stopped breathing immediately after receiving routine admini... Pt became unresponsive, turned blue and stopped breathing immediately after receiving routine administration of 6 month vaccines, COVID and Influenza. Pt. became flaccid, eyes rolled back in her head, and she stopped breathing immediately after receiving the Prevnar vaccine. Sternal rub administered by nurse and patient immediately taken to physician where continued external stimuli was provided and patient began to respond. Color improved and patient began to cry. Vital signs obtained and patient observed for approximately 15 minutes. Patient returned to baseline and was discharged home with parents without further incident. More
2869221 38 F TX 10/29/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA




Alopecia, Angina pectoris, Anxiety, Bursitis, Decreased appetite; Fibromyalgia, ... Alopecia, Angina pectoris, Anxiety, Bursitis, Decreased appetite; Fibromyalgia, Gait disturbance, Hypermobility syndrome, Impaired driving ability, Insomnia; Laboratory test abnormal, Medial tibial stress syndrome, Migraine, Mixed connective tissue disease, Muscle rupture; Nasal ulcer, Nausea, Neurological symptom, Neuropathy peripheral, Pericardial effusion; Postmenopause, Soft tissue necrosis, Splenomegaly More
Not treated yet! Started having unbearable shin splint pain in 2022, tested positive for autoimmune ... Not treated yet! Started having unbearable shin splint pain in 2022, tested positive for autoimmune disease, rheumatology said I have fibromyalgia, pain begins in heart end of 2023, cardiologist says I have a pericardial effusion, neuropathy begins same time as heart pain. Trips to the ER and many Dr visits continue weekly. Now I have an enlarged spleen, bilateral tears in my gluteals minimus (not from injury but no reason as to why) and may need surgery. Can barely walk or drive far as of 10/29/2025. Large sore in nose that I?m having looked at for a second time. Necrotic tissue appears on my lower left flank. I have mixed connective tissue disease, bursitis, hyper mobility, have had a stroke-like event, migraines, severe anxiety, post menopause, insomnia, loss appetite, nausea and hair loss. These symptoms and diagnoses are all current. Lots of medicine pushed on me but nothing seems to help More
✓ ✓
2869222 39 M MI 10/29/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 NB3X7
Bell's palsy, Facial paralysis Bell's palsy, Facial paralysis
I developed Bells Palsy (left facial paralysis) 2 days after receiving the injection and had to go t... I developed Bells Palsy (left facial paralysis) 2 days after receiving the injection and had to go to the emergency department to make sure i was not having a stroke, was seen by an ED physician and a neurology specialist, was prescribed prednisone and acyclovir, multiple labs sent, follow up appointment is scheduled with neurologist More
✓
2869224 54 F TX 10/29/2025 FLU3
 SEQIRUS, INC.
 AX63Y2A
Pruritus Pruritus
Itching all over the body. Itching all over the body.
2869262 10/29/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product storage error Product storage error
Product storage error; This non-serious case was reported by a consumer via sales rep and described ... Product storage error; This non-serious case was reported by a consumer via sales rep and described the occurrence of incorrect storage of drug in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Product storage error). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date:13-OCT-2025 The reporter stated that, the Priorix vaccine was freeze and the provider did not discard the product. The reporter stated that, no direct problem cause, the vaccine was administered to patient when supposed to be discard after freezing. The reporter did not consent to follow up. The batch number was not provided, and we are unable to contact the reporter. More
2869263 36 F KY 10/29/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 LG749
Underdose Underdose
Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non... Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. On 13-OCT-2025, the patient received Engerix B pediatric. On 13-OCT-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Pediatric dose administered to adult patient) and adult use of a child product (Verbatim: Pediatric dose administered to adult patient). The outcome of the accidental underdose and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:14-OCT-2025 Nurse Practitioner mentioned she accidentally gave a pediatric dose to an adult patient. Second line agent asked caller and turns out that it was the second dose of a Hepatitis B vaccine for the patient, but brand name, lot number and expiration date for the first dose were not asked. The reporter consented to follow up. More
2869265 10/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Ophthalmic herpes zoster, Peripheral swelling, Vaccination failure Ophthalmic herpes zoster, Peripheral swelling, Vaccination failure
Shingles on right eye nerves/suspected vaccination failure; Shingles on right eye nerves; Swollen ar... Shingles on right eye nerves/suspected vaccination failure; Shingles on right eye nerves; Swollen arm from the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles on right eye nerves/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles on right eye nerves) (serious criteria GSK medically significant) and swelling arm (Verbatim: Swollen arm from the shot). The outcome of the vaccination failure, ophthalmic herpes zoster and swelling arm were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The reporter considered the swelling arm to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. The company considered the swelling arm to be related to Shingles vaccine. Additional Information: GSK receipt date: 18 Oct 2025 This case was reported by a consumer via interactive digital media. The patient got swollen arm from the shot and experienced shingles around right eye nerve. This case was reported as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2869270 M WI 10/29/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 TC47K
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
dose of Pediarix was given to a 13-year-old patient; This non-serious case was reported by a nurse v... dose of Pediarix was given to a 13-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis. On 17-OCT-2025, the patient received Pediarix. On 17-OCT-2025, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: dose of Pediarix was given to a 13-year-old patient). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. More
2869271 29 F SC 10/29/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 72742
Exposure during pregnancy, Product administered to patient of inappropriate age,... Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered More
Drug Exposure During Pregnancy; Arexvy was given to a pregnant woman; Arexvy was given to a pregnant... Drug Exposure During Pregnancy; Arexvy was given to a pregnant woman; Arexvy was given to a pregnant woman; Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72742, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On 24-SEP-2025, the patient received Arexvy. The patient did not receive Abrysvo. On 24-SEP-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was given to a pregnant woman) and wrong vaccine administered (Verbatim: Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy) and drug use in unapproved population (Verbatim: Arexvy was given to a pregnant woman). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population, inappropriate age at vaccine administration and wrong vaccine administered were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Exposure (Abrysvo): Trimester unknown Estimated Delivery/Due date: 17-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-OCT-2025 A licensed practical nurse reported that a pregnant patient was inadvertently administered Arexvy instead of the intended Abrysvo vaccine.; Sender's Comments: US-GSK-US2025137785:SAME REPORTER US-GSK-US2025137784:SAME REPORTER US-GSK-US2025137800:SAME REPORTER US-GSK-US2025137805:SAME REPORTER US-GSK-US2025137807:SAME REPORTER More
2869272 27 F SC 10/29/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 72742
Exposure during pregnancy, Product administered to patient of inappropriate age,... Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered More
pregnant patient received Arexvy instead of Abrysvo; received Arexvy instead of Abrysvo; received Ar... pregnant patient received Arexvy instead of Abrysvo; received Arexvy instead of Abrysvo; received Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72742, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On 21-OCT-2025, the patient received Arexvy. The patient did not receive Abrysvo. On 21-OCT-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: received Arexvy instead of Abrysvo) and product use in unapproved population (Verbatim: received Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and product use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Exposure (Abrysvo): To mother in third trimester Estimated Delivery/Due date: 28-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-OCT-2025 The nurse had reported that a pregnant patient had received Arexvy instead of Abrysvo. This was 1 of the 6 cases, reported by the same reporter; Sender's Comments: US-GSK-US2025137784:SAME REPORTER US-GSK-US2025137805:SAME REPORTER US-GSK-US2025137800:SAME REPORTER US-GSK-US2025137791:SAME REPORTER US-GSK-US2025137807:SAME REPORTER More
2869275 F 10/29/2025 COVID19
 MODERNA
Chills, Malaise, Pyrexia, Rash, SARS-CoV-2 antibody test Chills, Malaise, Pyrexia, Rash, SARS-CoV-2 antibody test
felt really crappy; fever; chills; COVID rash; This spontaneous case was reported by a consumer and ... felt really crappy; fever; chills; COVID rash; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt really crappy), PYREXIA (fever), CHILLS (chills) and RASH (COVID rash) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu shot (When the patient was younger, got the regular flu shot, never had any side effects), Pneumonia shot (When the patient got the pneumonia shot, well, that was even worse. So, it always went away like in two days) and Flu shot (The first-time patient got the senior flu shot; it was the exact same thing. The fever and stuff like that). Past adverse reactions to the above products included Fever with Flu shot; No adverse effect with Flu shot; and Vaccination adverse reaction with Pneumonia shot. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt really crappy), PYREXIA (fever), CHILLS (chills) and RASH (COVID rash). At the time of the report, MALAISE (felt really crappy) and RASH (COVID rash) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: antibodies were very high. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. The patient was over 70 years old. The patient did not have any other pre-existing conditions. No concomitant medication was reported. The patient was over 70 years old. The patient did not have any other pre-existing conditions. It was reported that the patient was getting ready to get her COVID booster shot this year and that she had Modern as all along. It was reported that every single shot the patient got, she had fever and chills for like 2 days and felt really crappy. The very first patient got, the patient had COVID rash. Primary care doctor of the patient did do yearly blood work of the patient, where they checked to see antibodies for COVID and everything, and said that the patient might probably get more side effects because her body responded to it a lot more because her antibodies were very high. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. More
2869276 70 M 10/29/2025 COVID19
 MODERNA
Cholangiocarcinoma Cholangiocarcinoma
Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer; Thi... Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGIOCARCINOMA (Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In March 2023, the patient experienced CHOLANGIOCARCINOMA (Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer) (seriousness criterion medically significant). The patient was treated with Ivosidenib (Tibsovo) at an unspecified dose and frequency and Surgery (Underwent surgery for removing half the liver and gallbladder) for Cholangiocarcinoma. At the time of the report, CHOLANGIOCARCINOMA (Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer) had not resolved. No concomitant medication was reported. The patient had been receiving Moderna COVID-19 vaccine doses ever since the vaccine came out, had it a couple times, at least 5 times. It was reported that the patient being diagnosed with cancer, discovered it in March 2023. It was in liver or bile duct. The name of the cancer was called cholangiocarcinoma, and it was a bile duct cancer. Reporter stated that medical interventions were done and patient's half liver and gallbladder were removed, and that was through surgery. The patient had received two types of chemotherapy, targeted radiation and then had immunotherapy. The patient was currently on targeted therapy drug called Tibsovo. It was unknown if the patient experienced any additional symptoms or events.; Reporter's Comments: Causality was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report. More
2869277 F 10/29/2025 COVID19
 MODERNA
COVID-19 COVID-19
Patient states she had Covid; This spontaneous case was reported by a consumer and describes the occ... Patient states she had Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient states she had Covid) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced COVID-19 (Patient states she had Covid). At the time of the report, COVID-19 (Patient states she had Covid) had resolved with sequelae. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Patient age was reported as over 80. No concomitant medication was reported. The patient did not experience any additional symptoms/events. No treatment medication was reported. More
2869278 66 F CA 10/29/2025 COVID19
 MODERNA
COVID-19 COVID-19
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ... covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (Patient started getting the Moderna COVID-19 vaccines from when they first came out and she had gotten all of them up to the last booster.). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. Concurrent medical conditions included Immune system disorder NOS (she had immune system issues). In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In February 2025, the patient experienced COVID-19 (covid 19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in 2025 for COVID-19, at an unspecified dose and frequency. In 2025, COVID-19 (covid 19) had resolved with sequelae. No concomitant medication was reported. The patient was not sure when her last Moderna COVID-19 vaccine was. She believed it might have been during Fall of 2024. The patient started getting the Moderna COVID-19 vaccines from when they first came out, and she had gotten all of them up to the last booster. She did not get her last booster on time, and she ended up getting sick. She got COVID for the first time, and she was down in bed 80% of the time for about 5 and a half weeks. She was concerned about getting sick. If she got sick it would be her downfall because she had just got COVID in Feb-2025. It was reported that if she was able to get that last booster, she doubted she would have gotten COVID. She had been exposed to people, even her kids, with COVID, and with all the Moderna boosters she had had, she never got COVID. She thought she had got COVID because she didn't have the last booster. It gave her really bad edema, swelling in one leg, and it was really bad. She had broken a bunch of blood vessels. When the caller got COVID, she was able to get Paxlovid because she qualified through a financial program. Paxlovid was probably what saved her life because she had gotten a pretty bad case of COVID. It was unknown if the patient experienced any additional symptoms/events. More
2869279 65 F AL 10/29/2025 RSV
 PFIZER\WYETH
 LL8391
Device connection issue, Needle issue, Soft tissue foreign body Device connection issue, Needle issue, Soft tissue foreign body
luer lock failed, the syringe was no longer attached to the needle; needle still hanging from patien... luer lock failed, the syringe was no longer attached to the needle; needle still hanging from patient's arm; luer lock failed, liquid leaked down arm; when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm; when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm; This is a spontaneous report received from a Pharmacist. A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Oct2025 as dose number unknown, single (Lot number: LL8391, Expiration Date: May2026) at the age of 65 years for immunisation, Device Lot Number: HT4720, Device Expiration Date: Dec2026 (Diluent Syringe); Device Lot Number: J591,Device Expiration Date: 29Nov2028 (Vial Adapter). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious) with onset 23Oct2025, outcome "unknown", described as "luer lock failed, liquid leaked down arm"; DEVICE CONNECTION ISSUE (non-serious) with onset 23Oct2025, outcome "unknown", described as "luer lock failed, the syringe was no longer attached to the needle"; INJURY ASSOCIATED WITH DEVICE (non-serious) with onset 23Oct2025, outcome "unknown", described as "needle still hanging from patient's arm"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 23Oct2025, outcome "unknown", EXPOSURE VIA SKIN CONTACT (non-serious) with onset 23Oct2025, outcome "unknown" and all described as "when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm". Causality for "luer lock failed, the syringe was no longer attached to the needle", "needle still hanging from patient's arm", "luer lock failed, liquid leaked down arm" and "when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v. Additional Context: Reporter regarding Abrysvo, had 2 shots malfunction today. The first one, literally, was injecting into patient's arm. The little plastic piece that locks onto luer lock, when she went to push it in, the luer lock part failed, with needle still hanging from patient's arm. The syringe was no longer attached to the needle, the liquid shot out the side. The first one, when the luer lock failed, the needle was still hanging from her arm. Clarified, was today, 23Oct2025, this occurred. Clarified specific presentation being referred to is, kit with separate antigen powder vial, diluent syringe and adapter piece. The adapter is what she was trying to describe before, the thing they try to poke the bottle with, the adapter, the piece that screws on to adapter, almost like a luer lock piece, the one that was lose. When she tried to do shot in patient's arm, it shot out the side of that. The luer lock was coming out the screw part. Clarified, when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm. Clarified, other than the liquid leaking down patient's arm, none of the leaking liquid had come into contact with anyone else. Reporter was wearing gloves.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500210836 same patient and different events; More
2869280 10/29/2025 COVID19
 PFIZER\BIONTECH
 NA0738
Angioedema, Tongue oedema Angioedema, Tongue oedema
Chronic Spontaneous Angioedema with tongue, lips, throat, nasal swelling; Chronic Spontaneous Angioe... Chronic Spontaneous Angioedema with tongue, lips, throat, nasal swelling; Chronic Spontaneous Angioedema with tongue, lips, throat, nasal swelling; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, single (Lot number: NA0738), in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE, start date: 2025; BABY ASPIRIN, start date: 2025; ROSUVASTATIN, start date: 2025; FAMOTIDINE, start date: 2025; OZEMPIC, start date: 2025. The following information was reported: ANGIOEDEMA (medically significant), TONGUE OEDEMA (non-serious) all with onset 20Sep2025, outcome "recovering" and all described as "Chronic Spontaneous Angioedema with tongue, lips, throat, nasal swelling". Therapeutic measures were taken as a result of angioedema, tongue oedema. Clinical course: Patient not received other vaccine same date and not received ther vaccine in four weeks. Other medications in 2 weeks received included Omeprazole, Baby Aspirin, Rosuvastatin, Ozempic. Therapeutic measures for adverse events included High dose antihistamine and then Xolair. Patient had no known allergies. No follow-up attempts are possible. More
2869281 M 10/29/2025 COVID19
 PFIZER\BIONTECH
Death Death
my great uncle died and nobody ever told him that people were dying after taking this; This is a spo... my great uncle died and nobody ever told him that people were dying after taking this; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 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 and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "my great uncle died and nobody ever told him that people were dying after taking this". The date and cause of death for the patient were unknown. Clinical course: Reporter inquired about legally required Pfizer as a corporation to report any and all medical malpractice issues for example, if the patient has been administered a Comirnaty vaccine, and got forbit they died and whether it was a vaccine or not and it was now a medical malpractice case, because they just got the vaccine walked out of the doctor's office now they are dead it is debatable, they are going to do some evaluation, why the patient died or maybe a patient got very sick, when they were hospitalized for 6 months after taking covid 19 vaccine reporter was just using the example, per caller speaking hypothetically if the patient has died or become very very sick. or they got a terrible injury, or they got a giant sore on their arm, and they lost their arm, was being a little silly here, if there was some serious injury that patient has experienced it. where it was a vaccine whether a patient had an abscess on the arm. and had nothing to do with the vaccine, Comirnaty vaccine, reporter was asking legally required as a company any and all issues to the prospective patient such is myself who is wanting to take this vaccine, are you legally obligated to tell me about any and all documented cases of medical malpractice issues as such? Do you know?. per caller he was looking at the consultative function of the company, wanted to find out form the representative at the interactive level, to resolve his questions, per caller not sure if that that effective in terms of writing (verified with caller no legal matter with Pfizer at the time of the call, per caller just wanted to know his rights as an (withheld) citizen, per caller reporter wanted to know his legal rights and protections as a citizen before he were to get the vaccine) inquiring as a corporate entity required to divulge any in all malpractice cases associated with the vaccine such as Comirnaty 2025-2026 formula? so if he call he know you are legally required to tell me any in all issues, so he was safe as a consumer not like well you never asks as about it so we never told you, oh well gilt by omission or whatever they say. if yo never tell me how would I know to ask, reporter was relaying on the fact that he was legally protected that you would tell me ahead of time. Explained again that if he would have adverse event to report we would connect him to our safety department to report the feedback. per caller he want to protect himself as a patient in terms of potential adverse reactions, instead of working retroactively he took this vaccine and nobody ever tell me and now you know I am very sick, I got malpractice case or god forbit died you know they died well what they can do my great uncle died and nobody ever told him that people were dying after taking this, particular vaccine he just don't know, he just don't know if the patient as a legal (withheld) citizen has a right to be informed mandatory to receive mandatory communication, from the pharmaceutical company about a serious issues pertaining to the vaccine. Explain that in terms of any legal matter we would refer him to Pfizer legal department, in terms of regulatory agency we would refer him to FDA, explained that he has reached Pfizer medical information and we can provide information about a product. per caller I know you are just one representative, you are not a company but I wanted to know if there is any issues with the vaccine I want to know upfront. per caller I never going to read enough literature and know enough knowledge to interpret information as a patient because I have to be a doctor or scientist to understand the implications of thematical information. per caller I am calling you to day for you to alert me any medical malpractice, a patient died a patient lost their arm or got very sick I wanted to know that you tell me before the end of the conversation before I take that vaccine, before I call my doctor's office I want to know ahead of time because I don't want to walk in to take the vaccine that could kill me or injure me. give me medical malpractice and you never told me. you never asked why we should tell you that's not enough legal defense for me. Reporter want to know that you are required by law to any and everything bad about the vaccine, I don't care what it I want to know upfront. per caller I am not taking about oh well 10 % of people had their arm itching for a week, that is not going to kill me that is not going to permanently disable me, explained that a product labeling has all the information approved by the FDA including warnings precautions, adverse reactions listed there also refer caller to treating HCP, at this point caller moved on to other questions about a vaccine. If there were serious reactions to the vaccine if your company was experiencing a serious issue like patients were dying and or patients were getting very sick with something very serious, they became paralyzed in heir left arm or right arm or whatever but after taking they vaccine they were permanently paralyzed, serious medical malpractice issue, would you tell me as a patient that was going on? would you legally be require to do that or would you voluntarily said we have an issue with this vaccine we are not goanna allow you to become trapped. in a terrible deathly situation. or situation that can be seriously injurious to you as a patient, would you tell me that or is it possible that as a patient, I could talk to you ask you any question under the sun and you would never tell me that there was a serious issue with the vaccine. Explained to the caller that I can provide them with the information as approved by the FDA included in the product labeling, Anything outside of that as he has mentioned legal matters, I would refer to legal department. Explained that if he would report the adverse event we would connect him to our safety department to document that. If the patietns were getting very sick and dying from the vaccine, is the healthcare provider required to inform your organization? Are the healthcare providers who administering the vaccine 2025-2026 are legally required to report to you any and all medical malpractice cases? Refer caller to the HCP providers he was questioning regarding legal implications, refer to FDA and Pfizer legal department. Explained that reporter can speak to the medical information department only, again explained that if we would receive report of adverse event, we would connect person or forward information to our safety group. per caller in the topic with medical malpractice that he was discussing are you as an entity required, as an organization are you required to communicate issues upfront? to the caller such as myself, to say we are legally required to inform you of a serious issues of the vaccine there were x number of malpractice cases and would you like more information on malpractice cases? there have been serious side effects that have been recognized by a medical community and they are considerable and we want to alert you ahead of time, would you like more information on the serious side effect that have been reported. would safety department be able to help me with those questions? Explained that I can connect him to our safety department so he could check directly with them, in terms of legal matters again refer caller to Pfizer legal department. Explained that I had information specific to the product as approved by the FDA. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Death More
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2869282 43 F CA 10/29/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chills, Fatigue, Headache, Nausea, Pyrexia; Vaccination site erythema, Vaccinati... Chills, Fatigue, Headache, Nausea, Pyrexia; Vaccination site erythema, Vaccination site pain, Vaccination site swelling More
Fever up to 102f; Chills; Nausea; Headache; Fatigue; Swelling at site of injection; Redness at site ... Fever up to 102f; Chills; Nausea; Headache; Fatigue; Swelling at site of injection; Redness at site of injection; Pain at site of injection; This is a spontaneous report received from a Consumer or other non HCP. A 43-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 21Oct2025 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "nsclc currently ned" (ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE], on 30Sep2025; TAGRISSO, start date: 20Oct2025; PROZAC, start date: 03Jul2023; TRI-SPRINTEC, start date: 01Jan2025. Past drug history included: Ibuprofen, reaction(s): "Allergy"; Penicillin, reaction(s): "allergy". The following information was reported: CHILLS (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering"; FATIGUE (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering"; PYREXIA (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering", described as "Fever up to 102f"; HEADACHE (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering"; NAUSEA (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering", described as "Pain at site of injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering", described as "Redness at site of injection"; VACCINATION SITE SWELLING (non-serious) with onset 22Oct2025 at 07:00, outcome "recovering", described as "Swelling at site of injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, nausea, headache, fatigue, vaccination site swelling, vaccination site erythema, vaccination site pain. Additional information: Facility where vaccine was administered: Doctor's office/urgent care. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2869283 F NJ 10/29/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
tested positive for COVID- 19 for the first time; tested positive for COVID- 19 for the first time; ... tested positive for COVID- 19 for the first time; tested positive for COVID- 19 for the first time; This is a literature report for the following literature source(s) A 15-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for COVID- 19 for the first time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: the patient had received mRNA coronavirus disease 2019 (COVID-19) vaccine (Pfizer/BioNTech) earlier that year (2021), with the second vaccination (June 2021) occurring approximately 7 weeks before the reported onset of symptoms. She had no known recent exposures to COVID-19 or mononucleosis. Two months after hospital discharge, she developed chest pain and cough with blood-tinged mucus and tested positive for COVID-19 for the first time.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (COVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-PV202500125702 Same article/drug/patient and different event; More
2869284 40 F NJ 10/29/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Body temperature, Body temperature increased, Fatigue, Headache, Pain; Vaccinati... Body temperature, Body temperature increased, Fatigue, Headache, Pain; Vaccination site pain, Vaccination site pruritus, Vaccination site swelling More
aches; 100.0 temperature; headache; fatigue; swelling at injection site; severe pain at injection si... aches; 100.0 temperature; headache; fatigue; swelling at injection site; severe pain at injection site; itching at injection site; This is a spontaneous report received from a Consumer or other non HCP. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Oct2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "100.0 temperature"; PAIN (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering"; HEADACHE (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "itching at injection site"; VACCINATION SITE PAIN (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "severe pain at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "swelling at injection site". The patient underwent the following laboratory tests and procedures: Body temperature: (23Oct2025) 100 Centigrade. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information : Facility where vaccine was administered: Pharmacy or Drug Store. 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(s) for which you are reporting?: No Were you/Was the patient taking any other medications within 2 weeks of the event starting?: Yes . Reported Event: 100.0 temperature, aches, headache, fatigue, swelling at injection site, severe pain at injection site, itching at injection site. More
2869285 82 M PA 10/29/2025 COVID19
 PFIZER\BIONTECH
 NA4457
Abnormal dreams, Dizziness, Nightmare, Pain in extremity Abnormal dreams, Dizziness, Nightmare, Pain in extremity
Pain in right upper arm/ache; Realistic dreams, nightmares; Realistic dreams, nightmares; Dizzy; Thi... Pain in right upper arm/ache; Realistic dreams, nightmares; Realistic dreams, nightmares; Dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 82-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Oct2025 as dose 8 (booster), single (Lot number: NA4457) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (Dose 1), administration date: 01Apr2021, for COVID-19 immunisation; comirnaty (Dose 2), administration date: 22Apr2021, for COVID-19 immunisation; comirnaty (Dose 3), administration date: 25Oct2021, for COVID-19 immunisation; comirnaty (Dose 4), administration date: 06Apr2022, for COVID-19 immunisation; comirnaty (Dose 5), administration date: 19Apr2022, for COVID-19 immunisation; comirnaty (Dose 6), administration date: 01Oct2023, for COVID-19 immunisation; comirnaty (Dose 7), administration date: 12Oct2024, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 23Oct2025, outcome "unknown", described as "Dizzy"; PAIN IN EXTREMITY (non-serious) with onset 24Oct2025, outcome "unknown", described as "Pain in right upper arm/ache"; ABNORMAL DREAMS (non-serious), NIGHTMARE (non-serious) all with onset 24Oct2025, outcome "unknown" and all described as "Realistic dreams, nightmares". Therapeutic measures were not taken as a result of dizziness, pain in extremity, abnormal dreams, nightmare. Additional information: E-transmitting possible duplicate as it was a transfer from safety by pawloa02 Reportum wabn86s1 Attachments: 1 Consent to Contact Reporter: N/A Consent to Contact HCP: N/A HCP Contact Information Available: No Patient Age: 82 years old Reporter Subtype: Patient PQC Present: No AE Present: Yes PQC Details: Request Name: REQ- 1834921 Product: COMIRNATY (2025-2026 Formula) Question: transfer from safety by pawloa02 Reportum wabn86s1 Caller is a patient 82 years old Per safety: calling regarding Pfizer covid 19 vaccine Comirnaty he wanted to know if realistic dreams and nightmares have been reported after covid 19 vaccination? per safety it was regarding patient most recent covid 19 vaccination he had back in October 23rd. per caller: it scared the heck out of me, I never had anything like that before and I actually had called my brother and we had argument about it because i has involved his nieces chosen husband, and it was so closely related to the date that I have taken the vaccine. I never had done anything like that I actually picked up the phone and called people and had discussions with them and they did not know what I was taking about. I am 82 years old I haven't had any violent tendency yet. I never had an experience like that in my life. Nothing explains it except the fact that I had a vaccination. I can not belive that I actually picked up the phone and called my brother and had a big fight, I am so bizarrely affected by it because I actually could see pictures I could see it happening in front of my eyes, and was taking to people and doing the right thing. It was terrifying. per caller my medical history if fairly flat, being a spoiled child I hurt my leg running in the neighborhood and being a wise guy and I had to be send to hospital in (withheld city, state) but I actually picked up a little polio as it turns out, he was put by a doctor through variety tests and was told there is something is going on with your hands because my left hand was losing muscle very rapidly, and I never had experience like that either and I think it was related to the Polio but we did not know this is was before the polio vaccine. of course I started taking the vaccines and nothing happened after that. per caller how possible that I had a dream like that it was way too real, when I was 5 years old I remember being a little kid and had to have my tonsils removed. Remember the nurses walking around I don't think they put me under very far. I am a little bit concerend why I should have been having dream like that. Never seen anything that realistic ever. DSU: E-transmitting possible duplicate as it was a transfer from safety by pawloa02 Reportum wabn86s1 Response: Searched attached resources, searched terms: dream/nightmare - no information found PI Revised: 8/2025 LAB-1490-15.0 A review of the Prescribing Information for <Pfizer Product Name> did not find information regarding [Adverse Reaction]. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because your doctor/healthcare provider is most familiar with your medical condition. More
2869286 M OR 10/29/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A... Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jan2025 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient stated he was diagnosed with COVID, and the doctor wrote a prescription for Paxlovid. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2869287 M 10/29/2025 COVID19
 PFIZER\BIONTECH
Vaccination site pain Vaccination site pain
soreness at injection site; This is a spontaneous report received from a Consumer or other non HCP. ... soreness at injection site; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 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: VACCINATION SITE PAIN (non-serious) with onset 2025, outcome "unknown", described as "soreness at injection site". Additional information: During general conversation, individual stated that he recently got his Pfizer COVID shot. He stated he had soreness at injection site. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2869288 F 10/29/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Feeling hot, Pain in extremity Feeling hot, Pain in extremity
Arm ache; Hot feeling all over her body, arms, legs, face; This spontaneous case, initially received... Arm ache; Hot feeling all over her body, arms, legs, face; This spontaneous case, initially received on 15-Oct-2025, was reported by a non-health professional and concerns a female patient. The relevant medical history was reported as unknown. Administration of company suspect drug: On 08-Sep-2025, the patient received Fluad (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: No batch number available, would not be obtained due to no follow-up consent provided No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date in 2025, the patient experienced Arm ache (outcome: Recovered / Resolved, stop date: 2025), Hot feeling all over her body, arms, legs, face (outcome: Not recovered / Not resolved). Patient got a flu shot on 08-Sep-2025, and she experienced arm ache for 5 to 6 days, but it was recovered and recently she started to experience, what she described, as a hot feeling all over her body, arms, legs, face. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter (non-health professional) considered the events as non-serious and causality assessment was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, the events were assessed as related for reporting puirpose More
2869289 0.33 M MI 10/29/2025 FLU3
 SEQIRUS, INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
no symptoms, vaccine given to early no symptoms, vaccine given to early
2869290 48 F FL 10/29/2025 COVID19
 PFIZER\BIONTECH
 NA0738
Urticaria Urticaria
The patient reported hives within a day of getting the shot. The patient reported hives within a day of getting the shot.
2869291 57 M VA 10/29/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 AH2G4
Back pain, Muscle spasms, Rash Back pain, Muscle spasms, Rash
Back pain and cramping started the evening of the vaccine. Now he has a rash lower right back to st... Back pain and cramping started the evening of the vaccine. Now he has a rash lower right back to stomach. He has pain which was relieved somewhat by Advil. More
2869292 77 F 10/29/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Chills, Fatigue, Head injury, Joint injury, Limb injury; Loss of consciousness, ... Chills, Fatigue, Head injury, Joint injury, Limb injury; Loss of consciousness, Mobility decreased, Nausea, Pain, Pyrexia; Swelling More
chills, fever, nausea, black out (fainting),fatigue chills, fever, nausea, black out (fainting),fatigue
2869293 62 F 10/29/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Chills, Diarrhoea, Malaise, Migraine, Pain; Vertigo, Vomiting Chills, Diarrhoea, Malaise, Migraine, Pain; Vertigo, Vomiting
Got the flu vax at 1:00p on 10/28 in [withheld] University, Medical Center. By 4 o?clock, I was viol... Got the flu vax at 1:00p on 10/28 in [withheld] University, Medical Center. By 4 o?clock, I was violently ill, head, spinning, diarrhea, vomiting, migraine, chills, and aches. More
2869294 47 F FL 10/29/2025 FLU3
 SANOFI PASTEUR
 UT877OKA
Eye swelling, Fundoscopy normal, Visual impairment Eye swelling, Fundoscopy normal, Visual impairment
Employee states ?my left eye became swollen after receiving the flu vaccine, and it still hasn?t ful... Employee states ?my left eye became swollen after receiving the flu vaccine, and it still hasn?t fully recovered. My vision in that eye has changed and feels weaker than before. Vaccine given 10/01/2025 and symptom started that same evening. She went to (withheld name) eye Institute 10/23/2025 and was prescribed artificial tears. More
2869299 68 F FL 10/29/2025 FLU3
 SANOFI PASTEUR
Erythema, Peripheral swelling, Skin warm Erythema, Peripheral swelling, Skin warm
Redness Swelling Hot from shoulder down to elbow from approximately 3-4 after injection through 10/2... Redness Swelling Hot from shoulder down to elbow from approximately 3-4 after injection through 10/27/2025 pm. Visited urgent care on 10/27/2025 am for a check on progress to be sure I did not have to do anything further. Had applied ice compresses consistently through the reaction days. More
2869300 83 M IN 10/29/2025 FLU3
 SANOFI PASTEUR
 U8823CA
Atrial fibrillation, Dizziness, Tinnitus, Vision blurred Atrial fibrillation, Dizziness, Tinnitus, Vision blurred
Patient reports at this medicine check that he had a flare up of his Afib, lightheadedness, tinnitus... Patient reports at this medicine check that he had a flare up of his Afib, lightheadedness, tinnitus, and blurry vision in left eye. All symptoms were resolved within 24 hours except he is still noticing some blurry vision in left eye. More
2869301 86 M IA 10/29/2025 COVID19
 MODERNA
 8146367
Death Death
Resident expired Resident expired
✓
2869302 81 M IA 10/29/2025 COVID19
 MODERNA
 3046731
Death Death
Resident passed away Resident passed away
✓
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