🏥 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 💀 🏥 🚑 ♿ ⚠️
2866650 73 M KS 10/17/2025 COVID19
 MODERNA
Unevaluable event Unevaluable event
Resting pulse 102 vs normal around 65. Resting pulse 102 vs normal around 65.
2866651 82 F MN 10/17/2025 COVID19
 PFIZER\BIONTECH
 na0738
Fatigue, Gait disturbance, Urinary incontinence Fatigue, Gait disturbance, Urinary incontinence
patient states she became very fatigued and could barely walk. She also lost all control of her bla... patient states she became very fatigued and could barely walk. She also lost all control of her bladder overnight More
2866652 72 F MO 10/17/2025 UNK
 UNKNOWN MANUFACTURER
 U8875AA
Nausea, Orbital oedema, Pyrexia, Vomiting Nausea, Orbital oedema, Pyrexia, Vomiting
Patient came through our Drive Thru Flu Clinic at approx 11am on Wed 10/15/25. She received a Fluzon... Patient came through our Drive Thru Flu Clinic at approx 11am on Wed 10/15/25. She received a Fluzone HD Influenza vaccine by one of the nurses, [withheld name], RN, IM in R Deltoid. She states approx 12 hours later, 11 pm, she started having a fever, lasting about 5-6 hours. Emesis x2 through the night. The next morning, Thurs 10/16, she had orbital edema and nausea all day. She has improved today, 10/17, but does still have some edema around her eyes. Recommendations for patient. Use cold compresses on eye area, stay cool and continue Loratadine as directed, and try Diphenhydramine 25mg at bedtime. Keep head elevated. Seek medical treatment/911 if she worsens or starts having breathing difficulties. She is agreeable and is gracious for call to check on her. More
2866653 55 F IL 10/17/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J5T3B
Urticaria Urticaria
hives to trunk, upper legs, bilateral arms, face and ears developed evening of 10/15/2025. evaluated... hives to trunk, upper legs, bilateral arms, face and ears developed evening of 10/15/2025. evaluated by occ med NP. Instructed to take Benadryl and utilize cold compress. More
2866654 58 F 10/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3G5T3
3G5T3
Chills, Injection site erythema, Injection site pain, Injection site pruritus, I... Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Pyrexia More
Patient got the vaccine on 13 th and got fever and chills that day by evening and saw the swelling, ... Patient got the vaccine on 13 th and got fever and chills that day by evening and saw the swelling, itching , pain and redness on the arm below the shot was given by next day. She came back to pharmacy on 16th morning to show the site. consulted on her and gave cortisone 1% cream to apply on the area for itching and lidoaine 4% cream to apply for pain. Followed up with with her in the afternoon and the swelling and redness went down a lot. she said it doesn't itch her anymore and the pain went down also. Spoke to patient on 10/17. It's getting better, not fully cleared More
2866655 58 M MD 10/17/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8827AA
UT8770JA
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
Patient received the Fluzone influenza vaccine on 10/8/25. On 10/15/25, he requested to receive the... Patient received the Fluzone influenza vaccine on 10/8/25. On 10/15/25, he requested to receive the COVID vaccine. However, he was given another dose of the Fluzone influenza vaccine in error. The patient was contacted on 10/16/25 and informed of the error. He denied any adverse side effects and stated he was feeling well. More
2866656 48 F WI 10/17/2025 FLU3
 SANOFI PASTEUR
 UT8817KA
Injection site erythema, Injection site pain, Injection site warmth Injection site erythema, Injection site pain, Injection site warmth
Patient reports she had a flu shot on Wednesday in her left arm and awoke this morning with a patch ... Patient reports she had a flu shot on Wednesday in her left arm and awoke this morning with a patch of redness on her left upper arm. Patient has never had a reaction to the flu vaccine before. No other stings or bites or anything in the area. The area is warm and somewhat painful More
2866657 62 M CA 10/17/2025 UNK
 UNKNOWN MANUFACTURER
 flu shot
Arthralgia, Cough, Eye haemorrhage, Inner ear inflammation, Peripheral swelling Arthralgia, Cough, Eye haemorrhage, Inner ear inflammation, Peripheral swelling
*9/12. cough continue to now.?*10/8. left eye bleeding?*10/10. both the tip of the toe are swelling... *9/12. cough continue to now.?*10/8. left eye bleeding?*10/10. both the tip of the toe are swelling and pain?10/11, both the inside of the ears were inflamed?10/13. right eye bleeding ?10/14. left knee pain?10/16. right knee pain? More
2866658 45 F TX 10/17/2025 FLU3
 SANOFI PASTEUR
 UT8826KA
Diarrhoea, Dizziness, Dyspnoea, Heart rate increased, Paraesthesia Diarrhoea, Dizziness, Dyspnoea, Heart rate increased, Paraesthesia
The patient called today to report an adverse reaction following administration of the influenza vac... The patient called today to report an adverse reaction following administration of the influenza vaccine. She received the vaccine on 10/15/25 at 9:13 AM. She reported that symptoms began on 10/16/25 at approximately 1:00 AM. The patient described experiencing symptoms similar to her known allergic reaction to Benadryl, including generalized tingling sensations, rapid heart rate, difficulty breathing, dizziness, and some diarrhea. She stated that the symptoms resolved spontaneously after approximately an hour and a half, and she did not seek emergency care. The following morning, she visited her primary care provider. During the call, the patient requested the name of the vaccine and the manufacturer, and this information was provided. She explained that she wanted this information in order to review the ingredients of the vaccine. More
2866659 30 M MA 10/17/2025 MENB
MNQ
PNC20
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH
 47KS7
Z453D
MG7421
Dizziness, Epistaxis; Dizziness, Epistaxis; Dizziness, Epistaxis Dizziness, Epistaxis; Dizziness, Epistaxis; Dizziness, Epistaxis
Patient experienced minor nosebleed for 2 days post vaccination. Patient also reports severe lighthe... Patient experienced minor nosebleed for 2 days post vaccination. Patient also reports severe lightheadedness and dizziness for 1 week with no resolution. More
2866660 26 F AR 10/17/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052586
U8864AA
Cold sweat, Hyperhidrosis, Pallor; Cold sweat, Hyperhidrosis, Pallor Cold sweat, Hyperhidrosis, Pallor; Cold sweat, Hyperhidrosis, Pallor
After immunizing the patient at 12:30PM , the patient stated they felt dizzy and lightheaded at appr... After immunizing the patient at 12:30PM , the patient stated they felt dizzy and lightheaded at approximately 12:32PM, patient was sweating, clammy and pale. We gave patient a cold pack and some cold water to cool her down and she started feeling better. After a few minutes, the patient started feeling worse but did not lose consciousness. We then called EMS. Patient started feeling better when EMS arrived was not as pale or sweating. EMS took her vitals (bp and blood sugar) and they were normal. Patient continued to improve and declined going to hospital. More
2866661 66 M GA 10/17/2025 FLU3
 SANOFI PASTEUR
 u8859ba
Underdose Underdose
Patient was only given half the dose. The other half went out his arm. Patient was only given half the dose. The other half went out his arm.
2866662 5 M ME 10/17/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4D255
4D255
Dyskinesia, Eye movement disorder, Fall, Flushing, Presyncope; Skin discolourati... Dyskinesia, Eye movement disorder, Fall, Flushing, Presyncope; Skin discolouration, Skin warm, Tachycardia More
Child tolerated injection well. Within 1-2 minute child's eyes looked up and fell over, another... Child tolerated injection well. Within 1-2 minute child's eyes looked up and fell over, another staff member preventing the child's head from hitting the floor. Very brief jerky movements in arms, skin flushed and warm, dusky green-tinged circumoral coloring. radial pulse tachycardic. Child responded to voice and touch within 5-10 seconds. Child denied symptoms except for not feeling well, but was visibly sluggish and shaky. Approx 15 min total until symptoms resolved with juice and rest. Medical Director consulted via phone with assessment given- likely vasovagal response. Parents contacted personal pediatrician for follow up guidance. More
2866663 54 M NJ 10/17/2025 COVID19
 MODERNA
 3052663
Borrelia test, HIV test, Helicobacter test, Mechanical urticaria, Urticaria chro... Borrelia test, HIV test, Helicobacter test, Mechanical urticaria, Urticaria chronic More
Severe chronic urticaria, dermographism, continuing but resolving as of 10/17/2025. Hive outbreak b... Severe chronic urticaria, dermographism, continuing but resolving as of 10/17/2025. Hive outbreak began on back four days after shot, spread to arms and legs, Multiple rounds of Prednisone is finally bringing the condition under control. Presently showing great improvement, not fully resolved. No other symptoms (fever, fatigue, etc.) before or during this event. More
2866665 81 F NC 10/17/2025 COVID19
 PFIZER\BIONTECH
 NA0739
Arthralgia, Mobility decreased, X-ray Arthralgia, Mobility decreased, X-ray
patient reports significant pain in right shoulder and inability to lift right arm; she denies numbn... patient reports significant pain in right shoulder and inability to lift right arm; she denies numbness or tingling in right arm More
2866666 25 M HI 10/17/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 041B21A
041B21A
041B21A
041B21A
Abdominal distension, Alcohol intolerance, Brain fog, Burning sensation, Chest p... Abdominal distension, Alcohol intolerance, Brain fog, Burning sensation, Chest pain; Exercise tolerance decreased, Fatigue, Gastrooesophageal reflux disease, Histamine intolerance, Histamine level increased; Hot flush, Imaging procedure, Magnetic resonance imaging heart, Magnetic resonance imaging normal, Pain in extremity; Palpitations, Paraesthesia, Poor quality sleep, Pyrexia, Thrombin-antithrombin III complex increased More
Chest pain and palpitations began the night after injections and were especially pronounced for seve... Chest pain and palpitations began the night after injections and were especially pronounced for several weeks but lingered until treatment. Fever and hot flashes, whole body tingling and burning sensations occurred the night following injection and intermittently until treatment, affecting sleep quality. Poor tolerance for alcohol and exercise, bloating and reflux, histamine intolerance, and chronic fatigue all developed over the following months and remain chronic. Cardiac MRI 13 December 2023 ruled out myocarditis. Additional chronic fatigue and brain fog, as well as intermittent jabbing pains in the extremities, led to getting treated for vaccine injury by clinic starting August 2024, which included 6 months of triple therapy (eliquis, plavix and aspirin) and mast cell stabilizers and antihistamines. This was supplemented with 40 hyperbaric chamber sessions. The treatment reduced most symptoms but did not eliminate them except for the chest pain and jabbing pain in extremities, bringing them to a chronic but manageable level. More
✓
2866667 67 F WA 10/17/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UT8794CA
MA2488
Erythema, Product administered at inappropriate site, Swelling; Erythema, Produc... Erythema, Product administered at inappropriate site, Swelling; Erythema, Product administered at inappropriate site, Swelling More
pt had swelling and redness, the size of a golfball. Patient feels the vaccine was administered too ... pt had swelling and redness, the size of a golfball. Patient feels the vaccine was administered too low on the arm. More
2866668 60 M CA 10/17/2025 RSV
 MODERNA
 3041770
Extra dose administered Extra dose administered
Pt received RSV last year 10/23/2024, RSV is only a one time dose. Pt received RSV last year 10/23/2024, RSV is only a one time dose.
2866669 0.17 F AL 10/17/2025 DTAP
HIBV
IPV
PNC15
RSV
RV5
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 JP227
UK304AA
YID03P1
Y019380
UK203AA
Y020006
Injection site rash; Injection site rash; Injection site rash; Injection site ra... Injection site rash; Injection site rash; Injection site rash; Injection site rash; Injection site rash; Injection site rash More
Patient has a rash on left arm where she received IPV. Patient was prescribed prednisone for the all... Patient has a rash on left arm where she received IPV. Patient was prescribed prednisone for the allergic reaction. More
2866670 9 F 10/17/2025 FLU3
HEP
HEPA
IPV
TDAP
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
 406987
9n9py
273h3
y1a212m
u8564aa
Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizz... Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor More
After administering the vaccines patient felt dizzy and looked paled. Both feet elevated, Wet compre... After administering the vaccines patient felt dizzy and looked paled. Both feet elevated, Wet compress placed on forehead. Fan placed on patient. juice given to patient. Vital signs 98/64, 84, 26 temp 98.6. After 10 mins patient felt better. denies dizziness at this time. Dad given instructions to call EMS if any problems at home. More
2866671 88 F IL 10/17/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052731
U8800DA
Systemic inflammatory response syndrome; Systemic inflammatory response syndrome Systemic inflammatory response syndrome; Systemic inflammatory response syndrome
SIRS, Systematic Inflammatory Response Syndrome SIRS, Systematic Inflammatory Response Syndrome
✓
2866675 88 F TX 10/17/2025 RSV
RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 na
na
na
Asthenia, Blood pressure decreased, Constipation, Cough, Dehydration; Dizziness,... Asthenia, Blood pressure decreased, Constipation, Cough, Dehydration; Dizziness, Dyspnoea, Ear pain, Gait inability, Headache; Heart rate increased, Paraesthesia, Pneumonia, Pyrexia, Tongue discomfort More
FEVER, WEAKNESS, TONGUE ON FIRE, SEVERE EAR PAIN, SHARP PAIN IN HEAD, COUGHING, DIZZINESS, LABORED ... FEVER, WEAKNESS, TONGUE ON FIRE, SEVERE EAR PAIN, SHARP PAIN IN HEAD, COUGHING, DIZZINESS, LABORED BREATHING, UNABLE TO WALK, TINGLING IN EXTREMITIES, CONSTIPATION, RAPID HEART BEAT, DECREASE IN BLOOD PRESSURE, DEHYDRATION; PATIENT ULTIMATELY TREATED IN HOSPITAL FOR SYMPTOMS BUT CONTRACTED HOSPITAL PNEUMONIA. More
✓
2866677 30 M MS 10/17/2025 MENB
MNQ
PNC20
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH
 47KS7
Z453D
MG7421
Dizziness, Impaired driving ability; Dizziness, Impaired driving ability; Dizzin... Dizziness, Impaired driving ability; Dizziness, Impaired driving ability; Dizziness, Impaired driving ability More
Patient stated per phone call that he has been experiencing light headedness and cannot drive since ... Patient stated per phone call that he has been experiencing light headedness and cannot drive since he had all 3 vaccines administered on 10/9/2025. Patient was 30 years old when he had MenACWY Menveo, MenB Bexsero and Pneumococcal Prevnar20 administered on 10/9/2025. More
2866678 7 M TX 10/17/2025 FLU3
 SANOFI PASTEUR
 U8823AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Auto generated said: Here?s a polished version of what to type for Item 18 ? written in VAERS-appro... Auto generated said: Here?s a polished version of what to type for Item 18 ? written in VAERS-appropriate language and clear chronological order: Item 18 ? Describe the adverse event(s), treatment, and outcome(s): Patient presented for influenza vaccination. The vaccine ordered in the chart was Fluarix (quadrivalent, standard dose); however, documentation showed the lot number for Flublok (recombinant influenza vaccine) was signed out and administered. When questioned, the medical assistant confirmed that Flublok was given in error. The patient is 7 years old, and Flublok is only indicated for ages 9 years and older. There is no documentation that the parent was notified of the administration error in the chart. Dr was informed and stated she would contact the mother to notify her. Outcome of notification is unknown. No adverse reactions were reported at the time of discovery. More
2866679 63 F MI 10/17/2025 FLU3
 SEQIRUS, INC.
 407271
Chills, Feeling abnormal, Nervousness, Pain Chills, Feeling abnormal, Nervousness, Pain
After the vaccine the patient went gym, worked out then played bocci ball then came home and had din... After the vaccine the patient went gym, worked out then played bocci ball then came home and had dinner. A neighbor called and had fallen so patient went over to neighbors to assist. When she came home she felt very weak, shaky, had chills and overall aches. She went to bed and began to feel better the next day. I talked to her today 10/17 and she said she feels fine now. She has had flu shots in the past and never felt like this after so was wondering if this was maybe a bad batch or maybe too much of a dose for her because she isn't very big. Wondering if she had ever had the senior dose before? More
2866681 58 M IL 10/17/2025 FLU3
FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SEQIRUS, INC.
SEQIRUS, INC.

407007
407007
Back pain, Muscular weakness, Neuralgic amyotrophy; Back pain, Hypoaesthesia, Ma... Back pain, Muscular weakness, Neuralgic amyotrophy; Back pain, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness, Paraesthesia; Back pain, Muscular weakness, Neuralgic amyotrophy; Back pain, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness, Paraesthesia More
beginning 2 days after vaccination into left arm, right upper back pain lasting 3 days, followed by ... beginning 2 days after vaccination into left arm, right upper back pain lasting 3 days, followed by right hand/arm weakness, went to neurologist and diagnosed with Parsonage-Turner Syndrome More
2866682 66 M TX 10/17/2025 FLU3
 SEQIRUS, INC.
Osteoarthritis, Spinal osteoarthritis, X-ray of pelvis and hip abnormal Osteoarthritis, Spinal osteoarthritis, X-ray of pelvis and hip abnormal
Osteo arthritis, which has since deteriorated to severe. The latest Diagnosis by MD, 10/21/2024, bas... Osteo arthritis, which has since deteriorated to severe. The latest Diagnosis by MD, 10/21/2024, based on imaging, is recorded as: "Progressive severe bilateral hip joint space narrowing is present with osteophytosis, subchondral sclerosis and cystic changes. Osteopenia is noted. Degenerative changes are present in the spine and sacroiliac joints." Hip replacement (both hips) has since been recommended repeatedly by multiple orthopedic physicians and an Assistant Professor, Joint Reconstruction. More
2866683 57 F CA 10/17/2025 COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 NA0587
NA0587
NA0587
U8832AA
U8832AA
U8832AA
Decreased appetite, Dizziness, Dysstasia, Fatigue, Gait disturbance; Headache, M... Decreased appetite, Dizziness, Dysstasia, Fatigue, Gait disturbance; Headache, Mobility decreased, Muscular weakness, Pain, Pyrexia; Tremor; Decreased appetite, Dizziness, Dysstasia, Fatigue, Gait disturbance; Headache, Mobility decreased, Muscular weakness, Pain, Pyrexia; Tremor More
Day after injections, tired, slight fever, loss of appetite, body aches, headaches. Advil helped wit... Day after injections, tired, slight fever, loss of appetite, body aches, headaches. Advil helped with fever/body aches. By day 5, symptoms are still present and add muscle weakness. Unable to walk up stairs, lift off of chairs, toilet. Unable to lift 24oz filled water bottle above my head. Hand tremors. Day 9, attempted to go shopping, Got dizzy from walking 10+ minutes. Went home and slept. Still no appetite, muscles still weak-difficulty walking and lifting objects, hand tremors. Day 16, was able to go to a restaurant, appetite inreasing a little. Could not walk more than two blocks. Day 25, able to walk longer but not able to climb stairs or get up from a seated position easily, Day 28, able to get up from a seated postion easier but not walk up stairs, Lost 12 lbs in 4weeks. More
2866684 65 M WY 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75d3a
Pain in extremity Pain in extremity
Left arm pain every day since the immunization was administered Left arm pain every day since the immunization was administered
2866686 58 M MO 10/17/2025 COVID19
UNK
 MODERNA
UNKNOWN MANUFACTURER

Arthralgia, Migraine, Mobility decreased, Pyrexia, Rash; Arthralgia, Migraine, M... Arthralgia, Migraine, Mobility decreased, Pyrexia, Rash; Arthralgia, Migraine, Mobility decreased, Pyrexia, Rash More
Rash of raised red weeping blisters on feet hands and arms, especially dense near elbows.. Also low ... Rash of raised red weeping blisters on feet hands and arms, especially dense near elbows.. Also low fever, migraine, and severe joint pain, especially hands elbows shoulders, toes, and hips. Unable to fully straighten some fingers and both elbows . More
2866687 1.17 M CA 10/17/2025 DTAP
HIBV
PNC15
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 4CA03C2
UK233AA
Z003633
Urticaria; Urticaria; Urticaria Urticaria; Urticaria; Urticaria
Patient developed urticaria /hives on his body, arms, legs the day after vaccine was given Patient developed urticaria /hives on his body, arms, legs the day after vaccine was given
2866688 61 F SC 10/17/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 B5NJ9
Erythema, Pruritus, Swelling Erythema, Pruritus, Swelling
PATIENT REPORTED RED, SWOLLEN, AND ITCHING IN AREA PATIENT REPORTED RED, SWOLLEN, AND ITCHING IN AREA
2866689 F WA 10/17/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Malaise; Malaise Malaise; Malaise
She felt sick; This is a spontaneous report received from a Nurse from medical information team. A ... She felt sick; This is a spontaneous report received from a Nurse from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She felt sick". Additional information: It was reported that her daughter in law also took the two vaccines (COVID and flu) and she felt sick that night but she was fine. . The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2866690 50 F CA 10/17/2025 COVID19
 PFIZER\BIONTECH
 EW0150
Cerebrovascular accident Cerebrovascular accident
Had a reaction like a stroke like event 3 weeks after the second shot; This is a spontaneous report ... Had a reaction like a stroke like event 3 weeks after the second shot; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: EW0150) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperreflexia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Apr2021, outcome "unknown", described as "Had a reaction like a stroke like event 3 weeks after the second shot". Clinical course: The patient had a reaction like a stroke like event 3 weeks after the second shot (Pfizer COVID-19 Vaccine). The patient did not correlate the stroke like event to the vaccine because she would had it 3 weeks before, it never occurred to her that could have a response or reaction, adverse reaction several weeks after the shot, but it was like clockwork 3 weeks and 3 weeks for both of them and when she did a timeline, she realized this is the vaccine and it was so extreme that she really feel like she almost died, it was very. More
2866691 69 F MD 10/17/2025 COVID19
 PFIZER\BIONTECH
 FG3527
Headache, Tinnitus Headache, Tinnitus
I had a slight headache every time; I have tinnitus and it gets worse every time I get a covid vacci... I had a slight headache every time; I have tinnitus and it gets worse every time I get a covid vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old female patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose number unknown, single (Lot number: FG3527) at the age of 69 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 06Apr2021, for COVID-19 IMMUNISATION, reaction(s): "HEADACHE". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I had a slight headache every time"; TINNITUS (non-serious), outcome "unknown", described as "I have tinnitus and it gets worse every time I get a covid vaccine". Additional information: Upon reporting for recent vaccine, patient mentioned that she woke up with a headache which has been her reaction to previous covid vaccines. She had first covid shot on 06Apr2021 and had a slight headache every time. More
2866692 72 F MD 10/17/2025 COVID19
 PFIZER\BIONTECH
 HN0477
Headache, Tinnitus Headache, Tinnitus
A slight headache every time; Has tinnitus and it gets worse every time the patient gets a COVID vac... A slight headache every time; Has tinnitus and it gets worse every time the patient gets a COVID vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Apr2024 as dose 1, 0.3ml, single (Lot number: HN0477) at the age of 72 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 shot, administration date: 06Apr2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "slight headache", "tinnitus"; comirnaty (Lot Number: FG3527, intramuscular, right arm, 0.3ml), administration date: 08Nov2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "slight headache", "tinnitus"; comirnaty original/omicron ba.4-5 (Lot Number: GJ3277, intramuscular, right arm, 0.3ml), administration date: 12Oct2022, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "slight headache", "tinnitus"; comirnaty omicron xbb.1.5 (Lot Number: HG2282, intramuscular, left arm, 0.3ml), administration date: 09Oct2023, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "slight headache", "tinnitus". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "A slight headache every time"; TINNITUS (non-serious), outcome "unknown", described as "Has tinnitus and it gets worse every time the patient gets a COVID vaccine". More
2866693 F 10/17/2025 COVID19
 PFIZER\BIONTECH
Antinuclear antibody positive, Breast mass, Dry skin, Hypersensitivity, Pruritus Antinuclear antibody positive, Breast mass, Dry skin, Hypersensitivity, Pruritus
Itching; Breast lumps; Dry skin; Other allergic reaction; positive ANA; This is a spontaneous report... Itching; Breast lumps; Dry skin; Other allergic reaction; positive ANA; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2020 as dose 2, 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, manufacturer unknown.), for Covid-19 immunization. The following information was reported: BREAST MASS (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "Breast lumps"; DRY SKIN (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025); PRURITUS (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "Itching"; HYPERSENSITIVITY (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "Other allergic reaction"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset Jan2020, outcome "recovered with sequelae" (Aug2025), described as "positive ANA". Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. Patient stated side effects such as itching, breast lumps, and dry skin, and other allergic reactions. Also stated the patient had a positive ANA. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2866694 76 F CA 10/17/2025 COVID19
 PFIZER\BIONTECH
 GJ6738
Balance disorder, Fatigue, Tremor Balance disorder, Fatigue, Tremor
Extreme fatigue; developed gradually balance problem; tremor; This is a spontaneous report received ... Extreme fatigue; developed gradually balance problem; tremor; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 76 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no other diagnosed illnesses/medical history/chronic health conditions to report. The patient is not allergic to any previous vaccination, medications, food or other products. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Location of injection/shot: arm, lot number: EW0150), administration date: 12Apr2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "Extreme fatigue", "developed gradually balance problem", "Tremor"; BNT162b2 (Dose 2, Location of injection/shot: arm, lot number: ER8735), administration date: 04May2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "Surgery to remove cancerous kidney", "Extreme debilitating fatigue, longterm", "couldn't walk at all", "developed gradually balance problem/can't stand for more than a couple of seconds", "Tremor"; BNT162b2 (Dose 3, Location of injection/shot: arm, lot number: FJ1620), administration date: 29Nov2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "extreme debilitating fatigue, long term", "developed gradually balance problem", "Tremor"; BNT162b2 (Dose 4, Location of injection/shot: arm, lot number: FJ4991), administration date: 13May2022, when the patient was 76-year-old, for Covid-19 immunization, reaction(s): "Extreme fatigue", "increasing balance problems/I can't stand for more than a couple of seconds at a time", "Tremor", "gradually decreased walking to 15 mins, then 10 mins, then 5 ending at her door gasping for breath". The following information was reported: FATIGUE (Medically Significant), outcome "not recovered", described as "Extreme fatigue"; BALANCE DISORDER (non-serious), outcome "unknown", described as "developed gradually balance problem"; TREMOR (non-serious), outcome "unknown". The event "extreme fatigue" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500107080 same patient, different dose and event; More
✓
2866696 41 F 10/17/2025 COVID19
 PFIZER\BIONTECH
 NA0587
Vaccination site pain Vaccination site pain
Mild injection site pain; This is a spontaneous report received from a Physician. A 41-year-old fem... Mild injection site pain; This is a spontaneous report received from a Physician. A 41-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 14Oct2025 as dose 1, single (Lot number: NA0587) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; ORAL CONTRACEPTIVE NOS. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Oct2025, outcome "recovering", described as "Mild injection site pain". Therapeutic measures were not taken as a result of vaccination site pain. No follow-up attempts are possible. More
2866697 38 F NY 10/17/2025 COVID19
 PFIZER\BIONTECH
 na4452
Menstrual disorder Menstrual disorder
started menstruating; This is a spontaneous report received from a Consumer or other non HCP. A 38-... started menstruating; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 02Oct2025 as dose 1, single (Lot number: na4452) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "depression" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 07Oct2025, outcome "recovered" (14Oct2025), described as "started menstruating". Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Patient have no known allergies. Patient started menstruating. She do not have regular periods because of birth control, so this was abnormal and impactful to her life. More
2866698 F HI 10/17/2025 COVID19
 PFIZER\BIONTECH
Opsoclonus myoclonus Opsoclonus myoclonus
OMAS (opsoclonus-myoclonus-ataxia syndrome); This is a spontaneous report received from a Physician.... OMAS (opsoclonus-myoclonus-ataxia syndrome); This is a spontaneous report received from a Physician. A 77-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient took rheumatoid arthritis medications. The following information was reported: OPSOCLONUS MYOCLONUS (medically significant), outcome "unknown", described as "OMAS (opsoclonus-myoclonus-ataxia syndrome)". It was unknown if therapeutic measures were taken as a result of opsoclonus myoclonus. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event opsoclonus myoclonus and the suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate. More
2866699 F MA 10/17/2025 RSV
 PFIZER\WYETH
Exposure during pregnancy, Premature delivery Exposure during pregnancy, Premature delivery
Patient delivered premature; This is a spontaneous report received from a Nurse from a sales represe... Patient delivered premature; This is a spontaneous report received from a Nurse from a sales representative. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient was 32 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: PREMATURE DELIVERY (non-serious), outcome "recovered", described as "Patient delivered premature". The baby was delivered, delivery date unknown. It was unknown if therapeutic measures were taken as a result of premature delivery. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2866700 63 M WA 10/17/2025 PNC20
 PFIZER\WYETH
Influenza, Pain in extremity Influenza, Pain in extremity
Mild flu symptoms; Upper arm soreness; This is a spontaneous report received from a Consumer or othe... Mild flu symptoms; Upper arm soreness; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 15Oct2025 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for immunisation. The patient's relevant medical history included: "Pre Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Congestive Heart Failure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; CARVEDILOL. The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The following information was reported: INFLUENZA (non-serious) with onset 16Oct2025, outcome "recovering", described as "Mild flu symptoms"; PAIN IN EXTREMITY (non-serious) with onset 16Oct2025, outcome "recovering", described as "Upper arm soreness". Therapeutic measures were not taken as a result of influenza, pain in extremity. The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received. More
2866701 M 10/17/2025 COVID19
 PFIZER\BIONTECH
Body height, Body height increased, Therapeutic response unexpected Body height, Body height increased, Therapeutic response unexpected
used to have eczema/got the COVID-19 shot in 2021, since then he has not experienced eczema/at least... used to have eczema/got the COVID-19 shot in 2021, since then he has not experienced eczema/at least 5 inches or more taller than most of the people/ thinks those are 2 potential benefits to look into; at least 5 inches or more taller than most of the people in family/thinks those are 2 potential benefits to look into; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021189 (Biontech SE). A 16-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "used to have eczema/got the COVID-19 shot in 2021, since then he has not experienced eczema/at least 5 inches or more taller than most of the people/ thinks those are 2 potential benefits to look into"; BODY HEIGHT INCREASED (non-serious), outcome "unknown", described as "at least 5 inches or more taller than most of the people in family/thinks those are 2 potential benefits to look into". Additional information: The patient used to have eczema. He got the COVID-19 shot in 2021, since then he has not experienced eczema. The reporter did not treat the patient in the past for eczema due to side effects from available drugs for eczema. It was also reported that the patient is at least 5 inches or more taller than most of the people in the reporter's family and the reporter's wife's family. The reporter thinks those are 2 potential benefits to look into regarding COVID-19 vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : AE-021189 Biontech SE;US-PFIZER INC-PV202500122833 same reporter/suspect vaccine/event; different patient; More
2866702 M 10/17/2025 COVID19
 PFIZER\BIONTECH
Therapeutic response unexpected Therapeutic response unexpected
Both of my sons (ages 16 and 8) used to have eczema. They both got the covid-19 shots in 2021, since... Both of my sons (ages 16 and 8) used to have eczema. They both got the covid-19 shots in 2021, since then they have not experienced eczema.; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021189. An 8-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "eczema" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Both of my sons (ages 16 and 8) used to have eczema. They both got the covid-19 shots in 2021, since then they have not experienced eczema.". Additional information: Both of the reporter's sons (ages 16 and 8) used to have eczema. They both got the covid-19 shots in 2021, since then they have not experienced eczema. The reporter did not treat sons in the past for eczema due to side effects from available drugs for eczema. 16 years old son is at least 5 inches or more taller than most people in family or wife's family. The reporter thinks those 2 potential benefits to look into regarding Covid-19 vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : AE-021189 Biontech SE;US-PFIZER INC-PV202500122832 same reporter/suspect vaccine/event; different patient; More
2866703 10/17/2025 COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR





Abdominal discomfort, Blood pressure measurement, Body temperature, Chills, Hear... Abdominal discomfort, Blood pressure measurement, Body temperature, Chills, Heart rate; Hypertension, Malaise, Pain in extremity, Pyrexia, Tremor; Vaccination site pain; Abdominal discomfort, Blood pressure measurement, Body temperature, Chills, Heart rate; Hypertension, Malaise, Pain in extremity, Pyrexia, Tremor; Vaccination site pain More
developed did not feel well; I had the shakes/started getting the shakes at the left arm as well as ... developed did not feel well; I had the shakes/started getting the shakes at the left arm as well as right arm/both started shaking and couldn't stop; stomach was upset; high blood pressure; went to move my arm and it felt like somebody was stabbing me with a knife, it was extremely painful. And arm was still a little sore, but by Sunday i was perfectly fine; pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/ arm really hurt/pain was terrible; chills; fever/later a fever of 101.9 F/had fever of 101.6 F; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA290218 (Sanofi). Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from patient. This case involves an unknown age and unknown gender patient who had the shakes/ started getting the shakes at the left arm as well as right arm/both started shaking and could not stop, heart rate wasn't too bad, it was 92 something, stomach was upset, high blood pressure, went to move my arm and it felt like somebody was stabbing me with a knife. it was extremely painful&my arm was still a little sore, but by sunday i was perfectly fine, pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/arm really hurt/pain was terrible, did not feel well, chills and fever/later a fever of 101.9 F/had fever of 101.6 F after receiving Influenza USP trival A-B subvirion NO preservative vaccine [Fluzone] and covid-19 vaccine MRNA. The patient's past vaccination (s) included covid-19 vaccine on 29-JAN-2021, Pfizer BioNTech covid-19 vaccine on 17-FEB-2021, Pfizer BioNTech covid-19 vaccine on 25-SEP-2021, Pfizer BioNTech COVID-19 vaccine on 22-APR-2022, Pfizer BioNTech covid-19 vaccine on 09-SEP-2022, Spikevax XBB.1.5 on 04-OCT-2023, Spikevax XBB.1.5 on 22-MAR-2024, spikevax 2024-2025 (KP.2) on 30-AUG-2024 with Dose 8, and spikevax 2024-2025 (KP.2) on 02-MAR-2025. The patient's past medical history, medical treatments) and family history were not provided. At the time of the event, the patient had ongoing Hypertension in 2013, Arrhythmia in 2013 and Respiration abnormal in 2013. On 12-Sep-2025, the patient received 1 DF (Dosage form) of suspect Influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (Unknown strength, Lot and expiry date) via Intramuscular route in unknown administration site for Influenza and dose 10 of 1 DF of suspect covid-19 vaccine MRNA Injection (Unknown strength, lot and expiry date) not produced by Sanofi Pasteur via intramuscular route in unknown administration site for covid-19 Prophylaxis. Information on the batch number was requested corresponding to the one at time of event occurrence. On 12-SEP-2025, the patient had the shakes/started getting the shakes at the left arm as well as right arm/both started shaking and could not stop (tremor), stomach was upset (abdominal discomfort), high blood pressure (hypertension), went to move my arm and it felt like somebody was stabbing me with a knife, it was extremely painful. And arm was still a little sore, but by Sunday i was perfectly fine (pain in extremity), pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/arm really hurt/pain was terrible (vaccination site pain), chills and fever/later a fever of 101.9 F/ had fever of 101.6 F (pyrexia) (Latency same day) following the administration of Influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. On 13-Sep-2025, the patient developed did not feel well (malaise) (Latency 1 day) following the administration of influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. On an unknown date in SEP-2025, the patient developed heart rate was not too bad, it was 92 something (heart rate increased) (unknown latency) following the administration of Influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. Relevant laboratory test results included: Body temperature - On 12-Sep-2025: 101.6 F; on 13-Sep-2025: 97.9 F and Heart rate - In September 2025: 92 UNK [92]. Action taken was not applicable. The patient was treated with paracetamol (tylenol) for Vaccination site pain, Pain in extremity and Pyrexia and codeine for Pain in extremity and Vaccination site pain. At time of reporting, the outcome was Recovering / Resolving for the event Vaccination site pain, was Recovered / Resolved on an unknown date Sep-2025 for the event Pain in extremity and was Unknown for other the events. More
2866721 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fungal infection Fungal infection
face has what looks fungal; This non-serious case was reported by a consumer via interactive digital... face has what looks fungal; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fungal infection in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fungal infection (Verbatim: face has what looks fungal). The outcome of the fungal infection was not reported. It was unknown if the reporter considered the fungal infection to be related to Shingrix. It was unknown if the company considered the fungal infection to be related to Shingrix. Additional Information: GSK Receipt Date: 08-OCT-2025 The patient received Shingrix vaccine and the face had looks fungal it washes away with effaclar, but immediately comes back. More
2866722 F 10/17/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; ill with RSV; This serious case was reported by a consumer via inter... Suspected vaccination failure; ill with RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: ill with RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 10-OCT-2025 This case was reported by a reporter who knew the patient via interactive digital media. The patient was ill with respiratory syncytial virus infection (RSV) despite vaccination was scary. This case was considered as suspected vaccination failure as details of time to onset and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter. This case was linked with US2025AMR131395, reported by same reporter for different patient.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving RSV vaccine, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR131395:Case for Another girl More
2866724 F OR 10/17/2025 COVID19
 PFIZER\BIONTECH
Blood glucose, Body temperature, Feeling abnormal, Pyrexia, Therapeutic response... Blood glucose, Body temperature, Feeling abnormal, Pyrexia, Therapeutic response unexpected More
near normal blood sugars; feeling atrocious; low grade fever; This is a spontaneous report received ... near normal blood sugars; feeling atrocious; low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetic" (ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2025, outcome "unknown", described as "feeling atrocious"; PYREXIA (non-serious) with onset Oct2025, outcome "unknown", described as "low grade fever"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Oct2025, outcome "unknown", described as "near normal blood sugars". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Type 1 diabetic patient stated having consistent blood sugar levels after getting Covid 19 Vaccine since this morning (15Oct2025), despite feeling atrocious and having a low grade fever. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2866725 F NY 10/17/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Dizziness, Gait inability, Malaise Dizziness, Gait inability, Malaise
I could not even walk; Felt extremely sick at night; Feeling very dizzy; This spontaneous case, init... I could not even walk; Felt extremely sick at night; Feeling very dizzy; This spontaneous case, initially received on 07-Oct-2025, was reported by a non health professional and concerns a female patient. Medical history: unknown Concomitant medication: refer to appropriate section. It was also reported over the counter medicines. Administration of company suspect drug: On 05-Oct-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, dose: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: No batch number available and will be asked on follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 05-Oct-2025, the patient experienced Felt extremely sick at night (outcome: Unknown). On 06-Oct-2025, the patient experienced I could not even walk (outcome: Unknown). On unknown date in Oct-2025, the patient experienced Feeling very dizzy (outcome: Unknown). The patient had taken the Fluad vaccine on Sunday (05-Oct-2025), which was intended for patients over 65 years of age. That night, the patient had felt extremely sick, and the previous day of report had been unable to walk due to feeling very dizzy. As a result, the patient had requested to speak with someone from the research team - a doctor - who could explain why such a dangerous and powerful vaccine was being given to older people. The patient had questioned why something meant to help was causing such effects and had insisted on receiving a call back the same day for a full explanation. (The patient was persistent on having a call back from someone from the research team to have all the explanations.) Fluad (TIV) action taken: Not Applicable Treatment medication: Tylenol Reporter's assessment: The reporter assessed Felt extremely sick at night, Felt extremely sick at night, Feeling very dizzy as seriousness unknown and causality was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes. More
📋 Privacy Policy & Data Disclaimer