🏥 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 💀 🏥 🚑 ♿ ⚠️
2873342 70 F IL 11/18/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052669
3052669
Erythema, Headache, Nervousness, Pain in extremity, Peripheral swelling; Pruritu... Erythema, Headache, Nervousness, Pain in extremity, Peripheral swelling; Pruritus More
Per patient, arm became red & sore and swollen around 11pm the night of the shot, after midnight... Per patient, arm became red & sore and swollen around 11pm the night of the shot, after midnight, it became itchy, she developed a headache that won't go away and her arms & legs keep feeling very shaky. More
2873345 5 F CA 11/18/2025 FLU3
 SANOFI PASTEUR
 U8863AA
Tic Tic
Developed facial motor tics following 2nd dose of flu vaccine. Had an allergic reaction to the first... Developed facial motor tics following 2nd dose of flu vaccine. Had an allergic reaction to the first dose and consulted with MD and she suggested moving forward with 2nd dose. Went to see MD to consult on tics. Referral to neurologist made. No other treatment recommendations made. dose 2 NDC 49281-425-88 More
2873346 5 F CA 11/18/2025 FLU3
 SANOFI PASTEUR
 UT87925A
Rash, Rash erythematous, Rash papular, Urticaria Rash, Rash erythematous, Rash papular, Urticaria
Red raised rash/hives on face. Both sides of face. Red rash on body (trunk). Consulted with MD. Sho... Red raised rash/hives on face. Both sides of face. Red rash on body (trunk). Consulted with MD. Showed pictures. More
2873348 45 F PA 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2CA5M
Bursitis, Injected limb mobility decreased, Pain in extremity Bursitis, Injected limb mobility decreased, Pain in extremity
C/O pain and decreased mobility of left arm. Went to urgent care 3 days after injection due decreas... C/O pain and decreased mobility of left arm. Went to urgent care 3 days after injection due decrease ROM. diagnosed with Bursitis and Tapering Prednisone with initiated with referral to Physical therapy. More
2873349 0.08 F CA 11/18/2025 DTAPIPVHIB
DTAPIPVHIB
RV5
RV5
UNK
UNK
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UK110AA
UK110AA
Y014320
Y014320
Y017360
Y017360
Diarrhoea, Discomfort, Infant irritability, Malaise, Rotavirus test negative; Vo... Diarrhoea, Discomfort, Infant irritability, Malaise, Rotavirus test negative; Vomiting projectile; Diarrhoea, Discomfort, Infant irritability, Malaise, Rotavirus test negative; Vomiting projectile; Diarrhoea, Discomfort, Infant irritability, Malaise, Rotavirus test negative; Vomiting projectile More
On the day of and the days following the vaccine, Patient increasingly vomited and was generally un... On the day of and the days following the vaccine, Patient increasingly vomited and was generally unwell. By October 5 (Sunday), she was increasingly uncomfortable. On October 7 (Tuesday), Patient had very big diarrhea, projective vomited, and was very unwell. That day, she was seen by her pediatrician. In the evening, we went to [withheld] in [withheld] where she was examined and received an IV. The next day, on October 8, Patient was admitted at [withheld] in [withheld] from which she was discharged on October 21. Patient had extreme diarrhea, lost a lot of her body mass, and we had to feed via IV for days before we were able to start her on Pedialite, then powder, until she was able to be fed via bottle again. The symptoms were consistent with a rotavirus infection but Patient tested negative for rotavirus. More
✓
2873350 62 M MI 11/18/2025 FLU3
 SANOFI PASTEUR
Herpes zoster, Injection site rash, Rash, Varicella virus test positive Herpes zoster, Injection site rash, Rash, Varicella virus test positive
First noticed by the patient on the morning of 11/06/2025, an acute rash began developing on the rig... First noticed by the patient on the morning of 11/06/2025, an acute rash began developing on the right arm and eventually extending from the upper arm near the injection site down to the right thumb. The patient visited an urgent care facility (withheld name) on 11/09/2025. The doctor felt that the rash was not an allergic reaction to the vaccine, but more likely consistent with shingles. A PCR test sample was taken which came back the next day positive for Varicella zoster. More
2873351 63 F 11/18/2025 FLU3
 SANOFI PASTEUR
 u8800da
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was given high dose at 63. Patient was given high dose at 63.
2873353 64 F AZ 11/18/2025 FLU3
PNC20
RSV
VARZOS
 SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8923AA
MG7416
G347X
5A727
Injection site induration, Injection site pruritus, Injection site reaction, Inj... Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth, Rash pruritic; Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth, Rash pruritic; Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth, Rash pruritic; Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth, Rash pruritic More
Patient had an injection site reaction in her LEFT arm. Started 2 days after injection as an itchy r... Patient had an injection site reaction in her LEFT arm. Started 2 days after injection as an itchy rash. Next day (Saturday) site was hard, itchy and hot to touch. Sunday was worse than the day before. Monday reaction started to lessen after application of ice pack More
2873359 27 F AK 11/18/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 3052733
3052733
3052733
Computerised tomogram head normal, Differential white blood cell count abnormal,... Computerised tomogram head normal, Differential white blood cell count abnormal, Fatigue, Full blood count, Headache; Metabolic function test, Nausea, Pain, Syncope, Temperature intolerance; Vertigo, Viral test negative, Vomiting More
Symptoms included: Fatigue, Nausea, Body Aches, Severe Headache, Vomiting, Hot/Cold Intolerance, Syn... Symptoms included: Fatigue, Nausea, Body Aches, Severe Headache, Vomiting, Hot/Cold Intolerance, Syncope, Vertigo. Treatment included: First heading to the clinic for treatment at 09:30am and then having to go with EMS to the ER for treatment after syncope episodes. CT scan of the head was also performed. IV fluids given as well as Zofran and Toradol. Zofran was given in the tablet form to bring home. I was advised to return to the clinic if my symptoms got worse or did not get better and to continue with Ibuprofen every 8 hours until my symptoms resolved. Quad Plex (RSV/FLU A-B/ COV-SARS-2), CMP, and CBC w/Diff were performed. More
2873360 37 F CA 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 5EF45
Immediate post-injection reaction, Injection site discomfort, Injection site mas... Immediate post-injection reaction, Injection site discomfort, Injection site mass, Pain, Swelling More
EE reports receiving a flu shot on 10/23/2025 to her R deltoid at [withheld name] clinic. EE reports... EE reports receiving a flu shot on 10/23/2025 to her R deltoid at [withheld name] clinic. EE reports immediate onset of pain after receiving the vaccination. EE reports onset of soreness and swelling. EE reports prolonged pain; reports soreness is still present as of 11/18/2025. EE denies any current swelling. EE reports she can "feel a little bump" when palpating the R deltoid muscle. EE reports "pulling" sensation at injection site when rotating, lifting and moving R arm. EE denies any skin discoloration, denies itchiness, denies any numbness/tingling. EE denies any previous reactions to vaccines. More
2873364 46 F MN 11/18/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.
 NA0590
NA0590
409414
409414
Injected limb mobility decreased, Loss of personal independence in daily activit... Injected limb mobility decreased, Loss of personal independence in daily activities, Magnetic resonance imaging, Musculoskeletal stiffness, Pain in extremity; Weight bearing difficulty, X-ray; Injected limb mobility decreased, Loss of personal independence in daily activities, Magnetic resonance imaging, Musculoskeletal stiffness, Pain in extremity; Weight bearing difficulty, X-ray More
Patient states she experienced stiff and sore/painful right arm that evening of immunization adminis... Patient states she experienced stiff and sore/painful right arm that evening of immunization administration, which turned into not being able to move/straighten arm and then not being able to lift coffee cup with right arm, couldnt get dressed, loss of mobility .Patient saw provider 11/6/25 who advised PT, MRI, xray More
2873365 8 M 11/18/2025 COVID19
 MODERNA
 8146670
Incorrect dose administered, Product prescribing issue Incorrect dose administered, Product prescribing issue
Provider ordered the 50mcg dose and the MA administered the dose that was ordered, the wrong dose wa... Provider ordered the 50mcg dose and the MA administered the dose that was ordered, the wrong dose was ordered by the provider for a child under the age of 12, should have received 25mcg. MA did not question the provider and wrong dose was administerd More
2873367 73 F CA 11/18/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0167
FD7218
ER8731
Aggression, Amnesia, Confusional state, Dementia Alzheimer's type, Disturba... Aggression, Amnesia, Confusional state, Dementia Alzheimer's type, Disturbance in attention; Aggression, Amnesia, Confusional state, Dementia Alzheimer's type, Disturbance in attention; Aggression, Amnesia, Confusional state, Dementia Alzheimer's type, Disturbance in attention More
Early onset Alzheimer's disease including short term memory loss, confusion, difficulty complet... Early onset Alzheimer's disease including short term memory loss, confusion, difficulty completing detail-oriented tasks and staying focused on tasks at hand. Became unusually argumentative and confrontational, wanting to engage in irrational arguments over small matters for some time after the shots were received. More
✓
2873368 48 F MI 11/18/2025 FLU3
HEPAB
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 247L3
429JJ
K4979
No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event
No Adverse reaction No Adverse reaction
2873369 11 M 11/18/2025 FLU3
 SANOFI PASTEUR
 UT8836LA
Cellulitis, Injection site erythema, Injection site pain, Injection site warmth Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Patient was seen by PCM 11/14/2025 with complaints of an expanding area of non-itchy redness and war... Patient was seen by PCM 11/14/2025 with complaints of an expanding area of non-itchy redness and warmth around immunization site (L Deltoid). Complains of tenderness to the site. Patient received FLUZONE vaccine on 11/12/25. All vital signs stable. Afebrile. Provider diagnosed patient with cellulitis and prescribed Cephalexin 500 mg oral Q 8 hours X 10 days. More
2873370 4 M SD 11/18/2025 DTAPIPV
FLU3
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 93H32
LT9HP
Z011864
Febrile convulsion, Pyrexia, Vomiting; Febrile convulsion, Pyrexia, Vomiting; Fe... Febrile convulsion, Pyrexia, Vomiting; Febrile convulsion, Pyrexia, Vomiting; Febrile convulsion, Pyrexia, Vomiting More
Has had TDaP, IPV, MMR and Varicella previously, received 4 year boosters with combo vaccines on 11/... Has had TDaP, IPV, MMR and Varicella previously, received 4 year boosters with combo vaccines on 11/17 around 1 PM. Overnight developed fever Tmax 103, vomiting, febrile seizure x1. Fevers responding well to Tylenol/Motrin. More
2873371 54 F AL 11/18/2025 FLU3
 SEQIRUS, INC.
 948406
Abscess limb, Haematoma, Incisional drainage Abscess limb, Haematoma, Incisional drainage
Abscess/hematoma in right arm requiring I&D. Patient was hospitalized and required antibiotics a... Abscess/hematoma in right arm requiring I&D. Patient was hospitalized and required antibiotics and surgery. More
✓
2873372 0.75 F CA 11/18/2025 COVID19
COVID19
FLU3
FLU3
HEPA
HEPA
MMR
MMR
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 3053238
3053238
UT8858JA
UT8858JA
Z009549
Z009549
Z005718
Z005718
Crying, Cyanosis, Eye movement disorder, Face injury, Hypotonia; Infant irritabi... Crying, Cyanosis, Eye movement disorder, Face injury, Hypotonia; Infant irritability, Pallor, Respiratory arrest, Staring, Tremor; Crying, Cyanosis, Eye movement disorder, Face injury, Hypotonia; Infant irritability, Pallor, Respiratory arrest, Staring, Tremor; Crying, Cyanosis, Eye movement disorder, Face injury, Hypotonia; Infant irritability, Pallor, Respiratory arrest, Staring, Tremor; Crying, Cyanosis, Eye movement disorder, Face injury, Hypotonia; Infant irritability, Pallor, Respiratory arrest, Staring, Tremor More
11/4/2025 - At 8:51am, mom screamed out for help. Mom and mom report that after the last vaccine w... 11/4/2025 - At 8:51am, mom screamed out for help. Mom and mom report that after the last vaccine was administered, patient was picked up by mom and started having the following symptoms: blue skin in face around temples, shaking neck up, uncertain about shaking in other parts of body, eyes rolled back, had pause in breathing <20 seconds. Vitals were checked at that time and were within normal limits. Normal anterior fontanelle, normal heart and lung exam. Skin pink, cap refill < 2 sec. Was crying and fussy, but consolable. Mom and mom said that she has had breath holding spells after prior vaccines, but not to this extent. I check in on patient again at 9:20am and she is calm, awake, alert in mom's arms. She is tired, but mom and mom shared that it is her nap time. Normal fontanelle and cap refill < 2 seconds in setting of mom sharing that patient looked pale. 11/12/2025 Second episode MOC put patient in crib for nap. Patient pulled to stand after MOC left the room, hit side of face on railing of crib, mom heard it and ran up to room. Initially cried but then did not let out. Was facedown on bed. Mom picked up and eyes were glazed over, seemed like she was not all there. Arms and legs were limp. Mom rubbed her chest to stimulate Took 20-25 seconds to start crying again Called EMS, vitals were normal. Behavior is normal now More
2873373 64 M IN 11/18/2025 FLU3
 SANOFI PASTEUR
 UT8781CA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Gave high dose flu 65+ to a 64 year old patient. Gave high dose flu 65+ to a 64 year old patient.
2873375 50 F VA 11/18/2025 FLU3
 SEQIRUS, INC.
 AX6341A
Injection site cellulitis Injection site cellulitis
Cellulitis over right deltoid developing the same day as flu vaccination Cellulitis over right deltoid developing the same day as flu vaccination
2873376 78 F CA 11/18/2025 COVID19
 PFIZER\BIONTECH
 NA4452
Hypotension, Syncope Hypotension, Syncope
Syncope, hypotension Syncope, hypotension
2873377 72 F FL 11/18/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 MY9550
UT8781DA
Breast pain, Laboratory test, Oedema peripheral, Post-acute COVID-19 syndrome, S... Breast pain, Laboratory test, Oedema peripheral, Post-acute COVID-19 syndrome, SARS-CoV-2 antibody test positive; Breast pain, Laboratory test, Oedema peripheral, Post-acute COVID-19 syndrome, SARS-CoV-2 antibody test positive More
Diagnosed on 11/10/25 with "Long Covid" or "Post-Vaccine Syndrome"/swollen right... Diagnosed on 11/10/25 with "Long Covid" or "Post-Vaccine Syndrome"/swollen right armpit, right breast pain (stabbing and burning)...still resolving. Dr. More
2873378 70 M MI 11/18/2025 FLU3
 SEQIRUS, INC.
Wrong product administered Wrong product administered
Patient received Flucelvax instead of Fluad Patient received Flucelvax instead of Fluad
2873379 27 F IL 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Muscular weakness, Pain in extremity Arthralgia, Muscular weakness, Pain in extremity
LEFT SHOULDER AND ARM PAIN AND WEAKNESS. LEFT SHOULDER AND ARM PAIN AND WEAKNESS.
2873380 50 F AZ 11/18/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR

Arthralgia, Joint stiffness, Myalgia; Arthralgia, Joint stiffness, Myalgia Arthralgia, Joint stiffness, Myalgia; Arthralgia, Joint stiffness, Myalgia
The initial side effect was within common limits (right arm muscle pain) but lasted almost 2 full da... The initial side effect was within common limits (right arm muscle pain) but lasted almost 2 full days. Then starting around the date indicated, about 2 weeks post injection, I developed transient joint tightness/pain in the right shoulder, right elbow, and right hand. This seemed to stop occurring perhaps 11/11/25. More
2873387 74 F MI 11/18/2025 FLU3
 SEQIRUS, INC.
Injected limb mobility decreased, Pain in extremity, Sleep disorder Injected limb mobility decreased, Pain in extremity, Sleep disorder
Immediately following the injection I didn't experience any pain or discomfort at the injection... Immediately following the injection I didn't experience any pain or discomfort at the injection site for the remainder of the day. Upon retiring to bed that night, I began to experience pain in the left arm which worsened during the night. There was no redness or swelling at the site but the arm continued to ache and I had restricted movement. I used ice packs and ibuprofen to address the discomfort. It seemed to be worse at night when I was in bed. It affected my ability to sleep. I switched to warm packs to see if that would help, to no avail. Previously, I had a Fluad injection one year ago on 10/25/24 without any similar effects. As my discomfort and limited range of motion with my left arm continued, I approached my physical therapist, who was helping me with a pulled hamstring muscle to help with the pain and range of motion with my left arm. Starting 11/4/25, she was able to provide me with some relief from the discomfort with the use of ultrasound and massage. Now a month later, I am experiencing improvement in both my discomfort and range of motion. I am concerned why I had this reaction to the vaccine and have concern about getting a flu vaccine next year. More
2873388 54 F 11/18/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT870MA
UT870MA
Arthralgia, Hypoaesthesia, Loss of personal independence in daily activities, Pa... Arthralgia, Hypoaesthesia, Loss of personal independence in daily activities, Pain, Pain in extremity; Paraesthesia More
Received a flu shot on 11-11-25 at Employee Health and soon after, started experiencing tingling, nu... Received a flu shot on 11-11-25 at Employee Health and soon after, started experiencing tingling, numbness, and pain in the whole left arm (injection was in the left arm). Pain worsened over the next few days and is constant pain like arthritis. A week later and pain is still there and hard to use my left arm, and pain worsens especially when lifting or holding things. I'm also a lefty so it's become more difficult to do daily tasks. More
2873389 0.33 F ME 11/18/2025 FLU3
 SANOFI PASTEUR
 UT8817MA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
patient was under the recommended age to receive vaccine patient was under the recommended age to receive vaccine
2873391 58 F 11/18/2025 FLU3
PNC21
 SEQIRUS, INC.
MERCK & CO. INC.
 407004
Z006889
Nausea, Vertigo, Vomiting; Nausea, Vertigo, Vomiting Nausea, Vertigo, Vomiting; Nausea, Vertigo, Vomiting
Three days after her vaccinations, patient experienced severe vertigo, nausea, and vomiting. She had... Three days after her vaccinations, patient experienced severe vertigo, nausea, and vomiting. She had to go to the emergency room due to this. More
2873392 0.17 F MO 11/18/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 U8314AA
U8314AA
LX2496
LX2496
Y018378
Y018378
Infant irritability, Injection site discolouration, Injection site urticaria, Ra... Infant irritability, Injection site discolouration, Injection site urticaria, Rash macular, Skin discolouration; Urticaria, Wheezing; Infant irritability, Injection site discolouration, Injection site urticaria, Rash macular, Skin discolouration; Urticaria, Wheezing; Infant irritability, Injection site discolouration, Injection site urticaria, Rash macular, Skin discolouration; Urticaria, Wheezing More
Child to agency with mother and father this am for 2 month vaccines (DTaP, IPV, HIB, Hep B, PCV20, a... Child to agency with mother and father this am for 2 month vaccines (DTaP, IPV, HIB, Hep B, PCV20, and Rotavirus). Mother verbalized she would like the child to have the RSV monoclonal antibody as well. VIS forms were offered. Child was weighed and screened for precautions/contraindications. Child has no allergies to mother's knowledge. She has only recieved a Hepatitis B vaccine at birth. Nurse prepared vaccines and then administered them around 8:17 am. Child was fussy immediately following injections, not an atypical response for infants receiving vaccines. Nurse told mom and dad to please take their time in the exam room, and nurse would be back in a few minutes to check on them. Around 8:25 am, nurse was alerted by WIC staff that parents needed a nurse in the room. Baby was still not consolable by mom or dad. Upon visual inspection of child, nurse observed purple, blotchy skin and hives to bilateral lower extremities. Child did not have airway or breathing impairments at that moment, but cirulation to lower extremities was a concern due to the symptoms described in the previous statement. Nurse let mom and dad know she would be calling an ambulance. Nurse asked staff to call a code 44 over the intercom for additional help. RN arrived and continued assessing ABC's on the child while another RN called EMS. Call took place at 8:27 am. Nurse entered room again after stepping out for EMS call. RN had not been able to obtain an oxygen saturation on the child with the finger probe to the first left toe. RN applied the probe to right first toe to attempt obtaining oxygen saturation at a different site. While that was pending, nurse assessed breaths per minute as described below. Blood pressure and pulse obtained via machine at 8:33 am, as described below. BP was 107/83, and pulse was 132 beats per minute. EMS arrived around 8:34 am, and they were able to obtain an oxygen saturation. It was 99%, and they discussed placing child on oxygen but did not do so at that time. In between vitals RN prepared appropriate dosing of Benadryl for IM use. RN administered 0.125 mL of Benadryl IM to right vastus lateralis at 8:38 am. Following the Benadryl, nurse listened to breath sounds again and heard definitive wheezing. RN and EMS staff discussed appropriate dosing of epinephrine, and RN prepared the dose from the ampule (a filter needle was used for drawing up vaccine). RN administered 0.04 mL of epinephrine IM to left vastus lateralis at 8:42 am. After epi, EMS staff worked together to place child in safety seat on stretcher and get hooked up to vitals machine before wheeling out of the exam room to the ambulance. RN provided name, DOB, and vaccine information to EMS staff prior to their departure around 8:45 am. Nurse spoke with mom and dad briefly and let them know nurse would be calling later today to check in on the child. Parents did not have questions at this time. More
2873393 52 F TX 11/18/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052784
409108
Chills, Dizziness, Injection site pain, Malaise, Pyrexia; Chills, Dizziness, Inj... Chills, Dizziness, Injection site pain, Malaise, Pyrexia; Chills, Dizziness, Injection site pain, Malaise, Pyrexia More
Large painful spread at injection site- size of 3 quarters. Sore for 5 days. Chills and dizziness du... Large painful spread at injection site- size of 3 quarters. Sore for 5 days. Chills and dizziness during the day Thursday, fever of 103 in early evening, took 4 Tylenol and water. 8 hours later more Tylenol. Felt ill on Friday but fever was gone. More
2873395 38 F WI 11/18/2025 FLU3
 SANOFI PASTEUR
 37KF3
Injection site pain Injection site pain
Severe ARM pain at injection site, no swelling, redness, or fever. Severe ARM pain at injection site, no swelling, redness, or fever.
2873396 75 F WI 11/18/2025 FLU3
 SANOFI PASTEUR
 tfaa2407
Thrombocytopenia Thrombocytopenia
patient described that she developed thrombocytopenia shortly after receiving the flu vaccine last y... patient described that she developed thrombocytopenia shortly after receiving the flu vaccine last year which caused her to be transported by ambulance to the emergency room while looking to get a flu vaccine today. More
2873397 75 F CT 11/18/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052733
407981
Blood pressure decreased, Dizziness, Heart rate increased; Blood pressure decrea... Blood pressure decreased, Dizziness, Heart rate increased; Blood pressure decreased, Dizziness, Heart rate increased More
Starting the next morning, pt experienced increased heart rate, decreased blood pressure, and lighth... Starting the next morning, pt experienced increased heart rate, decreased blood pressure, and lightheadedness. This lasted for 4 days then resolved without intervention. More
2873398 23 M 11/18/2025 COVID19
COVID19
UNK
UNK
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 32131BD EX2626
32131BD EX2626
34305BD
34305BD
Arthralgia, Asthenia, Fatigue, Joint noise, Pruritus; Skin burning sensation, Te... Arthralgia, Asthenia, Fatigue, Joint noise, Pruritus; Skin burning sensation, Temperature intolerance; Arthralgia, Asthenia, Fatigue, Joint noise, Pruritus; Skin burning sensation, Temperature intolerance More
Allergies during coldness, fatigue, Joint pains and joint sounds, body weakness Allergies during coldness, fatigue, Joint pains and joint sounds, body weakness
2873400 28 M MI 11/18/2025 FLU3
FLU3
HPV9
HPV9
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 N4D3J
N4D3J
Z008262
Z008262
Anaphylaxis treatment, Dizziness, Dyspnoea, Feeling hot, Nausea; Pharyngeal swel... Anaphylaxis treatment, Dizziness, Dyspnoea, Feeling hot, Nausea; Pharyngeal swelling, Wheezing; Anaphylaxis treatment, Dizziness, Dyspnoea, Feeling hot, Nausea; Pharyngeal swelling, Wheezing More
HPV vaccination given in left deltoid Flu vaccination given in left deltoid This was his third HP... HPV vaccination given in left deltoid Flu vaccination given in left deltoid This was his third HPV with no previous reaction. He has had multiple previous influenza with no reaction. Patient stated to MA that "feeling funny/dizzy" Kept patient in room to monitor and he stated felt hot, when standing felt more increase in temp. Stated harder to breathe and throat swelling. Dr. first entered examined patient. I followed in shortly after. GIVEN 0.3 mg of EPI at around 4:12 pm 141/85 at 4:27 pm Patient noted feeling better, had him lay down. Monitored vitals. EMS was called. Arrived around 4:35 pm and took over care. Patient headed to ER Medical Decision Making 28-year-old male presents with concerns of an anaphylactic allergic reaction to vaccines he received today. I am evaluate the patient about 1 hour post IM epinephrine and 50 mg of IM Benadryl after he developed sensation of throat swelling and wheezing after 2 vaccines he received today. He has no clinical evidence of allergic reaction at this time, has a wheezing, no stridor, no evidence of angioedema or airway edema. Will continue to monitor, additionally provide Decadron and famotidine and reassess. Patient was monitored for a period of time, I 1 point it did become nauseous and was given ODT Zofran for this, otherwise he is without any evidence of the anaphylaxis clinically, no recurrence of symptoms, comfortable with discharge home at this time. I did which was given a prescription for an EpiPen, states he will send did family member to go pick it up from the pharmacy right now, given in his instructions on its use and indications, all questions were answered. He was informed that he could potentially have a similar reaction to future influenza vaccines and should notify his primary care doctor. More
2873401 44 F OR 11/18/2025 COVID19
 MODERNA
 3052859
Underdose Underdose
CCMA grabbed pediatric moderna vaccine that was placed in the adult moderna vaccine basket and vacci... CCMA grabbed pediatric moderna vaccine that was placed in the adult moderna vaccine basket and vaccine was then documented on vaccine worksheet and then administered to pt. Pt left clinic ambulatory. More
2873405 13 F CA 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 724TF
Muscle tightness, Pain Muscle tightness, Pain
Pateint had tightness in the right neck muscles in the morning when she woke up. She complained of ... Pateint had tightness in the right neck muscles in the morning when she woke up. She complained of pain turning her head to the right side. No fever or congestion or cough or sore throat or vomiting or diarrhea. More
2873418 F UT 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 N9CS2
Wrong product administered Wrong product administered
gave a regular dose of Flulaval to a patient that was Seventy instead of the High dose; This non-ser... gave a regular dose of Flulaval to a patient that was Seventy instead of the High dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 70-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number N9CS2, expiry date 05-JUN-2026) for prophylaxis. On 30-OCT-2025, the patient received Fluarix 2025-2026 season. On 30-OCT-2025, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced underdose (Verbatim: gave a regular dose of Flulaval to a patient that was Seventy instead of the High dose). The outcome of the underdose 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: 30-OCT-2025 The reporter reported that the medical assistants in one of our clinics gave a regular dose of Flulaval to a patient that was seventy years old instead of the high dose. More
2873420 63 F IA 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 JE74J
Extra dose administered Extra dose administered
a patient received 2 doses of Fluarix; This non-serious case was reported by a nurse via call center... a patient received 2 doses of Fluarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number JE74J, expiry date 30-JUN-2026) for prophylaxis. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX). On 13-NOV-2025, the patient received the 2nd dose of Fluarix 2025-2026 season .5 ml. On 13-NOV-2025, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced extra dose administered (Verbatim: a patient received 2 doses of Fluarix). The outcome of the extra dose administered 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-NOV-2025 CNA reported that a patient received 2 doses of Fluarix, one dose received on 24-SEP-2025 and one today on the day of reporting. The batch number was not provided upon follow- up with the reporter. More
2873421 F KY 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
female patient received an expired dose of Flulaval.; This non-serious case was reported by a pharma... female patient received an expired dose of Flulaval.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (expiry date 30-JUN-2025) for prophylaxis. On 12-NOV-2025, the patient received FluLaval 2024-2025 season. On 12-NOV-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: female patient received an expired dose of Flulaval.). The outcome of the expired vaccine used 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-NOV-2025 The reporter wants to be asked when have to revaccinate the patient. The reporter was consented to follow up. More
2873428 75 F 11/18/2025 COVID19
COVID19
 MODERNA
MODERNA

Asthenia, Dizziness, Gastrointestinal disorder, Malaise, Nausea; Vertigo Asthenia, Dizziness, Gastrointestinal disorder, Malaise, Nausea; Vertigo
Does not have the energy for that; Every time tries to lay down head just spins; As sick as she is f... Does not have the energy for that; Every time tries to lay down head just spins; As sick as she is feeling; sick to stomach; Nauseous, wants to throw up; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Does not have the energy for that), VERTIGO (Every time tries to lay down head just spins), MALAISE (As sick as she is feeling), GASTROINTESTINAL DISORDER (sick to stomach) and NAUSEA (Nauseous, wants to throw up) in a 75-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (has had Covid 5 times, sick to her stomach for nine months when had actual COVID, nauseous every day). Previously administered products included for Drug use for unknown indication: prednisone; for COVID-19 prophylaxis: Moderna covid-19 vaccine. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine and prednisone. In November 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In November 2025, the patient experienced ASTHENIA (Does not have the energy for that), VERTIGO (Every time tries to lay down head just spins), MALAISE (As sick as she is feeling), GASTROINTESTINAL DISORDER (sick to stomach), NAUSEA (Nauseous, wants to throw up) and DIZZINESS (Dizzy). At the time of the report, ASTHENIA (Does not have the energy for that), VERTIGO (Every time tries to lay down head just spins), MALAISE (As sick as she is feeling), GASTROINTESTINAL DISORDER (sick to stomach), NAUSEA (Nauseous, wants to throw up) and DIZZINESS (Dizzy) had not resolved. No concomitant medications provided by the reporter. It was reported that the patient received Moderna COVID vaccine earlier this week. Post vaccination the patient felt sick to her stomach, the patient was dizzy, every time she tried to lay down her head just spins, and she wanted to throw up. The patient had those symptoms for 4 days now, it was not going away by itself. she experienced similar symptom when she was sick with COVID for the second time. In the past she had covid five times. It was reported that the patient had Moderna vaccines in the past and present symptom did not happen to the patient. No treatment medications provided by the reporter. More
2873429 F MD 11/18/2025 COVID19
 MODERNA
Drug hypersensitivity Drug hypersensitivity
allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ... allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG HYPERSENSITIVITY (allergic reaction) in a female patient of an unknown age 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, the patient experienced DRUG HYPERSENSITIVITY (allergic reaction). At the time of the report, DRUG HYPERSENSITIVITY (allergic reaction) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were provided. Patient got the COVID shot and had an allergic reaction to it. It was unknown if the patient experienced any additional symptoms/events. Patient had to went to the urgent care and they gave some antibiotics. Reported causality was not reported. More
2873432 61 M OH 11/18/2025 PNC20
 PFIZER\WYETH
Blood cholesterol increased, Blood pressure increased, Condition aggravated, Per... Blood cholesterol increased, Blood pressure increased, Condition aggravated, Pericarditis More
Vaccine associated acute pericarditis; This is a spontaneous report received from a Consumer or othe... Vaccine associated acute pericarditis; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Apr2025 at 09:00 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) at the age of 61 years intramuscular for immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Type2 diabetic" (unspecified if ongoing); "high BP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant, life threatening) with onset 12Apr2025 at 17:00, outcome "recovering", described as "Vaccine associated acute pericarditis". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Blood pressure measurement: high. Therapeutic measures were taken as a result of pericarditis. Clinical course: No other vaccine was administered on same date or in four weeks. It was unknown if other medications were administered in two weeks. The event was reported as Vaccine associated acute pericarditis and it resulted in Life threatening illness (immediate risk of death from the event). Patient received treatment for pericarditis for 6 months. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
✓
2873433 11/18/2025 COVID19
 PFIZER\BIONTECH
Vaccination site pruritus Vaccination site pruritus
I got my covid shot this past Sunday it is now Wednesday and the site where I had my injection is st... I got my covid shot this past Sunday it is now Wednesday and the site where I had my injection is still itchy; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 09Nov2025 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 PRURITUS (non-serious) with onset Nov2025, outcome "not recovered", described as "I got my covid shot this past Sunday it is now Wednesday and the site where I had my injection is still itchy". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2873434 68 M CT 11/18/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Neuralgia; Neuralgia Neuralgia; Neuralgia
Bilateral nerve foot pain on the bottom of feet. This pain has happened with previous covid injectio... Bilateral nerve foot pain on the bottom of feet. This pain has happened with previous covid injections; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 28Oct2025 at 03:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 28Oct2025 as dose number unknown, single, in right arm for immunisation. The patient's relevant medical history included: "myelopathy" (unspecified if ongoing); "Pernicious anemia" (unspecified if ongoing); "radiculopathy" (unspecified if ongoing); "Lacunar infarct" (unspecified if ongoing); "Shellfish Allergy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Aug2020; B 12, start date: Apr2022; FOLIC ACID, start date: Apr2022; MELOXICAM, start date: Apr2022. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 12Mar2021, when the patient was 64-year-old, for covid-19 Immunization, reaction(s): "weakness", "Dizziness". The following information was reported: NEURALGIA (non-serious) with onset 03Nov2025, outcome "not recovered", described as "Bilateral nerve foot pain on the bottom of feet. This pain has happened with previous covid injections". Therapeutic measures were not taken as a result of neuralgia. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2873435 80 F NJ 11/18/2025 COVID19
 PFIZER\BIONTECH
Dizziness, Vaccination site pain Dizziness, Vaccination site pain
Unusual pain in arm she got vaccine in; extremely dizzy; This is a spontaneous report received from ... Unusual pain in arm she got vaccine in; extremely dizzy; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE] taken for gastrooesophageal reflux disease (ongoing); LEXAPRO taken for anxiety (ongoing); XANAX taken for anxiety (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 2024, outcome "unknown", described as "extremely dizzy"; VACCINATION SITE PAIN (non-serious) with onset Oct2024, outcome "unknown", described as "Unusual pain in arm she got vaccine in". Additional information: The patient had been getting Pfizer Covid vaccines since it came out. The only side effects she had was like, a little bit of sore arm where vaccine was given, maybe a little headache that lasted a day or 2, nothing major. The patient was told that, because she was senior citizen, she should get one every 6 months. Had one vaccine Oct2024, last year then, got one Apr2025. When she got the one in Apr2025, had severe unusual pain in arm that she got vaccine in. Could not even lift arm for almost a week. The thing she was most concerned about was that, she suddenly woke up one day, was extremely dizzy. Was like, the world was spinning out of control, could not stand up, had to crawl into bathroom. She usually receive the flu vaccine in October. 2 years ago, She got pneumonia and RSV vaccines. She only received the RSV vaccine once, and it should remain effective for a lifetime. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2873437 M NY 11/18/2025 COVID19
 PFIZER\BIONTECH
Asthenia, Illness, Malaise, Pyrexia Asthenia, Illness, Malaise, Pyrexia
Exceptionally sick/still sick; So sick; Was in bed for 2 days and now he is still weak; High tempera... Exceptionally sick/still sick; So sick; Was in bed for 2 days and now he is still weak; High temperature; not feel well from the shot; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "Exceptionally sick/still sick"; ASTHENIA (non-serious), outcome "unknown", described as "So sick; Was in bed for 2 days and now he is still weak"; PYREXIA (non-serious), outcome "unknown", described as "High temperature"; MALAISE (non-serious), outcome "unknown", described as "not feel well from the shot". Therapeutic measures were taken as a result of illness, asthenia, pyrexia, malaise. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional Information: Reporter stated COVID-19 vaccine made patient exceptionally sick. It was so bad and patient was so sick. He was high temperature. He was in bed for 2 days and now he is still weak. This vaccine very dangerous to the people in their 70s. He does not feel well from the shot and he was sleeping. The patient did not have any medical history or lab details. The patient had taken Tylenol and Advil. More
2873439 53 F 11/18/2025 COVID19
FLUX
PPV
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Pain, Pyrexia; Pain, Pyrexia; Pain, Pyrexia Pain, Pyrexia; Pain, Pyrexia; Pain, Pyrexia
body ache; fever; Initial information received on 08-Nov-2025 regarding an unsolicited valid non-se... body ache; fever; Initial information received on 08-Nov-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 54 years old female patient who had body ache and fever while being treated with DUPILUMAB [DUPIXENT] delivered via single dose pre-filled pen, Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s), concomitant disease or risk factor and family history were not provided. On an unknown date in July 2023, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength 300 mg) at loading dose of 600 mg 1X followed by 300 mg QOW since 2023 subcutaneously for Asthma. On 11-Jun-2025, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer via unknown route in unknown administration site; On the same day, the patient received a unknown dose of suspect Covid-19 Vaccine not produced by Sanofi Pasteur via unknown route in unknown administration site; On the same day, the patient received a unknown dose of suspect Pneumococcal Vaccine not produced by Sanofi Pasteur (strength, expiry date and lot number not reported for all vaccines) via unknown route in unknown administration site as prophylactic vaccination (immunization) On 06-Nov-2025 the patient developed a non-serious event "body ache" (pain) (approximately 2 years 4 months latency) following the first dose intake (unknown batch number, expiry date) of DUPILUMAB and (latency: 4 months 26 days) following the administration of Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. On 06-Nov-2025 the patient developed a non-serious event "fever" (pyrexia) (approximately 2 years 4 months latency) following the first dose intake (unknown batch number, expiry date) of DUPILUMAB and (latency: 4 months 26 days) following the administration of Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient reported she received vaccines: covid, flu and pneumonia on 06-Nov-2025 and had had body aches and fever after receiving the vaccines, ongoing but improving. patient reports using tylenol for symptom relief. Md (Doctor of medicine) aware". Action taken: Unknown for DUPILUMAB and not applicable for Influenza Vaccine, Pneumococcal Vaccine and Covid-19 Vaccine. The patient was treated with PARACETAMOL (TYLENOL) for Pain and Pyrexia. At time of reporting, the outcome was Recovering / Resolving for both events. More
2873441 74 M NY 11/18/2025 FLU3
 SANOFI PASTEUR
Discomfort, Fatigue, Injection site pain Discomfort, Fatigue, Injection site pain
discomfort; tiredness; muscle pain at the injection site; Initial information received on 10-Nov-202... discomfort; tiredness; muscle pain at the injection site; Initial information received on 10-Nov-2025 and live follow up received on same date both were processed together regarding an unsolicited valid non-serious case received from a patient. This case is linked to US-SA-2025SA335403. This case involves a 76 years old male patient who experienced discomfort, tiredness and muscle pain at the injection site after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number and expiry date not reported) strength: high dose, via unknown route in the left upper arm for immunisation. Information on the batch number was requested corresponding to the one at time of event occurrence. On a unknown date in 2025 the patient developed discomfort, tiredness (fatigue) (latency few days) and muscle pain at the injection site (vaccination site pain) (latency unknown). Reportedly:-Caller noted that they have both had adverse symptoms (peculiar) symptoms that they are not happy with. Neither caller nor spouse have contacted their healthcare provider. However, they both have an appointment scheduled next week for their routine 6 month appointments. They plan to discuss this with the provider at that time. Caller noted that their discomfort is not unbearable but it is noticeable. Complained of tiredness and muscle pain at the injection site in his left upper arm. The discomfort and fatigue started a couple of days after he received FLUZONE HD.He has taken a baby aspirin once in a while. Action taken was not applicable. The patient was treated with ACETYLSALICYLIC ACID [ASPIRIN] for (discomfort, tiredness and vaccination site pain). At time of reporting, the outcome was Unknown for all events.; Sender's Comments: US-SA-2025SA335403:02718195, for patient (wife) More
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