🏥 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 💀 🏥 🚑 ♿ ⚠️
2820874 62 F MO 01/14/2025 FLU3
 SEQIRUS, INC.
 388493
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
pt was administered a 65 plus vaccine and they were only 63 no clinical adverse effects pt was administered a 65 plus vaccine and they were only 63 no clinical adverse effects
2820875 1 M DC 01/14/2025 DTPPVHBHPB
DTPPVHBHPB
HEPA
HEPA
MMR
MMR
PNC20
PNC20
VARCEL
VARCEL
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 U7899AA
U7899AA
Y012054
Y012054
X019104
X019104
HR3650
HR3650
Y006524
Y006524
Abnormal behaviour, Computerised tomogram, Drooling, Electroencephalogram, Fatig... Abnormal behaviour, Computerised tomogram, Drooling, Electroencephalogram, Fatigue; Muscle twitching, Somnolence, Staring, Tremor, Unresponsive to stimuli; Abnormal behaviour, Computerised tomogram, Drooling, Electroencephalogram, Fatigue; Muscle twitching, Somnolence, Staring, Tremor, Unresponsive to stimuli; Abnormal behaviour, Computerised tomogram, Drooling, Electroencephalogram, Fatigue; Muscle twitching, Somnolence, Staring, Tremor, Unresponsive to stimuli; Abnormal behaviour, Computerised tomogram, Drooling, Electroencephalogram, Fatigue; Muscle twitching, Somnolence, Staring, Tremor, Unresponsive to stimuli; Abnormal behaviour, Computerised tomogram, Drooling, Electroencephalogram, Fatigue; Muscle twitching, Somnolence, Staring, Tremor, Unresponsive to stimuli More
REPORTS, 8-9PM NOT ACTING NORMAL, OBSERVED TWITCHING THEN DROWSY AND FATIGUED, AND STARE OFF INTO SP... REPORTS, 8-9PM NOT ACTING NORMAL, OBSERVED TWITCHING THEN DROWSY AND FATIGUED, AND STARE OFF INTO SPACE, T100.3f, THEN PROGRESSED TO DROOLING, SHAKING AND UNRESPONSIVE, TRANSFERRED TO ED, GIVEN MIDAZZ AND TOOK A WHILE TO STOP TWITCHING AND SHAKING, RECEIVED RECTAL TYLENOL IN ED. THEN ADMITTED TO HOSPITAL More
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2820876 35 F KS 01/14/2025 COVID19
 PFIZER\BIONTECH
 LN0591
Erythema, Peripheral swelling Erythema, Peripheral swelling
Pt returned to clinic with concern for redness and swelling to left arm. She believes it may be rela... Pt returned to clinic with concern for redness and swelling to left arm. She believes it may be related to covid vaccination More
2820877 60 M MO 01/14/2025 FLU3
 SEQIRUS, INC.
 388493
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
none the +65 age shot was given to someone 60yo none the +65 age shot was given to someone 60yo
2820878 31 M NV 01/14/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
MODERNA
MODERNA
MODERNA
 1808978
1808978
1808978
039D21A
039D21A
039D21A
Acoustic stimulation tests, Balance test, Blood test, Brain fog, Catheterisation... Acoustic stimulation tests, Balance test, Blood test, Brain fog, Catheterisation cardiac; Colonoscopy, Computerised tomogram, Confusional state, Dizziness, Endoscopy; Hypoacusis, Laboratory test, Magnetic resonance imaging, Nausea; Acoustic stimulation tests, Balance test, Blood test, Brain fog, Catheterisation cardiac; Colonoscopy, Computerised tomogram, Confusional state, Dizziness, Endoscopy; Hypoacusis, Laboratory test, Magnetic resonance imaging, Nausea More
Starting in July 2022, became suddenly confused with dizziness and hearing deficit. Confusion and br... Starting in July 2022, became suddenly confused with dizziness and hearing deficit. Confusion and brain fog resolved months later but dizziness and hearing deficit persist. Chronic Nausea now present, starting early 2025. More
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2820879 55 F MO 01/14/2025 FLU3
 SEQIRUS, INC.
 388493
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
65+ vaccine given to a LTC pt that was only 55 years old no clinical events occurred 65+ vaccine given to a LTC pt that was only 55 years old no clinical events occurred
2820880 69 M NY 01/14/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 YO11819
YO11819
Arthralgia, Decreased appetite, Erythema, Fatigue, Headache; Irritability, Pain,... Arthralgia, Decreased appetite, Erythema, Fatigue, Headache; Irritability, Pain, Pyrexia, Swelling More
redness, swelling, painm fever, loss of appetite, irritablity, tired, headache, joint pain redness, swelling, painm fever, loss of appetite, irritablity, tired, headache, joint pain
2820881 35 F MI 01/14/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 K4JH7
Wrong product administered Wrong product administered
Received pediatric Hep B vaccine instead of Helisav-B Received pediatric Hep B vaccine instead of Helisav-B
2820883 19 F WI 01/14/2025 COVID19
 MODERNA
 3044186
No adverse event No adverse event
Patient received COVID 6 m-11 years injection as error. Patient is 19 years of age and should of rec... Patient received COVID 6 m-11 years injection as error. Patient is 19 years of age and should of received the 12 years +. Provider and patient notified. Patient will return another time to receive full dose patient had no adverse reaction. Moderna COVID-19 2024-2025 formula 0.25 mL single dose NDC 80777-291-80 LOT 3044186 EXP 06-21-2025 More
2820884 67 M KS 01/14/2025 RSV
 PFIZER\WYETH
 HM9854
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adr mentioned, he came in for another RSV vaccine and we discovered he'd already had 2. No adr mentioned, he came in for another RSV vaccine and we discovered he'd already had 2.
2820885 58 F IA 01/14/2025 HEPAB
PNC21
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.

Dizziness, Injection site erythema, Injection site pain, Injection site swelling... Dizziness, Injection site erythema, Injection site pain, Injection site swelling; Dizziness, Injection site erythema, Injection site pain, Injection site swelling More
pain, swelling and redness at and below the site of injection. also complains of dizziness. pain, swelling and redness at and below the site of injection. also complains of dizziness.
2820886 3 F MN 01/14/2025 MMRV
 MERCK & CO. INC.
 Y015990
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
patient received PROQUAD vaccine dose before age corresponded, she is 3 years and 7 months old. patient received PROQUAD vaccine dose before age corresponded, she is 3 years and 7 months old.
2820887 13 M CA 01/14/2025 COVID19
 MODERNA
 B0001
Pallor, Syncope, Vomiting Pallor, Syncope, Vomiting
The patient fainted , turned pail and vomited. The patient fainted , turned pail and vomited.
2820888 65 F OH 01/14/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 PK9C5
Pain, Pain in extremity Pain, Pain in extremity
Patient called stating she got vaccine and had normal arm pain for 2-3 days after and then it went a... Patient called stating she got vaccine and had normal arm pain for 2-3 days after and then it went away for about 5-7 days then the pain came back and now she can't lift her arm without having pain. Questioned her on whether or not she had any other injury to arm (bang against something etc). Patient states that didn't happen. Counseled to have PCP or Urgent care evaluate right away to make sure something else hasn't happened to her arm in the meantime. More
2820889 1 M 01/14/2025 HEPA
MMR
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 X026327
C24B9
Injection site erythema, Injection site oedema; Injection site erythema, Injecti... Injection site erythema, Injection site oedema; Injection site erythema, Injection site oedema More
Erythematous and edematous area larger than a quarter-size on bilateral legs noted by provider immed... Erythematous and edematous area larger than a quarter-size on bilateral legs noted by provider immediately after injections. More
2820890 13 M TX 01/14/2025 HEP
HEPA
IPV
MMR
MNQ
TDAP
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 X006977
Y007585
W1C831M
X026222
U8271AB
3CA22C1
Y007176
Disorientation, Loss of consciousness, Nervousness, Syncope; Disorientation, Los... Disorientation, Loss of consciousness, Nervousness, Syncope; Disorientation, Loss of consciousness, Nervousness, Syncope; Disorientation, Loss of consciousness, Nervousness, Syncope; Disorientation, Loss of consciousness, Nervousness, Syncope; Disorientation, Loss of consciousness, Nervousness, Syncope; Disorientation, Loss of consciousness, Nervousness, Syncope; Disorientation, Loss of consciousness, Nervousness, Syncope More
Patient received start over vaccinations including Tdap, IPV, Hep. A, Hep. B, MMR, Varicella, and MC... Patient received start over vaccinations including Tdap, IPV, Hep. A, Hep. B, MMR, Varicella, and MCV4. Patient was nervous while receiving vaccines, this nurse ensured to remind patient to take deep breaths and relax in between each shot. Once completing the vaccines, patient fainted. This nurse called for help and immediately got an ice pack and water and put the ice pack behind patients neck. Patient woke up immediately and was disoriented for a minute but then was able to recite his full name, birthday and where he was. Patient was then given a granola bar and water to drink. When asked, patients parent stated that patient had not eaten any food today. Initial vitals were BP 89/64 P 49 02 99% room air. Vitals rechecked after 15 minutes, were as follows. BP 138/83 P63 02 99% room air. Parents were advised to take patient to hospital to have patient checked out. Parents agreed to take patient. Both mother and father were present. Discharge papers given to patients parents. More
2820891 64 F OH 01/14/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 U8524DA
LC1279
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Patient arrived to clinic for flu vaccine. Patient is 64 years old with insurance and history of bre... Patient arrived to clinic for flu vaccine. Patient is 64 years old with insurance and history of breast cancer/lumpectomy. Verified patient name and DOB prior to vaccine administration. Discussed with patient additional recommendation for pneumonia vaccine as patient last had Pneumovax 23 in 2019 (verified by this provider). Patient consented to this vaccine as well. Documented both vaccines on paper form prior to administration. Discovered after patient left while inputting vaccines into medical record that patient is 64 years old not 65. Notified supervisor and attempted to make patient contact but voicemail box was full. Made incident report per company guidance and submitted VAERS report. Was later able to contact patient and notified of error. Patient did not have any concerns regarding vaccine error. More
2820892 55 M AL 01/14/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR

Amnesia, Blood pressure increased, Condition aggravated, Confusional state, Hype... Amnesia, Blood pressure increased, Condition aggravated, Confusional state, Hypertension; Laboratory test, Pyrexia More
fever, confusion, blood pressure higher than normal, memory loss/confusion time course: continuin... fever, confusion, blood pressure higher than normal, memory loss/confusion time course: continuing More
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2820893 1.33 M CA 01/14/2025 DTAP
HIBV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 9PT2F
Y003145
Cough, Pyrexia, Unresponsive to stimuli; Cough, Pyrexia, Unresponsive to stimuli Cough, Pyrexia, Unresponsive to stimuli; Cough, Pyrexia, Unresponsive to stimuli
PER PATIENT'S MOTHER ON 01/05/2025 PATIENT WAS HAVING A FEVER AND COUGH, MOM GAVE TYLENOL TO TH... PER PATIENT'S MOTHER ON 01/05/2025 PATIENT WAS HAVING A FEVER AND COUGH, MOM GAVE TYLENOL TO THE PATIENT AND NEXT DAY PATIENT WAS UNRESPONSIVE. More
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2820894 77 F MN 01/14/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR

Headache, Seizure; Headache, Seizure Headache, Seizure; Headache, Seizure
Pt states she has a severe headache/seizure 12 hrs post administration Pt states she has a severe headache/seizure 12 hrs post administration
2820895 16 M OK 01/14/2025 MENB
MENB
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 2G3SP
2G3SP
AMV0044A
AMV0044A
Blood pressure decreased, Fatigue, Headache, Nausea, Pallor; Tremor, Vision blur... Blood pressure decreased, Fatigue, Headache, Nausea, Pallor; Tremor, Vision blurred; Blood pressure decreased, Fatigue, Headache, Nausea, Pallor; Tremor, Vision blurred More
Vision blurrines, Fatigue, Tremor, Paller, Nausea, Headache. BP lower than when he originally came i... Vision blurrines, Fatigue, Tremor, Paller, Nausea, Headache. BP lower than when he originally came in at 9 Started around 12:00 came to office at 12:15 monitored SPo2 and HR and BP. BP did drop from 109/66 to 95/64, gave benadryl and tylenol More
2820896 59 M UT 01/14/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 LM2221
LM2221
LM2221
Eyelid function disorder, Facial paralysis, Fatigue, Headache, Hypoaesthesia ora... Eyelid function disorder, Facial paralysis, Fatigue, Headache, Hypoaesthesia oral; Impaired driving ability, Injection site pain, Lacrimation increased, Magnetic resonance imaging head normal, Neck pain; Paraesthesia oral, Photophobia, Sleep disorder, Tongue discomfort, Vision blurred More
12/15/2024 - Started with pain on right side of the neck from back of the right ear to right neck an... 12/15/2024 - Started with pain on right side of the neck from back of the right ear to right neck and to shoulders including right arm injection site. Dull pain causing loss of sleep.12/26/2024 - Saw Dr for annual check-up and was experiencing Benign paroxysmal positional vertigo from the right ear. 1/3/2025 - experience increased pain on right side of the head behind the ear, under right jaw, through back right side of the head and shoulders. Continued all weekend up to 1/7/2025. Noticed right eye drooping a bit during the weekend. 1/7/2025 - woke up and had trouble brushing teeth, unable to control right side of the lips. Eyes are not in sync and right eye is drooping more. Checked-in to ER at 1030AM. ER Physician ordered MRI and checked for stroke. MRI results ruled out stroke. ER Physician diagnosed Bell's Palsy caused by virus. Prescribed MethylPrednisolone 4mg therapy pak, vaIACYclovir 1g 1000mg tab every 8 hours for 7 days. 1/08/2025 - 1/12/2025 Ball's Palsy symptoms have progressed. Right eyelid weak, unable to fully close and having trouble blinking. Eyes are watery and unable to focus, get blinded by outside light, unable to drive and gets really tired. Unable to eat on right side of the mouth due to inner cheek muscles unusable, food getting stuck. Unable to drink from glass or cup, had to use straw with fingers to seal lips to sip liquids. Mid-line of upper and lower lips feel numb/tingling. Right side of tongue feels different. Experiencing pain on right side of the head to include behind the ear, under the ear by the jaw, back of the neck down to right shoulder. Unable to have continuous sleep. 1/13/2025 - Office visit with Dr Advised Dr of the above health problem and timeline. Dr confirmed that it is Bell's Palsy. Recommend rest and to complete prescribed medication by ER. Scheduled Follow-up in two weeks with him. 1/14/2025 - Woke up at 3AM with extreme pain on right side of head specifically, behind the right ear, right just below cheek bone, under the right eye, behind the right neck and to right shoulder. It feels like pain from a dental work done on the right side of my face. Stayed in bed taking naps until 10AM. Pain subsided then. Previous Moderna Covid 19 vaccinations (total 6 shots) didn't have any adverse reactions. First time vaccinated with Pfizer Covid booster on 12/5/2024 -Submitted this report for possible Bell's Palsy side effect from Pfizer Covid Booster. More
2820897 0.92 F NM 01/14/2025 HIBV
 SANOFI PASTEUR
 UK006AA
Expired product administered Expired product administered
There were no physical symptoms. The vaccine had expired at the end of December 2024 and was not re... There were no physical symptoms. The vaccine had expired at the end of December 2024 and was not removed from the refrigerator. The RN administering failed to check the expiration date prior to administration. software caught the error during documentation of the visit. More
2820898 0.33 M MI 01/14/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 u7970ba
lg5576
2088619
No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event
no adverse events noted when patient was contacted no adverse events noted when patient was contacted
2820899 58 F CA 01/14/2025 FLU3
 SEQIRUS, INC.
Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Shoulde... Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Shoulder injury related to vaccine administration More
Had left deltoid pain that began within 24 hours of vaccine and is still present 8 weeks later. She ... Had left deltoid pain that began within 24 hours of vaccine and is still present 8 weeks later. She has decreased range of motion, pain with shoulder abduction. Suspect SIRVA. More
2820901 F NJ 01/14/2025 COVID19
 PFIZER\BIONTECH
Death Death
passed away; This is a spontaneous report received from a Consumer or other non HCP. A female patie... passed away; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "passed away". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007761 Same event/vaccine, different patient;; Reported Cause(s) of Death: Unknown cause of death More
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2820902 F 01/14/2025 COVID19
 PFIZER\BIONTECH
Fall, Illness, Vaccination site irritation Fall, Illness, Vaccination site irritation
had a fall after receiving covid shot; she has injection site irritation with this medication and fr... had a fall after receiving covid shot; she has injection site irritation with this medication and from the covid vaccine; was sick; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2021SA282813 (Sanofi). A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 10Jul2020) at 300 mg (300 mg every other week), subcutaneous and second regimen since 13Nov2020) at 300 mg (300 mg qow (every other week)) for asthma. The patient's relevant medical history included: "unspecified asthma/ severe persistent asthma, uncomplicated" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (hospitalization) with onset 2024, outcome "unknown", described as "was sick"; FALL (hospitalization), outcome "unknown", described as "had a fall after receiving covid shot"; VACCINATION SITE IRRITATION (hospitalization), outcome "unknown", described as "she has injection site irritation with this medication and from the covid vaccine". The action taken for dupilumab was temporarily withdrawn. Clinical course: Initial information received on 23Aug2021 regarding an unsolicited valid case received from a Non- Healthcare Professional; this case became serious on 25Mar2024. Patient was in the hospital, was sick, had a fall after receiving covid shot, injection site irritation with dupilumab and from the covid vaccine and it was painful while being treated with dupilumab [Dupixent] via dupilumab prefilled syringe and covid-19 vaccine. On 10Jul2020, the patient started taking dupilumab Solution for injection at a dose of 300 mg every other week subcutaneously (strength: 300 mg/2ml) for unspecified asthma/ severe persistent asthma, uncomplicated. On 13Nov2020 the patient restarted the therapy at dose of 300 mg QO W. On an unknown date, the patient started taking covid-19 vaccine (with an unknown form, dose, frequency, strength, route) for COVID-19 vaccination. Patient had injection site irritation with dupilumab and from the covid vaccine. Patient also had a fall after receiving covid shot; unknown if md (Doctor of Medicine) was aware. Pt (patient) stated that dupixent was painful. Pt was in the hospital (hospitalization) (onset and latency unknown) (unknown batch number and expiry date) and had missed an injection (dupilumab), date unknown. MD was aware. Hospital dates, reason, and duration not provided. Pt would resume dupilumab therapy on an unknown date. Pt was due for dose 01Nov2024, was sick (illness) (onset: 2024), hadn't taken dose all of November 2024. Patient reported missed dupilumab dose on 15Nov2024. Patient took next dupilumab dose on 22Nov2024. No further information given. Unknown if MD was aware. It was unknown if there were lab data/results available. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. BNT162B2 is under agreement with BIONTECH SE. More
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2820903 72 F 01/14/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Arthralgia, Cataract, Computerised tomogram, Cough, Dizziness; Dyspnoea exertion... Arthralgia, Cataract, Computerised tomogram, Cough, Dizziness; Dyspnoea exertional, Feeling hot, Inappropriate schedule of product administration, Mass, Respiratory tract congestion; Visual impairment, Vitreous floaters, Weight, Weight increased, Wheezing More
cataract surgery; having floaters; experiencing issues with her vision; weight gain; she begins whee... cataract surgery; having floaters; experiencing issues with her vision; weight gain; she begins wheezing; joint pain; having a bad cough; trouble breathing after doing a lot of activity; getting hot; multiple CT scans which found lumps; lightheadedness; congestion; one day late in giving Dupixent with no reported adverse event; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017301 (BioNTech), 2024SA265479 (Sanofi). A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; dupilumab (DUPIXENT), as 200mg/1.14ml, dose of 200 mg qo w (every other week)) subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CATARACT (medically significant), outcome "unknown", described as "cataract surgery"; VITREOUS FLOATERS (non-serious), outcome "unknown", described as "having floaters"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "experiencing issues with her vision"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "weight gain"; WHEEZING (non-serious), outcome "unknown", described as "she begins wheezing"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; COUGH (non-serious), outcome "unknown", described as "having a bad cough"; DYSPNOEA EXERTIONAL (non-serious), outcome "unknown", described as "trouble breathing after doing a lot of activity"; FEELING HOT (non-serious), outcome "unknown", described as "getting hot"; MASS (non-serious), outcome "unknown", described as "multiple CT scans which found lumps"; DIZZINESS (non-serious), outcome "unknown", described as "lightheadedness"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "congestion"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "one day late in giving Dupixent with no reported adverse event". The patient underwent the following laboratory tests and procedures: Computerised tomogram: which found lumps; Weight: gain. The action taken for dupilumab was unknown. Clinical course: Patient reported she had weight gain, joint pain, having a bad cough, trouble breathing after doing a lot of activity, getting hot, she begins wheezing, experiencing issues with her vision, having floaters and multiple CT (Computerized tomogram) scans which found lumps, lightheadedness and congestion while being treated with Dupilumab delivered via prefilled syringe and Covid-19 Vaccine. The patient reported that she was one day late in giving Dupixent with no adverse event reported directly linked to this inappropriate schedule of product administration. Patient reported "weight gain, joint pain, missed dose. The patient reported that she was one day late in giving Dupixent due to not knowing the process for obtaining her medication. Patient reported having a bad cough that has persisted ever since receiving her last Covid vaccine. She reported only have limitations and trouble breathing after doing a lot of activity or getting "hot", then she begins wheezing and had to use her rescue inhaler. Patient reported that overall, her exacerbations have improved since starting the medication. Patient reported one missed dose in October, when the shipment was late. Patient reported experiencing issues with her vision and having 'floaters". She reported being in contact with her optometrist and getting cataract surgery. Patient reported having the cough and getting multiple CT (computerized tomogram) scans which found lumps. Patient reported attending several appointments with her pulmonologist." Therapeutic measures were taken as a result of cataract, wheezing, dyspnoea exertional, feeling hot. Batch/lot number is not provided, and it cannot be obtained. BNT162B2 is under agreement with BIONTECH SE. More
2820916 86 M FL 01/14/2025 PNC20
 PFIZER\WYETH
 LG5577
Decreased appetite, Fatigue, Feeding disorder Decreased appetite, Fatigue, Feeding disorder
fatigue/was very tired; little appetite/could not eat anything, had no appetite; This is a spontaneo... fatigue/was very tired; little appetite/could not eat anything, had no appetite; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 86-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Jan2025 as dose number unknown, 0.5ml single (Lot number: LG5577, Expiration Date: Apr2026) at the age of 86 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2019, for Immunization. The following information was reported: FATIGUE (non-serious) with onset 07Jan2025, outcome "recovering", described as "fatigue/was very tired"; DECREASED APPETITE (non-serious) with onset 07Jan2025, outcome "recovering", described as "little appetite/could not eat anything, had no appetite". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient wants to know if prevnar20 had a generic and he also wants to know if the label says Privacy, are they are also allowed to make under PREVNAR20 name. Patient could not get out of bed, was unstable, with fatigue and with little appetite. But today patient feeling much better , are this common side effects patient was worried there was a generic product or someone was using the prevnar 20 name other than pfizer. Call regarding Prevnar 20. First of all, wanted to make sure Pfizer was the only company that manufactures this. The reason he wanted to know was, he received the Prevnar 20 vaccine Monday (06Jan2025). The whole day yesterday, could not eat anything, had no appetite, was very tired, had to maker sure he did not fall. Wants to make sure it was not another company, manufacturing under Pfizer name because, he did have Prevnar 13, he believes, 6 years ago. Never experienced anything like he did yesterday (07Jan2025). Wanted to make sure, sometimes at doctor's office, they might put name Prevnar on it. Could also be another company manufacturing on their behalf. Suspect product: Prevnar 20. Ask them to print label that came off small vial with half a cc. Do have some information. Had to get magnifying glass, it was very small, hard to read. Will read from the top. Conjugate vaccine, Prevnar 20 1 dose (0.5ml) for intramuscular use only refrigerate, do not freeze, shake well. Clarified, these details printed from pharmacy from label, was not the actual label. Asked for label because he had to send it, to get money. Description of complaint: caller questioning if given generic vaccine, if other manufacturer allowed to manufacturer under Pfizer name. Product strength and count size dispensed: 0.5ml dose. Additional lot numbers: PAA201729 More
2820917 F MD 01/14/2025 COVID19
 PFIZER\BIONTECH
Lymphadenopathy, Mammogram, Vaccination site pain Lymphadenopathy, Mammogram, Vaccination site pain
she recently had a mammogram, and they discovered a swollen lymph node on her left side; her left ar... she recently had a mammogram, and they discovered a swollen lymph node on her left side; her left arm has been aching for three months now. She described it as very painful and so heavy that she can't even lift it/ right on that site where they gave me that injection; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown), in left arm 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; Covid-19 vaccine (Dose 2; manufacturer unknown), for COVID-19 immunization; Tetanus shot (Dose unknown; manufacturer unknown), for Immunization, reaction(s): "they hurt like I do not know what/make your arm ache". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "not recovered", described as "her left arm has been aching for three months now. She described it as very painful and so heavy that she can't even lift it/ right on that site where they gave me that injection"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "she recently had a mammogram, and they discovered a swollen lymph node on her left side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain. Additional information: The caller dialed in to file a safety report on the side effects she experienced after receiving the COVID-19 vaccine. The caller mentioned that her left arm has been aching for three months now. She described it as very painful and so heavy that she can't even lift it. She received previous doses of the vaccine twice and did not experience something similar. She mentioned that she already went to the pharmacy, but they did not give her anything or set expectations as to what might happen. She tried various treatment options (Tylenol, topicals, patches, etc.) to manage the side effects, but nothing worked. She was still experiencing the side effects. She also mentioned that she noticed something unusual with the person who administered the vaccine, which she did not experience with her previous vaccines. Additionally, she mentioned that she recently had a mammogram, and they discovered a swollen lymph node on her left side. She stated that she did not have this before, but now she does, and she will be having a repeat mammogram in May to see if it was still there. She wanted to know if this was a normal side effect or not. Complainant does not have the product with them at the time of call, hence lot not provided. Consumer stated, "Alright, two months ago now maybe a little longer, patient went to a privacy (pharmacy name) and patient got the Pfizer COVID (Clarified as Pfizer COVID-19 Vaccine) that was out now. They told her they were using Pfizer, that was why she went there and she went back to get something to show she had a shot because they are not required to use the card as the government put out in the beginning and she do not have no proof of she went there, instead they gave her paper. It did not say anything about Pfizer, it had a chemical name on it and that was a shame on her. Patient should have put that in front of herself. She figured it started with the C8, something. Anyway, to make a long story short, her arm that they gave her that injection has been aching ever since and She went back to them about three weeks ago because she used the store and she went up steps over to the counter about that until she said listen she need to pick up something for her own home record that she had this shot, that they gave it to her and she asked them, was there anything they can give her or what will they suggest? It feels like she had a tetanus shot, she does not know if Pfizer are familiar with tetanus shot but they hurt like she do not know what. They make arm ache and that was what she experiencing and it has been three, 3 months ago now and she wanted to know now because they do not give her anything to prep Pfizer or to inform Pfizer of any side effects. Asked is this a normal side effect of her arm to keep aching and that was right on that site where they gave her that injection? Like her arm being broken into or something." When paraphrased the above concern, consumer stated, "Yes. Maybe a little she was trying to see what was going on three months, yes and everybody there was nice but very nice weather and she had it so yes. She was worried about it now because now when she lift her arm, she have to be careful and now she do not see no bruises there, that was another thing. There was something else going on so. When requested for further probing, consumer stated, "Not right now. She does not have time for anything like that. She needed to get the best help for what she was calling for, please. If vaccination card handy for LOT# and expiration date: Consumer stated, No, they do not have all that. She was in states name withheld, it was just like a simple part as far as to keep it on us but and it was generic like black and white card and nothing like that, no numbers or anything on it. It was all handwritten so. Reassurance: Consumer stated, "No, not at this time." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820918 U 01/14/2025 RSV
 PFIZER\WYETH
Diarrhoea, Dizziness, Vomiting Diarrhoea, Dizziness, Vomiting
Diarrhea; Vomiting; Lightheadedness; This is a spontaneous report received from a Consumer or other ... Diarrhea; Vomiting; Lightheadedness; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Jan2025 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Jan2025, outcome "unknown", described as "Diarrhea"; DIZZINESS (non-serious) with onset Jan2025, outcome "unknown", described as "Lightheadedness"; VOMITING (non-serious) with onset Jan2025, outcome "unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2820919 F OK 01/14/2025 RSV
 PFIZER\WYETH
Respiratory syncytial virus infection, Respiratory syncytial virus test positive... Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination failure More
diagnosed with RSV by PCR despite receiving ABRYSVO; diagnosed with RSV by PCR despite receiving ABR... diagnosed with RSV by PCR despite receiving ABRYSVO; diagnosed with RSV by PCR despite receiving ABRYSVO; This is a spontaneous report received from a Physician from a sales representative. A 71-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 10Nov2023. The following information was reported: VACCINATION FAILURE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset Jan2025, outcome "recovering" and all described as "diagnosed with RSV by PCR despite receiving ABRYSVO". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (Jan2025) diagnosed with RSV. It was unknown if therapeutic measures were taken as a result of vaccination failure, respiratory syncytial virus infection. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event respiratory syncytial virus infection based on the known safety profile and temporal association. More
2820920 49 F NY 01/14/2025 PNC20
 PFIZER\WYETH
 LJ5280
Injection site erythema, Injection site induration, Injection site pruritus, Inj... Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth More
Large red induration to left deltoid 4 days after injection was received; Site is red, warm to the t... Large red induration to left deltoid 4 days after injection was received; Site is red, warm to the touch, and itchy; Site is red, warm to the touch, and itchy; Site is red, warm to the touch, and itchy; This is a spontaneous report received from a Nurse. A 50-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 03Jan2025 as dose number unknown, single (Lot number: LJ5280) at the age of 49 years, in left deltoid for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE INDURATION (non-serious) with onset 07Jan2025, outcome "recovering", described as "Large red induration to left deltoid 4 days after injection was received"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 07Jan2025, outcome "recovering" and all described as "Site is red, warm to the touch, and itchy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site induration, vaccination site erythema, vaccination site warmth, vaccination site pruritus. Additional Information: The patient did not receive any other vaccines on the same date or within 4 weeks prior as the suspect vaccine. The patient was taking other medications within 2 weeks of the event starting. The patient saw provider on 09Jan2025 for exam and was instructed to take diphenhydramine (BENADRYL). More
2820921 F FL 01/14/2025 COVID19
 PFIZER\BIONTECH
Abdominal pain upper, Dyspepsia, Nausea, Non-cardiac chest pain Abdominal pain upper, Dyspepsia, Nausea, Non-cardiac chest pain
pain on right side of the chest and heartburn; chest to stomach pain; pain on right side of the che... pain on right side of the chest and heartburn; chest to stomach pain; pain on right side of the chest and heartburn; nausea; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Oct2024, outcome "not recovered", described as "chest to stomach pain"; NAUSEA (non-serious) with onset Oct2024, outcome "unknown"; NON-CARDIAC CHEST PAIN (non-serious) with onset Oct2024, outcome "not recovered", DYSPEPSIA (non-serious) with onset Oct2024, outcome "unknown" and all described as "pain on right side of the chest and heartburn". The events "pain on right side of the chest and heartburn", "chest to stomach pain" and "nausea" required physician office visit. Additional information: Patient had nausea, pain on right side of the chest and heartburn, she did have GERD and acid reflux but not like this sharp pain and it had not disappeared not completely and some soreness, chest to stomach pain and digestive system issues. Her cardiologist checked and it was not a heart thing, and she was having an endoscopy next week but the gastroenterologist said that it could have been an immune response to the vaccine. It had been 3 months and she still had pain. The night, right after she had it, which she got it around 5, the next night after dinner she had terrible pain in her right side like heartburn and was a little nauseous. Since then, she has had constant like indigestion pains that go from her chest to her stomach like gas and like a heaviness in chest and stomach. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820922 U 01/14/2025 COVID19
 PFIZER\BIONTECH
Influenza like illness, Tremor, Vomiting Influenza like illness, Tremor, Vomiting
Uncontrollable tremors; Severe flu-like symptoms; Vomiting; This is a spontaneous report received fr... Uncontrollable tremors; Severe flu-like symptoms; Vomiting; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; WELLBUTRIN; PREGABALIN; CYMBALTA; TIZANIDINE; HYDROCODONE; ESTRADIOL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: TREMOR (non-serious), outcome "recovered", described as "Uncontrollable tremors"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Severe flu-like symptoms"; VOMITING (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of tremor, influenza like illness, vomiting. Additional information: The patient had no known allergy. Hospitalization prolonged reported as no. The patient did not receive any other vaccines on the same date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The patient taking other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2820923 80 M FL 01/14/2025 COVID19
 PFIZER\BIONTECH
Mass Mass
he had in Nov2024, after the shot that the hard lump occurred; This is a spontaneous report received... he had in Nov2024, after the shot that the hard lump occurred; This is a spontaneous report received from a Pharmacist. An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Nov2024 as dose number unknown, single. Vaccination history included: comirnaty (DOSE 1, SINGLE, Anatomical Site of injection: Unknown, thinks left arm., Lot number: EL9265), administration date: 03Feb2021, when the patient was 76-year-old, for Covid-19 immunization; comirnaty (DOSE 2, SINGLE, Anatomical Site of injection: Right or left arm., Lot number: EL9267), administration date: 24Feb2021, when the patient was 76-year-old, for Covid-19 immunization; comirnaty (DOSE 3 (BOOSTER), SINGLE , Lot number: FD8448), administration date: 31Aug2021, when the patient was 77-year-old, for Covid-19 immunization; comirnaty (DOSE 4 (BOOSTER), SINGLE , Lot number: FL3197), administration date: 05Apr2022, when the patient was 77-year-old, for Covid-19 immunization; comirnaty bivalente ba.4/ba.5 (DOSE 5 (BOOSTER), SINGLE , Lot number: Not quite sure, looks like GJ5342), administration date: 09Sep2022, when the patient was 78-year-old, for Covid-19 immunization; Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE, Anatomical Site of injection: Arm Right), administration date: Mar2024, when the patient was 79 years old, for Covid-19 immunization, reaction(s): "large lump in abdomen", "lipoma", "Developed something hard, like a cyst, at injection site", "lost 15 pounds". The following information was reported: MASS (non-serious) with onset Nov2024, outcome "unknown", described as "he had in Nov2024, after the shot that the hard lump occurred". Additional information: Prior Vaccinations (within 4 weeks): No With the last one that he had in Nov2024, after the shot that the hard lump occurred after, had Flu shot and Covid shot. Had 1 in each arm. Did not have any problems with anything. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820924 M MD 01/14/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vacci... COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vaccination failure More
we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginni... we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct; we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct; This is a spontaneous report and received from Consumer or other non HCPs, Program ID. A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: 2 years ago I think, we had tested positive; (Oct2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. More
2820925 F 01/14/2025 COVID19
 PFIZER\BIONTECH
Cough, Oropharyngeal pain, Rhinorrhoea, Secretion discharge, Sneezing Cough, Oropharyngeal pain, Rhinorrhoea, Secretion discharge, Sneezing
cough; sneezing; mucous and runny nose; mucous and runny nose; sore throat; This is a spontaneous re... cough; sneezing; mucous and runny nose; mucous and runny nose; sore throat; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA070709 (Sanofi). A 66-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), on 17Feb2024 as 600 mg 1 x followed by 300 mg qow (every other week)) and in 2024 as 600 mg 1 x followed by 300 mg qow (every other week)), all subcutaneous for asthma. The patient's relevant medical history included: "Covid", start date: Aug2024 (unspecified if ongoing), notes: diagnosed with covid last week (week of 01Aug2024, exact date unknown) and had a runny nose.; "had a runny nose", start date: Aug2024 (unspecified if ongoing), notes: diagnosed with covid last week (week of 01Aug2024, exact date unknown) and had a runny nose.; "headache", start date: 2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 16Nov2024, outcome "not recovered"; SECRETION DISCHARGE (non-serious), RHINORRHOEA (non-serious) all with onset 16Nov2024, outcome "not recovered" and all described as "mucous and runny nose"; SNEEZING (non-serious) with onset 16Nov2024, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 16Nov2024, outcome "not recovered", described as "sore throat". The action taken for dupilumab was dosage reduced. Therapeutic measures were taken as a result of cough, sneezing, secretion discharge, rhinorrhoea, oropharyngeal pain. Additional information: Initial information was received on 27Feb2024 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Health Care Professional). This case involves a 65-year-old female patient who had headache, diagnosed with covid last week and had a runny nose, cough, sneezing, mucous and runny nose and sore throat while being treated with DUPILUMAB [DUPIXENT] delivered via dupixent single dose prefilled pen and CO VID-19 VACCINE. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On 17Feb2024, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection strength: 300 mg/2ml at a dose of 600 mg 1 X followed by 300 mg QOW (Every other week) on an unknown date in 2024 subcutaneously delivered via Dupixent single dose prefilled pen for Asthma. In Aug2024 the patient developed a non-serious event "diagnosed with covid last week and had a runny nose" (covid-19) (rhinorrhoea) (latency: approximately 6 months) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. On an unknown dale in 2024 the patient developed a non-serious event "headache" (unknown latency) (unknown batch number and expiry date) following the first dose intake of DUPILUMAB. On 13Nov2024, the patient received COVID-19 VACCINE, 1x (once) for booster (3rd) (unknown formulation, strength, and route). On 16Nov2024 the patient developed a non-serious event "cough" (latency: 9 months) following the first dose intake of DUPILUMAB and (latency) 3 days following the first dose intake of COVID-19 VACCINE (unknown batch number and expiry date of both drugs). On 16Nov2024 the patient developed a non-serious event "sneezing" (latency: 9 months) following the first dose intake of DUPILUMAB and (latency) 3 days following the first dose intake of COVID-19 VACCINE (unknown batch number and expiry date of both drugs). On 16Nov2024 the patient developed a non-serious event "mucous and runny nose' (rhinorrhoea) (latency: 9 months) following the first dose intake of D UPIL UM AB and (latency) 3 days following the first dose intake of COVID-19 VACCI NE (unknown batch number and expiry date of both drugs). On 16Nov2024 the patient developed a non-serious event "sore throat" (oropharyngeal pain) (latency: 9 months) following the first dose intake of DUPILUMAB and (latency) 3 days following the first dose intake of COVID-19 VACCINE (unknown batch number and expiry date of both drugs). Information regarding batch number and expiration date corresponding to the one al Ii me of event occurrence was requested. It was reported "patient stated she had a headache, stated nothing new since starling dupixent, but unknown when started. Reported she wanted to end call because she had headache, unable to get more information. Unsure MD (Doctor of medicine) aware. Patient reports last Dupixent dose was 5 days late due to shipping issues. Patient states she was diagnosed with covid last week (week of 01Aug2024, exact date unknown) and had a runny nose (MD aware, unknown if covid or runny nose is ongoing). Patient states she spent 1 night in the emergency and was not admitted to the hospital. Patient reports she received a covid shot (3rd booster shot) last Wednesday (13Nov2024) then on Saturday (16Nov2024) she developed cough, sneezing, sore throat, mucous and runny nose ( symptoms ongoing). Patient's pulmonary doctor prescribed antibiotics and steroids and she started both today (21Nov2024, ongoing). It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available'. Action taken: no action taken for all events with Dupilumab and not applicable with Covid-19 vaccine. Corrective treatment: Not reported for headache and Covid-19; and was prescribed unknown antibiotics and steroids for rest of the events. Outcome: Unknown for headache and Covid-19; and not recovered for rest of the events. Additional information was received on 12Jun2024 from patient: no new significant information was added, text amended accordingly. Additional information was received on 21Aug2024 from patient. Age was added. Event: (covid-19) with symptom of (rhinorrhoea) was added. Text amended accordingly. Additional information was received on 21Nov2024 from patient: Co-suspect was added, Event of cough, sneezing, rhinorrhoea and oropharyngeal pain was added, clinical course was updated and text was amended accordingly. More
2820926 U OH 01/14/2025 COVID19
 PFIZER\BIONTECH
Tinnitus Tinnitus
horrible tinnitus; This is a spontaneous report received from a Consumer or other non HCP, Program I... horrible tinnitus; 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 (kp.2) (COMIRNATY (2024-2025 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: TINNITUS (non-serious), outcome "unknown", described as "horrible tinnitus". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820927 U NJ 01/14/2025 COVID19
 PFIZER\BIONTECH
Abdominal discomfort, Diarrhoea Abdominal discomfort, Diarrhoea
stomach has been terrible with constant diarrhea; stomach has been terrible with constant diarrhea; ... stomach has been terrible with constant diarrhea; stomach has been terrible with constant diarrhea; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Dec2024 at 10:40 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: DIARRHOEA (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "stomach has been terrible with constant diarrhea". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820928 64 M PA 01/14/2025 RSV
RSV
RSV
RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 LN5463
LN5463
LN5463
LN5463
LN5463
Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Blood creatinine... Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Blood creatinine, Blood test; Blood urea, Borrelia test, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax; Electrocardiogram, Full blood count, Gait inability, Laboratory test, Lumbar puncture; Magnetic resonance imaging abdominal, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Muscular weakness; Paraesthesia, Protein urine, Quadriplegia, Stool analysis, Urine analysis More
Sudden onset of weakness starting at toes, rapidly ascending to head, affecting all neuromuscular or... Sudden onset of weakness starting at toes, rapidly ascending to head, affecting all neuromuscular organs except lungs and heart. Vague symptoms started 12/21 with toe tingling. 12/22, weakness in left arm. 12/23 could not ambulate, taken to hospital ER and has been in hospital system since then. Paralyzed from head to toe, other than breathing and heart. That includes face, swallowing, Gi tract, kidneys, pancreas, and entire body More
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2820932 10 F CT 01/14/2025 FLU3
 SANOFI PASTEUR
 UT8459MA
Syncope Syncope
Several minutes after receiving flu vaccination while waiting in the vaccination room, patient'... Several minutes after receiving flu vaccination while waiting in the vaccination room, patient's guardian reported that the patient had fainted and had concerns that a seizure may have occurred (although pharmacy staff was not present at the time to observe or confirm). Patient visually looked ok, although shaken. Description of the event and how the patient was feeling seemed characteristic of a vasovagal reaction. EMS was contacted and although no further details were provided to the pharmacy, the patient was visibly ok when leaving the premises. More
2820933 76 F 01/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X72D2
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
The patient's right arm was red and warm to the touch, about an inch beneath the believed injec... The patient's right arm was red and warm to the touch, about an inch beneath the believed injection site, and spread towards the inner arm. The red area was about the size of the patient's palm. The patient was advised to monitor if the swelling became worse, or spread over more surface area, and to contact their primary care doctor if so. More
2820934 49 F WA 01/14/2025 COVID19
 PFIZER\BIONTECH
 LN0589
Injected limb mobility decreased, Limb discomfort, Pain in extremity Injected limb mobility decreased, Limb discomfort, Pain in extremity
As of 1/14/25, patient states that she is still experiencing right arm pain/discomfort with reduced ... As of 1/14/25, patient states that she is still experiencing right arm pain/discomfort with reduced range of motion. She has been taking over-the-counter ibuprofen to help with pain. More
2820935 43 F WA 01/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 99Y4J
Chills, Dry throat, Injection site erythema Chills, Dry throat, Injection site erythema
Patient presented to the site of vaccination (the pharmacy) on 1/14/25 with redness below injection... Patient presented to the site of vaccination (the pharmacy) on 1/14/25 with redness below injection site about the size of a human palm. The area did not look swollen to the eye. The patient said she was experiencing chills and dry throat. Patient declined any swelling in the mouth, lips or throat. She declined any trouble breathing. She said she had not had a fever. Pharmacist looked at reddness and asked follow up questions. Pharmacist discussed over the counter options but directed the patient to go to the Urgent Care Clinic right away and patient agreed. More
2820936 80 F GA 01/14/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was inappropriately given RSV Arexvy vaccination when they had already received this vaccine... Patient was inappropriately given RSV Arexvy vaccination when they had already received this vaccine in October 2023. No indication for a second dose. No side effects reported. More
2820937 78 M FL 01/14/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Patient received two doses of Arexvy after pharmacist did not check vaccine history for the patient,... Patient received two doses of Arexvy after pharmacist did not check vaccine history for the patient, first dose was received 10-17-2023 and second dose was received on 1-10-2025 More
2820938 61 F FL 01/14/2025 FLU3
 SEQIRUS, INC.
 946626
Lymphadenopathy Lymphadenopathy
Pt said that she got swollen glands along her jawline after vaccine Pt said that she got swollen glands along her jawline after vaccine
2820939 82 M GA 01/14/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was inappropriately given RSV Arexvy vaccination when they had already received this vaccine... Patient was inappropriately given RSV Arexvy vaccination when they had already received this vaccine in October 2023. No indication for a second dose. No side effects reported. More
2820940 76 F UT 01/14/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3042439
390224
Injected limb mobility decreased, Injection site mass, Injection site pain; Inje... Injected limb mobility decreased, Injection site mass, Injection site pain; Injected limb mobility decreased, Injection site mass, Injection site pain More
Pt had a lump which turned into pain that moved from lower deltoid to upper tricep and only has 10% ... Pt had a lump which turned into pain that moved from lower deltoid to upper tricep and only has 10% movement in left shoulder. Pt visited an urgent care facility, regular visits with PCP, and physical therapy. Doctors allegedly claim that the needle for the vaccine may have hit the bursa of the shoulder, exacerbating the pain. More
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