🏥 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 💀 🏥 🚑 ♿ ⚠️
2873621 53 M MA 11/19/2025 COVID19
 MODERNA
 3053258
Presbyvestibulopathy, Vertigo Presbyvestibulopathy, Vertigo
peripheral vestibulopathy w vertigo peripheral vestibulopathy w vertigo
2873623 45 F KS 11/19/2025 COVID19
FLU3
HEP
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
DYNAVAX TECHNOLOGIES CORPORATION


Muscle spasms, Muscle twitching; Muscle spasms, Muscle twitching; Muscle spasms,... Muscle spasms, Muscle twitching; Muscle spasms, Muscle twitching; Muscle spasms, Muscle twitching More
muscle spasm or twitching along the left side of nose. Involuntary and consistently happening over ... muscle spasm or twitching along the left side of nose. Involuntary and consistently happening over several hours. More
2873629 75 F MA 11/19/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052082
3052082
Asthenia, Blood test normal, Computerised tomogram normal, Dizziness, Hypotonia;... Asthenia, Blood test normal, Computerised tomogram normal, Dizziness, Hypotonia; Magnetic resonance imaging normal More
EXTREME WEAKNESS, LOSS OF MUSCLE TONE FOR ABOUT 15 MINUTES, DIZZINESS FOR ABOUT 8 HRS. EXTREME WEAKNESS, LOSS OF MUSCLE TONE FOR ABOUT 15 MINUTES, DIZZINESS FOR ABOUT 8 HRS.
2873632 53 F MA 11/19/2025 COVID19
 MODERNA
 3043332
Arthralgia, Injected limb mobility decreased, Loss of personal independence in d... Arthralgia, Injected limb mobility decreased, Loss of personal independence in daily activities, Rotator cuff syndrome, X-ray limb abnormal More
Extreme pain, limited range of motion. Initially ice, rest, OTC, and prescription pain medication by... Extreme pain, limited range of motion. Initially ice, rest, OTC, and prescription pain medication by patient. Employee health which administered injection recommended ice and OTC meds. Pain severe for over 2 weeks, Employee health stated to follow up with primary MD. Primary MD unable to see until 2/26, took next available appt with PA 10/25. Pain and limited ROM continue to have meaningful impact on daily activities and rest. Had x-ray 11/17/25 which shows calcific tendinopathy. Revisited employee health nurse 11/19/25 which recommended filling out an incident report and a VAERS. More
✓
2873639 10 F 11/19/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
FLUN3
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
 3052668
3052668
3052668
3052668
3052668
3052668
3052668
3052668
3052668
3052668
3052668
3052668
3052668
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
YH2674B
Alanine aminotransferase normal, Aspartate aminotransferase increased, Ataxia, B... Alanine aminotransferase normal, Aspartate aminotransferase increased, Ataxia, Base excess, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase normal; Blood creatinine normal, Blood glucose normal, Blood lactic acid normal, Blood pH normal, Blood potassium normal; Blood sodium normal, Blood urea normal, C-reactive protein increased, CSF glucose normal, CSF protein normal; CSF red blood cell count positive, CSF white blood cell count negative, Carbon dioxide normal, Cryptococcus test, Cytomegalovirus test negative; Dizziness, Drug screen negative, Electrocardiogram normal, Electroencephalogram normal, Enterovirus test negative; Eosinophil percentage decreased, Escherichia test negative, Gram stain negative, Haematocrit normal, Haemoglobin normal; Haemophilus test, Headache, Herpes simplex test negative, Human herpes virus 6 serology negative, Listeria test; Lumbar puncture normal, Lymphocyte percentage, Magnetic resonance imaging head normal, Monocyte percentage increased, Muscular weakness; Neisseria test negative, Neutrophil percentage, Nystagmus, PCO2 normal, PO2 decreased; Platelet count normal, Procalcitonin increased, Protein total normal, Pyrexia, Romberg test positive; Streptococcus test negative, Urine analysis normal, Varicella virus test negative, Viral test negative, Vomiting; White blood cell count normal; Alanine aminotransferase normal, Aspartate aminotransferase increased, Ataxia, Base excess, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase normal; Blood creatinine normal, Blood glucose normal, Blood lactic acid normal, Blood pH normal, Blood potassium normal; Blood sodium normal, Blood urea normal, C-reactive protein increased, CSF glucose normal, CSF protein normal; CSF red blood cell count positive, CSF white blood cell count negative, Carbon dioxide normal, Cryptococcus test, Cytomegalovirus test negative; Dizziness, Drug screen negative, Electrocardiogram normal, Electroencephalogram normal, Enterovirus test negative; Eosinophil percentage decreased, Escherichia test negative, Gram stain negative, Haematocrit normal, Haemoglobin normal; Haemophilus test, Headache, Herpes simplex test negative, Human herpes virus 6 serology negative, Listeria test; Lumbar puncture normal, Lymphocyte percentage, Magnetic resonance imaging head normal, Monocyte percentage increased, Muscular weakness; Neisseria test negative, Neutrophil percentage, Nystagmus, PCO2 normal, PO2 decreased; Platelet count normal, Procalcitonin increased, Protein total normal, Pyrexia, Romberg test positive; Streptococcus test negative, Urine analysis normal, Varicella virus test negative, Viral test negative, Vomiting; White blood cell count normal More
Patient with fever 11/11, resolved with OTC medication. That evening, she experienced acute onset a... Patient with fever 11/11, resolved with OTC medication. That evening, she experienced acute onset ataxia, dizziness, and vomiting. She was taken to ED where code stroke was activated for exam concerning for cerebellar stroke (per notes, b/l nystagmus, ataxia, mild weakness of b/l legs, + Romberg). Brain MRI, EEG, and LP were performed and all normal. CRP elevated, but other labs normal. Patient was admitted overnight for observation and seen by pediatric neurology. She was improved but still dizzy and ataxic. Weakness was resolved. Neurology suspected functional neurologic disorder and patient was discharged. Patient recovered over the next 2 days, but started having headache with sitting and standing. She went to ED 11/15 where she was thought to have Post-dural puncture headache, told to drink caffiene and more fluids. She was seen in clinic 11/18 as follow up. Ataxia resolved, HA still present but improving. No sign of leak at LP site. Patient advised to continue resting/lying down for comfort, drink caffiene and lots of fluids. More
✓
2873641 67 F CA 11/19/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 8146743
407263
Inflammation, Laboratory test normal, Pain in extremity; Inflammation, Laborator... Inflammation, Laboratory test normal, Pain in extremity; Inflammation, Laboratory test normal, Pain in extremity More
Patient complaint of pain on her right arm. Patient saw PCP and received Norco 10mg generic and Medr... Patient complaint of pain on her right arm. Patient saw PCP and received Norco 10mg generic and Medrol Dosepak generic for pain and inflammation. Potential inflammation/pain could be due to her medical conditions. More
2873665 69 F MA 11/19/2025 COVID19
 MODERNA
Illness Illness
sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick... sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. On 08-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In November 2025, the patient experienced ILLNESS (sick). In November 2025, ILLNESS (sick) had resolved. Not Provided Patient had no medical conditions. No other vaccines were received by the patient 4 weeks prior. No concomitant medication was reported. Patient got the COVID shot and she was sick for 1 day. Patient was sick, but not as her husband, she was not throwing up, she was just blah. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-791434 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-791434:Master case, husband's case More
2873666 F 11/19/2025 COVID19
 MODERNA
Respiratory syncytial virus infection Respiratory syncytial virus infection
RSV; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SY... RSV; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Currently, the patient had enough problems and did not want to add it. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV). At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. The patient received all Moderna COVID vaccinations. The reporter called the global contact center to ask about locating the mRESVIA vaccine. The patient had RSV disease. The patient had it before and was told they had to wait 2 weeks afterward to get it. The patient had RSV and has not had an RSV vaccine because the patient forgot all about it after 2 weeks. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-791540 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-791540:Same reporter, different patient (Multiple Patient's case) More
2873667 F 11/19/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

COVID-19, Influenza like illness; COVID-19, Influenza like illness COVID-19, Influenza like illness; COVID-19, Influenza like illness
flu like symptoms; contracted Covid after getting vaccinated; This spontaneous case was reported by ... flu like symptoms; contracted Covid after getting vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and COVID-19 (contracted Covid after getting vaccinated) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. The patient's past medical history included Throbbing headache (severe throbbing headache). Previously administered products included for Drug use for unknown indication: Floxin; for Product used for unknown indication: Flu (normally had same post 12-hour reactions to other vaccines like Shigrix, pneumonia, but not seasonal flu shots.), PNEUMOCOCCAL VACCINE (normally had same post 12-hour reactions to other vaccines like Shigrix, pneumonia, but not seasonal flu shots.), SHINGRIX (normally had same post 12-hour reactions to other vaccines like Shigrix, pneumonia and but not seasonal flu shots.). Past adverse reactions to the above products included Allergy with Floxin; No adverse effect with Flu; and Vaccination adverse reaction with PNEUMOCOCCAL VACCINE and SHINGRIX. Concurrent medical conditions included Allergy to antibiotic (Floxin allergy reactions has been on allergy list for severe throbbing headache which may because of high blood pressure interaction.) and Blood pressure high (Floxin allergy reactions has been on allergy list for severe throbbing headache which may because of high blood pressure interaction.). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). an unknown date, the patient experienced COVID-19 (contracted Covid after getting vaccinated). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and COVID-19 (contracted Covid after getting vaccinated) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. Patient was over 70 years old and had Covid vaccines and updated about every 6 months. Initially patient had Pfizer but have had some follow-up with Moderna and Pfizer, all based on availability. Patient had never had an immediate reaction but usually occurred 12 hours after with flu-like symptoms that lasted for 3-5 days. Patient even contracted Covid after getting vaccinated. Planned on getting the new Moderna. It was reported that wanted to know what the difference and risks were before vaccination. Patient doctors said there was no difference between any Covid vaccinations (Pfizer or Moderna) but only to get them. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. More
2873668 69 F VA 11/19/2025 COVID19
 MODERNA
Pain in extremity Pain in extremity
Expected sore arm for about a week. The soreness has evolved into an intermittent dull ache punctuat... Expected sore arm for about a week. The soreness has evolved into an intermittent dull ache punctuated with intense jabbing - like an eraser - not a needle. Not constant but every day.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Expected sore arm for about a week. The soreness has evolved into an intermittent dull ache punctuated with intense jabbing - like an eraser - not a needle. Not constant but every day.) in a 69-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 19-Sep-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. On 19-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced PAIN IN EXTREMITY (Expected sore arm for about a week. The soreness has evolved into an intermittent dull ache punctuated with intense jabbing - like an eraser - not a needle. Not constant but every day.). At the time of the report, PAIN IN EXTREMITY (Expected sore arm for about a week. The soreness has evolved into an intermittent dull ache punctuated with intense jabbing - like an eraser - not a needle. Not constant but every day.) had not resolved. The patient's date of birth was reported as 1956. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2873669 85 M 11/19/2025 COVID19
 MODERNA
Constipation, Dyschezia Constipation, Dyschezia
severe constipation; caller was in pain until he went to the bathroom; This spontaneous case was rep... severe constipation; caller was in pain until he went to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (severe constipation) and DYSCHEZIA (caller was in pain until he went to the bathroom) in an 85-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in October 2025. Past adverse reactions to the above products included No adverse effect with INFLUENZA VACCINE. Concurrent medical conditions included Osteoporosis. On 12-Nov-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 13-Nov-2025, the patient experienced CONSTIPATION (severe constipation) and DYSCHEZIA (caller was in pain until he went to the bathroom). On 13-Nov-2025, CONSTIPATION (severe constipation) and DYSCHEZIA (caller was in pain until he went to the bathroom) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that 3 weeks before patient took flu shot. It was reported that the patient was experiencing severe constipation approximately 12 hours after receiving the vaccine, describing it as the most painful constipation ever. Patient mentioned that he had never experienced constipation before. After about 5 hours, patient was able to go to the bathroom and empty his bowels. The caller was in pain until he went to the bathroom and unsure about what was happening. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. More
2873670 54 F PA 11/19/2025 COVID19
 MODERNA
Asthenia, Fatigue, Headache, Myalgia Asthenia, Fatigue, Headache, Myalgia
weakness; muscle pain; fatigue; headache; This spontaneous case was reported by a consumer and descr... weakness; muscle pain; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 09-Oct-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. On 09-Oct-2025, the patient experienced ASTHENIA (weakness), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache). On 10-Oct-2025, ASTHENIA (weakness), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache) had resolved. The patient's date of birth was reported as December 1970. No concomitant medications were reported. It was reported that, approximately 6 hours after receiving COVID booster, began feeling muscle pain, weakness, fatigue and headache that was similar to a very bad case of the flu. It came on very suddenly and was quite severe. She did not have a fever. Lasted approximately 12 hours then wore off and she was completely fine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2873671 70 F 11/19/2025 COVID19
 MODERNA
Asthenia, Fatigue, Myalgia, Vaccination site pain Asthenia, Fatigue, Myalgia, Vaccination site pain
sore injection site, upper arm was quite sore; low energy; aches, achy, body aches; tired; This spon... sore injection site, upper arm was quite sore; low energy; aches, achy, body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site, upper arm was quite sore), ASTHENIA (low energy), MYALGIA (aches, achy, body aches) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Osteoarthritis, Depression and Traumatic brain injury (survivor). Concomitant products included Influenza vaccine for an unknown indication. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site, upper arm was quite sore), ASTHENIA (low energy), MYALGIA (aches, achy, body aches) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore injection site, upper arm was quite sore), ASTHENIA (low energy), MYALGIA (aches, achy, body aches) and FATIGUE (tired) outcome was unknown. The patient received a flu shot 3 weeks before. It was reported that the patient had a sore injection site and expressed the following upper arm was quite sore and the day after patient received the vaccine, the patient felt tired and achy. The patient had low energy and experienced some body aches. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2873672 70 F CA 11/19/2025 COVID19
COVID19
 MODERNA
MODERNA
 041L20A
041L20A
Angiogram, Biopsy skin, Blood test, Magnetic resonance imaging, Rash pruritic; R... Angiogram, Biopsy skin, Blood test, Magnetic resonance imaging, Rash pruritic; Red blood cell count More
itchiness on back with a rash/ it has travelled to all parts of my body; This spontaneous case was r... itchiness on back with a rash/ it has travelled to all parts of my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchiness on back with a rash/ it has travelled to all parts of my body) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 041L20A, 001A21A and 034F21A) for COVID-19 prophylaxis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular use) dosage was changed to 1 dosage form and dose of mRNA-1273 (Spikevax) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced RASH PRURITIC (itchiness on back with a rash/ it has travelled to all parts of my body). The patient was treated with Triamcinolone for Itchy, at an unspecified dose and frequency; Doxepin hydrochloride (Doxepin) for Itchy, at an unspecified dose and frequency and Naltrexone hydrochloride (Naltrexone) for Itchy, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchiness on back with a rash/ it has travelled to all parts of my body) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: Negative. On an unknown date, Biopsy skin: Negative. On an unknown date, Blood test: Negative. On an unknown date, Magnetic resonance imaging: Negative. On an unknown date, Red blood cell count: Some irregularities with red blood cells. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. It started with itchiness on back with a rash. Over the past 5 years it had travelled to all parts of the body but no longer have a rash. It was unknown if the patient experienced any additional symptoms/events. Patient had numerous blood tests, Patch tests, Flynn Chamber Patch test, MRA, MRI, skin biopsy's, tested her home for mold. Almost all tests are negative. Some irregularities with red blood cells. It was unknown if there were additional lab data/results available. Patient tried triamcinolone when itchy. tried doxepin, naltrexone and antihistamines. More
2873673 41 F 11/19/2025 COVID19
COVID19
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 8058581
8058581
Joint range of motion decreased, Limb discomfort, Lymphoedema, Neuralgia, Pain i... Joint range of motion decreased, Limb discomfort, Lymphoedema, Neuralgia, Pain in extremity; Rash, SARS-CoV-2 test positive, Skin warm More
Lymphedema; limited range of motion; COVID arm symptoms; small patch of rash [on the arm]; COVID arm... Lymphedema; limited range of motion; COVID arm symptoms; small patch of rash [on the arm]; COVID arm symptoms; pain [on the arm]; Nerve pain; Heaviness in whole arm; COVID arm symptoms; burning, warmth on the arm; This non-serious, initial spontaneous safety report was received by Novavax on 20-DEC-2023 from a consumer via the web portal. A 41-year-old female of an unspecified race was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (batch number 8058581) 0.5 milliliter suspect COVID-19 vaccine dose 2 (dose 4 of COVID-19 vaccine) in the left arm on 16-DEC-2023 at a pharmacy. Medical history included Endometriosis, Hyperthyroidism (in remission), and SARS-CoV-2 test positive on 25-OCT-2022. Allergies included Food allergy (legumes), Dermatitis contact (surgical tape and glue), and Allergy to vaccine (unspecified influenza and mRNA vaccines). The individual experienced Neuralgia, Limb discomfort, Rash, Pain in extremity, and Skin warm after prior vaccination with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1 on 07-JUL-2021 and dose 2 on 27-JUL-2021, and Novavax COVID-19 Vaccine, Adjuvanted (original formula) dose 1 (dose 3 of COVID-19 vaccine) on 23-FEB-2022. The individual was not taking any concomitant medications. On unspecified dates, after vaccination, the individual experienced nerve pain (PT: Neuralgia) and heaviness in her whole arm (PT: Limb discomfort). She also experienced COVID arm symptoms, including a small patch of rash (PT: Rash), pain (PT: Pain in extremity), and warmth on the arm (PT: Skin warm). It was reported the individual developed these symptoms after every vaccine. She received no treatment for the adverse events. At the time of reporting, the event outcome of Neuralgia, Limb Discomfort, Rash, Pain in extremity, and Skin warm were recovering/resolving. On 24-Jun-2024, additional information was received from a consumer via a query response: Updated the onset date of the following events Nerve pain, Heaviness in whole arm, COVID arm symptoms; small patch of rash (on the arm), COVID arm symptoms; pain (on the arm), COVID arm symptoms; warmth on the arm to 17-Dec-2023. Updated treatment performed to Yes with Treatment description physical therapy for COVID arm symptoms; pain (on the arm), COVID arm symptoms; warmth on the arm. Updated the outcome of the events nerve pain, heaviness in whole arm, pain on the arm, and warmth on the arm to Not Recovered/Not Resolved. Updated the outcome of the event COVID arm symptoms; small patch of rash (on the arm) to Recovered/Resolved with cessation date of 15-Jan-2024. New events were added to the case: Lymphedema and limited range of motion with unknown onset date and outcome of Not Recovered/Not Resolved/Ongoing. Treatment included physical therapy. A discrepancy was noted on the source document. The event cessation date was documented as 15-Jan-2023 which was before the event onset date. On 11-Sep-2024, additional information was received from a consumer via a query response: Updated disease type of Allergy to Legumes and added Seasonal Allergies under Medical History. Updated patient's past therapy with removed adverse reactions to previous vaccination. Updated COVID-19 mRNA Vaccine and Flu Vaccine Start Date under Patient Past Therapy. Updated therapy dosage text. Updated Lymphedema outcome to "Recovered/Resolved" and added cessation date of Jul-2024 Added an additional event reported term of burning for PT: Skin Warm Added COVID-19 Molecular Test Positive Lab Data Sender's Comments: This 41 year-old Female experienced Lymphoedema, Joint range of motion decreased, Neuralgia, Limb discomfort, Rash, Pain in extremity and Skin warm after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The events Lymphoedema, Joint range of motion decreased, Neuralgia, Limb discomfort, Rash, Pain in extremity and Skin warm were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible. Additional information was received on 11-Nov-2025 from consumer/ non-healthcare professional: Batch number added, Causality and listedness updated as not added in the previous version, narrative amended accordingly.; Sender's Comments: US-Novavax, Inc-2023NVX-US-000001973: More
2873675 72 F NJ 11/19/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination... Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus More
Large erythema went to 3 inches wide to 2 inches height, It became a lump was severely itchy; Large ... Large erythema went to 3 inches wide to 2 inches height, It became a lump was severely itchy; Large erythema/ itching and erythema started that same day/ told it might get red at injection site; Large erythema/ itching and erythema started that same day/ told it might get red at injection site; sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 10Nov2025 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (ongoing); "thyroid condition" (ongoing). Concomitant medication(s) included: FLUAD taken for immunisation, in Oct2025 as dose number unknown, single. Vaccination history included: Moderna covid-19 vaccine (Dose number unknown, single, Location: left arm), administration date: 2021, for Covid-19 immunization, reaction(s): "neurological problems"; Shingles vaccine (Dose number unknown, single, right deltoid), for Immunization, reaction(s): "Adverse event NOS"; Sars covid 19 vaccine (Dose number unknown, single), for Covid-19 immunization; Tdap vaccine (right deltoid), for Immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 10Nov2025, outcome "recovering", described as "Large erythema went to 3 inches wide to 2 inches height, It became a lump was severely itchy"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 10Nov2025, outcome "recovering" and all described as "Large erythema/ itching and erythema started that same day/ told it might get red at injection site"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2025, outcome "recovered" (Nov2025), described as "sore arm". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site mass, pain in extremity. Additional information: Patient stated that, the erythema and itching in right deltoid. Stated vaccine was administered, 10Nov2025, 2:30 PM, clarified, itching and erythema started that same day, about an hour to 2 hours it all began. Was told it might get red at injection site. She had large erythema, went to 3 inches wide to 2 inches height. It became a lump, was severely itchy. The severe itching was like, if she got 10 mosquito bites, is relentless itching. Got worse, then started to get better, about, maybe a day before it started looking mean and red. Lump started to go down, is barely there. Now, still has pink looking red, like a little erythema. Itching almost gone but, still slightly itching, has been 96 hours, since Monday, for 4 days. Never had this reaction. Has had a lot of vaccines in life. Treatment: she needed dose of Prednisone. Nothing worked, itching was internal, really severe. Only thing she could do is aloe, icing and, some lidocaine, that is about it. Only had sore arm, maybe first day, that went away. Took 1 Tylenol as soon as she got home. Drank 8 glasses of water. After that, was barely there, which is unusual because, usually has sore arm with other vaccines. The sore arm dissipated, maybe after 2 hours. Never had any reaction, fatigue, chills, headache, nothing but relentless itching. Patient took Fluad, Trivalent 2 weeks prior before latest Covid booster. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2873676 31 F VA 11/19/2025 COVID19
 PFIZER\BIONTECH
 NA0738
Polydipsia, Polyuria Polydipsia, Polyuria
Significant diuresis/where I urinated once per hour/The diuresis ended 72 hours after I received the... Significant diuresis/where I urinated once per hour/The diuresis ended 72 hours after I received the vaccine; Some mild polydipsia/but not to the same degree as the diuresis; This is a spontaneous report received from a Physician. A 31-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2025 as dose 1, single (Lot number: NA0738) at the age of 31 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: POLYURIA (non-serious) with onset 08Oct2025, outcome "recovered" (10Oct2025), described as "Significant diuresis/where I urinated once per hour/The diuresis ended 72 hours after I received the vaccine"; POLYDIPSIA (non-serious) with onset 08Oct2025, outcome "recovered" (10Oct2025), described as "Some mild polydipsia/but not to the same degree as the diuresis". Therapeutic measures were not taken as a result of polyuria, polydipsia. Additional information: The patient had no known allergy. The patient was not hospitalized for events. The patient received vaccine at doctor's office/urgent care. The patient did not receive any other vaccines on the same date as the vaccine for which the events are reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine for which the events are reported. The patient took other medication with 2 weeks of the event started. Patient reported that she was a physician who received the COVID booster for 2025. Approximately 24 hours after she received the vaccine, she experienced significant diuresis, where she urinated once per hour. Some mild polydipsia, but not to the same degree as the diuresis. The diuresis ended 72 hours after she received the vaccine. More
2873677 85 M IL 11/19/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 NA4457
NA4457
NA4457
NA4457
NA4457
NA4457
Chills, Dyschezia, Dysuria, Headache, Limb discomfort; Muscle spasms, Tremor; Fe... Chills, Dyschezia, Dysuria, Headache, Limb discomfort; Muscle spasms, Tremor; Feeling hot, Mobility decreased, Muscle spasms; Chills, Dyschezia, Dysuria, Headache, Limb discomfort; Muscle spasms, Tremor; Feeling hot, Mobility decreased, Muscle spasms More
Chills; Headache; terrible spasms; his arm was swinging away; he could not urinate or defecate for 2... Chills; Headache; terrible spasms; his arm was swinging away; he could not urinate or defecate for 24 hours; he could not urinate or defecate for 24 hours; he got underneath the covers and still shaking out of control/His legs were kicking the wall when he would pick his legs up, and his arms were swinging back and forth and hitting were the walls.; This is a spontaneous report received from a Consumer or other non HCP. An 85-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Nov2025 as dose 1, 0.3 ml single (Lot number: NA4457, Expiration Date: 23Jul2026) at the age of 85 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, dose number: Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 06Nov2025, outcome "recovered" (07Nov2025); HEADACHE (non-serious) with onset 06Nov2025, outcome "recovered" (07Nov2025); MUSCLE SPASMS (non-serious) with onset 06Nov2025, outcome "recovered" (07Nov2025), described as "terrible spasms"; DYSURIA (non-serious), DYSCHEZIA (non-serious) all with onset Nov2025, outcome "recovered" (Nov2025) and all described as "he could not urinate or defecate for 24 hours"; TREMOR (non-serious) with onset Nov2025, outcome "recovered" (Nov2025), described as "he got underneath the covers and still shaking out of control/His legs were kicking the wall when he would pick his legs up, and his arms were swinging back and forth and hitting were the walls."; LIMB DISCOMFORT (non-serious) with onset Nov2025, outcome "recovered" (07Nov2025), described as "his arm was swinging away". Additional information: Additional Context: Caller was a consumer calling about the Covid-19 vaccine. Caller said that he was up in age and stated that he got brain freeze every once in a while, when he was providing the name of the product. He got the vaccine on 06Nov2025 and has gotten the vaccine the year before and the year before that. He normally, by bedtime he gets the chills and a headache. He puts on a couple of blankets and by the next morning he was fine. This time about the same time at night, he started getting a little bit of chills and a headache, but then he got terrible spasms. It started when he was on his phone and could not hold the phone and his arm was swinging away from him and coming back at him and was hitting him in the head with the phone. His arm was out of control. Stated that his symptoms were better by about 6pm on 07Nov2025. Clarified that with the spasms he was having a hard time holding the phone and then his arm started taking it 18 inches away from his head and then came back and started slamming him in the head with the phone. He went to the bathroom to take a pill and he got a glass of water and was trying to fill it up and his hand was swinging back and forth and he tried to steady it with his other hand and it was still swinging and throwing water on the wall on the left and right side. He could not fill up the glass. He took the pill, and said that had to get a heavy quilt. His legs were kicking the wall when he would pick his legs up, and his arms were swinging back and forth and hitting were the walls. If he was not in the hallway he would have fallen. When he got in the bed, he dove intro the bed and thankfully he made it there it safe. Finally, he got underneath the covers and was still shaking out of control. His body got so hot, not from the quilt, it felt so great. He was in extreme heat and extreme comfort for about 15 minutes then it started to calm down and he was in bed for 24 hours. He said that he could not urinate or defecate for 24 hours, he got out of bed a few times and nothing worked. Caller does not have the NDC, lot, or expiration date for the previous 2 doses of the Covid-19 vaccine that he received. Caller clarified that on the paperwork he received from (pharmacy name withheld) that it had the name of the vaccine as Comirnaty. More
2873678 50 M 11/19/2025 COVID19
 PFIZER\BIONTECH
 EW0175
Cardiac discomfort, Respiratory disorder Cardiac discomfort, Respiratory disorder
breathing problems; Heart pressure; This is a spontaneous report received from a Consumer or other n... breathing problems; Heart pressure; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2021 at 12:00 as dose 1, single (Lot number: EW0175) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CARDIAC DISCOMFORT (non-serious) with onset 01Jun2021, outcome "not recovered", described as "Heart pressure"; RESPIRATORY DISORDER (non-serious) with onset 01Jun2021, outcome "not recovered", described as "breathing problems". Therapeutic measures were not taken as a result of respiratory disorder, cardiac discomfort. Additional information: Reported Heart pressure and breathing problems. Vaccine was administered at Doctor's office/urgent care. No known allergies. The patient did not received any other vaccines on the same date as the vaccine for which it was reported. The patient did not received any other vaccines within 4 weeks prior to the vaccine for which it was reported. The patient was not taking any other medications within 2 weeks of the event starting. More
2873679 F OR 11/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 00069-2528-10
00069-2528-10
Arthralgia, Dyspnoea, Fatigue, Headache, Myalgia; Nausea, Pyrexia Arthralgia, Dyspnoea, Fatigue, Headache, Myalgia; Nausea, Pyrexia
dyspnea; Extreme muscle and joint pain; Extreme muscle and joint pain; fever; headache; nausea; fati... dyspnea; Extreme muscle and joint pain; Extreme muscle and joint pain; fever; headache; nausea; fatigue; This is a spontaneous report received from a Nurse. A 63-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Nov2025 at 12:00 as dose 1, single (Lot number: 00069-2528-10), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hashimotis thyroiditis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, start date: 04Nov2025, stop date: 04Nov2025. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 12Nov2025, outcome "recovering" and all described as "Extreme muscle and joint pain"; DYSPNOEA (non-serious) with onset 12Nov2025, outcome "recovering", described as "dyspnea"; FATIGUE (non-serious) with onset 12Nov2025, outcome "recovering"; PYREXIA (non-serious) with onset 12Nov2025, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 12Nov2025, outcome "recovering"; NAUSEA (non-serious) with onset 12Nov2025, outcome "recovering". Therapeutic measures were not taken as a result of dyspnoea, myalgia, arthralgia, pyrexia, headache, nausea, fatigue. More
2873681 F CA 11/19/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



Arthralgia, Fatigue, Headache, Pain, Pain in extremity; COVID-19, Drug ineffecti... Arthralgia, Fatigue, Headache, Pain, Pain in extremity; COVID-19, Drug ineffective; Arthralgia, Fatigue, Headache, Pain, Pain in extremity; COVID-19, Drug ineffective More
Fatigue; Headache; Arm pain; Joint pain; Achy; This is a spontaneous report received from a Consumer... Fatigue; Headache; Arm pain; Joint pain; Achy; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A 50-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PAIN (non-serious), outcome "unknown", described as "Achy". Additional Information: The patient had had many Pfizer covid vaccines- beginning in Feb/Mar2021 through current day (this was her 9th dose).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500224225 same patient and product; different event and time;US-PFIZER INC-202500197429 same patient and product; different event and time; More
2873682 F 11/19/2025 COVID19
 PFIZER\BIONTECH
Condition aggravated, Dyspnoea, Eczema, Malaise, Middle insomnia Condition aggravated, Dyspnoea, Eczema, Malaise, Middle insomnia
she was not feeling well; had 1 episode of night waking due to turning off the air conditioning and ... she was not feeling well; had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe; had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe; eczema flared up; eczema flared up; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from License Party. Other Case identifier(s): 2025SA310937 (Sanofi), AE-021614 (BioNTech). Initial information received on 14Oct2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 55 years old female patient who missed a dose of dupixent, as she was not feeling well, had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe and eczema flared up while being treated with DUPILUMAB [DUPIXENT] via prefilled syringe and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rhinitis allergic, Eczema and allergies: isovue-300 61% multipack; penicillin v potassium; ofloxacin 300 mg tablet. Concomitant medications included unspecified allergy shots biweekly. In 2019, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg QOW subcutaneous for Asthma. On an unknown date, the patient started taking COVID-19 VACCINE Unknown dosage unknown for Immunisation. In 2020 the patient developed a non-serious event "eczema flared up" (eczema) (approximately few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. On 08Oct2025 the patient developed a non-serious event "missed a dose of dupixent, as she was not feeling well" (malaise) (approximately 5 years few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. In Oct2025 the patient developed a non-serious event "had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe" (middle insomnia) (approximately 5 years few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. In Oct2025 the patient developed a non-serious event "had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe" (dyspnoea) (approximately 5 years few months latency) following the first dose intake (batch number: FW0841, expiry date on 31Aug2027) of DUPILUMAB and (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE. It was reported "The patient stated that since starting on dupixent "i haven't been having (asthma) crisis like i was having before". She reports having allergic rhinitis, and she stated that she gets allergy shots biweekly. She stated that she missed a dose of dupixent on 08Oct2025, as she was not feeling well. She informed that last week she had 1 episode of night waking due to turning off the air conditioning and not having circulating air, it became hard for her to breathe. She denies having to use her rescue inhaler. She stated that after the air began circulating her symptoms resolved. She reported that she had eczema when she was younger but it flared up in 2020 after she took the covid vaccine. She stated that dupixent does not help her eczema symptoms". Action taken with DUPILUMAB was drug withdrawn in 2025 for malaise, unknown for other events. Action taken with COVID-19 VACCINE was unknown for all events. It was not reported if the patient received a corrective treatment for all events. At time of reporting, the outcome was Recovering for malaise; eczema; was Recovered in Oct2025 for other events. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2873683 11/19/2025 COVID19
 PFIZER\BIONTECH
Dermatitis contact Dermatitis contact
I believe your Covid shot formula caused a mutation in my body making me allergic to deodorants; Thi... I believe your Covid shot formula caused a mutation in my body making me allergic to deodorants; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "I believe your Covid shot formula caused a mutation in my body making me allergic to deodorants". Additional information: The patient believed that Covid shot formula caused a mutation in body making the patient allergic to deodorants. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2873684 11/19/2025 FLU3
UNK
 SANOFI PASTEUR
UNKNOWN MANUFACTURER
3051995
Chills, Hyperhidrosis, Myalgia, Polymyalgia rheumatica, Red blood cell sedimenta... Chills, Hyperhidrosis, Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased; Chills, Hyperhidrosis, Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased More
polymyalgia, rheumatica-like reactions; that was PMR; drenching sweats; severe myalgia; shaking chil... polymyalgia, rheumatica-like reactions; that was PMR; drenching sweats; severe myalgia; shaking chills; Initial information received on 10-Nov-2025 regarding an unsolicited valid serious case received from a physician. This case involves patient of unknown demographics who experienced polymyalgia, rheumatica-like reactions; that was pmr, drenching sweats, severe myalgia and shaking chills after receiving COVID-19 vaccine mRNA omicron (mRNA 1283) [Mnexspike 2024-2025 formula] and influenza USP trival A-B subvirion vaccine [Fluzone]. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were reported. No Medical History information was reported. On 21-Oct-2025, the patient received a 1 DF (dosage form) of suspect Influenza USP Trival A-B Subvirion Vaccine Suspension for injection (batch number, expiry date: not reported) via unknown route in unknown administration site for immunization and 10 microgram of suspect Mnexspike 2024-2025 formula not produced by Sanofi Pasteur injection of lot 3051995 (strength, expiry date: not reported) via intramuscular route in unknown administration site for Covid-19 prophylaxis. On 22-OCT-2025 the patient developed polymyalgia, rheumatica-like reactions; that was pmr (polymyalgia rheumatica), drenching sweats (hyperhidrosis), severe myalgia (myalgia) and shaking chills (chills) (latency: 1 day) Seriousness criteria: These events were assessed as medically significant. Relevant laboratory test results included: Red blood cell sedimentation rate - On an unknown date: [117 a sed (sedimentation) rate of over 100, that was PMR] Action taken was not applicable. No corrective treatment was received for the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the events.; Sender's Comments: Sanofi company comment dated 17-Nov-2025: This case involves patient of unknown demographics who experienced polymyalgia, rheumatica-like reactions; that was pmr, drenching sweats, severe myalgia and shaking chills after receiving COVID-19 vaccine mRNA omicron (mRNA 1283) [Mnexspike 2024-2025 formula] and influenza USP trival A-B subvirion vaccine [Fluzone]..The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed More
2873687 74 F VA 11/19/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Erythema, Hypersensitivity Erythema, Hypersensitivity
She had a allergic reaction to; From the neck down she was red, so she had a pretty severe reaction;... She had a allergic reaction to; From the neck down she was red, so she had a pretty severe reaction; This spontaneous case, initially received on 10-Nov-2025, was reported by a health professional and concerns an elderly female patient. There was no patient history and no allergy information. Concomitant medication reported as unknown. There was no product complaint associated with this case. Administration of company suspect drug: On an unknown date in Dec-2024, the patient received Fluad (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: No batch number available, and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On Dec-2024, the patient experienced She had a allergic reaction to (outcome: Unknown), From the neck down she was red, so she had a pretty severe reaction (outcome: Unknown), (Intensity: Severe). It was reported that the pharmacist reported they had a patient who got the Fluad 2023-2024 in unknown date in 2024, and then they got the 2024-2025 in unknown date in Dec-2024, however, the one in Dec-2024, she had an allergic reaction too. She was on prednisone and some other items. From the neck down she was red, so she had a pretty severe reaction, so pharmacist guessed and wanted to know what the differences were so that the pharmacist could put on her file about what was the difference. Fluad (TIV) action taken: Not Applicable Treatment medication: Prednisone Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, all events are considered related for the reporting purposes. Related for both events considering implied temporal relationship (she had an allergic reaction too in dec-2024) and biological plausibility. More
2873688 70 F 11/19/2025 FLUX
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 No batch number
No batch number
Burning sensation, Condition aggravated, Contusion, Hereditary angioedema, Injec... Burning sensation, Condition aggravated, Contusion, Hereditary angioedema, Injection site pain; Injection site pruritus, Injection site swelling, Peripheral swelling, Pruritus More
Hereditary angioedema attack reported as HAE attack; Site where they gave her the flu shot was swoll... Hereditary angioedema attack reported as HAE attack; Site where they gave her the flu shot was swollen; Site where they gave her the flu shot was itchy; Site where they gave her the flu shot was a little sore; Itching so profusely on her ancle and knee; Left hand is puffy; Bruising on arms from itching; Intense itching and burning; This spontaneous case, initially received on 07-Nov-2025, was reported by a non health professional and concerns an elderly female patient. Concomitant medication: refer to appropriate report section, also included blood pressure and cholesterol medications. Administration of company suspect drug: On 04-Nov-2025, the patient received Influenza virus vaccine for Indication not reported, Dose regimen: not reported, route of administration: not reported, Anatomical location: Right arm, Lot number: No batch number available and would be requested upon follow up. Non-company suspect drugs: Haegarda (Complement C1 esterase inhibitor), Indication: Every 4-5 days dosing in the context of prophylaxis, HAE. The patient also received Haegarda on 07-Nov-2025, Dose regimen: not reported, route of administration: not reported, Lot number: Not reported. Adverse reactions/events and outcomes: On 06-Nov-2025, the patient experienced Itching so profusely on her ankle and knee (outcome: Unknown), Left hand is puffy (outcome: Unknown), Bruising on arms from itching (outcome: Unknown), Intense itching and burning (outcome: Unknown). On an unknown date, the patient experienced Hereditary angioedema attack reported as HAE attack (Medically Significant, outcome: Not Reported), Site where they gave her the flu shot was swollen (outcome: Recovering / Resolving), Site where they gave her the flu shot was itchy (outcome: Unknown), Site where they gave her the flu shot was a little sore (outcome: Unknown). The patient had called and stated that she used Haegarda for HAE. The patient informed that she had gone to her primary care doctor for a checkup and had received the flu shot on her right arm on Tuesday morning. The patient stated that the site where they had given her the flu shot was swollen and a little sore and itchy. The patient did not know which flu shot she had taken. The patient obtained Haegarda from pharmacy and she had taken a dose that day after experiencing severe symptoms following the flu shot. The patient stated that the previous day she had itching so profusely on her ankle and knee that she had applied hydrocortisone on it. The patient stated that that morning her hands and arms had itched so badly that she now had bruising on her arms from itching intensely. The patient informed that her left hand was puffy. The patient reported intense itching and burning. The patient stated that the itching had subsided because she had used a lot of hydrocortisone. The hydrocortisone had helped and her skin had calmed down although she had bruises now from the itching. The patient stated Haegarda worked like a charm for her and she had been on it for years. The patient stated this had not been a full-fledged outbreak; it had started with swelling at the flu shot injection site and had almost gone down. The patient did not believe her symptoms were due to Haegarda. The patient stated her symptoms were the same she got just before she had an HAE attack. The patient informed she did not take many other medications - only lisinopril, blood pressure and cholesterol medications, and Sertraline for depression. The patient stated she had last used Haegarda on Sunday or Monday and then that day due to this issue. The patient stated she had never had an issue with Haegarda. The patient stated she had trashed the bottle she had used that day but had provided the lot for another bottle that she had. Case was upgraded to serious upon company assessment of the reported event (Hereditary angioedema attack reported as HAE attack) clinical significance. Influenza virus vaccine action taken: Not Applicable Treatment medication: Hydrocortisone Reporter's assessment: The primary reporter considered the events as non-serious and causality assessment was not reported.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. Considering close anatomical proximity for vaccination site pain, vaccination site swelling and vaccination site pruritus. Considering plausible temporal relationship for events pruritus, peripheral swelling and intense burning and itching (2 days post vaccination). The event contusion is attributed to intense itching which led to bruising on arms. The event HAE attack is attributed to underlying condition of hereditary angioedema (attributed to co-suspect medication Haegarda). More
2873689 63 F GA 11/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 NA0589
NA0589
Brain fog, Decreased appetite, Diarrhoea, Dizziness, Fatigue; Hypersomnia, Nause... Brain fog, Decreased appetite, Diarrhoea, Dizziness, Fatigue; Hypersomnia, Nausea, Oropharyngeal pain, Pyrexia More
Pt started to feel light headed a couple hours later after vaccination & slept for 30 hours stra... Pt started to feel light headed a couple hours later after vaccination & slept for 30 hours straight. Starting second day she started having fever, fatigue, brain fog, no appetite, diarrhea, nausea and sore throat. Pt has all symptoms going on still now but the fever. Pt did a tele/ video visit with her Doc. on 10/14/25 (1st appt) and on 11/03/25 ( 2nd appt). Pt received vaccine on 10/01/25. Pt has Fibromyalgia, Chron's disease and chronic fatigue. Doc. thinks it is possibly a side effect from the vaccine and should go away. Doc. said she have had a pt with Fibromyalgia that had same reaction from covid vaccine. Doc. thinks vaccine may have triggered her immune system. More
2873705 3 M NY 11/19/2025 COVID19
 MODERNA
 3053855
Injection site reaction, Scab, Skin erosion, Skin lesion Injection site reaction, Scab, Skin erosion, Skin lesion
Night of vaccination, mom removed bandaid and noticed eroded area around site of vaccine, pencil era... Night of vaccination, mom removed bandaid and noticed eroded area around site of vaccine, pencil eraser diameter. Over the following days more small lesions were noted below that area, that appeared pinpoint and crusted. The larger open area crusted over and is now healing. There was no systemic reaction - no fever, no malaise, no induration, no redness at the site. He did not complain of pain, itching, or discomfort of the arm. Past COVID vaccination without reaction. No intervention tried at home and spot is almost resolved. More
2873709 54 F 11/19/2025 COVID19
UNK
 MODERNA
UNKNOWN MANUFACTURER
 D05443A
NA9AR
Contusion; Contusion Contusion; Contusion
big bruise on arm big bruise on arm
2873713 37 M IL 11/19/2025 YF
 SANOFI PASTEUR
 UK138AA
Lip swelling, Urticaria Lip swelling, Urticaria
PATIENT CALLED AND STATED HE HAD HIVES AND A SWOLLEN LIP ~2HOURS AFTER BEING VACCINATED. PATIENT CALLED AND STATED HE HAD HIVES AND A SWOLLEN LIP ~2HOURS AFTER BEING VACCINATED.
2873714 70 F AL 11/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EL9262
EL9262
Chills, Fatigue, Hypoaesthesia oral, Lethargy, Loss of personal independence in ... Chills, Fatigue, Hypoaesthesia oral, Lethargy, Loss of personal independence in daily activities; Skin wound More
Upon taking initial vaccine, my lips were numb and this lasted 15 - 20 minutes. Today, however, and... Upon taking initial vaccine, my lips were numb and this lasted 15 - 20 minutes. Today, however, and since taking three vaccine doses (initial 2-part vaccine and 1 booster), I have felt lethargic daily and have chills at various times during the day More
2873229 15 M NC 11/18/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 H017885
Unknown
Expired product administered, Herpes zoster, Pertussis, Product preparation erro... Expired product administered, Herpes zoster, Pertussis, Product preparation error, Varicella virus test positive; Expired product administered, Herpes zoster, Pertussis, Product preparation error, Varicella virus test positive More
and has also had pertussis in the last 6-12 months; patient that has an active shingles infection (d... and has also had pertussis in the last 6-12 months; patient that has an active shingles infection (diagnosed/PCR positive on 10/23/2025); PROQUAD (administered 4/4/2023, lot H017885), expiration date validated as: 2014-04-01; This spontaneous report was received from a physician (dermatologist) and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-JUN-2009, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), injection 0.5 mL, lot #0336Y [which has been verified to be an invalid lot number for Varicella Virus Vaccine Live (Oka-Merck)] (expiration date was not provided) and on 04-APR-2023, he was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), injection 0.5 mL, lot number H017885 [which has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date not reported but upon internal validation establish as 01-APR-2014 (expired product administered), both of them administered for prophylaxis (strength, dose numbers, vaccination schedules, routes and anatomical sites of administration were not provided). Both vaccines were reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported). On an unknown date (reported as in the last 6-12 months), the patient experienced pertussis and on 23-OCT-2025, the patient also experienced shingles infection (diagnosed/PCR positive on the same date). Otherwise, the rest of his medical history was "uneventful and pretty normal". At the time of the report (reported as currently), the patient was being treated with valacyclovir (VALTREX), and he was responding to treatment. In addition, the outcome of the events was unknown. The causal relationship between the events and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and Varicella Virus Vaccine Live (Oka-Merck), both reconstituted with sterile diluent, was not provided. Upon internal review, the event of pertussis was determined to be medically significant. More
2873232 78 F SC 11/18/2025 COVID19
 PFIZER\BIONTECH
 GH9694
COVID-19, Disease recurrence, Vaccination failure COVID-19, Disease recurrence, Vaccination failure
Suffering from COVID right now; had COVID, I think it was in Jan2024; had COVID, I think it was in J... Suffering from COVID right now; had COVID, I think it was in Jan2024; had COVID, I think it was in Jan2024; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 78 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EM9810, Expiration Date: Jun2021), in arm, on 08Mar2021 as dose 2, single (Batch/Lot number: unknown), in arm and on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ativan, reaction(s): "Drug allergy: Ativan"; Ativan, reaction(s): "Drug allergy: Vertigo"; Codeine, reaction(s): "Drug allergy: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "had COVID, I think it was in Jan2024"; DISEASE RECURRENCE (medically significant) with onset 03Nov2025, outcome "unknown", described as "Suffering from COVID right now". The patient underwent the following laboratory tests and procedures: COVID-19: (06Nov2025) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: Patient has all her vaccines. Well, she had her beginning vaccine and is taking Paxlovid for the second time. She has guess, two vaccines. She said that she didn't take the last one, that's her mistake, her further confusion. So, she does have her vaccines and she is taking Paxlovid for the second time. Well, she don't know that she have taken it before. They had COVID, she think it was in Jan2024, She's not sure, but she can't remember taking the Paxlovid, but they could have. She's not sure, but they did had all the vaccines, except for the very last one. They haven't had it yet. The vaccine, it just says here 1st dose COVID-19 and she have got a lot number, it's got Pfizer. LOT#, blank expiration Jun2021, but she don't see a name of the vaccine. Well, she think when it was available, they must have been sick and she wouldn't have taken it on. She don't know, they may she don't know. She's sorry. The patient stated that she suffering from COVID right now, yes. The 1st vaccine, she got was in doctor's care. She had an appointment near her and when she got there, they didn't have the record of the appointment. So, they wouldn't gave her the vaccine. So, then she have to relay after and she got home, she got a call from them and they said she missed her appointment. So, that's why she had to go to get her vaccine, that was a long drive. It was 16Feb2021. For 2nd dose, it was the same place. she went back to the doctor's care on 08Mar2021. Third dose on 17Oct2021. The facility, she don't know. They have got some different. This might be (withheld), maybe she got her last two shots at (withheld), because it's got '(withheld)'. She bet that's (withheld). For the 4th dose was in 16Sep2022. When probed if consumer got COVID again after the 4th dose: Consumer stated, Yes, that was all the vaccines she have had for COVID. You have to take one and then wait a month and take next and then you have to wait 6 months to take the next one, then they had another shot the year later, one year later in 22. She didn't realized it has been that long since she had her last vaccine. LOT#: Consumer stated, she don't think they wrote it down here. All that's got written is Pfizer and then they have got GH9694. The only one she have a LOT# is on the very first one, that she got in (withheld) and it got LOT#, EM9810. Furthermore, the patient stated that it started on Monday. She started with sore throat 03Nov2025, but she didn't know she had COVID until she tested on Thursday, which was 06Nov, the test confirmed she had tested positive for COVID. Treatment: Consumer stated, prior to taking Paxlovid. On Tuesday, after she started the sore throat after the 3rd. She had an appointment with the doctor the next morning. She didn't feel good enough to go to the doctor. She felt awful, so she called and cancelled her appointment and he called her in a Z-pak Azithromycin and also 4 tablet of Prednisolone. 250 milligrams and it was a fix pack were you take 6 pills. Patient took 500 milligrams on Tuesday. After that she just had to take one tablet and when she called her doctor and tell him she tested positive for the COVID. He tell her to stop taking these pills, not to take them anymore when she started the Paxlovid. Prednisolone 10 milligrams. It was late in the day so, she only got one and the first day once a day. Then next day she took two and the next day she took one. It was only 4 pills. More
2873233 F 11/18/2025 COVID19
 PFIZER\BIONTECH
Chronic kidney disease Chronic kidney disease
Chronic Kidney Disease; This is a spontaneous report received from a Consumer or other non HCP, Prog... Chronic Kidney Disease; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: CHRONIC KIDNEY DISEASE (medically significant), outcome "not recovered". Clinical course: The patient mentioned that she now has Chronic Kidney Disease and an uncertain but slight suspicion that this could have been a result of COVID-19 vaccination, although she recognized this was unlikely. Her last COVID-19 vaccine she thinks was in 2023. The specific vaccine manufacturer was unknown but it is possible/suspected that it could have been Comirnaty. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2873256 0.17 M MD 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 52TM4
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Wrong age; This non-serious case was reported by a physician via call center representative and desc... Wrong age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number 52TM4, expiry date 30-JUN-2026) for prophylaxis. On 13-NOV-2025, the patient received FluLaval 2025-2026 season. On 13-NOV-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date:14-NOV-2025 The pediatrician mentioned they accidentally administered FluLaval. Administration Facility was the same as primary reporter. More
2873257 64 M NY 11/18/2025 FLU3
 SANOFI PASTEUR
 U8837AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
administration of fluzone hd to a 64-year-old patient with no reported adverse event; Initial inform... administration of fluzone hd to a 64-year-old patient with no reported adverse event; Initial information received on 13-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old male patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination (Immunisation). On 29-Oct-2025, the patient received a dose 1, 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot U8837AA and expiry 31-Jun-2026) with no adverse event (Product administered to patient of inappropriate age) (Latency same day) via intramuscular route in the left deltoid for immunization. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2873258 45 F NY 11/18/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0167
EW0167
EW0167
EW0167
EW0167
EW0167
EW0167
EW0167
EW0184
EW0184
EW0184
EW0184
EW0184
EW0184
EW0184
EW0184
Abdominal discomfort, Agitation, Anxiety, Arthralgia, Blood test; Brain fog, Bur... Abdominal discomfort, Agitation, Anxiety, Arthralgia, Blood test; Brain fog, Burning sensation, Bursitis, COVID-19, Chills; Constipation, Depression, Diarrhoea, Epstein-Barr virus infection, Fatigue; Fibromyalgia, Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema; Injection site mass, Injection site reaction, Injection site warmth, Lymphadenopathy, Magnetic resonance imaging; Malaise, Migraine, Muscle spasms, Myalgia, Oropharyngeal pain; Pain, Peripheral swelling, Post-acute COVID-19 syndrome, Pyrexia, Tendonitis; Ultrasound scan, Visual impairment, Weight decreased, X-ray; Abdominal discomfort, Agitation, Anxiety, Arthralgia, Blood test; Brain fog, Burning sensation, Bursitis, COVID-19, Chills; Constipation, Depression, Diarrhoea, Epstein-Barr virus infection, Fatigue; Fibromyalgia, Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema; Injection site mass, Injection site reaction, Injection site warmth, Lymphadenopathy, Magnetic resonance imaging; Malaise, Migraine, Muscle spasms, Myalgia, Oropharyngeal pain; Pain, Peripheral swelling, Post-acute COVID-19 syndrome, Pyrexia, Tendonitis; Ultrasound scan, Visual impairment, Weight decreased, X-ray More
Left arm swelled up twice its size. Hot burning , red large lump in muscle at injection site the siz... Left arm swelled up twice its size. Hot burning , red large lump in muscle at injection site the size of a tangerine. Unable to use arm. Swollen lymphnodes, fever, sore throat, headache, migraines, extreme fatigue and malaise, joint pain, muscle pain, body aches , chills, drenching night sweats, Brain fog , overwhelm, anxiety, depression, digestive upset diarrhea and constipation, 18 lb unintended weight loss, vision deterioration, muscle cramps, tendinitis, bursitis left shoulder, diagnosed with long covid, fibromyalgia, chronic fatigue, Epstein-Barr virus. More
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2873320 15 F NY 11/18/2025 FLU3
 SANOFI PASTEUR
 UT8802KA
Dizziness, Hyperhidrosis, Hypotension, Malaise Dizziness, Hyperhidrosis, Hypotension, Malaise
3 minutes after administration, patient started not to feel well. Patient was diaphoretic, hypotensi... 3 minutes after administration, patient started not to feel well. Patient was diaphoretic, hypotensive, dizzy, nauseous, and feeling faint. Patient was laid down with feet raised. Multiple blood pressures were taken and patient drank an apple juice. Provider did an assessment on the patient. After about 5 minutes, patient started feeling better and was able to ambulate out of the office without feeling any effects from the vaccines. More
2873323 38 F PA 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9FG5M
Laboratory test, Loss of personal independence in daily activities, Magnetic res... Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging, Motor dysfunction, Pain in extremity More
Severe pain 10:10 with loss of motor function in hand and arm. Went to ER 11/11 when I could no long... Severe pain 10:10 with loss of motor function in hand and arm. Went to ER 11/11 when I could no longer pick up a drink or push the elevator button More
2873324 66 M FL 11/18/2025 COVID19
 MODERNA
Dyspnoea Dyspnoea
Day after injection started having difficulty breathing. It?s been since November 3 that I had the i... Day after injection started having difficulty breathing. It?s been since November 3 that I had the injection and the difficulty breathing continues to get worse. More
2873326 86 M MI 11/18/2025 FLU3
 SEQIRUS, INC.
 407247
Extra dose administered Extra dose administered
Patient already received Flu vaccine on 9-23-25 and a second Flu vaccine was administered on 11-17-2... Patient already received Flu vaccine on 9-23-25 and a second Flu vaccine was administered on 11-17-25. More
2873327 62 F FL 11/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9JC49
Injection site swelling, Pain, Pyrexia, Vomiting Injection site swelling, Pain, Pyrexia, Vomiting
Fever, vomiting, pain, and swelling at the injection site. Fever, vomiting, pain, and swelling at the injection site.
2873329 69 M GA 11/18/2025 FLU3
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient presented to facility to receive free flu vaccine provided with partnership with Pharmacy. ... Patient presented to facility to receive free flu vaccine provided with partnership with Pharmacy. The flu clinic is offered on 2 separate dates. The patient signed up and presented at both dates to receive flu vaccine. There are no adverse effects reported from the patient; however, the duplication was noticed when entering vaccination record into the patients electronic medical record More
2873330 85 F NJ 11/18/2025 FLU3
 SANOFI PASTEUR
 U8837BA
Eyelid rash, Rash, Rash macular Eyelid rash, Rash, Rash macular
Patient received flu vaccine on 11/11/25. Called the triage line on 11/14/25 to state she had develo... Patient received flu vaccine on 11/11/25. Called the triage line on 11/14/25 to state she had developed a blotchy rash on face a few hours after receiving the vaccine. As of 11/14/25 she still had the rash on face and left eyelid. Patient was seen in office on 11/14/25 by the Nurse Practitioner who examined and stated the patient had a rash that involved the right forehead, right upper and lower lids. There was concern that it was herpes zoster ophthalmicus. Patient was also referred to ophthalmology and was seen that same day. She was prescribed valacyclovir 1g tablet by mouth 3 times a day. Patient had a follow up appointment with Dr. {withheld} on 11/17/25 and it was noted that patient was still taking the valtrex and eye ointment prescribed by ophthalmology and also had a follow up appointment with them as well. More
2873332 79 F FL 11/18/2025 FLU3
 SANOFI PASTEUR
 U8874CA
Injection site pain, Pain Injection site pain, Pain
Patient reports that she has experienced muscle soreness at the injection site for the past two week... Patient reports that she has experienced muscle soreness at the injection site for the past two weeks since she received the vaccine. She reports having trouble moving her arm without it being uncomfortable. I recommended to the patient reach out to her primary care doctor to get evaluated. More
2873334 78 F GA 11/18/2025 PNC21
 MERCK & CO. INC.
 Z002626
Dizziness, Feeling cold Dizziness, Feeling cold
dizziness and feeling cold dizziness and feeling cold
2873336 53 F MN 11/18/2025 COVID19
FLUN3
 MODERNA
MEDIMMUNE VACCINES, INC.
 3052864
YH3388
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
Flumist administered to 53-year-old client. Flumist should only be given to client aged 2-49 years. Flumist administered to 53-year-old client. Flumist should only be given to client aged 2-49 years.
2873337 52 F NC 11/18/2025 FLU3
FLU3
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
 U8823DA
U8823DA
MA2523
MA2523
Injection site cellulitis, Injection site erythema, Injection site mass, Injecti... Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site swelling; Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site swelling More
Patient had 2 adverse events. 1) Developed cellulitis. Patient had a red, swollen, itchy area develo... Patient had 2 adverse events. 1) Developed cellulitis. Patient had a red, swollen, itchy area develop around injection site. Went to PCP and diagnosed with cellulitis and treated with antibiotics. Symptoms resolved over the next week. 2) small painful lump. Patient reports around one of the injections (she is unsure if it was vaccine given first (flu up top) or second (prevnar given below)) a small / painful lump developed that is continue to linger and be present. Patient still receiving / going to pcp for care for this. Still unresolved. More
2873338 65 F IL 11/18/2025 COVID19
 MODERNA
Headache, Hypertension Headache, Hypertension
after getting the vaccine her head started hurting a couple of days later and her BP was running 170... after getting the vaccine her head started hurting a couple of days later and her BP was running 170/101. Her head continued to hurt and BP kept reading high. She went to walk in clinic. her BP 177/89. She was told to limit her physical activities and try to relax. She was told to follow up with PCP. On 11/10 she went to her PCP. Her BP was 144/94. She was prescribed her BP meds to take if her BP went over 150. On the 11/11 in the PM is was 163/94 and is now running 129/88. She has not had to take the meds as it continues to come down. She checked it again on 11/17 it was 129/84 in the AM. This morning on 11/18 it is now 129/88. More
2873339 62 F MN 11/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

CSF shunt operation, Cerebral ventricle dilatation, Gait disturbance, Hydrocepha... CSF shunt operation, Cerebral ventricle dilatation, Gait disturbance, Hydrocephalus, Magnetic resonance imaging head abnormal; Memory impairment, Mental impairment, Orthosis user More
A year after vaccine. feet sticks to the floor, like shuffling, forgetfulness, not thinking clearly.... A year after vaccine. feet sticks to the floor, like shuffling, forgetfulness, not thinking clearly. Went to several doctors. had a brace on foot for a while which didn't help. went to see a neurologist. was seen by a neurosurgeon. had MRI, had water on brain and enlarged ventricles. had surgery on 10/10/2025. had a shunt put in, a procedure in her abdomen, a tube on 10/10/2025. Done at Hospital on 10/10/2025. Now, doing better. walking good. More
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