🏥 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 💀 🏥 🚑 ♿ ⚠️
2872636 80 M IL 11/13/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Blood test, Chills, Computerised tomogram, Culture, Feeling abnormal; Feeling co... Blood test, Chills, Computerised tomogram, Culture, Feeling abnormal; Feeling cold, Malaise, Nausea, Pyrexia, Respiration abnormal; Tremor, Urine analysis More
tremors; feeling of being cold to the bone; He felt unsteady and thought he had a fever; respiration... tremors; feeling of being cold to the bone; He felt unsteady and thought he had a fever; respirations were rapid and labored; chills; nausea; unsteady and thought he had a fever; he felt a bit unwell earlier in the day; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors), FEELING COLD (feeling of being cold to the bone), FEELING ABNORMAL (He felt unsteady and thought he had a fever), RESPIRATION ABNORMAL (respirations were rapid and labored) and MALAISE (he felt a bit unwell earlier in the day) in an 80-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Unspecified septicemia (septicemia). Previously administered products included for Product used for unknown indication: Pfizer (dose 2), Pfizer (dose 1), Pfizer (dose 4) and Pfizer (dose 3). Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, Pfizer and Pfizer. On 13-Oct-2025 at 10:30 AM, the patient received fifth 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 13-Oct-2025, the patient experienced MALAISE (he felt a bit unwell earlier in the day). On 13-Oct-2025 at 4:00 PM, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced TREMOR (tremors), FEELING COLD (feeling of being cold to the bone), FEELING ABNORMAL (He felt unsteady and thought he had a fever), RESPIRATION ABNORMAL (respirations were rapid and labored), CHILLS (chills), NAUSEA (nausea) and PYREXIA (unsteady and thought he had a fever). At the time of the report, TREMOR (tremors), FEELING COLD (feeling of being cold to the bone), FEELING ABNORMAL (He felt unsteady and thought he had a fever), RESPIRATION ABNORMAL (respirations were rapid and labored), MALAISE (he felt a bit unwell earlier in the day), CHILLS (chills), NAUSEA (nausea) and PYREXIA (unsteady and thought he had a fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2025, Blood test: Negative. In October 2025, Computerised tomogram: Negative. In October 2025, Culture: Negative. In October 2025, Urine analysis: Negative. No concomitant medication was reported. On 13-Oct-2025, the patient experienced a sudden onset of chills, tremors, and a feeling of being cold to the bone in the afternoon. He felt unsteady and thought he had a fever. He also had some nausea but no vomiting. His respirations were rapid and labored. The patient received the shot around 10:30 AM, and these symptoms began around 4:00 in the afternoon. Initially, he felt a bit unwell earlier in the day, but the significant symptoms started at 4:00 PM. His condition did not improve overnight, leading him to visit the ER, where he spent 7.5 hours. The medical team was concerned about sepsis due to his history of septicemia, but all tests, including blood work, cultures, urinalysis, and a CT scan, were negative. This led to the consideration that the COVID shot might be the cause, as this was his first Moderna vaccine after four Pfizer doses. The patient was not specifically informed about receiving Moderna, and since previous COVID shots were uneventful, patient did not inquire further. After several hours and test results, it was concluded that the vaccine was the likely cause, as no other factors changed that day. He did not have sepsis on 13-Oct-2025, although there was concern due to his history in Nov-2024 and Dec-2024. Following a battery of tests, sepsis was ruled out. A week later, an infectious disease doctor confirmed it was not an infection. It was unknown if the patient experienced any additional symptoms/events. He received treatment, including IVs, and began to feel better. Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2025: Live follow-up received: Reporter email id corrected, ROA updated, and reference ids added. More
2872637 65 TX 11/13/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Dyspepsia; Dyspepsia Dyspepsia; Dyspepsia
digestive discomfort, such as stomach churning and gurgling noises; This spontaneous case was report... digestive discomfort, such as stomach churning and gurgling noises; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (digestive discomfort, such as stomach churning and gurgling noises) in a 65-year-old patient of an unknown gender who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The non-company product 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, Pre-filled Syringe (unknown route) at an unspecified dose and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (digestive discomfort, such as stomach churning and gurgling noises). At the time of the report, DYSPEPSIA (digestive discomfort, such as stomach churning and gurgling noises) had not resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. No concomitant medication was reported. Patient was experiencing digestive discomfort, such as stomach churning and gurgling noises, and was seeking advice on how to restore normal gut function. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2872638 78 F MA 11/13/2025 COVID19
 MODERNA
Vaccination site reaction Vaccination site reaction
reaction on arm below injection site/COVID arm; This spontaneous case was reported by a consumer and... reaction on arm below injection site/COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction on arm below injection site/COVID arm) in a 78-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 05-Nov-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced VACCINATION SITE REACTION (reaction on arm below injection site/COVID arm). At the time of the report, VACCINATION SITE REACTION (reaction on arm below injection site/COVID arm) was resolving. No concomitant medication was reported. Patient had Covid-19 shot on 05-Nov-2025, first time had reaction on arm below injection site. It fits all description of Covid arm. On the day of reporting, the arm was feeling better but still visible, injection had small faded black and blue. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2872639 CA 11/13/2025 PNC20
 PFIZER\WYETH
 LN4930
Cellulitis, Erythema, Swelling Cellulitis, Erythema, Swelling
cellulitis; extreme redness; swelling; This is a spontaneous report received from an Other HCP. A p... cellulitis; extreme redness; swelling; This is a spontaneous report received from an Other HCP. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4930) for immunisation, Device Lot Number: LN4930. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant), outcome "unknown"; ERYTHEMA (medically significant), outcome "unknown", described as "extreme redness"; SWELLING (medically significant), outcome "unknown". The events "cellulitis", "extreme redness" and "swelling" required emergency room visit. Clinical course: It was reported that they have a lot number that gave some patients what the doctor was considering abnormal reactions. Reporter stated they have another 16 doses of the same lot they just found that was affected. Stated that about 7 patients were involved with the previous report. Caller didn't have patient details to provide. Clarified abnormal reactions - stated the email she received states cellulitis, extreme redness, and swelling with one patient that went to the ER. States she not reporting anything new, just updating they have 16 doses of the same lot number that they found and quarantined. Confirms not administered to patients. She was looking to replace the 16 doses. The product sample was available to be returned. Packaging was sealed and intact. Causality for "cellulitis", "extreme redness" and "swelling" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: As there is limited information in the case provided, the causal association between the events cellulitis, erythema, and swelling; and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate. More
2872640 M TN 11/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Influenza virus test, SARS-CoV-2 test COVID-19, Drug ineffective, Influenza virus test, SARS-CoV-2 test
I tested positive this morning, today/ sick for about four- about five weeks or more and they finall... I tested positive this morning, today/ sick for about four- about five weeks or more and they finally determined that I had COVID; I tested positive this morning, today/ sick for about four- about five weeks or more and they finally determined that I had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation as dose number unknown, single; ATORVASTATIN taken for blood cholesterol abnormal; IRBESARTAN taken for blood pressure abnormal. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2025, outcome "unknown" and all described as "I tested positive this morning, today/ sick for about four- about five weeks or more and they finally determined that I had COVID". The patient underwent the following laboratory tests and procedures: Influenza virus test: (06Nov2025) Negative; SARS-CoV-2 test: (06Nov2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient reported that they have COVID after receiving vaccinations (Later vaccine name clarified as Pfizer COVID-19 Vaccine). Patient is prescribed the Paxlovid medication (Treatment). The patient stated he had a Pfizer Vaccine, and they said it was the most up to date one that he had it like the end of Sep2025. They said it was an up-to-date version. Consumer further stated, "Well, I had the vaccination right at the end of Sep and I got diagnosed with COVID today but I have been sick for probably four or five weeks or more. I am not saying that vaccine had anything to do with it, that's the reason I got the vaccine so I would not catch COVID. I do not know, I am not saying the vaccine caused it. It's the coincidence, I guess." When probed if consumer want to proceed with report or not, consumer stated, "Well, I am not blaming Pfizer. I have taken every COVID Shot, I have had ever since they came out with them and I have been five Pfizer already (Pfizer COVID-19 Vaccine). I have used every time because I have had never had a problem with them. I am happy with Pfizer. I am not trying to say Pfizer caused me to get sick." Date of vaccination: Consumer stated, "I am guessing right at the end of September and I do not know the exact date I got the vaccine. Somewhere around the 01Oct, I got end of Sep2025." Anatomical location, Consumer stated, "It might have been Sep. It's right at the end of Sep, I think. I am not sure because I got a Flu Shot one arm and I probably got it in the left arm but I do not know for sure. I did not get the shots the same day, I got them about a week apart. I got the COVID shot and about a week later, I got the Flu shot. So, I do not, probably my left arm but I can sure to it." Lab test: Consumer stated, "It has been longer than two weeks, I had this morning, they did a flu test and a covid test and flu test came back negative and the covid test swab came back positive. I have been sick probably five weeks, but this is getting worse." When clarified if tested positive after recent covid vaccine: Consumer stated, "This morning they tested me and said it was positive for covid." Patient did not receive any vaccines on the same date as Pfizer covid vaccine. If previously took Pfizer covid vaccine: Consumer stated, "I had every one, that they have come out with, I think I am up to date on my booster shot, this is first time I had covid." Treatment for covid: Consumer stated, "No, I just now felt I had it, I have not had a chance to go pick it up yet, when we hang up, I am going to head to drug store and get my medicine, 'while I can get started on it'." When clarified if prescribed with Paxlovid as a treatment: Consumer stated, "Yes." More
2872642 79 M OH 11/13/2025 COVID19
 PFIZER\BIONTECH
Heart rate, Heart rate increased, Hyperhidrosis, Tremor, Vomiting Heart rate, Heart rate increased, Hyperhidrosis, Tremor, Vomiting
experiencing shaking after bath; sweating; vomiting; heart beats very quickly; This is a spontaneous... experiencing shaking after bath; sweating; vomiting; heart beats very quickly; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: . A 79-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Nov2025 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing), notes: in 2020, he got COVID and went to hospital.; "Chronic Lymphocytic Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bnt162b2, start date: 2020, for COVID-19 immunization, reaction(s): "shaking", notes: in 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period; Bnt162b2, start date: 2020, for COVID-19 immunization, reaction(s): "sweating", notes: in 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period; Bnt162b2, start date: 2023, for COVID-19 immunization, reaction(s): "shaking", notes: after 3 years he was administered with COVID vaccine and had the same reaction; Bnt162b2, start date: 2023, for COVID-19 immunization, reaction(s): "sweating", notes: after 3 years he was administered with COVID vaccine and had the same reaction. The following information was reported: TREMOR (hospitalization, life threatening) with onset Nov2025, outcome "recovered", described as "experiencing shaking after bath"; HEART RATE INCREASED (non-serious) with onset Nov2025, outcome "unknown", described as "heart beats very quickly"; HYPERHIDROSIS (non-serious) with onset Nov2025, outcome "recovered", described as "sweating"; VOMITING (non-serious) with onset Nov2025, outcome "unknown". The patient underwent the following laboratory tests and procedures: Heart rate: very quickly. Additional information: Caller elaborated that he was last administered with Comirnaty on 04Nov2025 and in 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period, after 3 years he was administered with COVID vaccine and had the same reaction. When paraphrased the above concern, consumer stated, "I started, in 2020, I got COVID and spend 11 days in ICU. 21 comes along and I took the shot (Pfizer COVID-19 Vaccine) and that evening until the next morning, I had sweats and shaking and very uncomfortable. Next year comes around, I do the same thing, this year, I come around I do the same thing, except this time, I throw up and my heart was just pounding. My concern is like I said I spend 11 days in ICU, I am thinking, should I continue to take this shot? Because I am 79 years old." The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
✓ ✓
2872643 11/13/2025 COVID19
 PFIZER\BIONTECH
Arteriosclerosis, Cerebrovascular accident, Type 2 diabetes mellitus Arteriosclerosis, Cerebrovascular accident, Type 2 diabetes mellitus
CVA; uncontrolled type 2 DM; atherosclerotic CVD; This is a spontaneous report received from a Physi... CVA; uncontrolled type 2 DM; atherosclerotic CVD; This is a spontaneous report received from a Physician. 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 was not reported. The patient took concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (death, hospitalization), outcome "fatal", described as "CVA"; TYPE 2 DIABETES MELLITUS (death, hospitalization), outcome "fatal", described as "uncontrolled type 2 DM"; ARTERIOSCLEROSIS (death, hospitalization), outcome "fatal", described as "atherosclerotic CVD". Therapeutic measures were taken as a result of cerebrovascular accident, type 2 diabetes mellitus, arteriosclerosis. The patient date of death was Feb2021. Reported cause of death: "CVA", "uncontrolled type 2 DM", "atherosclerotic CVD". It was not reported if an autopsy was performed. Clinical course: HCP is Nephrologist is a large private practice. One of his HD patients developed a CVA 5 weeks after Cormirnaty. He ascribes this to the vaccine and did not take into account uncontrolled type 2 DM and atherosclerotic CVD as potential confounding factors. Ae resulted in: Hospitalization, Patient died. Date of death: Feb2021. If autopsy performed: Unknown. If treatment AE: Yes. AE treatment: Details not known The information on the batch/lot number for [BNT162B2 OMICRON (LP.8.1)] will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events cerebrovascular accident, type 2 diabetes mellitus, and arteriosclerosis; and the suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.; Reported Cause(s) of Death: CVA; uncontrolled type 2 DM; atherosclerotic CVD More
✓ ✓
2872644 M OH 11/13/2025 COVID19
 PFIZER\BIONTECH
Discomfort, Hyperhidrosis, Tremor Discomfort, Hyperhidrosis, Tremor
sweats; shaking; Very uncomfortable; This is a spontaneous report received from a Consumer or other ... sweats; shaking; Very uncomfortable; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 75-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing); "ICU", start date: 2020 (unspecified if ongoing), notes: 11 days in ICU. The patient's concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "recovered", described as "Very uncomfortable"; TREMOR (non-serious) with onset 2021, outcome "recovered", described as "shaking"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "recovered", described as "sweats". Additional information: The patient experience about the Pfizer COVID-19 Vaccine. So, just want to add some more information that the patient experiences shaking and sweating after the Pfizer COVID-19 Vaccine and then, it takes 12 hours to get rid of what they experienced. When paraphrased the above concern, consumer stated, patient started, in 2020, he got COVID and spend 11 days in ICU. 21 comes along and he took the shot (Pfizer COVID-19 Vaccine) and that evening until the next morning, he had sweats and shaking and very uncomfortable. Next year comes around, he did the same thing, this year, he comes around he do the same thing, except this time, he throws up and his heart was just pounding. His concern was like he said he spend 11 days in ICU, he was thinking, should he continue to take this shot. Because he was 79 years old. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2872645 11/13/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

COVID-19, Drug ineffective; COVID-19, Drug ineffective COVID-19, Drug ineffective; COVID-19, Drug ineffective
Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP. Other Ca... Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790706 (Moderna). 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; elasomeran (SPIKEVAX), as dose 1, single intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported that the patient never had COVID in the last five years. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN (received every single vaccine that was ever been offered. Some were moderna, some were Pfizer)), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2025, outcome "recovering" and all described as "Covid-19". The event "covid-19" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: On 01Sep2025 the patient got the COVID at the beach. The patient was a little sick. The symptoms were not like a typical cold sore throat and then the patient had a tight chest. The patient did not experience sneezing or coughing, but the patient had a tight chest. The patient received treatment of Paxlovid in Sep2025 for COVID-19, and the patient symptoms get better after 7 days. The patient believed this COVID-19 infection must be very mutated interaction. Because the patient received every single vaccine that was ever been offered. Like with example Some were moderna, some were Pfizer, and the patient traveled to seven countries and four continents, and never had COVID-before. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2872646 11/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19 COVID-19
I got my Covid vaccines, but still had a few hours with Covid anyway; This is a spontaneous report r... I got my Covid vaccines, but still had a few hours with Covid anyway; 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: COVID-19 (non-serious), outcome "unknown", described as "I got my Covid vaccines, but still had a few hours with Covid anyway". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2872647 4 F 11/13/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Dysstasia, Gait disturbance, Injection site erythema, Injection site rash, Injec... Dysstasia, Gait disturbance, Injection site erythema, Injection site rash, Injection site warmth; Motor dysfunction, Muscular weakness, Pain in extremity, Pruritus More
motor skills and lower limb strength have decreased significantly; frequently tripping; unable to st... motor skills and lower limb strength have decreased significantly; frequently tripping; unable to stand without sitting for a length of time; lower limb strength have decreased significantly; legs hurt; injection site was red; injection site was hot to the touch; injection site was red, hot to the touch, with a rash running up and down; extreme itchiness; Initial information received on 05-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves a 4 years old female patient who had motor skills and lower limb strength have decreased significantly, frequently tripping, unable to stand without sitting for a length of time, extreme itchiness, lower limb strength have decreased significantly, legs hurt, injection site was red, injection site was hot to the touch and injection site was red, hot to the touch, with a rash running up and down after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Oct-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) . Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 24-OCT-2025 the patient had injection site was red (vaccination site erythema), injection site was hot to the touch (vaccination site warmth), injection site was red, hot to the touch, with a rash running up and down (vaccination site rash) and extreme itchiness (pruritus) (latency 1 day). On an unknown date in Nov 2025 the patient had motor skills and lower limb strength have decreased significantly (psychomotor skills impaired), frequently tripping (fall),unable to stand without sitting for a length of time (dysstasia),lower limb strength have decreased significantly (asthenia)and legs hurt (pain in extremity) (latency2 weeks approximately). It was reported "they were looking to order blood tests to rule out GBS (Guillain Barre syndrome), myositis, SMA (Spinal muscular atrophy), Lyme, etc. My 2year old daughter received the same vaccine at the same time without incident" Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome was Recovered / Resolved on 25-Oct-2025 for the events vaccination site erythema,vaccination site warmth, vaccination site rash and pruritus, unknown for other events More
2872649 67 F PA 11/13/2025 FLU3
 SANOFI PASTEUR
 U8874BA
Heart rate increased, Hypertension, Pharyngeal swelling, Uvulitis Heart rate increased, Hypertension, Pharyngeal swelling, Uvulitis
diagnosed with uvulitis; back of their throat was swollen; had high blood pressure; high heart rate;... diagnosed with uvulitis; back of their throat was swollen; had high blood pressure; high heart rate; Initial information received on 06-Nov-2025 regarding an unsolicited valid non-serious case (along with live follow -up attached with csd dated:06-Nov-2025) received from a Patient. This case involves a 67 years old female patient who had diagnosed with uvulitis, high blood pressure and high heart rate after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Nov-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8874BA, expiry date: 30-Jun-2026, frequency: once, strength high dose, via intramuscular route in the left arm for Influenza [Influenza immunisation]. On 04-Nov-2025 the patient had diagnosed with uvulitis (uvulitis), had high blood pressure (hypertension), back of their throat was swollen (pharyngeal swelling) and high heart rate (heart rate increased) (latency: 2 days). Relevant laboratory test results included: Blood pressure measurement - On 04-Nov-2025: 157/84 UNK [157/84] Heart rate - On 04-Nov-2025: 122 beats/min Action taken was not applicable. Treatment: The patient was treated with Ketorolac tromethamine (Toradol) through the IV for Uvulitis and Pharyngeal swelling, Methylprednisolone sodium succinate (Solu medrol) for Uvulitis and Pharyngeal swelling and when they were discharged, given with Prednisone. It was not reported if the patient received a corrective treatment for the events (high blood pressure and high heart rate). At time of reporting, the outcome was Unknown for all the events. More
2872650 10 M CA 11/13/2025 COVID19
 MODERNA
 3052583
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient 10 years old, was administered Moderna 12 years+ COVID-19 vaccination. Dose not appropriate ... Patient 10 years old, was administered Moderna 12 years+ COVID-19 vaccination. Dose not appropriate for age More
2872651 32 F MA 11/13/2025 COVID19
 NOVAVAX
 6315MF001C
Chest pain, Echocardiogram abnormal, Electrocardiogram normal, Pericardial effus... Chest pain, Echocardiogram abnormal, Electrocardiogram normal, Pericardial effusion, Pericarditis More
Chest pain began with within one hour of vaccine administration and continued. Patient presented to ... Chest pain began with within one hour of vaccine administration and continued. Patient presented to the emergency department the following day. Concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion More
✓
2872652 47 F NJ 11/13/2025 FLU3
 SANOFI PASTEUR
 U8881DA
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Patient complains of Redness, and swelling to the injection site on left arm. Area is itchy too. Patient complains of Redness, and swelling to the injection site on left arm. Area is itchy too.
2872654 70 F NY 11/13/2025 FLU3
 SANOFI PASTEUR
 ut8794aa
Dizziness Dizziness
Pt complained of feeling dizzy a couple of hours after receiving the vaccine. She said she was goin... Pt complained of feeling dizzy a couple of hours after receiving the vaccine. She said she was going to go home and rest. More
2872655 62 F ID 11/13/2025 FLU3
 SEQIRUS, INC.
 AX4142A
Bursitis, Joint range of motion decreased, Pain, Sleep disorder Bursitis, Joint range of motion decreased, Pain, Sleep disorder
Pt states she had pain almost immediately after the flu vaccination that progressed over the next 3 ... Pt states she had pain almost immediately after the flu vaccination that progressed over the next 3 days. Has decreased range of motion and pain that wakes her during the night. Provider determined pain from bursitis of the right shoulder and patient received an injection of 3cc of 1% lidocaine with 2cc of Celestone into the bursa guided by ultrasound on 11/3/25. More
2872660 17 M WA 11/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0590
UT8861MA
Dizziness; Dizziness Dizziness; Dizziness
Per pt. mother, patient took blood pressure medication, Candesartan 15 mg, one hour prior to coming... Per pt. mother, patient took blood pressure medication, Candesartan 15 mg, one hour prior to coming for vaccinations. At the time of vaccination, patient' s parents did not mention it to me. Patient is a new patient to us. he received two vaccines, Corminaty and Fluzone TRIV, went to the restroom, then stopped by the drop off window. Approximately, 7 minutes after the vaccination, the patient felt light headness sat on the ground slowly without hitting his head. Patient was counseled regarding the possible side effects associated with the vaccines. EMS called by pt's father and patient was released by EMT after 15 minutes. More
2872662 70 M ID 11/13/2025 FLU3
 SANOFI PASTEUR
 UT8829AA
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Redness that is localized in a 3-inch diameter around injection site. It is warm to the touch compar... Redness that is localized in a 3-inch diameter around injection site. It is warm to the touch comparatively and slightly raised. No complaint of pain. More
2872669 40 F MN 11/13/2025 FLU3
 SANOFI PASTEUR
 UT8826JA
Arthralgia, Discomfort, Pain Arthralgia, Discomfort, Pain
Had radiating pain all the way medial to my shoulder blade. I have been taking Ibuprofen, using lid... Had radiating pain all the way medial to my shoulder blade. I have been taking Ibuprofen, using lidocaine patches and different pain creams(Penetrex, Voltaren, Biofreeze). Overnight and today it became very much worse and can find no comfortable position. More
2872670 84 M KS 11/13/2025 COVID19
FLU3
RSV
 MODERNA
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 3052035
u8862ca
cm9a5
Chills, Cough, Oropharyngeal pain, Productive cough; Chills, Cough, Oropharyngea... Chills, Cough, Oropharyngeal pain, Productive cough; Chills, Cough, Oropharyngeal pain, Productive cough; Chills, Cough, Oropharyngeal pain, Productive cough More
Pt recieved vaccines on Wed 11/5/26. By Thursday he was having chills. Saturday he started having a... Pt recieved vaccines on Wed 11/5/26. By Thursday he was having chills. Saturday he started having a sore throat, coughing, phlegm. He started feeling better Monday 11/10/25 More
2872671 84 M FL 11/13/2025 COVID19
 NOVAVAX
 6315MF002C
Chills, Fatigue, Laboratory test, Peripheral swelling, Pyrexia Chills, Fatigue, Laboratory test, Peripheral swelling, Pyrexia
PATIENT EXPERIENCED FEVER (100.5F), CHILLS, FATIGUE AND SWELLING OF BOTH LEGS. HE TOOK TYLENOL FOR T... PATIENT EXPERIENCED FEVER (100.5F), CHILLS, FATIGUE AND SWELLING OF BOTH LEGS. HE TOOK TYLENOL FOR THE FEVER. PATIENT NOTED HIS LEGS SWELLING ASOF THREE DAYS AGO (11/10/25) AND HAD TO SEE HIS PROVIDER. HE IS CURRENTLY BEING TREATED WITH FUROSEMIDE 20 MG DAILY AND PREDNISONE 20 MG DAILY FOR THE LEG SWELLING. More
2872672 83 M FL 11/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA4452
UT8781DA
Death, Fatigue, General physical health deterioration, Lethargy, Malaise; Death,... Death, Fatigue, General physical health deterioration, Lethargy, Malaise; Death, Fatigue, General physical health deterioration, Lethargy, Malaise More
Patient's son came to pharmacy 11/12/25 to inform pharmacy that the patient passed away 10/26/2... Patient's son came to pharmacy 11/12/25 to inform pharmacy that the patient passed away 10/26/25, 10 days post vaccines. He informed us that his father was in hospice for the past several months for cancer but was stable (though he remarked his father would have appeared unwell and should not have received vaccines though we had consent form where he did not indicate any cold, fever or acute illness) and a few days post vaccine he was feeling very fatigued and feel acutely ill/lethargic and went into care and passed that week later. Though his father had cancer his son feels that he should not have rapidly deteriorated in health so shortly after vaccines. More
✓
2872674 10 M MD 11/13/2025 COVID19
 PFIZER\BIONTECH
 T5727
Wrong product administered Wrong product administered
The patient received COMIRNATY 5-11Y vaccine instead of Varicella vaccine The patient received COMIRNATY 5-11Y vaccine instead of Varicella vaccine
2872675 42 M IL 11/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.

Pain, Pain in extremity; Pain, Pain in extremity Pain, Pain in extremity; Pain, Pain in extremity
Arm has felt similar to pain day after the vaccination. Dull pain around deltoid, below injection si... Arm has felt similar to pain day after the vaccination. Dull pain around deltoid, below injection site. Pain increases with different routine arm movements. More
2872676 16 M CO 11/13/2025 COVID19
FLU3
HEPA
HPV9
IPV
MNQ
TDAP
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 3052668
2NG23
MB599
Y018416
Y1A212M
9549B
4K7JP
Hypotonia, Loss of consciousness; Hypotonia, Loss of consciousness; Hypotonia, L... Hypotonia, Loss of consciousness; Hypotonia, Loss of consciousness; Hypotonia, Loss of consciousness; Hypotonia, Loss of consciousness; Hypotonia, Loss of consciousness; Hypotonia, Loss of consciousness; Hypotonia, Loss of consciousness More
Patient to receive 10 vaccines due to need to catch up on vaccines and Flu and COVID. Nurse number 1... Patient to receive 10 vaccines due to need to catch up on vaccines and Flu and COVID. Nurse number 1 was giving vaccines on patients right arm; Nurse #2 was giving vaccines on the left arm. When nurse #1 gave the 5th shot (HPV) on the right arm, patient slumped down. The nurses gently got patient to floor, elevated his legs, he felt better within seconds, patient stated "he dreamt for a few seconds, then woke up". Vital signs were monitored and he was kept on the floor with his feet elevated. He was given water and offered gummy fruit snacks which he took and fed himself. FOC was called, as he worked nearby. The school nurse and Nurse #2 explained the incident to the FOC. Also, advised him that the patient did not receive 2 vaccines (MMR & varicella). FOC declined further vaccine administration after incident. More
2872677 32 M AK 11/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR

Fatigue, Pain, Pyrexia; Fatigue, Pain, Pyrexia Fatigue, Pain, Pyrexia; Fatigue, Pain, Pyrexia
High fever, body aches and fatigue High fever, body aches and fatigue
2872679 72 F PA 11/13/2025 COVID19
 PFIZER\BIONTECH
 NA0590
Injection site pruritus, Injection site swelling Injection site pruritus, Injection site swelling
PT reported that approximately 4 hours after receiving the vaccine, the injection site was swollen a... PT reported that approximately 4 hours after receiving the vaccine, the injection site was swollen and itchy. Pt stated that she applied alcohol, but that did not resolve the issue. Reminded pt that while pain and swelling at the injection site are not uncommon after an immunization, combined with the itching there is a concern for possible infection. Recommended that the pt contact her physician for further medical advice on this situation,. More
2872680 54 M ID 11/13/2025 FLU3
 SEQIRUS, INC.
 408924
No adverse event, Wrong product administered No adverse event, Wrong product administered
No adverse reaction reported by the patient at this time. Patient was given FLUAD instead of FLUCELV... No adverse reaction reported by the patient at this time. Patient was given FLUAD instead of FLUCELVAX. More
2872683 62 F WA 11/13/2025 UNK
 UNKNOWN MANUFACTURER
 23E4B
Injection site reaction, Pain, Pyrexia, Rash erythematous Injection site reaction, Pain, Pyrexia, Rash erythematous
Pt reports fever and aches x2d after vaccine. Now have a red rash around injection site that spread ... Pt reports fever and aches x2d after vaccine. Now have a red rash around injection site that spread down to-bicep; pt reports rash is getting better. no other adverse reactions reported. More
2872684 53 M AL 11/13/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 U8823DA
LX4482
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient requested pneumonia vaccine. Patient profile (only contains one year of history) reviewed f... Patient requested pneumonia vaccine. Patient profile (only contains one year of history) reviewed for history of pneumonia vaccines in addition to state immunization registry neither of which reflected any history of patient ever receiving a pneumonia vaccine. Patient was given Prevnar 20 vaccine. We later received an email from pharmacy indicating that patient had already received a Prevnar 20 vaccine on 11/02/2023. Patient experienced no adverse effects and no treatment was required. More
2872685 72 F IL 11/13/2025 FLU3
 SANOFI PASTEUR
 U8855AA
Pruritus, Skin burning sensation Pruritus, Skin burning sensation
Patient got a flu shot (Fluzone HD) on 10/29/25. Pt reports that later that night she got a burning ... Patient got a flu shot (Fluzone HD) on 10/29/25. Pt reports that later that night she got a burning sensation on one side of her face. She says that feeling changed to an itching sensation and spread over her whole body. As of 11/12/25, she says she is still dealing with these symptoms. She has taken allergy medications and steroids but hasn't gotten rid of the itching yet. Patient states that she never developed a rash. More
2872690 43 M 11/13/2025 COVID19
 MODERNA
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient was inadvertently given Mnexspike at vaccination event instead of Spikevax despite no known ... Patient was inadvertently given Mnexspike at vaccination event instead of Spikevax despite no known health conditions that increase risk for severe outcomes from COVID. No adverse reaction noted. Patient notified of administration error. More
2872691 41 F WA 11/13/2025 COVID19
 MODERNA
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient was inadvertently given Mnexspike at vaccination event instead of Spikevax despite no known ... Patient was inadvertently given Mnexspike at vaccination event instead of Spikevax despite no known health conditions that increase risk for severe outcomes from COVID. No adverse reaction noted. Patient notified of administration error. More
2872703 45 F NJ 11/13/2025 FLU3
 SANOFI PASTEUR
 U9923DA
Pain, Pyrexia Pain, Pyrexia
Aprox. 6:30pm, same day as vaccination, started with a low grade fever and body aches. Temperature w... Aprox. 6:30pm, same day as vaccination, started with a low grade fever and body aches. Temperature went away by morning. Body aches lasted for 2 days. More
2872704 81 F NY 11/13/2025 FLU3
 SEQIRUS, INC.
 407275
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Severe pain in arm and shoulder. Patient went to doctor and needed to get steroid shot. Patient stat... Severe pain in arm and shoulder. Patient went to doctor and needed to get steroid shot. Patient stated some relief after steroid shot. More
2872173 M WI 11/12/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Areflexia, Diplopia, Eye movement disorder, Gag reflex test, HIV test negative; ... Areflexia, Diplopia, Eye movement disorder, Gag reflex test, HIV test negative; Herpes zoster, Herpes zoster reactivation, Lymph node pain, Ophthalmic herpes zoster, Oropharyngeal pain; Rash, Rash vesicular, Skin discolouration, Slit-lamp tests normal, Streptococcus test negative; Tonsillar exudate, Tonsillar hypertrophy, VIth nerve paralysis, Vaccination failure, Visual acuity reduced; Areflexia, Diplopia, Eye movement disorder, Gag reflex test, HIV test negative; Herpes zoster, Herpes zoster reactivation, Lymph node pain, Ophthalmic herpes zoster, Oropharyngeal pain; Rash, Rash vesicular, Skin discolouration, Slit-lamp tests normal, Streptococcus test negative; Tonsillar exudate, Tonsillar hypertrophy, VIth nerve paralysis, Vaccination failure, Visual acuity reduced More
right-sided scalp discoloration; vesicular rash; right-sided sore throat; tonsillar exudate; he had ... right-sided scalp discoloration; vesicular rash; right-sided sore throat; tonsillar exudate; he had a decreased gag reflex; tenderness to the preauricular and cervical chain lymph nodes; right tonsil was enlarged without exudate; dermatomal rash; suspected vaccination failure; Herpes zoster ophthalmicus / VZV reactivation; herpes zoster infection/Varicella zoster virus reactivation; cranial nerve VI palsy; acute double vision / diplopia; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old male patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Literature Reference: Co-suspect products included Herpes zoster (Zoster vaccine) for prophylaxis. The patient's past medical history included shingles (Years prior to his presentation). Previously administered products included zoster vaccine with an associated reaction of no adverse event (live zoster vaccine). Concurrent medical conditions included keratoconus, nuclear cataract (ophthalmology clinic), thyroid gland cancer, thyroidectomy, prostate cancer, radical retropubic prostatectomy, radioactive iodine therapy, hyperlipidemia, hypertension, mycobacterium avium complex infection, bronchiectasis and asthma. Additional patient notes included He had no vision changes, ear pain, ear drainage, headache, anosmia, or nose lesions. Concomitant products included sulfamethoxazole;trimethoprim. In 2019, the patient received Zoster vaccine. In 2018, the patient received Zoster vaccine. On an unknown date, an unknown time after receiving Zoster vaccine and Zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Herpes zoster ophthalmicus / VZV reactivation) (serious criteria GSK medically significant), herpes zoster (Verbatim: herpes zoster infection/Varicella zoster virus reactivation), vith nerve palsy (Verbatim: cranial nerve VI palsy) (serious criteria GSK medically significant), double vision (Verbatim: acute double vision / diplopia), skin discoloration (Verbatim: right-sided scalp discoloration), vesicular rash (Verbatim: vesicular rash), sore throat (Verbatim: right-sided sore throat), tonsillar exudate (Verbatim: tonsillar exudate), gagging (Verbatim: he had a decreased gag reflex), lymph node tenderness (Verbatim: tenderness to the preauricular and cervical chain lymph nodes), swollen tonsils (Verbatim: right tonsil was enlarged without exudate) and rash (Verbatim: dermatomal rash). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster, vith nerve palsy, skin discoloration, vesicular rash, sore throat, tonsillar exudate, gagging, lymph node tenderness and swollen tonsils were not reported and the outcome of the double vision was resolved (duration 3 days) and the outcome of the rash was resolving. The reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster, vith nerve palsy, double vision, skin discoloration, vesicular rash, sore throat, tonsillar exudate, gagging, lymph node tenderness, swollen tonsils and rash to be related to Zoster vaccine and Zoster vaccine. The company considered the vaccination failure, herpes zoster, double vision, skin discoloration, vesicular rash, sore throat, tonsillar exudate, gagging, lymph node tenderness, swollen tonsils and rash to be related to Zoster vaccine and Zoster vaccine. The company considered the ophthalmic herpes zoster and vith nerve palsy to be unrelated to Zoster vaccine and Zoster vaccine. Additional Information: GSK Receipt Date: 25-Mar-2024 The author presented an 82-year-old man with a past ocular history of keratoconus and bilateral nuclear sclerotic cataracts presented to the ophthalmology clinic with a 3-day history of acute double vision His past medical history was remarkable for thyroid cancer status post thyroidectomy and radioactive iodine, prostate cancer status post radical retropubic prostatectomy, hyperlipidemia, hypertension, severe asthma, and bronchiectasis, as well as history of pulmonary mycobacterium avium-intracellulare superimposed on pulmonary norcardiosis, for which he was on chronic trimethoprim/sulfamethoxazole and followed closely by infectious disease. Notably, he was HIV negative and with no other underlying immunologic or immunosuppressive conditions. Years prior to his presentation, he had shingles of his left flank. He received the live zoster vaccine in 2011 and the recombinant zoster vaccine in 2018 and 2019. Fourteen days prior to the onset of diplopia, he was seen by infectious disease for right-sided scalp discoloration and vesicular rash that began approximately 1 week after he had a right-sided sore throat with white, tonsillar exudate. On exam, he had a decreased gag reflex, tenderness to the preauricular and cervical chain lymph nodes, and the right tonsil was enlarged without exudate. A rapid strep test was negative. He had no vision changes, ear pain, ear drainage, headache, anosmia, or nose lesions. He was diagnosed with Herpes zoster ophthalmicus (HZO) and treated with a 10-day course of oral valacyclovir. The infectious disease specialist believed the sore throat was related to zoster polyneuropathy of cranial nerve IX and X. When presenting to the ophthalmology clinic, the patient described his double vision as constant, binocular, and horizontal. He stated that it became worse when looking right, and he experienced notable improvement when looking left. His visual acuity was 20/50 in each eye, and both pupils were equal and reactive without an afferent pupillary defect. Confrontation visual fields were full in both eyes. Extraocular movements were notable for limited abduction of the right eye. Extraocular movements were normal and full in the left eye. Slit lamp exam was negative for eyelid vesicular lesions, conjunctivitis, keratitis including dendritic lesions, and uveitis. He was diagnosed with a cranial nerve VI palsy of the right eye secondary to herpes zoster infection. Since he already completed a course of antiviral therapy, it was decided to forego any further treatment, especially given evidence of disease regression with the healing of the dermatomal rash. Oral steroids were not prescribed. Close observation and follow-up were recommended. Return precautions, including worsening double vision, decreasing vision, eye pain, light sensitivity, and eye redness, were reviewed with the patient. At his follow-up, he reported the double vision resolved spontaneously approximately 3 to 4 weeks after the onset of the symptoms. This case was considered as suspected vaccination failure since the details regarding vaccination scheduled and TTO were unknown. This article is not available for regulatory reporting purpose due to copyright restriction. Upon internal review the case was updated on: 26-Aug-2024. Suspect product coding was updated. Summary of Changes: Product tab updated.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Zoster vaccine. Ophthalmic herpes zoster and VIth nerve paralysis are unlisted events which are considered unrelated to GSK Zoster vaccine. More
2872176 CA 11/12/2025 FLU3
 SANOFI PASTEUR
 U8832CA
Expired product administered, No adverse event Expired product administered, No adverse event
expiration date for a FLUBLOK vaccine given to a patient back in September, with no reported adverse... expiration date for a FLUBLOK vaccine given to a patient back in September, with no reported adverse event; Initial information received on 03-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient with unknown age and gender who was given Influenza Trivalent Recombinant Vaccine [Flublok] and expiration date was back in september, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Sep-2025, the patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot U8832CA, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and expiration date for a flublok vaccine given to a patient back in september, with no reported adverse event (expired product administered) (latency same day). Reportedly, due to caller having an unknown issue with expiration documentation of a dose of Flublok thus having the pharmacist seeking the correct information. 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
2872194 78 F OR 11/12/2025 FLU3
 SANOFI PASTEUR
 UT8804CA
Erythema, Swelling Erythema, Swelling
patient reported that she had a raised patch of redness a day after received her flu shot. it has go... patient reported that she had a raised patch of redness a day after received her flu shot. it has gone away after a day with hot shower and some topical cream she used (not stated names of topical) More
2872195 68 M HI 11/12/2025 COVID19
 MODERNA
 3052155
Conjunctival haemorrhage Conjunctival haemorrhage
3 days after vaccination a subconjunctival hemorrhage developed in the nose side of the left eye. N... 3 days after vaccination a subconjunctival hemorrhage developed in the nose side of the left eye. No pain or other symptoms were noted. The area of blood in the white of the eye grew for 2 days covering the quadrant from 6 to 10 o'clock on a dial. On day 6 after appearance, the blood substantially cleared. The most recent prior subconjunctival hemorrhage occurred in 2014 in the right eye 1 day after cold symptoms appeared. More
2872196 47 F OR 11/12/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR

Dizziness, Fatigue, Laboratory test, Migraine, Vertigo; Dizziness, Fatigue, Labo... Dizziness, Fatigue, Laboratory test, Migraine, Vertigo; Dizziness, Fatigue, Laboratory test, Migraine, Vertigo More
Extreme fatigue, Extreme dizziness/vertigo, migraines Extreme fatigue, Extreme dizziness/vertigo, migraines
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2872197 6 F MI 11/12/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site induration, Injection site warmth Injection site erythema, Injection site induration, Injection site warmth
Injection site and 2? around became red, hot and hard. Ice and Zyrtec given. Urgent care visit 4 day... Injection site and 2? around became red, hot and hard. Ice and Zyrtec given. Urgent care visit 4 days post injection since area is still red and hot, advised to monitor, continue Zyrtec and start epsom salt soaks More
2872210 M 11/12/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
Epistaxis Epistaxis
THE REPORTER MENTIONED THAT SHE OBSERVED A CHILD BOY PATIENT TO HAVE A NOSEBLEED AFTER HAVING RECEIV... THE REPORTER MENTIONED THAT SHE OBSERVED A CHILD BOY PATIENT TO HAVE A NOSEBLEED AFTER HAVING RECEIVED FLUMIST. SHE ASKED IF THEY COULD RECEIVE DEMONSTRATION VIDEOS ON HOW TO ADMINISTER FLUMIST TO HAVE A RESOURCE.; A spontaneous report has been received from a other health professional. The report concerns a male patient (age not provided). No medical history was reported. No concomitant products were reported. The patient received Flumist, via nasal use for vaccine/influenza prevention on an unknown date. The patient received 1 dose(s). No malfunction has been reported for the Accuspray Single Dose device. On an unknown date, the patient experienced the reporter mentioned that she observed a child boy patient to have a nosebleed after having received flumist. she asked if they could receive demonstration videos on how to administer flumist to have a resource. (preferred term: Epistaxis). The outcome of the event(s) of the reporter mentioned that she observed a child boy patient to have a nosebleed after having received flumist. she asked if they could receive demonstration videos on how to administer flumist to have a resource. was unknown. The event was considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Non-significant correction on 15-Oct-2025: Primary reporter information updated. Narrative amended. Insignificant correction 14-Oct-2025: Null flavor added to primary reporter. Case corrected as result of MCQC. Non-significant correction on 12-Nov-2025: Null flavor for telephone and fax removed, narrative amended. More
2872215 79 F GA 11/12/2025 FLU3
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received 2 doses of fluzone hd in the same season with no reported adverse event; Initial in... patient received 2 doses of fluzone hd in the same season with no reported adverse event; Initial information received on 07-Nov-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 79 years old female patient who received 2 doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] in the same season with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Oct-2025 the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (dose, batch and expiry date unknown) via unknown route in unknown administration site for Influenza (Influenza immunization). On 07-Nov-2025, the patient again received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE dose 0.5 ml 1x(once) lot UT8781DA expiry date-30-Jun-2026 via intramuscular route in the left upper arm for Influenza (Influenza immunization) in the same season with no reported adverse event (extra dose administered) (latency same day). Action taken-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
2872216 47 F FL 11/12/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza like illness, Malaise, Oropharyngeal pain, Pyrexia, Sinus congestion Influenza like illness, Malaise, Oropharyngeal pain, Pyrexia, Sinus congestion
Had flu vaccine on Monday 27th October and then on the Thursday became sick with flu like symptoms (... Had flu vaccine on Monday 27th October and then on the Thursday became sick with flu like symptoms (sore throat, sinus congestion, fever) and am still sick as on Monday 3rd November More
2872217 NM 11/12/2025 COVID19
 MODERNA
 3052741
Product container issue Product container issue
Describe Event, Problem, or Product Use Error: Three doses of Moderna spikevax 2025-26 formula were ... Describe Event, Problem, or Product Use Error: Three doses of Moderna spikevax 2025-26 formula were empty upon receipt at providers' office More
2872218 56 M IL 11/12/2025 COVID19
COVID19
FLUX
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Blood test, Cardiac monitoring, Computerised tomogram, Dysstasia, Gait inability... Blood test, Cardiac monitoring, Computerised tomogram, Dysstasia, Gait inability; Guillain-Barre syndrome, Magnetic resonance imaging spinal, Musculoskeletal disorder, Nerve conduction studies abnormal; Blood test, Cardiac monitoring, Computerised tomogram, Dysstasia, Gait inability; Guillain-Barre syndrome, Magnetic resonance imaging spinal, Musculoskeletal disorder, Nerve conduction studies abnormal More
On 10/18/2024, my husband had the covid and flu shots administered together at a pharmacy (city, sta... On 10/18/2024, my husband had the covid and flu shots administered together at a pharmacy (city, state withheld). On 10/21, he developed Gillain-Barre' and was unable to walk, use his hands or stand up straight without hold onto something. After a series of tests, it was determined he had Gillain-Barre'. More
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2872219 64 F NY 11/12/2025 FLUX
 UNKNOWN MANUFACTURER
Bronchitis, Malaise, Sinusitis, Urticaria Bronchitis, Malaise, Sinusitis, Urticaria
Patient received a flu shot and dosed her Simlandi 40mg pen 3 days later. She then fell ill with a s... Patient received a flu shot and dosed her Simlandi 40mg pen 3 days later. She then fell ill with a sinus infection and bronchitis, and then started to develop hives in her thighs where she does the Simlandi injections. She normally takes daily allegra, but stopped it while sick as it exacerbated her illness, and that is when the hives appeared. Confirmed she rotates injection sites when she does her injections, and has withheld dose while this is occurring. More
2872220 F ME 11/12/2025 COVID19
 MODERNA
Pruritus, Urticaria Pruritus, Urticaria
Pruritis with long-term cetirizine use. I started using OTC cetirizine in 2021 when I moved to a new... Pruritis with long-term cetirizine use. I started using OTC cetirizine in 2021 when I moved to a new area and was experiencing fall allergies that I'd never had before. I had used it for childhood allergies and used it prn as an adult. I continue to use it about half of the time because it makes me drowsy, so if I was working a long shift the next day I would skip it the night before. I started to noticed that if I hadn't taken it for 2-3 days in a row, I would get hives very easily and be itchy all over. That would go away shortly after taking another one. I believe it was 2022 when I started to notice this, maybe early 2023. I still take 5-10mg of cetirizine almost every night, because I will start to get hives / itchiness 24-48 hours after taking it. I've tried cutting down to 5mg recently but the effects seem to wear off a little earlier. I told my doctor about this in June but I don't think he reported it, he suggested maybe switching to another antihistamine which I will try. Also, there were case studies a few years ago about patients who received Moderna having pruritis that goes away with cetirizine. I did not have a moderna vaccine until 2022, so the timing would be right. I am not sure if these two things are connected, but I think it's interesting that this is a drug that has been around for a long time and only now people are reporting this side effect. I'm a pharmacist and not anti-vax. I even got moderna again this year, to be clear. But I have a feeling this could be connected. I have used brand Zyrtec, store off-brand and store off-brand, I am not certain which I was using when I started to notice the issue. More
2872273 28 F NC 11/12/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4F2AJ
4F2AJ
Dizziness, Headache, Injection site rash, Musculoskeletal pain, Neck pain; Pain,... Dizziness, Headache, Injection site rash, Musculoskeletal pain, Neck pain; Pain, Pain in extremity More
Dizziness, feeling faint, left arm pain that is radiating to left scapula and into left side of neck... Dizziness, feeling faint, left arm pain that is radiating to left scapula and into left side of neck and headache. Patient reports having similar symptom the previous year but with localized rash at injection site. More
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