🏥 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 💀 🏥 🚑 ♿ ⚠️
2862284 09/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; I had the shots and shingles twice; First time nothing much; second t... Suspected vaccination failure; I had the shots and shingles twice; First time nothing much; second time wanted to die from the agony; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had the shots and shingles twice) and feeling abnormal (Verbatim: First time nothing much; second time wanted to die from the agony). The outcome of the vaccination failure, shingles and feeling abnormal were not reported. It was unknown if the reporter considered the vaccination failure, shingles and feeling abnormal to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and feeling abnormal to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-SEP-2025 This case was reported by a patient via interactive digital media.; Sender's Comments: A case of Vaccination failure, unknown time after receiving unknown dose of Shingles vaccine in a subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2862285 F 09/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
was diagnosed with shingles; This non-serious case was reported by a consumer via interactive digita... was diagnosed with shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: was diagnosed with shingles). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 23-SEP-2025 This case was reported by a patient via interactive digital media. The patient had both shots and was diagnosed with shingles. Now the patient was in fourth week and shingles was so painful.; Sender's Comments: US-GSK-US2025AMR124431:Same patient 2nd dose More
2862286 09/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; shingles; This serious case was reported by a consumer via interacti... Suspected Vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-SEP-2025 This case was reported by a patient via interactive digital media. The reporter reported that vaccine did not stop from getting shingles. The reporter got the vaccination and have shingles now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2862287 F 09/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
soreness at the site; This non-serious case was reported by a consumer via interactive digital media... soreness at the site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the site). The outcome of the injection site pain was resolved. The reporter considered the injection site pain to be related to Shingrix. The company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 24-SEP-2025 The patient only had arm soreness at the site with the first one, like a tetanus shot, so she was not prepared. The patient have since learned it was very common and just shows that it was working by stimulating immune response. Having had three bouts of shingles that progressively got worse, the one day of discomfort was worth it. This case is linked with US2025AMR124606, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR124606:same reporter US-GSK-US2025AMR124423:same reporter diff dose US-GSK-US2025AMR124422:same reporter diff dose More
2862288 51 F TX 09/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Influenza like illness, Pain, Pyrexia Influenza like illness, Pain, Pyrexia
Flu-like symptoms; Fever; Body aches; This non-serious case was reported by a pharmacist via call ce... Flu-like symptoms; Fever; Body aches; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 15-SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms), fever (Verbatim: Fever) and general body pain (Verbatim: Body aches). The outcome of the influenza-like symptoms, fever and general body pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and general body pain to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms, fever and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 The pharmacy manager called to inform that a patient got the first dose of Shingrix in 2022 and the patient had experienced flu-like symptoms, fever and body aches, that is why patient did not want the second dose right away. Can patient get the second dose now or does she need to restart the series. After receiving information from MIS, HCP asked the following if a patient had side effects on the first dose, will they experience the same on the second dose. More
2862289 18 F 09/30/2025 COVID19
 MODERNA
Thrombosis Thrombosis
Blood clots from this vaccine; This spontaneous case was reported by a consumer and describes the oc... Blood clots from this vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots from this vaccine) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots from this vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots from this vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Reporter was asking from this vaccine could you get blood clots and mentioned that the patient was 18 years old. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Upon internal review significant corrections were performed on 29-Aug-2025 after which the case was reassessed and determined to be valid. Patient details added, event verbatim updated.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report. More
2862290 09/30/2025 COVID19
 MODERNA
 Unknown
Pain in extremity Pain in extremity
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN E... Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Patient received the first dose of the Moderna COVID-19 vaccine about two weeks ago and had a sore arm. Patient was expected to receive the second dose sometime in Sep-2021. Patient had received first dose of the Moderna vaccine and wants to know if it is safe to travel in various scenarios also patient wants to know what to expect with the second dose of the Moderna vaccine. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Upon internal review significant corrections were performed on 29-Sep-2025 after which the case was reassessed and determined to be valid. event coding updated, suspect details updated, causality added, narrative updated. More
2862291 F 09/30/2025 COVID19
 MODERNA
Rheumatoid arthritis Rheumatoid arthritis
strong RA flare side effects to Moderna previously; This spontaneous case was reported by a consumer... strong RA flare side effects to Moderna previously; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (strong RA flare side effects to Moderna previously) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (strong RA flare side effects to Moderna previously) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (strong RA flare side effects to Moderna previously) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. They just wanted to notify that the Pfizer Covid vaccine patient had a week ago. Reporter saw the Finnish had noticed this in patients so wanted to let know. Maybe learning why that flared can lead to an understanding of menieres that can lead to medications that help. It was a debilitating condition. Reporter just wanted to give a heads up. It was stated that patient had strong RA flare side effects to Moderna previously and did great with yours. No treatment information was reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2862292 82 F MA 09/30/2025 COVID19
 MODERNA
Electrocardiogram, Pain in extremity Electrocardiogram, Pain in extremity
sore upper arm for a couple of days; This spontaneous case was reported by a consumer and describes ... sore upper arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore upper arm for a couple of days) in an 82-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Iritis, Arthritis, Spinal stenosis, Allergy to animals (dog and cat), Grass allergy (various grasses), IBD and Colitis. 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 PAIN IN EXTREMITY (sore upper arm for a couple of days). At the time of the report, PAIN IN EXTREMITY (sore upper arm for a couple of days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: showed something with the left ventricle possible causes, had either IBD or colitis. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. It was reported that the patient had iritis so she must take ketorolac. She had to get a stress test because the EKG showed something with the left ventricle possible causes. She was putting off the stress test because there was a 1 in 5000 risk of dying from the test. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-789601 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2025: Live non-significant follow-up received included reference numbers were added. More
2862293 M 09/30/2025 COVID19
 MODERNA
Immunisation reaction, Speech disorder Immunisation reaction, Speech disorder
he knows he affected the matter the vaccines affect him; You can hear how he talks. He cannot talk; ... he knows he affected the matter the vaccines affect him; You can hear how he talks. He cannot talk; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (he knows he affected the matter the vaccines affect him) and SPEECH DISORDER (You can hear how he talks. He cannot talk) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (he knows he affected the matter the vaccines affect him) and SPEECH DISORDER (You can hear how he talks. He cannot talk). At the time of the report, IMMUNISATION REACTION (he knows he affected the matter the vaccines affect him) and SPEECH DISORDER (You can hear how he talks. He cannot talk) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789631 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789631:Master case More
2862294 74 F 09/30/2025 COVID19-2
 MODERNA
Vomiting Vomiting
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING ... Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The patient's past medical history included CAPD (CAPD (dialysis)) since an unknown date. Concurrent medical conditions included Type I diabetes mellitus. On 15-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VOMITING (Vomiting). In January 2023, VOMITING (Vomiting) had resolved. No concomitant medications were provided. It was reported that patient had taken all Covid vaccines since 2021 till now, which was 7-8 vaccines. It was reported that at each time almost 10 hours after the vaccine she would start vomiting every 20 to 30 minutes and this would last for 6-8 hours. The patient received the Moderna COVID-19 vaccine in 2021. On 28-Apr-2022, patient received a 0.5 mL dose of the Moderna COVID-19 Vaccine Booster. Patient had other 4 vaccines (Spikevax NOS), but she had no information about them. It was mentioned that she had diabetes type 1 and was on dialysis (CAPD). No treatment medication was provided. This case was linked to MOD-2025-789725 (Patient Link). More
2862295 75 F 09/30/2025 COVID19
 MODERNA
Vomiting Vomiting
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING ... Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The patient's past medical history included CAPD (CAPD (dialysis)) since an unknown date. Concurrent medical conditions included Type 1 diabetes mellitus. On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VOMITING (Vomiting). In October 2023, VOMITING (Vomiting) had resolved. No concomitant medications were provided. It was reported that patient had taken all Covid vaccines since 2021 till now, which was 7-8 vaccines. It was reported that at each time almost 10 hours after the vaccine she would start vomiting every 20 to 30 minutes and this would last for 6-8 hours. It was reported that she had always taken Moderna vaccines. The patient received the Moderna COVID-19 vaccine in 2021. On 28-Apr-2022, patient received a 0.5 mL dose of the Moderna COVID-19 Vaccine Booster. On 15-Jan-2023, the patient was administered the Moderna COVID-19 Bivalent Vaccine. Patient had received other 4 vaccines (Spikevax NOS), but she had no information about them. It was mentioned that she had diabetes type 1 and was on dialysis (CAPD). No treatment medication was provided. This case was linked to MOD-2025-789725 (Patient Link). More
2862296 76 F 09/30/2025 COVID19
 MODERNA
Vomiting Vomiting
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING ... Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included CAPD (CAPD (dialysis)) since an unknown date. Concurrent medical conditions included Type 1 diabetes mellitus (Type1 diabetes). On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. In September 2024, the patient experienced VOMITING (Vomiting). In September 2024, VOMITING (Vomiting) had resolved. No concomitant medications provided by the reporter. The patient received the Moderna COVID-19 vaccine in 2021. On 28-Apr-2022, patient received a 0.5 mL dose of the Moderna COVID-19 Vaccine Booster. On 15-Jan-2023, the patient was administered the Moderna COVID-19 Bivalent Vaccine. Subsequently, on 19-Oct-2023, patient received the Spikevax 2023-2024 PFS and SPIKEVAX NOS on an unknown date. It was reported that patient received all COVID-19 vaccines since 2021 till now, which was 7-8 vaccines. It was reported that post COVID-19 vaccination each time almost 10 hours after the vaccine the patient used to start vomit for every 20 to 30 minutes and that vomit used to last for 6-8 hours for the patient. It was reported that patient used to receive Moderna vaccines except for once she got Pfizer Covid-19 vaccine, but she experienced the same symptom. In addition, there were for other 4 other Moderna -Covid-19 vaccine patient had no information. No treatment medications provided by the reporter. This case was linked to MOD-2025-789725 (Patient Link). More
2862297 F 09/30/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Vomiting; Vomiting Vomiting; Vomiting
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING ... Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) 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 CAPD (CAPD (dialysis)) since an unknown date. Concurrent medical conditions included Type 1 diabetes mellitus (Type 1 diabetes). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. The patient received the Moderna COVID-19 vaccine in 2021. On 28-Apr-2022, patient received a 0.5 mL dose of the Moderna COVID-19 Vaccine Booster. On 15-Jan-2023, the patient was administered the Moderna COVID-19 Bivalent Vaccine. Subsequently, on 19-Oct-2023, patient received the Spikevax 2023-2024 PFS and on 24-Sep-2024 patient received the SPIKEVAX 2024-2025 PFS. It was reported that patient received all Covid vaccines since 2021 till now, which was 7-8 vaccines. It was reported that post COVID-19 vaccination each time almost 10 hours after the vaccine the patient used to start vomit for every 20 to 30 minutes and that vomit used to last for 6-8 hours for the patient. It was reported that patient used to receive Moderna vaccines except for once she got Pfizer but experienced the same symptom. In addition, there were for other 4 other Moderna -Covid-19 vaccine patient had no information. No treatment medications provided by the reporter. This case was linked to MOD-2025-789725 (Patient Link). More
2862298 19 F MS 09/30/2025 COVID19
 PFIZER\BIONTECH
 ff2589
Abortion spontaneous, Exposure during pregnancy, Haemorrhage in pregnancy, Human... Abortion spontaneous, Exposure during pregnancy, Haemorrhage in pregnancy, Human chorionic gonadotropin, Muscle spasms More
Miscarriage of a 9 week pregnancy on May 3rd 2022. Cramping, intense bleeding, passing of a fetus. Miscarriage of a 9 week pregnancy on May 3rd 2022. Cramping, intense bleeding, passing of a fetus.
2862299 F 09/30/2025 COVID19
 MODERNA
Illness Illness
Patient was not sick as a dog next week after receiving the shot; This spontaneous case was reported... Patient was not sick as a dog next week after receiving the shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient was not sick as a dog next week after receiving the shot) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient was not sick as a dog next week after receiving the shot). At the time of the report, ILLNESS (Patient was not sick as a dog next week after receiving the shot) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication use information was not provided by reporter. Patient always gets a COVID-19 shot every year and was about to receive the vaccine next week. It was inquired whether advil, tylenol, or something else was recommended. It was wanted by the reporter to know what should be bought from the supermarket at the time of reporting so that the patient was not sick as a dog next week after receiving the shot. The patient could not remember what took last year. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. More
2862301 11 M NC 09/30/2025 FLU3
FLU3
FLU3
HEPA
HEPA
HEPA
HPV9
HPV9
HPV9
MNQ
MNQ
MNQ
TDAP
TDAP
TDAP
VARCEL
VARCEL
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UT8770NA
UT8770NA
UT8770NA
J4K4X
J4K4X
J4K4X
Y018398
Y018398
Y018398
U8573AA
U8573AA
U8573AA
U8122AA
U8122AA
U8122AA
Y019318
Y019318
Y019318
Blood test, Computerised tomogram, Dyskinesia, Electrocardiogram, Fall; Foaming ... Blood test, Computerised tomogram, Dyskinesia, Electrocardiogram, Fall; Foaming at mouth, Musculoskeletal stiffness, Nervousness, Pallor, Tearfulness; Unresponsive to stimuli; Blood test, Computerised tomogram, Dyskinesia, Electrocardiogram, Fall; Foaming at mouth, Musculoskeletal stiffness, Nervousness, Pallor, Tearfulness; Unresponsive to stimuli; Blood test, Computerised tomogram, Dyskinesia, Electrocardiogram, Fall; Foaming at mouth, Musculoskeletal stiffness, Nervousness, Pallor, Tearfulness; Unresponsive to stimuli; Blood test, Computerised tomogram, Dyskinesia, Electrocardiogram, Fall; Foaming at mouth, Musculoskeletal stiffness, Nervousness, Pallor, Tearfulness; Unresponsive to stimuli; Blood test, Computerised tomogram, Dyskinesia, Electrocardiogram, Fall; Foaming at mouth, Musculoskeletal stiffness, Nervousness, Pallor, Tearfulness; Unresponsive to stimuli; Blood test, Computerised tomogram, Dyskinesia, Electrocardiogram, Fall; Foaming at mouth, Musculoskeletal stiffness, Nervousness, Pallor, Tearfulness; Unresponsive to stimuli More
After last vaccine was administered, pt began leaning/falling backwards with eyes partially assisted... After last vaccine was administered, pt began leaning/falling backwards with eyes partially assisted him in sitting upright. Pt then began displaying bilateral arms and legs stiffening, and pt was unresponsive. Pt then displayed full body jerking for approximately 5 seconds, remaining unresponsive. Foaming saliva was noted in the edge of his mouth. He was lowered onto his side on the exam table, in the recovery position. Additional staff arrived and 911 was called. Pt skin was pale, warm and moist. Pt quickly began responding and was alert and oriented to person and place. Pt was tearful and nervous. Pt remained in lying position on exam table. Mom and Dad both remained in the room, with Mom at the bedside. EMS first responders arrived and assumed care of pt. Pt was transported to hospital for further evaluation. Follow up on pt on 09/29/2025 when in facility d/t needed school physical. Pt and parents report child has been feeling well since 9/26/25. Pt appears well and is in no distress. Pt mother and father reported pt had CT scan, bloodwork and "they checked his heart" while being seen in the ER on 9/26/25. Parents were given instructions for pt to f/u with a provider if he experienced similar episode again. More
2862302 62 F PA 09/30/2025 FLU3
 SEQIRUS, INC.
 ax5591B
Blood glucose normal, Dizziness, Immediate post-injection reaction, Nausea, Palp... Blood glucose normal, Dizziness, Immediate post-injection reaction, Nausea, Palpitations More
Flu shot administered at 8:50am Immediately after injection pt began feeling lightheaded and having ... Flu shot administered at 8:50am Immediately after injection pt began feeling lightheaded and having palpitations. VS: BP 160/90 HR 122 O2: 99% Glucose 115 LS clear- no stridor, no hives, Neuro check WNL Placed in trendelenberg. O2 applied. Orange juice given. Vagal maneuver attempted. HR was regular and began to slow to 80s HR remains WNL but pt continued to feel lightheaded and nauseous. EMS called and Pt transferred to ED at (withheld name) Medicine in stable condition, aox3, speaking in full uncompromised sentences, WNL neuro checks. More
2862303 0.17 F KY 09/30/2025 FLU3
 SEQIRUS, INC.
 406996
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Flu vaccine given in error. Contraindicated, not approved under 6 months of age Flu vaccine given in error. Contraindicated, not approved under 6 months of age
2862304 25 F PA 09/30/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052669
3052669
Chills, Hyperhidrosis, Injection site swelling, Pain, Pruritus; Pyrexia Chills, Hyperhidrosis, Injection site swelling, Pain, Pruritus; Pyrexia
Swelling in injection site, itchiness, fever lasting around 8 hours, chills, sweating, body aches Swelling in injection site, itchiness, fever lasting around 8 hours, chills, sweating, body aches
2862306 56 F MI 09/30/2025 FLU3
FLU3
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
 U8767BA
U8767BA
MA2505
MA2505
Blister, Blister rupture, Peripheral swelling, Pyrexia, Rash; Scab; Blister, Bli... Blister, Blister rupture, Peripheral swelling, Pyrexia, Rash; Scab; Blister, Blister rupture, Peripheral swelling, Pyrexia, Rash; Scab More
patient states that when she woke up the next morning it was blistered. it has since popped and no... patient states that when she woke up the next morning it was blistered. it has since popped and now has a scab on it. this will be for the Influenza vaccine. Prevnar 20 patient states that she had a low-grade fever and her arm swelled up. she stated there was a rash on half of the arm. More
2862307 40 F VA 09/30/2025 FLU3
 SANOFI PASTEUR
 UT8770NA
Erythema, Injection site paraesthesia, Injection site warmth, Pruritus, Urticari... Erythema, Injection site paraesthesia, Injection site warmth, Pruritus, Urticaria More
9/26/2025 @ approximately 3:15 pm received Sanofi Fluzone- regular dose. Initially noted warmth and ... 9/26/2025 @ approximately 3:15 pm received Sanofi Fluzone- regular dose. Initially noted warmth and tingling near on shoulder of arm that received vaccine in. Colleagues noted employee?s chest appeared red. Upon examining her shoulder and upper arms there were hives and she was itching. When came back to Health at Work clinic location at 1540 for assessment she was also noted to have small area of hives on left upper abdomen.Benadryl 25mg po @ 1541 Vitals stable and no progression of hives 1600. Cleared to leave at 1615. More
2862309 9 F WV 09/30/2025 MNP
 PFIZER\WYETH
 LT0075
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No reported adverse reactions. No reported adverse reactions.
2862310 74 M TX 09/30/2025 COVID19
FLU3
PNC13
VARZOS
 MODERNA
SEQIRUS, INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS



Condition aggravated, Neuropathy peripheral, Pain in extremity; Condition aggrav... Condition aggravated, Neuropathy peripheral, Pain in extremity; Condition aggravated, Neuropathy peripheral, Pain in extremity; Condition aggravated, Neuropathy peripheral, Pain in extremity; Condition aggravated, Neuropathy peripheral, Pain in extremity More
Severe pain in feet has neuropathy, but has always had no feeling numbness now severe pain Severe pain in feet has neuropathy, but has always had no feeling numbness now severe pain
2862311 80 F FL 09/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Patient received two doses of RSV. Patient received two doses of RSV.
2862312 65 F NC 09/30/2025 COVID19
 PFIZER\BIONTECH
Nausea, Pain, Pyrexia, Swollen tongue, Tongue coated Nausea, Pain, Pyrexia, Swollen tongue, Tongue coated
Fever, aches, nausea, white and swollen tongue Fever, aches, nausea, white and swollen tongue
2862313 1.5 M OH 09/30/2025 DTAP
DTAP
DTAP
PNC21
PNC21
PNC21
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.





Crying, Fatigue, Food refusal, Gait disturbance, Gait inability; Injection site ... Crying, Fatigue, Food refusal, Gait disturbance, Gait inability; Injection site mass, Injection site reaction, Injection site swelling, Lethargy, Pyrexia; Tremor; Crying, Fatigue, Food refusal, Gait disturbance, Gait inability; Injection site mass, Injection site reaction, Injection site swelling, Lethargy, Pyrexia; Tremor More
Patient was administered two shots on September 19, 2025 - Tdap and Pneumococcal, one in each thigh.... Patient was administered two shots on September 19, 2025 - Tdap and Pneumococcal, one in each thigh. After he woke up from a nap around 2 pm, he had a low-grade fever (101), shaking, acted lethargic, would not eat, and would not walk on his legs. In addition, he had a mild rash on both legs, a hard lump on his left leg with some swelling. He would cry when moved and would just lie down. These same symptoms lasted for 3 days. When he finally started to walk again, he would with a limp and would still tire out quickly. By day 5 he was back to normal. He is only 1.5 years old. More
2862314 92 F AR 09/30/2025 COVID19
 MODERNA
 8146670
COVID-19 COVID-19
hospitalized with COVID hospitalized with COVID
✓
2862315 76 F GA 09/30/2025 FLU3
 SANOFI PASTEUR
Rash Rash
rash, 2 + weeks on right arm and traveling in patches down body on right hand side rash, 2 + weeks on right arm and traveling in patches down body on right hand side
2862316 83 F NH 09/30/2025 COVID19
 MODERNA
Pneumonia Pneumonia
pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONI... pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in an 83-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Patient had received all the COVID-19 vaccines from Moderna since the earliest days of the pandemic). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2025, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in 2025 to sometime in 2025 due to PNEUMONIA. In 2025, PNEUMONIA (pneumonia) had resolved. No concomitant medications were reported. Patient had received all the COVID-19 vaccines from Moderna since the earliest days of the pandemic. However, when the time came in the spring of 2025 for the patient to get the second dose of the Spikevax vaccine for 2024-25, she was in the hospital with pneumonia. Then, the patient just waited longer to get her a second dose. Eventually, in Aug-2025, the reporter began to search for a pharmacy that still had some 2024-25 COVID-19 vaccines left. The reporter was able to find a pharmacy that had some Pfizer vaccines left for 2024-25. Since reporter did not know when the new vaccines would be available, the patient went ahead and got a second dose of a 2024-25 COVID vaccine (this time from Pfizer vaccine) in August. The reporter raised concern about how long the patient must wait before getting the 2025-26 COVID-19 vaccine from Moderna. It was reported that one local pharmacist described the time interval as 3 months, and another pharmacist described the time interval as 6 months, and reporter then asked about which one was correct. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The event of Pneumonia was assessed as not related to suspected vaccine due to lack of biological plausibility. Patient's advanced age was assessed as a confounding factor. The benefit-risk relationship of product is not affected by this report. More
✓
2862317 42 F WI 09/30/2025 COVID19
COVID19
HEP
HEP
IPV
IPV
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
 3043335
3043335
MD9SL
MD9SL
X1D141M
X1D141M
Arthralgia, Immediate post-injection reaction, Mobility decreased, Muscular weak... Arthralgia, Immediate post-injection reaction, Mobility decreased, Muscular weakness, Pain; Sleep disorder; Arthralgia, Immediate post-injection reaction, Mobility decreased, Muscular weakness, Pain; Sleep disorder; Arthralgia, Immediate post-injection reaction, Mobility decreased, Muscular weakness, Pain; Sleep disorder More
Client reported that pain was "immediate" after receiving vaccine. Pain is reported as con... Client reported that pain was "immediate" after receiving vaccine. Pain is reported as constant and sharp, but it is aggravated when client sleeps on that side/arm, or when client lifts or picks-up things. Pain is in right shoulder - client also reports "it feels like the needle is still there." Per client, it has continued to hurt over the past 9 months. Client reports only using/taking tylenol for pain relief. Client denies seeking medical attention for the arm/shoulder pain. Client had visible limited range of motion on that shoulder and weakness on the right arm. Both arms evaluated - no palpable lumps or visible discoloration or swelling. Client was instructed to follow-up with her provider. More
2862318 60 F FL 09/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Leg amputation, Thrombosis COVID-19, Leg amputation, Thrombosis
About a week after vaccination I got Covid and about a month later blood clots formed and I had left... About a week after vaccination I got Covid and about a month later blood clots formed and I had left below knee amputation More
✓ ✓ ✓
2862319 56 F GA 09/30/2025 FLU3
PNC20
TDAP
 SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 u8823aa
ma2523
4ya34
Injection site bruising, Injection site haemorrhage, Injection site swelling; In... Injection site bruising, Injection site haemorrhage, Injection site swelling; Injection site bruising, Injection site haemorrhage, Injection site swelling; Injection site bruising, Injection site haemorrhage, Injection site swelling More
patient's arm was swollen, raised bump at injection site, slightly bruised and bleeding more th... patient's arm was swollen, raised bump at injection site, slightly bruised and bleeding more than usual. I applied pressure to stop the bleeding and it did stop bleeding. Slight bump remained. The patient was fine and left. No other symptoms. More
2862320 67 F FL 09/30/2025 PNC20
 PFIZER\WYETH
 ma2523
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient got this Prevnar-20 in June 2023. We overlooked and gave it to her again on 9/28/2025. I spo... Patient got this Prevnar-20 in June 2023. We overlooked and gave it to her again on 9/28/2025. I spoke to patient, and she was fine. More
2862321 55 M MN 09/30/2025 COVID19
COVID19
FLU3
FLU3
UNK
UNK
 MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 3052583
3052583
948400
948400
948400
948400
Dyspnoea, Electrocardiogram, Rash; Dyspnoea, Rash, Urticaria; Dyspnoea, Electroc... Dyspnoea, Electrocardiogram, Rash; Dyspnoea, Rash, Urticaria; Dyspnoea, Electrocardiogram, Rash; Dyspnoea, Rash, Urticaria; Dyspnoea, Electrocardiogram, Rash; Dyspnoea, Rash, Urticaria More
Client reported a severe reaction with rash over his whole body and difficulty breathing requiring ... Client reported a severe reaction with rash over his whole body and difficulty breathing requiring a visit to Urgent care to receive steroids. More
2862322 67 F FL 09/30/2025 UNK
 UNKNOWN MANUFACTURER
 390104
Blood pressure increased, Dizziness, Immediate post-injection reaction, Renal fu... Blood pressure increased, Dizziness, Immediate post-injection reaction, Renal function test normal More
Immediate spike in blood pressure, dizziness and feeling faint upon standing. Remained in office un... Immediate spike in blood pressure, dizziness and feeling faint upon standing. Remained in office until BP normalized. More
2862324 1 M GA 09/30/2025 FLU3
FLU3
HEPA
HEPA
MMR
MMR
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 4F2AJ
4F2AJ
Z003748
Z003748
Z003402
Z003402
Z008195
Z008195
Crying, Cyanosis, Immediate post-injection reaction, Lethargy, Oxygen saturation... Crying, Cyanosis, Immediate post-injection reaction, Lethargy, Oxygen saturation decreased; Somnolence; Crying, Cyanosis, Immediate post-injection reaction, Lethargy, Oxygen saturation decreased; Somnolence; Crying, Cyanosis, Immediate post-injection reaction, Lethargy, Oxygen saturation decreased; Somnolence; Crying, Cyanosis, Immediate post-injection reaction, Lethargy, Oxygen saturation decreased; Somnolence More
Patient in for 12 month WCC appointment 9/29/25 and received routine vaccines: MMR, VVX, Hep A + Flu... Patient in for 12 month WCC appointment 9/29/25 and received routine vaccines: MMR, VVX, Hep A + Flu. He cried immediately then stopped crying and lips turned blue. PCP evaluated patient and cyanosis resolved but patient was still very sleepy & lethargic. Difficult to waken. More
2862325 71 F TN 09/30/2025 PNC20
 PFIZER\WYETH
 LX4482
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient received vaccine only three years after first dose, which is less than CDC recommends patient received vaccine only three years after first dose, which is less than CDC recommends
2862326 12 F AL 09/30/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012776
Y012776
Balance disorder, Dizziness, Headache, Hypotension, Influenza virus test negativ... Balance disorder, Dizziness, Headache, Hypotension, Influenza virus test negative; Injection site urticaria, Nausea, Pain, Pyrexia, Urticaria More
She developed headache and dizziness right after getting the vaccine. Observed for 30 minutes and f... She developed headache and dizziness right after getting the vaccine. Observed for 30 minutes and felt better. Developed fever on the way home to 101. That evening had low blood pressure until 8PM. Hives around injection site and down her arm. Continued with nausea and dizziness overnight. Morning of 9/23 she felt unsteady and continued to have nausea and dizziness. Also had body aches. Rechecked in clinic - flu negative. More
2862327 0.83 F WA 09/30/2025 DTAPIPVHIB
PNC15
 SANOFI PASTEUR
MERCK & CO. INC.
 UK232AB
Z010141
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
ADVERSE TREATMENT- VACCINE BOOSTERS ADMINISTERED IN ERROR. PATIENT WAS NOT YET DUE. PARENTS ADVISED ADVERSE TREATMENT- VACCINE BOOSTERS ADMINISTERED IN ERROR. PATIENT WAS NOT YET DUE. PARENTS ADVISED
2862328 73 F MN 09/30/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 WF2584B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
NONE - NOT AGE APPROPRIATE ADMINISTRATION NONE - NOT AGE APPROPRIATE ADMINISTRATION
2862329 87 F OH 09/30/2025 COVID19
 MODERNA
 3052736
Injection site urticaria, Urticaria Injection site urticaria, Urticaria
Pt woke up the following morning with hives around the injection site which spread to her neck and c... Pt woke up the following morning with hives around the injection site which spread to her neck and chest. At time of reporting the hives were getting better More
2862330 46 M CA 09/30/2025 FLU3
 SEQIRUS, INC.
 948396
Flushing, Hypersensitivity, Paraesthesia oral, Urticaria Flushing, Hypersensitivity, Paraesthesia oral, Urticaria
Allergic reaction - hives, flushing, tingling lips about 15 minutes after vax - was taken to the ED ... Allergic reaction - hives, flushing, tingling lips about 15 minutes after vax - was taken to the ED on site for further treatment More
2862331 72 M LA 09/30/2025 COVID19
COVID19
UNK
UNK
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Cardiac monitoring normal, Chronic inflammatory demyelinating polyradiculoneurop... Cardiac monitoring normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Hypoaesthesia, Immunoglobulin therapy, Laboratory test; Limb discomfort, Loss of consciousness; Cardiac monitoring normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Hypoaesthesia, Immunoglobulin therapy, Laboratory test; Limb discomfort, Loss of consciousness More
About 3 days after being vaccinated. He started having numbness in both hands and both legs as they ... About 3 days after being vaccinated. He started having numbness in both hands and both legs as they were numb. He thought the this would go away after a few days but they continued to be numb. He passed out when leaving the gym but then came to. The ambulance came to check vitals and he was let go because they were back to normal. He went to his doctor and was given a heart monitor to wear for 6 days. Results were negative. His hand and legs became heavier. He was referred to Dr. He was diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy. He was sent to a hematologist. He was put on B12 injections and supplements. He started getting some strength back where he can start doing things again. He still has the heaviness in the limbs and continues IVIG treatments every three weeks. More
✓
2862333 87 M 09/30/2025 COVID19
 MODERNA
Atrial fibrillation Atrial fibrillation
afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRIL... afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (afib) in an 87-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Emphysema. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (afib) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that a patient visited his GP who had been his doctor for the past 10 years and was advised not to receive any COVID-19 vaccine this year. He received twice a year, and from the start of COVID in 2019-2020 he had taken Moderna shots every time. Patient's GP told him that what was happening was that the COVID shot was metastasizing, it was mentioned that this might be the incorrect word, with the previous shots and could cause their own little malady that affects the heart and lungs. It was reported that, patient was inquiring whether he should receive a COVID-19 vaccine. Patient suffered from emphysema and had been receiving Moderna's COVID-19 vaccines in recent years. Patient's doctor informed him that receiving a COVID-19 vaccine this year could potentially exacerbate his condition and create complications. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 18-Sep-2025: Live significant follow-up received: Reporter name, medical history and reference id added; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2862334 51 F MN 09/30/2025 FLU3
FLU3
PNC20
PNC20
 SEQIRUS, INC.
SEQIRUS, INC.
PFIZER\WYETH
PFIZER\WYETH
 407001
407001
MA2505
MA2505
Chills, Erythema, Fatigue, Pain in extremity, Peripheral swelling; Pyrexia; Chil... Chills, Erythema, Fatigue, Pain in extremity, Peripheral swelling; Pyrexia; Chills, Erythema, Fatigue, Pain in extremity, Peripheral swelling; Pyrexia More
left arm sore, red, swollen - fever, aches, chills, exhaustion. 48 hours post injection redness spre... left arm sore, red, swollen - fever, aches, chills, exhaustion. 48 hours post injection redness spread on arm More
2862335 4 M IL 09/30/2025 DTAPIPV
DTAPIPV
FLUN3
FLUN3
MMRV
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
MERCK & CO. INC.
MERCK & CO. INC.
 U8209CB
U8209CB
YH3387C
YH3387C
Z009076
Z009076
Injection site erythema, Injection site pain, Injection site reaction, Injection... Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Livedo reticularis; Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Livedo reticularis; Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Livedo reticularis More
Left arm with significant swelling, from a few inches above elbow up to his shoulder. It is red, m... Left arm with significant swelling, from a few inches above elbow up to his shoulder. It is red, mottled, and warm to touch and running fevers around 100. Some tenderness to the site. Has full range of motion. More
2862336 82 F IA 09/30/2025 FLU3
 SEQIRUS, INC.
 407252
Erythema, Localised infection, Product administered at inappropriate site Erythema, Localised infection, Product administered at inappropriate site
Vaccine administered low. Patient presented with redness and infection in left arm. Antibiotics pr... Vaccine administered low. Patient presented with redness and infection in left arm. Antibiotics prescribed and started on 09/30; Patient reported incident More
2862337 51 F CA 09/30/2025 PNC20
 PFIZER\WYETH
 MA2523
Injection site rash, Injection site swelling Injection site rash, Injection site swelling
Rash and swelling on the injection site Right deltoid Rash and swelling on the injection site Right deltoid
2862338 66 F CO 09/30/2025 RSV
RSV
TDAP
TDAP
 PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LN5470
LN5470
H4K3S
H4K3S
Dizziness, Full blood count, Headache, Injection site erythema, Injection site p... Dizziness, Full blood count, Headache, Injection site erythema, Injection site pain; Injection site swelling, Injection site warmth, Metabolic function test, Ultrasound Doppler normal; Dizziness, Full blood count, Headache, Injection site erythema, Injection site pain; Injection site swelling, Injection site warmth, Metabolic function test, Ultrasound Doppler normal More
Patient received both RSV and Tdap vaccinations in the same arm on 9/17. On 9/29 patient woke up to ... Patient received both RSV and Tdap vaccinations in the same arm on 9/17. On 9/29 patient woke up to a red, swollen, and tender/hot area on the upper left arm, and was feeling dizziness and headache. Patient went into the ER and was found have a BP if 199/80 at that time. the ER completed full blood panel and ultrasound of the arm was taken with no findings. Patient was sent home after 3 hours and told to monitor blood pressure. Upon returning to the pharmacy on 9/30, her BP was at 168/118 and patient was instructed to set up follow-up appointment with primary care physician More
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