๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2850595 07/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rash Rash
I had a rash after 1st vaccine; This non-serious case was reported by a consumer via interactive di... I had a rash after 1st vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: I had a rash after 1st vaccine). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Shingles vaccine. It was unknown if the company considered the rash to be related to Shingles vaccine. Additional Information: GSK Receipt date: 13-JUL-2025 This case was reported by a patient via interactive digital media. The reporter said to the other person you were lucky as you did not got sick. The patient had a rash after 1st dose of Shingles vaccine, so could not take it. More
2850596 07/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
Worst pain ever; This non-serious case was reported by a consumer via interactive digital media and ... Worst pain ever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: Worst pain ever). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 14-JUL-2025 This case was reported by a patient via interactive digital media. The reporter agrees with her it was worst pain ever. More
2850597 07/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
i got the Shingrix vaccine in 2019 and mistakenly got the vaccine again today (1st shot); This non-s... i got the Shingrix vaccine in 2019 and mistakenly got the vaccine again today (1st shot); This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019 on an unknown date). On 14-JUL-2025, the patient received Shingrix. On 14-JUL-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: i got the Shingrix vaccine in 2019 and mistakenly got the vaccine again today (1st shot)). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 14-JUL-2025 The patient received the Shingrix vaccine in 2019 and mistakenly got the vaccine again on the reporting day (1st shot), which led to extra dose administered. More
2850598 07/21/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine and 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 resolved (duration 6 weeks). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the 2 step vaccine a few years ago and diagnosed with shingles in February lasting about 6 weeks at least. Had nothing for comparison. Distressed to learn people have had it several times. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and regarding laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2). More
2850599 07/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I have shingles now; This serious case was reported by a consumer via... Suspected vaccination failure; I have shingles now; 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: I have shingles now). 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: 15-JUL-2025 This case was reported by a patient via interactive digital media. The patient had shingles now but thankfully not a bad case. The patient had the vaccine a few years ago. The patient also mentioned his/her had them when was young and was heartbreaking watching her in so much pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2850600 M MA 07/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 B32NG
Expired product administered Expired product administered
maladministration of an expired dose of Boostrix; This non-serious case was reported by a pharmacist... maladministration of an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis. On 26-JUN-2025, the patient received Boostrix. On 26-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: maladministration of an expired dose of Boostrix). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-JUL-2025 Pharmacist reported the maladministration of an expired dose of Boostrix. Patient received expired dose of Boostrix, which led to expired vaccine used. More
2850601 16 M FL 07/21/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 E4A39
Expired product administered Expired product administered
Menveo 1 vial less than 30 days expired dose administration; This non-serious case was reported by a... Menveo 1 vial less than 30 days expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis. On 01-JUL-2025, the patient received Menveo. On 01-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo 1 vial less than 30 days expired dose administration). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 11-JUL-2025 A Health Care Provider wanted to know how to proceed after administering an expired dose of Menveo 1 vial (one day after the expiration date) which led to expired vaccine usage. More
2850602 2 M MD 07/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 F3Y25
Expired product administered Expired product administered
Expired dose administered.; This non-serious case was reported by a nurse via call center representa... Expired dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis. On 10-JUL-2025, the patient received Havrix. On 10-JUL-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-JUL-2025 The nurse practitioner called to inform that a medical assistant used a dose of Havrix and that it was expired and administered to a patient. According to reporter, dose had expired on 15th February 2025 and was administered on 10th July 2025 which led to expired vaccine used. The reporter mentioned that the expired dose was administered to two twins. The vaccine administration facility was the same as primary reporter. More
2850603 19 F TX 07/21/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 E4A39
Expired product administered Expired product administered
administered an expired dose of Menveo; This non-serious case was reported by a nurse via call cente... administered an expired dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis. On 15-JUL-2025, the patient received Menveo. On 15-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Menveo). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 15-JUL-2025 The registered Nurse called but there were connectivity issues and outbound call was placed and caller explained she administered an expired dose of Menveo (1-vial) to a patient on 15-JUL-2025. Dose expired on J30-JUN-2025, which led to expired vaccine used. More
2850604 69 F MS 07/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 G22GH
Extra dose administered Extra dose administered
two doses administered to the same patient; This non-serious case was reported by a pharmacist via c... two doses administered to the same patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G22GH, expiry date 01-JUL-2025) for prophylaxis. Previously administered products included Arexvy (received 1st dose on 23-AUG-2023 with batch number: 9B2Y4 and expiry date: 20-JAN-2024). On 06-SEP-2024, the patient received the 2nd dose of Arexvy. On 06-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: two doses administered to the same patient). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 16-JUL-2025 The pharmacist called to ask for information about the administration of two doses of Arexvy to the same patient which led to extra dose administered. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2850605 18 MO 07/21/2025 COVID19
 MODERNA
 B0005
Eating disorder, Poor quality product administered, Product temperature excursio... Eating disorder, Poor quality product administered, Product temperature excursion issue More
Eating disorder; Vaccine was administered after excursion on 17-Dec-2024; Liquid vaccine was exposed... Eating disorder; Vaccine was administered after excursion on 17-Dec-2024; Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes; This spontaneous case was reported by a nurse and describes the occurrence of EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024) in an 18-year-old patient of an unknown gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. B0005) for COVID-19 prophylaxis. Concurrent medical conditions included Dermatitis since 17-Nov-2021, Scoliosis (Mild scoliosis) since 22-Oct-2018 and ADHD, combined type since 09-Jan-2018. Concomitant products included Ethinylestradiol, Ferrous fumarate, Norethisterone acetate (Loestrin 24 fe) from 05-Jul-2022 to an unknown date for Contraception, Influenza vaccine inact split 3v (Flulaval) and Meningococcal vaccine B (MenB) for an unknown indication. On 17-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Dec-2024, the patient experienced EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). At the time of the report, EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered EATING DISORDER (Eating disorder) to be not related. No further causality assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). HCP reported multiple excursions in their refrigerator over a period ranging from 03-Dec-2024 to 11-Jun-2025. The exact highest temperature and total combined excursion time were reported as 47.91 degrees Fahrenheit and 33 minutes. On 13-Dec-2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range were reported as 16. No Moderna pediatric vaccine was stored in their refrigerator after 04-Feb-2025. No adverse reactions noted by patient with respect to vaccinations of 17-Dec-2024. No treatment medication was reported. This case contains information for the 5th patient out of 9 patients as described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-787640 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2025: Follow up contains significant information. Reporter's details, patient details (initials, age, height, weight, race, medical history), suspect product details were added, co suspects were added, event was added and narrative was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787640:Patient 1 (Master case) More
2850606 86 M FL 07/21/2025 COVID19
 MODERNA
COVID-19, Pneumonia COVID-19, Pneumonia
currently her husband is sick with Covid after he was hospitalized for pneumonia; currently her husb... currently her husband is sick with Covid after he was hospitalized for pneumonia; currently her husband is sick with Covid after he was hospitalized for pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (currently her husband is sick with Covid after he was hospitalized for pneumonia) in an 86-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (currently her husband is sick with Covid after he was hospitalized for pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (currently her husband is sick with Covid after he was hospitalized for pneumonia). At the time of the report, PNEUMONIA (currently her husband is sick with Covid after he was hospitalized for pneumonia) and COVID-19 (currently her husband is sick with Covid after he was hospitalized for pneumonia) had not resolved. No concomitant medications were reported. It was reported that, currently the patient was sick with Covid after he was hospitalized for pneumonia. His last vaccination with Covid vaccine was 2-3 months ago. It was unknown if the patient experienced any additional symptoms/events No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-023706 (E2B Linked Report). This case was linked to MOD-2021-022223 (Patient Link).; Reporter's Comments: Company comment: Event pneumonia was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-023706:Wife case More
โœ“
2850607 M 07/21/2025 COVID19
 MODERNA
 205F23-A
COVID-19 COVID-19
worse symptoms during his covid infection; This spontaneous case was reported by a consumer and desc... worse symptoms during his covid infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (worse symptoms during his covid infection) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205F23-A) for COVID-19 prophylaxis. The patient's past medical history included CPAP (sleep apnea and uses CPAP). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 VACCINE (Batch Lot No: 04A2A, Dose 1) on 05-Mar-2021, Moderna COVID-19 VACCINE (Batch Lot No: 007B21A, Dose 2) on 04-Apr-2021, Moderna COVID-19 VACCINE (Batch Lot No: 051F21A, Dose 3) on 03-Nov-2021, Spikevax (Batch Lot No: 016B22A, Dose 4) on 05-Jul-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Batch Lot No: 059F22A, Dose 5) on 26-Oct-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Batch Lot No: A87170B and Dose 6) on 09-Jun-2023. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 VACCINE, Moderna COVID-19 VACCINE, Moderna COVID-19 VACCINE, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) and Spikevax. Concurrent medical conditions included Sleep apnea (sleep apnea and uses CPAP). On 29-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (worse symptoms during his covid infection). At the time of the report, COVID-19 (worse symptoms during his covid infection) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that her husband, had also taken 9 doses of Covid vaccines and experienced worse symptoms during his covid infection around the same time that she had hers. It was reported that the patient administered SPIKEVAX 2023-2024 (Dose 8) on 29-Apr-2024, SPIKEVAX 2023-2024 (Dose 9, Booster) on 30-Jun-2024 and SPIKEVAX 2024-2025 PFS (Dose 10) on 30-Jun-2025. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788129 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788129:Master Case (Wife) More
2850608 07/21/2025 COVID19
 MODERNA
COVID-19 COVID-19
I got Covid and ended up in the hospital; This case was received via an unknown source (no reference... I got Covid and ended up in the hospital; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jul-2025 and was forwarded to Moderna on 18-Jul-2025. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got Covid and ended up in the hospital) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma, Breast cancer (on cancer therapy) and Autoimmune disorder. 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 COVID-19 (I got Covid and ended up in the hospital) (seriousness criterion hospitalization). At the time of the report, COVID-19 (I got Covid and ended up in the hospital) outcome was unknown. Patient was disabled and lost the insurance and no income. Patient having asthma and on cancer therapy for breast cancer and autoimmune disease. Patient had all the Covid injections and was due in August for booster. Patient got Covid and ended up in the hospital twice. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
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2850610 52 F 07/21/2025 PNC20
 PFIZER\WYETH
Pain in extremity, Rash, Rash erythematous Pain in extremity, Rash, Rash erythematous
Red rash on left arm and slight pain in same area; Red rash on left arm and slight pain in same area... Red rash on left arm and slight pain in same area; Red rash on left arm and slight pain in same area; Red rash on left arm and slight pain in same area; This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), on 10Jul2025 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Jul2025 at 06:00, outcome "not recovered" and all described as "Red rash on left arm and slight pain in same area". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site rash, vaccination site pain. Additional Information: Patient have allergy to unspecified drug. The patient did not receive any other vaccines on the same date as the vaccines for which you are reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccines for which you are reporting. The patient did not take any other medications within 2 weeks of the event starting The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2850613 F TX 07/21/2025 COVID19
 PFIZER\BIONTECH
Biopsy, Lymphadenopathy Biopsy, Lymphadenopathy
The patient's lymph node enlarged and was biopsied; This is a spontaneous report received from ... The patient's lymph node enlarged and was biopsied; This is a spontaneous report received from an Other HCP from a sales representative. A 19-year-old female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "The patient's lymph node enlarged and was biopsied". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy. Additional information: Treatment received for the adverse event reported as biopsy. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2850614 F TX 07/21/2025 COVID19
 PFIZER\BIONTECH
Lymphadenopathy Lymphadenopathy
Lymph node enlargement; This is a spontaneous report received from a healthcare professional from a ... Lymph node enlargement; This is a spontaneous report received from a healthcare professional from a sales representative. An adult female patient (unknown if pregnant) received BNT162b2 Omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph node enlargement". It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional Information: It was unknown if the patient was taking any other medication within 2 weeks of the event starting. It was unknown if the patient received any other vaccines within 4 weeks prior or on the same date as the suspect vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2850615 07/21/2025 COVID19
 PFIZER\BIONTECH
Bell's palsy Bell's palsy
Bell's palsy; This is a spontaneous report received from a Consumer or other non HCP. A patien... Bell's palsy; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset Jul2025, outcome "unknown". After taking the second COVID vaccine (Cominarty) two weeks ago later patient was diagnosed with Bell's Palsy. More
2850616 F 07/21/2025 MENB
 PFIZER\WYETH
Fatigue, Injection site pain, Injection site swelling, Injection site warmth Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Patient experienced Fatigue/recurrent Fatigue; her arm where she received the vaccine is tender, swo... Patient experienced Fatigue/recurrent Fatigue; her arm where she received the vaccine is tender, swollen and warm; her arm where she received the vaccine is tender, swollen and warm; her arm where she received the vaccine is tender, swollen and warm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025-APL-0001286. A 27-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 07Jul2025 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; pegcetacoplan (PEGCETACOPLAN), on 05Apr2023 (ongoing) as 1080 mg, 2x/week (twice weekly as directed) (Lot number: 2117470, Expiration Date: 31Jul2026) subcutaneous for paroxysmal nocturnal haemoglobinuria. The patient's relevant medical history included: "Fatigue" (unspecified if ongoing). Concomitant medication(s) included: SOLIRIS; PENICILLIN NOS; FOLIC ACID. The following information was reported: FATIGUE (non-serious) with onset 08Jul2025, outcome "recovering", described as "Patient experienced Fatigue/recurrent Fatigue"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 08Jul2025, outcome "not recovered" and all described as "her arm where she received the vaccine is tender, swollen and warm". The action taken for pegcetacoplan was dosage not changed. Additional information: On an unknown date, the patient experienced Fatigue. The patient stated she has been fatigued this past week. She stated since school ended for the summer she has been slacking in taking her folic acid. However, since starting to take it again more consistently, she has noticed an improvement in fatigue at this time. No other symptoms reported. On 08-JUL-2025, the patient experienced Vaccination site pain, Vaccination site swelling, Vaccination site warmth and recurrent Fatigue. The patient reported that she received Trumenba vaccine the day prior. Today, 08-JUL-2025, her arm where she received the vaccine was tender, swollen and warm. She also stated that she was noticing some fatigue today. The events Vaccination site pain, Vaccination site swelling, Vaccination site warmth and recurrent Fatigue reported for product Empaveli had a Not applicable dechallenge and Not applicable rechallenge. Company Comments: The reporter assessed Fatigue (1st occurrence and recurrence) to have an unknown relationship to Empaveli (pegcetacoplan). The reporter assessed Vaccination site pain, Vaccination site swelling, and Vaccination site warmth to be not related to Empaveli (pegcetacoplan). The reporter assessed Fatigue (1st occurrence and recurrent) to have an unknown relationship to Trumenba. The reporter assessed Vaccination site pain, Vaccination site swelling, and Vaccination site warmth to be related to Trumenba. The company assessed Fatigue as not related to Empaveli (1st occurrence and recurrence), and can be plausibly explained by the underlying paroxysmal nocturnal hemoglobinuria. The company assessed Vaccination site pain, Vaccination site swelling, Vaccination site warmth as not related to Empaveli and are due to the co-suspect drug Trumenba. The company assessed Fatigue (1st occurrence and recurrence) as not related Trumenba since it can be explained by the underlying disease. The company assessed Vaccination site pain, Vaccination site swelling and Vaccination site warmth as related to Trumenba due to close temporal relationship between onset of events and administration of Trumenba. Batch/lot number is not provided, and it cannot be obtained. More
2850617 M MA 07/21/2025 COVID19
 PFIZER\BIONTECH
Body temperature, Infantile vomiting, Pyrexia Body temperature, Infantile vomiting, Pyrexia
experienced a vomiting following immunization with Comirnaty; experienced a 103F fever following imm... experienced a vomiting following immunization with Comirnaty; experienced a 103F fever following immunization with Comirnaty; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): AE-020050 (BioNTech). A 9-month-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2025, outcome "unknown", described as "experienced a 103F fever following immunization with Comirnaty"; INFANTILE VOMITING (non-serious) with onset 2025, outcome "unknown", described as "experienced a vomiting following immunization with Comirnaty". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: A friend reported that his 9-month-old son recently experienced a 103F fever and vomiting following immunization with Comirnaty. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2850619 07/21/2025 COVID19
 PFIZER\BIONTECH
Tinnitus Tinnitus
tinnitus; This is a spontaneous report received from a Physician. A patient (age and gender not pro... tinnitus; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2850620 53 F CA 07/21/2025 PNC21
 MERCK & CO. INC.
 Z006076
Pain, Syncope Pain, Syncope
PATIENT'S REPRESENTATIVE STATES THAT PATIENT FAINTED AND LOTS OF PAIN. PATIENT WENT TO ER FOR T... PATIENT'S REPRESENTATIVE STATES THAT PATIENT FAINTED AND LOTS OF PAIN. PATIENT WENT TO ER FOR THE PAIN More
2850621 4 F OR 07/21/2025 DTAPIPV
DTAPIPVHIB
 SANOFI PASTEUR
SANOFI PASTEUR
 U8209CB
Z008219
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Provider ordered two combination vaccines(by mistake), newly graduated Medical assistant did not cat... Provider ordered two combination vaccines(by mistake), newly graduated Medical assistant did not catch that at time of draw up or prior to administration. Provider discussed with parent. No adverse reactions based on that conversation. More
2850629 11 F IN 07/21/2025 HPV9
MENB
TDAP
 MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 1965046
HG6057
H4279
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Patient was mistakenly given Meningococcal B instead of Meningococcal Conjugate vaccine. Patient was mistakenly given Meningococcal B instead of Meningococcal Conjugate vaccine.
2850630 18 M CA 07/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 T5D73
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Engerix-B (Age 20+) is approved for 20 years and older, but the patient was18 years old. Patient sho... Engerix-B (Age 20+) is approved for 20 years and older, but the patient was18 years old. Patient should have been given Engerix-B (Age 0-19) instead. The error was discovered as the patient was seeking to get the second dose of Engerix B series. Patient did not have any signs of adverse reactions in the past month. More
2850631 1.25 F OR 07/21/2025 TDAP
 SANOFI PASTEUR
 U8231AA
Wrong product administered Wrong product administered
TDAP was given instead of a DTAP, at this time no signs or symptoms TDAP was given instead of a DTAP, at this time no signs or symptoms
2850632 61 M FL 07/21/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8503AA
U8503AA
Abdominal pain upper, Arthralgia, Diarrhoea, Neck pain, Pain in extremity; Pyrex... Abdominal pain upper, Arthralgia, Diarrhoea, Neck pain, Pain in extremity; Pyrexia More
Pain, in upper arm, neck, shoulders within 7 hours, fever up to 102.8 within 24 hours, moderate to s... Pain, in upper arm, neck, shoulders within 7 hours, fever up to 102.8 within 24 hours, moderate to severe joint pain shoulders, knees; stomach cramps within 24 hours, diarrhea within 36 hours. Only fever has stopped since within 72 hours. Other symptoms still present. More
2850633 31 F ID 07/21/2025 HEP
 MERCK & CO. INC.
Underdose Underdose
A pediatric dose of .5ml was administered to a 31 year old adult who was in need of the 1ml adult d... A pediatric dose of .5ml was administered to a 31 year old adult who was in need of the 1ml adult dose. More
2850634 77 F CA 07/21/2025 TDAP
TDAP
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 333SK
333SK
2HJ99
2HJ99
Arthralgia, Dysphagia, Mobility decreased, Musculoskeletal stiffness, Neck pain;... Arthralgia, Dysphagia, Mobility decreased, Musculoskeletal stiffness, Neck pain; Oropharyngeal discomfort, Pain; Arthralgia, Dysphagia, Mobility decreased, Musculoskeletal stiffness, Neck pain; Oropharyngeal discomfort, Pain More
Patient stated the morning after she received the 2 vaccines, she felt stiffness and pain radiated f... Patient stated the morning after she received the 2 vaccines, she felt stiffness and pain radiated from both of her shoulders up to her neck. She could not move her neck and she also had trouble swallowing her food. The pain and stiffness lasted until 7/4/2025. She still has a very minor residual sensation in her throat sometimes. More
2850635 54 F WA 07/21/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Blood test, Depression, Electric shock sensation, Impaired work ability, Magneti... Blood test, Depression, Electric shock sensation, Impaired work ability, Magnetic resonance imaging head; Magnetic resonance imaging neck, Pain in extremity, Peripheral sensory neuropathy, Reflex test, Sleep disorder More
Post vaccine sensory neuritis in the my hands and feet that started on Sept 18,2024. 10 days after I... Post vaccine sensory neuritis in the my hands and feet that started on Sept 18,2024. 10 days after I got the flu vaccine. It progressed to my feet. It was very painful, zaps of pain in my hands and feet and interrupted my sleep and work life. I am gabapentin and Cymbalta for pain. I saw a neurologist on Dec 18, 2024 who put me on the gabapentin. My primary put me on Cymbalta for pain and depressed as i got very depressed from the hellish pain as a result of the flu vaccine. More
2850644 18 F NC 07/21/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 7MN4C
Headache, Injection site pain, Injection site swelling Headache, Injection site pain, Injection site swelling
(L) Deltoid swelling & pain Headache Treatment: antibiotic, sling, Ibuprofen, Benadryl Follow up... (L) Deltoid swelling & pain Headache Treatment: antibiotic, sling, Ibuprofen, Benadryl Follow up: 2-3 days More
2850645 41 F IA 07/21/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6203
EN6203
EN6203
EN6203
EN6203
Ageusia, Anosmia, Arthralgia, Blood pressure abnormal, Chills; Cognitive disorde... Ageusia, Anosmia, Arthralgia, Blood pressure abnormal, Chills; Cognitive disorder, Diarrhoea, Dizziness, Executive dysfunction, Fatigue; Headache, Heart rate increased, Inflammation, Influenza, Laboratory test; Memory impairment, Myalgia, Pain, Pyrexia, Rash erythematous; Swelling, Upper respiratory tract infection More
The most noticeable one was on & off chills & flu symptoms, upper respiratory infections, in... The most noticeable one was on & off chills & flu symptoms, upper respiratory infections, inflammations, worstening headaches, fevers off & on, skin rashes (red) swelling & soreness, muscle & joint pain, & terrible fatigue! Loss of taste & small since getting Covid 3x. Had dizziness & diarrhea, & worstening of Blood Pressure & high pulse. Worstening of cognitive memory & executive functioning tasks. More
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2850420 11 M CA 07/20/2025 MNQ
 SANOFI PASTEUR
 U8558AA
Injection site erythema, Injection site induration Injection site erythema, Injection site induration
Hardness in the left deltoid at injection site. A clear defined red ring 3 inches in diameter. Hardness in the left deltoid at injection site. A clear defined red ring 3 inches in diameter.
2850421 77 F TN 07/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3237h
Exfoliative rash, Rash, Rash macular, Rash pruritic Exfoliative rash, Rash, Rash macular, Rash pruritic
Pt developed rash all over body in patch-like formations. Started at back. Itchy, splotchy rash. ... Pt developed rash all over body in patch-like formations. Started at back. Itchy, splotchy rash. Patient thought it was shingles appearing but rash did not form the painful blisters commonly seen with the rash. Rash/itchy scaly section is still present in the scalp. Has continued but slowed down in progression over the last 5 weeks More
2850422 69 F FL 07/20/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 DVX 945663
Inappropriate schedule of product administration Inappropriate schedule of product administration
Dose 2 was administered 3 days too soon. Dose 2 was administered 3 days too soon.
2850423 75 M FL 07/20/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 DVX 945663
Inappropriate schedule of product administration Inappropriate schedule of product administration
Dose #2 of Heplisav was administered 3 days before recommended Dose #2 of Heplisav was administered 3 days before recommended
2850424 3 F CA 07/20/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash erythematous; Rash macular Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash erythematous; Rash macular
Fever, blotchy red bumps behind ears and face, diarrhea, loss of appetite Fever, blotchy red bumps behind ears and face, diarrhea, loss of appetite
2850425 2 M NC 07/20/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Irritability, Muscle contractions involuntary Irritability, Muscle contractions involuntary
24 hours after vaccinations; Mom noticed muscle fasciculations that were random and in both arms/leg... 24 hours after vaccinations; Mom noticed muscle fasciculations that were random and in both arms/legs - never synchronized; never tonic clonic. Child was fussy prior to nap. Mom noted fasciculations while sleeping. Woke up with resolution of fasciculations. Spiked fever to 101.5 later after his nap. Seen in office. Neurological normal; never had altered mental status. No more fasciculations or fever in the 2 days after this event. More
2850427 60 F OH 07/20/2025 PNC20
 PFIZER\WYETH
 LX4484
Injection site pain, Injection site swelling Injection site pain, Injection site swelling
Pain and swelling at injection site one week later. Patient then went to an urgent care and was pres... Pain and swelling at injection site one week later. Patient then went to an urgent care and was prescribed antibiotics. More
2850428 38 F PA 07/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Exposure during pregnancy; Exposure during pregnancy Exposure during pregnancy; Exposure during pregnancy
Ended pregnancy because of spontaneous membrane rupture on 04/13/ 2022, 18 weeks pregnant Ended pregnancy because of spontaneous membrane rupture on 04/13/ 2022, 18 weeks pregnant
2850429 0.17 M AZ 07/20/2025 DTAP
DTAP
HIBV
HIBV
IPV
IPV
PNC15
PNC15
RV5
RV5
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 3CA20C1
3CA20C1
UK111AA
UK111AA
Y1A212M
Y1A212M
Y017360
Y017360
Y014320
Y014320
Feeding disorder, Infant irritability, Pyrexia, Rash, Rash erythematous; Skin wa... Feeding disorder, Infant irritability, Pyrexia, Rash, Rash erythematous; Skin warm, Tenderness; Feeding disorder, Infant irritability, Pyrexia, Rash, Rash erythematous; Skin warm, Tenderness; Feeding disorder, Infant irritability, Pyrexia, Rash, Rash erythematous; Skin warm, Tenderness; Feeding disorder, Infant irritability, Pyrexia, Rash, Rash erythematous; Skin warm, Tenderness; Feeding disorder, Infant irritability, Pyrexia, Rash, Rash erythematous; Skin warm, Tenderness More
Developed bright red erythematous, tender, warm rash from lower abdomen and along both legs to feet ... Developed bright red erythematous, tender, warm rash from lower abdomen and along both legs to feet evolving within 1 hour of immunization. Had fever up to 101 and fussiness and poor feeding for 20 hrs after immunization. More
2850430 58 F IL 07/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7zm55
Blister, Injection site hypersensitivity, Injection site rash, Rash erythematous Blister, Injection site hypersensitivity, Injection site rash, Rash erythematous
Red Rash, blistering and sensitivity at the injection site Red Rash, blistering and sensitivity at the injection site
2850431 72 F FL 07/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 Shingrix
Blister, Rash Blister, Rash
rash, blisters on stomach and back right side. started next day after vaccine. continues even after ... rash, blisters on stomach and back right side. started next day after vaccine. continues even after taking antiviral medication and applying cream. 5 days now More
2850458 72 F NV 07/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3J2S2
Rash Rash
PT had rash the next day , and it gradually spread to the whole body. Pt said she has to go to ... PT had rash the next day , and it gradually spread to the whole body. Pt said she has to go to the hospital. She is ok today when she came tin to report the adverse effect More
2850459 6 M MA 07/20/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Confusional state, Headache, Mental status changes, Pain, Vomiting Confusional state, Headache, Mental status changes, Pain, Vomiting
Headache for 3 days, vomiting, body aches, confusion/ acting out of it Headache for 3 days, vomiting, body aches, confusion/ acting out of it
2850460 1 F IA 07/20/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Oral mucosal eruption, Rash; Oral mucosal eruption, Rash Oral mucosal eruption, Rash; Oral mucosal eruption, Rash
A little over two weeks later, developed a rash on mouth, knees, back, butt, feet, and chest. A little over two weeks later, developed a rash on mouth, knees, back, butt, feet, and chest.
2850387 F IL 07/19/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z005469
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE; administration of GARDASIL-9 to an 18-year old female patient outside the recommen... No additional AE; administration of GARDASIL-9 to an 18-year old female patient outside the recommended dosing interval.. Caller states the first dose was administered on 18-APR-2025, the second dose on 30-MAY- 2025, and the third dose on 21-JUN-2025.; This spontaneous report was received from a pharmacist and refers to an 18-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Apr-2025 and 30-May-2025, the patient was vaccinated with the first and second doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), Suspension for injection, 5 mL (lot # and expiration date were not reported) as prophylaxis. On 21-Jun-2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) Suspension for injection (lot #Z005469, expiration date: 27-Feb-2026), 5 mL, as prophylaxis (Inappropriate schedule of product administration). No adverse events were provided. Lot # is being requested and will be submitted if received More
2850388 1 NV 07/19/2025 VARCEL
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Z003767
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
no adverse event; HCP calling to report on the administration of an extra dose of VARIVAX to a patie... no adverse event; HCP calling to report on the administration of an extra dose of VARIVAX to a patient. Patient inadvertently received 3 doses of VARIVAX. First and second dose on 02/02/2023 and 05/19/2023 respectively. The extra dose was administered on 5/28/2025. Co; This spontaneous report was received from a Nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-FEB-2023, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, (lot #, dose, strength, route of administration, anatomical location of vaccine and expiration date were not reported); On 19-MAY-2023, with the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #, dose, strength, route of administration, anatomical location of vaccine and expiration date were not reported); and on 28-MAY-2025, the patient inadvertently received a third dose (extra dose) with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (dose, strength, route of administration and anatomical location of vaccine were not reported), lot #Z003767, expiration date was reported as 30-JAN-2027, diluted with sterile diluent (MERCK STERILE DILUENT) (Lot# and expiration date were not reported) with no symptoms (no adverse event); all three doses were administered for prophylaxis. More
2850389 UT 07/19/2025 PNC21
 MERCK & CO. INC.
 Y019158
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; Caller reported CAPVAXIVE administered during temperature excursion. No other inf... no adverse event; Caller reported CAPVAXIVE administered during temperature excursion. No other information provided. No additional AE/PQC reported. ? Names of vaccines involved (including lot/exp) CAPVAXIVE Y019158 5/20/2026 ? Temperature 18C; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started was vaccinated with an improperly stored dose of Pneumococcal 21-valent Conjugate Vaccine Injection (CAPVAXIVE) (route of administration and anatomical location of vaccine); lot #Y019158, expiration date reported as 20-MAY-2026 0.5 mL for Prophylaxis. On 25-JUN-2025, the dose experienced a Temperature excursion of 18C for a time fram of 5 hours and 30 minutes. No previous excursion was reported. No additional adverse event were reported. More
2850390 41 F CA 07/19/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.





Alopecia, Blindness, Blood thyroid stimulating hormone decreased, Brain fog, Fat... Alopecia, Blindness, Blood thyroid stimulating hormone decreased, Brain fog, Fatigue; Graves' disease, Hot flush, Hyperthyroidism, Weight decreased, Weight fluctuation; Alopecia, Blindness, Blood thyroid stimulating hormone decreased, Brain fog, Fatigue; Graves' disease, Hot flush, Hyperthyroidism, Weight decreased, Weight fluctuation; Alopecia, Blindness, Blood thyroid stimulating hormone decreased, Brain fog, Fatigue; Graves' disease, Hot flush, Hyperthyroidism, Weight decreased, Weight fluctuation More
Neurological injury; Emotional disorder; Autoimmune Injuries; hyperactive thyroid/ Hair loss/ hot fl... Neurological injury; Emotional disorder; Autoimmune Injuries; hyperactive thyroid/ Hair loss/ hot flashes/ weight loss; Brain fog/fatigue/memory loss; Emotional suffering; Pain; Grave's disease/weight loss/vision loss; Information has been received from a lawyer regarding a case in litigation concerning a 42-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On unknown day (when she was 41 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot number, and expiry ate were not provided) as prophylaxis . Then on unknown date (when she was 42 years old), she received the second and third dose of the suspect vaccine (as described above). On unknown day, within days of the second dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL), patient began to experience hot flashes, fatigue, hair loss, and weight loss. Moreover, she had to wear protective styles and wigs for her thinning hair. Therefore, patient scheduled an appointment with her gynecologist and primary care provider to evaluate her symptoms. Providers performed blood work and the results showed she had hyperactive thyroid. Then, in June 2023, she was diagnosed with Grave's disease. Hence, the patient was treated with medication (unspecified) and saw an endocrinologist to monitor her disorder. In addition, se continued experienced daily brain fog, vision loss, hot flashes, and her weight continued to fluctuate. Patient had suffered and continues to suffer severe and permanent emotional injuries, including pain and suffering. As a direct and proximate result of her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the patient suffered economic losses, including considerable financial expenses for medical care and treatment. The outcome of the events was considered as not recovered (as reported has suffered and continues to suffer severe and permanent physical injuries). The lawyer considered all events to be related to quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL). In addition, all the events were considered as disabling. More
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