🏥 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 💀 🏥 🚑 ♿ ⚠️
2840777 05/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise, Pyrexia Malaise, Pyrexia
got really sick; high fever; This non-serious case was reported by a consumer via interactive digita... got really sick; high fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (Received 1st dose of Shingrix vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got really sick) and fever (Verbatim: high fever). The outcome of the sickness and fever were not reported. It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine. It was unknown if the company considered the sickness and fever to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR056754 Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. It was reported that due to the second one, the patient got really sick, high fever. For tolerance to first dose refer case US2025AMR056754.; Sender's Comments: US-GSK-US2025AMR056754: More
2840778 05/13/2025 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; have shingles; This serious case was reported by a consumer via inter... Suspected vaccination failure; have 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. On an unknown date, 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: have 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 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: 06-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the 2 part shingle vaccinations last year (2024) and at the time of reporting have shingles. The patient hoping the anti-viral and steroid has been prescribed will decrease the possible long lasting effect. 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2) More
2840779 05/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Burning sensation, Localised infection, Pain, Vaccination failure, Zoster sine h... Burning sensation, Localised infection, Pain, Vaccination failure, Zoster sine herpete More
Suspected vaccination failure; Internal shingles; Foot infection; This serious case was reported by ... Suspected vaccination failure; Internal shingles; Foot infection; 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. The patient's past medical history included shingles (had 20 years ago) and rash. 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), zoster sine herpete (Verbatim: Internal shingles) and foot infection (Verbatim: Foot infection). The patient was treated with gabapentin. The outcome of the vaccination failure and foot infection were not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and foot infection 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 zoster sine herpete and foot infection to be related to Shingles vaccine. Additional Information: GSK receipt date: 06-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine a couple years ago. And just had to be on several antibiotics for a foot infection, which wiped out the immune system and now had internal shingles. The patient did not have rash because he/she had vaccine but had the pain and burning sensation. He/she was on gabapentin. It sounded like everyone got on that. The patient asked if anyone had the internal shingles. 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: 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
2840780 M OH 05/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not receive second dose; This non-serious case was reported by a consumer via call center repres... did not receive second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 19th June 2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 06-MAY-2025 The reporter reported that a he received first dose of the Shingrix vaccine on 19th June 2018. The reporter understand the next dose is recommended to be 2 to 6 months apart. For some reason that it might have been availability and then forgetfulness, did not receive our second dose until 11th December 2021. The reporter was ask the effectiveness of the timing of these two doses. This case is linked with US2025AMR057413, reported by same reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025AMR057413:same reporter different patient More
2840781 F 05/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Nausea, Vomiting Nausea, Vomiting
patient developed nausea; vomiting; This non-serious case was reported by a consumer via sales rep a... patient developed nausea; vomiting; This non-serious case was reported by a consumer via sales rep and described the occurrence of nausea in a 55-year-old 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, several hours after receiving Shingrix, the patient experienced nausea (Verbatim: patient developed nausea) and vomiting (Verbatim: vomiting). Shingrix was discontinued. The outcome of the nausea and vomiting were not reported. It was unknown if the reporter considered the nausea and vomiting to be related to Shingrix. It was unknown if the company considered the nausea and vomiting to be related to Shingrix. Additional Information: GSK Receipt Date: 09-MAY-2025 The reporter reported that the patient took the 1 dose of the Shingrix. Within a few hours the patient developed nausea and vomiting. Her side effects were so severe that her doctor decided not to give her dose 2 of the series. More
2840782 F TN 05/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
first dose of Shingrix on 18Dec2023 and the second dose in February 2025; This non-serious case was ... first dose of Shingrix on 18Dec2023 and the second dose in February 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (a patient received the first dose of Shingrix on 18-Dec-2023). In FEB-2025, the patient received the 2nd dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix on 18Dec2023 and the second dose in February 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 05-MAY-2025 Pharmacist reported that a patient received the first dose of Shingrix on 18 December 2023 and the second dose in February of 2025 which led to drug dose administration interval too long. Consented to follow up. More
2840783 17 M WV 05/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 3553D
Expired product administered Expired product administered
Maladministration of Menveo One-vial Presentation After the Expiration Date; This non-serious case w... Maladministration of Menveo One-vial Presentation After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3553D, expiry date 28-FEB-2025) for prophylaxis. On 05-MAY-2025, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Maladministration of Menveo One-vial Presentation After the Expiration Date). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 05-MAY-2025 Nurse reported that on a pediatric male patient received Menveo one vial presentation after the expiration date, which led to expired vaccine used. More
2840784 96 F FL 05/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L5P2
Injection site erythema, Injection site pain, Injection site warmth Injection site erythema, Injection site pain, Injection site warmth
Site of injection sore; Site of injection warm to the touch; Site of injection red; This non-serious... Site of injection sore; Site of injection warm to the touch; Site of injection red; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 9L5P2, expiry date 27-OCT-2026) for prophylaxis. On 02-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: Site of injection sore), injection site warmth (Verbatim: Site of injection warm to the touch) and injection site erythema (Verbatim: Site of injection red). The outcome of the injection site pain, injection site warmth and injection site erythema were not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix. Additional Information: GSK receipt date: 06-MAY-2025 Other HCP reported that a patient got first dose of Shingrix on May 2nd 2025, but at the time of reporting the area of injection was red and warm to the touch, and when she presses on it was sore, and it had been like that for 4 days already, was still ongoing till the time of reporting. Consented to follow up. More
2840785 63 F IL 05/13/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 X011430
Expired product administered Expired product administered
administered an expire Priorix vaccine; This non-serious case was reported by a other health profess... administered an expire Priorix vaccine; 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 63-year-old female patient who received MMR (Priorix) (batch number X011430) for prophylaxis. On 06-MAY-2025, the patient received Priorix. On 06-MAY-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: administered an expire Priorix vaccine). 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: 06-MAY-2025 Other HCP reported that they administered an expire Priorix vaccine, the vaccine was expired since 5 days ago, which led to expired vaccine used. More
2840786 M IL 05/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a physician via sales rep... Suspected vaccination failure; shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, 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 unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 The patient had developed a shingles rash reaction after receiving the Shingrix vaccine. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix More
2840787 80 M 05/13/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 E7335
FA95N/4Z4JG
Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
Extra dose; Late second dose; This non-serious case was reported by a nurse via call center represen... Extra dose; Late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number E7335, expiry date 15-JUN-2026) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number FA95N/4Z4JG, expiry date 28-JUL-2023) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 28-APR-2021 expiry date 30-OCT-2022). On 24-OCT-2024, the patient received the 3rd dose of Shingrix. On 16-AUG-2022, the patient received the 2nd dose of Shingrix. On 16-AUG-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). On 24-OCT-2024, the patient experienced extra dose administered (Verbatim: Extra dose). The outcome of the extra dose administered and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date: 07-MAY-2025 The registered Nurse who requested to remain anonymous and declined consent to follow up with Safety, explained that a patient received a late second dose and a third extra dose of Shingrix which led to extra dose administered. The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. More
2840788 F 05/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient received just 1 vaccine; This non-serious case was reported by a pharmacist via call center ... patient received just 1 vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient that received her first Shingrix shot in sept 2021, just 1 vaccine). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received just 1 vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 07-MAY-2025 Other HCP reported that a female patient received her first Shingrix shot in sept 2021, just 1 vaccine. Did not consent to follow-up. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. More
2840789 AZ 05/13/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Wrong product administered Wrong product administered
Wrong vaccine administered; This non-serious case was reported by a consumer via call center represe... Wrong vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On an unknown date, the patient received Bexsero, did not receive Menveo and Menquadfi. On an unknown date, an unknown time after receiving Bexsero and not applicable after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the wrong vaccine administered 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: 07-MAY-2025 The GSK Representative explained that a Pediatrician mentioned that an 11 year old patient received a Bexsero vaccine instead of MenQuadfi or Menveo, but GSK Representative did not have further details for the adverse event report which led to wrong vaccine administered. Outbound call placed to get further adverse event details, no answer, agent left a voicemail with case number. They would send a follow up email to safety team in case that they were able to contact the physician later. More
2840790 68 M AZ 05/13/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 342RC
Expired product administered Expired product administered
administered an expired dose of priorix; This non-serious case was reported by a other health profes... administered an expired dose of priorix; 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 68-year-old male patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis. On 07-MAY-2025, the patient received Priorix. On 07-MAY-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of priorix). 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: 08-MAY-2025 The Vaccine Administration Facility is the same as Primary Reporter. The Health Center Manager called to ask about guidance on revaccination for an adult male patient that was administered an expired dose of Priorix vaccine which led to expired vaccine used. More
2840791 CA 05/13/2025 JEV1
 INTERCELL AG
 JEV22H63E
Ear infection Ear infection
The patient is due today (13 May 2024) for his 2nd dose of Japanese encephalitis vaccine (IXIARO). T... The patient is due today (13 May 2024) for his 2nd dose of Japanese encephalitis vaccine (IXIARO). The patient got an ear infection 2 days ago (11 May 2024), and started antibiotics. The patient received his first dose of IXIARO on 08 Apr 2024.; The patient is due for his 2nd IXIARO dose, but he got an ear infection 2 days ago and started antibiotics yesterday; The following information was received from a Healthcare Professional via service provider on 13 May 2024. A 40-year-old male received his first dose of IXIARO (Japanese encephalitis vaccine, batch number JEV22H63E) i.m. on 08 Apr 2024. Concomitant medication included Allopurinol (allopurinol) and his medical history was stated as gout. On 11 May 2024 he experienced an ear infection and was treated with Amox/Kclav 875/125 mg (amoxicillin, clavulanic acid) since 12 May 2024. On 13 May 2024 he was due for his second dose of IXIARO. The outcome of the event ear infection was not reported.; Sender's Comments: Causality assessed as not related, as inactivated vaccines do not cause infections. Causality assessment is not applicable for the event Incomplete course of vaccination, as this is no adverse event. More
2840792 M NH 05/13/2025 COVID19
 MODERNA
 3046731
Agitation, Mental disorder, Pyrexia, Slow response to stimuli, Speech disorder Agitation, Mental disorder, Pyrexia, Slow response to stimuli, Speech disorder
altered mental status; increased agitation; slow response; limited speech; fever; This spontaneous c... altered mental status; increased agitation; slow response; limited speech; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever). At the time of the report, MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. This case contains information about 2nd patient out of 2 patients as reported by reporter. No concomitant medications were reported. HCP stated that patient received a Spikevax dose in October 2024, but no other vaccines in the last four weeks and was unable to provide medical history. HCP stated that patient was changed from the regular baseline and ended up going to the emergency room. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-785850 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785850:Patient 02 More
2840793 M NH 05/13/2025 COVID19
 MODERNA
 3046731
Agitation, Mental disorder, Pyrexia, Slow response to stimuli, Speech disorder Agitation, Mental disorder, Pyrexia, Slow response to stimuli, Speech disorder
altered mental status; increased agitation; slow response; limited speech; fever; This spontaneous c... altered mental status; increased agitation; slow response; limited speech; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever). At the time of the report, MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. This case contains information about 1st patient out of 2 patients as reported by reporter. No concomitant medications were reported. HCP stated that patient received a Spikevax dose in October 2024, but no other vaccines in the last four weeks and was unable to provide medical history. HCP stated that patient changed from the regular baseline and ended up going to the emergency room. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-785851 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785851:Patient 02 More
2840794 66 M 05/13/2025 COVID19
 MODERNA
Neoplasm malignant, Weight, Weight decreased Neoplasm malignant, Weight, Weight decreased
unexplained weight-loss; This spontaneous case was reported by a patient and describes the occurrenc... unexplained weight-loss; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (unexplained weight-loss) in a 66-year-old male patient 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 WEIGHT DECREASED (unexplained weight-loss). At the time of the report, WEIGHT DECREASED (unexplained weight-loss) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neoplasm malignant: but it's coming up negative. On an unknown date, Weight: unexplained weight-loss. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that the patient had experienced unexplained weight loss and had undergone every possible test for cancer and other conditions that his doctor had conducted, but all the results had come back negative. He stated that the only possible explanation he could think of was that it might be due to the vaccine he had taken two to three years ago. It was unknown if the patient experienced any additional symptoms or events No treatment medications were reported. More
2840795 05/13/2025 COVID19
 PFIZER\BIONTECH
Pulmonary mass Pulmonary mass
getting a biopsy on a nodule in my lung; This is a spontaneous report received from a Consumer or ot... getting a biopsy on a nodule in my lung; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: PULMONARY MASS (non-serious), outcome "unknown", described as "getting a biopsy on a nodule in my lung". Additional information: The patient was getting a biopsy on a nodule in lung that patient want to have the pathologist to check for the mRNA from the 2 covid vaccines received. The patient was asking what tests to tell the doctor and pathologist to get check and what test to run. The patient non symptomatic and these nodule's came out of nowhere. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2840796 M 05/13/2025 COVID19
 PFIZER\BIONTECH
Electrocardiogram, Ventricular tachycardia Electrocardiogram, Ventricular tachycardia
super-ventricular tachycardia, so two of the pathways to his heart were shot; This is a spontaneous ... super-ventricular tachycardia, so two of the pathways to his heart were shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 40-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VENTRICULAR TACHYCARDIA (life threatening, medically significant), outcome "unknown", described as "super-ventricular tachycardia, so two of the pathways to his heart were shot". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (06May2025) Unknown results. Clinical course: The patient received the vaccine, and has super-ventricular tachycardia, so two of the pathways to his heart were shot. But he mentioned he has incredibly good health otherwise. The patient inquired on if Pfizer had been sued because of this, because if he hadn't request an EKG in his check up on Tuesday, he might have dropped dead. He mentioned he wanted to know the lawsuit information, because he wanted to know what Pfizer was doing to make this better. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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2840797 F 05/13/2025 PNC20
 PFIZER\WYETH
Pain Pain
it being to painful for the child; This is a spontaneous report received from a Physician from a sal... it being to painful for the child; This is a spontaneous report received from a Physician from a sales representative. A 22-month-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Nov2024, outcome "recovered" (Dec2024), described as "it being to painful for the child". It was unknown if therapeutic measures were taken as a result of pain. Additional information: Vaccine administration time was 02:00 PM. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2840798 49 F 05/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 LM2210
388527
COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vacci... COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vaccination failure More
Tested positive for Covid. Experiencing mild symptoms.; Tested positive for Covid. Experiencing mild... Tested positive for Covid. Experiencing mild symptoms.; Tested positive for Covid. Experiencing mild symptoms.; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Lot number: LM2210) at the age of 49 years, in right deltoid for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 03Oct2024 as dose number unknown, single (Lot number: 388527), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2025, outcome "recovering" and all described as "Tested positive for Covid. Experiencing mild symptoms.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2025) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. More
2840799 F NY 05/13/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vacci... COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vaccination failure More
As of 10May2025 I contracted Covid-19 based on the Lucira test taken; As of 10May2025 I contracted C... As of 10May2025 I contracted Covid-19 based on the Lucira test taken; As of 10May2025 I contracted Covid-19 based on the Lucira test taken; This is a spontaneous report received from a Consumer or other non HCP. An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Oct2024 at 10:15 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 02Oct2024 as dose number unknown, single), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2025 at 14:00, outcome "not recovered" and all described as "As of 10May2025 I contracted Covid-19 based on the Lucira test taken". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2025) contracted Covid-19. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The reporter informed that the vaccine location was at the upper left arm and the facility type was workplace clinic. The patient has no other vaccine in four weeks and has no other medications in two weeks. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2840800 F 05/13/2025 COVID19
 PFIZER\BIONTECH
Lung disorder Lung disorder
patient was now in ICU with fulminanat lung issues; This is a spontaneous report received from a Phy... patient was now in ICU with fulminanat lung issues; This is a spontaneous report received from a Physician. An elderly female patient (not 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. Vaccination history included: Covid-19 vaccine (dose 1), for covid-19 immunization; Covid-19 vaccine (dose 2), for covid-19 immunization; Covid-19 vaccine (dose 3), for covid-19 immunization; Covid-19 vaccine (dose 4), for covid-19 immunization; Covid-19 vaccine (dose 5), for covid-19 immunization; Covid-19 vaccine (dose 6), for covid-19 immunization; Covid-19 vaccine (dose 7), for covid-19 immunization; Covid-19 vaccine (dose 8), for covid-19 immunization; Covid-19 vaccine (dose 9), for covid-19 immunization; Covid-19 vaccine (dose 10), for covid-19 immunization; Covid-19 vaccine (dose 11), for covid-19 immunization; Covid-19 vaccine (dose 12), for covid-19 immunization; Covid-19 vaccine (dose 13), for covid-19 immunization. The following information was reported: LUNG DISORDER (hospitalization, life threatening), outcome "not recovered", described as "patient was now in ICU with fulminanat lung issues". It was unknown if therapeutic measures were taken as a result of lung disorder. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the implied temporal relationship, the association between the event "fulminant lung issue" with BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)) can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
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2840801 67 F OR 05/13/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH
GJ6739
Blood test, COVID-19, Drug ineffective, Interchange of vaccine products; Blood t... Blood test, COVID-19, Drug ineffective, Interchange of vaccine products; Blood test, COVID-19, Drug ineffective, Interchange of vaccine products More
Dose 1, dose 2, dose 3: Moderna, dose 4, dose 5: Pfizer; I got COVID four times after getting five v... Dose 1, dose 2, dose 3: Moderna, dose 4, dose 5: Pfizer; I got COVID four times after getting five vaccinations; I got COVID four times after getting five vaccinations; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM7553) intramuscular, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "NASH/MASH/Metabolic Acquired Steatohepatitis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "inflammatory" (ongoing), notes: now; "cancer/liver cancer", start date: 2018 (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "porosis" (unspecified if ongoing); "heart disease" (ongoing), notes: now; "Cirrhosis of the liver" (unspecified if ongoing), notes: her liver was too damaged, have cirrhosis of the liver, had it 25 years; "Hep C" (unspecified if ongoing), notes: had Hep C for 40 years; "had surgery on knee" (unspecified if ongoing); "Covid", start date: 2019 (unspecified if ongoing), notes: first round of Covid in 2019, when COVID came out and she tested positive. She had cancer before she got really sick with the first round of Covid in 2019. When COVID came out and she tested positive It was Non-A, Non-B, pneumonia, she swore it was Covid, it was late Dec2019, early 2020 and it lasted for 4 months almost. She had herbal formula (cold formula plus with vitamin D and zinc) that's made with Chinese medicine that kick COVID, it got her out of COVID within three days. She stayed on it (herbal formula) like for prophylactic reasons but now, she was not on it now. She had surgery on her knee, and she got so sick right after that, it was horrible. The patient had over a 100 conditions. Concomitant medication(s) included: SYNTHROID; NIFEDIPINE XL; JARDIANCE taken for diabetes mellitus; VALIUM. There was no vaccine administered on the same date with Pfizer COVID-19 Vaccine and there was no vaccine administered prior to four weeks administration of Pfizer COVID-19 Vaccine because the patient was so scared to take vaccine, she did not mix anything (vaccination) with anything (vaccination). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1, dose 2, dose 3: Moderna, dose 4, dose 5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID four times after getting five vaccinations". Clinical course: The patient had received five vaccinations, dose 1, dose 2 and dose 3 were Moderna Covid-19 vaccine, dose 4 and dose 5 were Pfizer covid-19 vaccines. The patient had COVID four times after getting five vaccinations, unable to take Paxlovid because she had a really messed up liver, her liver was too damaged, cirrhosis of the liver, had it 25 years. She was way too fragile physically. The patient was not prescribed with Paxlovid. Within the last two or three weeks, she had lab test, the blood results and everything that she had been doing to stay healthy was working. Her blood work all looks good in every area except she had antibodies for rheumatoid arthritis, had the antibodies for Hashimoto's so blood work wise everything look great but diagnosis wise. She still had these disease. Her blood work was normal but because she was only on four medications that was now, she used to be on 15. More
2840802 05/13/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Illness, Lethargy, Pyrexia; Illness, Lethargy, Pyrexia Illness, Lethargy, Pyrexia; Illness, Lethargy, Pyrexia
sick; feverish; lethargic; This is a spontaneous report received from a Consumer or other non HCP. ... sick; feverish; lethargic; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose 1, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "feverish"; LETHARGY (non-serious), outcome "unknown", described as "lethargic". Additional information: patient had Pfizer Covid 19 shot in one arm, and a flu shot for 65 years and older in the other arm, together at the same time and was sick in bed for one day, was feverish and lethargic. More
2840803 OK 05/13/2025 COVID19
 PFIZER\BIONTECH
Asthma Asthma
have been constantly struggling with my asthma; This is a spontaneous report received from a Consume... have been constantly struggling with my asthma; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), 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: ASTHMA (non-serious), outcome "not recovered", described as "have been constantly struggling with my asthma". Therapeutic measures were taken as a result of asthma. Additional information: Patient had received the Pfizer shots back in 2020 or 2021 since then patient have been constantly struggling with asthma where as patient never had to use any form of inhaler or anything now patient can even go 1 day without multiple breathing treatments. Patient don't have health insurance, Asked who's going to cover inhalers and breathing treatments. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2840804 F 05/13/2025 COVID19
 PFIZER\BIONTECH
Muscle spasticity Muscle spasticity
Reaction to Covid Vaccine (Spasticity in upper torso, Neck, Arms, and Hands); This is a spontaneous ... Reaction to Covid Vaccine (Spasticity in upper torso, Neck, Arms, and Hands); This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025BI01310025. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASTICITY (non-serious), outcome "unknown", described as "Reaction to Covid Vaccine (Spasticity in upper torso, Neck, Arms, and Hands)". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2840805 F 05/13/2025 FLU3
 SANOFI PASTEUR
Influenza, Pneumonia Influenza, Pneumonia
pneumonia; flu; Initial information received on 08-May-2025 regarding an unsolicited valid serious ... pneumonia; flu; Initial information received on 08-May-2025 regarding an unsolicited valid serious case received from a consumer/Non-Healthcare Professional. This case involves an unknown age female patient who experienced pneumonia and flu after receiving influenza USP trival A-B subvirion no preservative vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection, (lot number and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On an unknown date the patient developed pneumonia and flu (influenza) (unknown latency). Action taken: Not applicable. It was not reported if the patient received a corrective treatment for both the events (flu, pneumonia). At time of reporting, the outcome was Unknown for both the events. Seriousness Criteria: Medically significant for pneumonia.; Sender's Comments: Sanofi Company Comment dated 13-MAY-2025: This case involves an unknown age female patient who experienced pneumonia and flu after receiving influenza USP trival A-B subvirion no preservative vaccine [Fluzone]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. More
2840831 F AZ 05/13/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraesthesia
FBE calling on behalf of an HCP to report that a female patient in her 20's took her first dose... FBE calling on behalf of an HCP to report that a female patient in her 20's took her first dose of GARDASIL-9 "a few months ago" and experienced bilateral tingling and numbness in her fingers and hands that lasted "a day or two". Patient did not re; numbness in her fingers; This spontaneous report was received from a nurse practitioner and refers to an adult female patient (in her 20's). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (reported as a "few months ago"), the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, administered by Intramuscular route (lot # and expiration date were not reported). On 25-Apr-2025 (reported as "today"), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 2, administered by Intramuscular route (lot # and expiration date were not reported); both doses as prophylaxis. On an unknown date, the patient experienced bilateral tingling and numbness in her fingers and hands that lasted "a day or two". The patient did not report the issues until a few months later when she went back for her 2nd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). After the administration of the second dose, the patient informed the doctor of the experience with numbness and tingling on the prior dose and confirmed that she did not seek medical treatment at the time of the event. Patient has not reported any symptoms with second dose. The causal relationship between the event of bilateral tingling and numbness in her fingers and hands and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. More
2840832 17 M WV 05/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 3553D
Expired product administered Expired product administered
A 17 years old male patient received an expired dose of Menveo; This non-serious case was reported b... A 17 years old male patient received an expired dose of Menveo; 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 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3553D, expiry date 28-FEB-2025) for prophylaxis. On 05-MAY-2025, the patient received Menveo. On 05-MAY-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A 17 years old male patient received an expired dose of Menveo). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 05-MAY-2025 A clinical manager called to report the administration of an expired dose of Menveo (1 vial) to a patient on the day of reporting, which led to an expired vaccine used. The reporter wanted to know how long they have to wait to revaccinate the patient. More
2840833 F 05/13/2025 RSV
 PFIZER\WYETH
Guillain-Barre syndrome Guillain-Barre syndrome
Guillian- Barre; This is a spontaneous report received from a Consumer or other non HCP from a sales... Guillian- Barre; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, life threatening, medically significant), outcome "recovering", described as "Guillian- Barre". Therapeutic measures were taken as a result of guillain-barre syndrome. Clinical course: Patient experienced Guillian- Barre after Abrysvo, admitted to hospital and intubated. Still not fully recovered. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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2840834 F 05/13/2025 RSV
 PFIZER\WYETH
Guillain-Barre syndrome, Immunoglobulin therapy Guillain-Barre syndrome, Immunoglobulin therapy
Guillian Barre; This is a spontaneous report received from a Physician from a sales representative. ... Guillian Barre; This is a spontaneous report received from a Physician from a sales representative. An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "Guillian Barre". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 2 day(s)). The event "guillian barre" required emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Clinical course: Patient received Abrysvo and experience Guillian-Barre. She went to ER two days after injection and was admitted to hospital for 2 days, was given IVIg infusion. She is recovered. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known drug safety profile, and plausible temporal association the event Guillain-Barre syndrome is assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
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2840835 M 05/13/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



Blister, Blood pressure inadequately controlled, Blood pressure measurement, Blo... Blister, Blood pressure inadequately controlled, Blood pressure measurement, Blood test, Condition aggravated; Death, Haematocrit, Haematocrit decreased, Haemoglobin, Haemoglobin decreased; Metabolic function test, Pemphigoid, Peripheral swelling, Rash pruritic, Red blood cell count; Red blood cell count decreased, Skin lesion, Skin ulcer More
pemphigoid/severe bullous pemphigoid; Skin ulcer; Peripheral swelling (swollen feet and leg); Bliste... pemphigoid/severe bullous pemphigoid; Skin ulcer; Peripheral swelling (swollen feet and leg); Blister; Rash pruritic (itchy spots on body); Skin lesion; Blood pressure inadequately controlled; Condition aggravated; Red blood cell count decreased; Haemoglobin decreased; Haematocrit decreased; Passed away; This is a solicited report received from a Consumer or other non HCP and an Other HCP from License Party. Other Case identifier(s): AE-019124 (BioNTech). Initial information received on 02Apr2024 regarding a solicited valid serious case received from patient's grandson in the scope of patient support program Study Title. This case involves an 84 years old male patient who had severe bullous pemphigoid in patient's legs, blisters. itchy spots on body, worse, more lessions, bp is not controlled and refractory. rash Red blood cell count mildy decreasd, hemoglobin and hematocrit count mildly decreased and passed away while being treated with Duplimab (Dupixen) delivered via dupilumab single dose pre filled pen and COVID-19 vaccine. The patient's pest medical history included Squamous cell carcinoma, Hernia and Atrial fibrillation. The patient's pest medical treatment(s), vaccination (s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus and Hypertension and treated with atorvastatin, metprolol, metformin and Eliquis, Eczema and patient vas legally blind since several years. Social History of Single Question Alcohol Screening: 0 days. EIOH (Early Intraoperative Hypotension): none. Smoking status Nover smoker. Pneumonia vaccination or previously received Healthcare Proxy: No and Living Will: Yes patient had no known allergies. Alert: Premedication prior to procedures, no cough or shortness of breath. Concomitant medications included Nicotinic acid (Niacin); Ketoconazole (Ketoconazole); Pantoprazole (Pantoprazole); Propionic acid (Propionic acid); Apixaban (Eliquis); Triamcinolone (Triamcinolone); Hydrocortisone (Hydrocortisone); Metoprolol succinate (Metoprolol succinate); Methotrexate (Methotrexate); Atorvastatin calcium (Atorvastatin) for Hypertension; Naproxen (Naproxen) for Pain; Furosemide (Lasix); Sulfadiazine silver (Silvadene); Pantoprazole sodium sesquihydrate (Protonix); Metformin hydrochloride (Metformin) for Diabetes mellitus; Amoxicillin trihydrate, Clavulanate potassium (Augmentin); Mupirocin (Mupirocin); and Clobetasol (Clobetasol).On 19Aug2022, the patient started taking Dupilumab Solution for injection (Strength: 300mg/2ml) at a loading dose of 600 mg 1x as loading dose followed by 300 mg QOW (every other week) since 2022 subcutaneously delivered via dupilumab single dose prefilled pen for Atopic dermatitis, Unspecified/ atopic dermatitis. On 02Oct2024, patient had a shot of COVID-19 vaccine (with unknown dose, strength, route, formulation, frequency) for prophylactic vaccination. On an unknown date (latency: unknown) (with unknown batch number and expiry date) patient grandson stated since his grandfather started taking Dupixent he had periodic incidents of going suddenly blind in his left Eye and believes may be directly associated with taking Dupixent. Patients last incident of going blind in left eye suddenly took place on 24Dec2023. The granddaughter of patient stated that her grandfather has recently been going blind in his left eye, temporary and it periodically, it only began since he began taking the injection, he did not experience going blind in his left eye prior to taking Dupixent. At the time of the report, Dupixent is continued. Upon follow up On an unknown date in Jan2025 (Latency: 2 years 5 months) Doctor recommended patient to go to ER (emergency room) due to swollen legs (Peripheral swelling) and ulcers (Skin ulcer) and was then admitted to hospital from 07Jan2025 and 09Jan2025. Blood tests 07Jan2025, 08Jan2025 and 09Jan2025: CMP (comprehensive metabolic panel) mostly within normal range; CBC (complete blood count) mostly within normal range; except mildly decreased RBC and hemoglobin and hematocrit value was mildly decreased (Red blood cell count decreased)(Haemoglobin decreased)(Hematocrit decreased) (Latency: 2 years 5 months)(with unknown batch number and expiry date) Reportedly On an unknown date (Latency: unknown), patient's BP (blood pressure) was not controlled and refractory (Blood pressure inadequately controlled). Since Apr2024, patient could not taper oral prednisone below 30 mg qd (once daily) still new rash (Rash) and blisters (Blister)(onset and latency unknown) (with unknown batch number and expiry date). Reportedly On an unknown date (Latency: unknown) patient had itchy spots on body, worse, more lesions (skin lesion)(condition aggravated), (rash pruritic)(unknown batch number and expiry date). Upon follow-up, patient daughter stated that patient had passed away (death) (Onset: 09Feb2025) (Latency: 2 years 5 months 21 days) (unknown batch number and expiry date). It was unknown if an autopsy was done. Unknown cause of death. Upon follow-up medical assistant (MA), were not aware that the patient had died, no mention in the patient's chart, therefor they did not know cause of death, have any death details, and did not know if an autopsy was performed. They did not feel Dupixent was related to the death. His last office visit was on 17Jan2025, no mention of his atopic dermatitis but he was continued on Dupixent at that time. The MA stated there were events mentioned during the last office visit including severe bullous pemphigoid in his legs (pemphigoid) (onset, latency: unknown) (unknown batch number and expiry date) with an emergency room visit, he was on methotrexate for unknown reason and was on prednisone since Apr2024 for bullous pemphigoid. Information regarding batch number and expiry date corresponding to the one at time of event occurrence was requested. Relevant laboratory test results included: Full blood count - On 07Jan2025: [with in normal range]; on 08Jan2025: [with in normal range]; on 09Jan2025: [with in normal range] Haematocrit - On 07Jan2025: [mildly decreased]; on 08Jan2025: [mildly decreased]; on 09Jan2025: [mildly decreased] Haemoglobin - On 07Jan2025: [mildly decreased]; on 08-Jan-2025: [mildly decreased]; on 09Jan2025: [mildly decreased] Metabolic function test - On 07Jan2025: [with in normal range]; on 08Jan2025: [with in normal range]; on 09Jan2025: [with in normal range] Red blood cell count - On 07Jan2025: [mildly decreased]; on 08Jan2025: [mildly decreased]; on 09Jan2025: [mildly decreased]. Action Taken with dupilumab: No action taken for the event pemphigoid; Not applicable for death and unknown for rest all the events. Action Taken with COVID-19 vaccine: Not applicable for all events. Corrective treatment: The patient was treated with Doxycycline (Doxycycline), Furosemide (Furosemide) and Prednisone (Prednisone) for Pemphigoid and not reported for rest of the events. Outcome: Fatal for death and unknown for all the events. Reporter Causality with dupilumab: not related for the event death and not reported for all other events. Reporter Causality with COVID-19 vaccine: Not reported for all events. Company Causality with dupilumab: Not Reportable for all the events. Company Causality with COVID-19 vaccine: Not reportable for all events. Seriousness Criteria: The event death, pemphigoid along with symptoms was assessed as medically significant and death for the event death. Patient was hospitalized for the event pemphigoid and symptoms. Additional information was received on 03Apr2024 from granddaughter of the patient: Event blindness transient verbatim was updated. loading dose was added. Therapy start date was added. Clinical course was added. Narrative was updated. Additional information was received on 10Apr2025 from patient's daughter: event death, concomitant medications, strength were added and text amended accordingly. Additional information was received on 15Apr2025 from Medical assistant. New event of pemphigoid was added. Concomitant medication was added. Text amended accordingly. Additional information was received on 15Apr2025 from physician. new event Blister, Rash pruritic, Rash, Skin lesion, condition aggravated, Red blood cell count decreased, Haemoglobin decreased, Hematocrit decreased and Blood pressure inadequately controlled was added. Concomitants, medical history, treatment drugs were added. Event of blindness transient was deleted. Text amended. COMIRNATY (2024-2025 FORMULA) is under agreement with BIONTECH SE.; Sender's Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Case will be reassessed when follow-up information such medical history, concomitant medications and event term details especially death cause and autopsy results is received. There is no reasonable possibility that the events pemphigoid, skin ulcer, blister, skin lesions aggravated were related to Comirnaty (2024-2025 Formula). These are more likely associated with the history of squamous cell carcinoma. There is no reasonable possibility that the events peripheral swelling, red blood cell decreased, hemoglobin decreased, and hematocrit decreased were related to Comirnaty (2024-2025 Formula). These are more likely intercurrent conditions. The events blood pressure inadequately controlled is more likely associated with the history of atrial fibrillation. There is a reasonable possibility that the event rash is related to Comirnaty (2024-2025) based on known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death More
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2840836 M KY 05/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, P... tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: COVID-19 (non-serious) with onset 08May2025, outcome "unknown", described as "tested positive for Covid". The event "tested positive for covid" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: During an inbound call for financial assistance the patient stated, "I went to the ER last night and tested positive for Covid. And the doctor wrote the prescription for Paxlovid and sent it in this morning. But they can't fill it. I've had my first symptoms on Monday, I didn't know if they just didn't want to fill it because today's already Friday" . When asked for his member ID, the patient stated, "From Pfizer? No, I mean, I haven't gotten any, this is the first contact I've had with you folks, other than when I got my first vaccination, 3, 5 years ago." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2840837 57 F GA 05/13/2025 HEPAB
PNC21
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 M4B34
Z002626
Injection site erythema, Injection site induration, Injection site pain, Injecti... Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling More
Patient reporting swelling at the injection site, pain, redness, itching, feels hard. She is curren... Patient reporting swelling at the injection site, pain, redness, itching, feels hard. She is currently taking Aleve and benadryl also applying ice pack to the injection site. Reporting no improvement on day 5 More
2840838 37 F TX 05/13/2025 MMR
 MERCK & CO. INC.
 Y015022
Arthralgia, Gait disturbance, Muscular weakness Arthralgia, Gait disturbance, Muscular weakness
Bilateral leg weakness, difficulty walking, joint pain over the past month. Symptoms began 1 day af... Bilateral leg weakness, difficulty walking, joint pain over the past month. Symptoms began 1 day after vaccination. More
2840839 24 M IL 05/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 N/A
N/A
Miliaria, Urticaria chronic; Miliaria, Urticaria chronic Miliaria, Urticaria chronic; Miliaria, Urticaria chronic
Since about a month after I was vaccinated, I have experienced chronic heat rashes/Urticaria when en... Since about a month after I was vaccinated, I have experienced chronic heat rashes/Urticaria when engaging in exercise primarily, but also anytime I am feeling stressed. This can happen during meetings, arguments, or even when I am mentally stressing myself. It also occurs if my environment is warm. The hives break out along my arms, chest, and back primarily. The reactions last typically 5-10 minutes before subsiding. Allergy medication does nothing. I usually have at least one episode per day unless I remain in a cool and stress-free environment. This never occurred before the vaccination, and I am not obese or live a stagnant lifestyle. No over-the-counter treatment options have worked thus far, so I will seek a doctor's care now that I have discovered I am not the only one who has experienced this from the Moderna vaccine.... More
2840840 33 F FL 05/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 011jzoa
028lzoa
Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging; Hyp... Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging; Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging More
Developed left sided numbness 2 days following my second vaccine Developed left sided numbness 2 days following my second vaccine
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2840841 45 M AZ 05/13/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported. More
2840842 2 M 05/13/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
Rash, Urticaria Rash, Urticaria
generalized hives and rash generalized hives and rash
2840843 30 M AZ 05/13/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00015
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported. More
2840844 57 M GA 05/13/2025 PNC21
 MERCK & CO. INC.
 Y011819
Pruritus, Rash Pruritus, Rash
Patient's arm developed a rash and itching on 5/9/2025, He used hydrocortisone cream and took ... Patient's arm developed a rash and itching on 5/9/2025, He used hydrocortisone cream and took Allegra to help with the itching. More
2840845 63 F FL 05/13/2025 TDAP
 SANOFI PASTEUR
 4928140089
Arthralgia, Back pain, Loss of personal independence in daily activities Arthralgia, Back pain, Loss of personal independence in daily activities
When shot was administered I informed nurse that it felt like she hit a bone. Next day upper shoulde... When shot was administered I informed nurse that it felt like she hit a bone. Next day upper shoulder joint was painful, 2nd day upper shoulder joint and upper back are in and still are in severe pain. I can not get dressed or do ordinary daily activities without being in severe pain. Seems vaccine was administered in my shoulder joint, not the muscle in my arm and now I wonder if the vaccine is even effective. More
2840846 47 M AZ 05/13/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00015
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported. More
2840847 73 M VA 05/13/2025 RSV
 PFIZER\WYETH
 LN5469
Myocardial infarction Myocardial infarction
HEART ATTACK HEART ATTACK
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2840848 53 M AZ 05/13/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00016
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported. More
2840865 53 M AZ 05/13/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00016
No adverse event No adverse event
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto... The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported. More
2840866 77 F 05/13/2025 COVID19
 MODERNA
 3046731
Condition aggravated, Micturition urgency, Urinary incontinence Condition aggravated, Micturition urgency, Urinary incontinence
The patient reports urinary incontinence following the vaccine administration. She received her vacc... The patient reports urinary incontinence following the vaccine administration. She received her vaccine around 6:30 and reports symptoms started at bedtime. She says she started experiencing increased urgency and the loss of control of her function before making it to the bathroom. She says the symptoms have improved slightly in the last 24 hours. She does have some underlying urinary incontinence but never as bad as it was before. More
2840867 27 M AZ 05/13/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00015
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported. More
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