🏥 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 💀 🏥 🚑 ♿ ⚠️
2847925 CO 07/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
they have a patient that may have been given a Shingrix vaccine that was expired; This non-serious c... they have a patient that may have been given a Shingrix vaccine that was expired; 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 patient who received Herpes zoster (Shingrix) (expiry date SEP-2023) for prophylaxis. In DEC-2023, the patient received Shingrix. In DEC-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: they have a patient that may have been given a Shingrix vaccine that was expired). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 20-JUN-2025 Practice Manager reported that they had a patient that might had been given a Shingrix vaccine that was expired which led to expired vaccine used. More
2847926 36 F 07/01/2025 UNK
 UNKNOWN MANUFACTURER
Arthralgia, Pyrexia, Urticaria Arthralgia, Pyrexia, Urticaria
Articular pain seven days after, fever eight dats after, and urticaria 11 days after. I had dengue o... Articular pain seven days after, fever eight dats after, and urticaria 11 days after. I had dengue on February, 2024, don t know the serotype. More
2847927 0.4 F LA 07/01/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 U8267AA
U8267AA
LK6653
LK6653
2052020
2052020
Cough, Infant irritability, Influenza virus test negative, Pyrexia, Respiratory ... Cough, Infant irritability, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative; Respiratory viral panel, SARS-CoV-2 test negative, Streptococcus test negative, Vomiting; Cough, Infant irritability, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative; Respiratory viral panel, SARS-CoV-2 test negative, Streptococcus test negative, Vomiting; Cough, Infant irritability, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative; Respiratory viral panel, SARS-CoV-2 test negative, Streptococcus test negative, Vomiting More
4/23/25 Received first dose of vaccines below. 4/30/25 Reported cough + fussiness since receiving va... 4/23/25 Received first dose of vaccines below. 4/30/25 Reported cough + fussiness since receiving vaccines. 6/25/25 Received second dose of vaccines listed below. 6/26/25 Reports vomiting, fever, and fussiness that started directly after receiving vaccines. More
✓
2847929 61 F NC 07/01/2025 TDAP
 SANOFI PASTEUR
 U8353AA
Hypoaesthesia, Imaging procedure, Laboratory test Hypoaesthesia, Imaging procedure, Laboratory test
Patient seen at ED at Hospital. Stated numbness on one side of body. Patient seen at ED at Hospital. Stated numbness on one side of body.
2847930 16 F CA 07/01/2025 HPV9
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 Z007847
57H54
Injection site cellulitis; Injection site cellulitis Injection site cellulitis; Injection site cellulitis
Right deltoid cellulitis. tx: Bactrim DS 800mg - 160mg BID x5 days. Right deltoid cellulitis. tx: Bactrim DS 800mg - 160mg BID x5 days.
2847985 63 M WI 07/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Product preparation issue Product preparation issue
Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that c... Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix; Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number PJ353) for prophylaxis. On 19-JUN-2025, the patient received Shingrix. On 19-JUN-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix) and inappropriate dose of vaccine administered (Verbatim: Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 20-JUN-2025 The healthcare professional reported that a Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The final product was administered to the patient. More
2847986 07/01/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Expired product administered Expired product administered
administration of expired vaccine; This non-serious case was reported by a physician via sales rep a... administration of expired vaccine; This non-serious case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a adult patient who received Men ACWY-CRM NVS (Menveo) (expiry date 31-MAR-2025) for prophylaxis. On 01-APR-2025, the patient received Menveo (unknown arm). On 01-APR-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administration of expired vaccine). On 01-APR-2025, the outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter reported that the patient was administered the Menveo vaccine one day after expiration which led to expired vaccine used. More
2847987 07/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
Two days after I had my first vaccine, I got shingles; This non-serious case was reported by a consu... Two days after I had my first vaccine, I got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Two days after I had my first vaccine, I got shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a consumer via interactive digital media. Two days after the patient had his/her Shingles vaccine, he/she got shingles. More
2847988 07/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Illness Illness
very sick for about a day; This non-serious case was reported by a consumer via interactive digital ... very sick for about a day; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: very sick for about a day). The outcome of the sickness was resolved (duration 1 day). It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that both Shingrix shots kicked butt. The reporter was very sick for about a day. But shingles was way worse. More
2847989 07/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site pain Injection site pain
The second shot hurt like/ well just say it hurt, but rather that than shingles; This non-serious ca... The second shot hurt like/ well just say it hurt, but rather that than shingles; 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 (Shingles vaccine) for prophylaxis. 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 pain (Verbatim: The second shot hurt like/ well just say it hurt, but rather that than shingles). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a consumer via interactive digital media. The second shot hurt like well, just said it hurt, but rather that than shingles. More
2847990 07/01/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
I still have severe pain in my arm that I got the vaccines; This non-serious case was reported by a ... I still have severe pain in my arm that I got the vaccines; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: I still have severe pain in my arm that I got the vaccines). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to RSV vaccine. It was unknown if the company considered the pain in arm to be related to RSV vaccine. Additional Information: GSK Receipt Date: 21-JUN-2025 This case was reported by a patient via interactive digital media. Patient had severe pain in his/her arm that he/she got the vaccines. More
2847991 07/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Injection site swelling; Injection site erythema; This non-serious case was reported by a consumer v... Injection site swelling; Injection site erythema; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Injection site swelling) and injection site erythema (Verbatim: Injection site erythema). The outcome of the injection site swelling and injection site erythema were not reported. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site swelling and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that after 1st dose of Shingrix the patient had redness and swelling at injection site. More
2847992 07/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pyrexia Pyrexia
How long will the fever last with the shingles vaccine; This non-serious case was reported by a cons... How long will the fever last with the shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever (Verbatim: How long will the fever last with the shingles vaccine). The outcome of the fever was not reported. It was unknown if the reporter considered the fever to be related to Shingles vaccine. It was unknown if the company considered the fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date:11-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter asked that how long would the fever last with the shingles vaccine. More
2847993 07/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I never got my second shot. Am I protected at all; This non-serious case was reported by a consumer ... I never got my second shot. Am I protected at all; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after not receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I never got my second shot. Am I protected at all). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-JUN-2025 This case was reported by a consumer via interactive digital media. The patient never got his/her second shot and asked he/she was protected at all. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. More
2847994 F TX 07/01/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 EB499
Mobility decreased, Pain in extremity, Peripheral swelling Mobility decreased, Pain in extremity, Peripheral swelling
Arm swelling; Arm pain 7/10; Mobility decreased; This non-serious case was reported by a other healt... Arm swelling; Arm pain 7/10; Mobility decreased; This non-serious case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis. On 02-JUN-2025, the patient received Boostrix. In JUN-2025, less than 3 weeks after receiving Boostrix, the patient experienced swelling arm (Verbatim: Arm swelling), pain in arm (Verbatim: Arm pain 7/10) and mobility decreased (Verbatim: Mobility decreased). The outcome of the swelling arm, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the swelling arm, pain in arm and mobility decreased to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the swelling arm, pain in arm and mobility decreased to be related to Boostrix and Boostrix Pre-Filled Syringe Device. 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: 17-JUN-2025 GlaxoSmithKline Account Manager did not provide any vaccination date and no patient demographics at all and only provided lot number (no other vaccine detail). Account Manager requested a call back to the Practice Manager. Once the call back was successful, the Practice Manager confirmed all the vaccination date, vaccine detail and patient demographics. No Medical Information question or concern arise in this call back.; Sender's Comments: US-GSK-US2025075891:same reporter /different patient US-GSK-US2025075891:same reporter /different patient More
2847995 F IN 07/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4BX39
Incorrect dose administered Incorrect dose administered
A 2-year-old patient received an adult dose of Engerix-B; A 2-year-old patient received an adult dos... A 2-year-old patient received an adult dose of Engerix-B; A 2-year-old patient received an adult dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-year-old female patient who received HBV (Engerix B adult) (batch number 4BX39, expiry date 29-JUL-2027) for prophylaxis. Previously administered products included Engerix B (received 1st dose on an unknown date) and Engerix B (received 2nd dose on an unknown date). On an unknown date, the patient received the 3rd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: A 2-year-old patient received an adult dose of Engerix-B) and overdose (Verbatim: A 2-year-old patient received an adult dose of Engerix-B). The outcome of the adult product administered to child and overdose were 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: 20-JUN-2025 The medical assistant called to reported that they administered an adult dose of Engerix-B to a patient who was 2 years old which led to, adult product administered to child and overdose. The reporter mentioned that this was the 3rd dose of Engerix-B that the patient had received. The reporter had a questioned what was next steps to follow. More
2847996 36 M PA 07/01/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Early 2nd dose; This non-serious case was reported by a other health professional via call center re... Early 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 36-year-old male patient who received HAV (Havrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact (Havrix). On 23-JUN-2025, the patient received the 2nd dose of Havrix. On 23-JUN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). The outcome of the drug dose administration interval too short 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: 23-JUN-2025 The reporter calling because a patient was given a vaccine (Havrix) too early. The vaccine administration facility was the same as primary reporter. During the call, the healthcare professional informed that this was about Havrix. The patient received the 1st dose on 21st May 2025 and then the 2nd dose on 23rd June 2025 which led to shortening of vaccination schedule. More
2847997 F OR 07/01/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 42DM9
Product storage error Product storage error
Havrix plus Administration after temperature excursion; This non-serious case was reported by a phar... Havrix plus Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 18-month-old female patient who received HAV (Havrix) (batch number 42DM9, expiry date 22-JAN-2027) for prophylaxis. On 18-JUN-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix plus Administration after temperature excursion). The outcome of the incorrect storage of drug 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: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated. Havrix Temperature 26.5 degree Fahrenheit which led to incorrect storage of drug. This case has been linked to US2025079380 reported by the same reporter.; Sender's Comments: US-GSK-US2025079380:Same reporter different patient More
2847998 M OR 07/01/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 57H54
Product storage error Product storage error
Menveo plus Administration after temperature excursion; This non-serious case was reported by a phar... Menveo plus Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 57H54, expiry date 31-JAN-2026) for prophylaxis. On 20-JUN-2025 13:10, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo plus Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated and Menveo (1 vial) Temperature was 26.5 degree Fahrenheit stored and received on 20th June 2025 which led to incorrect storage of drug. This is the 1 out of 6 cases reported by the same reporter.; Sender's Comments: US-GSK-US2025079375:Same reporter different patient US-GSK-US2025079376:Same reporter different patient US-GSK-US2025079378:Same reporter different patient GSK-US2025079384:Same reporter different patient US-GSK-US2025079387:Same reporter different patient More
2847999 49 F VA 07/01/2025 COVID19
COVID19
 MODERNA
MODERNA

COVID-19, Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonan... COVID-19, Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart; Pericarditis, White blood cell count More
COVID-19; pericarditis; This literature-non-study case was reported in a literature article and desc... COVID-19; pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (pericarditis) in a 49-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Concurrent medical conditions included Obesity and Diabetes. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant) and COVID-19 (COVID-19). The patient was treated with Colchicine at an unspecified dose and frequency and Rilonacept at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis) had resolved and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: Small effusion. On an unknown date, Ejection fraction: Preserved. On an unknown date, Electrocardiogram: normal value. On an unknown date, Magnetic resonance imaging heart: Circumferential pericardial late gadolinium enhancement (LGE). On an unknown date, White blood cell count (4.00-11.00 thousand per microlitre): 11.1 thousand per microlitre. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. This case referred to case no 6 from table 1 of the article. Concomitant medications were not reported. In this study patients presented with recurrent or incessant, difficult-to-treat pericarditis following SARS-CoV2 vaccination between October 2021 and January 2025. All patients had a clear temporal relationship between vaccination and the onset of symptoms of pericarditis, and all were negative for acute SARS-CoV2 infection. Patient had chest pain as clinical presentation. It was her first episode which was recurrent and the had 4 times recurrences. SARS-CoV2 test and C-reactive protein (CRP) was not done. Patient was treated with corticosteroids for 3 months. Patient had 4 times emergency department (ED) visits. Times from latest recurrence was 12 months. Corticosteroids were required in all eight patients due to persistent or worsening symptoms. Corticosteroids were tapered off gradually, two suffered side effects and four patients experienced a recurrence during tapering. Two experienced minor flares when the interval between the rilonacept dose was increased to every 3 and 4 weeks, with a resolution of symptoms when resuming weekly injections. All six (100 %) continue to be on weekly treatment at this time. Author concluded that pericarditis following SARS-CoV-2 vaccination can evolve into a recurrent, difficult-to-manage inflammatory condition. Effective treatment may require IL-1 blockade to disrupt the autoinflammatory cycle. Prompt recognition and early escalation of therapy are essential to reduce morbidity and prevent complications. This case was linked to US-MODERNATX, INC.-MOD-2025-787777 (E2B Linked Report).; Reporter's Comments: Concurrent medical conditions of Obesity and Diabetes are risk factors to develop pericarditis. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787777:49 Years Female More
2848000 49 F VA 07/01/2025 COVID19
COVID19
 MODERNA
MODERNA

Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonance imaging... Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Pericarditis; SARS-CoV-2 test, White blood cell count More
pericarditis; This literature-non-study case was reported in a literature article and describes the ... pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (pericarditis) in a 49-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: Concurrent medical conditions included Diabetes. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was treated with Colchicine at an unspecified dose and frequency and Rilonacept at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: Small effusion. On an unknown date, Ejection fraction: Preserved. On an unknown date, Electrocardiogram: normal value (NV). On an unknown date, Magnetic resonance imaging heart: Circumferential pericardial late gadolinium enhancement (LGE). On an unknown date, SARS-CoV-2 test: (Negative) COVID-19 testing was performed upon admission. On an unknown date, White blood cell count (4.00-11.00 thousand per microlitre): 7.6 thousand per microlitre. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. This case referred to case no 8 from table no 1 of the article. Concomitant medications were not reported. In this study patients presented with recurrent or incessant, difficult-to-treat pericarditis following SARS-CoV2 vaccination between October 2021 and January 2025. All patients had a clear temporal relationship between vaccination and the onset of symptoms of pericarditis, and all were negative for acute SARS-CoV2 infection. Patient had chest pain as clinical presentation. It was her first episode which was recurrent, and it recurred once. Patient had no history of COVID-19, C-reactive protein (CRP) was not done. Patient was treated with corticosteroids for 7 months. Patient had emergency department (ED) visit once. Times from latest recurrence was 17 months. Corticosteroids were required in all eight patients due to persistent or worsening symptoms. Corticosteroids were tapered off gradually, two suffered side effects and four patients experienced a recurrence during tapering. Two experienced minor flares when the interval between the rilonacept dose was increased to every 3 and 4 weeks, with a resolution of symptoms when resuming weekly injections. All six (100 %) continue to be on weekly treatment at this time. Author concluded that pericarditis following SARS-CoV-2 vaccination can evolve into a recurrent, difficult-to-manage inflammatory condition. Effective treatment may require IL-1 blockade to disrupt the autoinflammatory cycle. Prompt recognition and early escalation of therapy are essential to reduce morbidity and prevent complications. This case was linked to US-MODERNATX, INC.-MOD-2025-787776 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787776:49 Years Female More
2848002 53 F KY 07/01/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH




Blood cholesterol, Blood cholesterol increased, Blood test, Bone pain, Burning s... Blood cholesterol, Blood cholesterol increased, Blood test, Bone pain, Burning sensation; Drug hypersensitivity, Gait disturbance, Immune system disorder, Investigation, Laboratory test; Limb discomfort, Lip discolouration, Movement disorder, Oedema peripheral, Protein total; Protein total increased, Psoriasis, Psoriatic arthropathy, Red blood cell sedimentation rate increased, Speech disorder; Weight More
Psoriasis/Psoriatic arthritis; Psoriasis/Psoriatic arthritis; legs that stopped working; It started ... Psoriasis/Psoriatic arthritis; Psoriasis/Psoriatic arthritis; legs that stopped working; It started with her legs, then, to the hands/She states that her hands were not working/She states that she "couldn't move my lower section; difficulty walking; Blood tests showed that her autoimmune system was "in overdrive."; Patient experienced lesions with a burning sensation; experienced severe allergies; lips turned black; bones were so inflamed, bones were hurting so bad; wrists swollen; cholesterol went way up; arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control.; Protein went way up; she "can barely talk."; lower extremities started having issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 53-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1222721171676634364, Expiration Date: 19Apr2026) for skin lesion. The patient's relevant medical history included: "NSAIDs" (unspecified if ongoing); "migraines" (unspecified if ongoing); "bee stings" (unspecified if ongoing); "steroids" (unspecified if ongoing). Concomitant medication(s) included: IRON; VITAMIN C [ASCORBIC ACID]. Past drug history included: Morphine, reaction(s): "allergic to a lot of pain"; Morphine, reaction(s): "allergic to a lot of pain"; Dilaudid, reaction(s): "allergic to a lot of pain"; Dilaudid, reaction(s): "allergic to a lot of pain"; Ibuprofens, reaction(s): "allergic to a lot of pain"; Ibuprofens, reaction(s): "allergic to a lot of pain". Vaccination history included: BNT162b2 (DOSE NUMBER 1, SINGLE), administration date: 31Mar2021, for Covid-19 immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "Patient experienced lesions with a burning sensation"; PROTEIN TOTAL INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Protein went way up"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control."; BONE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "bones were so inflamed, bones were hurting so bad"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 2021, outcome "unknown", described as "cholesterol went way up"; GAIT DISTURBANCE (hospitalization) with onset 2021, outcome "unknown", described as "difficulty walking"; DRUG HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "experienced severe allergies"; MOVEMENT DISORDER (hospitalization) with onset 2021, outcome "not recovered", described as "legs that stopped working; It started with her legs, then, to the hands/She states that her hands were not working/She states that she "couldn't move my lower section"; LIP DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "lips turned black"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "lower extremities started having issues"; SPEECH DISORDER (non-serious) with onset 2021, outcome "unknown", described as "she "can barely talk.""; OEDEMA PERIPHERAL (non-serious) with onset 2021, outcome "unknown", described as "wrists swollen"; PSORIATIC ARTHROPATHY (hospitalization, medically significant), PSORIASIS (hospitalization) all with onset 2022, outcome "unknown" and all described as "Psoriasis/Psoriatic arthritis"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Blood tests showed that her autoimmune system was "in overdrive."". The event "blood tests showed that her autoimmune system was "in overdrive."" required emergency room visit. The event "psoriasis/psoriatic arthritis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood cholesterol: went way up; Blood test: autoimmune system was "in overdrive, notes: Blood tests showed that her autoimmune system was "in overdrive; arthritis sedimentation rate: 79, notes: arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control; went way up, notes: arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control; Lab work: Unknown results, notes: They did lab work for arthritis, sent her to arthritis specialist because, her bones were so inflamed, bones were hurting so bad; went sky high, notes: When looking at lab work, all her levels for labs, after she took shot; Protein total: went way up, notes: Protein went way up, rocketed up, everything went up, 3 months after the Covid shots; Weight: 195 pounds, notes: Height, Weight: just lost like 45 pounds, right now, is 5,5 and 195 pounds; 250 pounds, notes: Has been losing a lot of weight. At first, back then, when this started, was like 250 pounds. Therapeutic measures were taken as a result of psoriasis. Clinical course: Patient states that she received the Pfizer COVID-19 vaccine in 2021 and has since experienced many side effects since receiving the vaccine. Patient has many known allergies ("I'm allergic to everything") including NSAIDs and pain killers (caller did not specify which pain killers). Due to allergies, patient was originally hesitant to receive the vaccine but was urged to do so by her HCP to protect her mother who had lung cancer. Patient experienced side effects after the 2nd dose of the vaccine. She states that her hands were not working and she was unable to comb her hair or wipe herself. Upon consultation with a hand specialist, she did not receive treatment ("they couldn't do anything with my hand.") Patient recovered 1 week after. Patient also started to experience difficulty walking. She states that she transitioned from a cane, to a walker, to a wheelchair and was unable to get out of bed. She states that she "couldn't move my lower section." Patient was brought to the ER via ambulance. Blood tests showed that her autoimmune system was "in overdrive." Patient experienced lesions with a burning sensation. She states that she experiences "flare ups" and she "can barely talk." Caller states that "it's trying to kill me" and she just tries "to get through the day." In addition to aforementioned adverse effects involving her extremities, patient adds that she has since been diagnosed with Psoriasis and Psoriatic arthritis. Caller experienced lesions, was diagnosed with psoriatic arthritis and psoriasis and lips turned black, has lesions all over body and, the lesions burn, can hardly talk. There are flare ups, hard to get through the day. Thinks the vaccine was going to kill her, by the grace, she is still alive. She mentions that this affects her "all over" her body and her lips turned black. Despite independently seeking medical attention, HCPs are currently unable to help with her condition and have accused the patient of using illicit drugs. Patient states that she is not an illicit drug user. Due to difficulty receiving treatment, caller is attempting to seek treatment elsewhere and found a doctor who can potentially help her, but he (doctor) is not covered by her health insurance. Due to lack of coverage and lack of financial capability to fund treatment (caller is on retirement and disability), caller is seeking assistance in paying for medical expenses. Caller wants to know if it is possible to get reimbursement to help pay for the cost of treatment? They did lab work for arthritis, sent her to arthritis specialist because, her bones were so inflamed, bones were hurting so bad. When asked when her bones started hurting, she states, it just started hitting her. Clarified, she is still experiencing all of these experiences now, the legs and hands not working and the bone pain. It is all getting worse, that is why she was calling, to try and get help to get this out. When she picks up her grandbaby, her hands flare up. Can't really use her hands because, wrists swollen, having flare up. Whole body is flaring up now. If she does any extra movements if tries to use her hands, they hurt so bad. Like, when trying to cook, or turn key in car, is like, her body in flames. Has lesions all over her body. They said it is psoriasis, keeps scratching them. Never had pimple on body and now, these are all over. Can not even wear sundress, it is so bad. Clarified, the lesions started a year after the Covid shots. They just came popping out, like little nibbles. When putting lotion on, can feel them. Went to ER, thought it was blood clots because she never felt that before. Got mammogram, they said they could not do mammogram because of the bumps all over her breasts. They wanted her to go back to doctor, to get that cleared up before they would do mammogram. After that, the lesions started coming up black, was like a year later. They really got blacker and worse, when she took Rinvoq. Clarified, she took Rinvoq and the lesions started getting worse. They are itching really bad. They gave her Clobetasol, which was the only cream that helped. Is allergic to steroids so, they gave her Clobetasol which is a steroid, had to mix with diaper rash medicine, so it would not take the skin. It is the only thing that soothes it, tries to heal it but, it will come right back. Can't use steroids because they take the skin off her body, in her finger tips. Threw those away. They gave her pain medicine in hospital, they have those in her medical records. When looking at lab work, all her levels for labs, after she took shot, went sky high, cholesterol went way up, arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control. Protein went way up, rocketed up, everything went up, 3 months after the Covid shots. Asked doctor why they are not going back to normal. She does not drink or smoke, eats right. Asked doctor if she had cancer or AIDS. Has not been active since she had her son who is 15 years old. Was asking doctor to find out what this all is, he just said, it is long hauler's from the shots she took. Said it would take a year to get out of her blood. It is now going on 3 or 4 years. Seems like it is not getting better. Wants to get this shot out of her body. If they get this shot out of her body, she would be ok. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
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2848003 39 F NV 07/01/2025 COVID19
 PFIZER\BIONTECH
Myasthenia gravis Myasthenia gravis
autoimmune disease: myasthenia gravis; This is a spontaneous report received from a Consumer or othe... autoimmune disease: myasthenia gravis; This is a spontaneous report received from a Consumer or other non HCP. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunisation. The following information was reported: MYASTHENIA GRAVIS (caused and prolonged hospitalization, disability, medically significant) with onset 16Jan2022, outcome "not recovered", described as "autoimmune disease: myasthenia gravis". Soon after the booster shot, patient started feeling symptoms of her autoimmune disease myasthenia gravis. She was never even sick before she got the vaccines The patient was hospitalized and prolonged hospitalization for myasthenia gravis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of myasthenia gravis (prescription for myasthenia gravis). The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
✓ ✓
2848004 NY 07/01/2025 YF
 SANOFI PASTEUR
 UK134AA
Incorrect route of product administration Incorrect route of product administration
patient administered a dose of YF-VAX intramuscularly with no reported AE; Initial information recei... patient administered a dose of YF-VAX intramuscularly with no reported AE; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who was administered a dose of yellowfever vaccine-[YF-VAX] intramuscularly with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jun-2025, the patient received a dose of 0.5 ml of suspect yellowfever vaccine- intramuscularly (formulation: Solution for injection) (lot UK134AA, strength: standard and frequency: once, expiry date: 30-Nov-2025) via intramuscular route in the right deltoid for immunization with no reported adverse event (incorrect route of product administration) (Latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2848005 29 M WI 07/01/2025 HEP
MMRV
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
 945663
Z003307
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
Patient was supposed to receive MMRII & Varivax instead of Proquad, patient tolerated vaccine we... Patient was supposed to receive MMRII & Varivax instead of Proquad, patient tolerated vaccine well no allergy or adverse reaction to injection was noted, patient was advised by doctor to watch area for any reaction. More
2848006 64 F WA 07/01/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 1828508-04730
Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
I could barely use my right arm for the first two days, it ached and throbbed. Now, three weeks late... I could barely use my right arm for the first two days, it ached and throbbed. Now, three weeks later, I am in extreme pain when using this arm and cannot do things with this arm that were daily and routine without pain. It wakes me up at night due to the pain. More
✓
2848007 45 F 07/01/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 52N4S
9M2R7
Injection site rash; Injection site rash Injection site rash; Injection site rash
2 weeks after being administered vaccines, patient experienced a rash on the left arm where Menveo w... 2 weeks after being administered vaccines, patient experienced a rash on the left arm where Menveo was administered More
2848008 52 F AL 07/01/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 u8353aa
u8353aa
Cold sweat, Decreased appetite, Dizziness, Erythema, Fatigue; Influenza like ill... Cold sweat, Decreased appetite, Dizziness, Erythema, Fatigue; Influenza like illness, Pain, Peripheral swelling, Pyrexia, Skin warm More
Arm swelling, redness and hot to touch, pt had a fever of about 102 for about 30 hours, body aches a... Arm swelling, redness and hot to touch, pt had a fever of about 102 for about 30 hours, body aches and cold sweats, flu like symptoms, light headedness, fatigue, no appetite. Pt has been taking benadryl and tylenol. More
2848009 65 F PA 07/01/2025 PNC20
 PFIZER\WYETH
 LC1279
Colitis, Colonoscopy abnormal, Dehydration, Diarrhoea Colitis, Colonoscopy abnormal, Dehydration, Diarrhoea
three weeks of unrelenting diarrhea, resulting in severe dehydration, and colonoscopy that revealed ... three weeks of unrelenting diarrhea, resulting in severe dehydration, and colonoscopy that revealed acute attack of colitis More
✓
2848010 1.25 M RI 07/01/2025 UNK
 UNKNOWN MANUFACTURER
Wrong patient Wrong patient
Given Proquad and Kinrix in error,was supposed for siter Given Proquad and Kinrix in error,was supposed for siter
2848011 35 F MA 07/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 7NX57
Underdose Underdose
Patient received a pedi dose instead of adult Patient received a pedi dose instead of adult
2848012 65 F PA 07/01/2025 COVID19
 PFIZER\BIONTECH
 LM2210
Colitis, Colonoscopy abnormal, Diarrhoea Colitis, Colonoscopy abnormal, Diarrhoea
relentless diarrhea x 3 weeks relentless diarrhea x 3 weeks
✓
2848013 0.5 M GA 07/01/2025 HPV9
HPV9
RV1
RV1
HPV9
HPV9
RV5
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Z005055
Z005055
2142135
2142135
Product administered to patient of inappropriate age, Pyrexia, Wrong patient rec... Product administered to patient of inappropriate age, Pyrexia, Wrong patient received product; No adverse event, Vaccination error; Product administered to patient of inappropriate age, Pyrexia, Wrong patient received product; No adverse event, Vaccination error; Product administered to patient of inappropriate age, Pyrexia, Wrong patient received product; No adverse event, Vaccination error; Product administered to patient of inappropriate age, Pyrexia, Wrong patient received product; No adverse event, Vaccination error More
HPV vaccine that was meant for 12 year old son was given to 6 month old baby. Currently running a sl... HPV vaccine that was meant for 12 year old son was given to 6 month old baby. Currently running a slight fever. Shot administered around 9:45am fever began around 10:35am. More
2848015 15 F IA 07/01/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 EY57A
Underdose Underdose
Adult dose given instead of Pediatric dose in error. Adult dose given instead of Pediatric dose in error.
2848016 11 F IL 07/01/2025 IPV
MMR
MNQ
 SANOFI PASTEUR
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 X1D141M
Y004114
X7R4Z
Pain, Swelling face, Tenderness; Pain, Swelling face, Tenderness; Pain, Swelling... Pain, Swelling face, Tenderness; Pain, Swelling face, Tenderness; Pain, Swelling face, Tenderness More
pt. has swelling to right side of face. Performed by Family Medicine Right facial swelling MMR given... pt. has swelling to right side of face. Performed by Family Medicine Right facial swelling MMR given June 5, facial swelling presented 24 days later. Asymmetrical "mumps presentation" Painful while chewing. Painful to touch. No redness, no warmth, no fever. Per patients mother, the swelling has gone down since the initial occurrence. Will get an xray to rule out any abnormalities. Adverse effect of vaccine, initial encounter Unknown if vaccine reaction has occurred. MMR given June 5, facial swelling presented 24 days later. Painful while chewing. Painful to touch. No redness, no warmth, no fever. No lymph involvement Per patients mother, the swelling has gone down since the initial occurrence. Using ibuprofen for pain. More
2848017 70 M 07/01/2025 FLU3
 SANOFI PASTEUR
 U8524DA
Expired product administered, No adverse event Expired product administered, No adverse event
Administered expired dose (exp 6/30/25. Patient received vaccinations in preparation for travel (Hig... Administered expired dose (exp 6/30/25. Patient received vaccinations in preparation for travel (High-dose Fluzone, TDap, Typhoid, Hep A/B, Moderna COVID 24/25) with no incidence our adverse outcome. More
2848018 71 F MD 07/01/2025 PNC20
PNC20
PNC20
TDAP
TDAP
TDAP
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR





Abdominal pain, Blister, Dizziness, Dysphagia, Fatigue; Headache, Injection site... Abdominal pain, Blister, Dizziness, Dysphagia, Fatigue; Headache, Injection site erythema, Injection site induration, Injection site reaction, Mouth ulceration; Oedema, Pain, Pruritus, Pyrexia, Skin exfoliation; Abdominal pain, Blister, Dizziness, Dysphagia, Fatigue; Headache, Injection site erythema, Injection site induration, Injection site reaction, Mouth ulceration; Oedema, Pain, Pruritus, Pyrexia, Skin exfoliation More
Patient received Tdap (right) and pneumonia (left) vaccine on 06.25.25, on Friday she started with ... Patient received Tdap (right) and pneumonia (left) vaccine on 06.25.25, on Friday she started with localized pruritus bilaterally. Saturday with appearance of 4-6 0.5cm clear vessicles on the ventral surface of the left arm, located between the deltoid area and the lateral epicondyl, with associated symptoms of bilateral mild erythema and induratio, limited to ventral surface of bilateral upper arms. Patient pain, mouth ulcers, fever, headache, dizziness, peeling skin, fatigue, dysphagia, abdominal pain, or edema. She has had vaccines in the past, with no adverse response and has no known allergies. Left arm with around 6 clear, non-purulent vesicles, each approximately 0.5 cm, non-tender on the ventral surface, in the deltoid area; Bilateral skin is erythematous, blanchable, with mild induration confined to ventral upper aspect of the arm between the lower deltoid and lateral epicondyle area No signs of local infection, no mucosal involvement, no systemic symptoms. Findings consistent with delayed hypersensitivity reaction to vaccine, will treat with prednisone, cetirizine, and 1% hydrocortisone with follow-up in 3-days for improvement. More
2848019 65 F SC 07/01/2025 HEPAB
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Neuralgia, Paraesthesia; Neuralgia, Paraesthesia Neuralgia, Paraesthesia; Neuralgia, Paraesthesia
PT reported tingling and nerve pain radiating from clavicle to elbow. Spontaneous onset and rapid an... PT reported tingling and nerve pain radiating from clavicle to elbow. Spontaneous onset and rapid and lasts for a few seconds. PT reported this during the third dose of Twinrix. PT has also reported to doctor and may be seen by specialist to look into this issue. Counseled to journal and water and food and sleep to spot triggers. More
2848020 45 F 07/01/2025 HPV9
 MERCK & CO. INC.
 Z005469
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Pt was given the HPV vaccine a month to early. no symptoms or reactions after given vaccine. Vaccine... Pt was given the HPV vaccine a month to early. no symptoms or reactions after given vaccine. Vaccine will be considered an invalid dose. More
2848021 64 F 07/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 238H3
Extra dose administered Extra dose administered
THE PATIENT WAS GIVEN ZOSTER #3 SHE DIDN'T NEED IT THE PATIENT WAS GIVEN ZOSTER #3 SHE DIDN'T NEED IT
2848022 62 F 07/01/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5A4XG
5A4XG
Blister, Blister rupture, Joint stiffness, Muscle tightness, Myalgia; Pyrexia Blister, Blister rupture, Joint stiffness, Muscle tightness, Myalgia; Pyrexia
patient stated she has 4 blisters on the side of her face that are oozing clear liquid that started ... patient stated she has 4 blisters on the side of her face that are oozing clear liquid that started today (2 days after vaccination) also states had low grade fever yesterday and has muscle soreness/ tightness in her left shoulder blade and the left side of her neck that started yesterday (1 day after vaccination) patient will be calling prescriber to rule out other causes besides reaction to the vaccine More
2848023 53 F CA 07/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Blood glucose increased, Erythema, Lymphadenitis Blood glucose increased, Erythema, Lymphadenitis
Red mark on left arm is still present many weeks after injection. Looks/feels like a sunburn. Lymph ... Red mark on left arm is still present many weeks after injection. Looks/feels like a sunburn. Lymph nodes in keft armpit and breast have been very inflamed, and my blood sugar has not been going down at night as it should, requiring a lot of extra medication. More
2848025 M OH 07/01/2025 RSV
 MODERNA
 Rsv antibody no
Tremor Tremor
He started with shaking in one of his legs 2 weeks after the injection and then it became both legs.... He started with shaking in one of his legs 2 weeks after the injection and then it became both legs. It then turned into arm shaking with the legs and then also chin tremors and head shaking. His leg and arm tremors subsided about 8-9 weeks after injection. He still has some chin tremors and head tremors. More
2848026 16 F CA 07/01/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 DL4YY
Dizziness, Muscular weakness, Pain in extremity, Tremor Dizziness, Muscular weakness, Pain in extremity, Tremor
dizziness; shaking, soreness and weakness in left arm an hour after administration dizziness; shaking, soreness and weakness in left arm an hour after administration
2848027 1 F MT 07/01/2025 VARCEL
 MERCK & CO. INC.
 x017485
Expired product administered Expired product administered
Had vaccine expiration date checked by colleague, I did not double check. Had vaccine expiration date checked by colleague, I did not double check.
2848028 12 M 07/01/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Unevaluable event Unevaluable event
Nil Nil
2848029 7 M MI 07/01/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
None stated. None stated.
2848030 12 M 07/01/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Unevaluable event Unevaluable event
Nil Nil
2848031 10 F WI 07/01/2025 COVID19
 MODERNA
 80020
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Medical staff administered a SpikeVax vaccine to a 10 year old child. Medical staff was unaware of ... Medical staff administered a SpikeVax vaccine to a 10 year old child. Medical staff was unaware of the age recommendations for the SpikeVax. Child left facility without incident. Provider followed up and child was stated to be in fine health still. More
2848032 14 M 07/01/2025 COVID19
 PFIZER\BIONTECH
 LN7302
No adverse event No adverse event
Nil Nil
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