🏥 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 💀 🏥 🚑 ♿ ⚠️
2819782 U KY 01/07/2025 PNC15
 MERCK & CO. INC.
 y002643
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; patient received improperly stored vaccine. No additional AEs were reported, no f... no adverse event; patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643 10/4/2026) Temperature: 4; This spontaneous report was received from an Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 31-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date: 04-OCT-2026, administered for prophylaxis (strength, dose, units, and route of administration were not provided). It was reported that the patient received improperly stored vaccine after a temperature excursion of 46.6 F for a timeframe of 1h55min (Product storage error). There was no adverse event reported. More
2819783 1.25 F SC 01/07/2025 MMR
 MERCK & CO. INC.
 W022944
Hyporesponsive to stimuli, Lethargy, Pyrexia Hyporesponsive to stimuli, Lethargy, Pyrexia
Child developed fever 30 mins after receiving the vaccine. Fever started at 101.5F and then develope... Child developed fever 30 mins after receiving the vaccine. Fever started at 101.5F and then developed into 103F, lasted for 4 days. He was lethargic and disengaged. No other symptoms - no coughing or runny nose. More
2819784 0.75 F CO 01/07/2025 RV5
 MERCK & CO. INC.
 2003166
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pt was mistakenly given vaccine despite being 9 months old, and had not had any prior vaccines. Pt was mistakenly given vaccine despite being 9 months old, and had not had any prior vaccines.
2819785 17 F OR 01/07/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 Lm2224
TFAA2422
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No ADE. Patient underage at time of vaccination for Flublok No ADE. Patient underage at time of vaccination for Flublok
2819786 87 F IL 01/07/2025 COVID19
 MODERNA
 3043930
Pain in extremity Pain in extremity
Pain in arm. Next to injection site toward the patient's back. Discomfort since vaccine given... Pain in arm. Next to injection site toward the patient's back. Discomfort since vaccine given ( over 75 days) 3 on pain scale per patient. No redness, no injury spot seen. Middle of the upper arm. Movement of the arm does not help nor hurt the arm. More
2819787 73 F NC 01/07/2025 FLU3
 SANOFI PASTEUR
Dyspnoea, Gait inability, Tremor Dyspnoea, Gait inability, Tremor
Violent shaking, inability to walk, shortness of breath, about 12 hours after receiving shot. At mid... Violent shaking, inability to walk, shortness of breath, about 12 hours after receiving shot. At midnight I was able to hold onto the wall to get to my 650 mg Tylenol. The Tylenol eased the symptoms. I repeated in 4 hours. I was fine the next day. More
2819788 15 M CO 01/07/2025 COVID19
 MODERNA
 B0001
Expired product administered Expired product administered
Moderna Spikevax Vaccine. Expires 60 days from date taken out of freezer. Took vaccine out of freeze... Moderna Spikevax Vaccine. Expires 60 days from date taken out of freezer. Took vaccine out of freezer on 10/22/22. Was given to patient on 12/24/24. Vaccine had expired on 12/21/24. Noticed this error today when completing storage and handling duties of vaccines and chart reviews. Attempted to call parent today to inform them of error and discuss any concerns. Unable to reach parent today. More
2819789 71 M CO 01/07/2025 COVID19
 MODERNA
 3044186
Underdose Underdose
Patient given a Moderna Spikevax pediatric dose (6m-11year) by mistake. Lot # 3044186. Realized mis... Patient given a Moderna Spikevax pediatric dose (6m-11year) by mistake. Lot # 3044186. Realized mistake before they left the clinic and vaccinated with another dose of Pediatric Moderna Spikevax to equal the adult dose. (same lot #). More
2819790 14 F CO 01/07/2025 COVID19
 MODERNA
 B0001
Expired product administered, No adverse event Expired product administered, No adverse event
After reconciling number of vaccines in our storage, our clinic noticed this vaccine was expired whe... After reconciling number of vaccines in our storage, our clinic noticed this vaccine was expired when administered to this patient. The vaccine was taken out of the freezer and placed in the refrigerator on 10/22/24. Per manufacturer, vaccine expires 60 days after being taken out of the refrigerator. The vaccine, therefore, expired on 12/21/24. It was administered on 12/24/24. This nurse spoke to mother of patient today. She reported the child felt fine after receiving the vaccine and she had no concerns. More
2819791 68 F PA 01/07/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8429BA
U8527CA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Dr called the pharmacy and asked if the patient received two Fluzone HD injection this 2024 Flu Seas... Dr called the pharmacy and asked if the patient received two Fluzone HD injection this 2024 Flu Season. After checking the pharmacy systems, the patient did indeed receive 2 immunizations - 10/25/24 and 1/3/25 from two different pharmacist More
2819792 M NC 01/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Headache Fatigue, Headache
Fatigue; Headache; This non-serious case was reported by a consumer via sales rep and described the ... Fatigue; Headache; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-DEC-2024, the patient received Shingrix (left arm). On 09-DEC-2024, 2 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). On 10-DEC-2024, the outcome of the fatigue and headache were resolved (duration 1 day). The reporter considered the fatigue and headache to be related to Shingrix. The company considered the fatigue and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 11-DEC-2024 Consumer reported that he took Shingrix vaccine and experienced fatigue and headache. More
2819793 U 01/07/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Erythema, Feeling abnormal, Feeling hot, Pain in extremity Erythema, Feeling abnormal, Feeling hot, Pain in extremity
My arm is red; sore arm; arm is feels feverishly hot; felt badly; This non-serious case was reported... My arm is red; sore arm; arm is feels feverishly hot; felt badly; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities 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 erythema of extremities (Verbatim: My arm is red), pain in arm (Verbatim: sore arm), extremities hot feeling of (Verbatim: arm is feels feverishly hot) and feeling abnormal (Verbatim: felt badly). The outcome of the erythema of extremities, pain in arm, extremities hot feeling of and feeling abnormal were not reported. It was unknown if the reporter considered the erythema of extremities, pain in arm, extremities hot feeling of and feeling abnormal to be related to RSV vaccine. It was unknown if the company considered the erythema of extremities, pain in arm, extremities hot feeling of and feeling abnormal to be related to RSV vaccine. Additional Information: GSK Receipt Date: 08-DEC-2024 This case was reported by a patient via interactive digital media. The reporter reported that patient received Respiratory syncytial virus vaccine on Thursday and have felt badly. Patient arm was red and feels feverishly hot and sore. Also reporter hope it does not bother much longer. More
2819794 U 01/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
Arm soreness; This non-serious case was reported by a pharmacist via market research programs and de... Arm soreness; This non-serious case was reported by a pharmacist via market research programs and described the occurrence of pain in arm in an unspecified number of patients 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 pain in arm (Verbatim: Arm soreness). The outcome of the pain in arm was resolved. The reporter considered the pain in arm to be related to Shingles vaccine. The company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-DEC-2024 Pharmacist asked that if they already had soreness from another vaccine. This one caused a lot of soreness and it was liked being punched in arm 1000 times. It was implied in conversation that the reporter had personally seen individuals experience this side effect. More
2819795 U 01/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
developed shingles within 30 days of receiving their first dose of Shingrix; This non-serious case w... developed shingles within 30 days of receiving their first dose of Shingrix; This non-serious case was reported by a consumer and described the occurrence of shingles in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patients received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patients experienced shingles (Verbatim: developed shingles within 30 days of receiving their first dose of Shingrix). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 24-DEC-2024 The reporter knew five patients who developed shingles within 30 days of receiving their first dose of Shingrix. The case is linked with case US2024AMR165920, reported by the same reporter.; Sender's Comments: US-GSK-US2024AMR165920:Same reporter More
2819796 U IL 01/07/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
for about 30 years Boostrix has been administered to patients under 10 years; This non-serious case ... for about 30 years Boostrix has been administered to patients under 10 years; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: for about 30 years Boostrix has been administered to patients under 10 years). The outcome of the inappropriate age at vaccine administration was unknown. 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: 09-DEC-2024 The registered nurse called stating she has been working at her facility for 11.5 years and she stated that for about 30 years Boostrix had been administered to patients under 10 years which led to inappropriate age at vaccine administration.; Sender's Comments: US-GLAXOSMITHKLINE-US2021183475:SAME REPORTER More
2819797 M IN 01/07/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 4293K
ET475
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
A patient received a dose of Boostrix and Menveo today (12/9/2024), and also the patient received Bo... A patient received a dose of Boostrix and Menveo today (12/9/2024), and also the patient received Boostrix and Menveo 3 months ago (less than recommended interval); This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number ET475, expiry date 08-MAY-2026) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 4293K, expiry date 31-JUL-2025) for prophylaxis. Previously administered products included Boostrix (received 1st dose 3 months ago) and Menveo (received 1st dose 3 months ago). On 09-DEC-2024, the patient received the 2nd dose of Boostrix and the 2nd dose of Menveo. On 09-DEC-2024, an unknown time after receiving Boostrix and Menveo, the patient experienced extra dose administered (Verbatim: A patient received a dose of Boostrix and Menveo today (12/9/2024), and also the patient received Boostrix and Menveo 3 months ago (less than recommended interval)). The outcome of the extra dose administered was unknown. 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: 09-DEC-2024 The medical assistant called to report that on the day of reporting she administered a dose of Boostrix and Menveo to a patient, she mentioned that 3 months ago the patient had received also a dose of Boostrix and Menveo which led to extra dose administered. The reporter asked were there any safety recommendations. More
2819798 70 F VA 01/07/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Blood pressure increased, Fatigue, Headache, Injection site pruritus; Blood pres... Blood pressure increased, Fatigue, Headache, Injection site pruritus; Blood pressure increased, Fatigue, Headache, Injection site pruritus More
her left arm deltoid where the SHINGRIX was administered was having itchiness; she was more tired th... her left arm deltoid where the SHINGRIX was administered was having itchiness; she was more tired than normal; checked her BP and stated it was elevated at 126/104; 24 hours later started having a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 09-DEC-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) and the 1st dose of Arexvy (intramuscular, right deltoid). On 10-DEC-2024, 1 days after receiving Shingrix and Arexvy and not applicable after receiving Arexvy, the patient experienced injection site itching (Verbatim: her left arm deltoid where the SHINGRIX was administered was having itchiness), tiredness (Verbatim: she was more tired than normal), increased blood pressure (Verbatim: checked her BP and stated it was elevated at 126/104) and headache (Verbatim: 24 hours later started having a headache). The outcome of the injection site itching, tiredness, increased blood pressure and headache were not resolved. It was unknown if the reporter considered the injection site itching, tiredness, increased blood pressure and headache to be related to Shingrix. It was unknown if the reporter considered the tiredness, increased blood pressure and headache to be related to Arexvy. It was unknown if the company considered the injection site itching, tiredness, increased blood pressure and headache to be related to Shingrix. It was unknown if the company considered the tiredness, increased blood pressure and headache to be related to Arexvy. Additional Information: GSK Receipt Date: 10-DEC-2024 The reporter was the patient who stated she received the 2nd dose of Shingrix along with, Arexvy vaccine. The patient stated she was fine after receiving both injections, then, 24 hours later started having a headache and checked her blood pressure and stated it was elevated at 126/104. The patient did state this was quite unusual for her. The patient also stated she was more tired than normal and her left arm deltoid where the Shingrix was administered was having itchiness. More
2819799 M AZ 01/07/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
it is been 10 years and he never received the Second Dose; This non-serious case was reported by a p... it is been 10 years and he never received the Second Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Patient received first dose 10 years ago). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: it is been 10 years and he never received the Second Dose). The outcome of the incomplete course of vaccination was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:11-DEC-2024 Pharmacist called to report about Twinrix and asked What if a Patient had the first dose and then, it had been 10 years, and he never received the Second Dose. First dose of Twinrix was administered 10 years ago and Patient did not receive the second the dose which led to incomplete course of vaccination. More
2819800 73 M CA 01/07/2025 FLUX
RSV
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS

Dyspnoea, Lethargy; Dyspnoea, Lethargy Dyspnoea, Lethargy; Dyspnoea, Lethargy
Shortness of breath; Lethargic; This non-serious case was reported by a consumer via call center rep... Shortness of breath; Lethargic; This non-serious case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Influenza vaccine (Flu vaccine VII) for prophylaxis. On 12-DEC-2024, the patient received the 1st dose of Arexvy (intramuscular, left deltoid) and Flu vaccine VII. On 13-DEC-2024, 1 days after receiving Arexvy, the patient experienced shortness of breath (Verbatim: Shortness of breath) and lethargy (Verbatim: Lethargic ). The outcome of the shortness of breath and lethargy were not resolved. It was unknown if the reporter considered the shortness of breath and lethargy to be related to Arexvy. It was unknown if the company considered the shortness of breath and lethargy to be related to Arexvy. Additional Information: GSK Receipt Date:11-DEC-2024 Reporter was the patient who received the Arexvy vaccine on 12-DEC-2024 in the left deltoid. Reporter also stated that he received the Arexvy vaccine and a flu vaccination at the same time 12-DEC-2024 in different arms. 12 Hours after the Arexvy and flu vaccine was given the reporter stated lethargic and shortness of breath that was ongoing. The reporter was unaware of the name of the Flu vaccine. More
2819801 61 M PA 01/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose; ad... administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose; administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-DEC-2024, the patient received the 2nd dose of Shingrix. On 03-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose) and inappropriate dose of vaccine administered (Verbatim: administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that the nurse administered only the liquid (adjuvant) part of the vaccine alone to a patient for a second dose of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked was there any advise on when to give another valid dose. More
2819802 U PA 01/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect dose administered, Product preparation error Incorrect dose administered, Product preparation error
Shingrix reconstituted with sterile water; Shingrix reconstituted with sterile water; This non-serio... Shingrix reconstituted with sterile water; Shingrix reconstituted with sterile water; 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 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 wrong solution used in drug reconstitution (Verbatim: Shingrix reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Shingrix reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 16-DEC-2024 The nurse supervisor reported that they had a Shingrix reconstituted with sterile water instead of the included diluent and they were currently running reports to find out who was the patient involved, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked does the effect the efficacy of the vaccine and stated that they found the error during vaccine counts. The patient's information was not available at the moment. More
2819803 1 F MN 01/07/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 LM99N
Inappropriate schedule of product administration Inappropriate schedule of product administration
given a second dose of HAVRIX less than six months apart; This non-serious case was reported by a nu... given a second dose of HAVRIX less than six months apart; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old female patient who received HAV (Havrix) (batch number LM99N, expiry date 04-MAR-2026) for prophylaxis. Previously administered products included Havrix (received 1st dose on 25-JUN-2024, lot number 423NL, expiry date 16-MAR-2025). On 14-NOV-2024, the patient received the 2nd dose of Havrix. On 14-NOV-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: given a second dose of HAVRIX less than six months apart). The outcome of the drug dose administration interval too short was unknown. 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: 16-DEC-2024 The registered nurse reported that a pediatric patient that was given a second dose of Havrix less than six months apart. The reporter asked about further guidance on that topic. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule. More
2819804 75 F CA 01/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Consumer states in 2024 she has had several small outbreaks of shingl... Suspected vaccination failure; Consumer states in 2024 she has had several small outbreaks of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 10-OCT-2018, the patient received the 2nd dose of Shingrix. On 30-JUL-2018, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Consumer states in 2024 she has had several small outbreaks of shingles). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 26-DEC-2024 The case was self reported by patient. The patient received both doses on Shingrix vaccine and in 2024 she had several small outbreaks of shingles (lack of effect). The outbreaks are on the middle part of the front of her body and her legs. Consumer states that she does take Acyclovir. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2819805 69 F IL 01/07/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA




Alanine aminotransferase, Alpha-1 anti-trypsin, Antimitochondrial antibody, Anti... Alanine aminotransferase, Alpha-1 anti-trypsin, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase; Blood alkaline phosphatase, Blood iron, Ceruloplasmin, Cytomegalovirus test, Epstein-Barr virus test; Hepatic enzyme, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Herpes simplex test; Liver injury, Serology test, Smooth muscle antibody, Ultrasound abdomen, Ultrasound liver; Varicella virus test More
Liver Injury; This literature-non-study case was reported in a literature article and describes the ... Liver Injury; This literature-non-study case was reported in a literature article and describes the occurrence of LIVER INJURY (Liver Injury) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: The patient's past medical history included Cholecystectomy and Colonic polyp. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (Liver Injury) (seriousness criteria hospitalization and medically significant). At the time of the report, LIVER INJURY (Liver Injury) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: normalization (One Month Later), 103 U/L and 448 U/L (one week after 1st lab) showed an upward trend.. On an unknown date, Alpha-1 anti-trypsin: Negative. On an unknown date, Antimitochondrial antibody: Negative. On an unknown date, Antinuclear antibody: Low positive ANA titer 1:80. On an unknown date, Aspartate aminotransferase: normalization (One Month Later), 121 U/L and 341 U/L (one week after 1st lab) showed an upward trend.. On an unknown date, Blood alkaline phosphatase: normalization (One Month Later), 136 U/L and 382 U/L (one week after 1st lab) showed an upward trend.. On an unknown date, Blood iron: Negative. On an unknown date, Ceruloplasmin: Negative. On an unknown date, Cytomegalovirus test: Negative. On an unknown date, Epstein-Barr virus test: 147 international unit per millilitre mildly positive but insignificant EBV PCR. On an unknown date, Hepatic enzyme: during admission showed improvement. On an unknown date, Hepatitis A virus test: Negative. On an unknown date, Hepatitis B virus test: Negative. On an unknown date, Hepatitis C virus test: Negative. On an unknown date, Herpes simplex test: Negative. On an unknown date, Serology test: (Negative) celiac serology. On an unknown date, Smooth muscle antibody: Negative. On an unknown date, Ultrasound abdomen: negative for any significant finding. On an unknown date, Ultrasound liver: revealed patent hepatic and portal veins. On an unknown date, Varicella virus test: (Negative) Varicella zoster virus Negative. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered LIVER INJURY (Liver Injury) to be related. Concomitant medication and treatment information were not provided. Patient presented to her primary care office with fatigue, myalgia, and anorexia one week after receiving her fourth COVID-19 vaccination. Initial laboratory tests revealed elevated liver enzymes. Repeat labs after one week showed an upward trend, prompting her to be sent to the emergency department (ED). There was no sign of acute liver failure was noted. The patient denied alcohol use, intravenous drug use, tattoos, herbal supplements, or new medications. During her hospital admission, repeat laboratory tests showed an improvement in liver enzyme levels. She was discharged with instructions for outpatient follow-up. Although a liver biopsy was offered, the patient declined. One month later, repeat blood work showed near normalization of her ALT, AST, and ALP levels. It was reported that in this case, lab workup was insignificant other than ANA titers being mildly positive. Given the timeline it was likely her symptoms were secondary to the vaccine.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
✓
2819806 F 01/07/2025 COVID19-2
 MODERNA
Dizziness, Neurological examination Dizziness, Neurological examination
feeling dizzy; This spontaneous case was reported by a patient and describes the occurrence of DIZZI... feeling dizzy; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (feeling dizzy) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced DIZZINESS (feeling dizzy). At the time of the report, DIZZINESS (feeling dizzy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neurological examination: Negative. No concomitant medication was reported. She received a Moderna covid-19 shot back in Sep-2022 with no issues. She was feeling dizzy for the past two months since OCT-2024. No treatment information was reported. More
2819807 F MA 01/07/2025 COVID19
 MODERNA
Herpes zoster Herpes zoster
shingles; This spontaneous case was reported by an other health care professional and describes the ... shingles; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (shingles) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Shingrix first dose in 2024. Past adverse reactions to the above products included No adverse effect with Shingrix first dose. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. It was reported that, 7 days after receiving the vaccine the recipient developed shingles. Patient attended the ER and was diagnosed and began treatment. Patient was treated with antivirals and returned to work 3 weeks after initial diagnosis. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2025-780516 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-780516:invalid case for multiple patients More
2819808 F NY 01/07/2025 COVID19
 PFIZER\BIONTECH
Urticaria Urticaria
Widespread skin hives within 14 days of 2024-2025 Comirnaty; This is a spontaneous report received f... Widespread skin hives within 14 days of 2024-2025 Comirnaty; This is a spontaneous report received from a Company Representative. An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Widespread skin hives within 14 days of 2024-2025 Comirnaty". It was unknown if therapeutic measures were taken as a result of urticaria. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2819809 M 01/07/2025 COVID19
 PFIZER\BIONTECH
Asthenia, Guillain-Barre syndrome, Loss of personal independence in daily activi... Asthenia, Guillain-Barre syndrome, Loss of personal independence in daily activities, Myelitis transverse More
Transverse Myelitis; Guillain Barre; general weakness and loss of strength; he is now a couch potato... Transverse Myelitis; Guillain Barre; general weakness and loss of strength; he is now a couch potato/now he has become a weakling; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 58-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: MYELITIS TRANSVERSE (medically significant), outcome "not recovered", described as "Transverse Myelitis"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "not recovered", described as "Guillain Barre"; ASTHENIA (non-serious), outcome "not recovered", described as "general weakness and loss of strength"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "he is now a couch potato/now he has become a weakling". Therapeutic measures were taken as a result of myelitis transverse, guillain-barre syndrome. Clinical course: Patient experienced general weakness and loss of strength, he want to know how to get better. At first they thought it was Guillain Barre then neurology diagnosed Transverse Myelitis, the doctor sent report to Pfizer and CDC. He has basically been on prednisone 2 and a half years and has not gotten better or healed. He mentioned there might be other people with this problem. He said he was a big promoter of the vaccine but unfortunately, he got this adverse reaction. He is reaching out for help as the doctors have not been able to treat his AE or deal with it or they have not been able to get him better and nothing has changed. He described he is now a couch potato per his words and that he is 58 years old and that he was outgoing and physically strong 3 years ago and now he has become a weakling. He wants to know or find out any direction. He has not been able to work for all 3 years, he has lost 3 years of income and on top the thousand of dollars he has invested on getting better. He want to know how to best deal with this cases as the Pfizer vaccine has caused him harm. He has stopped prednisone and was transferred to another specialist doctor but he could not help him. He also let me know that this was not helpful and that he is tired of hearing sorry. That Pfizer is his last resort. Talked with the No Info SRD for his specific question and provided that according to the PI there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Comirnaty. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2819810 61 F 01/07/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FK9896
FK9896
Burning mouth syndrome, Hypoaesthesia, Oral pain, Pain, Pharyngeal hypoaesthesia... Burning mouth syndrome, Hypoaesthesia, Oral pain, Pain, Pharyngeal hypoaesthesia; Vomiting More
vomited for 45-60 min; Numbness on left side of face; Numbness on left side of face, continued to th... vomited for 45-60 min; Numbness on left side of face; Numbness on left side of face, continued to throat; Constant pain, 7-10 daily; Severe pain in the mouth; Diagnosed with Burning Mouth Syndrome; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LYRICA; LAMICTAL. Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot number: EW0191), administration date: 16Jun2021, for COVID-19 immunisation; comirnaty (DOSE 2, SINGLE, Lot number: EW0176), administration date: 06Jul2021, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Constant pain, 7-10 daily"; BURNING MOUTH SYNDROME (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Diagnosed with Burning Mouth Syndrome"; HYPOAESTHESIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Numbness on left side of face"; PHARYNGEAL HYPOAESTHESIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Numbness on left side of face, continued to throat"; ORAL PAIN (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Severe pain in the mouth"; VOMITING (non-serious) with onset 19Jan2022, outcome "not recovered", described as "vomited for 45-60 min". Therapeutic measures were taken as a result of vomiting, hypoaesthesia, pharyngeal hypoaesthesia, pain, oral pain, burning mouth syndrome. Additional information: The patient did not receive any other vaccines on the same date as the vaccine and did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. Clonazepam BID was given as treatment for the event. More
2819811 31 M NC 01/07/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure; Body temperatu... Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure; Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure More
tested positive for covid; tested positive for covid; This is a spontaneous report received from a C... tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP. The patient is also the reporter. A 31-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 03Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Is the patient a smoker/former smoker?: No" (unspecified if ongoing); "suspicious that he had covid", start date: 2019, stop date: 2019, notes: in 2019 he was suspicious that he had covid but this is the first time he has ever tested positive for covid. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Moderna (DOSE 2, SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Pfizer covid vaccines (DOSE 4 (BOOSTER), SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Pfizer covid vaccines (DOSE 5 (BOOSTER), SINGLE, left arm and all were intramuscular), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2025, outcome "not recovered" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2025) Positive; Body temperature: (01Jan2025) he has not had a fever. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Indication as Reported by the Primary Source: just the annual vaccine to stay up with them. This report was not related to a study or programme. Investigations: Yes. A Pfizer colleague and verified he is reporting on himself as the patient. He is calling as he is required to call about adverse events or lack of effect and he is calling about the Pfizer Covid vaccine which is the MRNA one. He got his booster on 03Oct2024 he believed and on 01Jan2025 tested positive for covid and stated he felt definitely clinical. Caller confirmed his awareness date of these reported events as 01Jan2025. He believes his first three covid vaccines were Moderna and the rest he had were Pfizer covid vaccines but he does not have the dates of administration to provide and does not know how many covid vaccines he had and thinks the one he had in Oct2024 that that was his 6th dose of covid vaccine or somewhere around there. Treatment included (but reporter classified as concomitant medications): He took a Claritin the day before on 31Dec2024 and believes it is actually the generic version cetirizine and was 10mg orally and he started that on 31Dec2024 because he had sneezing and watery eyes; the sneezing and watery eyes are ongoing and are improved. He did get all these free tests from work. States there are no further testing or testing results to include and since he got the positive covid test he was taking Dayquil and Nyquil to help with the clinical signs and that includes more than the sneezing and watery eyes and he also has coughing, congestion and body aches. The coughing, congestion and body aches all began 01Jan2025 and are ongoing and he would say everything is improving except the coughing and the coughing is persisting. For the outcome of taking the Dayquil and Nyquil he would say those are helping. He is taking off from work. He thinks all of his vaccines for covid were in the left arm and all were intramuscular. States as far as he knows this is the only time he has had a positive test for covid and back when there were no tests, in 2019 he was suspicious that he had covid but this is the first time he has ever tested positive for covid. Vaccination Facility Type: nurse's office at work. Vaccine Administered at Military Facility? No. Prior Vaccinations (within 4 weeks): had a flu vaccine the same date on 03Oct2024. Family Medical History Relevant to Adverse Events (AEs): He has had other family members and in-laws from the Christmas and new years gathering test positive for covid as well and his awareness date for that event is the same day he took the test on 01Jan2025. Treatment: No other than Nyquil and Dayquil and generic for Claritin. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. Did the patient display clinical signs at rest indicative of severe systemic illness? checking his temperature and he has not had a fever and is also taking Dayquil and NyQuil also that is keeping it down so he will say no for that. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Please provide information on any new or worsened symptoms/signs during the COVID-19 illness experienced(including date of/worsening): He would say the coughing. The patient was not a smoker/former smoker. Have no pre-existing diseases worsened during the SARS-CoV2 infection. Has the patient been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination?: Yes, he got the flu vaccine at the same time on 03Oct2024 and they put it in the opposite arm said that was their procedure; has no name or manufacturer name or lot number to provide for the flu vaccine. There was a product complaint to report. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2819812 U MN 01/07/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

COVID-19, Drug ineffective; COVID-19, Drug ineffective COVID-19, Drug ineffective; COVID-19, Drug ineffective
I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine; I got put on Paxlovid 10Jul2023... I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine; I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 71-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had covid before and take Pfizer vaccines 6 times in the past. And patient had took Paxlovid in 10Jul2023 and had helped. Patient is concerns that cannot afford for this prescription. During the call, patient states, "I have covid. I've had six Pfizer vaccines, and this is my second time with covid and the last time I had it I got Paxlovid, and it helped and this time I went to the emergency room, and they gave me a script for Paxlovid". Later in the call, the representative asks if the patient would like to be transferred to "our medical line" because the patient has taken Paxlovid before and the patient declines to be transferred. Later in the call, the patient states, "I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine so now I've had six vaccines and I've had it twice but I get so sick so I'm assuming the vaccine is keeping me alive."; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400083171 same patient, same event, different dose of vaccine; More
2819813 M 01/07/2025 COVID19
 PFIZER\BIONTECH
Illness, Pyrexia Illness, Pyrexia
sick; a high fever; This is a spontaneous report received from an Other HCP and a Consumer or other ... sick; a high fever; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 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 "a high fever". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2819814 79 F CA 01/07/2025 PNC20
 PFIZER\WYETH
 LG5575
Burning sensation, Cellulitis, Pain, Pruritus, Rash Burning sensation, Cellulitis, Pain, Pruritus, Rash
patient came to pharmacy on 1/6/25 to pickup prescription for antibiotic, ICD- 10 L03114, cellulitis... patient came to pharmacy on 1/6/25 to pickup prescription for antibiotic, ICD- 10 L03114, cellulitis of left upper limb per MD. She stated this was a reaction from her prevnar-20 vaccine that was given on 12/31/24. Per patient, she developed pain, swelling, rash and itchiness, hot burning sensation 24hrs after vaccination, she took benadryl for 2 days, and on 1/5 she took tylenol since it was painful. She went to see provider on 1/6/25. Doctor prescribed an antibiotic for cellulitis, she came to pharmacy on 1/6 to pickup antibiotic and reported the adverse reaction from the vaccine to pharmacist. More
2819815 15 M CO 01/07/2025 COVID19
FLU3
HEP
HEPA
HPV9
IPV
MMR
MNQ
TDAP
VARCEL
 PFIZER\BIONTECH
SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 LM2221
UT8415MA
Y004552
MZ474
Y008640
W1C751M
X014243
U8370AA
3CA17C1
Y0110115
Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythe... Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous; Dyspnoea, Pyrexia, Rash, Rash erythematous More
Patient reports that after returning home from receiving vaccines he had a fever. After waking up t... Patient reports that after returning home from receiving vaccines he had a fever. After waking up the morning after receiving vaccines he had a rash purple in color that covered his entire body from his face down to his feet that lasted for three days. He also reported that he had shortness of breath and difficulty breathing that lasted for three days. Patient's mother reports that she did not take him to a medical provider because the family does not have insurance coverage. More
2819816 12 M CA 01/07/2025 HPV9
 MERCK & CO. INC.
 Y013469
Feeling abnormal, Head injury, Loss of consciousness Feeling abnormal, Head injury, Loss of consciousness
Patient received vaccine, stood up and passed out. Patient came to within seconds. States his head h... Patient received vaccine, stood up and passed out. Patient came to within seconds. States his head had felt "fuzzy". Patient was given ice pack to his head and a Pedialyte popsicle and lay down for 10 minutes before leaving with his mom. No trauma found on head where he had hit a corner of the rounded baby scale on his way to his knees before he was caught by mom and LVN present. More
2819817 15 F TN 01/07/2025 COVID19
 MODERNA
 3043333
Dyspnoea, Loss of consciousness Dyspnoea, Loss of consciousness
After vaccine was administered by tech, pt lost consciousness for a few moments, gasp, then regained... After vaccine was administered by tech, pt lost consciousness for a few moments, gasp, then regained consciousness. More
2819823 88 M NY 01/07/2025 COVID19
 PFIZER\BIONTECH
 HM7009
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
Patient was administered a vaccination for COVID-19 Comirnaty vaccination booster on 12/03/2023 but ... Patient was administered a vaccination for COVID-19 Comirnaty vaccination booster on 12/03/2023 but the information was processed under a different patient's profile that had the same name but different date of birth and address. The patient realized this on there paperwork on January 7th, 2024 and made the pharmacy aware. More
2819824 8 M ID 01/07/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 WJ2662C
No adverse event No adverse event
No abnormal symptoms at this time reported by parent No abnormal symptoms at this time reported by parent
2819825 82 M FL 01/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 h529m
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pt received 2 rsv shots around a year apart. Pt did not realize he had an rsv shot before. He has no... Pt received 2 rsv shots around a year apart. Pt did not realize he had an rsv shot before. He has no adverse effects. More
2819826 5 M ID 01/07/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
No adverse event No adverse event
NO ADVERSE SYMPTOMS AT THIS TIME REPORTED BY PARENT NO ADVERSE SYMPTOMS AT THIS TIME REPORTED BY PARENT
2819827 F CA 01/07/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945655
Unevaluable event Unevaluable event
Not Available Not Available
2819828 77 F 01/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Extra dose administered Extra dose administered
Patient received 2 doses of RSV vaccine on 09/11/2023 and 12/30/2024 Patient received 2 doses of RSV vaccine on 09/11/2023 and 12/30/2024
2819829 67 F DE 01/07/2025 FLU3
FLU3
FLU3
FLU3
FLU3
PNC20
PNC20
PNC20
PNC20
PNC20
RSV
RSV
RSV
RSV
RSV
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 371597
371597
371597
371597
371597





3ak2k
3ak2k
3ak2k
3ak2k
3ak2k
Alpha 2 globulin, Alpha-1 anti-trypsin, Balance disorder, Blood 25-hydroxycholec... Alpha 2 globulin, Alpha-1 anti-trypsin, Balance disorder, Blood 25-hydroxycholecalciferol, Blood albumin; Blood homocysteine, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood thyroid stimulating hormone; Cryoglobulins, Electromyogram, Electrophoresis protein, Gait disturbance, Hypoaesthesia; Immunoelectrophoresis, Immunoglobulins, Magnetic resonance imaging spinal, Peroneal nerve palsy, Protein total; Scan with contrast, Vitamin B1, Vitamin B6; Alpha 2 globulin, Alpha-1 anti-trypsin, Balance disorder, Blood 25-hydroxycholecalciferol, Blood albumin; Blood homocysteine, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood thyroid stimulating hormone; Cryoglobulins, Electromyogram, Electrophoresis protein, Gait disturbance, Hypoaesthesia; Immunoelectrophoresis, Immunoglobulins, Magnetic resonance imaging spinal, Peroneal nerve palsy, Protein total; Scan with contrast, Vitamin B1, Vitamin B6; Alpha 2 globulin, Alpha-1 anti-trypsin, Balance disorder, Blood 25-hydroxycholecalciferol, Blood albumin; Blood homocysteine, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood thyroid stimulating hormone; Cryoglobulins, Electromyogram, Electrophoresis protein, Gait disturbance, Hypoaesthesia; Immunoelectrophoresis, Immunoglobulins, Magnetic resonance imaging spinal, Peroneal nerve palsy, Protein total; Scan with contrast, Vitamin B1, Vitamin B6 More
bi lateral drop foot, numbness in calf, poor balance, poor gait, numbness in both legs - below and ... bi lateral drop foot, numbness in calf, poor balance, poor gait, numbness in both legs - below and above knee More
2819830 65 F GA 01/07/2025 UNK
 UNKNOWN MANUFACTURER
 52Z52
Extra dose administered Extra dose administered
PATIENT RECEIVE AREXVY VACCINE ON FEBRUARY 10TH, 2024 AND RECEIVED ANOTHER ONE 10 JANUARY 04, 2025.... PATIENT RECEIVE AREXVY VACCINE ON FEBRUARY 10TH, 2024 AND RECEIVED ANOTHER ONE 10 JANUARY 04, 2025. THI VACCINE IS ONLY GIVING 1 DOSE FOR LIFE More
2819831 63 M SC 01/07/2025 PNC20
 PFIZER\WYETH
 lc5485
Extra dose administered Extra dose administered
Patient received a second dose of Prevnar 20 on 1/6/25, received first dose on 5/25/24. Outside of C... Patient received a second dose of Prevnar 20 on 1/6/25, received first dose on 5/25/24. Outside of CDC guidelines, More
2819832 25 M AZ 01/07/2025 COVID19
 MODERNA
Urticaria Urticaria
Hives (urticaria) Hives (urticaria)
2819833 50 F DE 01/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Chest X-ray normal, Chest pain, Electrocardiogram normal, Immediate post-injecti... Chest X-ray normal, Chest pain, Electrocardiogram normal, Immediate post-injection reaction, Pain in extremity; Paraesthesia More
My entire left side of my body from my head to my toe has been tingling and my left arm and in my le... My entire left side of my body from my head to my toe has been tingling and my left arm and in my left chest area is aching. I was fine after my first Shingrix injection but immediately after the second one I have been having these problems. These symptoms do not come and go they are constant when I go to bed and when I wake up. I did go to the doctor for chest pain and left arm pain he did a chest X-ray and ekg which were negative. More
2819834 70 M CA 01/07/2025 COVID19
FLU3
 NOVAVAX
SEQIRUS, INC.

COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
Covid infection, on-going Covid infection, on-going
2819835 12 M NY 01/07/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Autonomic nervous system imbalance, Cardiovascular disorder, Chronic fatigue syn... Autonomic nervous system imbalance, Cardiovascular disorder, Chronic fatigue syndrome, Echocardiogram, Erythema; Gastrooesophageal reflux disease, Photophobia, Postural orthostatic tachycardia syndrome, Rash, Small fibre neuropathy More
Severe rash the whole body that lasted 2 weeks, dysregulation of the circulation( redness of feet an... Severe rash the whole body that lasted 2 weeks, dysregulation of the circulation( redness of feet and hand), POTS symptoms, dysautonomia, photophobia, small fiber neuropathy, chronic fatigue syndrome. Chronic acid reflux More
✓
2819848 1 M MA 01/07/2025 HEPA
HEPA
MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y011731
Y011731
X027902
X027902
Y011019
Y011019
Pallor, Pyrexia, Rash, Rash erythematous, Rash papular; Streptococcus test negat... Pallor, Pyrexia, Rash, Rash erythematous, Rash papular; Streptococcus test negative; Pallor, Pyrexia, Rash, Rash erythematous, Rash papular; Streptococcus test negative; Pallor, Pyrexia, Rash, Rash erythematous, Rash papular; Streptococcus test negative More
Erythematous raised confluent blanching rash to trunk extremities and cheeks starting 1/2/2025. One ... Erythematous raised confluent blanching rash to trunk extremities and cheeks starting 1/2/2025. One day of fever on 12/30/2024. More
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