๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2848699 AZ 07/07/2025 VARCEL
 MERCK & CO. INC.
 Y013350
No adverse event, Product storage error No adverse event, Product storage error
there were no symptomatic events reported/No additional AE; HCP called regarding T/E for VARIVAX. Se... there were no symptomatic events reported/No additional AE; HCP called regarding T/E for VARIVAX. See T/E case 02821980. HCP reported that there were no symptomatic events reported. HCP agrees to be primary and correspondence contact for AE case. No additional AE/No PQC. Names of vaccines involved (including; This spontaneous report was received from an other health professional and refers to a(n) 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 03-Jun-2025, the patient was vaccinated with improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), formulation: injection, lot #Y013350, expiration date: 02-Aug-2026, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). Administered dose of vaccine was exposed to the temperature excursion of 25.5 degrees Fahrenheit for 7 hours and 15 minutes (product storage error). There were no symptomatic events reported (no adverse event). More
2848700 TX 07/07/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019465
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE; Customer called to report TE. One of the vaccines was administered to one patient:... No additional AE; Customer called to report TE. One of the vaccines was administered to one patient: PROQUAD Y019465 05/24/2026. No symptoms reported. No additional AE/no PQC. ? Names of vaccines involved (including lot/exp) PROQUAD Y019465 05/24/2026; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JUN-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 ml, lot #Y019465, expiration date: 24-MAY-2026, administered by unknown route as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The vaccine was administered after temperature excursion (Product storage error). No additional adverse events. At the reporting time, the outcome of the events was not known. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was not reported but established as not applicable. More
2848701 KS 07/07/2025 MMRV
 MERCK & CO. INC.
 Y012074
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
PROQUAD was inadvertently administered to a 77-year-old consumer instead of MMR-II; PROQUAD was inad... PROQUAD was inadvertently administered to a 77-year-old consumer instead of MMR-II; PROQUAD was inadvertently administered to a 77-year-old consumer instead of MMR-II; no additional AE reported; This spontaneous report was received from an other health professional and refers to a 77-year-old patient of unknown gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 02-Jul-2025, the patient was inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #Y012074 has been verified to be valid, and expiration date was established as 05-Jan-2026) (strength, dose, route of administration, anatomical location was not reported) with reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, route, lot# and expire date was not reported) for prophylaxis instead of Measles, Mumps, and Rubella (Wistar RA 27-3) (M-M-R II) (Wrong product administered, Product administered to patient of inappropriate age). No additional adverse event was reported. More
2848702 NJ 07/07/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 T013725
Antibody test negative; Antibody test negative Antibody test negative; Antibody test negative
They drew titers and they are low; This spontaneous report was received from a pharmacy student on 0... They drew titers and they are low; This spontaneous report was received from a pharmacy student on 01-Jul-2025and refers to an adult patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-Jun-2021, the patient was vaccinated with a first dose Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #T013725, expiration date: 21-Apr-2022) (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) administered on the same date (dose, dose number, lot#, expiration date and route of administration were not reported) for prophylaxis. On 29-Jun-2021(conflicting information reported as the same date of vaccination by the reporter) an antibody test was performed and the result showed that the patient's titers drew, and they were low (Antibody test abnormal). At the reporting time, the outcome of the event was unknown. The causal relationship between the event, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), and sterile diluent (MERCK STERILE DILUENT) was unknown. More
2848704 OH 07/07/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 Unknown
Nervousness, Panic attack, Presyncope Nervousness, Panic attack, Presyncope
Almost passed out after receiving a COVID vaccine; Terrible case of nerves; Pure panic; A report has... Almost passed out after receiving a COVID vaccine; Terrible case of nerves; Pure panic; A report has been received from a non-health professional, regarding a subject enrolled in study (withheld). The report concerns a male patient (age not provided). The patient's past and current medical history included coronavirus test (dates not reported). No concomitant products were reported. On an unknown date, the patient experienced almost passed out after receiving a covid vaccine (preferred term: Near death experience), pure panic (preferred term: Panic attack) and terrible case of nerves (preferred term: Neuralgia). The dose of Flumist (flumist, influenza virus vaccine polyvalent, q/laiv) was not changed. The outcome of the event(s) of almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves was unknown. The following event(s) were considered serious due to medically significant:almost passed out after receiving a covid vaccine. The following events were considered non-serious:pure panic and terrible case of nerves. The reporter did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): almost passed out after receiving a covid vaccine, pure panic and terrible case of nerves. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No; Sender's Comments: Presyncope is not a listed event for the core data sheet for Q/LAIV. Due to limited information on patient demographics, underlying comorbidities, past medical history and concomitant medications, suspect product start date, indication, and action taken, circumstances leading to event, details of the event including onset date and outcome, risk factors, treatment details, clinical course, detailed etiological, diagnostic workup as clinical examination, complete blood workup, the evaluation did not find evidence to suggest a causal relationship between event and suspect drug. More
2848705 07/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rheumatoid arthritis Rheumatoid arthritis
rheumatoid arthritis; This serious case was reported by a consumer via interactive digital media and... rheumatoid arthritis; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis 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 rheumatoid arthritis (Verbatim: rheumatoid arthritis) (serious criteria GSK medically significant). The outcome of the rheumatoid arthritis was not resolved. The reporter considered the rheumatoid arthritis to be related to Shingles vaccine. The company considered the rheumatoid arthritis to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 25-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported this was damn vaccine. Two years ago (from the date of reporting), the patient almost died and developed rheumatoid arthritis. Further patient stated after taking several medications until today (till the day of reporting) and the patient never had support from anyone at the laboratory. The patient mentioned not to take it. The patient was suffering every day because of the vaccine.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2848706 M NC 07/07/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center ... Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient. The patient did not receive Twinrix. The patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination 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: 27-JUN-2025 The patient received the accelerated dosing of Twinrix in 2013/2014. The reporter does not believe the patient received the 4th dose. Till the time of reporting the patient did not receive the booster dose of Twinrix, which led to incomplete course of vaccination. This case is linked with case US2025081315, reported by the same reporter.; Sender's Comments: US-GSK-US2025081315:Same reporter,Different patient More
2848707 07/07/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Stress, Vaccination failure; Herpes zoster, Stress, Vaccination f... Herpes zoster, Stress, Vaccination failure; Herpes zoster, Stress, Vaccination failure More
Suspected Vaccination failure; I have been going through a small outbreak for the last few weeks; Cu... Suspected Vaccination failure; I have been going through a small outbreak for the last few weeks; Currently dealing with a lot of stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 84-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have been going through a small outbreak for the last few weeks) and stress (Verbatim: Currently dealing with a lot of stress). The outcome of the vaccination failure and shingles were not reported and the outcome of the stress was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and stress to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-JUN-2025 This case was reported by a patient via interactive digital media. Reporter was vaccinated twice for shingles but he/she had been going through a small outbreak for the last few weeks. Fortunately it did not seemed to be spreading. Reporter was 84 years old and currently dealing with a lot of stress. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2) More
2848708 07/07/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; diagnosed with shingles; This serious case was reported by a consumer... Suspected vaccination failure; diagnosed with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 27-JUN-2025 This case was reported by a patient via interactive digital media. The patient too had the shingles vaccine and have just been diagnosed with shingles. The patient mentioned that he/she had both doses of vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2). More
2848709 07/07/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Post herpetic neuralgia, Vaccination failure; Herpes zoster, Post... Herpes zoster, Post herpetic neuralgia, Vaccination failure; Herpes zoster, Post herpetic neuralgia, Vaccination failure More
Suspected vaccination failure; still got shingles a year ago; still have chronic nerve pain; This se... Suspected vaccination failure; still got shingles a year ago; still have chronic nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles a year ago) and post herpetic neuralgia (Verbatim: still have chronic nerve pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUN-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she had both shots of Shingles vaccine and still got shingles a year ago. The patient reported he/she still have chronic nerve pain. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine More
2848710 07/07/2025 VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes z... Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure More
Suspected vaccination failure; still got shingles; had more than two vaccines for it; This serious c... Suspected vaccination failure; still got shingles; had more than two vaccines for it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and extra dose administered (Verbatim: had more than two vaccines for it). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUN-2025 This case was reported by a patient via interactive digital media. It was reported as not necessarily true. The patient never had chicken pox but had more than two vaccines for it which led to extra dose administered and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1, 2 & 3). More
2848711 07/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Extra dose administered Extra dose administered
Patient had 3 shingles shot in 8 years; This non-serious case was reported by a consumer via interac... Patient had 3 shingles shot in 8 years; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on an unknown date) and Shingles vaccine (received 2nd dose on an unknown date). On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: Patient had 3 shingles shot in 8 years). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 28-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that the shingles can be internal, on your lungs, heart etc. The patient had 3 shingles shots in 8 years which led to extra dose administered. The patient would have one every year to keep from getting shingles. My close friend has had painful shingles for 3 years. More
2848712 07/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
not feeling well; This non-serious case was reported by a consumer via interactive digital media an... not feeling well; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 21-JUN-2025, the patient received the 2nd dose of Shingles vaccine. In JUN-2025, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: not feeling well). In JUN-2025, the outcome of the feeling abnormal was resolved (duration 24 hrs). It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine. Additional Information: GSK receipt date: 26-JUN-2025 This case was reported by a patient via interactive digital media. Patient stated that just got second vaccine past Saturday. Felt like crap for 24 hours. But patient indicated that it was worth it. More
2848713 07/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I currently have Shingles; This serious case was reported by a consum... Suspected vaccination failure; I currently have Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I currently have Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 25-JUN-2025 This case was reported by a patient via interactive digital media. Patient received both doses of shingrix vaccine 3 years ago and he/she currently have shingles. Patient could confirm it was the most painful thing he/she had ever experienced. The itching, the burning, and the pain was indescribable. He/she was really hoping the antiviral medication and steroid cream helps. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2) More
2848714 16 F HI 07/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 AE2J7
Expired product administered Expired product administered
received an expired dose of Flulaval; This non-serious case was reported by a other health professio... received an expired dose of Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AE2J7, expiry date 16-JUN-2025) for prophylaxis. On 17-JUN-2025, the patient received FluLaval 2024-2025 season. On 17-JUN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: received an expired dose of Flulaval). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-JUN-2025 The patient received an expired dose of Flulaval on the day of reporting morning, which led expired vaccine used. The reporter consented to follow up. More
2848715 M MD 07/07/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVV064A
Erythema, Product preparation error, Skin warm, Swelling Erythema, Product preparation error, Skin warm, Swelling
sterile water was used to reconstitute the lyophilized component of Menveo; sterile water was used t... sterile water was used to reconstitute the lyophilized component of Menveo; sterile water was used to reconstitute the lyophilized component of Menveo; arm turning really red; arm hot; arm turned a knot; This non-serious case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVV064A) for prophylaxis. On 19-JUN-2025, the patient received Menveo. In JUN-2025, an unknown time after receiving Menveo, the patient experienced erythema of extremities (Verbatim: arm turning really red), extremities hot feeling of (Verbatim: arm hot) and local swelling (Verbatim: arm turned a knot). On 19-JUN-2025, the patient experienced wrong solution used in drug reconstitution (Verbatim: sterile water was used to reconstitute the lyophilized component of Menveo) and inappropriate dose of vaccine administered (Verbatim: sterile water was used to reconstitute the lyophilized component of Menveo). The outcome of the erythema of extremities, extremities hot feeling of and local swelling were not reported and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of and local swelling to be related to Menveo. It was unknown if the company considered the erythema of extremities, extremities hot feeling of and local swelling to be related to Menveo. Additional Information: GSK Receipt Date: 24-JUN-2025 Medical assistant called to report on 19th June 2025 sterile water was used to reconstitute the lyophilized component of Menveo and vaccine was administered which led to wrong solution used wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Once they spoke with the parents, they did note he had a pretty significant reaction as far as his arm turning really red, hot and a knot. They just wanted to make sure there was not any indication that he should not receive the full vaccine. More
2848716 RI 07/07/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 B32NG
Expired product administered Expired product administered
Maladministration of an expired dose; This non-serious case was reported by a other health professio... Maladministration of an expired dose; 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 DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis. On 26-JUN-2025, the patient received Boostrix. On 26-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Maladministration of an expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 26-JUN-2025 Medical Assistant called to ask for further steps regarding the maladministration of an expired dose of Boostrix which led to expired vaccine use. Vaccination date and vaccine detail were obtained in this call (these were reactively mentioned from the Medical Assistant๏ฟฝs end). No patient demographics were obtained in this call. No further information was obtained in this call. More
2848717 F 07/07/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH
 ES49H
Interchange of vaccine products; Interchange of vaccine products Interchange of vaccine products; Interchange of vaccine products
received a dose of Trumemba instead of a dose of Bexsero as a second dose; This non-serious case was... received a dose of Trumemba instead of a dose of Bexsero as a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ES49H, expiry date 31-MAY-2027) for prophylaxis. Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis. On 26-JUL-2024, the patient received the 1st dose of Bexsero. On an unknown date, the patient received the 2nd dose of Trumenba. On an unknown date, an unknown time after receiving Bexsero and Trumenba, the patient experienced interchange of vaccine products (Verbatim: received a dose of Trumemba instead of a dose of Bexsero as a second dose). The outcome of the interchange of vaccine products 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: 27-JUN-2025 A pharmacist called asking advice regarding a 19-year-old female patient dosing schedule. Patient received Bexsero 1st dose on 26th July 2024. Then the patient received Trumenba by mistake instead of Bexsero which led to interchange of vaccine products. Reporter questioned that did the patient had to get the next dose of Bexsero. More
2848718 M CA 07/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component); M... Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-JUL-2025, the patient received Shingrix. On 01-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B Adjuvant of Shingrix alone (without the Lyophilized Antigen Component)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 02-JUL-2025 The reporter called to ask about the specific timeframe for a valid dose of Shingrix, since a patient was administered with the adjuvant alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Vaccination date and patient demographics were obtained in this call. No vaccine detail was obtained from the Registered Nurse. No further information was obtained in this call. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. More
2848719 F NJ 07/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix late second dose/now wants to receive the second dose; This non-serious case was reported b... Shingrix late second dose/now wants to receive 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 elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (04-JUN-2024, 1st dose was received). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose/now wants to receive the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 02-JUL-2025 A Health Care Provider wanted to know how to proceed after a patient received the first dose of Shingrix and now wanted to receive the second dose. The Vaccine Administration Facility is the same as Primary Reporter. No lot number nor expiration date known of the first Shingrix dose. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination. More
2848720 MI 07/07/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 42B22
Product storage error Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis. In JUN-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 03-JUL-2025 The pharmacy technician reported that they have the Hep B vaccine in his/her refrigerator, Engerix B, and they going to need some information about temperature it went out of range for 5 minutes. And then, his/her county needs information about its use. The reporter would tell you right now that it had already been used. The reporter did not have the patient's information and said that the administration might have administered the same day of the excursion (26-JUN-2025) or probably 2 days after that. The Engerix B vaccine stored outside recommended conditions and administered to patient, which led to an incorrect storage of drug. More
2848721 M 07/07/2025 COVID19
 MODERNA
COVID-19, Cardiac failure COVID-19, Cardiac failure
he went into heart failure; diagnosed with COVID; This spontaneous case was reported by a consumer a... he went into heart failure; diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (he went into heart failure) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Family history included Heart rate low (slow heart rate, mother died from heart failure). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2024, the patient experienced COVID-19 (diagnosed with COVID). On an unknown date, the patient experienced CARDIAC FAILURE (he went into heart failure) (seriousness criteria death and medically significant). The patient died on an unknown date. The reported cause of death was he went into heart failure. It is unknown if an autopsy was performed. At the time of death, COVID-19 (diagnosed with COVID) had resolved. No concomitant medications provided by the reporter. Patient went to attend a family wedding on Dec-2024 and patient was fully vaccinated. He had been diagnosed with COVID after the wedding. That was because some person came to the wedding that apparently was not vaccinated and COVID was spread it to everyone. There were over 100 people at that wedding. Every single person at that wedding got COVID. Reporter had no information if other attendees were vaccinated or with what vaccine. It was reported that patient had all the vaccines that recommended for COVID but despite that patient got very, very sick and he was on a very extensive antibiotic as treatment medication to get over that COVID infection. Patient was recovered with an antibiotic treatment when he did get COVID. Patient had died from heart failure. Before that patient was taken to surgery to do a pacemaker, but he did not want it. It was reported that the reason he passed away was he refused to have the pacemaker. It was also reported that patient had a genetic propensity for a slow heart rate and death was not related with COVID. This case was linked to US-MODERNATX, INC.-MOD-2025-787904 (E2B Linked Report).; Reporter's Comments: Family history is a risk factor for the event. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787904:Patient 2 (Brother's case); Reported Cause(s) of Death: he went into heart failure More
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2848722 64 F CT 07/07/2025 COVID19
 MODERNA
 3046732
Binocular visual dysfunction, Visual impairment Binocular visual dysfunction, Visual impairment
Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lig... Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere; Margining vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere) and BINOCULAR VISUAL DYSFUNCTION (Margining vision) in a 64-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 23-Jun-2025, the patient experienced VISUAL IMPAIRMENT (Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere) and BINOCULAR VISUAL DYSFUNCTION (Margining vision). In 2025, BINOCULAR VISUAL DYSFUNCTION (Margining vision) had resolved. On 23-Jun-2025, VISUAL IMPAIRMENT (Weird vision changes about 12 hours after vaccine administered/interference along with twinkling lights shaped like a right angle on left side of vision sphere) had resolved. No concomitant medication was reported. Patient had weird vision changes about 12 hours after vaccine administered. Patient had margining vision and interference along with twinkling lights shaped like a right angle on left side of vision sphere. It was unknown if the patient experienced any additional symptoms/events. Patient went to emergency room, and they did a CT scan of head and neck, result was unknown. No treatment medication was reported. Reporter causality was not provided. More
2848723 71 F 07/07/2025 COVID19
 MODERNA
Heart rate, Heart rate decreased Heart rate, Heart rate decreased
Heart rate is very low; This spontaneous case was reported by a consumer and describes the occurrenc... Heart rate is very low; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (Heart rate is very low) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS in 2024. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Family history included Heart failure (Mother died from heart failure) and Heart rate low (genetic propensity for a slow heart rate) since an unknown date. In June 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In June 2025, the patient experienced HEART RATE DECREASED (Heart rate is very low). At the time of the report, HEART RATE DECREASED (Heart rate is very low) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2025, Heart rate: Heart rate was very low. Concomitant medication use information was not provided by reporter. In September 2025, the patient's age would be 72. The patient received Spikevax two weeks ago in June 2025 and last year in 2024. All previous doses of COVID-19 vaccine were Moderna. It was reported that there was a genetic propensity for a slow heart rate. That's all, it was not related to COVID. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-787905 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787905:Patient 2 (Brother's case) More
2848724 F VA 07/07/2025 COVID19
 PFIZER\BIONTECH
Anaphylactic reaction, Confusional state Anaphylactic reaction, Confusional state
Full anaphylaxis; mental fog; This is a spontaneous report received from a Consumer or other non HCP... Full anaphylaxis; mental fog; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes, many" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (disability, life threatening, medically significant), outcome "unknown", described as "Full anaphylaxis"; CONFUSIONAL STATE (disability, life threatening), outcome "unknown", described as "mental fog". Therapeutic measures were taken as a result of anaphylactic reaction, confusional state. More
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2848725 68 F CA 07/07/2025 PNC20
 PFIZER\WYETH
 LN4930
Cellulitis, Injection site pain, Red blood cell count decreased, White blood cel... Cellulitis, Injection site pain, Red blood cell count decreased, White blood cell count increased More
Cellulitis in the elbow; Severe pain upon administration of Prevnar 20; White blood cell count was h... Cellulitis in the elbow; Severe pain upon administration of Prevnar 20; White blood cell count was high; Red blood cell count was low; This is a spontaneous report received from a Nurse. A 68-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 26Jun2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: 01Jul2026) at the age of 68 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RED BLOOD CELL COUNT DECREASED (non-serious) with onset 01Jul2025, outcome "unknown", described as "Red blood cell count was low"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 01Jul2025, outcome "unknown", described as "White blood cell count was high"; CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis in the elbow"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Severe pain upon administration of Prevnar 20". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cellulitis, white blood cell count increased, red blood cell count decreased, vaccination site pain. Additional information: It was reported that the patient had a complaint of severe pain upon administration of Prevnar 20. The patient had seen the doctor for cellulitis and cellulitis in the elbow. The patient had been assessed by the doctor. The patient had blood work done yesterday (01Jul2025) but it was in the hospital. Her white blood cell count was high and red blood cell count was low. The reporter stated, treatment: "yes, she went to the emergency room." causality: "yes." More
2848726 MO 07/07/2025 PNC20
 PFIZER\WYETH
Respiratory symptom Respiratory symptom
upper respiratory symptoms; This is a spontaneous report received from a Nurse. A patient (age and ... upper respiratory symptoms; This is a spontaneous report received from a Nurse. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY SYMPTOM (non-serious) with onset Jun2025, outcome "unknown", described as "upper respiratory symptoms". Therapeutic measures were taken as a result of respiratory symptom. Additional information: Clarified the potential adverse event is that reporter said a patient received Prevnar 20 on a Monday, on Wednesday patient had called and said patient was having some sort of upper respiratory symptoms. Reporter believes it was seasonal allergies and reporter recommended that patient take antihistamines, and that is the last reporter heard of it. Caller believes it would have been last week when this all occurred. Caller unknown if the upper respiratory symptoms are ongoing.No dates were provided to caller by reporter. Caller believes it would have been last week when this all occurred. Caller unknown if the upper respiratory symptoms are ongoing. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2848727 F ID 07/07/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
This is the fifth time the patient has had COVID; This is the fifth time the patient has had COVID; ... This is the fifth time the patient has had COVID; This is the fifth time the patient has had COVID; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation. Vaccination history included: Bnt162b2 (Primary Immunization completed), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "This is the fifth time the patient has had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not feel well and could not sleep at night. Her nose was too stuffy, so she did not sleep that night. The next day she went on with her day and then that night she kept thinking if this is a cold or allergies. She took some more drugs so she could sleep better. The second morning she woke up, she wondered if it's Covid. She did a Covid test at home, and it turned out to be Covid. She then called her doctor first thing in the morning and asked for prescription for Paxlovid, she took the Paxlovid. This is the fifth time the patient has had COVID. Batch/lot number is not provided, and it cannot be obtained. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received. More
2848728 71 F MD 07/07/2025 COVID19
 PFIZER\BIONTECH
 FH8028
Transient ischaemic attack Transient ischaemic attack
TIA; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female p... TIA; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 1, single (Lot number: FH8028) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2006 (ongoing), notes: diagnosed around 2006 or somewhere around there; "Hypertension" (ongoing). There were no concomitant medications. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization) with onset 11Dec2021, outcome "unknown", described as "TIA". The patient was hospitalized for transient ischaemic attack (start date: 12Dec2021, discharge date: 13Dec2021, hospitalization duration: 2 day(s)). The event "tia" required emergency room visit. Therapeutic measures were not taken as a result of transient ischaemic attack. Clinical course: The vaccine was administered in a Pharmacy/drug store and not at a military facility. The patient did not receive any other vaccines on the same date and as the Pfizer vaccine nor within 4 weeks prior to the first administration. The patient had was a TIA, confirmed to be a transient ischemic attack. More
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2848736 07/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza like illness Influenza like illness
felt like the flu aches; Pains; This non-serious case was reported by a consumer via interactive dig... felt like the flu aches; Pains; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu-like aching 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, less than a day after receiving Shingrix, the patient experienced flu-like aching (Verbatim: felt like the flu aches) and pain (Verbatim: Pains). The outcome of the flu-like aching and pain were resolved (duration 1 day). It was unknown if the reporter considered the flu-like aching and pain to be related to Shingrix. It was unknown if the company considered the flu-like aching and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JUN-2025 This case was reported by a patient via interactive digital media. The patient only had symptoms the night of the 1st injection. It felt like the flu's aches and pains. Still better than full blown shingles. The next day patient was fine. More
2848737 F DE 07/07/2025 PNC20
TDAP
 PFIZER\WYETH
UNKNOWN MANUFACTURER

Urticaria; Urticaria Urticaria; Urticaria
She got urticaria, hives, all over her body come and go and she's had them on and off; This is ... She got urticaria, hives, all over her body come and go and she's had them on and off; This is a spontaneous report received from a Nurse. A 52-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Feb2025 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 04Feb2025 as dose number unknown, single) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Tdap (Unknown dose number, unknown manufacturer), for immunization. The following information was reported: URTICARIA (non-serious) with onset 05Feb2025, outcome "not recovered", described as "She got urticaria, hives, all over her body come and go and she's had them on and off". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. Additional information: When probed about the side-effects, Pfizer Employee stated, patient got urticaria, hives, all over her body come and go and she's had them on and off since she got the vaccine on February 4th, 2025. Dose, route of administration, indication and anatomical location: Pfizer Employee stated, "The indication is for 50 and older. She received the dose that she should have got was 0.5 milliliters and she got it in her arm, but Pfizer employee do not know if it was her left arm or right arm. So, she got it in her deltoid muscle. Other medications and medical conditions: Pfizer Employee stated, "The only other medication she was taking was Lisinopril and the same day she got the Prevnar shot, she got it Tdap in the other arm. She was taking Lisinopril, the only medication she takes. The representative was trying to share that it was the same day she got Prevnar 20, she also received a Tdap (Hence suspect captured as Tdap), it is a vaccine for Tetanus diphtheria and pertussis. It is called Tdap, she received it on the same day in different arm. Product details for Tdap (LOT#, Expiration date, NDC# and UPC#): Pfizer Employee stated, patient did not give him any of that. She said she received a Tdap in the past by itself and never had a problem, that is what patient told Pfizer representative. Causality: Pfizer Employee stated, "Yes, she does and in end June, July and she still sees her, and hives come and go. She said she never got rid of them. She said they are all over the body, they come and go.Date of adverse event: Pfizer Employee stated, patient said with in 24 hours. So, patient would say February 5th, 2025. Still experiencing: Pfizer Employee stated, "Yes, she is, it comes and go." Treatment: Pfizer Employee stated, "I do not find out." Lab work: Pfizer Employee stated, "No, I do not know anything. More
2848739 F 07/07/2025 COVID19
 PFIZER\BIONTECH
 EW2017
Thrombosis, Urticaria Thrombosis, Urticaria
Blood clot; Hives; This is a spontaneous report received from an Other HCP from a sales representati... Blood clot; Hives; This is a spontaneous report received from an Other HCP from a sales representative. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2021 as dose number unknown, single (Lot number: EW2017) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: THROMBOSIS (hospitalization) with onset 01Jul2021, outcome "recovered", described as "Blood clot"; URTICARIA (hospitalization) with onset 01Jul2021, outcome "recovered", described as "Hives". The patient was hospitalized for thrombosis, urticaria (start date: 01Jul2021, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of thrombosis, urticaria and included treatment with apixaban (ELIQUIS).; Sender's Comments: There is not a reasonable possibility that the reported events blood clot and urticaria were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate. More
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2848740 F 07/07/2025 COVID19
 PFIZER\BIONTECH
 33030BD
Allergy to vaccine Allergy to vaccine
had serious reactions for the last few years and has allergies; This is a spontaneous report receive... had serious reactions for the last few years and has allergies; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: 33030BD) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "had serious reactions for the last few years and has allergies". Additional information: patient was asking to get the list of ingredients for Pfizer Covid vaccine with lot number 33030BD because she had serious reactions for the last few years and has allergies. More
2848741 07/07/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Drug ineffective COVID-19, Disease recurrence, Drug ineffective
Covid/had it once before/taken Paxlovid; Covid/had it once before/taken Paxlovid; got Covid again/wa... Covid/had it once before/taken Paxlovid; Covid/had it once before/taken Paxlovid; got Covid again/was prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid/had it once before/taken Paxlovid"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "got Covid again/was prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: It was reported that the patient received 8 Pfizer COVID-19 vaccine shots, had COVID, had it once before and taken Paxlovid. The patient got COVID again and was prescribed Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2848742 F 07/07/2025 COVID19
 PFIZER\BIONTECH
Infertility female Infertility female
infertile/daughter became infertile after receiving the Pfizer COVID-19 vaccine three times.; This i... infertile/daughter became infertile after receiving the Pfizer COVID-19 vaccine three times.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, 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: INFERTILITY FEMALE (non-serious), outcome "unknown", described as "infertile/daughter became infertile after receiving the Pfizer COVID-19 vaccine three times.". Additional information: The reporter claimed that her daughter became infertile after receiving the Pfizer COVID-19 vaccine three times. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2848743 F CT 07/07/2025 COVID19
 PFIZER\BIONTECH
Breast cancer recurrent Breast cancer recurrent
recurrent Breast Cancer; This is a spontaneous report received from a Consumer or other non HCP. A ... recurrent Breast Cancer; This is a spontaneous report received from a Consumer or other non HCP. A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure / PACS" (unspecified if ongoing); "Blood pressure / PACS" (unspecified if ongoing); "Preventive cholesterol" (unspecified if ongoing); "Breast cancer", start date: 25Feb1997 (ongoing); "pulmonary nodule", start date: 2017 (unspecified if ongoing), notes: MRI indicated 2 pulmonary nodules which necessitated a CT scan. The 2 nodules were in the right side. The 2nd in the lingula which had grown from 6 mm - 10 mm since 2017. Concomitant medication(s) included: DILTIAZEM taken for blood pressure abnormal, supraventricular extrasystoles; LOSARTAN; VALSARTAN; HCTZ; ROSUVASTATIN taken for blood cholesterol abnormal; ANASTROZOLE. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE), administration date: 12Feb2021, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE), administration date: 12Mar2021, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 22Oct2021, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 30Mar2022, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 09Sep2022, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE), administration date: 16Jun2023, for Covid-19 immunization. The following information was reported: BREAST CANCER RECURRENT (medically significant) with onset 28Aug2024, outcome "unknown", described as "recurrent Breast Cancer". Clinical course: Patient have received 8 covid shots and received vaccinations from 2021-2025. The vaccination date for the 7th dose was also reported as 18Sep2023/23May2024. More
2848744 F 07/07/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
doesn't always prevent covid; doesn't always prevent covid; This is a spontaneous report r... doesn't always prevent covid; doesn't always prevent covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 58-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "doesn't always prevent covid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2848745 F 07/07/2025 COVID19
 PFIZER\BIONTECH
Blindness, Ear disorder, Macular degeneration, Osteomyelitis Blindness, Ear disorder, Macular degeneration, Osteomyelitis
macular degeneration to go bad; suddenly she couldn't see; tibia was infected; fluid in her ear... macular degeneration to go bad; suddenly she couldn't see; tibia was infected; fluid in her ear; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 10000329006 (Genentech). An 85-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "knee replacement" (unspecified if ongoing); "cataract surgery" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: MACULAR DEGENERATION (medically significant), outcome "unknown", described as "macular degeneration to go bad"; BLINDNESS (medically significant), outcome "unknown", described as "suddenly she couldn't see"; OSTEOMYELITIS (medically significant), outcome "unknown", described as "tibia was infected"; EAR DISORDER (non-serious), outcome "unknown", described as "fluid in her ear". Clinical course: On unknown date, patient started therapy with BioNTech Covid-19 Vaccine for unknown indication. On unknown date, it was reported that patient experienced: macular degeneration to go bad, suddenly she couldn't see. Tibia was infected, and fluid in her ear. Batch/lot number is not provided, and it cannot be obtained. More
2848746 IL 07/07/2025 IPV
 SANOFI PASTEUR
 X10141M
Extra dose administered, No adverse event Extra dose administered, No adverse event
received two doses of IPOL with no reported adverse event; Initial information received on 03-Jul-20... received two doses of IPOL with no reported adverse event; Initial information received on 03-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who received two doses of IPV (VERO) [IPOL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received two doses of IPV (VERO) Suspension for injection (strength- unknown, expiry date- 03-Oct-2026 and lot X10141M) via unknown route in unknown administration site for Immunization with no reported adverse event (extra dose administered) (same day latency). 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
2848747 F VA 07/07/2025 IPV
 SANOFI PASTEUR
 W1C751M
Product storage error Product storage error
New thermometers were being added to the refrigerator and it took a while for them to be adjusted pr... New thermometers were being added to the refrigerator and it took a while for them to be adjusted properly with human error for 46 hours 36 minutes with no reported adverse event; Initial information received on 03-Jul-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves an unknown age female patient where reporter reported IPV (Vero) [IPOL] new thermometers were being added to the refrigerator and it took a while for them to be adjusted properly with human error for 46 hours 36 minutes with no reported adverse event. Vaccine was not administered to patient(s). On 15-Jun-2025, dose of suspect IPV (VERO) Suspension for injection (batch number- W1C751M and expiry date- 18-NOV-2025) (dose, frequency, strength: not provided) for Immunization and new thermometers were being added to the refrigerator and it took a while for them to be adjusted properly with human error for 46 hours 36 minutes with no reported adverse event (product storage error). Reportedly, Low temperature reached: -15Jun2025: 1.0 degrees Celsius, 3 hours 24 minutes-16Jun2025: 1.1 degrees Celsius, 10 hours 50 minutes-17Jun2025: 1.3 degrees Celsius, 11 hours 7 minutes-19Jun2025: 1.1 degrees Celsius, 10 hours, 29 minutes-20Jun2025: 1.1 degrees Celsius, 10 hours 46 minutes, cumulative duration: 46 hours 36 minutes, Previous Excursion- No, Human error- Yes, Does extended stability data cover the excursion- No. Action taken- 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
2848748 23 F CO 07/07/2025 YF
 SANOFI PASTEUR
Pruritus, Urticaria Pruritus, Urticaria
A 23-year-old female presents with acute onset of pruritic, erythematous wheals consistent with urti... A 23-year-old female presents with acute onset of pruritic, erythematous wheals consistent with urticaria approximately 4 days after receiving a subcutaneous dose of yellow fever vaccine. The patient received the vaccine as part of pre-travel prophylaxis. There was no prior history of egg, gelatin, or latex allergy, and no known prior exposure to yellow fever vaccine. The urticarial eruption began on the right arm and spread to the left arm, bilateral inner thighs, and right flank area and was not associated with respiratory distress, angioedema, hypotension, or other systemic symptoms. Patient reports that the hives started 4 days after exposure, but the itching started immediately after injection at injection side. No fever, headache, or myalgia was reported at the time of reaction. The patient reports a similar reaction to penicillin. Patient has not taken anything for her symptoms. More
2848749 1 F NY 07/07/2025 HEPA
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y008338
Y004547
Rash; Rash Rash; Rash
Widespread rash Widespread rash
2848750 16 M OH 07/07/2025 MNQ
 SANOFI PASTEUR
 U8493AA
Blood glucose, Presyncope, Tremor Blood glucose, Presyncope, Tremor
Vasovagal reaction with tremor (seizure) -checked glucose, snack, monitored blood pressure Vasovagal reaction with tremor (seizure) -checked glucose, snack, monitored blood pressure
2848763 11 F PA 07/07/2025 HEP
HEPA
MMR
VARCEL
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 Y003449
H3N97
X027902
Y010373
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Extra dose given erroneously. Patient did not have any symptoms. Extra dose given erroneously. Patient did not have any symptoms.
2848764 49 M FL 07/07/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 y3z9p
Injection site bruising, Injection site pustule, Injection site swelling Injection site bruising, Injection site pustule, Injection site swelling
Patient reported swelling, pus, and bruising of the injection site the day following vaccination Patient reported swelling, pus, and bruising of the injection site the day following vaccination
2848765 68 M GA 07/07/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945663
Inappropriate schedule of product administration Inappropriate schedule of product administration
Pt received 2nd vaccine in series on day 27 instead of day 28 or later. Pt stated side effects are ... Pt received 2nd vaccine in series on day 27 instead of day 28 or later. Pt stated side effects are normal as with 1st dose (arm soreness, feeling tired after) More
2848766 76 F TX 07/07/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Z002626
F95YS
Injection site erythema, Injection site swelling, Pyrexia; Injection site erythe... Injection site erythema, Injection site swelling, Pyrexia; Injection site erythema, Injection site swelling, Pyrexia More
Patient reported she developed a severe fever, injection site swelling and redness later in the day ... Patient reported she developed a severe fever, injection site swelling and redness later in the day after being administered Shingrix and Capvaxive on 7/6/25 . Patient reported she was treated in emergency department on 7/6/25, since then most of her symptoms have resolved. She returned to pharmacy on 7/7/25 to report reaction, with leftover redness and swelling in injection site. More
2848767 61 F IL 07/07/2025 PNC20
TDAP
 PFIZER\WYETH
SANOFI PASTEUR

Arthralgia, Headache, Injection site pain, Musculoskeletal stiffness, Neck pain;... Arthralgia, Headache, Injection site pain, Musculoskeletal stiffness, Neck pain; Arthralgia, Headache, Injection site pain, Musculoskeletal stiffness, Neck pain More
Pain at injection site for Prevnar, spread to whole left shoulder and still neck by the next morning... Pain at injection site for Prevnar, spread to whole left shoulder and still neck by the next morning, bad headache. Neck and shoulder still very stiff and painful 4 days later More
2848768 57 F FL 07/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Circumstance or information capable of leading to medication error, Injection si... Circumstance or information capable of leading to medication error, Injection site haemorrhage More
PATIENT CAME IN FOR FIRST SHOT OF SHINGRIX ON 7/7/25 AT APPROXIMATELY 9:30AM. RECONSTITUTION WAS UNR... PATIENT CAME IN FOR FIRST SHOT OF SHINGRIX ON 7/7/25 AT APPROXIMATELY 9:30AM. RECONSTITUTION WAS UNREMARKABLE, HOWEVER, IN THE PROCESS OF ADMINISTERING THE VACCINE TO HER LEFT ARM, THE PATIENT JERKED TO THE RIGHT-- THUS REMOVING THE SHOT AFTER IT WAS INSERTED AND THE SUBSEQUENT VACCINE SQUIRTED ON HER LEFT ARM. IT APPEARS THAT AN UNDETERMINATED AMOUNT OF VACCINE ENTERED THE PATIENT'S ARM. IT CAN BE CONFIRMED THAT THE NEEDLE FROM THE SYRINGE DID BREAK SKIN AS THERE WAS A DROP OF BLOOD AT THE SITE OF INJECTION. I SUBSEQUENTLY GAVE THE PATIENT A 2ND SHOT FROM THE SAME VACCINE LOT TO THE RIGHT ARM. THIS SHOT WAS SUCCESSFUL WITH NO ISSUES. More
2848769 50 F FL 07/07/2025 HEP
VARZOS
 DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
 946063
7zm55
Induration, Skin warm, Vomiting; Induration, Skin warm, Vomiting Induration, Skin warm, Vomiting; Induration, Skin warm, Vomiting
Patient states arm is warm to the touch and hard. She reports vomiting today. I instructed her to ta... Patient states arm is warm to the touch and hard. She reports vomiting today. I instructed her to take some APAP and monitor arm to see if it seems to be getting better or not. More
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