🏥 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 💀 🏥 🚑 ♿ ⚠️
2826206 47 F CO 02/13/2025 PNC20
 PFIZER\WYETH
Erythema, Induration, Pain in extremity, Skin swelling, Skin warm Erythema, Induration, Pain in extremity, Skin swelling, Skin warm
Patient called at 7pm and reported issues with pain in arm,red hot and hard and puff spots. Requeste... Patient called at 7pm and reported issues with pain in arm,red hot and hard and puff spots. Requested pt take benadryl and ice the area. Patient will follow up with me 2/13/25 and if still irritated or unwell call dr for RX treatment More
2826207 86 M FL 02/13/2025 PNC20
 PFIZER\WYETH
 lj5283
Extra dose administered Extra dose administered
Patient did not need this vaccine as received 11/17/23 Patient did not need this vaccine as received 11/17/23
2826208 1 M FL 02/13/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Diarrhoea, Stool analysis normal, Urticaria Diarrhoea, Stool analysis normal, Urticaria
Diarrhea and hives Diarrhea and hives
2825861 F 02/12/2025 COVID19
 JANSSEN
 Unknown
Death Death
Death; This spontaneous report received from a health care professional concerned a female patient o... Death; This spontaneous report received from a health care professional concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced death. (Dose series 1). The patient died on June 2, 2024 after taking the shot. The action taken with janssen covid-19 vaccine was not applicable. It was unknown if an autopsy was performed. Reported cause of death was unknown cause of death. The patient died on 02-Jun-2024. This report was serious (death).; Sender's Comments: V0: janssen covid-19 vaccine -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: unknown cause of death More
✓
2825875 U 02/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hypocalcaemia Hypocalcaemia
Hypocalcemia; This serious case was reported by a other health professional via sales rep and descri... Hypocalcemia; This serious case was reported by a other health professional via sales rep and described the occurrence of hypocalcemia 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 hypocalcemia (Verbatim: Hypocalcemia) (serious criteria hospitalization). The outcome of the hypocalcemia was resolved. It was unknown if the reporter considered the hypocalcemia to be related to Shingrix. The company considered the hypocalcemia to be unrelated to Shingrix. Additional Information: GSK receipt date: 28-JAN-2025 Other HCP reported that patient was in hospital for Hypocalcemia from unknown date. Expiry Date of Shingrix were not known. Reporter did not know whether it was 1st or 2nd dose of Shingrix.; Sender's Comments: Hypocalcaemia is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
✓
2825876 U 02/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
both shingles and the shingles vaccine can put you in hospital; This serious case was reported by a ... both shingles and the shingles vaccine can put you in hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization 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 hospitalization (Verbatim: both shingles and the shingles vaccine can put you in hospital) (serious criteria hospitalization). The outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine. It was unknown if the company considered the hospitalization to be related to Shingles vaccine. Additional Information: GSK receipt date: 28-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that both shingles and the shingles vaccine can put you in the hospital. Patient said that he/she know from their experience, he/she took the 2 part vaccine as a preventative, also stated it was a big mistake. The follow-up could not be possible as no contact details were available.; Sender's Comments: Hospitalisation is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
✓
2825877 U 02/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Mobility decreased, Pain Mobility decreased, Pain
You can't sit, you can't lie down; it hurts to even wear clothes.; This non-serious case w... You can't sit, you can't lie down; it hurts to even wear clothes.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased 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 mobility decreased (Verbatim: You can't sit, you can't lie down) and pain (Verbatim: it hurts to even wear clothes.). The outcome of the mobility decreased and pain were not reported. It was unknown if the reporter considered the mobility decreased and pain to be related to Shingles vaccine. It was unknown if the company considered the mobility decreased and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient received Shingles vaccine and could not sit, could not lie down, it hurt to even wear clothes. This by far the worst vaccination patient ever had, however after seeing his/her mother, sister and husband live through this. There was no way patient would not keep up to date on vaccinations. More
2825878 0.17 F WV 02/12/2025 FLU3
 SANOFI PASTEUR
 UT8419CA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
inappropriate age at vaccine administration; 2-month old patient, was suppose to get VAXELIS but she... inappropriate age at vaccine administration; 2-month old patient, was suppose to get VAXELIS but she was administered FLUZONE (pf) instead with no reported adverse event; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who was suppose to get diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid [Vaxelis] but she was administered fluzone (pf) instead with no reported adverse event and inappropriate age at vaccine administration after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Feb-2025, the patient received 0.5 mL of suspect influenza usp trival a-b subvirion no preservative vaccine, Suspension for injection (lot UT8419CA, expiry date 30-Jun-2025; strength standard) via unknown route in unknown administration site for Immunization and Vaxelis not produced by Sanofi Pasteur (lot number, expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and 2-month old patient was suppose to get vaxelis but she was administered fluzone (pf) instead with no reported adverse event (wrong product administered),inappropriate age at vaccine administration (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2825914 U 02/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Deafness, Hearing aid user, Tinnitus Deafness, Hearing aid user, Tinnitus
loss of hearing; now have constant ringing in my ears; This serious case was reported by a consumer ... loss of hearing; now have constant ringing in my ears; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss 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 hearing loss (Verbatim: loss of hearing) (serious criteria GSK medically significant) and ringing in ears (Verbatim: now have constant ringing in my ears). The outcome of the hearing loss and ringing in ears were not resolved. It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingles vaccine. The company considered the hearing loss to be unrelated to Shingles vaccine. It was unknown if the company considered the ringing in ears to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-FEB-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and had severe reactions and loss of hearing. Now (at the time of reporting), the patient had constant ringing in his/her ears and require hearing aids. The patient asked to review the side effects of the vaccine. Further patient said if he/she had known about the side effects he/she might have passed on the vaccine.; Sender's Comments: Deafness is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2825915 F 02/12/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Constipation, Pain Constipation, Pain
has not pooped in 16 hours and has screamed in pain; This non-serious case was reported by a consume... has not pooped in 16 hours and has screamed in pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of constipation in a female patient who received Rotavirus vaccine for prophylaxis. On 31-MAY-2024, the patient received Rotavirus vaccine. On an unknown date, less than a day after receiving Rotavirus vaccine, the patient experienced constipation (Verbatim: has not pooped in 16 hours and has screamed in pain). The outcome of the constipation was not resolved. The reporter considered the constipation to be related to Rotavirus vaccine. The company considered the constipation to be related to Rotavirus vaccine. Additional Information: GSK Receipt Date: 04-FEB-2025 This case was reported via interactive digital media. Severe cases of rotavirus were very rare, and the prior vaccine of Rotarix had complications with intestinal blockage that it was removed from the market and put back in a couple of years later. If your child got the virus, the biggest risk was dehydration. The reporter's two cents this vaccine wasn't needed if they had access to medical care. If they were out in rural areas, the reporter would have had child get it. The reporter had friends whose babies developed the very symptoms it was supposed to prevent. The reporter chose to get it for the patient. The reporter were 50/50 on it knowing it was unnecessary but decided to do it because the side effects were pretty low and it contained no aluminum. The patient has not pooped in 16 hours and had screamed in pain for the first time (we got it the day before) from constipation. The follow-up could not be possible as no contact details were available. More
2825916 F IN 02/12/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Underdose Underdose
Patient did not receive both vials of Menveo; Patient did not receive both vials of Menveo; This non... Patient did not receive both vials of Menveo; Patient did not receive both vials of Menveo; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Patient did not receive both vials of Menveo) and inappropriate dose of vaccine administered (Verbatim: Patient did not receive both vials of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 04-FEB-2025 The Healthcare Professional reported that patient received the 1st dose of Menveo vaccine but did not received both vials. The patient received only adjuvant of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2825917 M 02/12/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes virus infection; Herpes simplex; Herpes virus infection; Herpes simplex Herpes virus infection; Herpes simplex; Herpes virus infection; Herpes simplex
I had a herpies outbreak two days later and still getting them now; This non-serious case was report... I had a herpies outbreak two days later and still getting them now; This non-serious case was reported by a consumer and described the occurrence of herpes virus infection in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 09-OCT-2024, the patient received Shingrix. In OCT-2024, 2 days after receiving Shingrix, the patient experienced herpes virus infection (Verbatim: I had a herpies outbreak two days later and still getting them now). The outcome of the herpes virus infection was not resolved. The reporter considered the herpes virus infection to be related to Shingrix. The company considered the herpes virus infection to be related to Shingrix. Additional Information: GSK Receipt Date: 06-FEB-2025 The patient had a herpes outbreak two days later and still got them now all the time. This was caused by GlaxoSmithKline vaccine More
2825918 0.17 F 02/12/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Wrong product administered Wrong product administered
2-month-old patient in ICU inadvertently given HepB (Engerix-B) alone instead of Pediarix; This non-... 2-month-old patient in ICU inadvertently given HepB (Engerix-B) alone instead of Pediarix; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 07-FEB-2025, the patient received Engerix B. On an unknown date, the patient received Pediarix. On 07-FEB-2025, an unknown time after receiving Engerix B and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: 2-month-old patient in ICU inadvertently given HepB (Engerix-B) alone instead of Pediarix). The outcome of the wrong vaccine 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: 07-FEB-2025 The pharmacist reported that the patient in intensive care unit (ICU) inadvertently given Hepatitis B (Engerix-B) alone instead of Pediarix, which led wrong vaccine administered. The reporter did not report any adverse effects and the infant was being monitored, More
2825919 F 02/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
Patient developed shingles after first dose administered; This non-serious case was reported by a nu... Patient developed shingles after first dose administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In MAY-2024, the patient received the 1st dose of Shingrix. In AUG-2024, between 2 and 4 months after receiving Shingrix, the patient experienced shingles (Verbatim: Patient developed shingles after first dose administered). The outcome of the shingles was 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: 10-FEB-2025 The nurse reported that patient developed shingles after administration of first dose of Shingrix vaccine The patient developed shingles in August 2024 before receiving second dose. More
2825920 U 02/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Supected vaccination failure; got shingles after I got the vaccination/ it was on neck and face; Thi... Supected vaccination failure; got shingles after I got the vaccination/ it was on neck and face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Supected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles after I got the vaccination/ it was on neck and face). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 2 months). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got shingles after vaccination about a month later. Patient reported that it was on neck and face. It lasted 2 long painful months. Patient ended up in the emergency room and the doctor was so excited to see it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2825921 U 02/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I had the vaccine, still got shingles; This serious case was reported... Suspected vaccination failure; I had the vaccine, still got 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine, still got 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. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-FEB-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2825922 U 02/12/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
still got sick; This non-serious case was reported by a consumer via interactive digital media and d... still got sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: still got sick). The outcome of the sickness was resolved. It was unknown if the reporter considered the sickness to be related to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 10-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got his/her shot and still got sick. Maybe not as bad and did not lasted as long. More
2825923 U 02/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
had my second dose of Shingrix yesterday and am feeling a bit achy and sore; This non-serious case w... had my second dose of Shingrix yesterday and am feeling a bit achy and sore; This non-serious case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On 30-JAN-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: had my second dose of Shingrix yesterday and am feeling a bit achy and sore). The outcome of the pain was resolved. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK receipt date: 03-FEB-2025 The patient reported that he/she had a second dose of Shingrix yesterday (day before posting) and experienced feeling a bit achy and sore but it was absolutely worth it to greatly reduce his/her risk of shingles. More
2825924 F FL 02/12/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received Twinrix dose 1 on 04-JUL-2024, dose 2 on 07-AUG-2024 but she has yet to receive dose 3; Thi... received Twinrix dose 1 on 04-JUL-2024, dose 2 on 07-AUG-2024 but she has yet to receive dose 3; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Received 1st dose of Twinrix vaccine on 04-JUL-2024.) and Twinrix (Received 2nd dose of Twinrix vaccine on 07-AUG-2024.). On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received Twinrix dose 1 on 04-JUL-2024, dose 2 on 07-AUG-2024 but she has yet to receive dose 3). 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: 13-JAN-2025 The reporter is the husband of a patient. The patient received Twinrix dose 1 on 04 July 2024 and dose 2 on 07 August 2024 but she had yet to receive dose 3 which led to incomplete course of vaccination. The reporter had mentioned at the end of the conversation that a pharmacy technician was a certified immunizer though he was not practicing currently. Did not consent to follow-up. More
2825925 19 F GA 02/12/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 XN575
Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered
received another dose of Boostrix by accident to patient 32 weeks pregnant; administered a 1st dose ... received another dose of Boostrix by accident to patient 32 weeks pregnant; administered a 1st dose of Boostrix to a pregnant; Two doses of Boostrix during pregnancy.; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 19-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number MC7HK, expiry date 25-JAN-2027) for prophylaxis. On 15-JAN-2025, the patient received the 2nd dose of Boostrix. On 02-JAN-2025, the patient received the 1st dose of Boostrix. On 15-JAN-2025, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Two doses of Boostrix during pregnancy.). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: received another dose of Boostrix by accident to patient 32 weeks pregnant) and vaccine exposure during pregnancy (Verbatim: administered a 1st dose of Boostrix to a pregnant). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing 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: 15-JAN-2025 The reporter informed that they administered a dose of Boostrix to a pregnant patient and same patient received another dose of Boostrix by accident, which led vaccine exposure during pregnancy and extra dose administered. Reporter mentioned patient was 32 weeks pregnant when she received the 2nd dose of Boostrix. The reporter consented to follow up More
2825926 U WA 02/12/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not come back to receive the third dose; This non-serious case was reported by a pharmacist via ... did not come back to receive the third 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 patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (2nd dose in September 2024). On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: did not come back to receive the third 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: 15-JAN-2025 The patient received first dose and second dose of Twinrix on time according to accelerated schedule (0, 7 days, 21 to 30 days, and 12 months), but they did not come back to receive the third dose that supposed to be given in October 2024, and it was January 2025 now. Till the time of reporting the patient had not received the third dose of Twinrix, which led to incomplete course of vaccination. The reporter did not had any patient demographics, and did not know why it was indicated for this patient to have an accelerated schedule. The reporter did not consent to follow-up. More
2825927 F NY 02/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
but has not received the second dose yet; This non-serious case was reported by a pharmacist via cal... but has not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose over one year ago). 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: but has not received the second dose yet). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 30-JAN-2025 The pharmacist reported that a patient received the first dose of Shingrix over one year ago but has not received the second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination More
2825928 53 F MI 02/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X5T42
Erythema, Product administered at inappropriate site, Skin irritation Erythema, Product administered at inappropriate site, Skin irritation
irritation; redness in her left arm; vaccine was given in a site close to the elbow instead of the l... irritation; redness in her left arm; vaccine was given in a site close to the elbow instead of the left deltoid; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of skin irritation in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number X5T42) for prophylaxis. On 31-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 31-JAN-2025, less than a day after receiving Shingrix, the patient experienced skin irritation (Verbatim: irritation), erythema of extremities (Verbatim: redness in her left arm) and vaccine administered at inappropriate site (Verbatim: vaccine was given in a site close to the elbow instead of the left deltoid). The outcome of the skin irritation and erythema of extremities were not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the skin irritation and erythema of extremities to be related to Shingrix. It was unknown if the company considered the skin irritation and erythema of extremities to be related to Shingrix. Additional Information: GSK Receipt Date: 15-JAN-2025 The pharmacist is the reporter who stated a patient received her first Shingrix vaccine 31-JAN-2025. Patient called with irritation, redness in her left arm. HCP noticed the vaccine was given in a site close to the elbow instead of the left deltoid, which led to vaccine administered at inappropriate site. This case is linked with case US2020238768 by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020238768:same reporter More
2825929 U NY 02/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
past the 6-month timeframe for the 2nd Shingrix dose.; This non-serious case was reported by a pharm... past the 6-month timeframe for the 2nd Shingrix 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 patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose on an unknown date). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: past the 6-month timeframe for the 2nd Shingrix dose.). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 04-FEB-2025 The pharmacist enquired, If it has been more than 6 months does the series need to be restarted for Shingrix vaccine. The pharmacist confirmed with the Health Care Professional that the patient was past the 6-month timeframe for the 2nd dose of Shingrix. The Vaccine Administration Facility is the same as Primary Reporter. As the patient did not receive the second dose of vaccine within the recommended timeframe, which led to incomplete course of vaccination More
2825930 F IL 02/12/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Decubitus ulcer, Depression, Gait disturbance, Guillain-Barre syndrome, Immunogl... Decubitus ulcer, Depression, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy; Limb discomfort, Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal disorder, Walking aid user More
Depression; diagnosed with Guillain-Barre Syndrome; acquired a stage III decubitus ulcer on her cocc... Depression; diagnosed with Guillain-Barre Syndrome; acquired a stage III decubitus ulcer on her coccyx; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. In JAN-2024, the patient received Arexvy (intramuscular). In FEB-2024, 2 weeks after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: diagnosed with Guillain-Barre Syndrome) (serious criteria hospitalization, disability, GSK medically significant and life threatening). On an unknown date, the patient experienced decubitus ulcer (Verbatim: acquired a stage III decubitus ulcer on her coccyx) (serious criteria disability and life threatening) and depression (Verbatim: Depression) (serious criteria hospitalization, disability and life threatening). The outcome of the guillain barre syndrome and depression were not resolved and the outcome of the decubitus ulcer was unknown. The reporter considered the guillain barre syndrome to be related to Arexvy. It was unknown if the reporter considered the decubitus ulcer and depression to be related to Arexvy. The company considered the guillain barre syndrome, decubitus ulcer and depression to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter was the daughter of the elderly patient. Before this incident, the patient was lived independently, driving, walking, cooking and performing all activities of daily living independently. The patient received her Arexvy vaccination in late January 2024, the daughter stated it was between January 29 and 31, 2024. Beginning 2 to 3 weeks later, she began had weakness in her legs. In mid-March 2024 she was struggled to walk and was struggled at home alone. By 25-MAR-2024 she was used a walker, and her right leg froze up. The report was that one day her legs felt heavy then the followed day one leg was slightly improved, but the other leg could not be moved, no matter how hard she tried. After many weeks of attempted to receive the correct diagnostic testing, she was diagnosed with Guillain-Barre Syndrome. She was hospitalized for several days, receiving IVIG treatment, and then discharged to a nursing home for physical rehabilitation. She was discharged to an Assisted Living Facility after not making progress in rehab. While in rehab, she acquired a stage III decubitus ulcer on her coccyx. The daughter was seeking some sort of financial relief due to this incident. She stated that her mother went from independent living to hospital to nursing home and now assisted living. She had spent half her savings in the past few months. Her monthly rent had gone from 1500 dollar to over 6000 dollars due to the loss of her independence. The incident had completely overturned the patient's life and that of the daughter, who was her primary caregiver and Power of Attorney. This had not yet been reported to VAERS, as the daughter was still gathering documentation needed for that report. She had contacted a friend in a legal office and was awaiting contact from an attorney. At the time of this report, she did not have the handout received from the pharmacy. Under the call note it was reported retiring in June 2025 and please contact before June 2025.; Sender's Comments: Guillain-Barre syndrome, Decubitus ulcer and Depression are unlisted events which are considered unrelated to GSK vaccine Arexvy. More
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2825931 73 F 02/12/2025 COVID19-2
 MODERNA
 AS7162B
Asthma, Liver disorder, Pneumonia, Respiratory syncytial virus infection Asthma, Liver disorder, Pneumonia, Respiratory syncytial virus infection
developed pneumonia; Asthma; liver problems; developed RSV; This spontaneous case was reported by a ... developed pneumonia; Asthma; liver problems; developed RSV; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (developed pneumonia) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (developed pneumonia) (seriousness criterion medically significant), ASTHMA (Asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV). At the time of the report, PNEUMONIA (developed pneumonia) had not resolved and ASTHMA (Asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV) outcome was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medication was reported. This case was linked to MOD-2025-782184 (Patient Link). Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2825932 77 F NY 02/12/2025 COVID19
COVID19
FLUX
FLUX
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



COVID-19, Circulatory collapse, Heart rate, Hypotension, Memory impairment; Musc... COVID-19, Circulatory collapse, Heart rate, Hypotension, Memory impairment; Muscular weakness, Pain; COVID-19, Circulatory collapse, Heart rate, Hypotension, Memory impairment; Muscular weakness, Pain More
all of a sudden, my legs gave out and I collapsed; COVID-19; usual soreness and all that stuff; I�... all of a sudden, my legs gave out and I collapsed; COVID-19; usual soreness and all that stuff; I'm not gonna remember everything you said; feel the weakness in the back of my legs; maybe I fainted because my pressure must have went down; This spontaneous case was reported by a patient and describes the occurrence of CIRCULATORY COLLAPSE (all of a sudden, my legs gave out and I collapsed) and COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Mobility decreased (bad mobility with my legs) and Pacemaker insertion (cardiac) (Cardiac pacemaker insertion) on 15-Apr-2024. Concurrent medical conditions included Diabetic and Blood pressure high. On 13-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Influenza vaccine (Flu) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CIRCULATORY COLLAPSE (all of a sudden, my legs gave out and I collapsed) (seriousness criteria medically significant and life threatening), COVID-19 (COVID-19) (seriousness criterion life threatening), PAIN (usual soreness and all that stuff), MEMORY IMPAIRMENT (I'm not gonna remember everything you said), MUSCULAR WEAKNESS (feel the weakness in the back of my legs) and HYPOTENSION (maybe I fainted because my pressure must have went down). The patient was treated with Amlodipine besilate, Benazepril hydrochloride (Amlodipine and benazepril hydrochloride) at an unspecified dose and frequency and Metoprolol tartrate at a dose of 25 milligram twice a day. At the time of the report, CIRCULATORY COLLAPSE (all of a sudden, my legs gave out and I collapsed), COVID-19 (COVID-19), PAIN (usual soreness and all that stuff), MEMORY IMPAIRMENT (I'm not gonna remember everything you said), MUSCULAR WEAKNESS (feel the weakness in the back of my legs) and HYPOTENSION (maybe I fainted because my pressure must have went down) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 89 (units not specified). The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient was on cardiac medication. The patient used shopping cart as walker. The patient walked up one of the blocks, all of a sudden, the back of her legs felt very weak. She got home, when she got up 3 blocks up, it's an up block and it's a sloping block and it was and pushed herself and determined to get home. The patient was collapsed, got up right away. It wasn't that knocked out or unconscious, got up from the floor on her own, sat down and rested, but was awake and waited and felt little better. Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2025: Significant live follow up received included. Additional event of COVID-19 was added. On 10-Feb-2025: Non-significant follow up received included: Reference number was added.; Reporter's Comments: Co-suspect product Influenza vaccine and Covid-19 disease are confounders for all events; past medical history of Pacemaker insertion, Concurrent medical conditions included Diabetic and Blood pressure high are confounders for events hypotension and circulatory collapse; past medical history of Mobility decreased and age are confounders for muscular weakness event. The benefit -risk relationship of product is not affected by this report. More
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2825933 F 02/12/2025 COVID19
 MODERNA
Decreased appetite, Dizziness, Fatigue Decreased appetite, Dizziness, Fatigue
loss of appetite; dizziness; fatigue; This spontaneous case was reported by a non-health professiona... loss of appetite; dizziness; fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of DECREASED APPETITE (loss of appetite), DIZZINESS (dizziness) and FATIGUE (fatigue) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, DECREASED APPETITE (loss of appetite), DIZZINESS (dizziness) and FATIGUE (fatigue) was resolving. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. More
2825934 F 02/12/2025 COVID19
 PFIZER\BIONTECH
Asthma, Hot flush, Vaccination site pain Asthma, Hot flush, Vaccination site pain
Asthma flare; experiencing hot flashes during the first injection of the medication; used the pen, i... Asthma flare; experiencing hot flashes during the first injection of the medication; used the pen, it hurts; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2023SA276982 (SANOFI), AE-017842 (LLP-BioNTech SE). This case Involves a 72-years- old female patient who experienced hot flashes during the first Injection of the medication, flare and used the pen, it hurts, and the medication did not enter her body, it spilled all over the floor while being treated with dupilumab [Dupixent) delivered via dupilumab single dose pre-filled pen and Covid-19 vaccine. The patient's past medical treatment(s), concomitant medication(s), vaccination(s), family history and any additional medical history, concomitant disease or risk factor were not provided. Concomitant medications included buspirone hydrochloride (Buspar); and venlafaxine hydrochloride (Effexor). On an unknown date, the patient started taking dupilumab solution for Injection at a dose of 300 mg every other week subcutaneously (Strength: 300mg/2mL, with an unknown batch number and expiry date) via dupilumab single dose pre-filled pen for Severe persistent asthma, uncomplicated. On an unknown date, the patient started taking covtd-19 vaccine (with an unknown strength, formulation, dose, frequency, route, batch number and expiry date) for Covid-19 vaccination. Product used for first time: No. On an unknown date the patient developed a non-serious event "experiencing hot flashes during the first Injection of the medication" (Hot flush) (unknown batch and expiry date) (latency: unknown) (unknown batch and expiry date) following the first dose Intake of dupilumab and (unknown latency) following the first dose intake of covtd-19 vaccine. On an unknown date the patient developed a non-serious event "flare" (Asthma) (latency: unknown) (unknown batch and expiry date) following the first dose intake of dupilumab and (unknown latency) (unknown batch and expiry date) following the first dose Intake of covtd-19 vaccine. On an unknown date the patient developed a non-serious event "used the pen, it hurts and the medication did not enter her body, it spilled all over the floor" (Injection sue pain) (latency: unknown)(lot-4F462A and expiry- 30 April 2026) following the first dose intake of dupilumab and (unknown latency)(unknown batch and expiry date) following the first dose Intake of covtd-19 vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "experiencing hot flashes during the first Injection of the medication. Patient states that the hot flashes would last around 24-48 hours, however "she didn't care that she was experiencing hot flashes, the drug is a miracle drug!" Patient reports no longer taking Effexor, as it was replaced by Buspar. Upon follow-up caller reported she received the covid vaccine which caused a flare. Has been on prednisone since 11/22. She is doing well now, and asthma almost completely controlled. It was unknown if the patient experienced any additional symptoms/events. It was unknown If there were lab data/results available. The patient stated that her pen did not work as it was dull. The patient further stated, "I used it and it hurts and the medication did not enter my body, it spilled all over the floor." The patient Is unaware If any part of her body was exposed to the medication. The pen is available for return and patient will be expecting to receive a prepaid mailer. Action taken with dupilumab (Dupixent) was continued for Injection site pain and unknown for Asthma, Hot flush. Action taken with covid-19 vaccine was not applicable for all the events. Corrective: The patient was treated with prednisone for the event (asthma) and not reported for rest of the events. Outcome: Recovering for the event (asthma) and unknown for the rest of the events. Additional information was received on 01Dec2023 from the patient via specialty pharmacy: new event (asthma), new suspect, indication and corrective drug added. Corresponding fields and narrative amended accordingly. Additional information was received on 10Jan2025 from the patient. New event: Injection site pain was added. Action taken updated. Clinical course updated and text amended accordingly. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2825935 F TX 02/12/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID after Vaccine; COVID after Vaccine; This is a spontaneous report received from a Consumer or o... COVID after Vaccine; COVID after Vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 64-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. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Vaccine". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID. The patient was coughing. The patient got the original two and then got a booster and a booster. The patient haven't gotten one this year, but patient got some of the vaccinations. Patient was not unvaccinated. More
2825936 M 02/12/2025 COVID19
 PFIZER\BIONTECH
Alopecia, Condition aggravated Alopecia, Condition aggravated
after receiving the COVID vaccine he noticed his hair loss became much more rapid; after receiving t... after receiving the COVID vaccine he noticed his hair loss became much more rapid; after receiving the COVID vaccine he noticed his hair loss became much more rapid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "after receiving the COVID vaccine he noticed his hair loss became much more rapid". Additional information: Patient was noticing hair loss due to alopecia, after receiving the COVID vaccine he noticed his hair loss became much more rapid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2825937 F 02/12/2025 COVID19
 PFIZER\BIONTECH
Hypersensitivity Hypersensitivity
allergic reaction after it was administer; This is a spontaneous report received from a Consumer or ... allergic reaction after it was administer; 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction after it was administer". Additional information: she was trying to report an allergic reaction after it was administer. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2825938 1.08 F MI 02/12/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7921AA
Febrile convulsion, Generalised tonic-clonic seizure, Lethargy, Vomiting project... Febrile convulsion, Generalised tonic-clonic seizure, Lethargy, Vomiting projectile More
Febrile seizure occurred approximately 12 hours after vaccine administration, described by mother as... Febrile seizure occurred approximately 12 hours after vaccine administration, described by mother as generalized tonic-clonic followed by projectile vomiting and lethargy. Temp in ED noted to be 102.7F rectal. More
2825939 77 M PA 02/12/2025 COVID19
 MODERNA
Abdominal discomfort, Chills, Malaise, Nausea, Pain in extremity Abdominal discomfort, Chills, Malaise, Nausea, Pain in extremity
Patient phoned clinic on 2/7/25 informing office of not feeling well, arms still feels achy, has som... Patient phoned clinic on 2/7/25 informing office of not feeling well, arms still feels achy, has some chills, taking tylenol PRN. Phoned office 2/10/25 complaining of nervous stomach issues, gurgling and jumpiness, nausea. More
2825940 53 M VA 02/12/2025 COVID19
 JANSSEN
 202A21A
Dyspnoea, Heart rate increased Dyspnoea, Heart rate increased
Rapid heart, high resting heart rate, difficulty breathing Rapid heart, high resting heart rate, difficulty breathing
2825941 54 F OH 02/12/2025 FLU3
PNC20
 SEQIRUS, INC.
PFIZER\WYETH
 946626
HG7740
Erythema, Pain in extremity, Peripheral swelling, Pruritus; Erythema, Pain in ex... Erythema, Pain in extremity, Peripheral swelling, Pruritus; Erythema, Pain in extremity, Peripheral swelling, Pruritus More
Patient received Prevnar-20 on 2/5/25. She came to the pharmacy on 2/10/25 to show me her arm which ... Patient received Prevnar-20 on 2/5/25. She came to the pharmacy on 2/10/25 to show me her arm which was red and swollen. She stated she had slight pain on the day she received the vaccine and 3 days later her right arm became itchy and had a raised area. On 2/9/25 redness appeared. I did inform patient that a swollen, red are may be a side effect of the Prevnar-20 vaccine, but if she was concerned she could visit her family physician or urgent care. She told me she was going to ice today and see if it improves and will call us back. I called patient back on 2/12/25 and she stated she may go to the doctor tomorrow - not completely resolved. More
2825942 26 F NY 02/12/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 LE1811
LE1811
LE1811
LE1811
Injection site bruising, Injection site discharge, Injection site reaction, Inje... Injection site bruising, Injection site discharge, Injection site reaction, Injection site swelling, Injection site warmth; Rash pruritic; Injection site bruising, Injection site discharge, Injection site reaction, Injection site swelling, Injection site warmth; Rash pruritic More
My left arm got really swollen warm to touch and bruised with a bumpy itchy rash with secretions on ... My left arm got really swollen warm to touch and bruised with a bumpy itchy rash with secretions on top of injection site which led me to visit my PCP. In which he recommend me not to get any more covid vaccinations due to life threatening reaction. More
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2825943 42 F KS 02/12/2025 MMR
 MERCK & CO. INC.
Infection, Injected limb mobility decreased, Injection site bruising, Injection ... Infection, Injected limb mobility decreased, Injection site bruising, Injection site mass, Injection site pain More
Pain, knot of right arm in area of the vaccine taken, bruising, difficult to do range of motion beca... Pain, knot of right arm in area of the vaccine taken, bruising, difficult to do range of motion because of pain. I have been icing and massages. More
2825944 79 M MO 02/12/2025 COVID19
 PFIZER\BIONTECH
 lm2222
Pain in extremity Pain in extremity
Patient states that vaccine, hurt when administered and is still having intermittent pain in arm, mo... Patient states that vaccine, hurt when administered and is still having intermittent pain in arm, mostly when he lays on the arm More
2825945 56 F NC 02/12/2025 PNC21
 MERCK & CO. INC.
 Y013009
Axillary pain, Breast pain, Oedema peripheral Axillary pain, Breast pain, Oedema peripheral
Patient states that starting the day of vaccination she has been experiencing swelling and pain in h... Patient states that starting the day of vaccination she has been experiencing swelling and pain in her axilla and breast. More
2825946 0.17 M MN 02/12/2025 DTAPHEPBIP
PNC13
RV5
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.


Apnoea, Hypotonia, Respiratory arrest; Apnoea, Hypotonia, Respiratory arrest; Ap... Apnoea, Hypotonia, Respiratory arrest; Apnoea, Hypotonia, Respiratory arrest; Apnoea, Hypotonia, Respiratory arrest More
SIDS episode four days later. I found him limp, lifeless, and not breathing. After some stimulation ... SIDS episode four days later. I found him limp, lifeless, and not breathing. After some stimulation he began breathing normal again. Hospital charted it as an apnea episode More
2825947 16 M NY 02/12/2025 MNQ
 SANOFI PASTEUR
 U8369BA
Abdominal pain upper, Disorientation, Nausea, Vomiting Abdominal pain upper, Disorientation, Nausea, Vomiting
Vaccine given at 2/11/2025 at 2:49 pm. Patient's mother called on-call Doctor around 2/11/2025 ... Vaccine given at 2/11/2025 at 2:49 pm. Patient's mother called on-call Doctor around 2/11/2025 at around 6pm for concerning symptoms including nausea, stomach cramps, vomiting, and disorientation. On call Doctor advised emergency care. On 2/12/2025 at 8:15am, RN called for follow up, mother stated that the disorientation and vomiting had subsided and was only having some nausea and stomach cramping. Mother stated that they decided to not seek care, against the advice of staff. More
2825948 0.33 F GA 02/12/2025 DTPPVHBHPB
DTPPVHBHPB
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
 U7767AA
U7767AA
Chest X-ray normal, Cyanosis, Electrocardiogram, Laboratory test, Musculoskeleta... Chest X-ray normal, Cyanosis, Electrocardiogram, Laboratory test, Musculoskeletal stiffness; Respiratory arrest More
10:30 p, pt stopped breathing for 4 min, stiff and blue, called 911 tilted chin back and she started... 10:30 p, pt stopped breathing for 4 min, stiff and blue, called 911 tilted chin back and she started to respond to breathing. 911 can and checked on her offered ED. pt did not go to the ED, episode lasted 4 mins. More
2825949 75 F 02/12/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255t2
Extra dose administered Extra dose administered
duplicate vaccine... also received in Octo bet 2024 duplicate vaccine... also received in Octo bet 2024
2825950 17 M MD 02/12/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 G334J
G334J
Chills, Eye pain, Influenza A virus test negative, Influenza B virus test negati... Chills, Eye pain, Influenza A virus test negative, Influenza B virus test negative, Injection site pain; Photophobia, Poor quality sleep, Pyrexia, Respiratory pathogen panel, Streptococcus test negative More
Fever, chills, pain behind eyes, light sensitivity, restless sleep due to pain at the vaccine site. Fever, chills, pain behind eyes, light sensitivity, restless sleep due to pain at the vaccine site.
2825951 57 F PR 02/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4h79y
Injection site erythema, Injection site swelling, Pyrexia Injection site erythema, Injection site swelling, Pyrexia
swelling and redness on the application site, fever swelling and redness on the application site, fever
2825952 77 F PA 02/12/2025 FLU3
 SANOFI PASTEUR
 U8524BA
Extra dose administered, No adverse event Extra dose administered, No adverse event
No Adverse events occurred. Patient received two doses of Fluzone HD. First Immunization given 10-9... No Adverse events occurred. Patient received two doses of Fluzone HD. First Immunization given 10-9-25 and 2nd immunization given 12-18-25. Patient had no side effects or adverse events. More
2825953 82 M PA 02/12/2025 FLU3
 SANOFI PASTEUR
 U8524BA
Extra dose administered, No adverse event Extra dose administered, No adverse event
No Adverse events occurred. Patient received two doses of Fluzone HD. First Immunization given 10-9... No Adverse events occurred. Patient received two doses of Fluzone HD. First Immunization given 10-9-25 and 2nd immunization given 12-18-25. Patient had no side effects or adverse events. More
2825954 27 F 02/12/2025 ANTH
 EMERGENT BIOSOLUTIONS
 300211A
Injection site cellulitis, Pyrexia Injection site cellulitis, Pyrexia
Patient presented on day 7 after vaccine, having first developed symptoms on day 5 after vaccine. S... Patient presented on day 7 after vaccine, having first developed symptoms on day 5 after vaccine. She was diagnosed with nonpurulent cellulitis at the vaccine site, with induration of approximately 8.5cm x 10cm. She did not have systemic symptoms, including fever. She was prescribed Keflex. More
2825955 16 M MN 02/12/2025 HEP
IPV
MMR
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
 47D3S
W1C751M
X018902
Balance disorder, Dizziness, Pallor, Syncope; Balance disorder, Dizziness, Pallo... Balance disorder, Dizziness, Pallor, Syncope; Balance disorder, Dizziness, Pallor, Syncope; Balance disorder, Dizziness, Pallor, Syncope More
Vaccine appointment, review eligibility, contraindications and VIS. Vaccine preparation, administrat... Vaccine appointment, review eligibility, contraindications and VIS. Vaccine preparation, administration and documentation. Scanned files into nightingale notes. Administered Hep B, without apparent reactions. Administered MMR and patient appeared pale and unsteady. He was able to stand and change sides without apparent difficulties. Administered Polio vaccine and placed band aid, patient appeared to faint, eyes remained open but slid off chair, forward onto knees. Guardian and writer were able to hold him steady with no apparent injuries. He was able to state name, birthday and reported feeling dizzy/lightheaded. Remained sitting on the floor, asked for water. Writer called (co worker) for additional support. Patient was able to stand and sit in chair. Vitals taken 98% O2, 74 P, 16RR and 118/68 BP. Remained with patient for 30 min, appeared comfortable and left for home. To call as needed. More
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