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
2826337 1 F CO 02/14/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X4T99
Wrong product administered Wrong product administered
Menveo was administered instead of MMR; This non-serious case was reported by a other health profess... Menveo was administered instead of MMR; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis. Co-suspect products included MMR (MMR vaccine) for prophylaxis. On 16-JAN-2025, the patient received Menveo. On an unknown date, the patient received MMR vaccine. On 16-JAN-2025, an unknown time after receiving Menveo and not applicable after receiving MMR vaccine, the patient experienced wrong vaccine administered (Verbatim: Menveo was administered instead of MMR). The outcome of the wrong vaccine administered was unknown. Additional Information: GSK Receipt Date: 16-JAN-2025 The reporter reported that a patient received Menveo 1 vial was administered to a baby who was 12 months, 5 days old instead of measles vaccine, mumps vaccine, rubella vaccine which led to wrong vaccine administered. More
2826338 F 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fear, Nausea Fear, Nausea
feeling very ill; feeling nauseous; This non-serious case was reported by a consumer via call center... feeling very ill; feeling nauseous; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-JAN-2025, the patient received the 1st dose of Shingrix. On 03-JAN-2025, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: feeling nauseous). On 07-JAN-2025, the patient experienced feeling unwell (Verbatim: feeling very ill). The outcome of the feeling unwell and nausea were not reported. It was unknown if the reporter considered the feeling unwell and nausea to be related to Shingrix. It was unknown if the company considered the feeling unwell and nausea to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that she was feeling very ill 4 days afterwards she received a first dose of Shingrix. She was feeling nauseous 4 hours after the shot, woke up in the middle of the night. Also said her physician was concerned of whether or not to receive the second shot, need some guidance on this topic. More
2826339 0.17 F MD 02/14/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 HP495
Immediate post-injection reaction, Underdose, Vomiting projectile Immediate post-injection reaction, Underdose, Vomiting projectile
patient projectile vomited immediately after giving it to her; Accidental underdose; This non-seriou... patient projectile vomited immediately after giving it to her; Accidental underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of vomiting projectile in a 2-month-old female patient who received Rota (Rotarix liquid formulation) (batch number HP495, expiry date 17-MAY-2026) for prophylaxis. On 17-JAN-2025, the patient received Rotarix liquid formulation. On 17-JAN-2025, immediately after receiving Rotarix liquid formulation, the patient experienced vomiting projectile (Verbatim: patient projectile vomited immediately after giving it to her) and accidental underdose (Verbatim: Accidental underdose). The outcome of the vomiting projectile and accidental underdose were unknown. It was unknown if the reporter considered the vomiting projectile to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the vomiting projectile to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-JAN-2025 The registered nurse stated they attempted to administer Rotarix to 2 month old and the patient projectile vomited immediately after giving it to her which led to Accidental underdose. The vaccine administration facility is the same as primary reporter. More
2826340 51 F NY 02/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Diarrhoea, Fatigue, Immediate post-injection reaction, Injection site erythema, ... Diarrhoea, Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site swelling; Muscular weakness, Nausea, Pyrexia, Retinal oedema, Weight decreased More
Fatigue; Nausea; weight loss; muscle weakness; diarrhea; swollen retina both eyes; Redness at inject... Fatigue; Nausea; weight loss; muscle weakness; diarrhea; swollen retina both eyes; Redness at injection site; Swelling at injection site; Fever; This serious case was reported by a other health professional via call center representative and described the occurrence of swelling of retina in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 07-JAN-2025, immediately after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site) and injection site swelling (Verbatim: Swelling at injection site). On 08-JAN-2025, the patient experienced swelling of retina (Verbatim: swollen retina both eyes) (serious criteria GSK medically significant) and fever (Verbatim: Fever). On 09-JAN-2025, the patient experienced fatigue (Verbatim: Fatigue). In JAN-2025, the patient experienced nausea (Verbatim: Nausea), weight loss (Verbatim: weight loss), muscle weakness (Verbatim: muscle weakness) and diarrhea (Verbatim: diarrhea). The outcome of the swelling of retina was resolved (duration 5 days) and the outcome of the injection site erythema and injection site swelling were resolved (duration 1 week) and the outcome of the fever was resolved (duration 2 days) and the outcome of the fatigue, nausea and weight loss were not resolved and the outcome of the muscle weakness and diarrhea were not reported. It was unknown if the reporter considered the swelling of retina, injection site erythema, injection site swelling, fever, fatigue, nausea, weight loss, muscle weakness and diarrhea to be related to Shingrix. The company considered the swelling of retina to be unrelated to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, fever, fatigue, nausea, weight loss, muscle weakness and diarrhea to be related to Shingrix. Additional Information: GSK receipt date: 30-JAN-2025 and 31-JAN-2025 The patient was an HCP (health care professional) and self-reported this case for herself. The reporter reported that she received Shingrix vaccine and experienced redness and swelling at the injection site that occurred immediately after the injection and lasted for a week in JAN-2025. The reporter reported that fever that occurred one day after injection that lasted two days and then resolved in JAN-2025. She had swollen retinas that occurred one day after injection that lasted 5 days and then resolved in JAN-2025. She reported that that she experienced fatigue that occurred 2 days after injection that was currently ongoing and had not resolved, nausea that occurred 9 days after injection that was still ongoing and had not resolved. The patient experienced weight loss that she noticed 3 weeks after the injection and had not resolved. The reporter did not have lot number or any identifying information for the vaccine. The reporter mentioned that nurse she spoke to was very kind, thorough, and she provided the information that was within her reach to help with some of the questions that she had. However, specific questions she had regarding side effects of the Guillain barre syndrome and how long it takes, were not provided to me because she was not allowed to give this information to a patient. She found this unacceptable she worked in the medical field. She worked with pharmaceutical companies, and she report side effects to the FDA, and she should have access to this information as a patient. The reporter mentioned that she had symptoms of muscle weakness, fatigue, nausea, diarrhea, among others and she was very concerned because it had been three weeks since her shot, and no one could provide information to her that was specific enough. The reporter reported that she was terrified, and she need information.; Sender's Comments: Retinal oedema is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2826341 M CO 02/14/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X4T99
Extra dose administered Extra dose administered
patient administered a second dose of Menveo; This non-serious case was reported by a other health p... patient administered a second dose of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis. Previously administered products included Menveo (received 1st dose on 20-SEP-2022). On 31-JAN-2025, the patient received the 2nd dose of Menveo. On 31-JAN-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: patient administered a second dose of Menveo). The outcome of the extra dose administered was unknown. Additional Information: GSK receipt date: 31-JAN-2025 The medical assistant reported that they administered a second dose of Menveo which led to, extra dose administered. The reporter wanted to know advise/safety concerns about this situation. The vaccination date, vaccine detail and patient demographics were obtained from the medical assistant๏ฟฝs end. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2826342 F MI 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Anxiety, Asthenia, Blood pressure increased, Pruritus Anxiety, Asthenia, Blood pressure increased, Pruritus
severe weakness; Anxiety; she experienced increased blood pressure; pressure in her head; itching on... severe weakness; Anxiety; she experienced increased blood pressure; pressure in her head; itching on her left arm and left leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In FEB-2025, the patient received the 1st dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: severe weakness), anxiety (Verbatim: Anxiety), increased blood pressure (Verbatim: she experienced increased blood pressure), head pressure (Verbatim: pressure in her head) and pruritus (Verbatim: itching on her left arm and left leg). The outcome of the weakness, anxiety, increased blood pressure, head pressure and pruritus were unknown. It was unknown if the reporter considered the weakness, anxiety, increased blood pressure, head pressure and pruritus to be related to Shingrix. It was unknown if the company considered the weakness, anxiety, increased blood pressure, head pressure and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 07-FEB-2025 The patient who received her first dose of Shingrix vaccine 2 days prior to the reporting date and after the dose, she experienced increased blood pressure, anxiety, itching on her left arm and left leg, pressure in her head and severe weakness. More
2826343 F WI 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Anaphylactic reaction, Endotracheal intubation Anaphylactic reaction, Endotracheal intubation
anaphylaxis; intubated; This serious case was reported by a other health professional via call cente... anaphylaxis; intubated; This serious case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included shellfish allergy. Concomitant products included lisinopril. On 04-FEB-2025, the patient did not received the 2nd dose of Shingrix (left arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced anaphylaxis (Verbatim: anaphylaxis) (serious criteria hospitalization, GSK medically significant, life threatening and clinically significant/intervention required) and intubation (Verbatim: intubated) (serious criteria hospitalization, life threatening and clinically significant/intervention required). The outcome of the anaphylaxis and intubation were not resolved. It was unknown if the reporter considered the anaphylaxis and intubation to be related to Shingrix. The company considered the anaphylaxis and intubation to be unrelated to Shingrix. Additional Information: GSK Receipt Date:10-FEB-2025 Other Healthcare Professional reported that the patient took Shingrix vaccine and experienced anaphylaxis and intubated. The reporter did not consent to follow-up.; Sender's Comments: Anaphylactic reaction is a listed event which, due to the following criteria (concurrent shellfish allergy, insufficient information regarding medical history, completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Endotracheal intubation is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
โœ“ โœ“
2826344 U PA 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site pain, Malaise Injection site pain, Malaise
Shingrix - sore arm at injection site; Patient felt sick for 24 hours after first dose; This non-ser... Shingrix - sore arm at injection site; Patient felt sick for 24 hours after first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Shingrix - sore arm at injection site) and sickness (Verbatim: Patient felt sick for 24 hours after first dose). The outcome of the injection site pain was unknown and the outcome of the sickness was resolved (duration 24 hrs). It was unknown if the reporter considered the injection site pain and sickness to be related to Shingrix. It was unknown if the company considered the injection site pain and sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-FEB-2025 The physician reported that a patient had extremely sore arm at injection site after first dose of Shingrix and felt sick for 24 hours. They want to know if patient should still get the second dose of Shingrix. More
2826345 64 M OH 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7zm55
Product preparation issue Product preparation issue
administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into li... administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid; administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7zm55, expiry date 15-NOV-2026) for prophylaxis. On 11-FEB-2025, the patient received Shingrix. On 11-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid) and inappropriate dose of vaccine administered (Verbatim: administered 2 adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK receipt date: 12-FEB-2025 The LPN (Licensed practical nurses) reported that day before reporting that the MA(Medical assistant) administered two adjuvants (1ml total) to a patient and did not put powder (antigen) component into liquid which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2826346 F MO 02/14/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 11 months old female patient received a dose of Kinrix.; This non-serious case was reported by a n... A 11 months old female patient received a dose of Kinrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 11 months old female patient received a dose of Kinrix.). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-FEB-2025 The nurse reported that they administered a dose of Kinrix to a 11 months old female patient which was intended to get DTaP and IPV, which led to inappropriate age at vaccine administration. The reporter ask was there any documentation regarding this. More
2826347 U TX 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
received the Shingrix active ingredient or just the diluent; received the Shingrix active ingredient... received the Shingrix active ingredient or just the diluent; received the Shingrix active ingredient or just the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: received the Shingrix active ingredient or just the diluent) and inappropriate dose of vaccine administered (Verbatim: received the Shingrix active ingredient or just the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 12-FEB-2025 The pharmacist contacted via chat on February 12th 2025 and mentioned that they had an incident where they do not know if a patient received the Shingrix active ingredient or just the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Chat was suddenly interrupted before agent could ask for additional details on the case. More
2826348 M 02/14/2025 COVID19
 JANSSEN
Guillain-Barre syndrome Guillain-Barre syndrome
Guillain-Barre syndrome; This spontaneous report received from a patient concerned a male patient of... Guillain-Barre syndrome; This spontaneous report received from a patient concerned a male patient of unspecified age. Received via J and J managed social media. 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, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced guillain-barre syndrome. (dose series 1) Now the patient have very weak muscles and now paralyzed. The action taken with janssen covid-19 vaccine was not applicable. The outcome of guillain-barre syndrome was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: janssen covid-19 vaccine -Guillain-Barre syndrome. This event(s) is labeled per RA and is therefore considered potentially related. More
2826349 70 M 02/14/2025 COVID19
 MODERNA
Aortic aneurysm, Atrial fibrillation, COVID-19 Aortic aneurysm, Atrial fibrillation, COVID-19
he had after being vaccinated started to have weird heart issue and found out afib and aortic aneury... he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm; he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm; COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIAL FIBRILLATION (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) (seriousness criterion medically significant), AORTIC ANEURYSM (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) and COVID-19 (COVID-19). At the time of the report, ATRIAL FIBRILLATION (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm), AORTIC ANEURYSM (he had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm) and COVID-19 (COVID-19) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Patient was in his 70s. No concomitant medication was reported. Patient had after being vaccinated started to have weird heart issue and found out afib and aortic aneurysm. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-782162, US-MODERNATX, INC.-MOD-2025-782163 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-782163:Patient US-MODERNATX, INC.-MOD-2025-782162:Patient's Aunt More
2826351 73 M WI 02/14/2025 COVID19
COVID19
FLUX
FLUX
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Eye disorder, Eye swelling, Lacrimation increased, Pruritus, Purulent discharge;... Eye disorder, Eye swelling, Lacrimation increased, Pruritus, Purulent discharge; Vision blurred; Eye disorder, Eye swelling, Lacrimation increased, Pruritus, Purulent discharge; Vision blurred More
large knot/knots in right eye/big knot that was on his right eye and, a lot of pus came out of it; N... large knot/knots in right eye/big knot that was on his right eye and, a lot of pus came out of it; Noticed under skin on eye, kept itching; his eyes running water, and is blurred/Blurry; his eyes running water; large knot/knots in right eye/big knot that was on his right eye and, a lot of pus came out of it; swelling in right eye; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 03Dec2024 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "Nerve damage in left arm" (unspecified if ongoing); "High blood pressure" (ongoing), notes: takes 9 pills a day. All of that, has been taking for years. The patient took concomitant medications. Vaccination history included: Moderna (Dose number unknown, single), for COVID-19 immunization, reaction(s): "No adverse effect". The following information was reported: EYE DISORDER (non-serious) with onset Dec2024, outcome "not recovered", PURULENT DISCHARGE (non-serious), outcome "not recovered" and all described as "large knot/knots in right eye/big knot that was on his right eye and, a lot of pus came out of it"; EYE SWELLING (non-serious) with onset Dec2024, outcome "not recovered", described as "swelling in right eye"; PRURITUS (non-serious), outcome "unknown", described as "Noticed under skin on eye, kept itching"; VISION BLURRED (non-serious), outcome "unknown", described as "his eyes running water, and is blurred/Blurry"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "his eyes running water". The events "large knot/knots in right eye/big knot that was on his right eye and, a lot of pus came out of it", "swelling in right eye", "noticed under skin on eye, kept itching", "his eyes running water, and is blurred/blurry" and "his eyes running water" required physician office visit. Therapeutic measures were not taken as a result of eye disorder, eye swelling, purulent discharge, pruritus, vision blurred, lacrimation increased. Additional information: Concomitant Products/Medical Conditions: High blood pressure medication, takes 9 pills a day. All of that, has been taking for years. Patient stated, he never took Pfizer before. Patient only taken Moderna, they gave him the Pfizer and, he never took that before. They wrote down on the paper that, they gave 2 injections at once, that they gave to him in left arm. They did not give it to him in left arm, has nerve damage over there, they gave to him in right arm. When clarifying specific Pfizer vaccine that he got, he states, it says, Pfizer injected intramuscularly into left deltoid. Unable to clarify was it was the Covid or flu shot that was Pfizer. One says Pfizer, guesses the other one was Pfizer too. Called pharmacy asked why they would write down, that they injected in left deltoid. That was a lie, has nerve damage, was partially paralyzed in left arm, that was why he had them give shot in right arm. They reported stuff that was not true, he does not take shots in left arm. Another thing they did not tell him was, they were giving him Pfizer. Had been taking Moderna all the time, all the shots. They should have the records, he has been taking Moderna, ever since Covid, all Moderna. This was first time, they did not tell what they were shooting him up with. They just came in with needle, gave to him. Told them to give shot in right arm because, he got shot in 1980, tore all nerves up in left arm. Pains him even to this day, has had problem with. When he called the, asked why they didn't tell him they were giving Pfizer, that he and never took that before. Was told, they didn't have Moderna, just gave the Pfizer. Does not like changing medicine. Had not had any problems after taking Moderna, didn't get knots on face and stuff, on forehead like that, when he took Moderna. That was what he was scared about, maybe they are not supposed to be mixing those. A lot of people do it, take Moderna one time then, take Pfizer the next time. He did not do that. If they looked at his record, would have seen, he never took Pfizer. Was always the same for Covid, to now. Clarified, both Covid and flu shot given in right arm, gave both at same. They put band-aid over it, was in store the, shopping. They gave him blue t-shirt, said to tell everyone, they can get free covid vaccine and flu shot, there. The first time he took Pfizer, there was reaction from that. Then, got swelling, real large knot on his right eye. Went to one the provider's nurses, an APNP, she saw the big knot that was on his right eye and, a lot of pus came out of it. Right after doctor appointment, told them he took Pfizer shot, and flu shot. Told them, that knot did not come on there until after he took shot, still had band aid on arm. Large knot, swelling in right eye: The swelling and knot first occurred, about a week or after the 2 shot injection in right arm, that he had, 03Dec2024. Noticed under skin on eye, kept itching, and didn't know what was. There was the pus coming out of that, getting into right eye. Was kind of blurry in there, still blurry, knows it still there. When he took and squeezed it, whole bunch of pus came of it. Still got something in there. There was 1 knot on the one side and 1 big one next to it, still has pus. Clarified, there are 2 knots in right eye. Still turns to water, all the time, still pus, can feel knot, like a hole in area, where he kept squeezing, busted, shot pus out. Still there now, still has pus in it. Has been going back and forth, from primary doctor, they keep sending him to those nurses, like the APNP he was seeing for pus in the eye. The last doctor didn't even look at it, was supposed to be sending him to some skin doctor. Test results: That nurse at doctor's office, when he went to see her, should have been taking sample of that, whatever that was, coming out the forehead. Old people are like guinea pigs. Treatment: They didn't give him anything, acted like they did not want to even look at it. AE required visit to Physician Office, Went to doctor, physician, hardly ever sees him but, once a year. That was kind of shameful but, got appointment coming up. They had it for 25Feb but, was sent letter canceling that, to something else. Does not know, has to call them. Has about 5 doctors. Has name of place they sent him, to look at the knot. AMV Dermatology referral. Just hopes with that medicine, that he does not loose his eye or something because, it was still blurry. Tries to drive, his peripheral vision on right side, when he looks out that way, when driving, his eyes running water, and was blurred. It blurs up, as if pus still running into eye. Did not know where he got that from. Did not come until after he got that shot. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2826352 62 F IL 02/14/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EJ1685
EJ1685
Allergy to vaccine, Dizziness, Headache, Vertigo, Vitreous floaters; Vomiting Allergy to vaccine, Dizziness, Headache, Vertigo, Vitreous floaters; Vomiting
lot of floaters in eyes; covid Pfizer was an allergy for her; dizzy; vertigo; throwing up; headache ... lot of floaters in eyes; covid Pfizer was an allergy for her; dizzy; vertigo; throwing up; headache behind right eye; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1685) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "hyperthyroid " (unspecified if ongoing); "Guillain-Barre" (unspecified if ongoing); "constipated person" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Low blood pressure" (unspecified if ongoing); "Pott's" (unspecified if ongoing); "asthma" (unspecified if ongoing), notes: in her late 20s. The patient's family history included: "hypothyroid" (unspecified if ongoing), notes: has a sister that's been on since high school. Sister is 10 years older. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). Past drug history included: Advair for asthma. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache behind right eye"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "throwing up"; VERTIGO (non-serious) with onset 2021, outcome "not recovered"; VITREOUS FLOATERS (non-serious), outcome "not recovered", described as "lot of floaters in eyes"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "covid Pfizer was an allergy for her". The events "vertigo", "throwing up", "headache behind right eye" and "dizzy" required physician office visit. Clinical course: Covid vaccine is listed as an allergy. After the first vaccine, patient ended up with lot of floaters in eyes. It seemed to disappear. Patient was working at the time to where she was vaccinated, but on leave because was non-essential. Patient got all the vaccines and all of them were the Pfizer. After the first vaccine, she contacted the doctor because she started getting dizzy. They kept her longer after first vaccine because of this. She was sent home and told to contact her own physician if anything worsened. By the time she got home, she was throwing up. She had headache behind right eye and then started vertigo. The patient contacted physician and got in to see her and she suggested to see ENT and eye doctor. The vertigo went away and so just she kept an appointment with an eye doctor. The patient want to make it very clear she is not an anti-vaxxer. She believes in vaccines. If it can determine with genetic testing that there would be a problem with certain meds, as patient has, there would be no anti-vaxxers. Patient stated it needs to be researched, most doctors think Pfizer has no liability. If it could be researched so someone else doesn't have problem.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033318 same pattient/product, different dose number/events;US-PFIZER INC-202500033305 same pattient/product, different dose number/events; More
2826353 62 F IL 02/14/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL9261
EL9261
EL9261
Allergy to vaccine, Blepharitis, Blood pressure measurement, Gait inability, Hea... Allergy to vaccine, Blepharitis, Blood pressure measurement, Gait inability, Headache; Laboratory test, Ophthalmological examination, Photopsia, Vertigo, Visual field tests; Vomiting More
Allergy to vaccine; Had the vertigo where couldn't walk at all and was throwing up; Had the ver... Allergy to vaccine; Had the vertigo where couldn't walk at all and was throwing up; Had the vertigo where couldn't walk at all and was throwing up; Had the vertigo where couldn't walk at all and was throwing up; Right eye had horrible headache with flashes; Right eye had horrible headache with flashes; Eye was bothering - both were immediately itching/Blepharitis; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Lot number: EL9261) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre" (unspecified if ongoing), notes: had before covid vaccines; "constipated person" (unspecified if ongoing); "Hyperthyroid" (unspecified if ongoing), notes: since covid has been changed from hypothyroid genetically to hyperthyroid then back to hypothyroid; "Asthma" (unspecified if ongoing), notes: Diagnosed with asthma in her late 20s; "Low blood pressure" (unspecified if ongoing); "Pott's" (unspecified if ongoing). The patient's family history included: "hypothyroid" (unspecified if ongoing), notes: has a sister that's been on since high school. Sister is 10 years older. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). Past drug history included: Advair for asthma, reaction(s): "glaucoma", notes: 1 puff in morning; Off of it because diagnosis of glaucoma. Vaccination history included: BNT162b2 (Dose 1, Single, Lot#: EJ1685, Manufacturer: Pfizer), administration date: 07Jan2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "throwing up", "headache", "Covid vaccine is listed as an allergy", "lot of floaters in eyes", "Dizzy", "vertigo". The following information was reported: BLEPHARITIS (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "Eye was bothering - both were immediately itching/Blepharitis"; VERTIGO (non-serious), VOMITING (non-serious), GAIT INABILITY (non-serious) all with onset 2021, outcome "unknown" and all described as "Had the vertigo where couldn't walk at all and was throwing up"; HEADACHE (non-serious) with onset 2021, outcome "unknown", PHOTOPSIA (non-serious) with onset 2021, outcome "recovered with sequelae" (2021) and all described as "Right eye had horrible headache with flashes"; ALLERGY TO VACCINE (non-serious), outcome "unknown". The events "right eye had horrible headache with flashes" and "eye was bothering - both were immediately itching/blepharitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of photopsia, blepharitis. Additional information: Covid vaccine is listed as an allergy. Been getting visual vestibular and neurological issues and visual issues. Got second vaccine 28Jan2021. Then felt better but eye was bothering. Clarified that both were immediately itching. Right eye had horrible headache with flashes. Never got headache before. Had the vertigo where couldn't walk at all and was throwing up. The vertigo went away and went to eye doctor who said caller had Blepharitis. They said it was okay and gave prescription for glasses. Reporter clarified that had glasses before that. Has a whole history beforehand. Within the next 4 months went through 4 prescriptions for eye glasses. Eye stabilized in Jun/Jul2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033318 same pattient/product, different dose number/events; More
2826355 M 02/14/2025 COVID19
 PFIZER\BIONTECH
Myocarditis Myocarditis
Myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A... Myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". Clinical course: Patient reported that The adverse affects I had to the flu shot and how I had covid once no shot because natural immunity. Friends with 4 or more Pfizer boosters got covid more times than boosters. My 2 friends sons with Myocarditis due to the covid vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033362 Same drug, AE, different patient; More
2826356 M TX 02/14/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL9262
EL9262
Vaccination site erythema, Vaccination site pain, Vaccination site swelling; Vac... Vaccination site erythema, Vaccination site pain, Vaccination site swelling; Vaccination site erythema, Vaccination site pain, Vaccination site scab, Vaccination site swelling; Vaccination site erythema, Vaccination site pain, Vaccination site swelling; Vaccination site erythema, Vaccination site pain, Vaccination site scab, Vaccination site swelling More
he has a red ring that never seemed to heal that scabs over and will swell up again.; feel pain in t... he has a red ring that never seemed to heal that scabs over and will swell up again.; feel pain in the muscle where the injection went into; he has a red ring that never seemed to heal that scabs over and will swell up again.; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (COMIRNATY), on 24Jan2021 as dose 1, single (Lot number: EL9262), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "feel pain in the muscle where the injection went into"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "he has a red ring that never seemed to heal that scabs over and will swell up again.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033720 same patient, different dose and AE; More
2826357 M TX 02/14/2025 COVID19
 PFIZER\BIONTECH
 EL9267
Vaccination site erythema, Vaccination site pain, Vaccination site swelling Vaccination site erythema, Vaccination site pain, Vaccination site swelling
feel pain in the muscle where the injection went into; he has a red ring that never seemed to heal t... feel pain in the muscle where the injection went into; he has a red ring that never seemed to heal that scabs over and will swell up again.; he has a red ring that never seemed to heal that scabs over and will swell up again.; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (COMIRNATY), on 14Feb2021 as dose 2, single (Lot number: EL9267), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (1st dose, lot EL9262), administration date: 24Jan2021, for covid-19 immunization, reaction(s): "vaccination site erythema", "vaccination site pain", "vaccination site swelling". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "feel pain in the muscle where the injection went into"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "he has a red ring that never seemed to heal that scabs over and will swell up again.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033581 same patient, different dose and AE;US-PFIZER INC-202500033721 same patient, different dose and AE; More
2826358 M TX 02/14/2025 COVID19
 PFIZER\BIONTECH
Vaccination site erythema, Vaccination site pain, Vaccination site swelling Vaccination site erythema, Vaccination site pain, Vaccination site swelling
he has a red ring that never seemed to heal that scabs over and will swell up again.; he has a red r... he has a red ring that never seemed to heal that scabs over and will swell up again.; he has a red ring that never seemed to heal that scabs over and will swell up again.; feel pain in the muscle where the injection went into; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (2nd dose, lot EL9267), administration date: 14Feb2021, for covid-19 immunization, reaction(s): "vaccination site pain", "vaccination site erythema", "vaccination site swelling"; comirnaty (1st dose, lot EL9262), administration date: 24Jan2021, for covid-19 immunization, reaction(s): "vaccination site swelling", "vaccination site swelling", "vaccination site swelling". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "he has a red ring that never seemed to heal that scabs over and will swell up again."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "feel pain in the muscle where the injection went into". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500033720 same patient, different dose and AE;US-PFIZER INC-202500033581 same patient, different dose and AE; More
2826359 27 F 02/14/2025 COVID19
 PFIZER\BIONTECH
Fall, Generalised tonic-clonic seizure Fall, Generalised tonic-clonic seizure
35 grand mal seizures; fell on my face when I fell off the bed; This is a spontaneous report receive... 35 grand mal seizures; fell on my face when I fell off the bed; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 31-year-old female patient received BNT162b2 (BNT162B2), on 28Jul2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: years ago. The patient's concomitant medications were not reported. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant), outcome "unknown", described as "35 grand mal seizures"; FALL (non-serious), outcome "unknown", described as "fell on my face when I fell off the bed". Clinical course: The patient had 35 grand mal seizures in the past 5 years and shared some of the photos she had from being injured from this covid vaccine. She added that it ruined her life. She had cancer years ago and it wasn't as life-threatening as this vaccine. A photo of her was attached wherein she fell on her face when she had fallen off the bed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2826360 F 02/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
After covid issues; After covid issues; This is a spontaneous report received from a Consumer or oth... After covid issues; After covid issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. An adult 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 "After covid issues". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2826361 F 02/14/2025 COVID19
 PFIZER\BIONTECH
Allergy to vaccine Allergy to vaccine
allergic reaction to the covid vaccine; This is a spontaneous report received from a Consumer or oth... allergic reaction to the covid vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . An elderly 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to the covid vaccine". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2826366 F TX 02/14/2025 COVID19
 PFIZER\BIONTECH
Asthma, COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test Asthma, COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Second time having COVID-19; Affecting her asthma; COVID-19; COVID-19 test positive; COVID-19; COVID... Second time having COVID-19; Affecting her asthma; COVID-19; COVID-19 test positive; COVID-19; COVID-19 test positive; This is a spontaneous report received from a consumer, Program ID: A 63-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) and in 2020 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1993 (ongoing), notes: Diagnosed 32 years ago; "Hypothyroid" (ongoing), notes: Diagnosed over 30 years ago. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19; COVID-19 test positive"; ASTHMA (non-serious) with onset 11Feb2025, outcome "not recovered", described as "Affecting her asthma"; DISEASE RECURRENCE (medically significant) with onset 11Feb2025, outcome "not recovered", described as "Second time having COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence, asthma. The patient has already taken her Pfizer COVID-19 Vaccine. While in the call, she is trying to talk, but her face is covered with a mask, so it is hard to speak. The patient currently has COVID-19 and was prescribed nirmatrelvir/ritonavir (PAXLOVID); COVID-19 test positive on 11Feb2025. This is her second time having COVID-19 and said that the first time was 2 years ago (2023). She is tired and is so confused. She is worn out. According to the patient, her chest is killing her. Her symptoms started off as head congestion, runny nose, fever, chills, coughing, and now it is affecting her asthma. She has coughing and congestion in her chest. She thought it was sinus infection but was diagnosed with COVID-19. She also had her flu vaccine. She got the Pfizer COVID-19 vaccine when the shots first came out; she received 2 doses. It was the 2-part series of the COVID-19 vaccine that she received in 2020, she thinks. Further, the patient had just got off the phone with the pharmacy to get the prescription she needs, paroxetine hydrochloride (PAXIL). The patient was going outside to take her mask off as she can't breathe. And then she would go to the doctors. That's what she was going for sinuses. The patient got COVID-19, and she had her Pfizer shot. The patient got COVID-19 which she thought was a sinus infection. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500034910 Same patient and product; different dose and events; More
2826367 68 F IL 02/14/2025 COVID19
PNC20
 MODERNA
PFIZER\WYETH
 3043838
LG5579
Injection site pain, Limb operation, Pain in extremity; Injection site pain, Lim... Injection site pain, Limb operation, Pain in extremity; Injection site pain, Limb operation, Pain in extremity More
Patient complained of pain at injection site the evening of the vaccine, then on 2/13 her arm appear... Patient complained of pain at injection site the evening of the vaccine, then on 2/13 her arm appeared red and still painful, she came into the pharmacy on 2/14 her arm was pink and she was still experiencing some pan More
2826369 27 F CO 02/14/2025 UNK
 UNKNOWN MANUFACTURER
 AREXVY (PF) 120
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Arexvy is not indicated for pregnant women at 31-32 weeks At the time patient was 31-32 weeks along. Arexvy is not indicated for pregnant women at 31-32 weeks At the time patient was 31-32 weeks along.
2826370 37 F CA 02/14/2025 VARCEL
 MERCK & CO. INC.
Injection site erythema, Injection site pruritus Injection site erythema, Injection site pruritus
Large itchy, red area around injection site. Large itchy, red area around injection site.
2826373 60 F GA 02/14/2025 PNC21
 MERCK & CO. INC.
 Y011819
Injection site pain, Rash Injection site pain, Rash
Rash on patient's left arm around the injection site. Patient had the rash for approximately 5 ... Rash on patient's left arm around the injection site. Patient had the rash for approximately 5 days and had been seen by the urgent care provider to rule out an infection. More
2826374 47 F PA 02/14/2025 COVID19
 PFIZER\BIONTECH
Dizziness, Heart rate increased, Paraesthesia, Syncope, Vision blurred Dizziness, Heart rate increased, Paraesthesia, Syncope, Vision blurred
Blood pressure 218/132, vision trouble focusing, almost fainted, pins and needles in hands, high pul... Blood pressure 218/132, vision trouble focusing, almost fainted, pins and needles in hands, high pulse, dizzy More
2826375 84 F AL 02/14/2025 PNC20
 PFIZER\WYETH
Extra dose administered Extra dose administered
Patient received an inappropriate dose of Prevnar 20. Patient had already received two doses of Prev... Patient received an inappropriate dose of Prevnar 20. Patient had already received two doses of Prevnar 20 in 2023 and 2024. These vaccines were not reported on registry and patient was told by her doctor that they were due to receive this vaccine. Patient did not report any adverse effects from receiving this vaccine. More
2826376 0.83 M MO 02/14/2025 DTAP
DTAP
DTAP
DTAP
FLU3
FLU3
FLU3
FLU3
PNC13
PNC13
PNC13
PNC13
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH











Affective disorder, Attention deficit hyperactivity disorder, Autism spectrum di... Affective disorder, Attention deficit hyperactivity disorder, Autism spectrum disorder, Constipation, Cytogenetic analysis normal; Decreased eye contact, Depression, Diarrhoea, Generalised anxiety disorder, Insomnia; Irritability, Neuropsychological test, Respiratory tract infection viral, Sensory processing disorder, Speech disorder developmental; Stereotypy, Toe walking, Unresponsive to stimuli; Affective disorder, Attention deficit hyperactivity disorder, Autism spectrum disorder, Constipation, Cytogenetic analysis normal; Decreased eye contact, Depression, Diarrhoea, Generalised anxiety disorder, Insomnia; Irritability, Neuropsychological test, Respiratory tract infection viral, Sensory processing disorder, Speech disorder developmental; Stereotypy, Toe walking, Unresponsive to stimuli; Affective disorder, Attention deficit hyperactivity disorder, Autism spectrum disorder, Constipation, Cytogenetic analysis normal; Decreased eye contact, Depression, Diarrhoea, Generalised anxiety disorder, Insomnia; Irritability, Neuropsychological test, Respiratory tract infection viral, Sensory processing disorder, Speech disorder developmental; Stereotypy, Toe walking, Unresponsive to stimuli More
The day after his 10 month shots, patient was whiny. He had diarrhea. Constipation followed, then di... The day after his 10 month shots, patient was whiny. He had diarrhea. Constipation followed, then diarrhea again a few weeks later. He wouldn't sleep at night. Over the weeks following the injections, he stopped responding to his name as well. He made less eye contact as well. He was sick with respiratory viruses for most of the year following the shots. He began toe walking and repetitive tasks, lining up toys, being fascinating by dripping water. His speech was delayed. He was diagnosed with Sensory Processing Disorder at his 4 year check up, then ADHD at 5, then a childhood mood disorder at 7. He finally received an autism disorder diagnosis at 9 which placed all of his previous disorders as symptoms of the umbrella autism diagnosis. More
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2826377 63 F NY 02/14/2025 PNC20
 PFIZER\WYETH
Limb mass, Pain in extremity, Pruritus, Skin discolouration Limb mass, Pain in extremity, Pruritus, Skin discolouration
Beside pain in the arm which last until the 14th, I experienced a discolored round circle extending ... Beside pain in the arm which last until the 14th, I experienced a discolored round circle extending to the sides of the arm. The arm continues to itch and I broke out in bumps along my left back shoulder and arm extended. More
2826378 37 M CA 02/14/2025 COVID19
COVID19
 MODERNA
MODERNA
 008c21a
044b21a
Chronic obstructive pulmonary disease, Clear cell renal cell carcinoma, Nephrect... Chronic obstructive pulmonary disease, Clear cell renal cell carcinoma, Nephrectomy, Renal cancer; Chronic obstructive pulmonary disease, Clear cell renal cell carcinoma, Nephrectomy, Renal cancer More
I now have COPD which is not normal for a 40 year old and I had Kidney cancer twice. I now have COPD which is not normal for a 40 year old and I had Kidney cancer twice.
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2826379 80 F HI 02/14/2025 PNC21
 MERCK & CO. INC.
 Y011819
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Patient has redness and swelling at injection site. Warm to the touch and was painful. Was over a we... Patient has redness and swelling at injection site. Warm to the touch and was painful. Was over a week long symptoms lasted More
2826380 45 F FL 02/14/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 5wa67
Er8727
Fk9895
Erythema, Hypoaesthesia, Paraesthesia, Raynaud's phenomenon, Skin discolour... Erythema, Hypoaesthesia, Paraesthesia, Raynaud's phenomenon, Skin discolouration; Erythema, Hypoaesthesia, Paraesthesia, Raynaud's phenomenon, Skin discolouration; Erythema, Hypoaesthesia, Paraesthesia, Raynaud's phenomenon, Skin discolouration More
A year and a half later I developed Raynaud?s disease where the tips of my fingers turn completely p... A year and a half later I developed Raynaud?s disease where the tips of my fingers turn completely pale. It tingles and feels numb. It started out lasting only 15 minutes and worked itself up to lasting longer. It occurs at random times. My feet also get beet red. Although I have not had a diagnosis for the feet, I did go tot the doctor for my hands and fingertips. This has never occurred with me and nobody in my family has ever had this happen. More
2833996 F MD 02/14/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity Pain in extremity
arm was "very sore"; This is a spontaneous report and received from Consumer or other non ... arm was "very sore"; This is a spontaneous report and received from Consumer or other non HCPs. 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was "very sore"". Additional information: The reporter stated that the arm of the patient was "very sore" after she received her COVID-19 vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. Follow-up (01Feb2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information included: New reporter and patient Information. Follow-up (12Feb2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information included: Primary Reporter Qualification. More
2823632 63 M 02/13/2025 COVID19
 JANSSEN
 XE444
Dyspnoea, Nasopharyngitis, Sudden death Dyspnoea, Nasopharyngitis, Sudden death
Patient had a cold. We did not know that he had covid. At that time we did not have our own ... Patient had a cold. We did not know that he had covid. At that time we did not have our own vehicle to go to hospital and people in the area did not want to take a chance to transport us to the nearest hospital. He just complaint that he had breathing difficulty and before I could call an ambulance, he suddenly passed away at home on 08/27/2022 More
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2826023 F 02/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue Fatigue
tiredness; This non-serious case was reported by a consumer via interactive digital media and descri... tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In JAN-2025, the patient received the 1st dose of Shingrix. In JAN-2025, 1 day after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness). The outcome of the tiredness was resolved. It was unknown if the reporter considered the tiredness to be related to Shingrix. It was unknown if the company considered the tiredness to be related to Shingrix. Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that she was vaccinated for the first of two shingles vaccines a couple of weeks ago. The only issue she had was tiredness the following day. More
2826024 F TX 02/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 G97Y2
Product preparation issue Product preparation issue
adjuvant only administered; only the adjuvant portion of Shingrix; This non-serious case was reporte... adjuvant only administered; only the adjuvant portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 15-NOV-2026) for prophylaxis. On 06-FEB-2025, the patient received Shingrix. On 06-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 The patient received only the adjuvant portion of Shingrix, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. More
2826025 67 M NC 02/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
States a male patient received three doses of SHINGRIX; This non-serious case was reported by a phar... States a male patient received three doses of SHINGRIX; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 10th September 2020) and Shingrix (received 2nd dose of Shingrix vaccine on 17th November 2020). On 10-FEB-2025, the patient received the 3rd dose of Shingrix. On 10-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: States a male patient received three doses of SHINGRIX). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 10-FEB-2025 The Healthcare professional was the reporter states that a male patient received three doses of Shingrix, extra dose, which led to extra dose administered. 1st dose was administered on 10-SEP-2020, 2nd dose was administered on 17-NOV-2020 and 3rd dose was received on 10-FEB-2025. No further information was provided including lot number, route or site of administration. More
2826027 1.25 F IN 02/13/2025 DTAPIPVHIB
HIBV
 SANOFI PASTEUR
SANOFI PASTEUR

No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
received 2-doses of HIB in the same day with no reported adverse event; received PENTACEL and ACTHIB... received 2-doses of HIB in the same day with no reported adverse event; received PENTACEL and ACTHIB at their appointment and they should have gotten DTAP and ACTHIB with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who received 2-doses of hib in the same day with no reported adverse event and received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero) and hib (prp/t) vaccine [ACT-HIB] at their appointment and they should have gotten diphtheria, tetanus and acellular pertussis vaccine and hib (prp/t) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included (Pneumococcal Vaccine Conj 20V (CRM197). On 30-Jan-2025, the patient received 0.5 mL of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in the right thigh, received 0.5mL dose of suspect hib (prp/t) vaccine, powder and solvent for solution for injection via unknown route in the left thigh,both for Prophylactic vaccination (Immunisation) and received 2-doses of hib in the same day with no reported adverse event (extra dose administered) and received pentacel and acthib at their appointment and they should have gotten diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer, unknown formulation and acthib with no reported adverse event (wrong product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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
2826028 7 F CO 02/13/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.

Dyspnoea, Heart rate increased, Increased bronchial secretion, Myalgia, Oxygen s... Dyspnoea, Heart rate increased, Increased bronchial secretion, Myalgia, Oxygen saturation decreased; Pyrexia, Seizure, Tremor More
Spike in HR into 140-150s, fever ranging from 101-103, severe difficulties breathing that even breat... Spike in HR into 140-150s, fever ranging from 101-103, severe difficulties breathing that even breathing treatments and 4L of O2 are not able to bring her saturations above 90%, several seizures, shaking, muscle pain, copious secretions - all of these began roughly 16 hours after vaccine, she was perfectly healthy with zero symptoms beforehand More
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2826036 28 F 02/13/2025 FLU4
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Abortion spontaneous, Haemorrhage in pregnancy, Maternal exposure before pregnan... Abortion spontaneous, Haemorrhage in pregnancy, Maternal exposure before pregnancy, Pregnancy test positive, Pregnancy with contraceptive device More
vaccine exposure before pregnancy; Reported Spontaneous Abortion; This is a retrospective pregnancy ... vaccine exposure before pregnancy; Reported Spontaneous Abortion; This is a retrospective pregnancy case. This 28-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu-mRNA vs QIV Dresden or Fluzone (intramuscular, unknown deltoid) on 08-NOV-2023 17:14, for prophylaxis. The subject's past medical history included normal birth (The subject had a history of 3 previous pregnancies with normal birth.). Concomitant products included levonorgestrel (Mirena), norethisterone acetate (Norethisterone) and paracetamol (Tylenol). On 17-FEB-2024, 101 days after receiving Flu-mRNA vs QIV Dresden or Fluzone, the subject developed severe - grade 3 spontaneous abortion (Verbatim: Reported Spontaneous Abortion). Serious criteria included clinically significant/intervention required. Additional event(s) included not applicable vaccine exposure before pregnancy (Verbatim: vaccine exposure before pregnancy). The outcome of spontaneous abortion was resolved on 17-FEB-2024. The outcome(s) of the additional event(s) included vaccine exposure before pregnancy (unknown). Diagnostic results (reference ranges are provided in parenthesis if available): Pregnancy test- 12-FEB-2024 positive and 17-FEB-2024 negative. The investigator considered that there was no reasonable possibility that the spontaneous abortion may have been caused by Flu-mRNA vs QIV Dresden or Fluzone. The company considered that there was no reasonable possibility that the spontaneous abortion and vaccine exposure before pregnancy may have been caused by Flu-mRNA vs QIV Dresden or Fluzone. Pregnancy exposure: Pregnancy Exposure (Flu-mRNA vs QIV Dresden or Fluzone): To mother before conception Last Menstrual Period Date: 06-JAN-2024 Estimated Delivery/Due date: 12-OCT-2024 Pregnancy Details (Neonate 1): Actual Delivery Date: Gestation Time at Delivery: 6 weeks Pregnancy Outcome: Spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present Linked case(s) involving the same subject: US2024059635 GSK receipt date: 27-FEB-2024, . The subject stated that despite being on birth control she took a home pregnancy test on 12feb24 and tested positive. starting on 13feb2024 she began experiencing light spotting that lasted through 15feb24. on 16feb24 heavy bleeding began on that same day she took another test and it was negative. she did not ever seek medical attention for this event. Subject weighs 118.2 kg and is 185.4 cm in height with BMI of 34.4. at the initial visit, the subject reported her method of contraception as being the placement of an Intra uterine device (IUD). Mirena on 01MAY2023. The subject also reported starting Norethisterone as another form of birth control on 08NOV2023. She has had 3 live births. This subject was a 29 year old female who reports being a current smoker. She states that she smokes about 6 cigarettes per day. Furtherer, she reports occasionally drinking consuming maybe 1 beer monthly. At the time of her visit, the subject said that she was in the process of moving back into her mother's house Type of conception used was Normal (includes use of fertility drugs). Mother using a method of contraception was mirena iud and oral norethisterone. AE was not related to study treatment SAE was not related to Study Participation Activities other than Study Treatment. Follow up information received on 10-May-2024;17-May-2024,29 MAY2024, 31May2024 Summary of changes: General narrative comments updated. New Event added- Reported Spontaneous Abortion. There is no medical confirmation of pregnancy or spontaneous abortion. On 31-May-2024 the case US2024059635 was identified as duplicate of US2024GSK025890 . The case US2024059635 was prepared for deletion. All future correspondence will be added to the case US2024GSK025890. Follow up information received on 4-Jun-2023 to 5-jun-2024 Summary of change : Event term updated form Reported Spontaneous Abortion. *There is no medical confirmation of pregnancy or of spontaneous abortion. *" to "Reported Spontaneous Abortion and narrative updated. Follow up information received on 06-Feb-2025 End of study Unblinding completed.; Sender's Comments: A case of Abortion spontaneous and Maternal exposure before pregnancy, 101 days and unknown time after receiving the 1st dose of Flu-mRNA vs QIV Dresden or Fluzone in a 28-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. US-GSK-US2024059635: More
2826037 U 02/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Myalgia Myalgia
muscle ache after administering Arexvy; This non-serious case was reported by a physician via sales ... muscle ache after administering Arexvy; This non-serious case was reported by a physician via sales rep and described the occurrence of muscle pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle pain (Verbatim: muscle ache after administering Arexvy). The outcome of the muscle pain was not reported. It was unknown if the reporter considered the muscle pain to be related to Arexvy. It was unknown if the company considered the muscle pain to be related to Arexvy. Additional Information: GSK Receipt Date: 04-DEC-2024 The physician reported that a patient received Arexvy vaccine and experienced muscle pain. The doctor got Arexvy vaccine and that said similar adverse event to Shingrix muscle aches. She said checks/makes sure patient get vaccines wants her to have health care professional guide. The doctor had patient who was copay too high on Arexvy. Gave co-pay card and she was going to call patient to came get it. More
2826038 95 F FL 02/13/2025 COVID19
 MODERNA
Chills, Fatigue, Malaise, Night sweats, Pain in extremity Chills, Fatigue, Malaise, Night sweats, Pain in extremity
reports beginning to feel, "not well"; sore arm; feel, "not well" specifically, ... reports beginning to feel, "not well"; sore arm; feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills); feeling "extreme tiredness/"too tired; night sweats; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (night sweats), MALAISE (reports beginning to feel, "not well"), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired) in a 95-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Feb-2025, the patient experienced NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired). On 03-Feb-2025, the patient experienced MALAISE (reports beginning to feel, "not well"). At the time of the report, NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold.. mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired) had not resolved and MALAISE (reports beginning to feel, "not well") outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no relevant medical history within the past 4 weeks. No concomitant medications were provided. Following the vaccination, patient experienced armed soreness from Saturday through Monday. On Monday, she began to feel unwell, describing sensations of alternating hot and cold, which was later identified as chills. Although this feeling subsided that night, her condition had progressively worsened since then. Additionally, she was experiencing night sweats, necessitating a changed of bedsheets that morning, and expressed feelings of extreme fatigue, stating that she was too tired to visit a doctor. No treatment medication was provided. More
2826041 16 M NY 02/13/2025 COVID19
 PFIZER\BIONTECH
 LM7786
Extra dose administered, No adverse event Extra dose administered, No adverse event
Child received covid vaccine on 2/12/25 when he had already gotten on 10/19/2024 Dr spoke to parent ... Child received covid vaccine on 2/12/25 when he had already gotten on 10/19/2024 Dr spoke to parent aware of additional vaccine site. No adverse effects reported today 2/13/25 More
2826053 11 F NC 02/13/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Y010656
AMVB043A
CX4HL
Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic; ... Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic More
red itchy rash to face, torso and bilateral arms red itchy rash to face, torso and bilateral arms
2826054 64 F PA 02/13/2025 RSV
 PFIZER\WYETH
 LN5460
Wrong product administered Wrong product administered
Patient and her mother came in for vaccines. The mother was to get RSV and the daughter Flu and Covi... Patient and her mother came in for vaccines. The mother was to get RSV and the daughter Flu and Covid. I accidently gave the RSV to the daughter, who is 64. When I spoke to the daughter and told her what happened she was fine with it as she wanted to get the RSV vaccine anyway. More
2826055 11 M FL 02/13/2025 HPV9
 MERCK & CO. INC.
 Y007322
Computerised tomogram head, Fall, Head injury, Seizure Computerised tomogram head, Fall, Head injury, Seizure
HAD A SEIZURE AND FELL OF THE EXAM TABLE HAD A SEIZURE AND FELL OF THE EXAM TABLE
2826056 36 F TN 02/13/2025 HEP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 PE9G5
Y009094
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
INCORRECT GIVEN IN THE SERIES. INCORRECT GIVEN IN THE SERIES.
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