🏥 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 💀 🏥 🚑 ♿ ⚠️
2536109 65 M AK 12/18/2022 COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EM9010
EM9010
em9010
Autoscopy, Dizziness, Hyperhidrosis, Injection site discolouration, Injection si... Autoscopy, Dizziness, Hyperhidrosis, Injection site discolouration, Injection site pain; Injection site swelling, Paraesthesia, Tremor; Hyperhidrosis, Injection site swelling, Tremor; Altered state of consciousness, Amnesia, Confusional state, Hyperhidrosis, Impaired work ability; Memory impairment, Paraesthesia, Vaccination site discolouration, Vaccination site pain, Vaccination site swelling More
Episodes preceded by the injection site becoming extremely tender ,, swollen and turning multiple co... Episodes preceded by the injection site becoming extremely tender ,, swollen and turning multiple colors Tingling behinning in feet moving up through abdomen then head leaving me dizzy...not in touch with my body followed by profuse sweating. On one occasion I was sweating on the left side of my body and nothing on the right side as if a line had been made down the middle of my face and body. This followed by intense shaking. No treatment. Episodes continue sporadically. More
2832004 M WA 03/18/2025 COVID19
 PFIZER\BIONTECH
Chest pain Chest pain
Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales repr... Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult 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. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain"; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain". The following information was reported: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain. Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s). 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-202500058266 same reporter/patient/event, different dose;US-PFIZER INC-202500058268 same reporter/patient/event, different dose;US-PFIZER INC-202500058267 same reporter/patient/event, different dose; More
2832005 M 03/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes ... He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago.; He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reporter mentioned that he wrote a letter to CEO of Pfizer because of the cost of Paxlovid. He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago. He said that he was shocked to know that the cost of Paxlovid is (Withheld). 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-PV202500031625 same patient, drug, event; different dose; More
2832006 81 M NY 03/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure, Weight COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
The patient was diagnosed with covid; The patient was diagnosed with covid; This is a spontaneous re... The patient was diagnosed with covid; The patient was diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP. An 81-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "COPD", start date: 2020 (unspecified if ongoing); "hospitalized" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "ear infection" (unspecified if ongoing). Concomitant medication(s) included: TOBRAMYCIN. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE; up to date.), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Mar2025, outcome "unknown" and all described as "The patient was diagnosed with covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2025) Positive; (10Mar2025) Positive, notes: Unit: Not Provided; Weight: (unspecified date) 185 lbs. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The reporter, who is the patient's wife, mentioned that the patient is on his third day of Paxlovid. The doctor prescribed Ciprofloxacin 500mg for an ear infection that the patient had before contracting COVID-19 and starting Paxlovid. The patient had previously been treated with an antibiotic for the ear infection, then contracted COVID-19, and now needs Ciprofloxacin again. The reporter confirmed that the patient has not yet started Ciprofloxacin and wanted to ensure there were no interactions with Paxlovid, especially since the patient is 81 years old and she wanted to avoid any medical emergencies. The patient is currently out picking up his prescription, and the reporter advised him to ask the pharmacist. Both the reporter and her husband have received all the Pfizer COVID-19 vaccines and recently visited urgent care. The patient tested positive for COVID-19 on 10Mar2025, using a test kit that was four months past its expiration date, but the urgent care confirmed the test was still valid. The reporter tested negative for COVID-19. The patient was diagnosed with an ear infection about three weeks ago and seems to have it again. He takes Paxlovid twice daily, at 7:00 AM and 7:00 PM. The patient has COPD, diagnosed about five years ago when he was hospitalized for bronchitis. The reporter confirmed that the patient's COPD, hospitalization, and bronchitis occurred before the Pfizer COVID-19 vaccines were available. The doctor wants to see the patient in two weeks. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2832007 M WA 03/18/2025 COVID19
 PFIZER\BIONTECH
Chest pain Chest pain
Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales repr... Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult male patient received BNT162b2 (BNT162B2 NOS), 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: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain. Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s). 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-202500057704 same reporter/patient/event, different dose;US-PFIZER INC-202500058267 same reporter/patient/event, different dose;US-PFIZER INC-202500058268 same reporter/patient/event, different dose; More
2832008 M WA 03/18/2025 COVID19
 PFIZER\BIONTECH
Chest pain Chest pain
Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales repr... Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain. Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s). 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-202500057704 same reporter/patient/event, different dose;US-PFIZER INC-202500058266 same reporter/patient/event, different dose; More
2832009 M WA 03/18/2025 COVID19
 PFIZER\BIONTECH
Chest pain Chest pain
Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales repr... Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain". The following information was reported: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain. Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s). 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-202500057704 same reporter/patient/event, different dose;US-PFIZER INC-202500058266 same reporter/patient/event, different dose; More
2832010 F 03/18/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Illness; Illness Illness; Illness
gets sick for two days after every COVID and Flu vaccine; This is a spontaneous report received from... gets sick for two days after every COVID and Flu vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "gets sick for two days after every COVID and Flu vaccine". Additional information: The patient informed she only gets Pfizer COVID vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2832011 F NY 03/18/2025 COVID19
FLUX
RSV
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Malaise, Pain in extremity; Malaise, Pain in extremity; Malaise, Pain in extremi... Malaise, Pain in extremity; Malaise, Pain in extremity; Malaise, Pain in extremity More
pain in arm; was sick; This is a spontaneous report received from a Consumer or other non HCP, Progr... pain in arm; was sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 205309. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE NUMBER UNKNOWN, patient got sick for two days after every COVID-19 vaccine), for COVID-19 immunization, reaction(s): "sick"; Flu vaccine (DOSE NUMBER UNKNOWN, patient got sick for two days after every Flu vaccine), for Immunization, reaction(s): "sick". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "recovered" (2024), described as "pain in arm"; MALAISE (non-serious) with onset 2024, outcome "recovered" (2024), described as "was sick". Additional information: she experienced pain in arm and was sick for two days after getting COVID-19, RSV, and Flu vaccines all at once. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2832012 M 03/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
had Covid about a week ago despite having to have Pfizer vaccine every time it goes out.; had Covid ... had Covid about a week ago despite having to have Pfizer vaccine every time it goes out.; had Covid about a week ago despite having to have Pfizer vaccine every time it goes out.; 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE; had COVID two years ago), for Covid-19 immunization, reaction(s): "Covid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "had Covid about a week ago despite having to have Pfizer vaccine every time it goes out.". Clinical course: The reporter mentioned that he wrote a letter to CEO of Pfizer because of the cost of Paxlovid. He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago. He said that he was shocked to know that the cost of Paxlovid is (Withheld). 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-202500057931 same patient, product, event; different dose; More
2832013 M TX 03/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19/tested positive; COVID-19/tested positive; This is a spontaneous report received from a Con... COVID-19/tested positive; COVID-19/tested positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2022 (unspecified if ongoing), notes: test COVID two years back after vaccination. The patient's concomitant medications were not reported. Past drug history included: Paxlovid, start date: 2022, for COVID-19 treatment. Vaccination history included: Bnt162b2 (Dose number unknown, single), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jul2024, outcome "unknown" and all described as "COVID-19/tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: two years back; after vaccination; (03Jul2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient and his wife took Pfizer vaccines. Saturday (29Jun2024), patient's wife got diagnosed with COVID. On 03Jul2024, patient was told to have tested positive and had been prescribed Paxlovid for COVID-19. Patient tested COVID two years back after vaccination and Paxlovid was never expensive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500032273 same reporter/product/event, different patient;US-PFIZER INC-202500059466 same reporter/patient/product/event, different dose; More
2832014 NY 03/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 antibody test COVID-19, Drug ineffective, SARS-CoV-2 antibody test
positive Covid test; positive Covid test; This is a spontaneous report received from a Consumer or o... positive Covid test; positive Covid test; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 78-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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 number unknown, single; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid test". The event "positive covid test" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was vaccinated and boosted and "everything else". Patient had a positive Covid test and the doctor prescribed Paxlovid. More
2832015 M 03/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a C... tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP and a Nurse, Program ID. A 75-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "Cancer" (unspecified if ongoing); "Pain" (unspecified if ongoing); "operation" (unspecified if ongoing); "operation" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN (ongoing); GABAPENTIN (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Dose number unknown, single; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Apr2024, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (prescribed Paxlovid). Clinical course: The patient was in rehab. Patient was diabetic and everything went downhill; patient got cancer, and everything was being covered (insurance). Patient was fine as far as he knows. Patient has gone through cancer and everything else, the last few years everything was being taken care of (insurance). Patient tested positive for Covid just yesterday (03Apr2024). Patient had all his shots, had all the boosters, and felt fine. He might ask them to give him another test because sometimes these tests provide false positive. It seemed that everybody was sick in the whole place where the patient was staying (rehab center). The patient stated there was nothing wrong with him and he felt quite fine. They got him locked up for 5 days in his room. Patient was not on anything special and just took his regular meds every day: Metformin for diabetes, pain killer, some vitamins, Gabapentin, meds for cholesterol, and meds for blood pressure - been taking those for years. Patient have gone through chemo and everything else and had two operations. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2832016 CA 03/18/2025 COVID19
 PFIZER\BIONTECH
 G36665
Immune thrombocytopenia, Investigation, Thrombosis with thrombocytopenia syndrom... Immune thrombocytopenia, Investigation, Thrombosis with thrombocytopenia syndrome More
ITP; VIITP; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A p... ITP; VIITP; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 as dose 4 (booster), single (Lot number: G36665) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), outcome "unknown", described as "ITP"; THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "VIITP". Clinical course was reported as follows: On 03Jan2023, I received my 4th dose of Pfizer COVID vaccine (2nd booster) Lot # G36665. A few days later, I was admitted to the hospital, and was diagnosed with ITP. Tested for numerous malfunctions of my system, given several platelet transfusions and after 3 days in the hospital, I was released back to my home. I was ultimately diagnosed with VIITP. More
✓
2832017 M 03/18/2025 COVID19
 PFIZER\BIONTECH
Pruritus Pruritus
itch from head to toe; This is a spontaneous report received from a Consumer or other non HCP from L... itch from head to toe; This is a spontaneous report received from a Consumer or other non HCP from License Party. An elderly male patient received BNT162b2 (BNT162B2 NOS), 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: PRURITUS (non-serious), outcome "unknown", described as "itch from head to toe". Additional information: The patient had a COVID shot and it triggered something that made him itch from head to toe. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2832018 0.5 CO 03/18/2025 FLU3
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
2nd dose given before 4 week mark with no reported adverse event; Initial information received on 01... 2nd dose given before 4 week mark with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old and unknown gender patient who received 2nd dose of influenza quadrival A-B multidose vaccine preserved [Fluzone] before 4 week mark with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2025, the patient received an unknown dose 1 of influenza quadrival A-B multidose vaccine preserved Suspension for injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for influenza protection (Influenza immunisation). On 31-Jan-2025 patient also received an unknown dose 2 of same vaccine with an unknown batch number via intramuscular route in unknown administration site for Influenza immunization before 4-week mark with no reported adverse event (inappropriate schedule of product administration) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832020 MA 03/18/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M77CC
Injection site swelling, Pain Injection site swelling, Pain
R deltoid swelling + persistent pain w ROM after 6 wks (given 1/27/25) R deltoid swelling + persistent pain w ROM after 6 wks (given 1/27/25)
2832021 44 F WA 03/18/2025 PNC20
 PFIZER\WYETH
 HN5980
Product substitution error Product substitution error
PCV-20 from VFC given to Adult Patient. PCV-20 from VFC given to Adult Patient.
2832033 MT 03/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
I tested positive Covid by about 48 hours ago maybe a little less/which I have taken in the past; I ... I tested positive Covid by about 48 hours ago maybe a little less/which I have taken in the past; I tested positive Covid by about 48 hours ago maybe a little less/which I have taken in the past; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 45-year-old patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "I tested positive Covid by about 48 hours ago maybe a little less/which I have taken in the past". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2025) positive. Clinical course: During an inbound call for financial assistance, the patient said that he/she tested positive Covid by about 48 hours ago maybe a little less. Later in the call, the patient said that it seemed crazy to him/her that they will personally give these shots away that are supposed to muscle the symptoms of covid if you get it, which he/she had taken in the past but then there's something that actually really works and they make it unobtainable for most people to even purchase. When explaining to the patient how the voucher information will be provided, then the patient realized that he/she had to do all of this while having covid and he/she can even hardly think straight right now. More
2832034 F DC 03/18/2025 COVID19
 PFIZER\BIONTECH
 Fk9896
Eye injury Eye injury
eye injury; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-old f... eye injury; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2022 at 18:00 as dose number unknown (booster), single (Lot number: Fk9896), in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: EYE INJURY (disability) with onset 01Feb2022, outcome "not recovered". It was unknown if therapeutic measures were taken as a result of eye injury. Additional information: eye injury, ever since receiving the Covid-19 Booster vaccine. This had tremendously affected patient's ability to operate her daily activities. Just need appropriate and specialized treatments which were covered by public insurance. The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting. More
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2832035 62 F CT 03/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N77J2
Injection site reaction, Rash erythematous Injection site reaction, Rash erythematous
2X2 RED RASH AROUND INJECTION SITE, NOT RAISED, ITCHY OR PAINFUL, PATIENT NOTICED 2 DAYS AFTER VACCI... 2X2 RED RASH AROUND INJECTION SITE, NOT RAISED, ITCHY OR PAINFUL, PATIENT NOTICED 2 DAYS AFTER VACCINE WHILE DRESSING More
2832036 0.75 M NM 03/18/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK167AA
Vomiting projectile Vomiting projectile
Pt projected vomited twice after receiving vaccine; first time approx 7 mins after vaccine and secon... Pt projected vomited twice after receiving vaccine; first time approx 7 mins after vaccine and second time five mins later More
2832054 59 F OH 03/18/2025 COVID19
FLU3
 NOVAVAX
SEQIRUS, INC.
 6024mf012
946611
Limb mass, Pain in extremity; Limb mass, Pain in extremity Limb mass, Pain in extremity; Limb mass, Pain in extremity
Patient stated they still had soreness in left arm and a bump from the vaccines 6 months later. Patient stated they still had soreness in left arm and a bump from the vaccines 6 months later.
2832055 63 F OH 03/18/2025 UNK
 UNKNOWN MANUFACTURER
 IM L Deltoid Pf
Dyspnoea, Injection site pruritus, Pain in extremity, Pruritus Dyspnoea, Injection site pruritus, Pain in extremity, Pruritus
Days 2 thru 4, I experienced lots of pain in my left arm, but then by Day 5. I experienced itching o... Days 2 thru 4, I experienced lots of pain in my left arm, but then by Day 5. I experienced itching over my entire body and especially over the injection site. By the next morning, things had died down. The pain was gone and I thought I was okay. I went to exercise and after 10 minutes of doing my Healthrider, I experienced intense itching again and had mild difficulty breathing which lasted most of the day and I contacted my family doctor. Then, the symptoms died down again, and a week later, the itching came back again, and I am also left with mild pain in my arm that feels like I sprained it. I again contacted my doctor and was advised that it was a reaction to the injection and that if it flared up again to come in or go to the nearest Urgent Care and I was given info about the shot. More
2832056 10 F MN 03/18/2025 COVID19
COVID19
 MODERNA
MODERNA

Anxiety, Condition aggravated, Laboratory test, Personality change, Social avoid... Anxiety, Condition aggravated, Laboratory test, Personality change, Social avoidant behaviour; Social problem More
Patient's personality has changed. She has become withdrawn and anxious. She struggles in soc... Patient's personality has changed. She has become withdrawn and anxious. She struggles in social situations. More
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2832057 12 F AZ 03/18/2025 DTAP
FLU3
HPV9
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
 5ST5M
FJ47R
x024727
U8370AA
Product administered to patient of inappropriate age, Wrong product administered... Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
A DTAP was given instead of Tdap to a 12 year old. A DTAP was given instead of Tdap to a 12 year old.
2832058 32 M GA 03/18/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 L5229
XN575
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
TWO DOSES OF BOOSTRIX WERE GIVEN IN A WEEK. ONE ON 02/21 AND ANOTHER ON 02/27. TWO DOSES OF BOOSTRIX WERE GIVEN IN A WEEK. ONE ON 02/21 AND ANOTHER ON 02/27.
2832059 80 F FL 03/18/2025 PNC20
 PFIZER\WYETH
 LK6650
Extra dose administered Extra dose administered
PATIENT RECEIVED PREVNAR 20 THREE TIMES OVER THE PAST 3 YEARS. PATIENT RECEIVED PREVNAR 20 THREE TIMES OVER THE PAST 3 YEARS.
2832060 68 F CA 03/18/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
UNK
UNK
UNK
UNK
UNK
UNK
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 022B21A
022B21A
022B21A
022B21A
022B21A
022B21A
050C21A
050C21A
050C21A
050C21A
050C21A
050C21A
Antibody test negative, Blood folate, Blood thyroid stimulating hormone, COVID-1... Antibody test negative, Blood folate, Blood thyroid stimulating hormone, COVID-19, CSF protein increased; Computerised tomogram head normal, Creutzfeldt-Jakob disease, Death, Electroencephalogram abnormal, Full blood count normal; HIV test negative, Impaired driving ability, Loss of personal independence in daily activities, Lumbar puncture abnormal, Magnetic resonance imaging head abnormal; Memory impairment, Metabolic function test, Metabolic function test normal, Personality change, Prion disease; Road traffic accident, SARS-CoV-2 test negative, Scan with contrast normal, Speech disorder, Treponema test; Urine analysis normal, Vision blurred, Vitamin B12 decreased, Weight decreased; Antibody test negative, Blood folate, Blood thyroid stimulating hormone, COVID-19, CSF protein increased; Computerised tomogram head normal, Creutzfeldt-Jakob disease, Death, Electroencephalogram abnormal, Full blood count normal; HIV test negative, Impaired driving ability, Loss of personal independence in daily activities, Lumbar puncture abnormal, Magnetic resonance imaging head abnormal; Memory impairment, Metabolic function test, Metabolic function test normal, Personality change, Prion disease; Road traffic accident, SARS-CoV-2 test negative, Scan with contrast normal, Speech disorder, Treponema test; Urine analysis normal, Vision blurred, Vitamin B12 decreased, Weight decreased; Antibody test negative, Blood folate, Blood thyroid stimulating hormone, COVID-19, CSF protein increased; Computerised tomogram head normal, Creutzfeldt-Jakob disease, Death, Electroencephalogram abnormal, Full blood count normal; HIV test negative, Impaired driving ability, Loss of personal independence in daily activities, Lumbar puncture abnormal, Magnetic resonance imaging head abnormal; Memory impairment, Metabolic function test, Metabolic function test normal, Personality change, Prion disease; Road traffic accident, SARS-CoV-2 test negative, Scan with contrast normal, Speech disorder, Treponema test; Urine analysis normal, Vision blurred, Vitamin B12 decreased, Weight decreased More
On 11/07/2022 we go to the Department of Neurology.We visit Dr.,he is a board-certified neurologist ... On 11/07/2022 we go to the Department of Neurology.We visit Dr.,he is a board-certified neurologist at the facility. Dr. say: Thank you for allowing us to review your mother's case and provide our opinion.The goal of your Expert Medical Opinion is to confirm your mother's diagnosis, whether additional evaluation is needed,and provide treatment options.Patient is 69 years old and has recently been diagnosed with CJD.You reported to Included health that patient was healthy until this past June,2022.It was noted that she had COVID-19 in January of 2022,but records available to us do not mention any symptoms clearly starting with this infection. There is one note stating that family thought some minor difficulties with memory may have started over this past year, but it is unclear when these difficulties may have occurred and it is agreed that symptoms become significant around June. On June 2,2022,she got lost while driving. Around this time, family had noted that she got into two car accidents, and she began experiencing difficulty speaking clearly as well. She tried to see her primary care provider, but when she called for an appointment on 07/11/22 she could not get an appointment sooner than early August, so she was instructed to go to the Emergency Department. In the ED, she told a neurologist that she was having difficulties with her memory and she was also having blurry vision. It was thought that her problems with driving may have been due to the vision difficulties. They performed a CT scan of her head and sent screening labs ( CBC, BMP, urinalysis, COVID-19 test ), but nothing was found. She was recommended to be admitted in order to have an MRI of her brain, an EEG, and possible spinal tap but, your family and patient decided against the admission and went home. She saw her primary care provider a few days later on 07/15/2022 who referred her to a neurologist and sent more labs, which were done on 08/11/2022, including looking for syphilis, signs of other organs in her body not functioning well with a comprehensive metabolic panel (CMP ), sings of thyroid problems with a TSH, as well as vitamin deficiencies including folate and vitamin B12. They found her B12 was low at 157 (normal >220 ). She was started on B12 supplements, both 1000 mcg solution to take by mouth each day as well as monthly injections. She first saw her neurologist some time before 08/15/2022 according to a primary care note (we do not have a copy of that note). She had an EEG done on 08/17/2022 which showed sharp waves (abnormal waves) on both sides of the brain (in the frontal and temporal lobes). She later had an MRI on 08/22/2022 that showed the outer portion of her brain called the cortex was abnormal, which the radiologist had noted as "possible cerebritis," which means inflammation of the brain. She was then sent to the emergency department on 08/30/2022 because of these MRI findings where an MRI with contrast was done and she had a spinal tap ( lumbar puncture ). This MRI with contrast did not show any signs of "enhancement" or signs that her brain was absorbing contrast. More labs were sent while in the emergency department, which showed her B12 was repleted (greater than 2000) and that her HIV test was negative and thus not likely a cause of her symptoms. After the initial results of the spinal tap did not show any signs of infection, patient and your family decided to go home instead of being admitted to the hospital. She was noted to have worsened quickly by her neurologist during her visit with him on 09/29/2022. In particular, she was noted to be forgetting conversations, misplacing and losing things, having difficulty with cooking, having difficulty with speaking in longer sentences, having difficulty with counting/math so that her family needed to help with finances, and she was no longer able to drive safely. At this visit, her neurologist explained results from her spinal fluid that showed sings of CJD, including a positive RT-QulC, elevated total tau protein, and elevated 14-3-3 (specifically, these tests were done by the facility, which rated the likelihood of prion disease as >98% using the combination of these spinal fluid results). An autoimmune encephalitis panel in the blood done by lab was negative. On 10/12/2022, you informed Included Health that patient had lost 20 pounds over the past 4 months, that her personality has changed (meaning much more emotional), and that she was walking slowly without falls. Patient Included Health on 10/12/2022 that she was not taking any medications. She had reported to her primary care physician on 08/15/2022 that the donepezil (Aricept) prescribed by Dr. made her dizzy so she stopped taking it. Patient followed Dr. recommendation, on 12/14/2022 she taked part in Hospice until she passed away. More
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2832061 71 M CA 03/18/2025 COVID19
 PFIZER\BIONTECH
Acute kidney injury, Blood test, Malaise, Urine analysis Acute kidney injury, Blood test, Malaise, Urine analysis
Two week following the vaccination I became ill with the same Covid symptoms I experienced two years... Two week following the vaccination I became ill with the same Covid symptoms I experienced two years prior. Approximately 35 days into the illness I was diagnosed with AKI (Acute Kidney Injury) More
2832062 70 F GA 03/18/2025 COVID19
 PFIZER\BIONTECH
 LM2221
Wrong product administered Wrong product administered
Patient requested moderna covid-19 vaccine, however, pt was given pfizer-bioNtech covid-19 vaccine Patient requested moderna covid-19 vaccine, however, pt was given pfizer-bioNtech covid-19 vaccine
2832063 69 M GA 03/18/2025 COVID19
 PFIZER\BIONTECH
 LM2221
Wrong product administered Wrong product administered
Patient requested moderna covid-19 vaccine, however, pt was given pfizer-bioNtech covid-19 vaccine Patient requested moderna covid-19 vaccine, however, pt was given pfizer-bioNtech covid-19 vaccine
2832064 60 F AZ 03/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 A5T73
Pain in extremity, Rash erythematous Pain in extremity, Rash erythematous
Red rash, arm very painful, took 2 Tylenol every 6-8 hours during the day. Red rash, arm very painful, took 2 Tylenol every 6-8 hours during the day.
2832065 56 M HI 03/18/2025 COVID19
COVID19
FLU3
FLU3
VARZOS
VARZOS
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS





Injection site pain, Muscle spasms, Pain, Product administered at inappropriate ... Injection site pain, Muscle spasms, Pain, Product administered at inappropriate site, Sleep disorder; X-ray limb; Injection site pain, Muscle spasms, Pain, Product administered at inappropriate site, Sleep disorder; X-ray limb; Injection site pain, Muscle spasms, Pain, Product administered at inappropriate site, Sleep disorder; X-ray limb More
from 10/20/2024 to 3/18/2025, I have experienced gradual increase and worsening of pain on right sho... from 10/20/2024 to 3/18/2025, I have experienced gradual increase and worsening of pain on right shoulder where shingles vaccine was administered high on shoulder. resulted in lack of sleep, mental hesitation to move freely, pain from annoying to spasmatic. More
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2832066 11 F 03/18/2025 HPV9
 MERCK & CO. INC.
Pharyngeal paraesthesia, Pharyngeal swelling Pharyngeal paraesthesia, Pharyngeal swelling
Pt reports feeling tingling in her throat and swelling in her throat. Pt reports feeling tingling in her throat and swelling in her throat.
2837328 AR 03/18/2025 BCG
 SANOFI PASTEUR
Incorrect route of product administration Incorrect route of product administration
BCG Intravenous; This spontaneous report was received from a Physician and refers to a patient of un... BCG Intravenous; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with BCG vaccine intravenously for enhance/produce longer and stronger response to the prevention of tuberculosis (lot # and expiration date were not reported) (Incorrect route of product administration). This is an invalid case due to lack of patient's identifiers. Additional information is not expected. More
2831634 F NM 03/17/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Exposure during pregnancy; Exposure during pregnancy Exposure during pregnancy; Exposure during pregnancy
a pregnant female patient that received first 2 doses of a 3 dose series of Gardasil 9 while pregnan... a pregnant female patient that received first 2 doses of a 3 dose series of Gardasil 9 while pregnant. The patient did not know she was pregnant a; This spontaneous report was received from a nurse Practitioner referring to an early 30s female patient. The patient's medical history included History of abnormal paps. The patient's concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, (indication, expiration date, and lot # were not reported). On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 2, (indication, expiration date, and lot # were not reported). The patient was pregnant while receiving the first 2 doses of a 3-dose series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Vaccine exposure during pregnancy). The patient did not know she was pregnant at the time. The outcome of the event was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as drug withdrawn. More
2831635 F 03/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Limb mass, Pain Limb mass, Pain
the lump from the second shot was as big as an egg/lump in arm; painful; This non-serious case was r... the lump from the second shot was as big as an egg/lump in arm; painful; This non-serious case was reported by a consumer and described the occurrence of local swelling in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix (recived 1st dose on 30-OCT-2024). Concurrent medical conditions included diabetes. Concomitant products included tirzepatide (Mounjaro) and empagliflozin (Jardiance). On 06-FEB-2025, the patient received the 2nd dose of Shingles vaccine. On 06-FEB-2025, less than a day after receiving Shingles vaccine, the patient experienced local swelling (Verbatim: the lump from the second shot was as big as an egg/lump in arm) and pain (Verbatim: painful). The outcome of the local swelling was resolving and the outcome of the pain was not reported. It was unknown if the reporter considered the local swelling and pain to be related to Shingles vaccine. It was unknown if the company considered the local swelling and pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 05-MAR-2025 The patient reported that she had recived 2nd dose of Shingrix vaccine and experienced lump in arm. The reporter mentioned that lump from the second shot was as big as an egg and very painful. It was a smaller now, but it was lasted a month. The expiry date of Shingles vaccine was unknown. More
2831636 11 F IL 03/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via ... Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. On 07-MAR-2025, the patient received Kinrix (intramuscular) .5 ml. On 07-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-MAR-2025 The reporter stated that she vaccinated an 11-year-old with a dose of Kinrix ,which led to inappropriate age at vaccine administration. No further information was provided/obtained. More
2831637 83 M 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Abdominal discomfort, Diarrhoea, Fatigue Abdominal discomfort, Diarrhoea, Fatigue
had diarrhea, an upset stomach, and just feeling tired out; This non-serious case was reported by a ... had diarrhea, an upset stomach, and just feeling tired out; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-MAR-2025, the patient received Shingrix (intramuscular) .5 ml. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced diarrhea (Verbatim: had diarrhea, an upset stomach, and just feeling tired out). The outcome of the diarrhea was not reported. It was unknown if the reporter considered the diarrhea to be related to Shingrix. It was unknown if the company considered the diarrhea to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAR-2025 The patient reported that after getting the shot yesterday, they have had diarrhea, an upset stomach, and just feeling tired out. No further information provided. More
2831638 03/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Getting the shingles vaccines didn't help at all.; This serious ... Suspected vaccination failure; Getting the shingles vaccines didn't help at all.; 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: Getting the shingles vaccines didn't help at all.). 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that, getting the shingles vaccines did not help at all. 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: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. 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
2831639 03/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; got the vaccine and still got them but a milder case; This serious ca... Suspected Vaccination failure; got the vaccine and still got them but a milder case; 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: got the vaccine and still got them but a milder case). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got them but a milder case that didn't surface on the skin and remained interior. The physician told the patient that it happens and still felt them sometimes after 9 months ago This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. 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
2831640 4 M KY 03/17/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 34MF9
Extra dose administered Extra dose administered
administred 4th dose of Pediarix; This non-serious case was reported by a other health professional ... administred 4th dose of Pediarix; 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 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. Previously administered products included Pediarix (At 2 months of age: 1st Pediarix dose), Pediarix (At 4 months of age: 2nd Pediarix dose) and Pediarix (At 6 months of age: 3rd Pediarix dose). On 27-SEP-2024, the patient received the 4th dose of Pediarix. On 27-SEP-2024, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: administred 4th dose of Pediarix). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-FEB-2025 The reporter reported that a 4 years old male patient received the vaccines fourth dose of Pediarix which led to Extra dose administered. At 4 years of age also received first Kinrix dose on 25 Feb 2025 with lot number 34MF9, expiry date 13 Feb 2026. More
2831641 F MO 03/17/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Underdose, Wrong product administered Underdose, Wrong product administered
Infanrix dose administered to an adult instead of Boostrix; patient that received a dose of Infanrix... Infanrix dose administered to an adult instead of Boostrix; patient that received a dose of Infanrix instead of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 43-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 05-MAR-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 05-MAR-2025, immediately after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix dose administered to an adult instead of Boostrix) and adult use of a child product (Verbatim: patient that received a dose of Infanrix instead of Boostrix). The outcome of the wrong vaccine administered and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-MAR-2025 Pharmacist called on behalf of a medical assistant to ask if a patient that received a dose of Infanrix instead of Boostrix could receive the latter, which led to wrong vaccine administered and adult use of a child product. The reporter consented to follow up. More
2831642 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Peripheral swelling Erythema, Peripheral swelling
Arm swollen after 1st dose of Shingles vaccine; Arm red after 1st dose of Shingles vaccine; This non... Arm swollen after 1st dose of Shingles vaccine; Arm red after 1st dose of Shingles vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm 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 swelling arm (Verbatim: Arm swollen after 1st dose of Shingles vaccine) and erythema of extremities (Verbatim: Arm red after 1st dose of Shingles vaccine). The outcome of the swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix. It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingrix. Additional Information: GSK receipt date: 06-MAR-2025 the reporter asked if she should get the 2nd dose of shingles vaccine or not. More
2831643 1.5 F 03/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2YS34
Expired product administered Expired product administered
administration of Havrix expired dose to a patient; This non-serious case was reported by a other he... administration of Havrix expired dose to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis. On 05-MAR-2025, the patient received Havrix. On 05-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administration of Havrix expired dose to a patient). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-MAR-2025 The medical assistant reported the administration of Havrix expired dose to a patient, which led to an expired vaccine used. The HCP (health care professional) requested guidance on this situation. More
2831644 1.25 M MD 03/17/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 XN575
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 15 months old male patient received a dose of Boostrix.; This non-serious case was reported by a n... A 15 months old male patient received a dose of Boostrix.; 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 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 15 months old male patient received a dose of Boostrix.). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-MAR-2025 A nurse practitioner called to report that a 15 months old patient received by error Boostrix, which led to an inappropriate age at vaccine administration. The reporter wanted to know if there was anything to be concerned of. More
2831645 1 F OH 03/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 24534
Expired product administered Expired product administered
Expired vaccine administered; This non-serious case was reported by a nurse via call center represen... Expired vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old female patient who received HAV (Havrix) (batch number 24534, expiry date 02-MAR-2025) for prophylaxis. On 07-MAR-2025, the patient received Havrix. On 07-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-MAR-2025 RN (registered nurse) reported the administration of an expired dose of Havrix to a patient, which led to an expired vaccine used. More
2831646 CO 03/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administered the Engerix-B adult dose to a 13 years old patient by accident; administered the Engeri... administered the Engerix-B adult dose to a 13 years old patient by accident; administered the Engerix-B adult dose to a 13 years old patient by accident; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 13-year-old patient who received HBV (Engerix B adult) for prophylaxis. On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: administered the Engerix-B adult dose to a 13 years old patient by accident) and adult product administered to child (Verbatim: administered the Engerix-B adult dose to a 13 years old patient by accident). The outcome of the accidental overdose and adult product administered to child were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:10-MAR-2025 The reporter reported that one of his/her providers administered the Engerix-B adult dose to a 13 years old patient by accident (6 months ago) and asked if there were there any adverse effects or concerned for the child, which led to accidental overdose and adult product administered to child. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. More
2831647 58 M IL 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
received an extra dose today; This non-serious case was reported by a other health professional via ... received an extra dose today; 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 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received a complete schedule on an unknown date). On 11-MAR-2025, the patient received the 3rd dose of Shingrix. On 11-MAR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received an extra dose today). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 11-MAR-2025 The medical assistant called to report a patient that received a complete schedule for Shingrix and received an extra dose today (on the day of reporting), which led to an extra dose administered. Medical assistant wanted guidance on this topic. No vaccine detail (lot number and expiration date) nor patient demographics were provided from the medical assistant's end. No further information was obtained or provided from the medical assistant's end in this call. More
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