🏥 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 💀 🏥 🚑 ♿ ⚠️
2845208 1 M MO 06/16/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 GG39D
Expired product administered Expired product administered
gave an expired infanrix to a patient; This non-serious case was reported by a other health professi... gave an expired infanrix 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 19-month-old male patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis. On 09-JUN-2025, the patient received Infanrix. On 09-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: gave an expired infanrix 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: 09-JUN-2025 Medical Assistant reported that we gave an expired infanrix to a patient, which led to expired vaccine used and reporter wanted to know if need to re-dose or not. The reporter was consented to follow up. More
2845209 63 F FL 06/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 4KS75
Expired product administered Expired product administered
patient received this expire dose; This non-serious case was reported by a pharmacist via call cente... patient received this expire dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number 4KS75, expiry date 03-JAN-2025) for prophylaxis. On 06-JUN-2025, the patient received Twinrix. On 06-JUN-2025, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient received this expire dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JUN-2025 The pharmacist was called and reported the following he /she was just called to see if had any extended stability information on the Twinrix vaccine or not. The reporter asked about if the product was exposed to a temperature excursion on that pharmacist answered no, it was expired. They need to know how long after the expiration date was good. The reporter asked if any patient received this expire dose on that pharmacist said yes. During the call, reported that the vaccine was administered last Friday and set this as 06-Jun-2025, which led to expired vaccine used. The reporter was consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. More
2845210 F MO 06/16/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 KR75K
27LR2
Product storage error; Product storage error Product storage error; Product storage error
A 52 years old female patient received a dose of Boostrix and a dose of Shingrix after a temperature... A 52 years old female patient received a dose of Boostrix and a dose of Shingrix after a temperature excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 27LR2, expiry date 25-MAR-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number KR75K, expiry date 27-AUG-2027) for prophylaxis. On an unknown date, the patient received Shingrix and Boostrix. On an unknown date, an unknown time after receiving Shingrix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: A 52 years old female patient received a dose of Boostrix and a dose of Shingrix after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-JUN-2025 The office manager called to ask about the stability of Boostrix and Shingrix, after a temperature excursion of minus 14 degree C for 24 hours. No prior excursion. Office Manager mentioned that they administered 1 dose of Boostrix and 1 dose of Shingrix to a 52 years old female patient after this temperature excursion, which led to Incorrect storage of drug. More
2845211 2 M GA 06/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3RE73
Wrong product administered Wrong product administered
inadvertently administered dose; This non-serious case was reported by a nurse via call center repre... inadvertently administered dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3RE73, expiry date 16-NOV-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 12-JUN-2025, the patient received Boostrix. On an unknown date, the patient received Infanrix. On 12-JUN-2025, immediately after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered dose). The outcome of the wrong vaccine 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: 12-JUN-2025 On 12 June 2025, a licensed practical nurse had called to report that she had inadvertently administered a dose of Boostrix to a 2-year-old patient instead of the scheduled dose of Infanrix earlier that same day, which led to wrong vaccine administered. She had asked how to proceed following the incorrect administration. More
2845212 38 F MD 06/16/2025 COVID19
COVID19
 MODERNA
MODERNA
 009C21A
009C21A
Blood creatine phosphokinase, Blood creatinine, Blood prolactin, Blood test, Dys... Blood creatine phosphokinase, Blood creatinine, Blood prolactin, Blood test, Dysstasia; Gait disturbance, Investigation, Lyme disease, Peripheral swelling, Protein total More
test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her under... test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area; She did swell up because her legs swells up and her feet swells up to the point one leg is bigger than the other/They swell up underneath her neck, her underarm, her groin; hard to even walk and stand; hard to even walk and stand; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Kidney failure (stage 2 kidney failure). On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYME DISEASE (test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area) (seriousness criterion medically significant). In 2021, the patient experienced PERIPHERAL SWELLING (She did swell up because her legs swells up and her feet swells up to the point one leg is bigger than the other/They swell up underneath her neck, her underarm, her groin), GAIT DISTURBANCE (hard to even walk and stand) and DYSSTASIA (hard to even walk and stand). At the time of the report, LYME DISEASE (test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area), PERIPHERAL SWELLING (She did swell up because her legs swells up and her feet swells up to the point one leg is bigger than the other/They swell up underneath her neck, her underarm, her groin), GAIT DISTURBANCE (hard to even walk and stand) and DYSSTASIA (hard to even walk and stand) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine phosphokinase: spike CK levels with creatine. On an unknown date, Blood creatinine: spike CK levels with creatine. On an unknown date, Blood prolactin: protein, her prolactin levels went up as if she was nursing again. On an unknown date, Blood test: blood levels for different things had been up and down since the vaccination. On an unknown date, Investigation: test results coming back positive for Lyme. On an unknown date, Protein total: protein, her prolactin levels went up as if she was nursing again. No concomitant medications were reported. On 20-May-2021, the first lymph node appeared underneath her left arm, and stayed for quite some time, until July 2021. The patient was still experiencing lymph nodes that came and went from underneath her underarms to her neck, as well as her groin area. They swell up underneath her neck, her underarm, her groin. She did swell up because her legs swell up and her feet swells up to the point one leg was bigger than the other at times, but it was not lymphedema. It had been like that since the vaccination in 2021. She had stage 2 kidney failure. Her leg swells up and her feet to the point she was on and off "cane" (unclear). The patient's daughter at the time was 3, she had stopped breastfeeding since she was 7 months. She was on lupus medication as well as steroids to try to get the swelling down on her legs. She had to see all different kinds of specialists from a vascular specialist doctor to a neurologist, she had different tests done to see what was going on because it triggered so bad after that to the point, she had work accommodation set at her job from the doctor because it was hard to even walk and stand at times.; Reporter's Comments: Concurrent medical conditions Kidney failure is a confounder for the events. Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2845213 58 M AR 06/16/2025 COVID19
COVID19
 MODERNA
MODERNA

Blood pressure measurement, Blood testosterone, Blood testosterone decreased, Ch... Blood pressure measurement, Blood testosterone, Blood testosterone decreased, Chest injury, Contusion; Loss of consciousness, Neck pain, Systemic lupus erythematosus, Weight More
diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain; ... diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain; pass out; "mess up" his ribs; pain in his neck; decrease in testosterone levels; bruises; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain), LOSS OF CONSCIOUSNESS (pass out) and CHEST INJURY ("mess up" his ribs) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), CHEST INJURY ("mess up" his ribs) (seriousness criterion medically significant), NECK PAIN (pain in his neck), BLOOD TESTOSTERONE DECREASED (decrease in testosterone levels) and CONTUSION (bruises). The patient was treated with Acetylsalicylic acid (Aspirin) at an unspecified dose and frequency and Testosterone at an unspecified dose and frequency. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain), LOSS OF CONSCIOUSNESS (pass out), CHEST INJURY ("mess up" his ribs), NECK PAIN (pain in his neck) and CONTUSION (bruises) had not resolved and BLOOD TESTOSTERONE DECREASED (decrease in testosterone levels) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: very high blood pressure. On an unknown date, Blood testosterone: decrease in testosterone levels. On an unknown date, Weight: lost a lot of weight. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient took Moderna Covid vaccines in 2021 and after 2 weeks patient felt bad, his liver and kidney were not working properly, had a lot of diarrheas and vomiting and he also lost a lot of weight. Doctors were not able to treat him but finally diagnosed him with Lupus. He reported that no one in his family had lupus and that the mRNA vaccine must have played in his DNA to change it and caused this disease. It was reported that he had been going on with this condition for 5 years. He tried from time to time to gain back his weight. But then sometimes he would need to take an aspirin, or any medication and it would make him feel as if his skin was on fire. It was also reported that his body was rejecting everything. He also experienced a lot of pain in his joints, and he lost his hair due to decrease in testosterone levels and he now needs to take testosterone injections. He also mentioned that after the vaccine he developed very high blood pressure, that would cause pain in his neck, and he would then pass out and hit the floor and he would have bruises and mess up his ribs. It was unknown if the patient experienced any additional symptoms or events; Reporter's Comments: Company comment: Events chest injury and contusion were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report. More
2845214 75 F 06/16/2025 COVID19
 MODERNA
 3046731
Fatigue, Heart rate, Heart rate abnormal, Palpitations, Paraesthesia Fatigue, Heart rate, Heart rate abnormal, Palpitations, Paraesthesia
Day she woke up and was exhausted "it felt like I had ran a marathon; Her heart seemed to be ra... Day she woke up and was exhausted "it felt like I had ran a marathon; Her heart seemed to be racing; Her hands and feet began to tingle; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Her heart seemed to be racing), PARAESTHESIA (Her hands and feet began to tingle) and FATIGUE (Day she woke up and was exhausted "it felt like I had ran a marathon) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. The patient's past medical history included Heart attack (Between 2010-2016, experienced several "broken heart" heart attacks due to stress.) and Stress. On 03-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 03-May-2025, the patient experienced PALPITATIONS (Her heart seemed to be racing) and PARAESTHESIA (Her hands and feet began to tingle). On 04-May-2025, the patient experienced FATIGUE (Day she woke up and was exhausted "it felt like I had ran a marathon). At the time of the report, PALPITATIONS (Her heart seemed to be racing), PARAESTHESIA (Her hands and feet began to tingle) and FATIGUE (Day she woke up and was exhausted "it felt like I had ran a marathon) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: heart rate was 122 bpm and heart rate was down to the 50s. On an unknown date, Heart rate abnormal: heart rate continued to go up and down for 5 hours.. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not provided. Reporter causality was not reported. Patient took no other vaccines within the past 4 weeks. It was reported that the patient tends to have alternate reactions with her COVID vaccines. She stated that she did not had anything that day at all, but 7 to 8 hours after receiving the vaccine, she sat down after dinner and noticed her heart seemed to be racing and her heart rate was 122 bpm on her fit bit which seemed a little high for her and within a minute later, her hands and feet began to tingle and her heart rate was down to the 50s. She stated that her heart rate continued to go up and down for 5 hours. Around midnight her heart rate seemed to have settled and the next day she woke up and was exhausted and it felt to her like she had ran a marathon. It was reported that 2 months before she received a comprehensive cardiac checkup and everything was normal. She filed an adverse reaction within the CDC online and had discussed this and future vaccines with her family physician and pharmacist and she will be seeing her cardiologist that next day. Treatment information was not reported. More
2845215 85 F NC 06/16/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Neck pain, Pruritus, Vaccination site erythema, Vaccination site mass, Vaccinati... Neck pain, Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pain; Vaccination site pruritus, Vaccination site swelling More
she experienced pain in her arm, redness, itching, a lump was left at the injection site/Having a lo... she experienced pain in her arm, redness, itching, a lump was left at the injection site/Having a lot of pain since had the shot; she experienced pain in her arm, redness, itching, a lump was left at the injection site; she experienced pain in her arm, redness, itching, a lump was left at the injection site; she experienced pain in her arm, redness, itching, a lump was left at the injection site; Rising on arm where like a indention cause swollen; itching and pain in her neck as well; itching and pain in her neck as well; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 85-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 14Jun2021 (ongoing), notes: It was placed 14Jun2021; "Blood pressure high" (unspecified if ongoing); "Pain" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: SOTALOL HCL oral taken for cardiac disorder (ongoing); DILT-XR oral taken for cardiac disorder (ongoing); LOSARTAN oral taken for hypertension (ongoing); HYDROCHLOROTHIAZID oral taken for hypertension (ongoing); WARFARIN oral taken for thrombosis prophylaxis (ongoing); ACETAMINOPHEN taken for pain (ongoing); SPIRIVA RESPIMAT taken for chronic obstructive pulmonary disease (ongoing). Vaccination history included: comirnaty (DOSE 1, SINGLE, Location of injection/shot: 0.3ml in arm, probably left arm, lot number: EK9231, Expiry date:30Apr2021, Also sees listed bud. 6hrs at right), administration date: 24Jan2021, when the patient was 81-year-old, for Covid-19 immunization; comirnaty (DOSE 2, SINGLE, Location of injection/shot: 0.3ml in left arm, lot number: EL964, Expiry date:03May2021), administration date: 14Feb2021, when the patient was 81-year-old, for Covid-19 immunization; comirnaty (DOSE 3 (BOOSTER), SINGLE, Location of injection/shot: right arm, lot number: FF8841, quantity 0.3, Expiry date:31Dec2021, Also, sees listed HCP She then stated it might have been the right arm she received all these previous dose), administration date: 09Sep2021, when the patient was 81-year-old, for Covid-19 immunization; comirnaty (DOSE 4 (BOOSTER), SINGLE, Location of injection/shot: think in right arm, lot number: SK9895, Expiry date:30Jun2022), administration date: 02Apr2022, when the patient was 82-year-old, for Covid-19 immunization; comirnaty original/omicron ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Location of injection/shot: Right arm, lot number: GH9697, Expiry date:15Dec2023), administration date: 18Oct2022, when the patient was 82-year-old, for Covid-19 immunization; comirnaty original/omicron ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Location of injection/shot: left arm, lot number: GL0447, Expiry date:31Jan2024), administration date: 23Apr2023, when the patient was 83-year-old, for Covid-19 immunization; comirnaty omicron xbb.1.5 (DOSE 7 (BOOSTER), SINGLE, Location of injection/shot: going to say right arm, lot number: HG4680, Expiry date:31Dec2023), administration date: 10Oct2023, when the patient was 83-year-old, for Covid-19 immunization; comirnaty kp.2 (DOSE 8 (BOOSTER), SINGLE, Location of injection/shot: going to say right arm, lot number: LM2216, Expiry date:10Mar2025), administration date: 01Sep2024, when the patient was 84-year-old, for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 09May2025, outcome "not recovered", described as "Rising on arm where like a indention cause swollen"; PRURITUS (non-serious), NECK PAIN (non-serious) all with onset 09May2025, outcome "not recovered" and all described as "itching and pain in her neck as well"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09May2025, outcome "recovered" (May2025), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE MASS (non-serious) all with onset 09May2025, outcome "not recovered" and all described as "she experienced pain in her arm, redness, itching, a lump was left at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 09May2025, outcome "not recovered", described as "she experienced pain in her arm, redness, itching, a lump was left at the injection site/Having a lot of pain since had the shot". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema. Additional information: Patient received a COVID-19 Boost and wants to know if there's anything she can do, if experiencing pain after getting the shot. Her PCP recommended voltaren. Patient got the boost on 08May2025 of this year, and she experienced pain in her arm, redness, itching, a lump was left at the injection site. Patient mentioned having itching and pain in her neck as well. Patient expected her symptoms to last for a week, however her symptoms have being going on since May. Patient Investigations was reported as no. Patient had a lot of pain since had the shot. Patient has a rising on arm where like a indention cause it's swollen. It's like a knot there. Patient had been taking acetaminophen and called the doctor who suggested, Voltaren. Having a lot of pain since had the shot: Arm was sore 09May2025 and then from then on had redness and itching, Redness: Clarified the redness has gone away. This went away like a week later. Treatment/Intervention: patient clarified she had just started the Voltaren. Patient just kept thinking it would go away. The pain had not impaired her. Patient cannot do anything because patient was so sore. The pain was moving up to neck to the top of shoulder. Confirmed the issues that patient had in the right arm. This was where patient was having the issues and the same arm where patient received this dose. The patient received any other vaccines on the same date as the Pfizer vaccine and the patient received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine was reported as no. The patient did not visit Emergency Room/Physician's Office for any of the reported event. The patient was hospitalized was reported as N/A. Any adverse events following the historical vaccination and allergic to any previous vaccination, medications, food or other products were reported as no. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2845216 F 06/16/2025 COVID19
 PFIZER\BIONTECH
Herpes zoster Herpes zoster
shingles; This is a spontaneous report received from a Consumer or other non HCP from medical inform... shingles; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "cardiac issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Additional information: Patient mentioned that around the year 2021 - 2022 she got the 2nd shot Pfizer Covid 19 Vaccine and got Shingles afterwards and she said that shingles were terrible. No follow-up attempts are possible. More
2845217 F 06/16/2025 COVID19
 PFIZER\BIONTECH
Breast cancer recurrent, Computerised tomogram, Magnetic resonance imaging, Posi... Breast cancer recurrent, Computerised tomogram, Magnetic resonance imaging, Positron emission tomogram, Thymic carcinoma More
thymic carcinoma; recurrent breast cancer; This is a spontaneous report received from a Consumer or ... thymic carcinoma; recurrent breast cancer; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer female" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, lot number: 006M2014, IM), administration date: 12Feb2021, for COVID-19 immunisation, reaction(s): "Drug ineffective", "Interchange of vaccine products", "COVID-19"; moderna COVID-19 vaccine (DOSE 2, SINGLE, lot number: 0016219, IM), administration date: 12Mar2021, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, lot number: 047C2114, IM), administration date: 22Oct2021, for COVID-19 immunisation, reaction(s): "Drug ineffective", "Interchange of vaccine products", "COVID-19"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, lot number: FK9895, IM), administration date: 30Mar2022, for COVID-19 immunisation, reaction(s): "Drug ineffective", "Interchange of vaccine products", "COVID-19"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 09Sep2022, for COVID-19 immunisation, reaction(s): "cold", "sore arm". The following information was reported: THYMIC CARCINOMA (medically significant), outcome "unknown"; BREAST CANCER RECURRENT (medically significant), outcome "unknown", described as "recurrent breast cancer". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown Results; Magnetic resonance imaging: Unknown Results; Positron emission tomogram: thymic carcinoma, notes: thymic carcinoma was identified during PET scan. Therapeutic measures were taken as a result of thymic carcinoma. Clinical course: Caller stated that she had her thymus removed due to a rare form of cancer known as "thymic carcinoma". According to the caller, thymic carcinoma was identified during PET scan, which was performed due to the caller's "recurrent breast cancer", along with an MRI and CAT scan. Caller was informed, by HCP, that "vaccines would not be as effective" with her thymus removed. Caller added that she has received "all eight shots" and that she is 76 years of age. In conclusion, caller was interested in information regarding whether the "potency" of the Pfizer COVID-19 vaccine would be affected due to her thymus having been removed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2845218 06/16/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Immunisation reaction, Pain, Pyrexia; Immunisation reaction, Pain, Pyrexia Immunisation reaction, Pain, Pyrexia; Immunisation reaction, Pain, Pyrexia
serious adverse effects; sick afterwards, like a fever and body aches; sick afterwards, like a fever... serious adverse effects; sick afterwards, like a fever and body aches; sick afterwards, like a fever and body aches; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (medically significant), outcome "unknown", described as "serious adverse effects"; PYREXIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "sick afterwards, like a fever and body aches". The patient reported she would usually take them on the weekend because she knew she was going to be sick afterwards, like a fever and body aches, etc. Company Comment: The causality of the event Immunisation reaction, Pain and Pyrexia was assessed conservatively as related, due to the unknown temporal association and limited information provided. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event immunization reaction based on the known safety profile and temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate. More
2845219 IN 06/16/2025 COVID19
 PFIZER\BIONTECH
Therapeutic response unexpected Therapeutic response unexpected
had "virago"/always needed a walker/had bad allergies/got a nail fungus; after the second ... had "virago"/always needed a walker/had bad allergies/got a nail fungus; after the second shot, wasn't dizzy/walked without a walker/allergies and nail fungus cleared up/asthma got better; 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Virago" (unspecified if ongoing), notes: always needed a walker; "always needed a walker" (unspecified if ongoing); "bad allergies" (unspecified if ongoing), notes: couldn't be outside; "nail fungus" (unspecified if ongoing), notes: was in 70's had first manicure, got nail fungus so bad/thought about getting thumb nails removed; "Dizzy" (unspecified if ongoing); "asthma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had "virago"/always needed a walker/had bad allergies/got a nail fungus; after the second shot, wasn't dizzy/walked without a walker/allergies and nail fungus cleared up/asthma got better". Additional information: The patient reported it was a miracle what Pfizer COVID-19 original vaccine did. The patient had vertigo/'virago" (as reported) and always needed a walker. The patient had bad allergies couldn't be outside. In the patient's 70's, the patient had their first manicure got a nail fungus so bad they thought about getting thumb nails removed. About 6 or 7 days after the second shot, the patient woke up, sat up and wasn't dizzy. Vertigo was gone. The patient walked around house without a walker. The patient could walk outside. The patient's allergies and nail fungus cleared up. Asthma got so much better and all the patient has to do was carry an inhaler. It worked for year 2 but with the changes, vertigo, allergies and asthma were coming back. The patient stated, "I need the original vaccine" as all was coming back. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2845220 54 F CA 06/16/2025 YF
 SANOFI PASTEUR
 UK134AA
Product preparation error Product preparation error
the vaccine was mixed with the incorrect diluent of sterile water with no reported AE; Initial infor... the vaccine was mixed with the incorrect diluent of sterile water with no reported AE; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 54 years old female patient who was administered yellowfever vaccine- [YF-VAX] that was mixed with the incorrect diluent of sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jun-2025, the patient received a dose of 0.5 ml of suspect yellowfever vaccine- solution for injection (lot UK134AA, strength: standard and frequency: once) (expiry date not reported) via unknown route in the left arm for immunization and was mixed with the incorrect diluent of sterile water with no reported adverse event (product preparation error) (Latency: same day). Reportedly, The pharmacist reported that 2 consumers received a medication error with the YF vaccine, that the consumers are family members. 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.; Sender's Comments: US-SA-2025SA166823:consumer 2 More
2845221 CA 06/16/2025 FLU3
 SANOFI PASTEUR
Vaccination error Vaccination error
whether there had been any specific instances of one Sanofi flu vaccine being mistaken for another a... whether there had been any specific instances of one Sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event; Initial information received on 12-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient for whom influenza usp trival a-b subvirion no preservative vaccine [Fluzone], there had been any specific instances of one sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect influenza usp trival a-b subvirion no preservative vaccine; Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization; whether there had been any specific instances of one sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been with no reported adverse event (wrong product administered) (latency: same day) Reportedly: She states that they have some new staff that is coming on board in the near future, and they are putting together training materials for them related to flu vaccination. When the nurse was asked whether there had been any specific instances of one Sanofi flu vaccine being mistaken for another and administered to a patient, she said that historically there may have been, but she cannot say for sure, and she does not have any information on any specific instances Action taken was not applicable. Information on the batch number was requested corresponding to the one at time of event occurrence. 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
2845222 IN 06/16/2025 YF
 SANOFI PASTEUR
 UK137AA
No adverse event, Product preparation error No adverse event, Product preparation error
suspects pharmacist reconstituted using sterile water with no reported adverse event; Initial inform... suspects pharmacist reconstituted using sterile water with no reported adverse event; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient for whom yellow fever vaccine - [YF-VAX] pharmacist reconstituted using sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine; Solution for injection with unknown strength (lot UK137AA with expiry date 31-JAN-2026) via unknown route in unknown administration site for Immunization; pharmacist reconstituted using sterile water with no reported adverse event (product preparation error) (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
2845226 18 M MA 06/16/2025 VARCEL
 MERCK & CO. INC.
 X028612
Product storage error Product storage error
No additional AE; Inbound call received from a nurse who said improperly stored doses of VARIVAX wer... No additional AE; Inbound call received from a nurse who said improperly stored doses of VARIVAX were administered to at least one patient.; This spontaneous report was received from a Nurse and refers to a(n) 18-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included seizure disorder. Concomitant medications included Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid), Hbhepb (Hepatitis b vaccine;HIB vaccine) . On 05-May-2025, the patient was vaccinated with an improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #X028612, expiration date: 13-Dec-2025), dose number 1, diluted in sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported) and were administered by Subcutaneous route in the Left Arm for prophylaxis. The vaccine had been exposed to a temperature of -11.31 C for 28 minutes. There were no previous temperature excursions. No adverse event was reported. This is one of two reports from the same reporter. More
2845227 M NY 06/16/2025 MMR
 MERCK & CO. INC.
Pallor, Urticaria Pallor, Urticaria
A FBE called to report an AE on behalf of an HCP for MMR II. The FBE stated she spoke with the HCP l... A FBE called to report an AE on behalf of an HCP for MMR II. The FBE stated she spoke with the HCP last Tuesday, 06/10/2025, then went out of town, and was just getting back to town and wanted to call and report the AE but the HCP also told the FBE t; This spontaneous report was received from a Physician and refers to a 4-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included rash. Historical drugs included COVID-19 vaccine (COVID-19 vaccine). Concomitant therapies were not reported. On an unknown date, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered by Unknown route (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). On an unknown date, the patient experienced hives on his shoulder and back that "blanched" within an unknown time-frame after the injection. The HCP stated she administered an antihistamine which improved the reaction of hives but when the antihistamine wore off, the hives would return until the hives resolved and got better all together on an unknown date or time-frame. The patient recovered/resolved from the event on an unspecified date. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent (reported as reaction from MMR II).; Reporter's Comments: More
2845228 M 06/16/2025 YF
 SANOFI PASTEUR
Pain, Pharyngitis, Pyrexia Pain, Pharyngitis, Pyrexia
body aches; throat infection; high fever; Initial information received on 12-Jun-2025 regarding an u... body aches; throat infection; high fever; Initial information received on 12-Jun-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves an unknown age male patient who had high fever, body aches and throat infection after receiving yellow fever vaccine - [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jun-2025, the patient received an unknown dose of suspect yellow fever vaccine, Solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On 12-Jun-2025 the patient developed high fever (pyrexia), body aches (pain) and throat infection (pharyngitis) (Latency: 3 days). Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. More
2845229 5 F TN 06/16/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK224AC
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
a 5 year and 1-day old patient was given PENTACEL with no reported adverse event; Initial informatio... a 5 year and 1-day old patient was given PENTACEL with no reported adverse event; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years and 1 day old female patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] 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 measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for prophylactic vaccination (Immunisation). On 11-Jun-2025, the patient received a dose of 0.5 ml (dose 5) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UK224AC and expiry date 31-Jul-2026) (strength: standard and frequency: once) via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (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
2845230 16 F IL 06/16/2025 HPV9
 MERCK & CO. INC.
 Y007991
Extra dose administered Extra dose administered
Pt given Gardasil injection IM to L deltoid, was not ordered (previous Gardasil vaccines given 6/16/... Pt given Gardasil injection IM to L deltoid, was not ordered (previous Gardasil vaccines given 6/16/20 and 8/2/21) More
2845231 61 F 06/16/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P2443.
P2443.
Chills, Dark circles under eyes, Decreased appetite, Diarrhoea, Headache; Influe... Chills, Dark circles under eyes, Decreased appetite, Diarrhoea, Headache; Influenza like illness, Pain, Pyrexia More
Patient experienced severe flu-like symptoms such as fever, chills, body aches, excessive diarrhea, ... Patient experienced severe flu-like symptoms such as fever, chills, body aches, excessive diarrhea, loss of appetite, black circles under her eyes, and severe headache. Patient has taken ibuprofen for the body aches and has been rehydrating with plenty of water and gatorade More
2845239 1 M 06/16/2025 HEPA
HIBV
MMRV
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.




Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Patient came to immunizations clinic for vaccines. Pt was given a dose of MMRII and Varicella along ... Patient came to immunizations clinic for vaccines. Pt was given a dose of MMRII and Varicella along with Hep A, Hib, Prevnar 20,. Patient was informed and was spoken to by the provider about adverse affects. Reports were made. More
2845240 1 F TX 06/16/2025 HEPA
MMR
PNC20
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 Y008483
Y014096
LN4929
Y019318
Rash, Rash vesicular; Rash, Rash vesicular; Rash, Rash vesicular; Rash, Rash ves... Rash, Rash vesicular; Rash, Rash vesicular; Rash, Rash vesicular; Rash, Rash vesicular More
On 6/11/2025, patient began to have vesicular rash that arose on legs, spread to arms, face in a wid... On 6/11/2025, patient began to have vesicular rash that arose on legs, spread to arms, face in a widespread distribution. No other symptoms noted. Seen by Dr. on 6/16/2025, noted to have widespread blisters, no mucosal lesions. Blister on hairline leaking clear fluid. More
2845241 43 F WA 06/16/2025 TDAP
 SANOFI PASTEUR
Wrong product administered Wrong product administered
Agreed to get the Tetanus shot. Multiple nurses and the doctor said they would "update" my... Agreed to get the Tetanus shot. Multiple nurses and the doctor said they would "update" my tetanus since its been 20 years (according to myself). Get home the next day looking at my paperwork, i was given the Tdap NOT just a regular tetanus. I was mislead. Only vaccine i have had in my life is the Tetanus so this makes me very angry and considering taking action! More
2845242 64 F TX 06/16/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LV4483
F95YS
Injection site rash, Injection site swelling, Injection site warmth, Rash; Injec... Injection site rash, Injection site swelling, Injection site warmth, Rash; Injection site rash, Injection site swelling, Injection site warmth, Rash More
Patient picked up medication on 6/16/25 for an abscess unrelated to the vaccine. At counseling, pati... Patient picked up medication on 6/16/25 for an abscess unrelated to the vaccine. At counseling, patient requested to speak to pharmacist in private. Patient reported severe swelling warm to touch at injection site for at least 4 days after administered doses of Prevnar21 and Shingrx on 6/10/2025 (about a week ago). As of 6/16/25 showed rash covering upper left arm below injection site. In addition, patient reported rash along the right side of her neck. Patient made an appointment with her PCP on 6/17/25 to look into her reaction because the rash is still present. According to patient, treatment at home included cold compress to help with the swelling around injection sites. More
2845243 63 M VA 06/16/2025 VARCEL
 MERCK & CO. INC.
 Y015557
Wrong product administered Wrong product administered
WE HAVE BEEN ADMINISTERED VARIVAX VACCINE INSTEAD OF MMR VACCINE WE HAVE BEEN ADMINISTERED VARIVAX VACCINE INSTEAD OF MMR VACCINE
2845016 1.25 M MI 06/15/2025 DTAP
HIBV
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH


Febrile convulsion, Protein urine present, Pyrexia; Febrile convulsion, Protein ... Febrile convulsion, Protein urine present, Pyrexia; Febrile convulsion, Protein urine present, Pyrexia; Febrile convulsion, Protein urine present, Pyrexia More
Fever of 102.7, Febrile seizure within 5 hours of fever beginning Fever of 102.7, Febrile seizure within 5 hours of fever beginning
2845017 33 F MO 06/15/2025 PNC21
 MERCK & CO. INC.
 Y019158
Injection site nodule, Injection site warmth Injection site nodule, Injection site warmth
patient experienced a knot develop at the site of administration that was warm to the touch that res... patient experienced a knot develop at the site of administration that was warm to the touch that resolved a few days after. More
2845018 18 F FL 06/15/2025 MNQ
 SANOFI PASTEUR
Extra dose administered, No adverse event, Wrong product administered Extra dose administered, No adverse event, Wrong product administered
This was given as an extra dose. Patient wanted to receive Bexsero. No adverse effects reported. ... This was given as an extra dose. Patient wanted to receive Bexsero. No adverse effects reported. Patient will receive Bexsero at a future date. More
2845019 56 F MD 06/15/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL0142
EL0142
EL0142
EL0142
EL0142
EL0142
EL0142
EL0142
EL9262
EL9262
EL9262
EL9262
EL9262
EL9262
EL9262
EL9262
Anaemia, Anti-cyclic citrullinated peptide antibody positive, Anxiety, Arthralgi... Anaemia, Anti-cyclic citrullinated peptide antibody positive, Anxiety, Arthralgia, Arthritis; Asthenia, Autoimmune thyroiditis, Blood cholesterol increased, Blood glucose increased, Bronchiolitis; Cough, Fatigue, Gait inability, General physical health deterioration, Glucose tolerance impaired; Haematocrit decreased, Haemoglobin decreased, Hypercholesterolaemia, Hypertension, Immunisation reaction; Impaired driving ability, Impaired quality of life, Joint swelling, Laboratory test, Loss of personal independence in daily activities; Menopausal symptoms, Mouth ulceration, Musculoskeletal disorder, Oral candidiasis, Pain; Red blood cell count decreased, Rheumatoid arthritis, Sick building syndrome, Soft tissue swelling, Stress; Vitamin B12 deficiency, X-ray limb abnormal; Anaemia, Anti-cyclic citrullinated peptide antibody positive, Anxiety, Arthralgia, Arthritis; Asthenia, Autoimmune thyroiditis, Blood cholesterol increased, Blood glucose increased, Bronchiolitis; Cough, Fatigue, Gait inability, General physical health deterioration, Glucose tolerance impaired; Haematocrit decreased, Haemoglobin decreased, Hypercholesterolaemia, Hypertension, Immunisation reaction; Impaired driving ability, Impaired quality of life, Joint swelling, Laboratory test, Loss of personal independence in daily activities; Menopausal symptoms, Mouth ulceration, Musculoskeletal disorder, Oral candidiasis, Pain; Red blood cell count decreased, Rheumatoid arthritis, Sick building syndrome, Soft tissue swelling, Stress; Vitamin B12 deficiency, X-ray limb abnormal More
Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild ... Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers. These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment. More
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2845020 65 M PA 06/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55th4
Dizziness, Injection site erythema Dizziness, Injection site erythema
pain redness injection site and dizziness day after...dizziness resolved 2nd day, still red pain redness injection site and dizziness day after...dizziness resolved 2nd day, still red
2845021 50 F IL 06/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Fatigue, Injection site erythema, Injection site warmth Chills, Fatigue, Injection site erythema, Injection site warmth
patient had severe s/e of chills, fatigue , sight of injection was warm at touch and redness was pat... patient had severe s/e of chills, fatigue , sight of injection was warm at touch and redness was patchy it seemed like patient had an allergic reaction More
2845022 54 F KS 06/15/2025 PNC21
 MERCK & CO. INC.
Erythema, Injection site erythema, Injection site pain Erythema, Injection site erythema, Injection site pain
There is redness extending outward from the injection site around to my armpit. It is approximately ... There is redness extending outward from the injection site around to my armpit. It is approximately 2-3 inches wide and 3-4 inches wide circling the arm. It is not hot to the touch but is still very tender withing the border of the redness/irritation. It does not itch. The redness was noticed on 14 June 2025, two days after injection. More
2845023 49 F HI 06/15/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 026L21B
026L21B
026L21B
026L21B
026L21B
Asthenia, Autonomic nervous system imbalance, Cardiac stress test, Catheterisati... Asthenia, Autonomic nervous system imbalance, Cardiac stress test, Catheterisation cardiac, Chest pain; Dizziness, Dyspnoea, Electrocardiogram ambulatory abnormal, Exercise tolerance decreased, Fatigue; Gastrointestinal disorder, Heart rate increased, Impaired work ability, Laboratory test, Loss of consciousness; Platelet rich plasma therapy, Presyncope, Scan, Stress, Syncope; Temperature regulation disorder, Vision blurred More
Development of dysautonomia. I got my covid vaccine (one of several but I think this was my 1st Mod... Development of dysautonomia. I got my covid vaccine (one of several but I think this was my 1st Moderna) Feb 22, 2022. On April 14, 2022 I had my 1st episode of high HR and passed out (I had had plasma knee inj the day before). I then have another episode of syncope later in the summer when I was at the amusement park and started being more careful about hydration and heat. Fast forward to my move March 2023. By May I was noticing high heart rate but it was too fast to really count accurately then I got my Apple watch and it verified that my heart rate was high at times. I noticed SOB and pre syncope walking up the big hill and just activity intolerance overall. Then Aug was my daughter s wedding (stressful) and then 10d later we lost someone (my nephew that committed suicide). With all the stress of the move, the wedding, the death it all snowballed and by Oct to Dec is when I remember the profound fatigue starting. Fast forward to now and I suffer daily from debilitating symptoms- fatigue, SOB, CP, GI symptoms, dizziness, blurry vision, & temperature dysregulation. I am no longer able to work FT. More
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2845024 19 F IL 06/15/2025 COVID19
 PFIZER\BIONTECH
Melanocytic naevus, Mole excision Melanocytic naevus, Mole excision
Two moles with mild and moderate atypia with positive margins that needed further removal. Two moles with mild and moderate atypia with positive margins that needed further removal.
2845025 61 M WA 06/15/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 016B21A
016B21A
016B21A
016B21A
012521A
012521A
012521A
012521A
03B21A
03B21A
03B21A
03B21A
Acute kidney injury, Arthralgia, Brain fog, Computerised tomogram abdomen abnorm... Acute kidney injury, Arthralgia, Brain fog, Computerised tomogram abdomen abnormal, Diarrhoea; Dyspnoea, Fatigue, Generalised oedema, Hypoaesthesia, Joint effusion; Magnetic resonance imaging abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Tendon disorder, Tendon rupture; Tenosynovitis, Vertebral foraminal stenosis; Acute kidney injury, Arthralgia, Brain fog, Computerised tomogram abdomen abnormal, Diarrhoea; Dyspnoea, Fatigue, Generalised oedema, Hypoaesthesia, Joint effusion; Magnetic resonance imaging abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Tendon disorder, Tendon rupture; Tenosynovitis, Vertebral foraminal stenosis; Acute kidney injury, Arthralgia, Brain fog, Computerised tomogram abdomen abnormal, Diarrhoea; Dyspnoea, Fatigue, Generalised oedema, Hypoaesthesia, Joint effusion; Magnetic resonance imaging abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Tendon disorder, Tendon rupture; Tenosynovitis, Vertebral foraminal stenosis More
Patient developed numbness and tingling in his extremities starting February 2022. This progressed ... Patient developed numbness and tingling in his extremities starting February 2022. This progressed to arthralgias that were severe and associated with labored breathing, fatigue, generalized swelling including of the prostate, brain fog and moments of deep insight over the summer and fall of 2022. He dealt with these symptoms for over 2 years. He also had an episode of severe diarrhea and acute kidney injury March 2024. More
2845026 21 M WI 06/15/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Dizziness Dizziness
After receiving vaccine patient became light headed. Laid patient down, applied cold pack and sympto... After receiving vaccine patient became light headed. Laid patient down, applied cold pack and symptoms resolved. Patient appeared recovered after leaving pharmacy. More
2845027 78 M IN 06/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Pruritus, Rash, Urticaria Pruritus, Rash, Urticaria
Patient had reported a rash/hives 2 days after receiving vaccine. Patient called asking what OTC pr... Patient had reported a rash/hives 2 days after receiving vaccine. Patient called asking what OTC product they could use for itching and mentioned it may have been from the vaccine because the same rash occurred after the first dose. The rash was reported to be all over the body, including the trunk and legs, but not the face. More
2845028 15 M HI 06/15/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8729
ER8729
Antinuclear antibody, Blood test, Culture urine, Double stranded DNA antibody, M... Antinuclear antibody, Blood test, Culture urine, Double stranded DNA antibody, Myocarditis; Respiratory viral panel, Urine analysis More
Myocarditis Myocarditis
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2845046 16 M NJ 06/15/2025 MNQ
 SANOFI PASTEUR
Abdominal pain, Vomiting Abdominal pain, Vomiting
Pt reports 3 episodes of nbnb vomiting within 6 hours of MCV vaccine given at pediatricians office y... Pt reports 3 episodes of nbnb vomiting within 6 hours of MCV vaccine given at pediatricians office yesterday 6/14/2025. Patient seen by myself at Urgent Care on 6/15/2025 for continued vomiting/abd pain. Pt threw up again today and has been complaining of abdominal pain since yesterday, 7/10 to umbilicus. No diarrhea or dizziness. More
2845047 45 F CA 06/15/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN9581 (01/29/2
EN6201 (02/18/2
Bell's palsy, Diplopia, Magnetic resonance imaging spinal abnormal, Multipl... Bell's palsy, Diplopia, Magnetic resonance imaging spinal abnormal, Multiple sclerosis; Bell's palsy, Diplopia, Magnetic resonance imaging spinal abnormal, Multiple sclerosis More
Double vision, Bells Palsy Double vision, Bells Palsy
2845048 66 F CO 06/15/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 Lx2497
47n3y (diluent
Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
Via phone on 6/14/25, patient reported that she had woken up with redness and puffiness in the area ... Via phone on 6/14/25, patient reported that she had woken up with redness and puffiness in the area where her injections were given on 6/13/25. Patient confirmed that area was hot to the touch when asked. Patient was asked to go to urgent care to be seen. Patient was seen at Urgent care on both 6/14/25 and 6/15/25. Via phone, PA stated that the patient appeared to have an injection site reaction. Prescribed antibiotics for patient prophylactically and stated that patient was not ill appearing. Patient will return to the urgent care for an additional follow up visit on 6/17/25. More
2845049 16 M OR 06/15/2025 HPV9
 MERCK & CO. INC.
 1957407
Rash, Rash pruritic, Skin burning sensation Rash, Rash pruritic, Skin burning sensation
Burning and itching rash right wrist area Burning and itching rash right wrist area
2845050 CO 06/15/2025 MMR
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS

Generalised oedema, Pain; Generalised oedema, Pain Generalised oedema, Pain; Generalised oedema, Pain
Over all body swelling and pain Over all body swelling and pain
2844989 12 M TN 06/14/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Amnesia, Cardiac arrest, Cardioversion; Amnesia, Cardiac arrest, Cardioversion Amnesia, Cardiac arrest, Cardioversion; Amnesia, Cardiac arrest, Cardioversion
cardiac arrest; short term memory loss; This spontaneous report was received from a Physician and re... cardiac arrest; short term memory loss; This spontaneous report was received from a Physician and refers to a 13-year-old male patient with no known history of cardiac events, family history, or reaction to 1st dose of GARDASIL-9. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-MAY-2025, the patient received his second dose of Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9), (lot # and expiration date were not reported) for prophylaxis. On 02-JUN-2025, the patient experienced cardiac arrest at his lacrosse practice. The patient sought medical attention, was shocked 3 times and witnessed short term memory loss and has since recovered. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9) was not provided. Upon internal review, the event of cardiac arrest was determined to be medically significant. Follow up information was received by telephone on 09-Jun-2025. It was reported that the patient had a diagnosis of Cranial stenosis as an infant. On 19-Jun-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9) (lot #, expiration date, strength, route of administration, anatomical location not provided); and on 23-May-2025, he received the second dose of the vaccine (lot #, expiration date, strength, anatomical location not provided), both as prophylaxis. On this date, the patient's height was 61.5 inches, weight was 94.5 lbs and his blood pressure was 120/60 (units not provided). No other vaccinations were administered this day. On 27-May-2025, the patient experienced the events of cardiac arrest and amnesia (previously reported as 02-Jun-2025). Lot # is being requested and will be submitted if received.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-06-09 , MNSC number : 02815081 , CLIC number : , ESTAR number : , IRMS number : US-009507513-2292076 , Central date : 2025-06-09 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : US-009507513-2292076 More
2844998 10 F 06/14/2025 MNQ
MNQ
TDAP
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Z92L4
Z92L4
D4J9L
D4J9L
Cold sweat, Crying, Erythema, Fear, Immediate post-injection reaction; Loss of c... Cold sweat, Crying, Erythema, Fear, Immediate post-injection reaction; Loss of consciousness, Pallor, Posture abnormal, Strabismus, Visual impairment; Cold sweat, Crying, Erythema, Fear, Immediate post-injection reaction; Loss of consciousness, Pallor, Posture abnormal, Strabismus, Visual impairment More
After administration of vaccines, agreed to meet family in lobby with updated vaccine records and fo... After administration of vaccines, agreed to meet family in lobby with updated vaccine records and forms. Mom did mention pateient's eyes appeared to cross briefly during administration of second (menveo) vaccine. Patient remained sitting talking to mom/nurse. When RN bringing forms out, PSR coming to back to alert me patient passed out. After stepping through door, this RN observed patient sitting leaning toward mom crying and a little red/visibly upset. Mom reports patient was sitting in chair when she passed out for a few seconds - closing her eyes, drained color, and slumped in chair. Patient verbalized disbelief about having passed out and scared about it happening again. 1445 HR 92, BP Right arm 108/76, skin a bit clammy. Patient reports vision looked funny for a moment but resolved. Given cool water. One of our doctors came out and briefly assessed patient who verbalizes feeling a little better after water. After crying stopped and consoled by mom, see pale color to face. Mom also has syncope with medical procedures such as mole treatment. Explained can happen after any vaccine and will have her sit with beverages in office for 10 minutes for any further symptoms. At 1450 HR 84, color and demeanor much improved. PCP came out & assessed & reassured patient/family. At 1455 RN checked on patient again who was standing in waiting room. Encouraged to secure shoes then accompanied out to car without any further symptoms. Mom will keep an eye on her and give her something to eat. More
2844999 79 F CT 06/14/2025 COVID19
 PFIZER\BIONTECH
 HG4677
Death, Haemorrhagic stroke Death, Haemorrhagic stroke
On October 29, 2023 (the day after receiving the CoVID vaccine) patient suffered a hemorrhagic strok... On October 29, 2023 (the day after receiving the CoVID vaccine) patient suffered a hemorrhagic stroke. She was taken to the hospital and passed away the following day, October 30. More
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2845000 16 F VA 06/14/2025 HPV9
 MERCK & CO. INC.
 Z002903
Pain in extremity Pain in extremity
prolonged arm pain since date vaccine administered prolonged arm pain since date vaccine administered
2845001 55 F MS 06/14/2025 PNC21
 MERCK & CO. INC.
Injection site bruising, Injection site erythema, Injection site pain, Injection... Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
patient came into store today 6/14 and the vaccine was given on 6/10. Large area of redness from inj... patient came into store today 6/14 and the vaccine was given on 6/10. Large area of redness from injection site to her elbow, swelling, bruising, and redness. patient reported itchiness and pain around the site, she had marked the area and area was growing throughout the week. More
2845002 1.33 F TX 06/14/2025 DTAP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
 5KR3R
UK210AA
MF0416
Injection site nodule; Injection site nodule; Injection site nodule Injection site nodule; Injection site nodule; Injection site nodule
Mom noted nodule to left thigh about 5 days after vaccinations were given (06/06/25). No tenderness,... Mom noted nodule to left thigh about 5 days after vaccinations were given (06/06/25). No tenderness, erythema, drainage noted. Came into office on 6/13/25 and assessment from myself (her PCP) noted ~1in subcutaneous nodule to left thigh on top. No abnormalities. Discussed mom it was from the vaccine and she does not have to do anything about it. Only to come back if causes pain or worsens. More
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