🏥 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 💀 🏥 🚑 ♿ ⚠️
2844922 F IL 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received Shingrix in April 2022 and did not complete the series; This non-serious case was reported ... received Shingrix in April 2022 and did not complete the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in APR 2022, batch no 3527M, expiry date 03-JUN-2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received Shingrix in April 2022 and did not complete the series). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-JUN-2025 The pharmacist reported that the patient received 1st dose of Shingrix and asked do we need now to restart the series or can she get the second dose 3 years later. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2844923 59 F 06/13/2025 COVID19
 MODERNA
Autonomic nervous system imbalance, Neuropathy peripheral, Postural orthostatic ... Autonomic nervous system imbalance, Neuropathy peripheral, Postural orthostatic tachycardia syndrome, Red blood cell sedimentation rate More
dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain;... dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain; neuropathy/vaccine my feet started burning/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain; why I always get dizzy when I stand up/POTS; This spontaneous case was reported by a consumer and describes the occurrence of AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) in a 59-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 2) and Moderna covid-19 vaccine (Dose 1). Past adverse reactions to the above products included Burning sensation with Moderna covid-19 vaccine and Moderna covid-19 vaccine. Concurrent medical conditions included Rheumatism. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain) (seriousness criterion disability), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain) (seriousness criteria disability and medically significant) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) (seriousness criterion disability). At the time of the report, AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/same burning and pain has spread to other parts of my body, including my calves, thighs and my arms/intense pain after an exertion/nights I can't even sleep because of the searing pain) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate: high. No concomitant medications were reported. After the outbreak of Covid, the patient got only Moderna vaccines. She got her first vaccine when they first came out and then got two additional shots. Unfortunately, shortly after her first Moderna vaccine her feet started burning, even though at the time she did not make any connection to the vaccine but when she got her second one, they started burning intermittently more, and by her third shot basically the burning had become chronic. And unfortunately, the same burning and pain had spread to other parts of her body, including her calves, thighs and her arms. It was reported that, the doctor had concluded that her symptoms were connected to the Moderna vaccine. Her immunologist and neurologist had concluded that it was most likely that she had an adverse response to the vaccine that made her immune system hyperactive. They thought it kicked up her immune system and caused dysautonomia, high SED rates, neuropathy and POTS and intense pain after an exertion. Her symptoms became disabling. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-787281 (Patient Link).; Reporter's Comments: Underlying rheumatism could be a confounding factor for the case. The benefit-risk relationship of product is not affected by this report. More
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2844924 59 F 06/13/2025 COVID19
COVID19
 MODERNA
MODERNA

Autonomic nervous system imbalance, Immune system disorder, Neuropathy periphera... Autonomic nervous system imbalance, Immune system disorder, Neuropathy peripheral, Postural orthostatic tachycardia syndrome, Red blood cell sedimentation rate; Red blood cell sedimentation rate increased More
dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain;... dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain; neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain; my immune system hyperactive; why I always get dizzy when I stand up/POTS; high SED rates; This spontaneous case was reported by a consumer and describes the occurrence of AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain), IMMUNE SYSTEM DISORDER (my immune system hyperactive) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatism. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain) (seriousness criterion medically significant), IMMUNE SYSTEM DISORDER (my immune system hyperactive) (seriousness criterion medically significant), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) (seriousness criterion medically significant) and RED BLOOD CELL SEDIMENTATION RATE INCREASED (high SED rates). At the time of the report, AUTONOMIC NERVOUS SYSTEM IMBALANCE (dysautonomia/and I can barely walk and exercise/I can't even sleep because of the searing pain), NEUROPATHY PERIPHERAL (neuropathy/vaccine my feet started burning/intense pain after an exertion/many nights I can't even sleep because of the searing pain), IMMUNE SYSTEM DISORDER (my immune system hyperactive), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (why I always get dizzy when I stand up/POTS) and RED BLOOD CELL SEDIMENTATION RATE INCREASED (high SED rates) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate: high. No concomitant medications were reported. After the outbreak of Covid, the patient got only Moderna vaccines. She got her first vaccine when they first came out and then got two additional shots. Unfortunately, shortly after her first Moderna vaccine her feet started burning, even though at the time she did not make any connection to the vaccine. It was reported that, the doctor had concluded that her symptoms were connected to the Moderna vaccine. Her immunologist and neurologist had concluded that it was most likely that she had an adverse response to the vaccine that made her immune system hyperactive. They thought it kicked up her immune system and caused dysautonomia, high SED rates, neuropathy and POTS and intense pain after an exertion. Her symptoms became disabling. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-787344 (Patient Link).; Reporter's Comments: Company comment: The concurrent medical condition of Rheumatism remains as a confounder. The benefit-risk relationship of product is not affected by this report. More
2844925 M 06/13/2025 COVID19
 MODERNA
Fall, Thrombosis Fall, Thrombosis
blood clots in both legs and passed away on Sept 18, 2024; following a fall on April 12, 2024/passed... blood clots in both legs and passed away on Sept 18, 2024; following a fall on April 12, 2024/passed away on Sept 18, 2024; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in both legs and passed away on Sept 18, 2024) in a male patient of an unknown age 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. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Apr-2024, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FALL (following a fall on April 12, 2024/passed away on Sept 18, 2024). On an unknown date, the patient experienced THROMBOSIS (blood clots in both legs and passed away on Sept 18, 2024) (seriousness criteria death and medically significant). The patient died on 18-Sep-2024. The reported cause of death was blood clots in both legs. An autopsy was not performed. At the time of death, FALL (following a fall on April 12, 2024/passed away on Sept 18, 2024) outcome was unknown. No concomitant medications were reported. No autopsy was done, but nursing home staff suggested a possible link to the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Company comment: Event fall was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Blood clots in both legs More
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2844926 49 F 06/13/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 031L20A
031L20A
031L20A
Antinuclear antibody, Cerebrovascular accident, Connective tissue disorder, Fibr... Antinuclear antibody, Cerebrovascular accident, Connective tissue disorder, Fibromyalgia, Gastrointestinal disorder; Headache, Polychondritis, Raynaud's phenomenon, Rheumatoid arthritis, Sjogren's syndrome; Small fibre neuropathy, Trigeminal neuralgia, Vasculitis More
disorder of connective tissue; sjogren's syndrome; rheumatoid arthritis; strokes; small fiber n... disorder of connective tissue; sjogren's syndrome; rheumatoid arthritis; strokes; small fiber neuropathy; severe vasculitis; raynaud's syndrome; fibromyalgia; trigeminal neuralgia; relapsing polychondritis; GI symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CONNECTIVE TISSUE DISORDER (disorder of connective tissue), SJOGREN'S SYNDROME (sjogren's syndrome), POLYCHONDRITIS (relapsing polychondritis), RHEUMATOID ARTHRITIS (rheumatoid arthritis) and CEREBROVASCULAR ACCIDENT (strokes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In March 2021, the patient experienced CONNECTIVE TISSUE DISORDER (disorder of connective tissue) (seriousness criterion hospitalization). In 2021, the patient experienced GASTROINTESTINAL DISORDER (GI symptoms) and HEADACHE (Headache). In 2022, the patient experienced POLYCHONDRITIS (relapsing polychondritis) (seriousness criterion medically significant). On an unknown date, the patient experienced SJOGREN'S SYNDROME (sjogren's syndrome) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant), SMALL FIBRE NEUROPATHY (small fiber neuropathy), VASCULITIS (severe vasculitis), RAYNAUD'S PHENOMENON (raynaud's syndrome), FIBROMYALGIA (fibromyalgia) and TRIGEMINAL NEURALGIA (trigeminal neuralgia). The patient was hospitalized on sometime in March 2021 due to CONNECTIVE TISSUE DISORDER. The patient was treated with Surgery (Carpal tunnel release surgery) for Polychondritis. At the time of the report, CONNECTIVE TISSUE DISORDER (disorder of connective tissue), SJOGREN'S SYNDROME (sjogren's syndrome), POLYCHONDRITIS (relapsing polychondritis), RHEUMATOID ARTHRITIS (rheumatoid arthritis), CEREBROVASCULAR ACCIDENT (strokes), SMALL FIBRE NEUROPATHY (small fiber neuropathy), VASCULITIS (severe vasculitis), RAYNAUD'S PHENOMENON (raynaud's syndrome), FIBROMYALGIA (fibromyalgia) and TRIGEMINAL NEURALGIA (trigeminal neuralgia) had not resolved and GASTROINTESTINAL DISORDER (GI symptoms) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Antinuclear antibody: Positive. No concomitant medications provided by the reporter. It was reported that after first dose of vaccination patient experienced GI symptoms and bad headache. After second vaccination patient was admitted to emergency room in Mar-2021. In Mar-2021 patient had lesions from head to toe, malaise, utter fatigue, and patient symptom was progressed. Patient was unable to walk or hear or speak. On 08-Jul-2021 patient was diagnosed with disorder of connective tissue and anti-nuclear factor was detected. On 20-Jul-2021 it was reported that diagnosis of disorder of connective tissue, presence of anti-nuclear factor caused rapid onset of other symptom for patient such as patient was bald within 3 months, patient was bedridden, and patient was unable to see or walk. Patient experienced lesions all over her body with excruciating painful and patient voice was still not right. Patient lost all function of her left hand and patient needed a Carpal tunnel release surgery due to the event of relapsing polychondritis. Patient nerves were dying. It was reported that mixed undifferentiated affects not diagnosed yet. It was reported that patient had to have surgery because of Relapsing Polychondritis which took over her body. Patient experienced strokes. It was unknown if the patient experienced any additional symptoms or events. No treatment medications provided by the reporter.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
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2844928 M PA 06/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
did not even get Covid for 5 years/my husband gets it; did not even get Covid for 5 years/my husband... did not even get Covid for 5 years/my husband gets it; did not even get Covid for 5 years/my husband gets it; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old 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: Covid-19 vaccine (Primary immunization series complete), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not even get Covid for 5 years/my husband gets it". The clinical course was reported as follows: The reporter said that they always had gotten their vaccines through Pfizer, and their boosters. They did not even get Covid for 5 years, when everybody around them got it, and finally, her husband gets it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2844929 42 M MA 06/13/2025 MMR
 MERCK & CO. INC.
 Y008591
Injection site oedema Injection site oedema
NOTED TO HAVE ERYTHEMIC AREA AT INJECTION SITE SLIGHT EDEMA NOTED TO HAVE ERYTHEMIC AREA AT INJECTION SITE SLIGHT EDEMA
2844930 06/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
did not work; did not work; This is a spontaneous report received from a Consumer or other non HCP, ... did not work; did not work; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not work". Clinical course: The COVID vaccine that media and politicians claimed was effective did not work. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2844931 5 F NE 06/13/2025 MMRV
 MERCK & CO. INC.
 Y014436
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Right thigh redness and tenderness for 1 week after reaction. Redness getting as big as 10 inches in... Right thigh redness and tenderness for 1 week after reaction. Redness getting as big as 10 inches in diameter per pt's guardian More
2844932 F MI 06/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 h39z4
Incorrect dose administered Incorrect dose administered
pt was given an adult dose of hep b and should have received a peds dose. pt was given an adult dose of hep b and should have received a peds dose.
2844933 1.25 F NJ 06/13/2025 HIBV
 SANOFI PASTEUR
 UK328AA
No adverse event, Product preparation error No adverse event, Product preparation error
Patient received the Hib vaccine on 5/20/2025; however, it was administered with sterile water inste... Patient received the Hib vaccine on 5/20/2025; however, it was administered with sterile water instead of the manufacturer-supplied diluent. The vaccine was given by a Medical Assistant in the office. The error was disclosed to the parents on 6/11/2025 by Dr. The parent did not report any symptoms or adverse reactions. More
2844934 6 M NE 06/13/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Injection site reaction, Rash, Rash erythematous, Rash papular Injection site reaction, Rash, Rash erythematous, Rash papular
Raised red rash on his left leg that hurts when you touch it- it was about a half dollar size of red... Raised red rash on his left leg that hurts when you touch it- it was about a half dollar size of redness yesterday 6/12/25 evening. No other symptoms. Dr. recommended to apply cold compress and give benadryl 9mL if redness continues and to f/u tomorrow if redness worsens by afternoon. More
2844935 25 F 06/13/2025 HPV9
 MERCK & CO. INC.
 X026926
Injection site pain Injection site pain
Patient complains of left upper arm pain since vaccination. Patient complains of left upper arm pain since vaccination.
2844936 7 F LA 06/13/2025 COVID19
 PFIZER\BIONTECH
 LM2045
No adverse event, Product storage error No adverse event, Product storage error
Given on 2/05/25 was stored in the freezer, we didn't know it was suppose to store in fridge re... Given on 2/05/25 was stored in the freezer, we didn't know it was suppose to store in fridge recieved on 9/18/24 , patient did not experience any signs or symptoms of adverse event was not seen again until 5/12/25 More
2844937 0.33 F TX 06/13/2025 DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
PNC20
PNC20
RV1
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2G273
2G273
UK208AA
UK208AA
MF0416
MF0416
3Z34X
3Z34X
Blood gases normal, Brief resolved unexplained event, Cyanosis, Echocardiogram n... Blood gases normal, Brief resolved unexplained event, Cyanosis, Echocardiogram normal, Electrocardiogram normal; Electroencephalogram normal, Eye movement disorder, Skin warm, Somnolence, Tremor; Blood gases normal, Brief resolved unexplained event, Cyanosis, Echocardiogram normal, Electrocardiogram normal; Electroencephalogram normal, Eye movement disorder, Skin warm, Somnolence, Tremor; Blood gases normal, Brief resolved unexplained event, Cyanosis, Echocardiogram normal, Electrocardiogram normal; Electroencephalogram normal, Eye movement disorder, Skin warm, Somnolence, Tremor; Blood gases normal, Brief resolved unexplained event, Cyanosis, Echocardiogram normal, Electrocardiogram normal; Electroencephalogram normal, Eye movement disorder, Skin warm, Somnolence, Tremor More
After vaccines infant was very sleepy, felt warm but no temperature measured, and on 6/1/25 around 6... After vaccines infant was very sleepy, felt warm but no temperature measured, and on 6/1/25 around 6 pm infant while feeding on a bottle infant had an episode of generalized body shaking, eyes rolling back, perioral cyanosis and bilateral hand cyanosis that lasted for about 3 minutes under the care of an aunt. After possible seizure infant returned back to her baseline. On 6/2/25 mother took infant for an evaluation at Hospital and infant was admitted for work up and evaluation overnight 6/2/25 to 6/3/25. More
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2844938 28 M TN 06/13/2025 TYP
 SANOFI PASTEUR
 x2a411m
Arthralgia, Pain, Sleep disorder Arthralgia, Pain, Sleep disorder
Patient stated deep joint pain. Pain is achy and hurts to sleep. Patient stated he is able to arti... Patient stated deep joint pain. Pain is achy and hurts to sleep. Patient stated he is able to articulate arm, but experiences pain when them arm is raised above his paid. More
2844939 63 M 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Patient began experiencing pain in left shoulder/arm about 1 week after receiving the vaccine. He r... Patient began experiencing pain in left shoulder/arm about 1 week after receiving the vaccine. He reported this to the pharmacy 37 days after the vaccine was administered. More
2844940 48 F IA 06/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 092C27A
092C27A
Cardiac flutter, Disturbance in attention, Dyspnoea, Exercise tolerance decrease... Cardiac flutter, Disturbance in attention, Dyspnoea, Exercise tolerance decreased, Nasopharyngitis; Palpitations, Visual impairment More
The evening of the vaccination, my vision was dull and I couldn?t focus mentally on anything like co... The evening of the vaccination, my vision was dull and I couldn?t focus mentally on anything like conversations or anything else. My heart was pounding and my family decided that I should go to bed and rest from the shot, which is what I did. The next day I felt somewhat better, with just cold-like symptoms, but also the flutters and pounding in my heart. For the next few weeks whenever I would experience any stress, such as making the tiniest decision about what to eat, I would get heart palpitations. This lasted for quite a long time and during this time I was more winded doing any exercise type of tasks. More
2844941 16 F OH 06/13/2025 HIBV
 MERCK & CO. INC.
 Y013470
No adverse event, Wrong product administered No adverse event, Wrong product administered
Pt. received HIB instead of Menveo. No signs or symptoms. Pt. received HIB instead of Menveo. No signs or symptoms.
2844942 5 M PA 06/13/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 GG39D
Expired product administered Expired product administered
Vaccine expiring on 6/7/25 administered on 6/12/25. Vaccine expiring on 6/7/25 administered on 6/12/25.
2844943 0.58 M CA 06/13/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 u8313aa
Injection site rash, Rash Injection site rash, Rash
rash on the injection site, right vastus lateralis and on the face which was fading rash on the injection site, right vastus lateralis and on the face which was fading
2844945 26 F ME 06/13/2025 HEP
 MERCK & CO. INC.
 946888
Chills, Dyspnoea, Syncope, Tachycardia, Tremor Chills, Dyspnoea, Syncope, Tachycardia, Tremor
tachycardia rate 160, chills, shaking, shortness of breath, syncope x 1. symptoms lasted 3 days slow... tachycardia rate 160, chills, shaking, shortness of breath, syncope x 1. symptoms lasted 3 days slowly resolved over time. More
2844946 72 F GA 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 y7xg3
Erythema, Skin warm, Tenderness Erythema, Skin warm, Tenderness
Patient presented with a hot, red and tender area on arm. Affected area was approx 3 inches down her... Patient presented with a hot, red and tender area on arm. Affected area was approx 3 inches down her arm. Patient's husband is a physician who treated the area with a warm compress and benadryl. More
2844947 49 M NJ 06/13/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Facial pain, Swelling face Facial pain, Swelling face
Left facial swelling and soreness. Left facial swelling and soreness.
2844948 44 F VA 06/13/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945662
Asthma, Condition aggravated, Dyspnoea, Oropharyngeal pain Asthma, Condition aggravated, Dyspnoea, Oropharyngeal pain
9am-employee received 1st dose of Heplisav. 11:15am-front staff came to my office informing me that... 9am-employee received 1st dose of Heplisav. 11:15am-front staff came to my office informing me that the person was having an allergic reaction and that she was standing outside. I went outside and asked her how she was feeling. Client was found outside on the stairwell in no apparent distress. She stated that she felt short of breath and that her throat hurt. Explained that most allergic reactions happen within 30 minutes of receiving the vaccine but could be later. She stated that her symptoms had been going on for about an hour. She informed me that she had used her inhaler for asthma and was trying not to be anxious about it. Client was outside near her car because she was going to go to the Emergency room. Hospital was within 2 miles of employment. She wanted to drive herself to the Emergency Room and get checked out. Client still appeared in no apparent distress and left to go to the Emergency Room. More
2844949 1 M NY 06/13/2025 MMR
 MERCK & CO. INC.
 Y008077
Extra dose administered Extra dose administered
Child was accidentally given MMR with MMRV on same day , parents were informed and DOH was consulted Child was accidentally given MMR with MMRV on same day , parents were informed and DOH was consulted
2844950 13 F PA 06/13/2025 HPV9
 MERCK & CO. INC.
 Y010466
Pain, Pain in extremity, Sleep disorder Pain, Pain in extremity, Sleep disorder
Child's mother emailed on 6/13/25 with concerns about child having pain in her arm when she mov... Child's mother emailed on 6/13/25 with concerns about child having pain in her arm when she moves and sleeps. Mother was advised to take child to primary care provider for evaluation. More
2844951 65 F MO 06/13/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 MMR unk
MMR unk
Arthralgia, C-reactive protein, Joint swelling, Laboratory test, Mobility decrea... Arthralgia, C-reactive protein, Joint swelling, Laboratory test, Mobility decreased; Pain in extremity, Red blood cell sedimentation rate, Rheumatoid factor More
5/15/25 significant swelling and aching p ain in joints limiting mobility. location of pain varied f... 5/15/25 significant swelling and aching p ain in joints limiting mobility. location of pain varied from knee, fingers, wrist, etc. after MMR vaccination More
2844952 4 M NC 06/13/2025 DTAPHEPBIP
DTAPHEPBIP
FLU3
FLU3
HEPA
HEPA
HIBV
HIBV
MMRV
MMRV
PNC20
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
 B532G
B532G
UT8475LA
UT8475LA
J4K4X
J4K4X
Y008355
Y008355
Y015355
Y015355
LK6653
LK6653
Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema,... Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema, Injection site induration; Rash; Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema, Injection site induration; Rash; Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema, Injection site induration; Rash; Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema, Injection site induration; Rash; Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema, Injection site induration; Rash; Dysphagia, Eye swelling, Injection site discolouration, Injection site erythema, Injection site induration; Rash More
one day after vaccines (5/15/2025), had "facial" rash with eyes swollen. no breathing issu... one day after vaccines (5/15/2025), had "facial" rash with eyes swollen. no breathing issues or difficulty swallowing noted. symptoms resolved on its own within 3 days. No treatment and did not seek medical intervention. Left deltoid with redness, swelling, and "knot" at injection site. on 6/13/2025, mom states left deltoid discoloration improved but knot still present. More
2844953 1.25 F 06/13/2025 DTAP
HEP
HIBV
PNC13
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SANOFI PASTEUR
PFIZER\WYETH



Paralysis; Paralysis; Paralysis; Paralysis Paralysis; Paralysis; Paralysis; Paralysis
reaction to it was kind of like reaction where she had like a type of palsy; Initial information re... reaction to it was kind of like reaction where she had like a type of palsy; Initial information received on 15-Apr-2025 regarding an unsolicited valid serious courtesy case received from a other health professional. This case involves a 15 months old female patient who experienced reaction to it was kind of like reaction where she had like a type of palsy after receiving pneumococcal vaccine CONJ 13V (CRM197) [Prevnar 13], hepatitis B vaccine,HIB (PRP/T) Vaccine [ACT-HIB] and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [Dtap]. 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 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, an unknown dose hepatitis B vaccine produced by unknown manufacturer via unknown route in unknown administration site, received an unknown dose of Prevnar 13 not produced by Sanofi Pasteur via unknown route in unknown administration site, and received an unknown dose of Dtap not produced by Sanofi Pasteur (formulation not reported) (strength, expiry date and lot number not reported for all) via unknown route in unknown administration site as all for Immunization. On an unknown date the patient developed a reaction to it was kind of like reaction where she had like a type of palsy (paralysis) (unknown latency). Reportedly, the patient was followed by an allergist and this made the allergist think there was an egg or animal component that could had caused the episode. Caller was unable to clarify palsy further to include location on body. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. Seriousness criteria: This event was assessed as medically significant. Additional information was received on 06-May-2025 from consumer/non-healthcare professional. Trade name of non-company suspect updated to Prevenar13. Narrative amended accordingly. Additional information was received on 09-Jun-2025 from consumer/non-healthcare professional- Suspect- HIB (PRP/T) Vaccine [ACT-HIB] has been added. Narrative amended accordingly.; Sender's Comments: Sanofi company comment for follow up dated 09-JUN-2025: This case involves a 15 months old female patient who experienced reaction to it was kind of like reaction where she had like a type of palsy after receiving pneumococcal vaccine CONJ 13V (CRM197) [Prevnar 13], hepatitis B vaccine,HIB (PRP/T) Vaccine [ACT-HIB] and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [Dtap]. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. More
2844954 18 M CT 06/13/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Arthralgia, Injected limb mobility decreased Arthralgia, Injected limb mobility decreased
Right shoulder pain and immobility. Treatment consists of rest, ice and NSAIDS. Outcome still being ... Right shoulder pain and immobility. Treatment consists of rest, ice and NSAIDS. Outcome still being monitored. More
2844955 4 M TX 06/13/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Z006280
Erythema, Skin warm; Erythema, Skin warm Erythema, Skin warm; Erythema, Skin warm
upper arm erythema, warmth, no overt ball upper arm erythema, warmth, no overt ball
2844956 11 F MI 06/13/2025 HPV9
 MERCK & CO. INC.
 y013712
Injection site erythema, Injection site pain, Pain Injection site erythema, Injection site pain, Pain
per visit note Hx from patient and her mother. She had a HPV vaccine 2 months ago and developed pain... per visit note Hx from patient and her mother. She had a HPV vaccine 2 months ago and developed pain at the injection site on her left arm. There was a small amount of redness after the injection for about 1 week, it resolved. No swelling. She continue to complain about pain in her left shoulder over the deltoid. Pain has improved a lot but still occurs with movement of her left arm, especially when reaching up and behind. Pain is mild and improving. No color change, numbness or tingling More
2844957 0.17 M TN 06/13/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 4L544
Y3H23
MF0415
3Z34X
Rash macular; Rash macular; Rash macular; Rash macular Rash macular; Rash macular; Rash macular; Rash macular
The patient was given vaccinations at 11:10 a.m. After the patient was given all of the vaccines, g... The patient was given vaccinations at 11:10 a.m. After the patient was given all of the vaccines, gotten dressed, and was about to exit the exam room, at 11:20 a.m., mom opened up the door and showed us the baby's head. I noticed the top of the infant' s head appeared with red blotchy spots over the entire head/crown. More
2844958 11 M MI 06/13/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Product administered to patient of inappropriate age, Wrong patient Product administered to patient of inappropriate age, Wrong patient
Patient came in with the sibling for his 11 year immunizations. The CMA gave the Covid vaccine that... Patient came in with the sibling for his 11 year immunizations. The CMA gave the Covid vaccine that was intended for the 14 year old sibling. More
2844959 33 F CT 06/13/2025 COVID19
 MODERNA
Angina pectoris, Heart rate increased, Myocarditis, Palpitations, Sleep disorder Angina pectoris, Heart rate increased, Myocarditis, Palpitations, Sleep disorder
pt got 1st dose in April and 2nd dose with in about 3 weeks. She states she is very athletic and aft... pt got 1st dose in April and 2nd dose with in about 3 weeks. She states she is very athletic and after 1st dose she woke up around 2 am and her heart was hurting and pounding with a very rapid heart beat. This happened regularly in the middle of the night waking her up. This slowly went away after a year or year and half. She states this was myocarditis and that it could have been life threating at the time when she was having these symptoms and now realizes it was life threatening. She did not seek medical treatment. More
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2844960 0.17 F MA 06/13/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8313AA
Crying, Injection site erythema, Injection site swelling, Injection site warmth Crying, Injection site erythema, Injection site swelling, Injection site warmth
Pt got Vaxelis vaccine around 10:15 am on 6/13/25. Administered into right thigh, pt originally tole... Pt got Vaxelis vaccine around 10:15 am on 6/13/25. Administered into right thigh, pt originally tolerated well, with no immediate adverse reaction. Around 1:30 after sleeping most of the morning, pt woke up and was inconsolable, thigh was red, swollen and warm to the touch. Parents checked temp rectally, no reported fever, gave one dose of Tylenol. Redness on thigh continued to expand to knee and hip. Parents brought baby into office to have us check vaccine site. By our measurements, area is 10 cm tall x 9 cm wide, does extend beyond knee or hip. More
2844961 68 F TN 06/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 EB499
Injection site swelling, Nausea Injection site swelling, Nausea
Raised bump at injection sight, patient experienced profound nausea Raised bump at injection sight, patient experienced profound nausea
2844962 16 F MO 06/13/2025 FLU3
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
 N7CX5
3E99M
Nausea, Vomiting; Nausea, Vomiting Nausea, Vomiting; Nausea, Vomiting
Nausea and vomiting for ~10 days Nausea and vomiting for ~10 days
2844963 77 F IL 06/13/2025 COVID19
 MODERNA
 3043333
Expired product administered, Product label issue Expired product administered, Product label issue
Mislabeled expired vaccine administered 3 days after expiration date. Unknown adverse outcomes. Mislabeled expired vaccine administered 3 days after expiration date. Unknown adverse outcomes.
2844964 13 F CA 06/13/2025 HEPA
HEPA
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y015027
Y015027
U8493AA
U8493AA
U8389AA
U8389AA
Cold sweat, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Seizure; Tremor; C... Cold sweat, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Seizure; Tremor; Cold sweat, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Seizure; Tremor; Cold sweat, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Seizure; Tremor More
Pt was walking out post vaccine and Pt started convulsing. Pt went stiff and arm shaking for approx... Pt was walking out post vaccine and Pt started convulsing. Pt went stiff and arm shaking for approx 30 secs. Pt was guided to chair. Pt sweaty and clammy and pale. Pt recovered approx 15 min. Pt examined by provider and discharged home with precautions. More
2844965 37 F MI 06/13/2025 HPV9
 MERCK & CO. INC.
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse reactions noted. Vaccine was Expired at time of injection. No adverse reactions noted. Vaccine was Expired at time of injection.
2844966 40 F MN 06/13/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 AK334
AK334
Allodynia, Burning sensation, Fine motor skill dysfunction, Hyperaesthesia, Inje... Allodynia, Burning sensation, Fine motor skill dysfunction, Hyperaesthesia, Injection site pain; Magnetic resonance imaging neck, Muscle contracture, Musculoskeletal stiffness, Pain More
In left arm (injection site) onset within days after injection- Ongoing and increased burning pain b... In left arm (injection site) onset within days after injection- Ongoing and increased burning pain beneath deltoid, running down arm, intense and ongoing burning pain in hand and fingers, Allodynia, Hyperalgesia, hand contractures, stiffness, loss of fine motor, weakness. Ruled out cervical radiculopathy and carpal tunnel so far, ongoing rule out CRPS after vaccine injection More
2844967 17 M TX 06/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 Y5X9T
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient received Engerix-B indicated for 20+ years old and patient was 17 years old at time of admin... Patient received Engerix-B indicated for 20+ years old and patient was 17 years old at time of administration. More
2844968 1 F MO 06/13/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK199AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
instead of the liquid portion of the Pentacel vaccine being administered, the ActHib portion was adm... instead of the liquid portion of the Pentacel vaccine being administered, the ActHib portion was administered after being reconstituted with sterile water, with no reported adverse event; Initial information received on 10-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old female patient who had instead of the liquid portion of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] being administered, the acthib portion was administered after being reconstituted with 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 20-May-2025, the patient received liquid portion of a dose 4 (0.25 mL to 2 mL for immunizations or 0.1 mL for TB skin test) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (lot UK199AA with unknown strength, formulation and expiry date) via intramuscular route in the right thigh for Immunization; being administered, the acthib portion was administered after being reconstituted with sterile water, with no reported adverse event (single component of a two-component product administered) (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
2844969 17 M 06/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 Y5X9T
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient received Engerix-B that's indicated for 20+ years old when he was 17 years old. Patient... Patient received Engerix-B that's indicated for 20+ years old when he was 17 years old. Patient did not have any adverse reactions. More
2844970 16 F LA 06/13/2025 MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MEN
MEN
MEN
MEN
MEN
MEN
MEN
MEN
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 U8256AB
U8256AB
U8256AB
U8256AB
U8256AB
U8256AB
U8256AB
U8256AB
Autopsy, Bacterial test negative, Biopsy bone, Biopsy bone marrow, Blood test; C... Autopsy, Bacterial test negative, Biopsy bone, Biopsy bone marrow, Blood test; Computerised tomogram, Death, Endotracheal intubation, Feeling abnormal, Haemofiltration; Haemophagocytic lymphohistiocytosis, Headache, Lumbar puncture, Lung assist device therapy, Mechanical ventilation; Multi-organ disorder, Plasmapheresis, Pyrexia, Viral test negative, X-ray; Bacterial test negative, Biopsy bone, Biopsy bone marrow, Blood test, Computerised tomogram; Death, Endotracheal intubation, Feeling abnormal, Haemophagocytic lymphohistiocytosis, Headache; Lumbar puncture, Lung assist device therapy, Mechanical ventilation, Plasmapheresis, Pyrexia; Viral test negative, X-ray; Autopsy, Bacterial test negative, Biopsy bone, Biopsy bone marrow, Blood test; Computerised tomogram, Death, Endotracheal intubation, Feeling abnormal, Haemofiltration; Haemophagocytic lymphohistiocytosis, Headache, Lumbar puncture, Lung assist device therapy, Mechanical ventilation; Multi-organ disorder, Plasmapheresis, Pyrexia, Viral test negative, X-ray; Bacterial test negative, Biopsy bone, Biopsy bone marrow, Blood test, Computerised tomogram; Death, Endotracheal intubation, Feeling abnormal, Haemophagocytic lymphohistiocytosis, Headache; Lumbar puncture, Lung assist device therapy, Mechanical ventilation, Plasmapheresis, Pyrexia; Viral test negative, X-ray More
Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple... Received Monday 5/19, started feeling bad, head ache, slight fever 5/21, higher fever 5/23, multiple Dr visits over the weekend, primary care 5/27, hospitalized & intubated 5/28, dx HLH unknown trigger-all tests for virus, bacteria etc were negative. Ecmo 6/2, deceased 6/3. Autopsy mult organ damage-unknown, extensive testing being performed. More
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2844971 42 F MN 06/13/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
057F22A
Abdominal discomfort, Abnormal loss of weight, Alpha tumour necrosis factor incr... Abdominal discomfort, Abnormal loss of weight, Alpha tumour necrosis factor increased, Artificial crown procedure, Blood test abnormal; Blood zinc decreased, Brain fog, Burning sensation, COVID-19, Candida infection; Chemokine test, Cytokine increased, Dehydroepiandrosterone decreased, Diarrhoea, Discomfort; Dysbiosis, Dysmenorrhoea, Dyspepsia, Endothelial dysfunction, Exercise tolerance decreased; Fatigue, Fear, Gastrointestinal microorganism overgrowth, Granulocyte-colony stimulating factor level normal, Headache; Heavy menstrual bleeding, Impaired healing, Influenza like illness, Interferon gamma level increased, Interleukin level; Interleukin level increased, Interleukin-2 receptor increased, Intermenstrual bleeding, Intestinal barrier dysfunction, Iron deficiency anaemia; Irritable bowel syndrome, Laboratory test abnormal, Menstruation irregular, Muscle discomfort, Muscle fatigue; Muscle twitching, Muscular weakness, Musculoskeletal stiffness, Myoclonus, Neuralgia; Neurological symptom, Pain, Pain in extremity, Polymenorrhoea, Post-acute COVID-19 syndrome; SARS-CoV-2 antibody test positive, SARS-CoV-2 test positive, Sleep disorder, Tendon pain, Tendonitis; Tinnitus, Tremor, Vascular endothelial growth factor assay, Vitamin A deficiency, Vitamin B12 deficiency; Vitamin D deficiency More
November 2022 - extreme tendonitis in both knees, but the left side was worse, weight 125lbs. Decem... November 2022 - extreme tendonitis in both knees, but the left side was worse, weight 125lbs. December 2022 - extreme tendonitis in both elbows, but the left side was worse, started PT as recommended by orthopedist. January 2023 - unintentional weight loss, blood work found iron deficiency anemia, B12 deficiency, D deficiency, continuation of tendon pain in elbows and knees, extreme fatigue, PT was making the pain worse, so discontinued PT. Weight loss down to 116 lbs. February 2023 - extreme pain/burning sensation in thighs, nerve pain in both legs, neurological symptoms - twitching muscles, brain fog, more unintentional weight loss, extreme fatigue, extreme tinnitus in both ears, start of unusual menstrual cycles that included very heavy bleeding and cramping. Legs were stiff, bending them or crossing my legs would make the pain even worse, so I had to keep them straight at all times. Weight loss down to 112 lbs. This is when I really started to notice sleep myoclonus hypnic jerking. It would happen many times throughout the day and not just when I was starting to fall asleep. I could be standing at the fridge about to get something and my whole arm, shoulder would jerk. It was very scary. March 2023 - Continuation of all the symptoms from February, plus gastrointestinal distress (diarrhea, undigested food particles in stool), discovered an intolerance to exercise - exercise produced extreme pain in both thighs that lasted for 2 and a half weeks, including the feeling of pressure, burning, searing pain. The main nerve up both legs was very painful as well. My body continued to have myoclonus hypnic jerking when awake and when going to sleep. April 2023 - Continuation of all the symptoms from March, diagnosed as vaccine injured by Dr. and her nurse based on blood work and extremely high cytokines, (started on a treatment protocol of Maraviroc and Pravastatin through August 2023). Also started seeing a nutritionist to address gut dysbiosis. May-July 2023 - Continuation of all the symptoms, plus SIBO, Candida overgrowth, leaky gut, weight loss down to 106 lbs. When I get my period, my legs flare up really badly. August 2023 - Thigh pain persists in both thighs, left elbow continued to have tendonitis (same arm all 4 mRNA shots were given), sometimes there is pain in the right elbow. Neurological symptoms of random muscle twitching and activating happened randomly throughout the day, tinnitus, vitamin deficiencies in iron, D, A, B12 binding capacity, and leaky gut. September-December 2023 - All the symptoms continued, my gut got worse, my legs got worse. After dental work was done to put a crown in, my gums would not heal, which lasted from September through November. We had switched to the Fullscript Post-Viral Recovery Protocol, which included Arterosil, Tollovid, MegaSporeBiotic, MegaPre, and ITIS. This protocol made my symptoms worse and I stopped at the end of November and switched to a functional integrative doctor. She did an Endopat test and found significant damage and stiffness in the endothelial lining of my vascular system (that is my layman?s understanding of that test and what it found). I continued taking Low Dose Naltrexone, and started on Ivermectin, B1 supplements, Tudca, and RegeneVasc. Early December 2023 - Got Covid for the first time with symptoms similar to vaccine effects that lasted for 3 weeks, headache, body aches, fatigue, brain fog, flu-like symptoms. I continued testing positive for Covid for weeks after initial infection. Took Paxlovid immediately after a positive covid test. January 2024 -March 2024 - Leg pain continued in both thighs, but throughout my vaccine injury, my left thigh has been the worst one. Diagnosed with IBS. Continued unusual menstrual cycles with periods that were heavy with lots of spotting weeks ahead of time. March 2024-June 2024 - Leg pain continues, issues with heavy and crampy periods, as well as periods coming every 2 and a half weeks. Started gaining weight, up to 115 lbs. by the end of June by addressing IBS with Nerva hypnotherapy app, as well as an anti-inflammatory diet (no gluten or sugar), and other digestive supplements as recommended by my nutritionist. July-Sept 2024 - Leg pain is mostly in the left thigh. Some days the pain is barely there and I can ignore it, and some days it?s more pronounced. My periods have been short and painful and bloody. Oct-Dec. 2024 - My legs were at a 1 on the pain scale if zero is pain-free. I had 3 weird days where my leg pain increased to a 4-5. My VEGF was low and my doctor believes that not enough oxygen is getting to my tissues, which might be causing leg pain and weakness. My period is very short, crampy, and heavy, which are all out of the ordinary. My DHEA, and Zinc are low. A spike protein antibody test showed I had greater than 25,000, but I have not been actively infected with Covid nor sick with anything else since December of 2023. Jan-June 2025 - Leg pain is under control due to supplements and drugs I?m taking. Thigh muscles are still not normal and can have discomfort and mild pain, which increases the more I exert them. They fatigue very easily (just bending over into a small squat to tie my shoes will tire them out). The left arm and elbow continue to have pain in the tendon area when used. Some nights I will wake up with internal tremors. I have gained weight and am back up to a semi-normal range for me around 121 pounds. My periods continue to be erratic and unusual. The cramps have been really intense. My period only lasts for 3-4 days and comes sometimes twice a month. Here is what I?ve been taking since January 2025 that seems to have helped the most with thigh pain and Post-Acute Covid-19 Vaccination Syndrome (PACVS) symptoms: LDN (Low Dose Naltrexone) Ivermectin - 26mg daily Augmented NAC Ortho digestzymes with every meal Mitocore TB-4 Peptides - (Started June 1, 2025) BCP-157 peptides Rhodiola Rosea Zinc with copper Vitamin D DHEA Femmenessence Harmony Pro SPM Active One Daily (Fish oil) June-July 2025 - I will be starting hypobaric oxygen therapy 6/16/25 at the recommendation of Dr. We will be running another covid long hauler panel after this therapy, as well as another GI Map. More
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2844972 62 F AL 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3273h
Injection site discomfort, Nausea, Pyrexia Injection site discomfort, Nausea, Pyrexia
patient has experienced discomfort at injection sight, fever, and nausea... patient has experienced discomfort at injection sight, fever, and nausea...
2844973 1.08 F NY 06/13/2025 HIBV
 SANOFI PASTEUR
 UK016AC
Expired product administered, No adverse event Expired product administered, No adverse event
expired HIB vaccines was accidentally administered to a patient with no reported adverse event; Init... expired HIB vaccines was accidentally administered to a patient with no reported adverse event; Initial information received on 12-Jun-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 13 months old female patient who accidentally got administered expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine for Immunisation. On 07-Jun-2025, the patient accidentally administered expired dose 4 of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength- standard) once lot UK016AC and expiry date- 31-MAY-2025 via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency- same day). Action taken- as 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
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