🏥 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 💀 🏥 🚑 ♿ ⚠️
2822080 36 M CA 01/21/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945660
Peripheral swelling Peripheral swelling
Patient received Hep B vaccine on 01/20/2025 and reported that he started getting swelling on the l... Patient received Hep B vaccine on 01/20/2025 and reported that he started getting swelling on the left feet 2-3 hours after receiving vaccination. Patient called today i.e., 01/21/2025 to get advise and I advised him to seek urgent care. He checked in with hospital. In a follow up call today, patient reported swelling on the right leg and feet too. More
2822081 18 M CA 01/21/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
DD72H
Arthralgia, Asthenia, Exercise tolerance decreased, Injection site pain, Joint r... Arthralgia, Asthenia, Exercise tolerance decreased, Injection site pain, Joint range of motion decreased; Loss of personal independence in daily activities More
Patient's right shoulder was sore at the injection site; after a couple of days, the pain incre... Patient's right shoulder was sore at the injection site; after a couple of days, the pain increased and patient struggled to work out. He noticed his range of motion and strength have been affected. He is a baseball pitcher and is struggling throwing, it is painful. The injection site is also still very painful to the touch at 8 days post-injection. He has done warm compress, ice, Aleve, stretching. He went to his pediatrician today who confirmed symptoms are not normal and likely from the MenB shot. Dr recommended a visit to orthopedist and physical therapy. Patient will also visit our chiropractor for laser to help with any possible inflammation and pain. More
2822082 24 M TX 01/21/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9CH4P
Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
1/16/25 3:16 Under observation, Pt c/o tingling sensation in throat, tongue and face. Vitals take... 1/16/25 3:16 Under observation, Pt c/o tingling sensation in throat, tongue and face. Vitals taken and pt assessed. All vitals, lung and heart sounds within normal range. No swelling present in face, tongue or throat, no signs of distress noted. Patient given Diphenhydramine 2 tables 25 mg each with water. Continually assessed pt until discharge. Monitored for 30 mins longer. Pt reported 0 tingling or any other symptoms. Pt " stated I feel normal". 3:50 Pt up walking around and then left. Called pt next morning, reported no more signs for symptoms of adverse reaction. RN More
2822096 8 M 01/21/2025 DTIPV
DTIPV
MMR
MMR
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

X007521
X007521
Chills, Fatigue, Febrile convulsion, Malaise, Pyrexia; Somnolence; Chills, Fatig... Chills, Fatigue, Febrile convulsion, Malaise, Pyrexia; Somnolence; Chills, Fatigue, Febrile convulsion, Malaise, Pyrexia; Somnolence More
febrile seizures; fatigue; drowsiness; chill; feeling unwell; fever; This spontaneous report was rec... febrile seizures; fatigue; drowsiness; chill; feeling unwell; fever; This spontaneous report was received from consumer and referred to an 8-year-old male patient. The patient's medical history was not reported. The patient's concurrent condition was not reported. Concomitant therapies were not reported. On 09-JUL-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) subcutaneous injection, 0.5 milliliter, lot #X007521, expiration date: 28-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided); and diphtheria vaccine toxoid, polio vaccine inact 3v (vero), tetanus vaccine toxoid (REVAXIS) suspension for injection, 0.5 milliliter, lot # W3H052V, administered for prophylaxis (strength, expiry date, and route of administration were not provided). On the same day, the patient experienced febrile seizures, fatigue, drowsiness, chill, feeling unwell and fever with body temperature 38 to 40.5 degrees Celsius. At the time of reporting, the patient was recovering from the events of febrile seizures, chill and feeling unwell. At the time of reporting, the patient had not recovered from the events of fatigue, drowsiness or fever. The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) was unknown. More
2822097 80 F 01/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
Shingles; This non-serious case was reported by a consumer via other manufacturer and described the ... Shingles; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included giant cell arteritis (other), shingles and ear carcinoma (cancer left ear). Concomitant products included Influenza vaccine (Fluzone), prednisone and hydrocodone. On 12-OCT-2020, the patient received Shingrix. On 15-OCT-2020, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 23-DEC-2024 The patient started therapy with Shingrix and experienced shingles. More
2822098 U 01/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
Broke out with shingles; This non-serious case was reported by a consumer via interactive digital me... Broke out with shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Broke out with shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-JAN-2025 This case was reported by a patient via interactive digital media. Patient had the shingles shots and two days later after the patient broke out with shingles. More
2822099 U 01/21/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; had the two shots and still got shingles; This serious case was repor... suspected vaccination failure; had the two shots and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the two shots and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 09-JAN-2025 This case was reported by a patient via interactive digital media. The patient stated that they had the two shots and still got shingles and also stated that doctor said it did not work. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (1st dose)and Shingles (2nd dose) More
2822100 U 01/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Got the vaccine and shingles again/ suspected vaccination failure; Got the vaccine and shingles agai... Got the vaccine and shingles again/ suspected vaccination failure; Got the vaccine and shingles again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine and shingles again/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the vaccine and shingles again). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-JAN-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and the shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2822101 U 01/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Musculoskeletal pain Musculoskeletal pain
kicked my butt HARD; This non-serious case was reported by a consumer via interactive digital media ... kicked my butt HARD; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of buttock pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced buttock pain (Verbatim: kicked my butt HARD). The outcome of the buttock pain was not reported. It was unknown if the reporter considered the buttock pain to be related to Shingles vaccine. It was unknown if the company considered the buttock pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JAN-2024 The patient reported that he/she did not if it was the shingles vaccine, or the one for pneumonia (got them simultaneously) but one of them kicked on buttock hard. More
2822102 U WI 01/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
received only the adjuvant of Shingrix without reconstituting the vaccine; received only the adjuvan... received only the adjuvant of Shingrix without reconstituting the vaccine; received only the adjuvant of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant of Shingrix without reconstituting the vaccine) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date:17-DEC-2024 Pharmacist called to inform that two patients (gender unknown) received only the adjuvant of Shingrix (without reconstituting the vaccine),which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Also mentioned that a few days later when they realized the error, the patient was called back and was given the vaccine, the adjuvant with the actual vaccine product. More
2822103 F TX 01/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4878Y
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Underage administration of a vaccine dose.; administer Gardasil for HPV but Shingrix was administere... Underage administration of a vaccine dose.; administer Gardasil for HPV but Shingrix was administered in error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-year-old female patient who received Herpes zoster (Shingrix) (batch number 4878Y, expiry date 13-NOV-2026) for prophylaxis. Co-suspect products included HPV vaccine VLP rL1 4v (yeast) (Gardasil) for prophylaxis. On 08-JAN-2025, the patient received Shingrix. On an unknown date, the patient received Gardasil. On 08-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration of a vaccine dose.) and wrong vaccine administered (Verbatim: administer Gardasil for HPV but Shingrix was administered in error). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 The vaccine coordinator or medical assistant called to reporting the underage administration or maladministration of a Shingrix dose to a female patient. The vaccine coordinator or medical assistant asked about any safety concerns or any information they had to be aware. No further information was obtained during this call. The vaccine administration facility was the same as primary reporter. The reporter mentioned that the intention was to administer Gardasil for HPV but Shingrix was administered in error which led to wrong vaccine administered. More
2822104 M KY 01/21/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 BL3ES
Expired product administered Expired product administered
A 11 years old male patient received an expired dose of Menveo (1 vial) on January 7, 2025.; This no... A 11 years old male patient received an expired dose of Menveo (1 vial) on January 7, 2025.; 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number BL3ES, expiry date 31-DEC-2024) for prophylaxis. On 07-JAN-2025, the patient received Menveo. On 07-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A 11 years old male patient received an expired dose of Menveo (1 vial) on January 7, 2025.). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 A medical assistant called to inform that they administered an expired dose Menveo (1 vial) to a 11 years old male patient. The vaccine expired on 31st December 2024. It was administered on 07th January 2025 which led to expired vaccine used. The reporter asked was there any safety information regarding this. More
2822105 M PA 01/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
first dose of Shingrix in 2018. He did not know that he needed a second dose at the time; This non-s... first dose of Shingrix in 2018. He did not know that he needed a second dose at the time; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2018. He did not know that he needed a second dose at the time). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter was the patient who received his first dose of Shingrix in 2018. The patient did not know that he needed a second dose at the time. The patient received his second dose on the day of reporting which led to lengthening of vaccination schedule. More
2822106 F SC 01/21/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
I accidentally gave her Kinrix; a 15 month old baby coming for her shot today; This non-serious case... I accidentally gave her Kinrix; a 15 month old baby coming for her shot today; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 15-JAN-2025, the patient received Kinrix. On an unknown date, the patient received Infanrix. On 15-JAN-2025, immediately after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: I accidentally gave her Kinrix) and inappropriate age at vaccine administration (Verbatim: a 15 month old baby coming for her shot today). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JAN-2025 The nurse called and reported that she had a 15 month old baby coming for her shot on the day of reporting and supposed to did Dtap (Infanrix), and the nurse accidentally gave the patient Kinrix which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. During the call, the healthcare professional mentioned that the intended vaccine was Infanrix, instead of Kinrix. More
2822107 42 U PA 01/21/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
 Unknown
Unknown
Unknown
Asthenia, Bladder dysfunction, Cervical radiculopathy, Emergency care, General p... Asthenia, Bladder dysfunction, Cervical radiculopathy, Emergency care, General physical health deterioration; Injury, Intervertebral disc operation, Lumbar radiculopathy, Lumbar spinal stenosis, Myalgia; Pain, Pain in extremity, Peripheral nerve lesion, Peroneal nerve palsy, Spinal osteoarthritis More
THE J&J VACCINE CAUSED ME TO LOSE MY HEALTH, MY FAMILY, MY CAREER, AND MY HOME.; INJURIES; MY BO... THE J&J VACCINE CAUSED ME TO LOSE MY HEALTH, MY FAMILY, MY CAREER, AND MY HOME.; INJURIES; MY BODY IS FAILING; Foot Drop; Chronic pain syndrome; Lesion of ulnar nerve, unspecified upper limb; Myalgia, unspecified site; Other lesions of median nerve, unspecified upper limb; Pain in unspecified limb; Radiculopathy, cervical region; Lumbar radiculopathy; Lumbar stenosis; Dysfunction, bladder; Spinal stenosis, lumbar region with neurogenic claudication; Spondylosis without myelopathy or radiculopathy, lumbar region; asthenia; Neurosurgery Microdisectomy; ER/Hospitalization; This spontaneous report received from a patient concerned a 42 year old of unspecified sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose and frequency not reported, administered on 18-Aug-2021, additional dosage information included: DOSE SERIES 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-Aug-2021, the patient experienced er/hospitalization. On Nov-2021, the patient experienced neurosurgery microdisectomy. On an unspecified date, the patient experienced the j&j vaccine caused me to lose my health, my family, my career, and my home., injuries, my body is failing, foot drop, chronic pain syndrome, lesion of ulnar nerve, unspecified upper limb, myalgia, unspecified site, other lesions of median nerve, unspecified upper limb, pain in unspecified limb, radiculopathy, cervical region, lumbar radiculopathy, lumbar stenosis, dysfunction, bladder, spinal stenosis, lumbar region with neurogenic claudication, spondylosis without myelopathy or radiculopathy, lumbar region, and asthenia. The j&j vaccine caused to lose the patients health, family, career, and home. The patient have not received any financial/medical support for my injuries. Patient's body is failing (dose series 1). On 30-aug-2021, ER/hospitalization (dose series 1). The initial diagnosis was: foot drop and was referred for neurosurgery (dose series 1).In Nov-2021, performed Microdisectomy. In feb-2023. Microdisectomy surgery (MRI scans/x-rays/ nerve-testing/ pain injection/ procedures. (dose series 1)Adverse events caused: 1) chronic pain syndrome (g89.4) 2) lesion of ulnar nerve, unspecified upper limb (g56.20) 3) myalgia, unspecified site (m79.10) 4) other lesions of median nerve, unspecified upper limb (g56.10) 5) pain in unspecified limb (m79.609) 6) radiculopathy, cervical region (m54.12) 7) lumbar radiculopathy (m54.16) 8) lumbar stenosis(m48.061) 9) dysfunction, bladder (n31.9) 10) spinal stenosis, lumbar region with neurogenicclaudication (m48.062) 11) spondylosis without myelopathy or radiculopathy, lumbar region(m47.816) (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of the j&j vaccine caused me to lose my health, my family, my career, and my home., injuries, my body is failing, foot drop, chronic pain syndrome, lesion of ulnar nerve, unspecified upper limb, myalgia, unspecified site, other lesions of median nerve, unspecified upper limb, pain in unspecified limb, radiculopathy, cervical region, lumbar radiculopathy, lumbar stenosis, dysfunction, bladder, spinal stenosis, lumbar region with neurogenic claudication, spondylosis without myelopathy or radiculopathy, lumbar region, asthenia, er/hospitalization and neurosurgery microdisectomy was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: Intervertebral disc operation/ Emergency care : The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: NATURE OF EVENT. Therefore, this event is considered not related. More
2822108 U 01/21/2025 COVID19
 PFIZER\BIONTECH
Guillain-Barre syndrome, Post-acute COVID-19 syndrome Guillain-Barre syndrome, Post-acute COVID-19 syndrome
she knew someone that worked at her place of employment that developed GBS after the COVID shot; Pat... she knew someone that worked at her place of employment that developed GBS after the COVID shot; Patient also was reported to have Long Covid; This is a spontaneous report received from a Pharmacist from a sales representative. A patient (age and gender not provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2024, outcome "unknown", described as "Patient also was reported to have Long Covid"; GUILLAIN-BARRE SYNDROME (medically significant) with onset 2024, outcome "unknown", described as "she knew someone that worked at her place of employment that developed GBS after the COVID shot". It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome, post-acute covid-19 syndrome. Clinical course: It was reported that event happened approximately one year ago. She was unsure which COVID vaccine it was and unsure of the manufacturer (not known if Pfizer vaccine). Patient also was reported to have Long Covid. No other details provided. It was unknown if any treatment was received. It was unknown if patient received any other vaccines on the same date as the vaccine and unknown if the patient receive any other vaccines within 4 weeks PRIOR to the vaccine. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Guillain-Barre syndrome, and post-acute COVID-19 syndrome; and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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
2822109 M 01/21/2025 COVID19
 PFIZER\BIONTECH
Cerebrovascular accident, Paralysis, Thrombosis Cerebrovascular accident, Paralysis, Thrombosis
he is now paralyzed; Had a stroke due to blood clot; stroke; This is a spontaneous report received f... he is now paralyzed; Had a stroke due to blood clot; stroke; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "Had a stroke due to blood clot"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "stroke"; PARALYSIS (medically significant), outcome "unknown", described as "he is now paralyzed". Clinical course: It was reported that patient had a stroke due to blood clot. Reporter was calling because her husband got the COVID vaccine, three and half years ago. She said she did not know the name of it, but she is just said it was the COVID Vaccine through Pfizer.When probed to clarify the vaccine name as COVID-19 Vaccine, transferring agent stated, "Yes, she said I guess that might just be the name of it, COVID-19 vaccine and I was sure she was not sure for the actual name too. So, she said it was the Pfizer COVID vaccine that her husband received three and a half years ago." The caller stated that her husband received the vaccine three and a half years ago and three months after receiving it, he had a stroke due to blood clot and he is now paralyzed." she was calling to see if they could receive help for physical therapy because insurance is not helping much. I am not sure if there is anything like that because she did state that. She is looking for a help getting her husband physical therapy so, he could maybe walk again. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2822110 F 01/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood pressure increased, Blood pressure measurement, Central nervous system les... Blood pressure increased, Blood pressure measurement, Central nervous system lesion, Confusional state, Hallucination; Magnetic resonance imaging, Vaccination site mass, Vaccination site pain More
confusion that progressed to hallucinations; BP now runs from 145-150/195-98 mmHg, elevated blood pr... confusion that progressed to hallucinations; BP now runs from 145-150/195-98 mmHg, elevated blood pressure; confusion; a new lesion of progression; knot and pain in arm at injection site; knot and pain in arm at injection site; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017453 (BioNTech SE), 2018SA137109 (Sanofi). A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; teriflunomide (AUBAGIO), since 12Apr2018) at 14 mg daily (14 mg, daily (once a day)), oral for multiple sclerosis; ofatumumab (KESIMPTA), first regimen) at first injection and second regimen) at second injection for multiple sclerosis; ozanimod hydrochloride (ZEPOSIA) for 26 days. The patient's relevant medical history included: "total hysterectomy", start date: 25Apr2017 (unspecified if ongoing), notes: without any hot flashes or mood swings; "lumbar puncture" (unspecified if ongoing), notes: spinal tap. Concomitant medication(s) included: VITAMIN D NOS taken for vitamin supplementation. The following information was reported: HALLUCINATION (medically significant), outcome "unknown", described as "confusion that progressed to hallucinations"; BLOOD PRESSURE INCREASED (medically significant), outcome "recovered", described as "BP now runs from 145-150/195-98 mmHg, elevated blood pressure"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confusion"; CENTRAL NERVOUS SYSTEM LESION (non-serious), outcome "unknown", described as "a new lesion of progression"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "knot and pain in arm at injection site". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 145-150 mmHg; (unspecified date) 195-98 mmHg; (07Jan2025) 150/90 mmHg, notes: yesterday afternoon; (08Jan2025) 160/95 mmHg, notes: this morning; Magnetic resonance imaging: (unspecified date) a new lesion of progression, notes: Central nervous system lesion. The action taken for teriflunomide was dosage not changed; for ofatumumab and ozanimod hydrochloride was unknown. Therapeutic measures were taken as a result of blood pressure increased. The patient blood pressure (BP) being high, her pre-teriflunomide baseline BP now runs from 145-150/195-98 mmHg, elevated blood pressure. The consumer's blood pressure was 150/90 yesterday afternoon and was 160/95 this morning. Treatment for elevated blood pressure included Losartan. Treatment for hot flashes included Estradiol. On an unknown date the patient received Pfizer covid vaccine. On an unknown date after unknown latency patient experienced knot and pain in at injection site (injection site mass and injection site pain). The patient sated her most recent MRI (magnetic resonance imaging) showed a new lesion of progression (Central nervous system lesion). Patient stated MRI done after she took second injection on Kesimpta. The action taken was not applicable for confusion, hallucination and central nervous system lesion; and no action taken and the therapy was continued for rest of the events for teriflunomide; unknown for all events for other suspects. Corrective treatment was losartan for blood pressure increased, not reported for rest. The event outcome was recovered/resolved blood pressure increased, unknown for injection site mass and injection site pain, confusion, hallucination and central nervous system lesion. The reporter causality was unassessable for confusion, hallucination and central nervous system lesion and not reported for other events. The company causality was not reportable for all events. The seriousness criteria was medically significant for hallucination. The reporter's assessment of the causal relationship of "confusion that progressed to hallucinations", "bp now runs from 145-150/195-98 mmhg, elevated blood pressure", "confusion", "a new lesion of progression" and "knot and pain in arm at injection site" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Company Comment: Withheld company comment dated 27Nov2024: This case involves a 43-year-old female patient who experienced confusion that progressed to hallucinations, while she was treated with terifiunomide (Aubagio) and Pfizer Covid vaccine, Ofatumumab (Kesimptal and Ozanimod hydrochloride [Zeposia]. The causal role of drug cannot be excluded for event. However, lack of information regarding event details, patient's compliance, treatment received, Jab data, medical and concomitant medications precludes the comprehensive assessment of the case. The case would be re-evaluated post the receipt of follow up information. Case serious was yes, company agent causal was no, case outcome was unknown. Batch/lot number is not provided, and it cannot be obtained. BNT162b2 is under agreement with BIONTECH SE.; Sender's Comments: There is not a reasonable possibility that the reported events hallucination, blood pressure increased, confusion state, CNS lesion was related to the suspect product event most likely due to patient underlying contributory factors. Causality to the events vaccination site mass and vaccination site pain are most likely due to the vaccination. More
2822111 F FL 01/21/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza, Tremor Influenza, Tremor
flu; flu vaccination causing uncontrollable shaking; Initial information received on 13-Jan-2025 reg... flu; flu vaccination causing uncontrollable shaking; Initial information received on 13-Jan-2025 regarding an unsolicited valid serious case received from a Patient. This case is linked to case 2024SA216487 (Same Patient). This case involves elderly female patient (weight-76.36 kg) who had flu and flu vaccination causing uncontrollable shaking after receiving Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COQ10, Omeprazole-Sodium Bicarbonate, Singulair 10 Mg Tablet, Memantine HCL 10 Mg Tablet, Levothyroxine Sodium 75 Mcg Tablet, Potassium Chloride 20 Meq Tablet Er, Lasix 40 Mg Tablet, Breo Ellipta 100-25 mcg Blst W/Dev, Lipitor 20 Mg Tablet, Atenolol 25 Mg Tablet, Albuterol Sulfate Hfa, Pradaxa 150 Mg Capsule for Product used for unknown indication. On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination. On an unknown date the patient developed flu (influenza) and flu vaccination causing uncontrollable shaking (tremor) (unknown latency) following the administration of Influenza Vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Patient Wanted To Inquire About Taking Dupixent Dose Following Hospitalization For Flu And Flu Vaccination Causing Uncontrollable Shaking. Patient Was In The Hospital With Flu, Dose Was Missed 10-Jan-2025, Needs To Know When Ok To Take Next Dose. Reports Missing A Dose Of Her Medication Dupixent, Mentioned Being In The Hospital And Having The Flu. Patient To Hold Off On Dose Of Dupixent If Comfortable In Tolerating A Prurigo Nodularis Flare Up Until Patient Stabilizes By Advising Patient To Take Next Dose On 24-Jan-2025 (Original Due 10-Jan-2025That Was Missed). Patient Advised That She Was Recently In The Hospital That Caused Her To Miss A Dose On 10-Jan-2025. Action taken with was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was unknown for both the events. Seriousness criteria: The patient was hospitalized for the event (influenza).; Sender's Comments: Sanofi company comment dated 20-Jan-2025: This case involves elderly female patient (weight-76.36 kg) who had flu and flu vaccination causing uncontrollable shaking after receiving Influenza Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
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2822112 F MA 01/21/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Drug ineffective, Influenza, Influenza A virus test positive Drug ineffective, Influenza, Influenza A virus test positive
Tested positive for Flu type A; Lack of efficacy; Started having symptoms which have progressed to m... Tested positive for Flu type A; Lack of efficacy; Started having symptoms which have progressed to moderate and occasionally severe; This spontaneous case initially received on 13-Jan-2025, was reported by a non health professional and concerns an adult female patient. No medical history was reported Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On 28-Dec-2024, the patient received Flucelvax (TIV) for an unknown indication, dose regimen: not reported, route of administration and anatomical location: not reported, Lot number: No batch number available, and wont be requested due to no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On 12-Jan-2025, 15 days after vaccination, the patient experienced Lack of efficacy (Medically Significant, outcome: Not Reported). On 12-Jan-2025, 15 days after vaccination, the patient experienced Tested positive for Flu type A (Medically Significant, outcome: Unknown). Associated symptoms included: Started having symptoms which have progressed to moderate and occasionally severe. Patient received the Flucelvax vaccine on 28-Dec-2024 at a pharmacy. On 12-Jan-2025, she tested positive for Flu type A, started having symptoms on 10-Jan-2025 which had progressed to moderate and occasionally severe. Quality assurance informed that this is not a PTC just an adverse event. Flucelvax (TIV) action taken: Not Applicable Reporter assessment: the reporter did not provide a seriousness and causality assessment for the events.; Reporter's Comments: Causality: Related for influenza and drug ineffective. Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the onset of protective effects of vaccination is usually 21 days post vaccination. This case is not considered an unusual failure of efficacy. More
2822121 73 F OR 01/21/2025 RSV
 PFIZER\WYETH
 LN5489
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
Registry immunization was down, Pt signed up to receive RSV vaccine on 1-18-25. Thoroughly went over... Registry immunization was down, Pt signed up to receive RSV vaccine on 1-18-25. Thoroughly went over the updated CDC guidelines and she was concerned with protection from RSV because she leaving to another country for 3 weeks and she has HX of asthma. Also, a friend of hers got RSV and was impacted and she did not want it. I was l led by her to believe she hasn't received any prior doses. Later that day, I reverified the database to discover she had already received a dose on 11-22-23 RSv Arexvy. Spoke with Pt day after 1-19-25 to inform her of the second dose above CDC guidelines and she said she was fine, felt normal with just a sore arm as she has had in the past with other vaccines. More
2822122 1.5 F NY 01/21/2025 COVID19
 PFIZER\BIONTECH
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
patient is a 20 month old who received adult dose of covid vaccine instead of infant dosing on dece... patient is a 20 month old who received adult dose of covid vaccine instead of infant dosing on december 4, 2024. Patient had no adverse reaction and was well at appearing with no issues at most recent visit. More
2822123 11 F CA 01/21/2025 HPV9
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 Y007197
AMAB030A
Differential white blood cell count, Full blood count, Laboratory test, Rash; Di... Differential white blood cell count, Full blood count, Laboratory test, Rash; Differential white blood cell count, Full blood count, Laboratory test, Rash More
non blanching rash, lower limbs. non blanching rash, lower limbs.
2822124 67 F TN 01/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Headache, Migraine with aura, Photopsia, Vision blurred Headache, Migraine with aura, Photopsia, Vision blurred
3 days after the injection, I starting have signs of migraine with aura. I've never had this b... 3 days after the injection, I starting have signs of migraine with aura. I've never had this before. The first episode was on day 3 after the shot, 2nd episode was on Jan. 5th, 3rd episode on Jan 18th, and again today (4th episode) on Jan 21st. Episode of flashing lights and blurred vision in both eyes that last for 20 min. Some are accompanied by headaches. NEVER had this before in my life. More
2822125 15 M NY 01/21/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00552
Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Priapism, Urine abnormal... Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Priapism, Urine abnormality More
Shot given gluteal. Patient experienced cloudy urine, numbness in leg, pain in buttox and back of le... Shot given gluteal. Patient experienced cloudy urine, numbness in leg, pain in buttox and back of leg, and temporary priapism More
2822155 37 F CA 01/21/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 P224H
Palpitations Palpitations
Daily heart palpitations multiple times a day since flu shot was given. Daily heart palpitations multiple times a day since flu shot was given.
2822156 34 F PA 01/21/2025 PNC20
 PFIZER\WYETH
 LG5579
Injection site erythema Injection site erythema
Patient got Prevnar 20, and her shoulder turned redness at injection site. She said she took Nyquil.... Patient got Prevnar 20, and her shoulder turned redness at injection site. She said she took Nyquil. The redness went away after 4 days. More
2822157 61 F WA 01/21/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Asthenia, Balance disorder, Dysphagia, Dyspnoea, Eye pain; Fatigue, Malaise, Mus... Asthenia, Balance disorder, Dysphagia, Dyspnoea, Eye pain; Fatigue, Malaise, Muscle contractions involuntary, Pain, Paraesthesia More
Paresthesia head to toe, weakness head to toe, dysphagia, pain, malaise, mild sob, difficulty with b... Paresthesia head to toe, weakness head to toe, dysphagia, pain, malaise, mild sob, difficulty with balance, fatigue, muscle fasiculation, eye pain More
2822158 54 F WI 01/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 n77j2
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Patient showed photos and stated she experienced swelling, redness, pain, and warm to the tough ski... Patient showed photos and stated she experienced swelling, redness, pain, and warm to the tough skin around the injection site that was 6 inches wide roughly. She stated it took about two weeks for the swelling to completely go away. More
2822159 75 M AL 01/21/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 929pn
255t2
Extra dose administered, Rash; Extra dose administered, Rash Extra dose administered, Rash; Extra dose administered, Rash
Patient received 2 doses of Arexvy a little over one year apart. Patient did report he had a chest ... Patient received 2 doses of Arexvy a little over one year apart. Patient did report he had a chest rash after the second dose. More
2822160 40 M IL 01/21/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LP1780
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
patient received 2024-2025 updated for covid (comirnity) as well as flu (fluzone). Patient was acci... patient received 2024-2025 updated for covid (comirnity) as well as flu (fluzone). Patient was accidentally administered HD flu, even though pt is only 40yo. It was grabbed from the fridge by mistake, thinking that it was the regular Fluzone product, and not the HD. Patient was contacted about the administration error and no adverse events have been self reported by patient. More
2822161 32 F WA 01/21/2025 RSV
RSV
RSV
RSV
RSV
RSV
RSV
RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 LN5464
LN5464
LN5464
LN5464
LN5464
LN5464
Epistaxis, Exposure during pregnancy, Haematuria, Platelet count decreased, Thro... Epistaxis, Exposure during pregnancy, Haematuria, Platelet count decreased, Thrombosis with thrombocytopenia syndrome; Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia; Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia; Epistaxis, Exposure during pregnancy, Haematuria, Platelet count decreased, Thrombosis with thrombocytopenia syndrome; Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia; Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia; Epistaxis, Exposure during pregnancy, Haematuria, Platelet count decreased, Thrombosis with thrombocytopenia syndrome; Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia; Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia More
Patient is a 32yo otherwise healthy lady who is at 33w gestation who presented with epistaxis and gr... Patient is a 32yo otherwise healthy lady who is at 33w gestation who presented with epistaxis and gross hematuria, found to have a platelet count of 0 (baseline normal). We are concerned that this is vaccine-induced ITP (has been reported in post-COVID vaccine cases before but not with RSV) More
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2822162 F AZ 01/21/2025 UNK
 UNKNOWN MANUFACTURER
Erythema, Pain, Swelling Erythema, Pain, Swelling
pain, redness, swelling pain, redness, swelling
2822163 14 M CA 01/21/2025 HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



X024650
X024650
X024650
X024650
Brain natriuretic peptide increased, Chest X-ray normal, Chest discomfort, Chest... Brain natriuretic peptide increased, Chest X-ray normal, Chest discomfort, Chest pain, Chills; Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Grunting, Malaise; Myopericarditis, Troponin increased; Chest pain, Laboratory test, Myocarditis, Pyrexia; Brain natriuretic peptide increased, Chest X-ray normal, Chest discomfort, Chest pain, Chills; Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Grunting, Malaise; Myopericarditis, Troponin increased; Chest pain, Laboratory test, Myocarditis, Pyrexia More
Patient received the 2nd dose of his HPV vaccine on Tuesday 1/14/2025 morning (he received his 1st d... Patient received the 2nd dose of his HPV vaccine on Tuesday 1/14/2025 morning (he received his 1st dose without issues). He woke up at 6-7 PM with chills, shivering, and temp 100.2F so mom gave him ibuprofen with relief. On Wednesday 1/15/2025, he began to complain about his chest "feeling weird" at 6-7PM, after which mom gave him his newly prescribed albuterol inhaler with relief. On Thursday 1/16/2025, he called mom from school at 11AM to ask if she can bring his inhaler because now he was having sternal chest pain (no radiation). He was fine until 9PM that evening when his sternal chest pain returned with associated shortness of breath, grunting, and "not feeling good", thus prompting presentation to Hospital. Found to have and treated for myopericarditis. Will follow up outpatient with Cardiology. More
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2822164 6 F TX 01/21/2025 VARCEL
 MERCK & CO. INC.
Injection site erythema Injection site erythema
Red patch where vaccine was administered Red patch where vaccine was administered
2821731 U SC 01/20/2025 MMR
 MERCK & CO. INC.
 X000178
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AEs; Nurse practitioner reported that a patient received an expired MMR II vaccine on ... No additional AEs; Nurse practitioner reported that a patient received an expired MMR II vaccine on 1/6/2025.; This spontaneous report was received from a nurse practitioner and referred to a patient with unknown age or gender on 06-JAN-2025. Information about concurrent condition, concomitant medication and medical history was not provided. On 06-JAN-2025, the patient was vaccinated with the expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, lot #X000178, expiration date: 02-JAN-2025 (Albumin status recombinant Human albumin (rHA)), administered for prophylaxis (strength and route of administration were not provided). No additional adverse events (AEs) were reported. More
2821732 F NY 01/20/2025 HPV9
 MERCK & CO. INC.
Antibody test negative Antibody test negative
Antibody test negative; This spontaneous report was received from Pharmacist and refers to a female ... Antibody test negative; This spontaneous report was received from Pharmacist and refers to a female of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (reported as patient as a child), the patient was vaccinated with 3 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unknown day, the reporter was calling inquiring regarding hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Would like to know if there would be a presence of antibodies detected via blood work. The patient who was told by her HCP that she no longer has immunity to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and they want to revaccinate her, despite getting the 3 required doses as a child (Antibody test negative).The outcome of the event was unknown. The causal relationship between Antibody test negative and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. More
2821733 1 U MN 01/20/2025 VARCEL
 MERCK & CO. INC.
 X001000
Expired product administered, No adverse event Expired product administered, No adverse event
expired VARIVAX inadvertently administered to a patient; no adverse event; This spontaneous report w... expired VARIVAX inadvertently administered to a patient; no adverse event; This spontaneous report was received from Other Health Professional and refers to a 12-month-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-JAN-2025, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dosage form, lot #X001000, expiration date: 09-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). On 15-JAN-2025, the patient experienced expired VARIVAX inadvertently administered to a patient, the patient experienced no adverse event. At the time of reporting, the outcome of the event expired VARIVAX inadvertently administered to a patient was not known, the outcome of the event no adverse event was not known. The action taken with VARIVAX regarding expired VARIVAX inadvertently administered to a patient was reported as Not Applicable. The action taken with VARIVAX regarding no adverse event was reported as Not Applicable. More
2821734 U PA 01/20/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Nurse called and reported that a consumer received the 1st dose of GARDASIL-9 as a teenager. The con... Nurse called and reported that a consumer received the 1st dose of GARDASIL-9 as a teenager. The consumer is now an adult and has not received any additional doses of GARDASIL-9 at this time. No additional AE reported. No PQC reported. ; Nurse called and reported that a consumer received the 1st dose of GARDASIL-9 as a teenager. The consumer is now an adult and has not received any additional doses of GARDASIL-9 at this time. No additional AE reported. No PQC reported. ; This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions concomitant therapies were not reported. On an unknown date, the patient received the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) as a teenager and had not received any additional doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at that time (Inappropriate schedule of product administration). No additional adverse event (AE) reported (No adverse event). Lot number is being requested and will be submitted if received. More
2821735 72 U 01/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; i had the shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; i had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included covid vaccine with an associated reaction of herpes zoster (same with covid). On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i had the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-JAN-2025 This case was reported by a patient via interactive digital media. The patient was about 72 when they got shingles vaccine and 2 months later he/she had the shingles, same with covid, he/she mentioned that through with our vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2821736 U CA 01/20/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Injection site pain, Injection site swelling, Rash, Rash pruritic Injection site pain, Injection site swelling, Rash, Rash pruritic
injection site pain; injection site swelling; itchy rash on chest and back; This non-serious case wa... injection site pain; injection site swelling; itchy rash on chest and back; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a 16-year-old patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: injection site pain), injection site swelling (Verbatim: injection site swelling) and itchy rash (Verbatim: itchy rash on chest and back). The outcome of the injection site pain, injection site swelling and itchy rash were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and itchy rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site swelling and itchy rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-JAN-2025 Physician gave first dose of Bexsero to a 16 year old who developed injection sight pain/ swelling and an itchy rash on chest and back. Patient almost went to emergency room because it was so bad. Physician was hesitant to gave the 2nd dose in 6 months because of this reaction. More
2821737 25 F MI 01/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 G7749
Expired product administered Expired product administered
it actually expired 03Nov2024. So 15 days pass expiration date; This non-serious case was reported b... it actually expired 03Nov2024. So 15 days pass expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number G7749, expiry date 03-NOV-2024) for prophylaxis. On 18-NOV-2024, the patient received Boostrix. On 18-NOV-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: it actually expired 03Nov2024. So 15 days pass expiration date). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JAN-2025 The nurse practitioner reported that they had a nurse who gave an expired dose of Boostrix injection and realized it actually 15 days passed expiration date, which led to expired vaccine used. The reporter was just wondering was there a protocol for that. The Vaccine Administration Facility was the same as Primary Reporter. More
2821738 M 01/20/2025 COVID19
 JANSSEN
 Unknown
Gait disturbance, Hypertension, Laboratory test, Renal failure, Vertigo Gait disturbance, Hypertension, Laboratory test, Renal failure, Vertigo
difficult to walk; high blood pressure; had bad vertigo for first month; KIDNEY FAILURE; This sponta... difficult to walk; high blood pressure; had bad vertigo for first month; KIDNEY FAILURE; This spontaneous report received from a consumer concerned a male patient of unspecified age. via social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose and frequency not reported, administered on Aug-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the patient experienced kidney failure, high blood pressure, and had bad vertigo for first month. On an unspecified date, the patient experienced difficult to walk and was hospitalized on an unspecified date.dose series 1 On 2022, laboratory data included: nerve conduction exam (NR: not provided) results not reported. It was reported that 10 days later ankles would not work , he moved maybe the vibration, knees will not lock almost to his diagram (dose series 1). Done nerve conduction testing that was in 2022. The action taken with janssen covid-19 vaccine was not applicable. The outcome of kidney failure, difficult to walk, high blood pressure and had bad vertigo for first month was not reported. This report was serious (caused/prolonged hospitalization and other medically important condition).; Sender's Comments: V0; Renal failure and Gait disturbance; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. More
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2821744 24 M TX 01/20/2025 COVID19
 PFIZER\BIONTECH
 LM7786
Completed suicide, Depression Completed suicide, Depression
Depression leading to suicide Depression leading to suicide
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2821749 71 F MD 01/20/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site pruritus Injection site erythema, Injection site pruritus
redness and itchiness around injection site; redness and itchiness around injection site; This spont... redness and itchiness around injection site; redness and itchiness around injection site; This spontaneous report was received from a pharmacist and refers to a 71-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JAN-2025, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided). On 14-JAN-2025, the patient experienced redness and itchiness around injection site (Vaccination site erythema, Vaccination site pruritus). The patient came back to speak to pharmacist. At the time of reporting, the patient had not recovered from the events. No additional information was known by reporter. The action taken with the suspect vaccine regarding both events was not applicable. The causal relationship between both events and pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) was not provided. Lot# is being requested and will be submitted if received. More
2821752 73 M AZ 01/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Bronchitis, COVID-19, Fall, Intervertebral disc degeneration, SARS-CoV-2 test po... Bronchitis, COVID-19, Fall, Intervertebral disc degeneration, SARS-CoV-2 test positive; Vaccine breakthrough infection More
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID... Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: patient admitted for #Recurring Mechanical Ground-Level Falls #Severe multilevel lumbar degenerative disc disease #Covid 19+ bronchitis discharged home Other Relevant HX: discharged to home Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination More
2821753 60 M AZ 01/20/2025 COVID19
 PFIZER\BIONTECH
Acute respiratory failure, Breakthrough COVID-19, COVID-19 pneumonia, Hypoxia, S... Acute respiratory failure, Breakthrough COVID-19, COVID-19 pneumonia, Hypoxia, SARS-CoV-2 test positive More
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVI... Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted for COVID pneumonia with acute on chronic hypoxic respiratory failure and discharged home after treatment. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination More
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2821754 76 M AZ 01/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 3032265
3032265
COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition a... COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated, SARS-CoV-2 test positive; Vaccine breakthrough infection More
Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID... Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient developed COVID PNA and COPD exacerbation. Received course of remdesivir and methylprednisolone. Improved and was discharged home after 7 days. Other Relevant HX: former smoker, COPD Group 4, pulmonary HTB, HFpEF, chronically on 5 mg on prednisone daily and azithromycin Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination More
2821755 74 M AZ 01/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 3031900
3031900
Atrial fibrillation, Breakthrough COVID-19, COVID-19, Cardiac failure acute, Ren... Atrial fibrillation, Breakthrough COVID-19, COVID-19, Cardiac failure acute, Renal impairment; SARS-CoV-2 test positive, Transaminases increased More
Reported Symptoms: 10054112:HOSPITALISATION; 10067923: VACCINE BREAKTHROUGH INFECTION; 10084268: COV... Reported Symptoms: 10054112:HOSPITALISATION; 10067923: VACCINE BREAKTHROUGH INFECTION; 10084268: COVID-19; Narrative: Patient found to be COVID positive on admission. Was also admitted for acute decompensated heart failure and atrial fibrillation. Due to elevated transaminases and kidney impairment, anti-virals were not given. Patient was mildly symptomatic, but COVID-19 infection was thought to contribute to overall initial presentation. Patient was discharged home after 8 days. Other relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination More
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2821756 78 M AZ 01/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 GJ5342
GJ5342
Breakthrough COVID-19, Chest X-ray normal, Dyspnoea, Oropharyngeal pain, Procalc... Breakthrough COVID-19, Chest X-ray normal, Dyspnoea, Oropharyngeal pain, Procalcitonin normal; Respiratory tract congestion, SARS-CoV-2 test positive, Sleep disorder More
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID... Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient presented to the ED for sudden worsening of congestion with SOB that woke him up from his sleep. Reports mild congestion and sore throat for 2 days prior. CXR clear and procalcitonin WNL. O2 saturation was 92% so was placed on oxygen. Received remdesivir and dexamethasone while in the hospital, was discharged home after 2 days with large improvement in symptoms. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination More
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