πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2860854 09/23/2025 COVID19
PFIZER\BIONTECH

Chills, Fatigue, Headache, Illness, Myalgia Chills, Fatigue, Headache, Illness, Myalgia
sick; fatigue; muscle aches; headaches; chills / teeth chattering; This is a spontaneous report rece... sick; fatigue; muscle aches; headaches; chills / teeth chattering; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-773535 (Moderna Clinical Safety and Pharmacovigilance). This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) in a patient who received mRNA-1273 (Moderna COVID-19 Vaccine). In January 2021, the patient received first dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering). On an unknown date, the patient experienced ILLNESS (sick) and EXTRA DOSE ADMINISTERED ((redacted) said that is why (redacted) has stuck with Moderna and has gotten everything (every vaccine) plus (redacted) 'unauthorized one'). At the time of the report, ILLNESS (sick) had resolved and FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches), CHILLS (chills / teeth chattering) and EXTRA DOSE ADMINISTERED ((redacted) said that is why (redacted) has stuck with Moderna and has gotten everything (every vaccine) plus (redacted) 'unauthorized one') outcome was unknown. No concomitant medications were reported. No vaccines were administered within the past 4 weeks. It was reported that, other than the first 2 doses in January/February 2021, when (redacted) got Pfizer, (redacted) always gets Moderna. It was reported that, (redacted) would get the vaccine in the morning and by 3 in the afternoon, (redacted) started to get the fatigue, muscle aches, headaches and chills. Sometimes (redacted) got teeth chattering and was sick the day after the vaccine but by that evening, (redacted) was fine. (redacted) tried to plan (redacted) activities accordingly. (redacted) got Moderna vaccine every 6 months because (redacted) was old and it was what (redacted) physician recommended. Somewhere in the beginning, (redacted) snuck in an extra dose because (redacted) was so petrified. (redacted) believed it was when there was a 2nd dose, where the first dose was a higher amount and the second dose was less. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500188016 same patient, different dose/event; More
2860855 1.75 F OH 09/23/2025 HIBV
SANOFI PASTEUR
UK208AA
No adverse event, Product preparation error No adverse event, Product preparation error
act-hib was mixed with sterile water with no reported adverse event; Initial information received on... act-hib was mixed with sterile water with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 months old female patient who received HIB (PRP/T) Vaccine [Act-Hib], which was mixed 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. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) for Immunization. On 04-Sep-2025, the patient received 0.5ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Strength Standard, frequency Once, lot UK208AA and expiry date 30-Apr-2026 via unknown route in right leg for immunisation, which was mixed with sterile water with no reported adverse event (product preparation error). 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
2860856 11 F PA 09/23/2025 FLU3
SANOFI PASTEUR
UT8802MA
No adverse event, Product storage error No adverse event, Product storage error
patient received FLUZONE NP which was exposed to temperature excursion due to Storage in cooler with... patient received FLUZONE NP which was exposed to temperature excursion due to Storage in cooler with ice packs where Max/low temperature reached was unknown for 4 hours with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which was exposed to temperature excursion due to storage in cooler with ice packs where maximum/lowest temperature reached was unknown for 4 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other immunizations On 13-Sep-2025, the patient received 0.5ml (Dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Suspension for injection, Strength Standard, lot UT8802MA and expiry date 30-Jun-2026 via intramuscular route in the right deltoid for immunisation which was exposed to temperature excursion due to storage in cooler with ice packs where max/low temperature reached was unknown for 4 hours with no reported adverse event (product storage error) (Latency Same day). Reportedly, this excursion occurred due to a human error, extended stability data did not cover the excursion, Previous excursion none. Action taken was not applicable This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA281965: More
2860857 1.42 F FL 09/23/2025 DTAPIPVHIB
SANOFI PASTEUR
UK226AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial infor... gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial information received on 18-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 months old female patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] but they only gave the diluent and not the vaccine 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 Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) for Immunisation; and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 11-Sep-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, lot UK226AA,, expiry date:31-Aug-2026, strength: standard, frequency: once, via intramuscular route in the left thigh for immunisation, but they only gave the diluent and not the vaccine 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
2860858 69 M KY 09/23/2025 COVID19
FLU3
MODERNA
SANOFI PASTEUR

UT8409CA
Rash, Urticaria; Rash, Urticaria Rash, Urticaria; Rash, Urticaria
developed a severe case or rash; developed a severe case or hives which lasted for more than 4 month... developed a severe case or rash; developed a severe case or hives which lasted for more than 4 month; Initial information received on 18-Sep-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves 69 years old male patient who developed a severe case or rash and hives which lasted for more than 4 month after receiving Elasomeran (Moderna COVID-19 vaccine) and Influenza USP TRIVAL A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past vaccination(s) included Fluzone HD for prophylactic vaccination (immunization) in 2020, 2021, 2023 with no adverse reaction and Moderna Covid Vaccine for COVID-19 immunization. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date in 2024, the patient received a dose of suspect Influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UT8409CA) for Influenza (Influenza immunization) and received a dose of suspect Moderna COVID-19 vaccine not produced by Sanofi Pasteur (unknown formulation and lot number) for COVID-19 immunization, both (strength, expiry date -not reported) via unknown route in unknown administration site. On an unknown date in 2024 the patient developed a severe case or rash (rash) and hives which lasted for more than 4 month (urticaria) (unknown latency) following the administration of Influenza USP trival A-B high dose subvirion vaccine and Moderna COVID-19 vaccine. Reportedly, Patient stated that last year, they got FLUZONE HD (high dose) and Moderna Covid Vaccines, but they developed a severe case or rash and hives which lasted for more than 4 month. Patient wanted to know if they can still get FLUZONE HD this year. Patient was not sure if it was really caused by FLUZONE HD because they also got the Moderna Covid Vaccine which they were also able to use before. Patient wanted to know if the ingredients of FLUZONE HD this year changed from last year. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events. More
2860859 1.25 F WV 09/23/2025 TDAP
SANOFI PASTEUR
3CA07C1
No adverse event, Wrong product administered No adverse event, Wrong product administered
15-month-old patient was administered with ADACEL instead of DTaP with no reported Adverse event; In... 15-month-old patient was administered with ADACEL instead of DTaP with no reported Adverse event; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was administered with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine 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 Inact (Vaqta) for Immunisation. On 17-Sep-2025, the patient received 0.5mL (dose 4) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 3CA07C1, expiry date 31-Dec-2025, strength standard and frequency once) via intramuscular route in the right thigh for Immunisation and it was administered instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine (lot, expiry date and strength not reported) with no reported adverse event (wrong 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
2860880 68 F NC 09/23/2025 FLUX
UNK
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Headache, Influenza like illness, Pain; Headache, Influenza like illness, Pain Headache, Influenza like illness, Pain; Headache, Influenza like illness, Pain
flu like symptoms/flu like symptoms, aches, headache A little better but still achy; This spontaneou... flu like symptoms/flu like symptoms, aches, headache A little better but still achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy) in a 68-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 28-Oct-2024. Concomitant products included Etodolac (Lodine) for an unknown indication. On 12-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 12-Sep-2025, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy). On 14-Sep-2025, INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no medical history, concomitant disease or risk factor. There were no lab data or results available. It was reported that within the first 24 hours after vaccination the patient had experienced flu-like symptoms, aches, headache. These symptoms were a little better but still achy until 48 hours. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. More
2860882 24 F FL 09/23/2025 UNK
UNK
UNK
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
Ink
Ink
Ink
Bell's palsy, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therap... Bell's palsy, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture; Magnetic resonance imaging, Malaise, Migraine, Muscular weakness, Nerve conduction studies; Paraesthesia, Wheelchair user More
Received 3 consecutive doses. Fell ill 30 days later, numbness and tingling of extremities, muscle w... Received 3 consecutive doses. Fell ill 30 days later, numbness and tingling of extremities, muscle weakness became reliant on wheelchair, Bell?s palsy, and eventually diagnosed with Guillien Barre Syndrome More
2860883 82 F NC 09/23/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
52Z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given second dose of Arexvy on 9/22 at off-site clinic. Followed up with patient on 9/23... Patient was given second dose of Arexvy on 9/22 at off-site clinic. Followed up with patient on 9/23. Patient stated to be doing well without any adverse events. More
2860884 60 F NC 09/23/2025 COVID19
MODERNA
3052663
Intertrigo, Rash, Rash erythematous, Rash pruritic Intertrigo, Rash, Rash erythematous, Rash pruritic
A rash started on my chest and continued to break out on shoulders, stomach and abdomen for 5-7 days... A rash started on my chest and continued to break out on shoulders, stomach and abdomen for 5-7 days. Urgent care diagnosed Intertrigo, on Wednesday 17Sep25 and Dermatologist diagnosed contact dermatitis possibly poison ivy on 19Sep25. Prescribe anti-viral, antibiotics and cream on 17Sep25 and told to stop and take Prednisone on 19Sep25. Rash is itchy but is not blistering. 23Sep25 still continues to be itchy and the redness is spreading at most of the spots. I have received 6 previous Moderna vaccines with no reactions. I received a Flu and RSV shot on 28Aug25. I think this rash may be related to the vaccine. I have no rash on hands, arms or legs. More
2860885 63 M CA 09/23/2025 FLU3
SEQIRUS, INC.
407247
No adverse event No adverse event
No Adverse event - Patient confirmed no symptoms - was okay No Adverse event - Patient confirmed no symptoms - was okay
2860886 42 M CA 09/23/2025 FLU3
SEQIRUS, INC.
407247
Unevaluable event Unevaluable event
None- None-
2860887 85 M TX 09/23/2025 COVID19
MODERNA
3052586
Arthralgia, Mobility decreased, Pain in extremity, Sleep disorder Arthralgia, Mobility decreased, Pain in extremity, Sleep disorder
Patient stated that after receiving the vaccine, he had pain in his arm/shoulder. He stated he coul... Patient stated that after receiving the vaccine, he had pain in his arm/shoulder. He stated he could not sleep for 4 to 5 days. He also stated it is still painful to the point that he can not raise his arm to screw in a light bulb. This was communicated to us today, 09/23/25. He has not gone in to see a physician. More
2860888 84 F NJ 09/23/2025 COVID19
FLU3
PFIZER\BIONTECH
SEQIRUS, INC.
my9548
407245
Dizziness, Loss of consciousness, Nausea; Dizziness, Loss of consciousness, Naus... Dizziness, Loss of consciousness, Nausea; Dizziness, Loss of consciousness, Nausea More
Patient was waiting after her vaccine administration in a chair and was feeling lightheaded. She s... Patient was waiting after her vaccine administration in a chair and was feeling lightheaded. She subsequently lost consciousness while sitting in the chair. With the help of her daughter, we lowered her to the ground and laid her flat and she regained consciousness but was very nauseous. 911 was called immediately and they took her to the hospital for evaluation. More
2860889 59 F CA 09/23/2025 COVID19
FLU3
PFIZER\BIONTECH
SEQIRUS, INC.
NA0739
948406
Peripheral swelling, Rash; Peripheral swelling, Rash Peripheral swelling, Rash; Peripheral swelling, Rash
Patient got vaccinated on 9/19/25 and reported left upper arm was really swollen on Saturday 9/20 an... Patient got vaccinated on 9/19/25 and reported left upper arm was really swollen on Saturday 9/20 and Sunday 9/21. Patient has taken advil and benadryl for past few days. She still noticed some swelling on left upper arm and rash spreading down her arm. More
2860890 74 M MI 09/23/2025 FLU3
SEQIRUS, INC.
406985
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Flu shot was accidentally administered by a technician instead of the requested COVID vaccine. Pati... Flu shot was accidentally administered by a technician instead of the requested COVID vaccine. Patient had already had FLUAD at a doctor's office last week. Patient is aware of side effects that could occur and the higher chance of experiencing them with the second flu shot administered on 9/23/25. More
2860900 70 F OH 09/23/2025 FLU3
SANOFI PASTEUR
U8855AA
Cough, Dry throat, Sputum increased Cough, Dry throat, Sputum increased
Four hours after patient received immunization patient experienced increased sputum production and c... Four hours after patient received immunization patient experienced increased sputum production and cough along with dry throat. Patient also stated potentially seeing blood in sputum. More
2860901 56 F KY 09/23/2025 COVID19
COVID19
COVID19
COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
EL 1284
EL 1284
EL 1284
EL 1284
EL 1284
Angina pectoris, Anxiety, Blood pressure increased, Brain fog, Chest discomfort;... Angina pectoris, Anxiety, Blood pressure increased, Brain fog, Chest discomfort; Confusional state, Depression, Dyspnoea, Head discomfort, Headache; Herpes simplex test positive, Herpes zoster, Immune system disorder, Insomnia, Laboratory test; Myocarditis, Neck pain, Neuralgia, Oesophageal disorder, Optic neuritis; Palpitations, Pyrexia, Tinnitus, Varicella virus test positive More
Right away I had tightness in chest with myocarditis and hard to breath in my lungs. Fever, Brain fo... Right away I had tightness in chest with myocarditis and hard to breath in my lungs. Fever, Brain fog and mild confustion and for the first 6 months shingles or herpes 2 nerve pain in left leg taking valtrex 1000 mg twice a day. The next 12 months from june2021 had issues with my immune systme attacking my esophagus. In spring of 2022 optic neuritis started in my vision and ear buzzing in left ear at the same time. The chicken pox viris and herpes 2 virus begain to spike high in my blood work and I have lived on up to 3000 mg of valtrex a day since then. I am on gabapenton for nerve pain in my crainial regeion of my entire head. from feb 2023 until summer of 2024 I was in ER 5 times thru that whole time frame with severe pain and pressure at the base of my skull and in my neck. In the winter of 2025 my blood pressure went way high and I went to ER. My had chest pain in my heart and had 2 more visits to the ER in that month. For the past 3 years I have had pounding heart rate from 3am to 6 am in the morning. The ear buzzing is continual in my left ear. The doctors fianlly gave me blood presure meds to stop the heart from pounding in the middle of the night. I have permanent insomnia now. There isn't any over the counter meds or melatonin that helps me sleep. I have struggled with depression and anxiety for the past 4 years not knowing when episodes of symptoms will send me to the ER. More
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2860902 91 F NY 09/23/2025 FLU3
SEQIRUS, INC.
407981
Chest pain, Dyspnoea, Malaise Chest pain, Dyspnoea, Malaise
About 5 minutes after I gave her her flu shot, she came back to pharmacy. Her daughters said she was... About 5 minutes after I gave her her flu shot, she came back to pharmacy. Her daughters said she wasn't feeling well. She had pain in her chest and her breathing was a little labored. She could still talk. I called EMS and they sent the EMS. She started feeling better as she was sitting in the counseling room. They checked everything and took her blood pressure and the daughter said everything was fine and she was feeling better, and they continued their shopping. I called her at 7:12 PM at night to see how she was doing, and she said she was doing fine. More
2860903 0.58 F UT 09/23/2025 DTAPHEPBIP
FLU3
MMRV
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
TF499
UT8779LA
2008864
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient received an incorrect vaccine (Proquad). This was given in error. No notable symptoms Patient received an incorrect vaccine (Proquad). This was given in error. No notable symptoms
2860904 81 F PA 09/23/2025 FLU3
SANOFI PASTEUR
u8823ca
Injection site rash, Injection site swelling, Injection site warmth, Rash erythe... Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous More
left arm further down below injection got red bumpy, warm and swollen but went away after 4 days left arm further down below injection got red bumpy, warm and swollen but went away after 4 days
2860905 16 M GA 09/23/2025 HPV9
TDAP
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
Y015179
9YB4G
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
N/A N/A
2860906 60 F WI 09/23/2025 PNC20
RSV
UNK
PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
ndc:00005-2000-
ndc:00069-2465-
ndc:0069-2528-1
Pruritus; Pruritus; Pruritus Pruritus; Pruritus; Pruritus
itchy on upper arm but not really a noticeable rash, self treated with hydrocortisone cream. the ri... itchy on upper arm but not really a noticeable rash, self treated with hydrocortisone cream. the right arm got the Comirnaty 12 + Covid 2025-26 More
2860907 33 F KS 09/23/2025 COVID19
MODERNA

Fatigue, Injection site pain, Myalgia, Pyrexia Fatigue, Injection site pain, Myalgia, Pyrexia
Fever of 100.8-101.4 for two days, extreme fatigue, and muscle pain around the injection site and th... Fever of 100.8-101.4 for two days, extreme fatigue, and muscle pain around the injection site and throughout body, all lasting two days More
2860908 13 F CA 09/23/2025 COVID19
MODERNA
3052741
Syncope Syncope
Patient fainted after. Possibly due to anxiety and low blood pressure/sugar Patient fainted after. Possibly due to anxiety and low blood pressure/sugar
2860909 10 F CA 09/23/2025 FLU3
SEQIRUS, INC.
948401
Blood test abnormal, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae Blood test abnormal, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae
DEVLEOPED PETECHIAL RASH THAT CONTINUED TO SPREAD - SEEN AT ER AND DIAGNOSED W/ ITP - IVIG GIVEN AND... DEVLEOPED PETECHIAL RASH THAT CONTINUED TO SPREAD - SEEN AT ER AND DIAGNOSED W/ ITP - IVIG GIVEN AND CONTINUED FOLLOW UP More
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2860910 90 F MO 09/23/2025 COVID19
FLU3
MODERNA
SEQIRUS, INC.
3052296
407252
Acute myocardial infarction, Death, Wheezing; Acute myocardial infarction, Death... Acute myocardial infarction, Death, Wheezing; Acute myocardial infarction, Death, Wheezing More
Resident received both flu and Covid vaccine around 9am without any adverse reactions. Daughter pre... Resident received both flu and Covid vaccine around 9am without any adverse reactions. Daughter present for vaccinations, then took her mom outside to visit. After returning to the room, the daughter noticed that the resident had begun wheezing and went to notify the nurse (resident has a hx of asthma and was receiving breathing txs). When the nurse and daughter returned to the room, the resident had already passed away. The coroner is calling the cause of death acute MI. More
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2860911 7 M AL 09/23/2025 FLU3
SANOFI PASTEUR
u8823aa
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was at an immunization clinic, Pharmacist was the supervisor and staff member was also an im... Patient was at an immunization clinic, Pharmacist was the supervisor and staff member was also an immunizer, staff member gave the shot to the patient, but she did not realize that there was an age restriction (9 and over ) for the Flublok, it is the fault of the supervisor for not realizing the child was under 9 and stopping the shot More
2860912 18 M MI 09/23/2025 COVID19
PFIZER\BIONTECH

Condition aggravated, Fatigue, Headache, Insomnia, Migraine Condition aggravated, Fatigue, Headache, Insomnia, Migraine
Chronic migraines fatigue, and insomnia started about a week or two after receiving the second shot.... Chronic migraines fatigue, and insomnia started about a week or two after receiving the second shot. It has gotten much worse since then. A few days after I ended up in the ER with a blinding headache. More
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2860913 33 F MI 09/23/2025 FLU3
SEQIRUS, INC.

Cellulitis, Erythema, Nasal congestion, Periorbital oedema, Swelling face Cellulitis, Erythema, Nasal congestion, Periorbital oedema, Swelling face
Periorbital edema/cellulitis/erythema, facial swelling, nasal congestion Periorbital edema/cellulitis/erythema, facial swelling, nasal congestion
2860914 11 M NY 09/23/2025 MNQ
NOVARTIS VACCINES AND DIAGNOSTICS

Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth More
On 9/12/25, 3:15pm after shot given, left upper arm pain at injection site. Applied ice pack. On 9/1... On 9/12/25, 3:15pm after shot given, left upper arm pain at injection site. Applied ice pack. On 9/12/25 at 9:16 pm, left upper arm pain, itchy. Applied ice pack. On 9/13/25 at 9:57am, left upper arm still sore, itchy, and red. Applied ice pack. On 9/13/25 at 6:34 pm, left upper arm is red, sore, itchy, swollen and warm to the touch. I took my son to Urgent Care and he was given Motrin. Urgent Care also drew a circle on my son's arm with a black sharpie marker and advised if the redness spreads outside of the black circle over the next 24 hours to have him seen again. Discharge instructions indicated to give ibuprofen 20ml every 6 hours as needed for pain and swelling, may use Benadryl 10ml by mouth for itchiness of reaction site. On 9/14/25 at 8:44am, the redness spread outside the black marker circle on his arm. I left a message for answering service. On 9/14/25 at 12:10pm, redness spread even more and we made a return trip to Urgent Care where they prescribed Cephalexin 250mg/5ml susp 200ml 10ml by mouth twice daily for 10 days. By 9/20/25, symptoms disappeared. More
2860915 60 F TN 09/23/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
793pt
Extra dose administered, No adverse event Extra dose administered, No adverse event
pt received two doses of tdap(boostrix) in one year. First dose was on 02/0 1/2025, and second dose ... pt received two doses of tdap(boostrix) in one year. First dose was on 02/0 1/2025, and second dose was on 09/15/2025.Patient doing well with no side effects More
2860916 37 M NC 09/23/2025 COVID19
PFIZER\BIONTECH
30155BA
Chest pain, Electrocardiogram, Immunisation reaction, Sleep disorder, X-ray Chest pain, Electrocardiogram, Immunisation reaction, Sleep disorder, X-ray
Woke up next morning with slight chest pain above left lung. Felt like an arrow was stuck in my left... Woke up next morning with slight chest pain above left lung. Felt like an arrow was stuck in my left shoulder. The pain progressed through the weekend waking me up several times through the night. Monday morning driving in to school I began to hunch over in severe continuous pain. I called my instructor informing him I was going to sick. More
2860917 13 M WI 09/23/2025 HPV9
MERCK & CO. INC.

Loss of consciousness, Mydriasis, Seizure Loss of consciousness, Mydriasis, Seizure
10 seconds aftee injection, my son leaned forward unconscious and pupils dialated. After lying him d... 10 seconds aftee injection, my son leaned forward unconscious and pupils dialated. After lying him down on his left he convulsed. I continued to encourage him to come back while Doctor was called back in. More
2860918 84 M 09/23/2025 PNC20
PFIZER\WYETH
LN4927
Extra dose administered Extra dose administered
PATIENT REQUEST A PREVNAR 20 VACCINE 09/04/25. THERE WAS NO RECORD OF THE PATIENT PREVIOUSLY RECEIVI... PATIENT REQUEST A PREVNAR 20 VACCINE 09/04/25. THERE WAS NO RECORD OF THE PATIENT PREVIOUSLY RECEIVING THE SHOT IN JULY OF 2023 IN THE AL IMMPRINT SYSTEM OR ON THE PATIENT'S TWO-YEAR PROFILE. THIS RESULTED IN THE PATIENT RECEIVING TWO PREVNAR 20 VACCINES IN A TWO-YEAR TIME FRAME. More
2860919 41 M CA 09/23/2025 COVID19
FLU3
HEP
PFIZER\BIONTECH
SEQIRUS, INC.
MERCK & CO. INC.



Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass
Nodule about 1 inch in diameter, rash and itchiness on right arm. Appeared next day after vaccine. P... Nodule about 1 inch in diameter, rash and itchiness on right arm. Appeared next day after vaccine. Persisted and slowly dissipated over 3 days. More
2860920 58 M CA 09/23/2025 FLU3
SANOFI PASTEUR
UT8763FA
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Patient is 58 years old and received fluzone high dose instead of the regular dose. No side effects... Patient is 58 years old and received fluzone high dose instead of the regular dose. No side effects. More
2860921 7 F CA 09/23/2025 FLU3
SEQIRUS, INC.
406982
Erythema, Induration, Pruritus, Skin mass, Swelling Erythema, Induration, Pruritus, Skin mass, Swelling
Large 2 inch diameter nodule, half the circumference of the arm, raised, hard red and itchy Sunday n... Large 2 inch diameter nodule, half the circumference of the arm, raised, hard red and itchy Sunday night. By day 3 nodule had gone away but still itchy. More
2860922 26 F TX 09/23/2025 COVID19
MODERNA
012M20A
Abortion spontaneous, Exposure during pregnancy, Malaise, Pyrexia, Ultrasound an... Abortion spontaneous, Exposure during pregnancy, Malaise, Pyrexia, Ultrasound antenatal screen abnormal More
Lost baby, was extremely ill with uncontrolled fever Lost baby, was extremely ill with uncontrolled fever
2860934 0.33 F OH 09/23/2025 FLU3
HEPA
MMR
VARCEL
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
Y0255
J4KYX
Y010046
Y017914
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; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Vaccines were given by mistake patient received vaccines too early. No swelling or redness at the si... Vaccines were given by mistake patient received vaccines too early. No swelling or redness at the sight. No immediate symptoms or sign of adverse reaction More
2860938 82 F AZ 09/23/2025 FLU3
SANOFI PASTEUR
U8830AA
Unevaluable event Unevaluable event
None stated. None stated.
2860226 FL 09/22/2025 HPV9
HPV9
MERCK & CO. INC.
MERCK & CO. INC.
W001494
W001494
Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More
The patient did not receive the third dose yet.; No additional AEs; This spontaneous report was rece... The patient did not receive the third dose yet.; No additional AEs; This spontaneous report was received from a Pharmacist and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Oct-2022, the patient was vaccinated with the 1st dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #W001494, expiration date: 15-Sep-2024), 1 dosage form total for prophylaxis. On 04-Dec-2022, the patient was vaccinated with the 2nd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #W001494, expiration date: 15-Sep-2024), 1 dosage form, total for prophylaxis. The patient did not receive the third dose yet (Inappropriate schedule of vaccine administered). No additional adverse event (no adverse event). More
2860227 M 09/22/2025 HPV9
HPV9
MERCK & CO. INC.
MERCK & CO. INC.


Chest pain, Chills, Electrocardiogram T wave inversion, Myopericarditis, Pain in... Chest pain, Chills, Electrocardiogram T wave inversion, Myopericarditis, Pain in jaw; Paraesthesia, Pyrexia, Troponin increased More
Myopericarditis; Arm Tingling and Jaw Pain; Arm Tingling and Jaw Pain; Chills and Fever; Chills and ... Myopericarditis; Arm Tingling and Jaw Pain; Arm Tingling and Jaw Pain; Chills and Fever; Chills and Fever; Crushing Chest Pain; This spontaneous, social-media report was received from a pharmacist via Business Partner and refers to an 18-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prohpylaxis. On an unknown date (within 24 hours), the patient experienced chills and phyrexia. The patient recovered without sequelae within 48 hours. On an unknown date (three days later), the patient experienced chest pain (reported as: crushing chest pain), pain in jaw, paraesthesia (reported as: arm tingling and jaw pain). The patient was triaged directly to the emergency room where he had troponins of greater that 11000 and T wave inversions on his EKG. Other diagnostic tests and labs showed normal heart anatomy and no early coronary artery disease. He was diagnosed with myopericarditis by cardiology. He was treated and recovered fully within 3 months. The reporter considered the event of myopericarditis to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (reported as: this case has a consistent causal relationship with vaccination). The causal relationship between the rest reported events and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown/not reported/not provided. Upon internal review, the event(s) of Myopericarditis was/were determined to be medically significant. More
2860228 M TX 09/22/2025 HEP
DYNAVAX TECHNOLOGIES CORPORATION

Injection site pain Injection site pain
First Dose of HEPLISAV-B In May of 2025, Told to Wait 6 Months for Second; Injection Site Pain; Init... First Dose of HEPLISAV-B In May of 2025, Told to Wait 6 Months for Second; Injection Site Pain; Initial report received on 14-Aug-2025. A consumer in the US (TX) reported that her husband, an 80-year-old male (race and ethnicity not reported), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not receive the second dose yet and experienced injection site pain. Medical history included allergies to amiodarone, propranolol, flecainide, MULTAQ (dronedarone), metoprolol, and sotalol. All medications caused throat swelling. No concomitant medications were reported. In May-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot #; expiration date and NDC #, route not available) in the left arm. In May-2025, after receiving HEPLISAV-B, the patient experienced injection site pain for two days. At the time of reporting, the patient had not received the second dose of HEPLISAV-B yet. The pharmacy instructed the patient to wait six months before receiving the second dose. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2860229 F IL 09/22/2025 HEP
DYNAVAX TECHNOLOGIES CORPORATION

Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
I am Pregnant, Gave Me HEPLISAV-B; Initial report received on 15-Aug-2025. Additional information r... I am Pregnant, Gave Me HEPLISAV-B; Initial report received on 15-Aug-2025. Additional information received on 29-Aug-2025 from the reporter that included the patient's last menstrual period date, estimated date of delivery, and concomitant medications. A physician reported that she, a 37-year-old female, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 12 weeks pregnant. No medical history was reported. Concomitant medications included prenatal vitamins, aspirin, rizatriptan, and TYLENOL (acetaminophen). On 11-Jul-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available) intramuscularly in the left deltoid. The patient presented to the pharmacy, filled out her paperwork, and notified staff that she was pregnant. The patient later found out she was given HEPLISAV-B. The patient was 12 weeks gestation at the time of injection. Her last menstrual period (LMP) was 18-Apr-2025. Her due date is 23-Jan-2026. No side effects were reported. She has had an uncomplicated pregnancy so far. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2860230 F VA 09/22/2025 HEP
DYNAVAX TECHNOLOGIES CORPORATION
943186
Incomplete course of vaccination Incomplete course of vaccination
Patient Received First Dose of HEPLISAV-B One Year Ago, Has Not Received The Second Dose; Initial re... Patient Received First Dose of HEPLISAV-B One Year Ago, Has Not Received The Second Dose; Initial report received on 27-Aug-2025. A pharmacy technician reported that a 26-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one year ago but never received the second dose. No medical history or concomitant medications were reported. The patient had no known drug allergies. On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 943186, expiration date 30-Nov-2025, and NDC number 43528-0003-05; site not available) intramuscularly. At the time of reporting, the patient had not received the second dose of HEPLISAV-B yet. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2860231 M 09/22/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
55TH4
Bell's palsy Bell's palsy
Bell's palsy; This serious case was reported by a consumer and described the occurrence of bel... Bell's palsy; This serious case was reported by a consumer and described the occurrence of bell's palsy in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 55TH4) for prophylaxis. Previously administered products included Shingrix (patient had 1st dose on 09-NOV-2024, with batch number GA99K). Concurrent medical conditions included diabetes. Concomitant products included metformin, levothyroxine, atorvastatin and lisinopril. On 26-APR-2025, the patient received the 2nd dose of Shingrix. On 29-AUG-2025, 125 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria hospitalization and GSK medically significant). The outcome of the bell's palsy was not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. The company considered the bell's palsy to be unrelated to Shingrix. Additional Information: GSK receipt date: 10-SEP-2025 The reporter reported seriousness for bell's palsy as intervention required.; Sender's Comments: A case of Bell's palsy, 125 days after receiving Shingrix, in a 58-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factor (Concurrent medical conditions included diabetes). More
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2860232 M TN 09/22/2025 HEPAB
GLAXOSMITHKLINE BIOLOGICALS
UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
second dose of vaccine is late; This non-serious case was reported by a consumer via call center rep... second dose of vaccine is late; 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 HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 03-SEP-2025, the patient received the 2nd dose of Twinrix (intramuscular) 1 ml. On 03-SEP-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of vaccine is late). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-SEP-2025 A patient who was transferred from the response center and had a question concerning Twinrix dose scheduling. The standard dosing schedule consists of 3 doses (1-ml each), given intramuscularly at 0, 1, and 6 months so the second dose of vaccine was late. The patient disconnected the call when asked details for filing a safety report. More
2860233 F 09/22/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GJ952
Neuralgia, Pain in extremity Neuralgia, Pain in extremity
Neuralgia; left arm pain; This non-serious case was reported by a other health professional and desc... Neuralgia; left arm pain; This non-serious case was reported by a other health professional and described the occurrence of neuralgia in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number GJ952, expiry date 25-APR-2027) for prophylaxis. On 08-AUG-2025, the patient received Shingrix (intramuscular) .5 ml. On 09-AUG-2025, 1 days after receiving Shingrix, the patient experienced neuralgia (Verbatim: Neuralgia) and pain in arm (Verbatim: left arm pain). The outcome of the neuralgia and pain in arm were not resolved. It was unknown if the reporter considered the neuralgia and pain in arm to be related to Shingrix. It was unknown if the company considered the neuralgia and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 05-SEP-2025 Reporter reported that the left arm pain appears to be neuralgia, dermatomal in location got affected. Pain became worse in the last two. The patient had two primary care visits related to that and had required medication management for pain. No rashes were observed. More
2860234 09/22/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Malaise Malaise
Sick for 5 days; This non-serious case was reported by a consumer via interactive digital media and ... Sick for 5 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included gastritis. Previously administered products included Flu vaccine (received a flu shot for least 30 years and had never got the flu once). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick for 5 days). The outcome of the sickness was resolved (duration 5 days). It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-AUG-2025 This case was reported by a patient via interactive digital media. The reporter love pharmaceuticals because reporter very rarely get sick. The reporter had a funny stomach and get gastritis which would put reporter down for a day. The only reaction the reporter had to any of the preventive shots. The reporter reported that was the Shingles shot. The reporter was sick for 5 days and never got the second shot. The reporter had got a flu shot for least 30 years and reporter have never got the flu once. When before the reporter got the shot would get it every year. The reporter believed they work. They could believe what you want, but reporter living proof they did work. And Covid reporter had a case of Covid in own household and being in his/her 70. The reporter would be prime candidate to get it which the reporter did not. The reporter granddaughter lived with reporter and she was the one that had it. She tested positive twice. The home tests that everyone got for free and also at a emergency clinic. More