๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
1798443 71 M NJ 10/19/2021 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA


029L20A
Asthenia, Blood creatine phosphokinase increased, Demyelinating polyneuropathy, ... Asthenia, Blood creatine phosphokinase increased, Demyelinating polyneuropathy, Diplopia, Electromyogram abnormal; Eyelid ptosis, Facial paralysis, Gait inability, Immunoglobulin therapy, Laboratory test abnormal; Limb discomfort, Magnetic resonance imaging head normal, Paraesthesia; Guillain-Barre syndrome, Laboratory test More
got vaccine 1/29/21, 2/2/21 developed heaviness, tingling of arms and legs. He developed double visi... got vaccine 1/29/21, 2/2/21 developed heaviness, tingling of arms and legs. He developed double vision on 2/4/21, unable to walk by 2/6/21. Was hospitalized. Developed right facial droop on 2/8/21. Had right ptosis on 2/9/21. Started on IVIG with slow resolution of symptoms. Today feels 70% recovered. He is able to walk unaided but still feel not back to full strength. More
โœ“
2835453 04/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I still got COVID anyway; I still got COVID anyway; This is a spontaneous report received from a Con... I still got COVID anyway; I still got COVID anyway; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 47-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I still got COVID anyway". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: During an inbound call for financial assistance, the patient was having some trouble getting Paxlovid prescription covered. The patient had all the vaccines with Pfizer and but still got COVID anyway. The patient wanted a coupon. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2835454 AR 04/09/2025 TDAP
 SANOFI PASTEUR
Incorrect route of product administration Incorrect route of product administration
inadvertently administered the vaccine via SC route instead of IM to a patient with no reported adve... inadvertently administered the vaccine via SC route instead of IM to a patient with no reported adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who was administered with Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] via sc route instead of im to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis Suspension for injection (strength, lot number, expiry date-unknown) via subcutaneous route instead of intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (incorrect route of product administration) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly- He inadvertently administered the vaccine via SC route instead of IM to a patient. 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
2835455 75 F TX 04/09/2025 RAB
 SANOFI PASTEUR
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient's 4th dose was administered earlier than scheduled with no reported ae; Initial informa... patient's 4th dose was administered earlier than scheduled with no reported ae; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 year old female patient who was administered with 4th dose of Rabies (HDC) vaccine [Imovax rabies] earlier than scheduled with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Mar-2025 the patient received an unknown dose (dose 1) of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection, On 27-Mar-2025 she also received an unknown dose (dose 2), On 31-Mar-2025 received an unknown dose (dose 3) and On 04-Apr-2025, the patient received an unknown dose (dose 4) all with standard strength, frequency-once, batch number, expiry date-unknown for post exposure vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On 04-Apr-2025 the patient was administered with 4th earlier than scheduled with no reported AE (inappropriate schedule of product administration) (latency-same day). Reportedly-Patient has been previously vaccinated and the current dose was for post exposure. 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
2835456 3 M HI 04/09/2025 TDAP
 SANOFI PASTEUR
 U8232AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
3 year child received Adacel with no reported ae; Initial information received on 07-Apr-2025 regard... 3 year child received Adacel with no reported ae; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old male patient who received Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported AE (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 (Havrix) for Immunisation. On 07-Apr-2025, a 3 year old male patient received a 0.5ml (dose 4) of suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection in pre-filled syringe standard strength, frequency-once (lot U8232AA, expiry date-31-May-2026) via intramuscular route in the left thigh for Immunization with no reported AE (product administered to patient of inappropriate age) (latency-same day). Reportedly- Their office inadvertently gave the Adacel to a child, ADACEL, which is indicated for 10 years to 64 years old. 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
2835457 CO 04/09/2025 FLU3
 SANOFI PASTEUR
 UT8415MA
Product storage error Product storage error
temperature excursion for Fluzone NP exposed to negative 13 F for 4 hours with no reported adverse e... temperature excursion for Fluzone NP exposed to negative 13 F for 4 hours with no reported adverse event.; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to US-SA-2025SA100631. This case involves an unknown age and unknown gender patient who administered influenza USP trival A-B subvirion vaccine [Fluzone] and that had temperature excursion exposed to negative 13 F 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. On 22-Jan-2025, the patient received an unknown dose of suspect influenza USP trival A-B subvirion vaccine, suspension for injection (lot UT8415MA and expiry date: 30-Jun-2025) via unknown route in unknown administration site for immunization and that had temperature excursion exposed to negative 13 F for 4 hours with no reported adverse event (poor quality product administered). Reportedly, Previous Excursion: 31-Dec-2024: 48 F for 30 minutes. Extended stability data did not cover the excursion. Human error was No. Reason: Fridge malfunction and product was administered. 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-2025SA100631: More
2835458 NY 04/09/2025 MEN
 UNKNOWN MANUFACTURER
 U82718C
Product storage error Product storage error
Menquadfi was given to a patient after the excursion with no ae; Initial information received on 08... Menquadfi was given to a patient after the excursion with no ae; Initial information received on 08-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an elderly and unknown gender patient who was administered with Meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI] after the excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength-unknown) (lot U82718C, expiry date- 31-Jan-2028) via unknown route in unknown administration site for Immunization after excursion (poor quality product administered) (latency-same day). Reportedly- Caller states that one their providers called previously to report a temperature excursion and some of the vaccines were not viable. She is calling to get information if they need to re-vaccinate the patient if the vaccine that was given were not viable. MENQUADFI that was no longer viable was given to a patient after temperature excursion 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
2835466 11 F GA 04/09/2025 UNK
 UNKNOWN MANUFACTURER
 Y007193
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; administered improperly stored GARDASIL 9 and VAQTA following a TE; This spontaneo... no adverse event; administered improperly stored GARDASIL 9 and VAQTA following a TE; This spontaneous report was received from a vaccine coordinator and refers to a 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Oct-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) administered for prophylaxis (lot #Y007193, expiration date: 06-Jun-2026) (dose, scheme, route of administration, and injection site were not reported), which underwent a temperature excursion of 25F for 1 hour (product storage error). No additional adverse event was reported. More
2835467 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Rash, Vaccination failure Herpes zoster, Rash, Vaccination failure
suspected vaccination failure; have had the shingles 3 times; This serious case was reported by a co... suspected vaccination failure; have had the shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have had the shingles 3 times). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient stated that get the vaccine. It would not prevent but it would make it less dangerous. Patient further stated he/she knew because he/she had the vaccination and had the shingles 3 times since and each time had a very light rash. The patient said he/she was grateful for science. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine." More
2835468 NY 04/09/2025 COVID19
 PFIZER\BIONTECH
Back pain, Hypoaesthesia, Muscular weakness, Pain in extremity Back pain, Hypoaesthesia, Muscular weakness, Pain in extremity
my muscle started becoming weaker number; my muscle started becoming weaker number; hands and back h... my muscle started becoming weaker number; my muscle started becoming weaker number; hands and back hurt; hands and back hurt; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (COMIRNATY), on 12Aug2021 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: MUSCULAR WEAKNESS (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "my muscle started becoming weaker number"; PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "hands and back hurt". Additional information: The patient took the vaccine on 12Aug2021 and muscle started becoming weaker and number. Should the patient's hands and back hurt, the patient doesn't have health insurance. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2835469 41 F MA 04/09/2025 COVID19
COVID19
 MODERNA
MODERNA

Anxiety, Brain fog, Depression, Fatigue, Impaired work ability; Musculoskeletal ... Anxiety, Brain fog, Depression, Fatigue, Impaired work ability; Musculoskeletal stiffness, Panic attack More
Extreme fatigue, depression, brain fog, panic attacks, anxiety, and stiffness, had to quit my job Extreme fatigue, depression, brain fog, panic attacks, anxiety, and stiffness, had to quit my job
โœ“
2835489 0.17 F PA 04/09/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
RV1
RV1
RV1
RV1
RV1
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS























Anti-NMDA antibody positive, Barium swallow normal, Blood lactic acid normal, C-... Anti-NMDA antibody positive, Barium swallow normal, Blood lactic acid normal, C-reactive protein normal, CSF cell count normal; CSF glucose normal, CSF protein normal, Culture negative, Cytomegalovirus test negative, Differential white blood cell count normal; Electroencephalogram, Encephalitis, Enterovirus test negative, Epstein-Barr virus test negative, Eyelid function disorder; Full blood count normal, Herpes simplex test negative, Infant irritability, Laboratory test normal, Lumbar puncture abnormal; Magnetic resonance imaging abdominal normal, Magnetic resonance imaging head normal, Magnetic resonance imaging pelvic, Magnetic resonance imaging thoracic normal, Metabolic function test normal; Musculoskeletal stiffness, Polymerase chain reaction negative, Poor feeding infant, Procalcitonin normal, Urine analysis normal; Anti-NMDA antibody positive, Barium swallow normal, Blood lactic acid normal, C-reactive protein normal, CSF cell count normal; CSF glucose normal, CSF protein normal, Culture negative, Cytomegalovirus test negative, Differential white blood cell count normal; Electroencephalogram, Encephalitis, Enterovirus test negative, Epstein-Barr virus test negative, Eyelid function disorder; Full blood count normal, Herpes simplex test negative, Infant irritability, Laboratory test normal, Lumbar puncture abnormal; Magnetic resonance imaging abdominal normal, Magnetic resonance imaging head normal, Magnetic resonance imaging pelvic, Magnetic resonance imaging thoracic normal, Metabolic function test normal; Musculoskeletal stiffness, Polymerase chain reaction negative, Poor feeding infant, Procalcitonin normal, Urine analysis normal; Anti-NMDA antibody positive, Barium swallow normal, Blood lactic acid normal, C-reactive protein normal, CSF cell count normal; CSF glucose normal, CSF protein normal, Culture negative, Cytomegalovirus test negative, Differential white blood cell count normal; Electroencephalogram, Encephalitis, Enterovirus test negative, Epstein-Barr virus test negative, Eyelid function disorder; Full blood count normal, Herpes simplex test negative, Infant irritability, Laboratory test normal, Lumbar puncture abnormal; Magnetic resonance imaging abdominal normal, Magnetic resonance imaging head normal, Magnetic resonance imaging pelvic, Magnetic resonance imaging thoracic normal, Metabolic function test normal; Musculoskeletal stiffness, Polymerase chain reaction negative, Poor feeding infant, Procalcitonin normal, Urine analysis normal; Anti-NMDA antibody positive, Barium swallow normal, Blood lactic acid normal, C-reactive protein normal, CSF cell count normal; CSF glucose normal, CSF protein normal, Culture negative, Cytomegalovirus test negative, Differential white blood cell count normal; Electroencephalogram, Encephalitis, Enterovirus test negative, Epstein-Barr virus test negative, Eyelid function disorder; Full blood count normal, Herpes simplex test negative, Infant irritability, Laboratory test normal, Lumbar puncture abnormal; Magnetic resonance imaging abdominal normal, Magnetic resonance imaging head normal, Magnetic resonance imaging pelvic, Magnetic resonance imaging thoracic normal, Metabolic function test normal; Musculoskeletal stiffness, Polymerase chain reaction negative, Poor feeding infant, Procalcitonin normal, Urine analysis normal More
5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, ... 5 days after immunizations, infant developed encephalitic symptoms including fussiness, stiff neck, fluttering eye movements, poor feeding. Infant was hospitalized and evaluation negative, including labs, cultures, pcr's and imaging. lumbar puncture done mildly abnormal. Testing for autoantibodies on csf mildly +NMDR Infant has spontaneous resolution of symptoms over hospital stay. More
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2835490 51 F MD 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75GZ7
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Large red area at site of injection, pt reported it was bandaid-sized (1x2in) on the first day then ... Large red area at site of injection, pt reported it was bandaid-sized (1x2in) on the first day then grew to about 2x3 inches within 48 hours. She reported site as painful and warm to the touch with mild swelling. More
2835491 4 F TX 04/09/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB (VFC -
Cellulitis, Erythema, Skin warm, Swelling Cellulitis, Erythema, Skin warm, Swelling
redness, warmth, swelling, dx cellulitis, treating with bactrim redness, warmth, swelling, dx cellulitis, treating with bactrim
2835492 52 F CA 04/09/2025 PNC20
 PFIZER\WYETH
 LX4483
Injection site pain, Injection site pruritus, Injection site rash, Rash erythema... Injection site pain, Injection site pruritus, Injection site rash, Rash erythematous More
injection site reaction with pain, itchiness, and erythematous rash to injection site area injection site reaction with pain, itchiness, and erythematous rash to injection site area
2835493 24 F TX 04/09/2025 MMR
 MERCK & CO. INC.
 YO13131
Fall Fall
Patient reports phobia for needles. Fell while sitting at the waiting area Patient reports phobia for needles. Fell while sitting at the waiting area
2835494 56 F TX 04/09/2025 PNC21
 MERCK & CO. INC.
 Y019158
Chills, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm Chills, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
PATIENT WOKE UP NEXT MORNING AFTER RECEIVING VACCINE WITH FEVER, CHILLS, SORE ARM, SWOLLEN ARM, AND ... PATIENT WOKE UP NEXT MORNING AFTER RECEIVING VACCINE WITH FEVER, CHILLS, SORE ARM, SWOLLEN ARM, AND WARM TO TOUCH More
2835495 72 F WI 04/09/2025 COVID19
 PFIZER\BIONTECH
 Em9810
Acute myocardial infarction, Dizziness, Nausea, Vomiting Acute myocardial infarction, Dizziness, Nausea, Vomiting
Sick to stomach dizzy, light headed, vomit..also had a widow maker heart attack after vaccines. No p... Sick to stomach dizzy, light headed, vomit..also had a widow maker heart attack after vaccines. No prob with heart prior More
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2834563 F GA 04/08/2025 UNK
 UNKNOWN MANUFACTURER
 X026658
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; Improper storage of product in use; This spontaneous report was received from a Co... No adverse event; Improper storage of product in use; This spontaneous report was received from a Consumer or other non health professional (reported as vaccine coordinator) and refers to a 22-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP). On 24-OCT-2024, the patient was vaccinated with an improper stored dose of hepatitis A Vaccine, Inactivated (lot #X026658, expiration date: 29-MAY-2025) administered by Intramuscular route as prophylaxis (exact dose and anatomical location were not provided). The temperature excursion was reported as 25 degrees Fahrenheit, for 1 hour, 0 minutes, and 0 seconds (improper storage of product in use). No previous temperature excursion. No symptoms were reported (No adverse event). This is one of several reports received from the same reporter. More
2834564 12 M GA 04/08/2025 FLUX
HPVX
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
X007193

X009193
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No adverse event; Product origin unknown; Improper storage of product in use; This spontaneous repor... No adverse event; Product origin unknown; Improper storage of product in use; This spontaneous report was received from vaccine provider and refers to a 12-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Oct-2024, the patient was vaccinated with improperly storage doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) or Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (reported as HPV) (Product origin unknown), invalid lot #X009193, expiration date: 06-Jun-2026, administered by Intramuscular route; Meningococcal vaccine B (MenB) lot#A2743, expiration date: 30-Sep-2027), administered by Intramuscular route, and Influenza vaccine (Fluzone) lot# UT8485LA, expiration date: 30-Jun-2026, administered by Intramuscular route (lot # was not reported). All the vaccines were administered for prophylaxis. No additional adverse events were reported. More
2834565 MD 04/08/2025 VARCEL
 MERCK & CO. INC.
 Y011712
No adverse event, Product storage error No adverse event, Product storage error
No symptomatic events reported; T/E for VARIVAX on 1/29/2025. reported that vaccines were administer... No symptomatic events reported; T/E for VARIVAX on 1/29/2025. reported that vaccines were administered to patients.; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5mL (vaccination site, route of administration, and vaccination scheme were not provided; lot #Y011712 which has been verified to be valid, expiration date reported on 29-Jan-2025, but upon internal review it was established as 02-Jul-2026) as a prophylaxis, along with a sterile diluent for dilution. However, the vaccine experienced a temperature excursion. The vaccine administered was stored at temperature of 14.65 degrees Fahrenheit (F) for a time frame of 3 hours and 15 minutes. There was no previous temperature excursion, and no data logger was used. No symptomatic events reported. More
2834567 64 M TX 04/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
prescribed Paxlovid/they have Covid/got the Pfizer Covid Vaccine; prescribed Paxlovid/they have Covi... prescribed Paxlovid/they have Covid/got the Pfizer Covid Vaccine; prescribed Paxlovid/they have Covid/got the Pfizer Covid Vaccine; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID:. A 64-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high; "Covid" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral; METFORMIN oral; GABAPENTIN oral; LORATADINE; TELMISARTAN/HCTZ oral; ALLERCLEAR; VITAMIN B-12; VITAMIN D NOS. The patient also took other concomitant therapy. The patient was taking a lot of different medications for high blood pressure. The patient also took a multivitamin and probiotics. Vaccination history included: BNT162b2 (LOT: EN6207, DOSE 1, SINGLE), administration date: 19Mar2021, when the patient was 60-year-old, for covid-19 immunization; Pfizer covid-19 vaccine (received one every six months), for covid-19 immunization. All the patient's previous vaccinations was Pfizer's vaccine. The patient normally get the vaccines on left arm. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "prescribed Paxlovid/they have Covid/got the Pfizer Covid Vaccine". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had Covid again. The physician had prescribed Paxlovid yesterday (26Mar2025). The patient was going to the pharmacy to pick up Paxlovid and a steroid (Intent: Treatment). The patient got the Pfizer Covid Vaccine this past Sep (Sep2024). Other than last year, the patient had received one every six months. No investigation. Patient will start taking Paxlovid as soon as he gets to the pharmacy. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. Follow-up (03Apr2025): This is a spontaneous follow-up report received from a Consumer or other non HCP from product quality group, Program ID:. Updated information included: treatment received. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2834568 VA 04/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP, Progra... got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 69-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jan2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took the Pfizer injection in Jan2025, got Covid "right" away (as reported).The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2834573 54 F VA 04/08/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LM2223
LM2223
Anxiety, Dizziness, Fatigue, Laboratory test normal, Magnetic resonance imaging;... Anxiety, Dizziness, Fatigue, Laboratory test normal, Magnetic resonance imaging; Malaise, Palpitations, Respiratory tract infection More
I started to have heart palpitations soon after these then resolved. Ever since this booster, I have... I started to have heart palpitations soon after these then resolved. Ever since this booster, I have had 8 respiratory infections. I am tired all the time. I get light headed standing up. I have new onset anxiety. I have exercise intolerance. My heart races when I get out of bed in the morning. I had a seizure 3 days after this shot. More
2834576 67 M 04/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 4L5My
Expired product administered Expired product administered
Arexvy less than 30 days expired dose administration; This non-serious case was reported by a pharma... Arexvy less than 30 days expired dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4L5My, expiry date 29-MAR-2025) for prophylaxis. On 02-APR-2025, the patient received Arexvy. On 02-APR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Arexvy less than 30 days expired dose administration). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 03-APR-2025 Pharmacist wanted to know how to proceed after administering an expired dose of Arexvy which led to expired vaccine used. The health care provider requested to remain anonymous. More
2834577 M TX 04/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7349L
Extra dose administered Extra dose administered
a third dose of Shingrix was inadvertently administered to a patient; This non-serious case was repo... a third dose of Shingrix was inadvertently administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 7349L, expiry date 25-MAR-2027) for prophylaxis. Previously administered products included Shingrix (First dose of Shingrix was given on 21st June 2023) and Shingrix (Second dose of Shingrix was given on 30th August 2023). On 03-APR-2025, the patient received the 3rd dose of Shingrix. On 03-APR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: a third dose of Shingrix was inadvertently administered to a patient). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date : 03-APR-2025 Pharmacist called to report a third dose of Shingrix was inadvertently administered to a patient which led to extra dose administered. The vaccine administration facility was the same as primary reporter. More
2834578 61 F VA 04/08/2025 COVID19
 MODERNA
Herpes simplex, Viral test Herpes simplex, Viral test
Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2; This spontaneous case was reported by a pati... Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2) in a 61-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Not sexually active (Had not been sexually active in over 20 years / patient remained sexually inactive). Concurrent medical conditions included Blood pressure high, Allergic asthma, Hashimoto's disease and Thyroid disorder. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2). The patient was treated with Valaciclovir hydrochloride (Valacyclovir) for Herpes infection, at a dose of 500 milligram twice a day. At the time of the report, HERPES SIMPLEX (Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: (Positive) HSV 1 and HSV 2. No concomitant medication was reported. The patient diagnosed with herpes. She was not sexually active in over 20 years. In 2019, learned late husband a different lifestyle in early years. She had doctor test for ALL STDs. She added herpes because it was automatically done. All returned negative. She had remained sexually inactive. She had the Moderna vaccine and booster. Two years later, went for routine woman's visit. She mentioned a sore on buttocks that wouldn't go away. Doctor tested it and was positive for herpes. Devastated, tested several more times. It was positive. She started researching. The patient did not experience any additional symptoms or events. The patient did not have any additional medical history, concomitant disease or risk factor. There were no additional lab data or results available. This case was linked to US-MODERNATX, INC.-MOD-2025-784464 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784464:Invalid case for multiple patients More
2834579 F 04/08/2025 COVID19
 MODERNA
Headache, Limb discomfort, Malaise, Nausea Headache, Limb discomfort, Malaise, Nausea
Patient was unwell after receiving the covid vaccine; legs are not good and a need to lie down; bad ... Patient was unwell after receiving the covid vaccine; legs are not good and a need to lie down; bad headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Patient was unwell after receiving the covid vaccine), LIMB DISCOMFORT (legs are not good and a need to lie down), HEADACHE (bad headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Pneumonia (Pneumonia before Christmas 2024). Previously administered products included for Product used for unknown indication: Covid-19 vaccine (bad headache), RSV Vaccine, Covid-19 vaccine and Covid-19 vaccine. Past adverse reactions to the above products included Headache with Covid-19 vaccine; Leg discomfort with Covid-19 vaccine; Nausea with Covid-19 vaccine; and No adverse effect with RSV Vaccine. Concurrent medical conditions included Urticaria and Allergic reaction to food (allergic reaction to Juniper Berries in Gin). On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient was unwell after receiving the covid vaccine), LIMB DISCOMFORT (legs are not good and a need to lie down), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, MALAISE (Patient was unwell after receiving the covid vaccine), LIMB DISCOMFORT (legs are not good and a need to lie down), HEADACHE (bad headache) and NAUSEA (nausea) outcome was unknown. No concomitant medication was reported. Patient was unwell after receiving the covid vaccine. She had bad headache, nausea, legs were not good and needed to lie down. It was the same with every covid vaccine. They report as if there was completely poisoned. Patient reported never having faced any issues with vaccine even when taking RSV vaccine. Moreover, over years never over the year had reaction to vaccines. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported. This case was linked to MOD-2025-784473 (Patient Link). More
2834582 04/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Cranial nerve paralysis, Diplopia, Ophthalmic herpes zoster, Vaccination failure Cranial nerve paralysis, Diplopia, Ophthalmic herpes zoster, Vaccination failure
Suspected vaccination failure; eye shingles; This serious case was reported by a consumer via intera... Suspected vaccination failure; eye 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: eye shingles) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by the patient via interactive digital media. The patient reported no one told you that it (eye shingles) could cause double vision, and it paralyzed your cranial nerves behind the eye. Because the patient had his/her shots 2 years ago in 2023 (from the date of reporting) and he/she was able to take prednisone and get his/her vision back to normal. However, without the Shingrix shots you would not get better. This was a terrible fate without the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming ophthalmic herpes zoster 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine." More
2834583 04/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Herpes zoster oticus, Vaccination failure Herpes zoster, Herpes zoster oticus, Vaccination failure
Suspected vaccination failure; still got shingles ear; still got shingles left side of scalp neck; T... Suspected vaccination failure; still got shingles ear; still got shingles left side of scalp neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: still got shingles ear) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles left side of scalp neck). The outcome of the vaccination failure, herpes zoster otitis externa and shingles were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster otitis externa 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: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had the Shingles vaccine and still got shingles left side of scalp, neck and ear. But it was not as bad as patient had expected it to be. So, patient guessed it helped to have the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary 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 shingles) is considered unrelated to GSK Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2834584 TX 04/08/2025 DTAP
DTAPIPV
FLU3
HEP
HEPA
HIBV
MENB
MMR
MNQ
RV1
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y97N7
42Y93
DJ22N

A3X2K
3A2KF
ZK9D4
KH2BB
X4T99
7E9Y2
5YB5G
Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Improper storage error/stored at 47.5F for 36 mins 11secs prior above temperature excursions; This n... Improper storage error/stored at 47.5F for 36 mins 11secs prior above temperature excursions; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) (batch number A3X2K, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number 7E9Y2, expiry date 30-MAY-2026) for prophylaxis, Men B NVS (Bexsero) (batch number ZK9D4, expiry date 30-APR-2027) and (batch number B4J4B, expiry date 31-OCT-2027) for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G, expiry date 09-OCT-2026) for prophylaxis, DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis, DTPa (Infanrix) (batch number Y97N7, expiry date 31-AUG-2026) for prophylaxis, MMR (Priorix) (batch number KH2BB, expiry date 01-JAN-2026) for prophylaxis, Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number DJ22N, expiry date 13-JUN-2025) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis, Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis and HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Havrix, Rotarix liquid formulation and Bexsero. On an unknown date, the patient received Boostrix, Kinrix, Infanrix, Priorix, FluLaval 2024-2025 season, Menveo, Hiberix and Engerix B. On an unknown date, an unknown time after receiving Havrix, Rotarix liquid formulation, Bexsero, Boostrix, Kinrix, Infanrix, Priorix, FluLaval 2024-2025 season, Menveo, Hiberix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Improper storage error/stored at 47.5F for 36 mins 11secs prior above temperature excursions). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 27-MAR-2025 The reporter reported the stability data for an excursion than occurred on 13th March 2025 for Bexsero, Menveo (1-vial), Flulaval, Havrix, Kinrix, Boostrix, Infanrix, Engerix-B, Hiberix, Rotarix (liq), Priorix stored at 47.5F for 36 mins 11secs which led to, incorrect storage of drug. The reporter stated the vaccines prior above temperature excursions, called into GlaxoSmithKline, details not provided. The reporter mentioned the several vaccines were used in patients prior to called to GlaxoSmithKline. More
2834586 4 M FL 04/08/2025 DTAPIPV
IPV
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 5G23D
X1D141M
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No adverse event to report. Wanted to inform of the extra dose. Put that the child received 5 doses ... No adverse event to report. Wanted to inform of the extra dose. Put that the child received 5 doses of IVP due to the extra vaccine given. An additional dose of IPV was administered by a newly on boarded medical assistant who was still becoming familiar with the immunization schedule. The issue has been addressed through immediate correction education and reinforcement of protocol. More
2834587 89 F IL 04/08/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA





Arthralgia, Brain fog, Death, Dizziness, Gastrointestinal disorder; Pneumonia, P... Arthralgia, Brain fog, Death, Dizziness, Gastrointestinal disorder; Pneumonia, Pulmonary embolism, Respiratory failure, Thrombosis; Arthralgia, Brain fog, Death, Dizziness, Gastrointestinal disorder; Pneumonia, Pulmonary embolism, Respiratory failure, Thrombosis; Arthralgia, Brain fog, Death, Dizziness, Gastrointestinal disorder; Pneumonia, Pulmonary embolism, Respiratory failure, Thrombosis More
Dizziness, Brain fog, Intestial problems joint pain, Blood clots My grand mother died on April 12, ... Dizziness, Brain fog, Intestial problems joint pain, Blood clots My grand mother died on April 12, 2022 due to Hypoxic Respiratory Failure, Pneumonia and pulmonary Embolism. She was in good health until she took the second Moderna and continue to get worse when she got the Booster. More
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2834588 18 F CO 04/08/2025 HPV9
HPV9
HPV9
MENB
MENB
MENB
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Y015179
Y015179
Y015179
DD72H
DD72H
DD72H
Activated partial thromboplastin time, Blood urine present, C-reactive protein i... Activated partial thromboplastin time, Blood urine present, C-reactive protein increased, Differential white blood cell count, Full blood count; Joint swelling, Metabolic function test, Protein urine absent, Prothrombin time prolonged, Purpura; Rash; Activated partial thromboplastin time, Blood urine present, C-reactive protein increased, Differential white blood cell count, Full blood count; Joint swelling, Metabolic function test, Protein urine absent, Prothrombin time prolonged, Purpura; Rash More
Rash and joint swelling noted 48 hours after receiving Men B & HPV. Rash to lower extremities is... Rash and joint swelling noted 48 hours after receiving Men B & HPV. Rash to lower extremities is consistent with purpura. More
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2834590 11 F PA 04/08/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 AMVB056A
L5229
Product preparation issue; Product preparation issue Product preparation issue; Product preparation issue
Menveo 2vial immunization given but only the powder reconstituted with sterile dilutant was given. C... Menveo 2vial immunization given but only the powder reconstituted with sterile dilutant was given. Contacted GSK medical information and they recommended giving another Menveo vaccine with all components to make sure patient is fully immunized. More
2834629 4 F WV 04/08/2025 MMRV
 MERCK & CO. INC.
 Y012343
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Mother states later in the evening after receiving the vaccine on her upper right leg, she started n... Mother states later in the evening after receiving the vaccine on her upper right leg, she started noticing some redness, mild swelling, and warmth at the site. It seemed to worsen in the next day, and There might have been some mild associated pain. Denies any other symptoms such as headaches, shortness of breath, fevers, N/V, changes in bowel or urinary habits, swelling of the throat, or any other systemic symptoms during this time. Mother does feel that the site has improved as compared to how it initially looked within the 1st 24 hours of receiving the injection but still notes that there is redness at the site. More
2834630 63 F IN 04/08/2025 MMR
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Back pain; Back pain Back pain; Back pain
Lower back pain Lower back pain
2834631 17 F ME 04/08/2025 COVID19
 MODERNA
 3043000
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
On 4/3/25, I made an inadvertent error in administering a COVID-19 vaccine dose to a 17-year-old pa... On 4/3/25, I made an inadvertent error in administering a COVID-19 vaccine dose to a 17-year-old patient. This occurred while I was experiencing flu-like symptoms, including brain fog, which contributed to my lapse in focus. I deeply regret the mistake and wish to offer a detailed explanation of the circumstances that led to the error. Background and Circumstances: That day, I had already encountered confusion due to the handling of different vaccine lot numbers, which was compounded by the fact that I was also managing the administration for a different provider. While this situation should not have influenced my ability to properly assess the patient's eligibility, it led to a series of mental lapses that caused the mistake. I had been dealing with Flu A symptoms and brain fog, but I recognize this does not serve as an excuse for the oversight. It is important to note that at the time of administering the vaccine, I was operating on autopilot, which led to an error in selecting the appropriate vaccine dosage for the patient. The dose administered was intended for a different age group (6 months to 11 years), which does not align with the recommended dosage for a 17-year-old. Immediate Actions Taken: As soon as I became aware of the mistake, I immediately reported the adverse event according to the protocol. I take full responsibility for the oversight and acted quickly to ensure that the situation was handled appropriately. I deeply regret the error and the potential implications it may have had on the patient's health and wellbeing. I am committed to improving my processes to ensure such an oversight does not occur again in the future. This includes taking additional steps to review vaccine guidelines and ensuring greater focus on patient eligibility criteria, especially during periods when I am unwell. Moving Forward: I will take steps to reinforce the importance of accuracy and vigilance in vaccine administration, especially during times of personal health challenges. I understand the gravity of this incident and am actively working to minimize any future risks to patients. I would like to reassure all involved parties that this event was promptly reported and fully acknowledged, and I am committed to ensuring the safety and well-being of those I serve. More
2834632 70 F AL 04/08/2025 COVID19
 MODERNA
Immunisation reaction, Injection site rash, Rash pruritic Immunisation reaction, Injection site rash, Rash pruritic
Covid arm: itchy rash at injection site manifested 3 days after jab Covid arm: itchy rash at injection site manifested 3 days after jab
2834633 47 M MI 04/08/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
No adverse event, Product preparation issue No adverse event, Product preparation issue
Patient received only the diluent without the active virus, after talking to patient, no adverse re... Patient received only the diluent without the active virus, after talking to patient, no adverse reaction for patient More
2834634 43 F CT 04/08/2025 SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
 BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
 96868
96868
96868
96868
Injection site erythema, Injection site induration, Injection site pain, Pain; A... Injection site erythema, Injection site induration, Injection site pain, Pain; Arthralgia, Electrocardiogram normal, Erythema, Pain; Injection site erythema, Injection site induration, Injection site pain, Pain; Arthralgia, Electrocardiogram normal, Erythema, Pain More
+tenderness induration erythema right posterior arm +painful ROM of right shoulder Ice Pack to affe... +tenderness induration erythema right posterior arm +painful ROM of right shoulder Ice Pack to affected area, Rest of right arm More
2834635 11 M AL 04/08/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y--7322
U84(4AA
54G74
Injection site erythema, Injection site induration, Injection site macule, Injec... Injection site erythema, Injection site induration, Injection site macule, Injection site pain, Injection site warmth; Injection site erythema, Injection site induration, Injection site macule, Injection site pain, Injection site warmth; Injection site erythema, Injection site induration, Injection site macule, Injection site pain, Injection site warmth More
The patient developed two warm, erythematous, tender, indurated macules around the injection sites o... The patient developed two warm, erythematous, tender, indurated macules around the injection sites of his Tdap and meningitis vaccines on his right arm. He did not run a fever. The patient went to stay with his father shortly after receiving his vaccines, so mom did not note the cutaneous reaction until patient can back to her house on 4/6/25. She is not sure how long before that the reaction was present. As of today, 4/8/25, the patient is starting to feel better with Tylenol and ibuprofen. The erythematous areas are shrinking per mom. I suspect a local reaction. More
2834636 1 M MS 04/08/2025 MMR
 MERCK & CO. INC.
 x019107
Mood altered, Screaming Mood altered, Screaming
screaming uncontrollably, not happy for 8 weeks, quit laughing screaming uncontrollably, not happy for 8 weeks, quit laughing
2834637 1.5 M MS 04/08/2025 DTAP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4745m
5ja57
Aphasia, Decreased activity, Decreased appetite, Decreased eye contact, Screamin... Aphasia, Decreased activity, Decreased appetite, Decreased eye contact, Screaming; Aphasia, Decreased activity, Decreased appetite, Decreased eye contact, Screaming More
screaming uncontrollably, lost all vocabulary, quit talking, quit eating, started stemming, quit mak... screaming uncontrollably, lost all vocabulary, quit talking, quit eating, started stemming, quit making eye contact, quit playing, quit engaging in other kids More
2834639 80 F TN 04/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 YZ9CY
Injection site erythema, Pruritus, Rash Injection site erythema, Pruritus, Rash
Patient reported rash on arm and red spot around injection site that has gotten better. She had itch... Patient reported rash on arm and red spot around injection site that has gotten better. She had itching that started shortly after injection on her back neck stomach and chest. Her provider had her take benadryl and now she picked up sarna to help with the itching. It is getting better after 1 week of benadryl but did not go away fully. More
2834640 44 F TN 04/08/2025 FLU3
 SEQIRUS, INC.
 388519
Pain in extremity Pain in extremity
The patient reported that her arm has been sore ever since she received her flu vaccine. She noticed... The patient reported that her arm has been sore ever since she received her flu vaccine. She noticed it 1-2 days after getting the vaccine. It has continued for around 1 month. The patient reported she might seek medical attention, but hasn't yet. More
2834641 1.17 M PA 04/08/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 B532G
Rash, Urticaria Rash, Urticaria
REPORTED TO THIS WRITER BY MOM: ~24 hrs post vaccination developed rash on trunk which then spread t... REPORTED TO THIS WRITER BY MOM: ~24 hrs post vaccination developed rash on trunk which then spread to extremities and progressed to "hives." Lasted 3 days per mom. More
2834642 1 F TX 04/08/2025 HEPA
MMRV
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 J4K4X
Y019465
LG5574
Y017914
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
None None
2834643 62 F CA 04/08/2025 PNC20
 PFIZER\WYETH
 LX4482
Erythema, Pruritus, Skin warm Erythema, Pruritus, Skin warm
Redness to L arm measuring 5cm x 5cm. Warm to touch. Per patient it is very itchy. Redness to L arm measuring 5cm x 5cm. Warm to touch. Per patient it is very itchy.
2834645 61 F MN 04/08/2025 PNC20
 PFIZER\WYETH
 LX4483
Cellulitis Cellulitis
Cellulitis of left arm treated with Cephalexin 500 mg every 8 hours X 5 days Cellulitis of left arm treated with Cephalexin 500 mg every 8 hours X 5 days
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