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
2419481 61 F IL 08/24/2022 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 006M20A
012L20A
012L20A
012L20A
Autoimmune disorder, COVID-19, Cystitis, Gastrointestinal disorder, Intestinal o... Autoimmune disorder, COVID-19, Cystitis, Gastrointestinal disorder, Intestinal operation; Abdominal pain, Crohn's disease, Cystitis, Diarrhoea, Gastrointestinal disorder; Inflammation, Intestinal obstruction, Malaise, Nausea, Small intestinal resection; Vomiting More
Patient developed bladder infection for three months. she was not responding to anything. that trigg... Patient developed bladder infection for three months. she was not responding to anything. that triggered to develop colon disease. after days , she got diagnosed with a auto immune disease. in order for her to get better , they had to removed her intestine due to having covid-19 vaccine right after . More
2848385 66 M IL 07/03/2025 PNC20
 PFIZER\WYETH
 LK6655
Disorientation, Swelling Disorientation, Swelling
Per patient, he is experiencing swelling on one side of body as well as disorientation beginning 24 ... Per patient, he is experiencing swelling on one side of body as well as disorientation beginning 24 hours post vaccination. More
2848386 1 M TX 07/03/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014095
Z004454
Rash; Rash Rash; Rash
Mother of patient called our nurse line to discuss symptoms; patient developed a rash this morning a... Mother of patient called our nurse line to discuss symptoms; patient developed a rash this morning around 8:00 AM. Rash is not bothering patient, no itchiness or discomfort per mother of care; rash is all over body (not on head or neck). Unsure if the rash is related to vaccines but mother of care wished to report it. More
2848387 17 F IN 07/03/2025 MENB
 PFIZER\WYETH
 HD2729
Dizziness Dizziness
lightheaded, staff gave patient crackers and juice lightheaded, staff gave patient crackers and juice
2848388 17 F NC 07/03/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 49M9N
U8325AB
Headache, Injection site erythema, Injection site swelling, Nausea, Vomiting; He... Headache, Injection site erythema, Injection site swelling, Nausea, Vomiting; Headache, Injection site erythema, Injection site swelling, Nausea, Vomiting More
Headaches, nausea & vomiting. Redness and swelling with tenderness at injection site about 3 cm.... Headaches, nausea & vomiting. Redness and swelling with tenderness at injection site about 3 cm. Advised to apply cool compress , Zofran 8 mg prescribed for nausea. More
2848389 0.33 F TX 07/03/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U8265AA
MF0416
EX434
Diarrhoea, Eye movement disorder, Skin warm, Vomiting; Diarrhoea, Eye movement d... Diarrhoea, Eye movement disorder, Skin warm, Vomiting; Diarrhoea, Eye movement disorder, Skin warm, Vomiting; Diarrhoea, Eye movement disorder, Skin warm, Vomiting More
Mom of patient reported symptoms started on 06/26/2025 patient felt warm, vomit, diarrhea, eyes mov... Mom of patient reported symptoms started on 06/26/2025 patient felt warm, vomit, diarrhea, eyes moving involuntary More
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2848390 16 F CA 07/03/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 77kA5
u8438AA
Dizziness; Dizziness Dizziness; Dizziness
Patient stated she felt lightheaded/dizzy after administering both vaccines. Patient stated she felt lightheaded/dizzy after administering both vaccines.
2848391 61 M WI 07/03/2025 TD
 SANOFI PASTEUR
 U8303BA
Erythema, Fatigue, Night sweats, Pyrexia, Swelling Erythema, Fatigue, Night sweats, Pyrexia, Swelling
Patient returns to the clinic on 6/23/25 with the following, redness and swelling of the left arm. P... Patient returns to the clinic on 6/23/25 with the following, redness and swelling of the left arm. Patient received a tetanus (only) shot in his left deltoid on 6/23/25 (Clinic). Notes that his left arm was very sore denied following the shot, he was unable to lay on that side of his body.. Patient then had a fever the next day of 101 Fahrenheit, positive for night sweats all night and did feel extremely fatigued. More
2848395 M 07/03/2025 PNC21
PPV
 MERCK & CO. INC.
MERCK & CO. INC.

Fatigue; Fatigue Fatigue; Fatigue
FBE calling to report an AE on behalf on an HCP in which the HCP did not want to provide any identif... FBE calling to report an AE on behalf on an HCP in which the HCP did not want to provide any identifying information and does not want to be contacted regarding the case. HCP stated a patient received CAPVAXIVE in April 2025 and stated that his body; "fatigued and run down more than normal; This spontaneous report was received from a healthcare professional and refers to a male patient of unknown age near 70 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2021, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), administered by Unknown route (lot # and expiration date were not reported). On an unknown date, the patient experienced a reaction. In Apr-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered by Intramuscular route (lot # and expiration date were not reported). Both vaccines were administered for Prophylaxis. After Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) vaccination, the patient stated that his body felt like it had a "stronger reaction than in previous vaccinations and that he felt fatigued and run down more than normal since 2025. The outcome of the events was unknown. No causality assessment was provided. More
2848396 M OR 07/03/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 7NX57
Product storage error Product storage error
Engerix B administration after temperature excursion; This non-serious case was reported by a pharma... Engerix B administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received HBV (Engerix B) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 19-JUN-2025 09:30, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix B administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUN-2025 The pharmacist called to verify if doses of vaccines that had been exposed to low temperatures (26.5๏ฟฝ Fahrenheit) and on 19 June 2025 at 09:30 am was administered to the patient which led to incorrect storage of drug. The reporter wanted to know if the dose should be repeated. The Vaccine Administration Facility is the same as Primary Reporter. More
2848397 0.33 F VA 07/03/2025 HIBV
 MERCK & CO. INC.
 w006595
Expired product administered Expired product administered
Expired vaccine. Parent notified. Plan to receive next scheduled HIB at 6 months, then add an additi... Expired vaccine. Parent notified. Plan to receive next scheduled HIB at 6 months, then add an additional HIB vaccine in the future (with 12 or 15 month vaccines) More
2848398 36 F FL 07/03/2025 HEP
MNQ
VARCEL
 DYNAVAX TECHNOLOGIES CORPORATION
NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 945662
57H54
Z002625
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
My wife was administered the Meningitis vaccine listed above without her knowledge and without her c... My wife was administered the Meningitis vaccine listed above without her knowledge and without her consent. More
2848399 7 F CA 07/03/2025 MMRV
 MERCK & CO. INC.
Cough, Dizziness, Fatigue, Pneumonia, X-ray Cough, Dizziness, Fatigue, Pneumonia, X-ray
Patient started experiencing a slight cough. She reported feelings of dizziness on the day of the va... Patient started experiencing a slight cough. She reported feelings of dizziness on the day of the vaccine and was directed to rest. Her cough got progressively worse and she reported fatigue and a second report of dizziness. By June 30,2025, patient's cough became more persistent and aggressive. She was diagnosed with a pneumonia on June 30,2025. More
2848400 78 F CA 07/03/2025 TDAP
UNK
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 N/A
Computerised tomogram, Laboratory test, Rash; Computerised tomogram, Laboratory ... Computerised tomogram, Laboratory test, Rash; Computerised tomogram, Laboratory test, Rash More
Pt had a rash on her left arm after receiving the Tdap vaccine at the hospital. Pt was given Kenalog... Pt had a rash on her left arm after receiving the Tdap vaccine at the hospital. Pt was given Kenalog to help with reaction. More
2848433 53 F IA 07/03/2025 HEPAB
HEPAB
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 m4b34
m4b34
35a77
35a77
Abdominal pain upper, Electric shock sensation, Headache, Hyperhidrosis, Injecte... Abdominal pain upper, Electric shock sensation, Headache, Hyperhidrosis, Injected limb mobility decreased; Injection site inflammation, Injection site pain, Injection site rash, Pain, Pain in extremity; Abdominal pain upper, Electric shock sensation, Headache, Hyperhidrosis, Injected limb mobility decreased; Injection site inflammation, Injection site pain, Injection site rash, Pain, Pain in extremity More
Patient was given immunization on 6/30/25 at a different pharmacy, but approached our pharmacy on 07... Patient was given immunization on 6/30/25 at a different pharmacy, but approached our pharmacy on 07/03/25 to ask about her adverse reaction. The following information was parsed based from database and the patient. She stated that she felt a shock down her arm at the time of vaccination. Over the course of the next couple days, she had throbbing pain in her left arm ,originating at the site of injection and moving down to her fingers. She mentioned difficulty with moving arm during this time. Other symptoms during this period included stomach cramps, headache, and profuse sweating. At presentation to our pharmacy on 7/3, patient stated the pain was still present but had decreased in magnitude. She also had a rash/inflammation about 3 inches in diameter, distal to the site of injection. She stated that the rash/inflammation had remained stable in size. Patient was encouraged to continue symptom management with ice packs, over the counter medications and to contact her primary if there were changes/worsening in the pain/rash. More
2848434 52 F CA 07/03/2025 UNK
 UNKNOWN MANUFACTURER
Guillain-Barre syndrome Guillain-Barre syndrome
Guillain Barre post Shingrix vaccine Guillain Barre post Shingrix vaccine
2848435 27 M CA 07/03/2025 HEPA
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Expired product administered; Expired product administered Expired product administered; Expired product administered
Patient was given Hepatitis A vaccine that was expired on 3//23/25. Patient was given Hepatitis A vaccine that was expired on 3//23/25.
2848436 33 F HI 07/03/2025 FLU3
HEP
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 AW1615C
MD9SL
Injected limb mobility decreased, Injection site pain, Shoulder injury related t... Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration, Tendonitis; Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration, Tendonitis More
pain at injection site at time of event and ongoing, difficulty using arm, doctor diagnosed patient ... pain at injection site at time of event and ongoing, difficulty using arm, doctor diagnosed patient with tendonitis and rotator cuff dysfunction related to vaccine administration More
2848437 30 F IN 07/03/2025 MENB
 PFIZER\WYETH
 LL0641
Erythema, Peripheral swelling, Skin warm Erythema, Peripheral swelling, Skin warm
Right distal redness, swelling, and warmth spreading and streaking down right arm. Right distal redness, swelling, and warmth spreading and streaking down right arm.
2848438 17 M 07/03/2025 MMRV
 MERCK & CO. INC.
Anaphylactic reaction, Urticaria, Wheezing Anaphylactic reaction, Urticaria, Wheezing
presented with hives and wheezing consistent with anaphylaxis. He was given benadryl and albuterol ... presented with hives and wheezing consistent with anaphylaxis. He was given benadryl and albuterol and sent to facility for observation and possible epipen More
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2848439 37 F WA 07/03/2025 YF
 SANOFI PASTEUR
 UK134AA
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Discovered on 07/03/2025 patient on skyrizi, a drug that will compromise immune system. began med 1.... Discovered on 07/03/2025 patient on skyrizi, a drug that will compromise immune system. began med 1.5 yrs ago. Now on maintenence sched (dosed every 3 mo). Last disp 05/01/25. YF vax administered on 06/27. Spoke to pt who confirms yf was administered. Pt reports no adverse effects except for redness tenderness around vaccine site. Advised patient to not take vivotif and to contact us if she experiences side effects. Called doctor and left message explaining situation. More
2848440 51 F CA 07/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 E754F
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Local, injection site reaction --- redness and swelling. Symptoms has improved by putting ice, stil... Local, injection site reaction --- redness and swelling. Symptoms has improved by putting ice, still still has reaction after almost a week. Patient to continue to put ice and monitor, seek medical attention if concerned or worsen More
2848441 0.5 M ND 07/03/2025 DTAPHEPBIP
DTAPHEPBIP
PNC20
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH



Culture, Injection site bruising, Injection site discharge, Injection site indur... Culture, Injection site bruising, Injection site discharge, Injection site induration, Injection site mass; Injection site pain; Culture, Injection site bruising, Injection site discharge, Injection site induration, Injection site mass; Injection site pain More
Left thigh developed hard lump by evening. Slight bruise coloring. Lump persisted with discoloration... Left thigh developed hard lump by evening. Slight bruise coloring. Lump persisted with discoloration until week of 7/3/2025 with no indication of pain. Week of 7/3/2025 showed signs of discomfort when pressure was applied. Small zit like bump appeared and afternoon of 7/3/2025 it began to leak yellow milky fluid. Patient was brought to a walk in clinic where a sample of fluid was taken and antibiotics were prescribed. More
2848090 07/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Nausea, Renal pain Chills, Nausea, Renal pain
had chills and nausea afterwards; nausea; pain in kidney area; This non-serious case was reported by... had chills and nausea afterwards; nausea; pain in kidney area; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 17-JUN-2025, the patient received Shingrix. In JUN-2025, less than a week after receiving Shingrix, the patient experienced chills (Verbatim: had chills and nausea afterwards), nausea (Verbatim: nausea) and perirenal pain (Verbatim: pain in kidney area). In JUN-2025, the outcome of the chills was resolved. The outcome of the nausea and perirenal pain were not reported. It was unknown if the reporter considered the chills, nausea and perirenal pain to be related to Shingrix. It was unknown if the company considered the chills, nausea and perirenal pain to be related to Shingrix. Additional Information: GSK Receipt Date: 18-JUN-2025 This case was reported by a consumer via (shingrix GRC Chatbot) interactive digital media. The patient had the Shingrix vaccine the day before reporting, had chills and nausea afterwards. Chills were gone, but he/she had sharp pain in kidney area. More
2848104 59 M 07/02/2025 FLU4
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Blood pressure increased, Cerebrovascular accident, Computerised tomogram head n... Blood pressure increased, Cerebrovascular accident, Computerised tomogram head normal, Magnetic resonance imaging head abnormal, Muscular weakness More
Stroke; This 59-year-old male subject was enrolled in a blinded study titled A phase 2a randomized, ... Stroke; This 59-year-old male subject was enrolled in a blinded study titled A phase 2a randomized, observer-blind, dose-finding study to evaluate the immunogenicity and safety of mRNA-based multivalent seasonal influenza vaccine candidates in adults 18 years of age and older. The subject received the 1st dose of Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD (intramuscular, left deltoid) on 03-JUN-2024 11:08, for prophylaxis. The subject's past medical history included lumbar pain (severe) and spinal laminectomy. Concurrent medical conditions included hypercholesterolemia, type ii diabetes mellitus, myopia (Bilateral), sciatica, numbness in hand (right (mild)), back pain (Generalized) and drug allergy (to Lisinopril). Concomitant products included atorvastatin, sitagliptin phosphate (Januvia), pregabalin (Lyrica), meloxicam (Mobic), dulaglutide (Trulicity), tizanidine hydrochloride (Zanaflex), valsartan and ezetimibe. On 22-JUL-2024, 49 days after receiving Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD, the subject developed moderate - grade 2 stroke (Verbatim: Stroke). Serious criteria included life threatening. The outcome of stroke was resolved on 22-JUL-2024. Relevant Tests: On an unknown date in 2024, MRI(magnetic resonance imaging) brain scan done, which did indicate that he had had a stroke. On 21-SEP-2024 MRI (magnetic resonance imaging) was obtained and impression were as follows: No acute territorial ischemia, acute intra-axial hemorrhage or focal intra-axial mass. However, there was extensive deep white matter and periventricular chronic microangiopathy changes and these were also seen in the posterior fossa.. Diagnostic results (reference ranges are provided in parenthesis if available): Blood pressure measurement-In 2024 Elevated. Computerised tomogram-In 2024 did not show evidence of stroke at that time.. The investigator considered that there was no reasonable possibility that the stroke may have been caused by Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD. The company considered that there was no reasonable possibility that the stroke may have been caused by Flu Seasonal mRNA vaccine vs Flu D-QIV or Fluzone HD. GSK Receipt date: 04-DEC-2024 Subject went to his physical therapist for a pre-existing leg weakness (no known diagnosis or information on this), who told him he was having a stroke and sent him to the ER(Emergency room). At the ER, subject was told he did not have the signs of a stroke and discharged him- recommended to follow up at PCP (primary care physician), office. Subject went to PCP, who also told him he was not having a stroke. Later the subject went to his optometrist, who informed him he did have a stroke. Subject had no stroke in the past, no any family history. Subject only had left leg weakness and elevated blood pressure as symptoms. No other information received to date. Serious adverse event (SAE) was not related to study participation activities other than study treatment. SAE was not related to study treatment Date event became serious: 22-JUL-2024 The subject was given concomitant medication Januvia (sitagliptin). Follow up information received on 09-DEC-2024 Summary of changes: Event outcome and date updated. Follow up information received on 10Dec2024 Summary of changes: General narrative comments updated. Lab data updated. Follow up information received on 31-JAN-2025 Summary of changes: The event start date and end date was updated from 10-JUL-2024 to 22-JUL-2024. TTO updated. Date event became serious was updated from 10-JUL-2024 to 22-JUL-2024. Lab data section, general narrative comment updated. Follow up information received on 05-FEB-2025. Summary of changes: General narrative comments updated, Lab data updated. Follow up information received on 27-Jun-2025 End of study Unblinding completed.; Sender's Comments: A case of Cerebrovascular accident, 49 days after receiving 1st dose of Flu D-QIV or Fluzone HD in a 59-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 factors ( Hypercholesterolemia, Type II Diabetes mellitus) based on medical history. More
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2848105 F TX 07/02/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 EB499
Peripheral swelling Peripheral swelling
Arm swelling; This non-serious case was reported by a other health professional via call center repr... Arm swelling; This non-serious case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 45-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis. On 09-JUN-2025, the patient received Boostrix. In JUN-2025, less than 2 weeks after receiving Boostrix, the patient experienced swelling arm (Verbatim: Arm swelling). The outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the swelling arm to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter The GlaxoSmithKline Account Manager called to report a Practice Manager mentioning the administration of Boostrix to a patient last week. GlaxoSmithKline Account Manager did not provide any vaccination date and no patient demographics at all and only provided lot number (no other vaccine detail). Account Manager requested a call back to the Practice Manager. Once the call back was successful, the Practice Manager confirmed all the vaccination date, vaccine detail and patient demographics. No Medical Information question or concern arise in this call back.; Sender's Comments: US-GSK-US2025075892:same reporter /different patient US-GSK-US2025075892:same reporter /different patient More
2848108 3 M WA 07/02/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Kinrix given to a 3-year-old patient with box recommendation for 4-years-old and above. No reaction ... Kinrix given to a 3-year-old patient with box recommendation for 4-years-old and above. No reaction noted. More
2848147 M TX 07/02/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Extra dose administered, Inappropriate schedule of product administration, No ad... Extra dose administered, Inappropriate schedule of product administration, No adverse event More
Patient Was Administered Heplisav-b in Three Doses on 08/22, Again on 06/2024, and Recently on 05/20... Patient Was Administered Heplisav-b in Three Doses on 08/22, Again on 06/2024, and Recently on 05/2025; Patient Was Administered Heplisav-b in Three Doses on 08/22, Again on 06/2024, and Recently on 05/2025; Initial report received on 05-Jun-2025. A pharmacist reported that a 48-year-old male received three doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. In Aug-2022, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). In Jun-2024, one year and ten months after receiving the first dose, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). In May-2025, 11 months after receiving the second dose , the patient received dose 3 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). The patient was administered three doses of HEPLISAV-B. The patient reported no side effects or adverse reactions. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2848148 M FL 07/02/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
What Do We Do With An Interrupted Dosing Schedule. Patient Received First Dose More Than 2 Months Ag... What Do We Do With An Interrupted Dosing Schedule. Patient Received First Dose More Than 2 Months Ago ?; Initial report received on 17-Jun-2025. A nurse reported that a 64-year-old if male (race, race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but did not receive the second dose. No medical history or concomitant medication were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)]. At the time of the report, the patient had not received the second dose yet. No additional information was reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2848149 M TX 07/02/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 943005
Incomplete course of vaccination Incomplete course of vaccination
We Had A Patient Who Received First dose on 6/10/2024, And Did Not Receive The 2nd Dose; Initial rep... We Had A Patient Who Received First dose on 6/10/2024, And Did Not Receive The 2nd Dose; Initial report received on 17-Jun-2025. A pharmacist reported that a 20-year-old male (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but had not yet received the second dose. No medical history or concomitant medication were reported. On 10-Jun-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 943005, expiration date 30-Sep-2025, NDC #, site, and route not available). At the time of this report, the patient had not received the second dose yet. The first dose was said to have been administered at a different facility than the reporter's facility. 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
2848150 74 F PA 07/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55TH4
Platelet count decreased Platelet count decreased
Low platelets; This non-serious case was reported by a consumer via call center representative and d... Low platelets; This non-serious case was reported by a consumer via call center representative and described the occurrence of platelets decreased in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis. On 07-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular use, left deltoid). On 11-JUN-2025, 35 days after receiving Shingrix, the patient experienced platelets decreased (Verbatim: Low platelets). The outcome of the platelets decreased was unknown. It was unknown if the reporter considered the platelets decreased to be related to Shingrix. It was unknown if the company considered the platelets decreased to be related to Shingrix. Additional Information: GSK receipt date: 18-JUN-2025 The reporter was a female patient that stated that she received the first dose of Shingrix on 7th May 2025, and she had blood work done on 11th June 2025 and her platelet count was 141, which was a little below what it should be according to the scale provided by the Lab. More
2848151 M NM 07/02/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Post herpetic neuralgia, Rash, Vaccination failure; Herpes zoster... Herpes zoster, Post herpetic neuralgia, Rash, Vaccination failure; Herpes zoster, Post herpetic neuralgia, Rash, Vaccination failure More
Suspected Vaccination failure; Shingles was reported as worsened/outbreak of shingles; Post herpetic... Suspected Vaccination failure; Shingles was reported as worsened/outbreak of shingles; Post herpetic neuralgia; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (getting shingles since 1996 around once a year.) and post herpetic neuralgia. Previously administered products included Zostavax (in 2016). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles was reported as worsened/outbreak of shingles) and post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The outcome of the vaccination failure was not reported and the outcome of the shingles and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 25-JUN-2025 The patient self-reported this case. He stated he had been getting shingles since 1996 around once a year. He stated he received 2 doses Shingrix in 2022, 2 to 6 months apart. He stated he was currently having an outbreak of shingles that started a few weeks ago. Shingles was reported as worsened. It was a red painful rash on left side of buttocks and outer thigh. He stated he had post herpetic neuralgia. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2) More
2848152 M MA 07/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient received the first dose of Shingrix in 2018 but never received the second dose; This non-ser... patient received the first dose of Shingrix in 2018 but never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose 2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In 2018, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Shingrix in 2018 but never received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-JUN-2025 The healthcare professional reported a patient received the first dose of Shingrix in 2018 but never received the second dose. Till the time of reporting, the patient did not receive 2nd dose Shingrix vaccine which led to incomplete course of vaccination. More
2848153 F 07/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site swelling, Vaccine positive rechallenge Injection site swelling, Vaccine positive rechallenge
After dose 1 she had a hard, swollen area around the injection site about 3 inches in diameter; This... After dose 1 she had a hard, swollen area around the injection site about 3 inches in diameter; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: After dose 1 she had a hard, swollen area around the injection site about 3 inches in diameter). Rechallenge with Shingrix was positive. The outcome of the injection site swelling was not reported. It was unknown if the reporter considered the injection site swelling to be related to Shingrix. It was unknown if the company considered the injection site swelling to be related to Shingrix. Additional Information: GSK Receipt Date:23-JUN-2025 Patient has had both doses of Shingrix. The area did swell after dose 2, but it nearly as much. More
2848154 NJ 07/02/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate schedule of vaccine (1 month apart); This non-serious case was reported by a other hea... Inappropriate schedule of vaccine (1 month apart); This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in the unspecified the number of patients who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On an unknown date, the patients received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine (1 month apart)). The outcome of the drug dose administration interval too short 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: 17-JUN-2025 General Response Center (did not raise an adverse event report) transferred a Nurse Manager that asked that they were following the previous Prescribing Information administering doses one month apart to some of the patients, which led to drug dose administration interval too short. They want to know if the patients have to receive a third dose, a booster, or what should they do? No vaccination date, no vaccine detail and no patient demographics were obtained in this call. No further information was obtained in this call. More
2848155 M GA 07/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 39H2S
Product preparation issue Product preparation issue
A patient could have potentially received only the adjuvant of Shingrix; A patient could have potent... A patient could have potentially received only the adjuvant of Shingrix; A patient could have potentially received only the adjuvant of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: A patient could have potentially received only the adjuvant of Shingrix) and inappropriate dose of vaccine administered (Verbatim: A patient could have potentially received only the adjuvant of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 On 18th June 2025, an nurse called to report that they may have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. At the time, it was unclear whether any form of immunity screening or antibody titers specific to Shingrix were available. It was also uncertain whether all seven patients would need to be revaccinated due to the possible administration of the adjuvant only. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient More
2848156 07/02/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation error Product preparation error
Menveo mixed with saline; Menveo mixed with saline; This non-serious case was reported by a nurse vi... Menveo mixed with saline; Menveo mixed with saline; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo mixed with saline) and inappropriate dose of vaccine administered (Verbatim: Menveo mixed with saline). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 A nurse mixed the vaccine with normal saline which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted to know the nurse have to re administer the vaccine. No further details were obtained since customer ended the chat abruptly. More
2848157 F NY 07/02/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 PX7E2
Underdose Underdose
An 18 years old female patient received a half dose (0.25 mL) of Bexsero.; This non-serious case was... An 18 years old female patient received a half dose (0.25 mL) of Bexsero.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number PX7E2, expiry date 30-SEP-2026) for prophylaxis. Previously administered products included Bexsero (received 1st dose in 2024) and Menactra. On 23-JUN-2025, the patient received the 2nd dose of Bexsero. On 23-JUN-2025, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: An 18 years old female patient received a half dose (0.25 mL) of Bexsero.). The outcome of the incomplete dose administered was not applicable. It was unknown if the reporter considered the incomplete dose administered to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the incomplete dose administered to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter reported that on 23rd June 2025 that an 18 year old female patient received a 0.25 mL dose of Bexsero because the patient moved the arm and some of it got wasted which led to incomplete dose administered. The patient received Menactra on 2018. The first dose of Bexsero was administered in 2024. On 23rd June 2025 the patient received the half dose of Bexsero as her second dose. The reporter asked what were the recommendations, should they had to give the full dose. More
2848158 64 M TX 07/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L944
Product preparation issue Product preparation issue
only received the liquid component and not the full reconstituted dose; only received the liquid com... only received the liquid component and not the full reconstituted dose; only received the liquid component and not the full reconstituted dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2027) for prophylaxis. On 18-JUN-2025, the patient received Shingrix. On 18-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only received the liquid component and not the full reconstituted dose) and inappropriate dose of vaccine administered (Verbatim: only received the liquid component and not the full reconstituted dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 23-JUN-2025 Reporter stated that they had a patient who only received the liquid component and not the full reconstituted dose. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2848159 15 F TX 07/02/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 223Y9
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Infanrix administration instead of Boostrix; Infanrix out of the recommended age administration/Infa... Infanrix administration instead of Boostrix; Infanrix out of the recommended age administration/Infanrix administration instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-year-old female patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 23-JUN-2025, the patient received Infanrix. On an unknown date, the patient did not receive Boostrix. On 23-JUN-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix administration instead of Boostrix) and adult use of a child product (Verbatim: Infanrix out of the recommended age administration/Infanrix administration instead of Boostrix). The outcome of the wrong vaccine administered and adult use of a child product were 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: 23-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter. The Health Care Provider wanted to know how to proceed after a 15 year old patient received Infanrix instead of Boostrix as a second dose in the immunization schedule which led to wrong vaccine administered and adult use of a child product. More
2848160 M OR 07/02/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9X7CD
Product storage error Product storage error
Menveo administration after temperature excursion; This non-serious case was reported by a pharmacis... Menveo administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7CD, expiry date 31-JAN-2026) for prophylaxis. On 18-JUN-2025 09:40, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 30-JUN-2025 Th pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated. The patient was given the vaccine after temperature excursion which led to incorrect storage of drug. This is 1 of the 6 linked cases reported by the same reporter.; Sender's Comments: GSK-US2025079381:Same reporter different patient US-GSK-US2025079376:Same reporter different patient GSK-US2025079378:Same reporter different patient GSK-US2025079384:Same reporter different patient GSK-US2025079387:Same reporter different patient More
2848161 F OR 07/02/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9X7CD
Product storage error Product storage error
Menveo administration after temperature excursion; This non-serious case was reported by a pharmacis... Menveo administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7CD, expiry date 31-JAN-2026) for prophylaxis. On 20-JUN-2025 09:30, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 30-JUN-2025 Th pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated. The patient was given the vaccine after temperature excursion which led to incorrect storage of drug. This is 1 of the 6 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025079375:Same reporter different patient GSK-US2025079381:Same reporter different patient US-GSK-US2025079384:Same reporter different patient US-GSK-US2025079378:Same reporter different patient US-GSK-US2025079376:Same reporter different patient More
2848162 68 F OH 07/02/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 b32ng
Expired product administered Expired product administered
administration of expired dose; This non-serious case was reported by a other health professional vi... administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number b32ng, expiry date 13-JUN-2025) for prophylaxis. On 20-JUN-2025, the patient received Boostrix. On 20-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administration of expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUN-2025 The Licensed Practitioner Nurse reported that on 20 June 2025 was given Boostrix that expired on 13 June 2025 which led to expired vaccine used. More
2848163 F AK 07/02/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 4T93R
Incorrect dose administered Incorrect dose administered
administration of an adult dose on a eighteen year old patient; administration of an adult dose on a... administration of an adult dose on a eighteen year old patient; administration of an adult dose on a eighteen year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 18-year-old female patient who received HAV (Havrix adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. On 20-JUN-2025, the patient received Havrix adult. On 20-JUN-2025, an unknown time after receiving Havrix adult, the patient experienced adult use of a child product (Verbatim: administration of an adult dose on a eighteen year old patient) and overdose (Verbatim: administration of an adult dose on a eighteen year old patient). The outcome of the adult use of a child product and overdose were 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: 24-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter Registered Nurse called asking for safety advise on the administration of an adult dose on a eighteen year old patient which led to adult use of a child product and overdose. No further information was obtained in this call. More
2848164 07/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product administered at inappropriate site Product administered at inappropriate site
Shingrix administered in the buttocks; This non-serious case was reported by a pharmacist via call c... Shingrix administered in the buttocks; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Shingrix administered in the buttocks). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK Receipt Date: 24-JUN-2025 As per Web form received on June 24th 2025, the pharmacist reported that they had a patient who had receive theirs in the buttocks at the physician's office which led to vaccine administered at inappropriate site. The pharmacist enquired was it ok or preferred to administer the Shingrix vaccine in the buttocks. The pharmacist mentioned that they were told deltoid is preferred since this is where it was studied in clinical trials. More
2848165 MD 07/02/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
greater than 6 months since the first dose; This non-serious case was reported by a pharmacist via c... greater than 6 months since the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose more than 6 months ago). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: greater than 6 months since the first dose). The outcome of the incomplete course of vaccination 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: 23-JUN-2025 The reporter asked what the guidance on the dosing interval was between the second and third doses if there was an interruption between the first and second doses. It had been greater than 6 months since the first dose was administered. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix vaccine which led to incomplete course of vaccination. No further details were available. More
2848166 20 F GA 07/02/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 AZ4TN
Underdose Underdose
20 year old patient received a pediatric dose of Engerix-B on June 25th 2025; 20 year old patient re... 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025; 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number AZ4TN, expiry date 25-JAN-2027) for prophylaxis. On 25-JUN-2025, the patient received Engerix B pediatric. On 25-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025) and underdose (Verbatim: 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025). The outcome of the adult use of a child product and underdose were 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: 25-JUN-2025 The nurse practitioner reported that a 20-year-old patient received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose More
2848167 4 M OK 07/02/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Circumstance or information capable of leading to medication error, Crying, Unde... Circumstance or information capable of leading to medication error, Crying, Underdose More
got a partial dose of Kinrix because the child started crying; This non-serious case was reported by... got a partial dose of Kinrix because the child started crying; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 25-JUN-2025, the patient received Kinrix. On 25-JUN-2025, an unknown time after receiving Kinrix, the patient experienced accidental underdose (Verbatim: got a partial dose of Kinrix because the child started crying ). The outcome of the accidental underdose 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: 26-JUN-2025 The licensed practical nurse wanted to know how to proceed after a child got a partial dose of Kinrix because the child started crying and the mom let go of his leg, which led to accidental underdose The Vaccine Administration Facility was the same as Primary Reporter. More
2848168 07/02/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 95DB2
Expired product administered Expired product administered
couple of patients receiving expired vaccines and they were approximately 1 month expired; This non-... couple of patients receiving expired vaccines and they were approximately 1 month expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. In JAN-2025, the patient received Havrix. In JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: couple of patients receiving expired vaccines and they were approximately 1 month expired). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-APR-2025 The reporter had a couple of patients who received an expired Havrix vaccines, and they were approximately 1 month expired. The reporter was calling to verify if GlaxoSmithKline have any data on effectiveness of their vaccines after the expiration, to see if they need to revaccinate these patients or if what was given was considered effective by some of GSKs post data. The vaccines were administered January 16th till January 30th, 2025. The vaccine administration facility was the same as primary reporter. No other information was provided. More
2848169 NY 07/02/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Boostrix out of the recommended age multiple administrations; This non-serious case was reported by ... Boostrix out of the recommended age multiple administrations; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix out of the recommended age multiple administrations). The outcome of the inappropriate age at vaccine administration 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-JUN-2025 The health care provider wanted to confirm that GlaxoSmithKline did not have a vaccine recommended for children from 7 to 10 for Diphtheria and Tetanus Toxoids and Acellular Pertussis immunization and mentioned that because of that, she was giving Boostrix to the patients in that range of age, which led to an inappropriate age at vaccine administration. The agent read the information found on the prescribing information of Boostrix, including the part of dosage and administration where mentioned cases where it could be given out the recommended age and offered to put on hold while searching further information (and if not, contacting second line) but the health care provider declined and mentioned that she was following the centers for disease control's recommendation, to which the agent reply that still would be needing to gather the data of the patients in between those ages that received the vaccine, but the health care provider commented that she would be needing to go back in the past and search all of the patients that she gave the vaccine to, because she received a lot from different countries and moved onto trying to collect the agent's contact details, so there was not the cooperation needed to collect the adverse event data. The vaccine administration facility was the same as primary reporter. More
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