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
2864179 64 F WV 10/07/2025 FLU3
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 TFAA2503
U8620BA
Dizziness, Visual impairment; Dizziness, Visual impairment Dizziness, Visual impairment; Dizziness, Visual impairment
Almost immediately, patient complained of dizziness/lightheadedness, and dark spots in her vision. ... Almost immediately, patient complained of dizziness/lightheadedness, and dark spots in her vision. She laid down with her feet up for a few minutes, and then felt better. More
2864180 64 F TN 10/07/2025 FLU3
 SANOFI PASTEUR
 u8855ba
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was 64 years old and received the fluzone HD indicated for ages 65 and up. PCP and patient w... Patient was 64 years old and received the fluzone HD indicated for ages 65 and up. PCP and patient was made aware. More
2864181 73 F FL 10/07/2025 FLU3
 SEQIRUS, INC.
 407261
Injection site bruising Injection site bruising
Patient received a bruise at the injection site Patient received a bruise at the injection site
2864182 48 F NM 10/07/2025 PNC21
 MERCK & CO. INC.
 z010761
Erythema, Skin warm Erythema, Skin warm
Patient states she had a red spot that increased in size and the arm was warm to touch since 10/4/2... Patient states she had a red spot that increased in size and the arm was warm to touch since 10/4/25. Patient also had Flublock in same arm and Mnexspike in left arm. I told her to apply ice and said she could take diphenhydramine and an nsaid. Later in the day, the patient said the ice had improved symptoms More
2864183 38 M ID 10/07/2025 FLU3
 SANOFI PASTEUR
 U8823DA
Dizziness, Feeling hot, Immediate post-injection reaction, Syncope Dizziness, Feeling hot, Immediate post-injection reaction, Syncope
Pt developed vasovagal syncope immediately following administration of flu vaccine and covid vaccine... Pt developed vasovagal syncope immediately following administration of flu vaccine and covid vaccine. Felt faint, BP normal at 120/63, pulse low at 44, O2 Sat=96%. Pt stated he felt light headed and extremely hot. We monitored him for 15 minutes during which time his BP and pulse improved to the point he felt like he could go home. I called him that evening and he said he was feeling fine. More
2864184 9 F NM 10/07/2025 FLU3
 SANOFI PASTEUR
 ut8779ka
Pain in extremity, Paraesthesia Pain in extremity, Paraesthesia
sore arm, tingling in arm sore arm, tingling in arm
2864185 1 M 10/07/2025 MMR
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 Y019905
MA2502
Z003767
Breath holding; Breath holding; Breath holding Breath holding; Breath holding; Breath holding
Breath holding spell Breath holding spell
2864187 70 F NM 10/07/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Adverse reaction, Dizziness, Head injury, Syncope Adverse reaction, Dizziness, Head injury, Syncope
Patient called the pharmacy on 10/07/2025 and reported that she believes she had an adverse reaction... Patient called the pharmacy on 10/07/2025 and reported that she believes she had an adverse reaction to the covid shot she received at the pharmacy on 10/04/2025. She states that she was fine after the shot, but woke up the next day on 10/05/2025 and began to feel dizzy. She then stated she fainted and hit her head on the floor of her kitchen. She then crawled to her couch and called a family friend, where she was then taken to the emergency room. Patient came to the pharmacy and wanted a print out of the vaccine she received that day, which was given to her. This is all the information I was able to gather from the patient. More
2864188 20 F PA 10/07/2025 COVID19
 NOVAVAX
Uterine spasm Uterine spasm
Intermittent strong uterine cramping beginning around 3 or 4 hours after administration, no blood or... Intermittent strong uterine cramping beginning around 3 or 4 hours after administration, no blood or discharge as of time writing, physically this feels like a menstrual period More
2864190 68 F 10/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 h529m
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse event. Patient just had a second dose a year later by mistake No adverse event. Patient just had a second dose a year later by mistake
2864191 30 F HI 10/07/2025 FLU3
FLU3
IPV
IPV
TD
TD
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8848AA
U8848AA
W1C741M
W1C741M
U8021BA
U8021BA
Anaphylaxis treatment, Choking, Cough, Heart rate decreased, Immediate post-inje... Anaphylaxis treatment, Choking, Cough, Heart rate decreased, Immediate post-injection reaction; Oxygen saturation decreased, Unresponsive to stimuli, Wheezing; Anaphylaxis treatment, Choking, Cough, Heart rate decreased, Immediate post-injection reaction; Oxygen saturation decreased, Unresponsive to stimuli, Wheezing; Anaphylaxis treatment, Choking, Cough, Heart rate decreased, Immediate post-injection reaction; Oxygen saturation decreased, Unresponsive to stimuli, Wheezing More
While in seated position on exam room table, patient received the 3 vaccinations listed above. IPOL... While in seated position on exam room table, patient received the 3 vaccinations listed above. IPOL and Tenivac were administered first in the left deltoid, then Fluzone in the right deltoid. Immediately after receiving Fluzone, the patient started coughing. Patient was asked if she was choking, and patient shook her head up and down. The emergency alert system was activated at this time. Patient was asked to sit back on exam room table but was unable to do so. Patient was lowered to floor safely. 2 other staff members reported to exam room to assist. At 1500, epinephrine 0.3 mg administered to left anterolateral thigh and 911 called by medical support staff. At 1501 oxygen administered via bag mask 100% flow. Vital signs were taken at 1504: BP 115/69, P 92, O2 sat 85%. Patient continued coughing, audible wheezing. Clinic medical director was then called to response to scene. At 1505, patient became unresponsive, pulse dropped to 44, O2 sat dropped to 74%. At 1506, epinephrine 0.3 mg administered to left anterolateral thigh as patient was laying on her right side on the floor. At 1507 patient responsive and coughing. Patient encouraged to take deep breathes. Vitals signs taken: BP 96/52, P 82, O2 sat 84%. At 1508, EMS and medical director arrived on the scene. At 1510, patient was placed on stretcher by EMS and transported to (name withheld) Medical Center emergency department. More
2864192 9 M AZ 10/07/2025 FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR


Blood creatine phosphokinase, Blood thyroid stimulating hormone, Electrocardiogr... Blood creatine phosphokinase, Blood thyroid stimulating hormone, Electrocardiogram, Full blood count, Hypotension; International normalised ratio, Lipase, Metabolic function test, Presyncope, Tachycardia; Troponin More
Patient arrived to the ED hypotensive, tachycardic, and almost passing out. Symptoms improved after ... Patient arrived to the ED hypotensive, tachycardic, and almost passing out. Symptoms improved after 1L NS, but he remained tachycardic, though the hypotension resolved. More
2864213 0.33 M IA 10/07/2025 DTPPVHBHPB
HIBV
RV5
 MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
 U8313AA
X017448
2142099
No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event
No ASE No ASE
2863268 F 10/06/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
she had her first dose of GARDASIL 9 in April 2025, and will not have her second dose until October ... she had her first dose of GARDASIL 9 in April 2025, and will not have her second dose until October 2025; No adverse event; This spontaneous report was received from a Consumer or other non health professional and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unspecified date in April 2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was mentioned that she would not have her second dose until October 2025 (Inappropriate schedule of product administration). No adverse event reported. More
2863269 83 M FL 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Injection site pain, Tremor Chills, Injection site pain, Tremor
severe shivering; Shaking; pain at injection site/ touchy at injection site/ sore at injection site;... severe shivering; Shaking; pain at injection site/ touchy at injection site/ sore at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (first dose of SHINGRIX was administered 90 days prior and patient had no issues with that dose). On 08-AUG-2025 12:35, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 08-AUG-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site/ touchy at injection site/ sore at injection site). On 08-AUG-2025 21:45, the patient experienced shivering (Verbatim: severe shivering) and tremor (Verbatim: Shaking). The patient was treated with paracetamol (Tylenol Arthritis). The outcome of the injection site pain was unknown and the outcome of the shivering and tremor were not resolved. It was unknown if the reporter considered the injection site pain, shivering and tremor to be related to Shingrix. It was unknown if the company considered the injection site pain, shivering and tremor to be related to Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 and 10-SEP-2025 The patient self-reported this case for himself and stated that after the vaccination the injection site was painful, touchy, and sore. Consumer stated the dose was administered at 12:35pm and he began shaking and shivering at 9:45pm which continued throughout the night with 2 different episodes happening. Patient took Tylenol Arthritis and that seemed to help with the shivering. Patient had his first dose of Shingrix administered 90 days prior and had no issues with that dose. No further information was obtained/provided. More
2863270 M TX 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received Shingrix shot #1 on 01-Nov-2021 but has yet to receive dose #2; This non-serious case was r... received Shingrix shot #1 on 01-Nov-2021 but has yet to receive dose #2; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 01-Nov-2021). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received Shingrix shot #1 on 01-Nov-2021 but has yet to receive dose #2). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 17-SEP-2025 The patient did not want to share his street address. More
2863271 76 M CA 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect dose administered Incorrect dose administered
Incomplete dose administered; This non-serious case was reported by a physician via call center repr... Incomplete dose administered; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In JUN-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete dose administered). The outcome of the incomplete dose administered was not applicable. Additional Information: GSDK receipt date- 24 September 2025 The reporter stated that, patient received half a dose of Shingrix instead of the full dose. The reporter did not know if that meant just that patient received just the adjuvant or half of the reconstituted vaccine. The dates of administration were between 23 June 2025 and 27 June 2025. The reporter consented to follow up. This was report 6 of 6.; Sender's Comments: US-GSK-US2025122806:Same reporter/Different patient US-GSK-US2025122813: More
2863272 GA 10/06/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product quality issue Product quality issue
more air than usual in the flu vaccines and they are uncomfortable administering it without removing... more air than usual in the flu vaccines and they are uncomfortable administering it without removing the bubble; This non-serious case was reported by a nurse via sales rep and described the occurrence of poor quality product administered in a patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) for prophylaxis. On an unknown date, the patient received FluLaval 2025-2026 season. On an unknown date, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced poor quality product administered (Verbatim: more air than usual in the flu vaccines and they are uncomfortable administering it without removing the bubble). The outcome of the poor quality product administered 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: 11-SEP-2025 Nurse reported that had noted there seems to be more air than usual in the flu vaccines and they are uncomfortable administering it without removing the bubble, which led to poor quality product administered. Batch number "UNK" and follow-up has been requested: The batch number was not provided and a request for this information has been made. More
2863274 10/06/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
suspected vaccination failure; got the shot and still got it; This serious case was reported by a co... suspected vaccination failure; got the shot and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: got the shot and still got it). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 01-OCT-2025 This case was reported by a patient via interactive digital media. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2863275 VA 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product storage error Product storage error
10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This no... 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; 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 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 incorrect storage of drug (Verbatim: 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 11-SEP-2025 Reporter called to report a temperature excursion involving Boostrix and Shingrix vaccines. The Reporter stated that the vaccines were exposed to a temperature of 32.8?๏ฟฝC for 93 hours, with no prior excursions reported. During the call, the HCP inquired about the stability of Boostrix and Shingrix following the excursion. They also mentioned that 6 doses of Boostrix and 4 doses of Shingrix had already been administered to 10 different patients after the temperature deviation. They asked whether revaccination would be necessary for the affected individuals.; Sender's Comments: GSK-US2025117354:same reporter US-GSK-US2025117352:same reporter, different patient US-GSK-US2025117358:same reporter US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117362:same reporter US-GSK-US2025117369:same reporter US-GSK-US2025117365:same reporter US-GSK-US2025117367:same reporter More
2863276 IL 10/06/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
Wrong vaccine; This non-serious case was reported by a nurse via call center representative and desc... Wrong vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a elderly patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. Co-suspect products included INFLUENZA VACCINE INACT SAG 3V (FLUAD) for prophylaxis. On an unknown date, the patient received FluLaval 2024-2025 season and did not receive FLUAD. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine). The outcome of the wrong vaccine administered 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: 11-SEP-2025 The Nurse Educator reported that an employee had administered FluLaval to a patient aged over 65 years. It was noted that Fluad is the recommended influenza vaccine for individuals in this age group due to its enhanced immunogenicity. During a call, the second line agent confirmed that the incident occurred because the patient had initially planned to receive a high-dose influenza vaccine. However, upon further probing, it was clarified that the administration of FluLaval was erroneous and not aligned with the intended vaccine choice. More
2863277 62 M TX 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2737J
Pruritus Pruritus
Itchiness all over the body after Shingrix second dose administration; This non-serious case was re... Itchiness all over the body after Shingrix second dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 2737J, expiry date 23-SEP-2025) for prophylaxis. On 30-JAN-2024, the patient received the 2nd dose of Shingrix. In FEB-2024, 2 weeks after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: Itchiness all over the body after Shingrix second dose administration). The patient was treated with gabapentin. The outcome of the generalized pruritus was unknown. It was unknown if the reporter considered the generalized pruritus to be related to Shingrix. It was unknown if the company considered the generalized pruritus to be related to Shingrix. Additional Information: GSK receipt date: 16-SEP-2025 A pharmacist wanted to get safety information on the appearance of itchiness all over the body after 2 weeks since he received the second dose of Shingrix. He also mentioned to start with a restrictive diet and taking Gabapentin after this. More
2863278 F MO 10/06/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9452S
Expired product administered Expired product administered
had an expiration date of September 14th 2025 that was given; This non-serious case was reported by ... had an expiration date of September 14th 2025 that was given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-day-old female patient who received HBV (Engerix B) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis. On 15-SEP-2025, the patient received Engerix B. On 15-SEP-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: had an expiration date of September 14th 2025 that was given). 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 :16-SEP-2025 Registered Nurse mentioned she had a dose of Engerix-B that had an expiration date of September 14th, 2025, that was given on September 15th, 2025, which led to expired vaccine used. The reporter was consented to follow up. More
2863279 F TX 10/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 AE435
Extra dose administered Extra dose administered
A patient received 2 doses of Arexvy.; This non-serious case was reported by a pharmacist via call c... A patient received 2 doses of Arexvy.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 30-OCT-2025) for prophylaxis. Previously administered products included Arexvy (1st dose was given in 2023). On 13-SEP-2025, the patient received the 2nd dose of Arexvy. On 13-SEP-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: A patient received 2 doses of Arexvy.). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 16-SEP-2025 The reporter called to report that a patient received two doses of Arexvy. The reporter wanted to know was there any concerns and possible side effects. More
2863280 F 10/06/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Twinrix missed second dose; This non-serious case was reported by a other health professional via ca... Twinrix missed second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old female patient who did not receive HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (First dose was received on 05-JUN-2025). The patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: Twinrix missed second 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: 18-SEP-2025 The healthcare professional (HCP) reported that a patient had received the first dose of Twinrix approximately three months prior. The HCP inquired about the maximum allowable interval between the first and second doses, and at what point the vaccination series should be reinitiated. More
2863281 9 F CO 10/06/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 7MN4C
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
9 year old actually got administered the Bexsero; This non-serious case was reported by a nurse via ... 9 year old actually got administered the Bexsero; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received Men B NVS (Bexsero) (batch number 7MN4C) for prophylaxis. On 30-SEP-2025, the patient received Bexsero. On 30-SEP-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 9 year old actually got administered the Bexsero). 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. More
2863282 56 F 10/06/2025 COVID19
COVID19
FLUX
FLUX
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Chills, Dyspnoea, Fatigue, Nasopharyngitis, Vaccination site inflammation; Vacci... Chills, Dyspnoea, Fatigue, Nasopharyngitis, Vaccination site inflammation; Vaccination site pain, Vaccination site urticaria; Chills, Dyspnoea, Fatigue, Nasopharyngitis, Vaccination site inflammation; Vaccination site pain, Vaccination site urticaria More
shortness of breath passed; exhaustion; he said " it's itching and it's making me a l... shortness of breath passed; exhaustion; he said " it's itching and it's making me a little bit insane. It itches and it hurts."; inflammation; cold; is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath passed), NASOPHARYNGITIS (cold), VACCINATION SITE URTICARIA (is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.), CHILLS (chills) and FATIGUE (exhaustion) in a 56-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 19-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 19-Sep-2025, the patient experienced NASOPHARYNGITIS (cold), VACCINATION SITE URTICARIA (is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.), CHILLS (chills), VACCINATION SITE PAIN (he said " it's itching and it's making me a little bit insane. It itches and it hurts.") and VACCINATION SITE INFLAMMATION (inflammation). On 20-Sep-2025, the patient experienced DYSPNOEA (shortness of breath passed) and FATIGUE (exhaustion). The patient was treated with Clobetasol propionate (Clobetasol) for Inflammation, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath passed) and FATIGUE (exhaustion) was resolving, NASOPHARYNGITIS (cold), CHILLS (chills), VACCINATION SITE PAIN (he said " it's itching and it's making me a little bit insane. It itches and it hurts.") and VACCINATION SITE INFLAMMATION (inflammation) outcome was unknown and VACCINATION SITE URTICARIA (is a sizable hot red welt that if I were to measure it about almost 2 inches diameter. That is not going down and it's itchy and red and hot.) had not resolved. No concomitant medication was reported. It was reported that patient had a new strange reaction that was not gone, that's why she had called. At the time of reporting she added that there was a sizable hot red welt that if she measured it was about almost 2 inches diameter. That was not going down, and it was itchy and red and hot. She also had short of breath on the weekend. She later confirmed during the call that the shortness of breath passed, but that was on Saturday and Sunday. It was Friday night. she had chills and she had a cold, but that would happen on Friday night and then she had chill. She had shortness of breath on Saturday and exhaustion and part of the days short of breath too๏ฟฝ And then she felt better, but that thing had remained on her arm for a few days." She stated that she actually received 2 vaccines that day, one was a flu shot, and the other was Spikevax. She stated that the flu shot was given in the upper arm, and the COVID was the lower arm. Both were given in the same arm (Left) and she had been applying clobetasol on it to reduce the inflammation. She said it was itching, and it was making her a little bit insane. She said that it itches, and it hurts. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-789610 (Patient Link). More
2863283 71 F OR 10/06/2025 FLU3
 SANOFI PASTEUR
 UT8794CA
Extra dose administered, No adverse event Extra dose administered, No adverse event
received two doses of the vaccine FLUZONE HD with no reported adverse event; Initial information rec... received two doses of the vaccine FLUZONE HD with no reported adverse event; Initial information received on 26-Sep-2025 (with live follow up process together with CSD: 26-Sep-2025) regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old female patient who received two doses of the vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Sep-2025, the patient received a dose 1 (0.5ml twice) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine; Suspension for injection in pre-filled syringe, (lot UT8794CA with expiry date 30-JUN-2026). On 20-Sep-2025 she also received a dose 2 (0.5ml twice) of vaccine with an unknown batch number and expiry date both via intramuscular route in the left arm for Influenza with no reported adverse event (extra dose administered) (latency: 7 days) 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
2863285 19 F IN 10/06/2025 UNK
 UNKNOWN MANUFACTURER
 948404
Back pain, Musculoskeletal stiffness Back pain, Musculoskeletal stiffness
Stiff neck; Having pain where her shoulder blade meets the spine; This spontaneous case , initially ... Stiff neck; Having pain where her shoulder blade meets the spine; This spontaneous case , initially received on 29-Sep-2025, was reported by a health professional and concerns an adult female patient. Concomitant medication reported as Birth control medication. Administration of company suspect drugs: On 28-Sep-2025 at 16:00, the patient received Flucelvax (TIV) for Active immunization for the prevention of inflenza disease, Dosage regimen: Not reported, Anatomical Location: Not reported, Route of administration: Not reported, Lot number: 948404, Expiry date: 13-Jun-2026. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Sep-2025, the patient experienced Stiff neck (outcome: Unknown), Having pain where her shoulder blade meets the spine (outcome: Unknown). It was reported that the patient woke up in the middle of the night with a stiff neck and she was having pain where her shoulder blade meets the spine. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Ibuprofen Reporter's assessment: The reporter did not provide seriousness (No hospitalization and it was unknown if it is a serious adverse event) and causality assessment of the events Stiff neck and Having pain where her shoulder blade meets the spine.; Reporter's Comments: Due to spontaneous nature of the case the events Stiff neck and Having pain where her shoulder blade meets the spine assessed as related for reporting purposes More
2863297 55 F DE 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received the first dose of SHINGRIX in 2020 and second dose of SHNGRIX yesterday, 17 September 2025;... received the first dose of SHINGRIX in 2020 and second dose of SHNGRIX yesterday, 17 September 2025; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date in 2020). On 17-SEP-2025, the patient received the 2nd dose of Shingrix. On 17-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received the first dose of SHINGRIX in 2020 and second dose of SHNGRIX yesterday, 17 September 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 18-SEP-2025 The patient received the first dose of Shingrix in 2020. The patient received the second dose of Shingrix on 17 September 2025. More
2863298 F 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Dizziness, Hypotension, Vaccine positive rechallenge Dizziness, Hypotension, Vaccine positive rechallenge
Dizziness; Low blood pressure; This non-serious case was reported by a pharmacist via sales rep and ... Dizziness; Low blood pressure; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of dizziness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). 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 dizziness (Verbatim: Dizziness) and low blood pressure (Verbatim: Low blood pressure). Rechallenge with Shingrix was positive. The outcome of the dizziness and low blood pressure were not reported. It was unknown if the reporter considered the dizziness and low blood pressure to be related to Shingrix. It was unknown if the company considered the dizziness and low blood pressure to be related to Shingrix. Linked case(s) involving the same patient: US2025119609 Additional Information: GSK Receipt Date: 17-SEP-2025 Patient had a similar reaction to a Boniva shot as well. Had the same reaction to both doses of Shingrix. This was 1 of the 2 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025119609:Same patient/different dose 1 More
2863299 M 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
shingles; This non-serious case was reported by a consumer via interactive digital media and describ... shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was resolved (duration 14 months). It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 30-SEP-2025 This case was reported by a patient via interactive digital media. It was not funny at all. Patient had shingles for 14 months and developed them shortly before he turned 70. he had received the shingles vaccine 5 days earlier. More
2863300 56 F 10/06/2025 COVID19
 MODERNA
Dizziness Dizziness
She states she has "had a reaction to Moderna before. I've had Moderna every year since CO... She states she has "had a reaction to Moderna before. I've had Moderna every year since COVID was known". She said the first 2-3 years "Moderna vaccine made me dizzy for half an hour; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She states she has "had a reaction to Moderna before. I've had Moderna every year since COVID was known". She said the first 2-3 years "Moderna vaccine made me dizzy for half an hour) in a 56-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (She states she has "had a reaction to Moderna before. I've had Moderna every year since COVID was known". She said the first 2-3 years "Moderna vaccine made me dizzy for half an hour). At the time of the report, DIZZINESS (She states she has "had a reaction to Moderna before. I've had Moderna every year since COVID was known". She said the first 2-3 years "Moderna vaccine made me dizzy for half an hour) had resolved. Concomitant medications details were not reported by the reporter. Patient had Moderna every year since COVID was known. She said the first 2-3 years "Moderna vaccine made her dizzy for half an hour. The first time, 1 hour, but most of the time she had dizziness for half an hour. Treatment medication was not reported by the reporter. This case was linked to MOD-2025-789607 (Patient Link). More
2863301 40 F CO 10/06/2025 FLU3
 SANOFI PASTEUR
 U8881AA
No adverse event, Occupational exposure to product, Syringe issue No adverse event, Occupational exposure to product, Syringe issue
grabbed the FLUZONE out of the fridge, set it down at her keyboard to note lot number, when she pick... grabbed the FLUZONE out of the fridge, set it down at her keyboard to note lot number, when she picked it up her hand was wet, half of the solution was already on her paperwork, and the plunger came out on the opposite side with no reported ae; grabbed the FLUZONE out of the fridge, set it down at her keyboard to note lot number, when she picked it up her hand was wet, half of the solution was already on her paperwork, and the plunger came out on the opposite side with no reported ae; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 40 years old female patient who was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] when, after retrieving the vaccine from the refrigerator and placing it near her keyboard to record the lot number, she noticed her hand was wet; half of the solution had leaked onto her paperwork, and the plunger had detached from the opposite end with no adverse event was reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2025, the patient was exposed to an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength) lot U8881AA and expiry date 30-Jun-2026 via unknown route in unknown administration site for influenza when, after retrieving the vaccine from the refrigerator and placing it near her keyboard to record the lot number, she noticed her hand was wet; half of the solution had leaked onto her paperwork, and the plunger had detached from the opposite end with no adverse event (accidental exposure to product) and (exposure via skin contact) (Latency Same day). Reportedly, MA (medical assistant) also mentioned that when she grabbed a different vaccine to administer to a patient, it was fine and only the first vaccine had a problem. 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
2863307 59 F TX 10/06/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 UT8792NA
Z006889
Erythema, Headache, Nausea, Pain, Rash; Erythema, Headache, Nausea, Pain, Rash Erythema, Headache, Nausea, Pain, Rash; Erythema, Headache, Nausea, Pain, Rash
IVR, body aches, headache, nausea, redness, rash, was prescribed antibiotic. IVR, body aches, headache, nausea, redness, rash, was prescribed antibiotic.
2863349 M 10/06/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
gave a dose of Kinrix to a patient who was 7 years and 4 months old as their 4th DTaP and 4th Polio ... gave a dose of Kinrix to a patient who was 7 years and 4 months old as their 4th DTaP and 4th Polio vaccine.; gave a dose of Kinrix to a patient who was 7 years and 4 months old as their 4th DTaP and 4th Polio vaccine.; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Kinrix (unknown arm). On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave a dose of Kinrix to a patient who was 7 years and 4 months old as their 4th DTaP and 4th Polio vaccine.) and inappropriate schedule of vaccine administered (Verbatim: gave a dose of Kinrix to a patient who was 7 years and 4 months old as their 4th DTaP and 4th Polio vaccine.). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 09-SEP-2025 The medical assistant administered a dose of Kinrix to a patient who was 7 years and 4 months old, as their fourth dose of DTaP and fourth dose of Polio vaccine. The state registry had listed Kinrix as the suggested vaccine for that visit. More
2863350 F 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Dizziness, Hypotension Dizziness, Hypotension
Dizziness; Low blood pressure; This non-serious case was reported by a pharmacist via sales rep and ... Dizziness; Low blood pressure; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of dizziness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included IBANDRONATE SODIUM (BONIVA) for prophylaxis. In OCT-2019, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, the patient received BONIVA. On an unknown date, an unknown time after receiving Shingrix and BONIVA, the patient experienced dizziness (Verbatim: Dizziness) and low blood pressure (Verbatim: Low blood pressure). The outcome of the dizziness and low blood pressure were resolved. The reporter considered the dizziness and low blood pressure to be related to Shingrix. It was unknown if the reporter considered the dizziness and low blood pressure to be related to BONIVA. The company considered the dizziness and low blood pressure to be related to Shingrix. It was unknown if the company considered the dizziness and low blood pressure to be related to BONIVA. Linked case(s) involving the same patient: US2025AMR120590 Additional Information: GSK Receipt Date: 17-SEP-2025 Patient had a similar reaction to a Boniva shot as well. Had the same reaction to both doses of Shingrix. This was 1 of the 2 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR120590:Same patient/different dose More
2863351 IL 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
States one vial of Shingrix adjuvant was wasted due to an issue when withdrawing the solution from t... States one vial of Shingrix adjuvant was wasted due to an issue when withdrawing the solution from the vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique 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 inappropriate reconstitution technique (Verbatim: States one vial of Shingrix adjuvant was wasted due to an issue when withdrawing the solution from the vial). The outcome of the inappropriate reconstitution technique was not applicable. Additional Information: GSK Receipt date:17-SEP-2025 The reporter state one vial of Shingrix adjuvant was wasted due to a reconstitution error. During the withdrawal process, the needle was prematurely withdrawn from the vial. As a result, the healthcare professional inadvertently filled the needle with air instead of the solution. The batch number was not provided, and we are unable to contact the reporter. More
2863352 F 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Paraesthesia Paraesthesia
Tingling skin; This non-serious case was reported by a physician via sales rep and described the occ... Tingling skin; This non-serious case was reported by a physician via sales rep and described the occurrence of tingling skin in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling skin (Verbatim: Tingling skin). The outcome of the tingling skin was not resolved. The reporter considered the tingling skin to be related to Shingrix. The company considered the tingling skin to be related to Shingrix. Additional Information: GSK Receipt Date: 18-SEP-2025 Tingling skin was reported as worsened. The patient was coming into the office afternoon, and additional information will be available upon examination. More
2863354 73 F NY 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Inappropriate schedule of product administration, Nausea Fatigue, Inappropriate schedule of product administration, Nausea
Nausea, felt nauseous; Tiredness, felt tired; late dose; This non-serious case was reported by a con... Nausea, felt nauseous; Tiredness, felt tired; late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 24-FEB-2020). On 13-AUG-2025, the patient received the 2nd dose of Shingrix. On 13-AUG-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late dose). On an unknown date, the patient experienced nausea (Verbatim: Nausea, felt nauseous) and tiredness (Verbatim: Tiredness, felt tired). The outcome of the nausea and tiredness were unknown and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the nausea and tiredness to be related to Shingrix. It was unknown if the company considered the nausea and tiredness to be related to Shingrix. Additional Information: GSK Receipt Date: 19-SEP-2025 Reporter was the patient who received first dose on 24-Feb-2020 and then second dose on 13-Aug-2025. Patient also felt nauseous and tired after second dose. More
2863356 89 F PA 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3EG9B
Inappropriate schedule of product administration Inappropriate schedule of product administration
first dose of Shingrix vaccine during the year 2024 and received today the 2nd dose of Shingrix in h... first dose of Shingrix vaccine during the year 2024 and received today the 2nd dose of Shingrix in her right arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 3EG9B, expiry date 02-MAY-2027) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date in 2024). On 19-SEP-2025, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On 19-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix vaccine during the year 2024 and received today the 2nd dose of Shingrix in her right arm). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 19-SEP-2025 The reporter inquired if the patient needed a booster. More
2863357 56 M CA 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Incomplete dose administered; This non-serious case was reported by a physician via call center repr... Incomplete dose administered; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In JUN-2025, the patient received Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete dose administered). The outcome of the incomplete dose administered was not applicable. Additional Information: GSK receipt date- 24-SEP-2025 The reporter stated that, patient received half a dose of Shingrix instead of the full dose. The reporter did not know if that meant just that patient received just the adjuvant or half of the reconstituted vaccine. The dates of administration were between 23 June 2025 and 27 June 2025. The reporter consented to follow up. This was report 5 of 6. The batch number was not provided and a request for this information had been made.; Sender's Comments: US-GSK-US2025122806:Same reporter/Different patient US-GSK-US2025122818:Same reporter/Different patient US-GSK-US2025122804:Same reporter/Different patient US-GSK-US2025122805:Same reporter/Different patient GSK-US2025122808:Same reporter/Different patient More
2863358 F PA 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never received the 2nd dose; This non-serious case was reported by a consumer via call center repres... never received the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in APR-2024 via intramuscular route in unknown arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient had incomplete course of vaccination (Verbatim: never received the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 02-OCT-2025 The reporter reported that she received the first dose of Shingrix from her local pharmacy in the last week of April 2024 (no specific date provided) and never received the second dose. The patient did not know the exact date she received the first dose of Shingrix and did not have the lot and expiry or location of administration. She have reported all that was provided about this adverse event. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. More
2863359 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
arm still sore from last shot; This non-serious case was reported by a consumer via interactive digi... arm still sore from last shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm still sore from last shot). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 17-SEP-2025 Patient reported that not going to get it, arm still sore from last dose. More
2863360 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
received three doses of Shingrix; This non-serious case was reported by a consumer via interactive d... received three doses of Shingrix; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on unknown date) and Shingrix (received second dose on unknown date). On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received three doses of Shingrix). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 20-SEP-2025 The reporter reported that the patient received three doses of Shingrix. More
2863363 M 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Only person know who had shingles never had it until after he got the... Suspected vaccination failure; Only person know who had shingles never had it until after he got the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Only person know who had shingles never had it until after he got the vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 27-SEP-2025 This case was reported by a patient via interactive digital media. The reporter knew that the person who had shingles never had it until after he got the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The batch number was not provided and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a adult male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2863364 10/06/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; Shingles on the side of neck; This serious case was reported by a con... Suspected Vaccination failure; Shingles on the side of 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) and shingles (Verbatim: Shingles on the side of neck). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: SK Receipt Date: 26-SEP-2025 This case was reported by a patient via interactive digital media. The patient got the shot last year in 2024. Somehow patient had shingles on the side of neck. The doctor said that even with the shot could still got them. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2863365 10/06/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; now suffering with the horrible case of shingles; This serious case w... Suspected vaccination failure; now suffering with the horrible case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now suffering with the horrible case of shingles) (serious criteria other: Serious as per reporter). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 29-SEP-2025 This case was reported by a patient via interactive digital media. The patient had both doses and now patient was suffering with horrible case of shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Herpes zoster, unknown time after receiving 2nd dose of Shingles vaccine and 1st dose of Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2863366 VA 10/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
patient received doses of Boostrix vaccine after a temperature excursion; This non-serious case was ... patient received doses of Boostrix vaccine after a 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 patient 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 incorrect storage of drug (Verbatim: patient received doses of Boostrix vaccine after a 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: 11-SEP-2025 Chief of pharmacy called to report that they had a temperature excursion and asked about the stability of Boostrix and Shingrix after a temperature excursion of 32.8 degree C for 93 hours. No prior excursion. HCP (health care professional) mentioned they administered 6 doses of Boostrix and 4 doses of Shingrix after this temperature excursion to 10 different patients and wanted to know do they need to revaccinate them. HCP only mentioned the initials of the patients who received the doses but did not provide further information about gender, age, lot number or expiration date. The batch number was not provided upon follow- up with the reporter. This was 1 of 10 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025117354:same reporter US-GSK-US2025117367:same reporter, different patient US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117358:same reporter US-GSK-US2025117361:same reporter US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117369:same reporter More
2863367 FL 10/06/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Expired product administered Expired product administered
MA gave the vaccine yesterday to a fifteen months old child, the Infanrix and it expired July thirte... MA gave the vaccine yesterday to a fifteen months old child, the Infanrix and it expired July thirteenth of twenty twenty-five; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug administered in a 15-month-old patient who received DTPa (Infanrix) (expiry date 13-JUL-2025) for prophylaxis. The patient experienced expired drug administered (Verbatim: MA gave the vaccine yesterday to a fifteen months old child, the Infanrix and it expired July thirteenth of twenty twenty-five). The outcome of the expired drug administered 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: 16-SEP-2025 The clinic coordinator reported that, a medical assistant gave the vaccine a day before day of reporting to a fifteen-month-old child, the Infanrix and it expired 13th July 2025. The healthcare professional did not have the lot number or the patient information. More
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