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
2836150 PA 04/15/2025 MMRV
 MERCK & CO. INC.
 Y018156
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 21-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.8 degree Fahrenheit for 115 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836151 PA 04/15/2025 MMRV
 MERCK & CO. INC.
 Y018156
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 21-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.8 degree Fahrenheit for 115 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836152 F NC 04/15/2025 VARCEL
 MERCK & CO. INC.
Antibody test negative Antibody test negative
HCP called to state that she ran titers for a patient and she is showing no immunity for VARIVAX; Th... HCP called to state that she ran titers for a patient and she is showing no immunity for VARIVAX; This spontaneous report was received from a Nurse Practitioner on 07-Apr-2025 and refers to a 61-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) (reported as DILUENT MRK) used to reconstitute the vaccine. On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka-Merck) (VARIVAX) (0.5mL/ series; formulation, route, lot # and expiration date were not reported) for Prophylaxis. The patient's vaccine history was unknown, so this case was serving as a precautionary adverse event (AE). On an unknown date, the reporter ran titers for the patient, who showed no immunity for the varicella virus vaccine live (Oka-Merck) (VARIVAX) (Immunodeficiency). The action taken with varicella virus vaccine live (Oka-Merck) (VARIVAX) was reported as Dose not changed. At the reporting time, the outcome of Immunodeficiency was unknown. The causal relationship between the event of Immunodeficiency and varicella virus vaccine live (Oka-Merck) (VARIVAX) was not provided. Upon internal review, the event of Immunodeficiency was determined to be medically significant. More
2836153 NY 04/15/2025 PPV
 MERCK & CO. INC.
 X014729
Expired product administered, No adverse event Expired product administered, No adverse event
so far has not experienced any side effects; patient was accidently administered an expired dose of ... so far has not experienced any side effects; patient was accidently administered an expired dose of PNEUMOVAX 23 on Apr 10, 2025; This spontaneous report was received from a licensed practical nurse (LPN) referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Apr-2025, the patient was accidently administered an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #X014729, expiration date: 22-Nov-2024) 0.5 mL for prophylaxis (strength and route of administration were not reported) (Expired product administered). At the time of the call, the reporter stated the patent received expired dose within the past thirty minutes, and so far, the patient had not experienced any side effects (No adverse event). At the reporting time, the outcome of the events was unknown. No further information provided. No additional adverse event (AE) or product quality complaint (PQC) was reported. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) was reported as not applicable. More
2836154 1 M TX 04/15/2025 HEPA
 MERCK & CO. INC.
 Y009094
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
No Additional AE; 12-month-old patient received an adult dose of VAQTA for their initial vaccination... No Additional AE; 12-month-old patient received an adult dose of VAQTA for their initial vaccination; This spontaneous report was received from an Other health professional and referred to a 12-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Apr-2025, the patient was vaccinated with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA INJ 50/1.0 U/ml) Injection (lot #Y009094, expiration date: 29-Nov-2025), dose number 1, 1 mL for prophylaxis (overdose). No Additional AE. More
2836155 F WI 04/15/2025 MMRV
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
No additional AE; inadvertent administration of PROQUAD to an adult patient on 11APR2025 who was sup... No additional AE; inadvertent administration of PROQUAD to an adult patient on 11APR2025 who was supposed to receive a dose of MMR-II; This spontaneous report was received from a registered nurse and refers to an adult female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical drug included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) in 1993. The reporter reported inadvertent administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis to an adult patient on 11-APR-2025 who was supposed to receive a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) for prophylaxis. Both suspect vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). No additional adverse event. The dose, strength, route, lot number and expiration date were not reported for suspect products. Lot number is being requested and will be submitted if received. More
2836156 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Death Death
unknown cause of death; This serious case was reported by a consumer via interactive digital media a... unknown cause of death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in an unspecified number of patients 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 unknown cause of death (Verbatim: unknown cause of death) (serious criteria death and GSK medically significant). The reported cause of death was unknown. The reporter considered the unknown cause of death to be related to Shingles vaccine. The company considered the unknown cause of death to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 11-APR-2025 This case was reported by a consumer via interactive digital media. The reporter stated that some had passed from shingles shot. This case was linked with case US2025AMR045186,reported by the same reporter.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR045186:same reporter /different patient; Reported Cause(s) of Death: unknown cause of death More
โœ“
2836157 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain Herpes zoster, Pain
got a very painful shingles two weeks later and it's been over three months and they were so pa... got a very painful shingles two weeks later and it's been over three months and they were so painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: got a very painful shingles two weeks later and it's been over three months and they were so painful). The outcome of the shingles was not resolved. 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:06-FEB-2024 This case was reported by a patient via interactive digital media The patient took Shingrix vaccine shots and two weeks later had the worse case of shingles and it's been over three months and they were so painful and stated hope he/she never get them again. The patient stated that after his/her close friend developed shingles, the patient saw how painful it could really be and live a full life and didn't want shingles to get in the way and here's the patient's story on why he/she started a conversation with his/her doctor about his/her shingles risk. More
2836158 F 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Axillary pain, Contusion, Mobility decreased, Pain in extremity, Skin warm Axillary pain, Contusion, Mobility decreased, Pain in extremity, Skin warm
armpit painful; aching; unable to move full range of motion; warm to touch; bruising; This non-serio... armpit painful; aching; unable to move full range of motion; warm to touch; bruising; This non-serious case was reported by a consumer and described the occurrence of axillary pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included gastroesophageal reflux disease. Concomitant products included pantoprazole sodium sesquihydrate (Protonix). On 26-MAR-2025 20:00, the patient received Shingrix. On 28-MAR-2025, 2 days after receiving Shingrix, the patient experienced axillary pain (Verbatim: armpit painful), pain (Verbatim: aching), mobility decreased (Verbatim: unable to move full range of motion), skin warm (Verbatim: warm to touch) and contusion (Verbatim: bruising). The outcome of the axillary pain, pain, mobility decreased and skin warm were not resolved and the outcome of the contusion was not reported. It was unknown if the reporter considered the axillary pain, pain, mobility decreased, skin warm and contusion to be related to Shingrix. It was unknown if the company considered the axillary pain, pain, mobility decreased, skin warm and contusion to be related to Shingrix. Additional Information: GSK Receipt Date: 31-MAR-2025 The patient self-reported this case for herself. Consumer reported that she took the Shingrix vaccine on Wednesday at 8pm (from the date of reporting) and experienced armpit painful, aching, unable to move full range of motion, warm to touch, it moved into the above pictures Friday, Saturday and Sunday. The bruising started on Friday evening; she had reached out to her PCP (primary care physician) for Monday morning. More
2836159 75 F VA 04/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Arthralgia, Back pain, Headache, Loss of personal independence in daily activiti... Arthralgia, Back pain, Headache, Loss of personal independence in daily activities, Nausea; Neck pain, Pain, Pelvic pain More
Pelvic pain/severe pain in the pelvic area; Back pain; incapacitated in bed all day; neck hurt badly... Pelvic pain/severe pain in the pelvic area; Back pain; incapacitated in bed all day; neck hurt badly; terrible headache; body aches; Hip pain/pain went down to her shoulder; Nausea/periodic nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (received Zostavax in 2013 or 2014), Prednisone and Prolia with an associated reaction of bone pain (receive Prolia injections for Osteoporosis twice per year for 5 years). Concurrent medical conditions included leg cramps and osteoporosis. Concomitant products included calcium, magnesium and docusate sodium (Stool Softener). On 24-MAR-2025, the patient received the 1st dose of Shingrix (left arm). In MAR-2025, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea/periodic nausea). On 24-MAR-2025, the patient experienced headache (Verbatim: terrible headache), general body pain (Verbatim: body aches), arthralgia (Verbatim: Hip pain/pain went down to her shoulder) and neck pain (Verbatim: neck hurt badly). On 25-MAR-2025, the patient experienced pelvic pain (Verbatim: Pelvic pain/severe pain in the pelvic area), back pain (Verbatim: Back pain) and bedridden (Verbatim: incapacitated in bed all day). The outcome of the headache, general body pain, nausea and neck pain were unknown and the outcome of the pelvic pain, back pain and arthralgia were not resolved and the outcome of the bedridden was resolved. It was unknown if the reporter considered the headache, general body pain, pelvic pain, back pain, arthralgia, nausea, neck pain and bedridden to be related to Shingrix. It was unknown if the company considered the headache, general body pain, pelvic pain, back pain, arthralgia, nausea, neck pain and bedridden to be related to Shingrix. Additional Information: GSK Receipt Date: 02-APR-2025 The patient received the first dose of Shingrix on Monday at a local pharmacy. The vaccine was injected into the left arm. Overnight, the patient began to experienced terrible headache and body aches. The patient was incapacitated in bed all day on the 25th and 26th March 2025. The patients stated her neck hurt badly and the pain went down to her shoulder. The patient was having severe pain in the pelvic area, in her back and hips, which was worse overnight and eases during the day. The pain in the pelvic area flares up after taking her Calcium and Multivitamin and then she goes to bed. The patient also experienced periodic nausea. The patient stated it was not the mattress that was causing her back and hip pain, because she had tried all 3 mattresses in her house without relief. The patient received Zostavax in 2013 or 2014. The patient took prednisone years ago. She had not taken prednisone since 2019. The patient used to receive Prolia injections for Osteoporosis twice per year for 5 years her last dose was May 2024. She experienced aching bones from Prolia. More
2836160 70 F NJ 04/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 47n3y
47n3y
Chills, Erythema, Infection, Injection site erythema, Injection site warmth; Pai... Chills, Erythema, Infection, Injection site erythema, Injection site warmth; Pain, Pyrexia, Rash macular More
she had an infection; Redness on left arm; she was having redness at injection site which got worsen... she had an infection; Redness on left arm; she was having redness at injection site which got worsened; injection site of her left arm was hot to the touch; skin was blotchy at injection site; Fever; Bodyaches; Shivering; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 47n3y) for prophylaxis. On 30-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 01-APR-2025, 2 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she was having redness at injection site which got worsened), injection site warmth (Verbatim: injection site of her left arm was hot to the touch ), injection site reaction (Verbatim: skin was blotchy at injection site), fever (Verbatim: Fever), general body pain (Verbatim: Bodyaches) and shivering (Verbatim: Shivering). On 02-APR-2025, the patient experienced infection (Verbatim: she had an infection) and erythema of extremities (Verbatim: Redness on left arm). The outcome of the injection site erythema, injection site warmth, injection site reaction, general body pain, shivering, infection and erythema of extremities were not resolved and the outcome of the fever was unknown. The reporter considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The reporter considered the infection to be unrelated to Shingrix. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix. The company considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The company considered the infection to be unrelated to Shingrix. It was unknown if the company considered the erythema of extremities to be related to Shingrix. Additional Information: GSK receipt date: 03-APR-2025 HCP was the reporter. Reporter stated 48 hours after the vaccine was administered the patient complained the injection site of her left arm was hot to the touch, her skin was blotchy at injection site, she was having redness at injection site, fever (temperature not reported) body aches, and shivering. The reporter stated the consumer went to urgent care 2 APR 2025 and was told that she had an infection. The reporter also stated the redness on the left arm at the injection site has spread to the entire left arm as of 2nd April 2025. The reporter was unable to specify where or what type of infection the consumer was diagnosed with. The reporter stated the consumer scheduled an appointment with her PCP 3rd April 2025 for evaluation and was being examined by the PCP at the time of reporting. No further information was obtained or provided. More
2836161 PA 04/15/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 955E2
Product preparation issue Product preparation issue
trouble withdrawing the Priorix out of the vial after reconstitution; changed the needle from 25 g t... trouble withdrawing the Priorix out of the vial after reconstitution; changed the needle from 25 g to 21g and still could not withdraw the vaccine out of antigen vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 955E2, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: trouble withdrawing the Priorix out of the vial after reconstitution) and wrong technique in drug usage process (Verbatim: changed the needle from 25 g to 21g and still could not withdraw the vaccine out of antigen vial). The outcome of the inappropriate preparation of medication and wrong technique in drug usage process 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: 03-APR-2025 The registered pharmacist reported that he had trouble withdrawing the Priorix out of the vial after reconstitution and he changed the needle from 25G to 21G and still could not withdraw the vaccine out of antigen vial and was not sure if the correct syringe was used the first time, which led to wrong technique in drug usage process and inappropriate preparation of medication. The reporter tried again and was able to withdraw the vaccine from the antigen vial and was able to administer the suspect product More
2836162 67 F TN 04/15/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Chills, Diarrhoea, Headache, Myalgia, Nausea; Pyrexia Chills, Diarrhoea, Headache, Myalgia, Nausea; Pyrexia
Muscle ache; Chills; Fever; Diarrhea NOS; Headache; Nausea; This non-serious case was reported by a ... Muscle ache; Chills; Fever; Diarrhea NOS; Headache; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 05-APR-2025, the patient received Arexvy (intramuscular, left deltoid). On 05-APR-2025, several minutes after receiving Arexvy, the patient experienced headache (Verbatim: Headache) and nausea (Verbatim: Nausea). On 06-APR-2025, the patient experienced muscle pain (Verbatim: Muscle ache), chills (Verbatim: Chills), fever (Verbatim: Fever) and diarrhea (Verbatim: Diarrhea NOS). The outcome of the headache, nausea, muscle pain, chills, fever and diarrhea were resolving. It was unknown if the reporter considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy. It was unknown if the company considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy. Additional Information: GSK Receipt Date: 07-APR-2025 The patient self-reported this case. The patient received Arexvy vaccine and within a few minutes she had headache and nausea. On the next day of vaccination she started having chills, fever, muscle aches and diarrhea and stated that the symptoms have all improved, however they are all ongoing. More
2836163 M 04/15/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Blister, Herpes zoster, Pain, Rash, Vaccination failure; Blister, Herpes zoster,... Blister, Herpes zoster, Pain, Rash, Vaccination failure; Blister, Herpes zoster, Pain, Rash, Vaccination failure More
Completed shingles immunization series in 2022, was diagnosed with shingles last week/ suspected vac... Completed shingles immunization series in 2022, was diagnosed with shingles last week/ suspected vaccination failure; Completed shingles immunization series in 2022, was diagnosed with shingles last week; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 65-year-old male 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: Completed shingles immunization series in 2022, was diagnosed with shingles last week/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Completed shingles immunization series in 2022, was diagnosed with shingles last week). The patient was treated with prednisone and valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. The company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 07-APR-2025 The patient completed shingles immunization series in 2022, was diagnosed with shingles last week. Male patient 65 years old showed up with rash on left arm, blisters and pain. The patient was treated with prednisone and valacyclovir due to suspected 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.; 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 Shingles vaccine (Dose 1 & 2). More
2836164 MI 04/15/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect route of product administration Incorrect route of product administration
subcutaneous product administered by other route; This non-serious case was reported by a pharmacist... subcutaneous product administered by other route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in an specified number of patients who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: subcutaneous product administered by other route). The outcome of the subcutaneous injection formulation administered by other route 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: 07-APR-2025 The reporter stated that 12 patients were given a dose of Priorix intramuscularly instead of subcutaneously. HCP was asked for initials, gender, DOB, lot number, location of IM injection, and date of administration for all 12 patients. The reporter did not want to give the information at the time of the call. The patients received Priorix intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route. More
2836165 M AZ 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not yet received his second dose; This non-serious case was reported by a consumer via call cent... has not yet received his second 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 male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received his second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 09-APR-2025 The patient self-reported this case. The patient received his first dose of Shingrix and he had not yet received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2836166 F PA 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Asthenia, Malaise, Nausea, Vomiting Asthenia, Malaise, Nausea, Vomiting
not feeling well; nauseous; feeling very weak; wanting to throw up; This non-serious case was report... not feeling well; nauseous; feeling very weak; wanting to throw up; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On 26-MAR-2025, the patient received the 2nd dose of Shingrix. On 27-MAR-2025, 1 days after receiving Shingrix, the patient experienced feeling unwell (Verbatim: not feeling well), nausea (Verbatim: nauseous), weakness (Verbatim: feeling very weak) and vomiting (Verbatim: wanting to throw up). The outcome of the feeling unwell was not resolved and the outcome of the nausea, weakness and vomiting were not reported. The reporter considered the feeling unwell, nausea, weakness and vomiting to be related to Shingrix. The company considered the feeling unwell, nausea, weakness and vomiting to be related to Shingrix. Additional Information: GSK receipt date: 31-MAR-2025 The patient received the 2nd dose of Shingrix on 26 March, but today on March 27 she woke up not feeling well feeling, very weak, very nauseous, wanting to throw up and she felt a little bit better in the middle of the day and then the evening she continued to not feel well. That's how the patient described it to the reporter. So this was from getting Shingrix again and wanted to just report it. Her age was probably close to 80 years and that was all the reporter know. More
2836167 56 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Exposure via skin contact, Syringe issue, Underdose Exposure via skin contact, Syringe issue, Underdose
dose leaked out of the syringe and down my arm. Less than 50% went in.; dose leaked out of the syrin... dose leaked out of the syringe and down my arm. Less than 50% went in.; dose leaked out of the syringe and down my arm. Less than 50% went in; Less than 50% went in; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of exposure via skin contact in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On 31-MAR-2025, the patient received the 2nd dose of Shingrix. On 31-MAR-2025, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: dose leaked out of the syringe and down my arm. Less than 50% went in.), inadvertent exposure to vaccine (Verbatim: dose leaked out of the syringe and down my arm. Less than 50% went in) and underdose (Verbatim: Less than 50% went in). The outcome of the exposure via skin contact, inadvertent exposure to vaccine and underdose were not applicable. Additional Information: GSK receipt Date: 31-MAR-2025 The patient received the second dose of Shingrix, but the dose leaked out of the syringe and down on arm, which led to exposure via skin contact and inadvertent exposure to vaccine products. Less than 50 percent went in, which led to underdose. More
2836168 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
got I ended up getting the shingles more than before; This non-serious case was reported by a consum... got I ended up getting the shingles more than before; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got I ended up getting the shingles more than before). The patient was treated with lysine (L-Lysine). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that wouldn't get another shot for any reason after the first shot ,he/she got ended up getting the shingles more than before, so consumer was use some royal almond gel to put on it made by and took l-Lysine. The follow-up could not be possible as no contact details were available. More
2836169 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
did have a mild case of shingles after the first vaccine; This non-serious case was reported by a co... did have a mild case of shingles after the first vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: did have a mild case of shingles after the first vaccine). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had the Shingles vaccine twice and had a mild case of shingles after the first vaccine. The patient family member had it in her eye still being followed by the ophthalmologist. Further, stated that shingles was not a joke. This case is linked with US2025AMR041385, reported by same reporter for different patient.; Sender's Comments: US-GSK-US2025AMR041385:same reporter different patient More
2836170 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
i only got one shot, I don't remember being told I need another one; This non-serious case was ... i only got one shot, I don't remember being told I need another one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: i only got one shot, I don't remember being told I need another one). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient only got one shot and didn't remember being told that he/she need another one Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. More
2836171 NY 04/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Fatigue, Herpes zoster, Nausea, Vaccination failure; Fatigue, Herpes zoster, Nau... Fatigue, Herpes zoster, Nausea, Vaccination failure; Fatigue, Herpes zoster, Nausea, Vaccination failure More
Suspected vaccination failure; I have shingles; This serious case was reported by a consumer via cal... Suspected vaccination failure; I have shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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 to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 06-APR-2025 The patient reported that not sure if GlaxoSmithKline was keeping track of Shingrix vaccine feedback. The patient had the vaccine 2 doses. The patient was one that was nauseous and very tired after. Now 2 years later the reporter had shingles. 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 completion of primary vaccination schedule and laboratory confirmation regarding shingles ) is considered unrelated to GSK vaccine Shingrix (Dose 1& 2). More
2836172 04/15/2025 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; still got shingles again; This serious case was reported by a consume... Suspected vaccination failure; still got shingles again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (still got shingles again). 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: still got shingles again). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The reporter stated that his/her friend had two vaccines and still got shingles again. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1&2). More
2836173 HI 04/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Expired product administered, No adverse event Expired product administered, No adverse event
administered expired Engerix B to 5 different consumers; This non-serious case was reported by a nur... administered expired Engerix B to 5 different consumers; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of expired vaccine used in a specified number of patients who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered expired Engerix B to 5 different consumers). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 Nurse practitioner reported that she inadvertently administered an expired Engerix B to 5 different consumers (patients), which led to an expired vaccine used. No additional detail or information were provided. No additional AE (adverse event) reported. No PQC (product quality complaint) reported. More
2836174 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Asthenia Asthenia
What to do shingrix causes weakness; This non-serious case was reported by a consumer via interactiv... What to do shingrix causes weakness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weakness 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 weakness (Verbatim: What to do shingrix causes weakness). The outcome of the weakness was not reported. The reporter considered the weakness to be related to Shingrix. The company considered the weakness to be related to Shingrix. Additional Information: GSK Receipt Date : 04-APR-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The reporter asked that what to do shingrix caused weakness. More
2836175 04/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Inappropriate schedule of product administration, Vaccination fai... Herpes zoster, Inappropriate schedule of product administration, Vaccination failure, Wrist fracture, Wrist surgery; Herpes zoster, Inappropriate schedule of product administration, Vaccination failure, Wrist fracture, Wrist surgery More
Suspected vaccination failure; surgery for a fractured wrist; shingles; Inappropriate schedule of va... Suspected vaccination failure; surgery for a fractured wrist; shingles; Inappropriate schedule of vaccine administered; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. 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), wrist surgery (Verbatim: surgery for a fractured wrist) (serious criteria clinically significant/intervention required), shingles (Verbatim: shingles) and drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the vaccination failure and wrist surgery were not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the vaccination failure, wrist surgery and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure and wrist surgery to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 The reporter reported that patient need some guidance on if he/she could take a second set of shots. Patient was vaccinated with Shingrix in 2021. His/her second dose was 6 months after the first one. This was in 2021. Patient had 2 cases of Shingles since then. One was happening now. Patient asked, what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose. He/she did the series of Shingrix. His/her second shot was 6 most after the first. Patient had 2 cases of Shingles since then. One after surgery for a fractured wrist, and the second case started a few days ago. Patient was wondering what the research says about getting a second series of shots. But here he/she with 2 cases of shingles after having the shots. The second shot was 7 months after the first. It was in 2021 during covid time. Patient asked that would had the shot again be an option for him/her. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2). Wrist surgery is an unlisted event which is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2). More
2836176 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; came down with it; This serious case was reported by a consumer via i... Suspected vaccination failure; came down with it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patients 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: came down with it). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. The reporter know people who got the shot and came down with it. One was his/her doctors wife, he was angry and gave her the Antivirus medicine. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2836177 04/15/2025 VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
Extra dose administered, Herpes zoster, Pain, Post herpetic neuralgia, Vaccinati... Extra dose administered, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure; Extra dose administered, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure; Extra dose administered, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure More
Post herpetic neuralgia; both kinds the one shot and the two shots; suspected vaccination failure; S... Post herpetic neuralgia; both kinds the one shot and the two shots; suspected vaccination failure; 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 and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2024, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia) and extra dose administered (Verbatim: both kinds the one shot and the two shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, shingles and post herpetic neuralgia to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 06-APR-2025 This case was reported by a patient via interactive digital media. The patient had both kinds, the one shot and the two shots of Shingles. The patient had shingles and still have the resulting post herpetic neuralgia, it was April 2025 when he/she writes this. The pain was horrible. The patient received 3 doses of Shingles vaccine, which led to an extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Post herpetic neuralgia are unlisted events which are considered unrelated to GSK Shingles vaccine. " More
2836178 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; have shingles; This serious case was reported by a consumer via inter... Suspected vaccination failure; have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she just got back from doctors. The patient reported to have shingles. The patient got the (Shingles vaccine) shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2836179 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Abdominal pain, Headache, Pain in extremity, Pyrexia Abdominal pain, Headache, Pain in extremity, Pyrexia
Fever; Headache; Tummy ache; Very sore arm; This non-serious case was reported by a consumer via int... Fever; Headache; Tummy ache; Very sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a 71-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever), headache (Verbatim: Headache), abdominal pain (Verbatim: Tummy ache) and pain in arm (Verbatim: Very sore arm). The outcome of the fever, headache, abdominal pain and pain in arm were resolved (duration 3 days). It was unknown if the reporter considered the fever, headache, abdominal pain and pain in arm to be related to Shingles vaccine. It was unknown if the company considered the fever, headache, abdominal pain and pain in arm to be related to Shingles vaccine. Additional Information: GSK receipt date: 05-APR-2025 The patient was sick for three days. The patient had fever, headache, tummy ache and very sore arm. The patient will be getting second in May. The patient was almost 71 years old and had one of the worst cases, six had seen. More
2836180 04/15/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspeceted vaccination failure; did get both rounds of shinglex but it didn't help at all; This... Suspeceted vaccination failure; did get both rounds of shinglex but it didn't help at all; 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. The patient's past medical history included shingles (flareups). 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: did get both rounds of shinglex but it didn't help at all). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 06-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she did get both rounds of Shinglex (Shingles vaccine), but it did not help at all. The patient mentioned that probably because he/she had already been having flareups long before there was a shot. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, insufficient information regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2836181 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Allergy to vaccine, Influenza, Rash Allergy to vaccine, Influenza, Rash
severe flu symptoms; rash all over my stomach and chest; allergic to that vaccine; This non-serious ... severe flu symptoms; rash all over my stomach and chest; allergic to that vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced flu symptoms (Verbatim: severe flu symptoms), rash (Verbatim: rash all over my stomach and chest) and allergy to vaccine (Verbatim: allergic to that vaccine). The outcome of the flu symptoms was resolving and the outcome of the rash was not resolved and the outcome of the allergy to vaccine was not reported. It was unknown if the reporter considered the flu symptoms, rash and allergy to vaccine to be related to Shingles vaccine. It was unknown if the company considered the flu symptoms, rash and allergy to vaccine to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-APR-2025 The patient got first Shingle shot last week. The patient really planned to get both shots because he/she knew shingles could be really painful. But after having first shot, the patient would not have the next. The patient had severe flu symptoms and never felt that bad in my life. And just when the patient started to feel a little better, now he/she has a rash all over stomach and chest. The patient guessed that he/she was allergic to that vaccine. More
2836182 M 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
sore arm for a week.; put me to bed; This non-serious case was reported by a consumer via interactiv... sore arm for a week.; put me to bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a male 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 muscle soreness (Verbatim: sore arm for a week.) and bedridden (Verbatim: put me to bed). The outcome of the muscle soreness was resolved (duration 1 week) and the outcome of the bedridden was resolved (duration 1 day). It was unknown if the reporter considered the muscle soreness and bedridden to be related to Shingles vaccine. It was unknown if the company considered the muscle soreness and bedridden to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The shot put reporter to bed for a day and sore arm for a week. The reporter said get the damn shot. This case has been linked to the US2025AMR043507 case reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR043507:same reporter More
2836183 M 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Discomfort Arthralgia, Discomfort
right shoulders hurts me; little discomfort for a few days; This non-serious case was reported by a ... right shoulders hurts me; little discomfort for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a male 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 shoulder pain (Verbatim: right shoulders hurts me) and discomfort (Verbatim: little discomfort for a few days). The outcome of the shoulder pain was not reported and the outcome of the discomfort was resolved. It was unknown if the reporter considered the shoulder pain and discomfort to be related to Shingles vaccine. It was unknown if the company considered the shoulder pain and discomfort to be related to Shingles vaccine. Additional Information: GSK receipt date: 06-APR-2025 This case was reported by a patient via interactive digital media. Patient was not happy that he got the shot. Patient got shot 3 years ago when right shoulders hurt him all the time. Patient did not know why or what they got in that shot as they call it patient's wife had shingles and it was not no big deal. Patient stated that a guy used to drive a truck with had shingles. No big deal again. Just a little discomfort for a few days. Patient indicated that do not let him fear over you and kill you with snake venom and animal DNA parts from little children. Patient indicated that let them fear do some research. Patient stated that they had to really press them hard to get the fact sheets of the side effects of their debilitating drugs. More
2836184 M 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; 9 months later got a horrible case of shingles; This serious case was... Suspected Vaccination failure; 9 months later got a 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 9 months later got a horrible case of shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-APR-2025 This case was reported by a patient's child via interactive digital media. The patient (dad) got the Shingles vaccine and 9 months later got a horrible case of shingles. The reporter stated that shingles vaccine didn't work and that was a propaganda. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2836185 04/15/2025 VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Blister, Condition aggravated, Herpes zoster, Migraine, Mobility decreased; Pain... Blister, Condition aggravated, Herpes zoster, Migraine, Mobility decreased; Pain, Vaccination failure; Blister, Condition aggravated, Herpes zoster, Migraine, Mobility decreased; Pain, Vaccination failure More
Shingles on forehead close to eyes/ suspected vaccination failure; Shingles on forehead close to eye... Shingles on forehead close to eyes/ suspected vaccination failure; Shingles on forehead close to eyes; spent a day in bed; Migraines were worse; 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: Shingles on forehead close to eyes/ suspected vaccination failure) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: Shingles on forehead close to eyes), bedridden (Verbatim: spent a day in bed) and migraine (Verbatim: Migraines were worse). The outcome of the vaccination failure, facial herpes zoster and migraine were not reported and the outcome of the bedridden was resolved. It was unknown if the reporter considered the vaccination failure, facial herpes zoster and migraine to be related to Shingles vaccine and Shingles vaccine. The reporter considered the bedridden to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster and migraine to be related to Shingles vaccine and Shingles vaccine. The company considered the bedridden to be related to Shingles vaccine. Additional Information: GSK receipt date: 07-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles on forehead close to the eyes. The patient suffered from severe migraines and it felt a lot like that. However, when the blisters showed up the patient realized what it was. The patient was so used to migraines and vomiting, that the patient mistook the pain. By the time the patient made it to the doctor it was too late to treat it but the doctor sent the patient to an ophthalmologist. Fortunately, the patient's eye was ok. The patient had both shingles vaccinations 3 years ago. The second shot made the patient sick and had spent a day in bed. The shingles pain was sharp and intense but the migraines were even worse because they were so frequent. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2836186 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
sick 3 days.; This non-serious case was reported by a consumer via interactive digital media and des... sick 3 days.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) 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 sickness (Verbatim: sick 3 days.). The outcome of the sickness was resolved (duration 3 days). It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she was sick 3 days. Did not get the 2nd shot. More
2836187 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Oral herpes Oral herpes
fever blister; This non-serious case was reported by a consumer via interactive digital media and de... fever blister; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included fever blister. Previously administered products included Shingles vaccine (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced fever blister (Verbatim: fever blister). The outcome of the fever blister was not reported. It was unknown if the reporter considered the fever blister to be related to Shingles vaccine. It was unknown if the company considered the fever blister to be related to Shingles vaccine. Additional Information: GSK receipt date: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient had both shots and it was easy. The patient had a fever blister last week and it was different from past ones. More
2836188 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Rash, Vaccination failure Herpes zoster, Rash, Vaccination failure
agitated nerves are just calming down now; Suspected vaccination failure; Shingles last month; This ... agitated nerves are just calming down now; Suspected vaccination failure; Shingles last month; 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. In MAR-2025, 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 last month). On an unknown date, the patient experienced agitation (Verbatim: agitated nerves are just calming down now). The outcome of the vaccination failure and shingles were not reported and the outcome of the agitation was resolving. It was unknown if the reporter considered the vaccination failure, shingles and agitation 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 and agitation to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported he/she got Shingles vaccine and got shingles last month (from the date of reporting) but thankfully a milder case and patient thanked to the vaccine. The patient was put on an antiviral medication which shortened the rash time, but the agitated nerves were just calming down now (at the time of reporting) 6 weeks later. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2836189 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
The first one made me sick; This non-serious case was reported by a consumer via interactive digital... The first one made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: The first one made me sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-APR-2025 The patient reported that the first (Shingles vaccine) made him/her sick. The patient was further informed that the second one would make him/her even more sick. The patient stated that they would have to get it when they had time to be sick More
2836190 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Had a shot and still got shingles/still have flare ups after 10 years... Suspected vaccination failure; Had a shot and still got shingles/still have flare ups after 10 years; 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: Had a shot and still got shingles/still have flare ups after 10 years). 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. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had a shot and still got shingles which never go away for good, still had flare ups after 10 years. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2836191 04/15/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected Vaccination failure; I got shingles after I took my second shot,hurt something horribly,it... Suspected Vaccination failure; I got shingles after I took my second shot,hurt something horribly,it has been 2 months and the pain is still unbearable,I have them on the inside; 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: I got shingles after I took my second shot,hurt something horribly,it has been 2 months and the pain is still unbearable,I have them on the inside). 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 to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient got shingles after he/she took second Shingles shot and it hurt something horribly and it has been 2 months and the pain was still unbearable and the patient have them on the inside This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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 Shingles vaccine (dose 1) and Shingles vaccine (dose 2). More
2836192 04/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; had 2 cases of Shingles since then. One is happening now; This seriou... Suspected vaccination failure; had 2 cases of Shingles since then. One is happening now; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 2 cases of Shingles since then. One is happening now). 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 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 to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via (Shingrix GSK Chatbot) interactive digital media. The consumer reported that he/she need some guidance on if he/she could take a second set of shots. The patient was vaccinated with Shingrix in 2021. His/her second dose was 6 months after the first one. This was in 2021. The patient had 2 cases of shingles since then. One was happening now (at the time of reporting) in 2025. 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2). More
2836193 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pruritus, Vaccination failure Herpes zoster, Pruritus, Vaccination failure
Suspected vaccination failure; Supposed to last 3, still have a mild case after 2 yrs; This serious ... Suspected vaccination failure; Supposed to last 3, still have a mild case after 2 yrs; 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Supposed to last 3, still have a mild case after 2 yrs). 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. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 08-APR-2025 This case was reported by a patient via interactive digital media. Patient developed shingles anyway 2 years after the shot. Patient stated it was supposed to last 3, but patient still had a mild case after 2 years. Patient reacted to the medication, at the time of reporting patient was using Biofreeze to relieve the itch. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2836194 04/15/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
suspected vaccibation failure/experienced shingles after the two vaccines; experienced shingles and ... suspected vaccibation failure/experienced shingles after the two vaccines; experienced shingles and pain after the two vaccines; 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 vaccibation failure/experienced shingles after the two vaccines) (serious criteria GSK medically significant) and shingles (Verbatim: experienced shingles and pain after the two vaccines). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient would not wish shingles on worst enemy. The patient never ever experienced such pain. The patient had two vaccines before all of this. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (dose 1 and 2). More
2836195 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Neuralgia Neuralgia
nerve pain on my back; This non-serious case was reported by a consumer via interactive digital medi... nerve pain on my back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of neuralgia 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 neuralgia (Verbatim: nerve pain on my back). The outcome of the neuralgia was not reported. It was unknown if the reporter considered the neuralgia to be related to Shingles vaccine. It was unknown if the company considered the neuralgia to be related to Shingles vaccine. Additional Information: GSK receipt date: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vaccine and it nearly killed me. The patient reported that now he/she had a nerve pain on his/her back. More
2836196 04/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise, Pain in extremity Malaise, Pain in extremity
Pain in arm; not feeling well; This non-serious case was reported by a consumer via interactive digi... Pain in arm; not feeling well; 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 (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Pain in arm) and feeling unwell (Verbatim: not feeling well). The outcome of the pain in arm and feeling unwell were not reported. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and feeling unwell to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR040571 Additional Information: GSK receipt date: 02-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that, got second shot on the day of reporting and patient's arm was hurting and not feeling well just like the first one. For tolerance of second dose, please refer US2025AMR040571. More
2836197 M PA 04/15/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 2JX7Y
Product storage error Product storage error
vaccine was not supposed to be frozen and accidentally gave to patient; This non-serious case was re... vaccine was not supposed to be frozen and accidentally gave to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old male patient who received MMR (Priorix) (batch number 2JX7Y) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: vaccine was not supposed to be frozen and accidentally gave to patient). 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: 02-APR-2025 Nurse reported that a new vaccine the MMR with a different brand that was not supposed to be frozen and accidentally gave to patient, which led to incorrect storage of drug. The Priorix vaccines were exposed to a temperature of minus 23.5๏ฟฝC. This case is linked with case US2025039712, reported by the same reporter.; Sender's Comments: US-GSK-US2025039712:SAME REPORTER More
2836198 F WV 04/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
have not received a second dose so far; This non-serious case was reported by a other health profess... have not received a second dose so far; 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 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 15-JUL-2019 of batch number 5TH3L and expiry date of 19-NOV-2021). Concurrent medical conditions included asthma (has asthma). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: have not received a second dose so far). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-APR-2025 The Pharmacy Technician had a patient that got first dose of Shingrix vaccine but they have not received a second dose so far. The pharmacist reported that patient had a history of asthma, but she was not sure if patient was considered immunocompromised. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Pharmacy Technician explained they do not have an email address for the facility so they declined consent to follow up with Safety Team. More
2836199 F AK 04/15/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient received only two doses of Twinrix; This non-serious case was reported by a nurse via call c... patient received only two doses of Twinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Patient received first dose on 1999) and Twinrix (Patient received second dose on 1999). On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received only two doses of Twinrix ). 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: 03-APR-2025 A Nurse Practitioner wanted to know if a patient could receive Heplisav-B instead of Twinrix (because they ran out of it at the facility) to complete the schedule for the immunization of Hepatitis B. Also wanted to know, if the latter it's possible, if the patient should receive one or two doses of Heplisav-B. Till the time of reporting the patient did not receive the third dose of Twinrix, which led to incomplete course of vaccination. More
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