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
2835020 F 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient has not yet received the second dose; This non-serious case was reported by a consumer via c... patient has not yet received the 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 female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix on 01-SEP-2024). 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: patient has not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter reported that the patient received the first dose of Shingrix on September 1, 2024. The patient had not yet received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835021 1 F NM 04/09/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X4T99
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
12 month old given Menveo (pink cap) in her left leg quad; This non-serious case was reported by a n... 12 month old given Menveo (pink cap) in her left leg quad; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis. On 20-MAR-2025, the patient received Menveo .5 ml. On 20-MAR-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 12 month old given Menveo (pink cap) in her left leg quad). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter called to speak to medical information department. The reporter stated that they gave a 12 month old a dose of Menveo (pink cap) in her left leg quad which led to inappropriate age at vaccine administration. This presentation was for use in individuals 10 through 55 years of age. Parents of minor child were not notified as of the time of call. More
2835022 M 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Arthritis, Condition aggravated Arthritis, Condition aggravated
worsening of arthritis; This non-serious case was reported by a consumer via call center representat... worsening of arthritis; This non-serious case was reported by a consumer via call center representative and described the occurrence of arthritis aggravated in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included joint replacement (joint replacement surgeries on his knees bilaterally and his left hip) and shingles. Concurrent medical conditions included arthritis and hypertension. Concomitant products included meloxicam. On 13-FEB-2025, the patient received Shingrix. On 01-MAR-2025, 16 days after receiving Shingrix, the patient experienced arthritis aggravated (Verbatim: worsening of arthritis). The outcome of the arthritis aggravated was not resolved. It was unknown if the reporter considered the arthritis aggravated to be related to Shingrix. It was unknown if the company considered the arthritis aggravated to be related to Shingrix. Additional Information: GSK Receipt Date: 20-MAR-2025 The patient called to inquire whether Shingrix can cause existing arthritis to worsen. He reported a history of arthritis including joint replacement surgeries on his knees bilaterally and his left hip. He stated that the arthritis pain in his left shoulder began to worsen around 1-Mar-2025 and gradually worsened since that date. The patient also had a shingles infection before he received the Shingrix vaccine, and waited until the vesicles were healed to get the vaccine. He refused to provide any additional information including his name, telephone and address and also refused to provide his initials and date of birth for this report. More
2835023 F 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
received her first dose of Shingrix in November 2022 and the second dose in October 2024; This non-s... received her first dose of Shingrix in November 2022 and the second dose in October 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in November 2022). In OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received her first dose of Shingrix in November 2022 and the second dose in October 2024). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 21-MAR-2025 The patient is the reporter. The patient received her first dose of Shingrix in November 2022 and the second dose in October 2024 which led to lengthening of vaccinations schedule. (Drug dose administration interval too long). More
2835024 M NJ 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Missed dose; This non-serious case was reported by a consumer via call center representative and des... Missed 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 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient had first dose 18 months ago). 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: Missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 21-MAR-2025 The patient received his first dose of Shingrix approximately 18 months ago and he has not yet had the 2nd dose. Till the time of reporting the patient did not received the second dose of Shingrix, which led to incomplete course of vaccination. More
2835025 47 F TX 04/09/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 4s5YG
Magnetic resonance imaging abnormal, Muscle rupture, Pain in extremity Magnetic resonance imaging abnormal, Muscle rupture, Pain in extremity
Torn muscle; Painful arm; This serious case was reported by a other health professional via call cen... Torn muscle; Painful arm; This serious case was reported by a other health professional via call center representative and described the occurrence of torn muscle in a 47-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4s5YG, expiry date 30-JUN-2025) for prophylaxis. On 16-DEC-2024, the patient received FluLaval 2024-2025 season (intramuscular). On 16-DEC-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced torn muscle (Verbatim: Torn muscle) (serious criteria GSK medically significant) and pain in arm (Verbatim: Painful arm). The outcome of the torn muscle and pain in arm were resolving. The reporter considered the torn muscle and pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The company considered the torn muscle to be unrelated to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The company considered the pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-MAR-2025 The patient received Flulaval vaccine and experienced pain in the left arm and magnetic resonance imaging showing a torn muscle.; Sender's Comments: Muscle rupture is an unlisted event which is considered unrelated to GSK vaccine FluLaval 2024-2025 season and FluLaval PRE-FILLED SYRINGE DEVICE. More
2835026 36 M IL 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 k4JH7
Underdose Underdose
administration of Engerix B -Pediatric instead of Engerix B- Adult; received administration of Enger... administration of Engerix B -Pediatric instead of Engerix B- Adult; received administration of Engerix B -Pediatric; This non-serious case was reported by a other health professional via sales rep and described the occurrence of adult use of a child product in a 36-year-old male patient who received HBV (Engerix B pediatric) (batch number k4JH7, expiry date 19-JUL-2026) for prophylaxis. On 14-MAR-2025, the patient received the 1st dose of Engerix B pediatric (left arm). On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administration of Engerix B -Pediatric instead of Engerix B- Adult) and underdose (Verbatim: received administration of Engerix B -Pediatric). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 24-MAR-2025 The reporter reported that the patient was an adult received administration of Engerix B -Pediatric instead of Engerix B- Adult, which led to adult use of a child product and underdose. More
2835027 F 04/09/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Dizziness, Erythema, Fatigue, Headache, Nausea; Pain in extremity, Skin warm Dizziness, Erythema, Fatigue, Headache, Nausea; Pain in extremity, Skin warm
arm had huge red and hot circle 4 inches plus in size; Nausea; tiredness; pain in arm; Headache is i... arm had huge red and hot circle 4 inches plus in size; Nausea; tiredness; pain in arm; Headache is intermittent; arm had huge red and hot circle 4 inches plus in size; dizziness; This non-serious case was reported by a consumer and described the occurrence of erythema in a 74-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (did not have any side effects with first Shingles shot). Concomitant products included tramadol hydrochloride (Tramadol), etodolac, lorazepam, estradiol benzoate (Estradiol) and Centrum Silver. On 19-MAR-2025 10:52, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced dizziness (Verbatim: dizziness). On 20-MAR-2025, the patient experienced erythema (Verbatim: arm had huge red and hot circle 4 inches plus in size), nausea (Verbatim: Nausea), tiredness (Verbatim: tiredness), pain in arm (Verbatim: pain in arm), intermittent headache (Verbatim: Headache is intermittent) and extremities hot feeling of (Verbatim: arm had huge red and hot circle 4 inches plus in size). The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). The outcome of the erythema, nausea, tiredness, pain in arm, intermittent headache and extremities hot feeling of were not resolved and the outcome of the dizziness was not reported. It was unknown if the reporter considered the erythema, nausea, tiredness, pain in arm, intermittent headache, extremities hot feeling of and dizziness to be related to Shingles vaccine. It was unknown if the company considered the erythema, nausea, tiredness, pain in arm, intermittent headache, extremities hot feeling of and dizziness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-MAR-2025 The patient was the reporter. The Shingles vaccine shot was administered at 10:52 Wednesday, 19th March 2025, symptoms became evident within a few hours, by Thursday 20th March 2025, the arm had very red, hot circle, which continued to grow throughout Thursday, Friday, Saturday, (it had grown to 4 inches from top to bottom) Sunday and today, Monday 24th March 2025. However it was getting lighter in color, it is growing to the underside of my arm, still painful. Headache was intermittent. Have been icing the site, alternating Advil and Tylenol for headache, and resting, also had dizziness. The patient also experienced the same thing with Covid shot. Did not have any side effects with first Shingles shot. The symptoms were not treated. More
2835029 M 04/09/2025 PPV
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Malaise, Pyrexia; Malaise, Pyrexia Malaise, Pyrexia; Malaise, Pyrexia
Low grade fever; felt a little ick; This non-serious case was reported by a consumer via sales rep a... Low grade fever; felt a little ick; This non-serious case was reported by a consumer via sales rep and described the occurrence of low grade fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine polysacch 23v (Pneumovax) for prophylaxis. On 08-MAR-2025, the patient received the 1st dose of Shingrix and Pneumovax. On 08-MAR-2025, 24 hrs after receiving Shingrix, the patient experienced low grade fever (Verbatim: Low grade fever) and feeling abnormal (Verbatim: felt a little ick). On 08-MAR-2025, the outcome of the low grade fever and feeling abnormal were resolved. The reporter considered the low grade fever and feeling abnormal to be related to Shingrix. The company considered the low grade fever and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 24-MAR-2025 This report was submitted via the online direct entry reporting system. Reporter shared that 24 hours after receiving Shingrix and Pneumovax he had a low grade fever and felt a little ick for 2 to 3 hours. The reporter considered the low grade fever and feeling abnormal to be related to Pneumovax. More
2835030 F 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3334Y
Herpes zoster Herpes zoster
Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles ... Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included metformin. On 13-MAR-2025, the patient received Shingrix. On 17-MAR-2025, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). 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: 24-MAR-2025 The reporter reported that the patient had received Shingrix vaccine and experienced shingles. The symptoms were treated. More
2835031 45 F TX 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 K4JH7
Underdose Underdose
Underdose; Engerix B pediatric dose was administered to an adult; This non-serious case was reported... Underdose; Engerix B pediatric dose was administered to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 45-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 17-MAR-2025, the patient received Engerix B pediatric. On 17-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Engerix B pediatric dose was administered to an adult). The outcome of the underdose and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-MAR-2025 The healthcare professional was the reporter. The reporter reported that on 17th march 2025 Engerix B pediatric dose was administered to a adult patient which led to underdose and adult use of a child product. More
2835032 57 F SC 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Nasopharyngitis, Pyrexia Nasopharyngitis, Pyrexia
Fever; Cold; This non-serious case was reported by a consumer via call center representative and des... Fever; Cold; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included cerebral palsy (Cerebral palsy consumer was wheelchair bound). Concomitant products included COVID-19 vaccine and Influenza vaccine (Flu vaccine VII). On 24-MAR-2025, the patient received Shingrix (left arm). In MAR-2025, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and cold (Verbatim: Cold). The outcome of the fever and cold were unknown. It was unknown if the reporter considered the fever and cold to be related to Shingrix. It was unknown if the company considered the fever and cold to be related to Shingrix. Additional Information: GSK receipt date: 25-MAR-2025 Reporter stated that patient received her first dose of Shingrix 24th March, 2025 in her left arm. Reporter stated consumer had a fever of 99.4 degrees Fahrenheit and was cold. The consumer had a diagnosis of cerebral palsy and is wheelchair bound (unknown date of diagnosis.) The consumer had 3 vaccines administered last week on unknown date and had a fever of 101.4 degrees Fahrenheit that resolved within a few days. Patient had COVID, flu and another vaccine (unknown name) administered at the same time last week. More
2835033 79 F CA 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 TS525
Injection site erythema, Injection site swelling, Injection site warmth, Pain, P... Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pain in extremity More
redness had spread down to elbow; Redness just below the injection site of the left arm; swollen jus... redness had spread down to elbow; Redness just below the injection site of the left arm; swollen just below the injection site of the left arm; warm just below the injection site of the left arm; usual soreness/ body aches; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number TS525, expiry date 10-MAR-2027) for prophylaxis. The patient's past medical history included polycythemia vera (had been controlled for 6-7 months). Previously administered products included Zostavax (received Zostavax about 10 years ago). Concurrent medical conditions included hypertension, cholesterol, osteoporosis and sleep disorder. Concomitant products included alprazolam (Xanax), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (Vitamins) and abaloparatide (Tymlos). On 21-MAR-2025, the patient received Shingrix (left arm). On 21-MAR-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). On 22-MAR-2025, the patient experienced general body pain (Verbatim: usual soreness/ body aches). On 23-MAR-2025, the patient experienced injection site erythema (Verbatim: Redness just below the injection site of the left arm), injection site swelling (Verbatim: swollen just below the injection site of the left arm) and injection site warmth (Verbatim: warm just below the injection site of the left arm). On 24-MAR-2025, the patient experienced erythema of extremities (Verbatim: redness had spread down to elbow). The action taken with Shingrix was unknown. On 22-MAR-2025, the outcome of the general body pain was resolved. The outcome of the injection site erythema, injection site swelling, injection site warmth, pain in arm and erythema of extremities were resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, general body pain, pain in arm and erythema of extremities to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, injection site warmth, general body pain, pain in arm and erythema of extremities to be related to Shingrix. Additional Information: GSK Receipt Date: 25-MAR-2025 and 26-MAR-2025 The patient was the reporter. The patient took medications for hypertension, Osteoporosis, and high cholesterol. The patient received the first dose of Shingrix on Friday afternoon on 21st march 2025. The next day, the patient experienced usual soreness and body aches. On Sunday, 23rd Match 2025, the patient noticed redness just below the injection site of the left arm, it was also swollen and warm, swelling had subsided but the redness remained although not as severe. Yesterday on Monday, 24th March 2025, the redness had spread down to her elbow, still a little sore. Today on 25th March 2025) the redness was barely visible. The patient received Zostavax about 10 years ago. More
2835034 F OK 04/09/2025 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; she was diagnosed with shingles she went to the emergency department ... Suspected Vaccination failure; she was diagnosed with shingles she went to the emergency department and currently experiencing another bout (4th breakout) of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female 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 (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, right arm). 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) and shingles (Verbatim: she was diagnosed with shingles she went to the emergency department and currently experiencing another bout (4th breakout) of shingles). 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: 25-MAR-2025 The patient self-reported this case. The patient completed the vaccination series of Shingrix vaccine and the first dose was administered some time after turning 50 years old and the second dose was administered 3 months later and since completion of vaccine series she had been diagnosed with shingles four times. The patient stated at the time of call to GSK she was currently experiencing another bout (4th breakout) of shingles. The shingles appeared on the right side of her bottom with each occurrence and the breakout lasts approximately a week or more. The patient first time she was diagnosed with shingles she went to the emergency department because she thought she had been bitten by a spider and was diagnosed and released from the emergency department. The patient had a questions whether the pharmacy administered Shingrix because she did not see the vial(s) the medication came from only a syringe filled with liquid. The patient provided vaccinating pharmacy information so lot numbers could be obtained. The patient did not had pictures that she could provide of her shingles breakout. This case was considered as suspected vaccination failure since the details regarding the 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 Shingrix (Dose 1 & 2). More
2835035 76 F CA 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 52F7M
Herpes zoster Herpes zoster
Shingles; This non-serious case was reported by a consumer via call center representative and descri... Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 52F7M) for prophylaxis. On 14-DEC-2024, the patient received the 1st dose of Shingrix. On 14-DEC-2024, less than a day after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was 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 : 25-MAR-2025 Patient took 1st dose of Shingrix and experienced shingles. More
2835036 NJ 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Abdominal discomfort Abdominal discomfort
upset stomach; This non-serious case was reported by a other health professional via sales rep and d... upset stomach; This non-serious case was reported by a other health professional via sales rep and described the occurrence of upset stomach in an specified number of patients 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 upset stomach (Verbatim: upset stomach). The outcome of the upset stomach was unknown. It was unknown if the reporter considered the upset stomach to be related to Shingrix. It was unknown if the company considered the upset stomach to be related to Shingrix. Additional Information: GSK Receipt Date: 25-MAR-2025 Reporter stated that two patients experienced upset stomach after first dose of Shingrix. Age or gender was not specified. More
2835037 F VT 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza Influenza
I had like flu symptoms; This non-serious case was reported by a consumer via call center representa... I had like flu symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included COVID-19 vaccine (had to get the Covid vaccine). In SEP-2019, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: I had like flu symptoms). The outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms to be related to Shingrix. Additional Information: GSK receipt date: 26-MAR-2025 The patient self-reported this case for herself. She received the 1st dose of Shingrix in September 2019 and had not received the 2nd dose yet. The patient reported for some reason the vaccine was not available at the time. She received the 1st dose at a local pharmacy. The patient reported that after that she had to get the Covid vaccine and forgot all about the 2nd dose of Shingrix. The patient inquired when should she get the 2nd dose. The patient reported that she had like flu symptoms with the 1st dose of Shingrix. The patient did not provide additional medical history or medications information. More
2835038 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site reaction Injection site reaction
Injection site reaction; This non-serious case was reported by a pharmacist via sales rep and descri... Injection site reaction; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site reaction in a unspecified number of patients 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 injection site reaction (Verbatim: Injection site reaction). The outcome of the injection site reaction was resolved. The reporter considered the injection site reaction to be related to Shingrix. The company considered the injection site reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 26-MAR-2025 Pharmacist reported that patients occasionally reported injection site reactions with Shingrix. More
2835039 M 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal Feeling abnormal
Felt like crap for a few days; This non-serious case was reported by a pharmacist via sales rep and ... Felt like crap for a few days; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of feeling abnormal in a 50-year-old male 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 feeling abnormal (Verbatim: Felt like crap for a few days). The outcome of the feeling abnormal was resolved. The reporter considered the feeling abnormal to be related to Shingrix. The company considered the feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 26-MAR-2025 The reporter reported that although patient felt like crap for a few days after the first Shingrix vaccination, he returned for the second vaccination. More
2835041 50 F MA 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Acne, Rash Acne, Rash
had tiny pimples all over cheeks; rash on her face; This non-serious case was reported by a consumer... had tiny pimples all over cheeks; rash on her face; This non-serious case was reported by a consumer via call center representative and described the occurrence of pimples in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included upper respiratory tract infection. Concomitant products included metoprolol and doxycycline. On 25-MAR-2025, the patient received the 1st dose of Shingrix. In MAR-2025, less than a day after receiving Shingrix, the patient experienced pimples (Verbatim: had tiny pimples all over cheeks) and rash (Verbatim: rash on her face). The outcome of the pimples and rash were resolving. It was unknown if the reporter considered the pimples and rash to be related to Shingrix. It was unknown if the company considered the pimples and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 27-Mar-2025 The reporter was the patient who received her first dose of Shingrix on Monday, 25 March 2025. She states that she developed a rash on her face the same night and it was as she had tiny pimples all over my cheeks. These were on both sides of her face. Symptoms had gotten better after use of an antihistamine recommended by her doctor. She also stated that she finished a dose of doxycycline a couple days ago for an upper respiratory infection developed prior to the dose. More
2835042 M NC 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never went back to receive the 2nd dose; This non-serious case was reported by a consumer via call c... never went back to receive the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix (Intramuscular) on 05-JAN-2021). 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: never went back to receive the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 27-MAR-2025 The reporter stated that he received his 1st dose of Shingrix and never went back to receive the 2nd dose Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been link with US2025037146, reported by the same reporter.; Sender's Comments: US-GSK-US2025037146:Same reporter/Different patient More
2835043 F NC 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not received the 2nd dose; This non-serious case was reported by a consumer via call center repr... did not received the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix (Intramuscular) on 05-JAN-2021). 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: did not received the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 27-MAR-2025 The reporter was the spouse of the patient who stated his wife received her 1st dose of Shingrix and never received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been link with US2025037142, reported by the same reporter.; Sender's Comments: US-GSK-US2025037142:Same reporter/Different patient More
2835044 M MN 04/09/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 3E99M
Incorrect route of product administration Incorrect route of product administration
of suspect vaccine subcutaneously instead of intramuscularly; This non-serious case was reported by ... of suspect vaccine subcutaneously instead of intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3E99M, expiry date 31-DEC-2025) for prophylaxis. On an unknown date, the patient received the 1st dose of Menveo (subcutaneous, left deltoid) .5 ml. On an unknown date, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: of suspect vaccine subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 The reporter was the healthcare professional calling from a facility to get further guidance from MI. The reporter stated that a minor child received first dose of suspect vaccine subcutaneously instead of intramuscularly in his left lower deltoid which led to intramuscular formulation administered by other route. The reporter did not provide the date that the vaccine was given. More
2835045 67 M IA 04/09/2025 COVID19
FLUX
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes z... Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure More
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via call cente... Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis. In APR-2023, the patient received the 2nd dose of Shingrix (left arm). In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On 27-OCT-2024, the patient received Influenza vaccine (left arm). In NOV-2024, the patient received COVID-19 vaccine (right arm). In OCT-2024, less 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: Shingles). The patient was treated with prednisone acetate (Prednisone). 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: 27-MAR-2025 The patient reported he received SHINGRIX dose 1 in Jan 2023 and dose 2 in April 2023 in the left arm. He stated on 27 October 2024, He received the regular flu shot (no name) in left arm. Had Covid shot in right arm in Nov 2024. He states he experienced itchy rash bumps (10 to 20) in a band/line, on front of left shoulder since October 2024. He was diagnosed with shingles and thinks SHINGRIX did not work for him. He stated a week later Nov 2024 he received the COVID shot in right arm. He still had not fully recovered from shingles. He stated he was given medicines like prednisone pills, prednisone shot, a cream for the itch and a gel that had silver in it, he purchased for the rash. Medical disclaimer provided. This case was considered as suspected vaccination failure as details regarding completion of laboratory confirmation regarding shingles were unknown at the time of reporting. It was unknown if the reporter considered the vaccination failure and shingles to be related to Flu vaccine and Covid-19 vaccine.; 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 & 2). More
2835046 64 M IL 04/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Inappropriate schedule of product administration, Rash; Inappropriate schedule o... Inappropriate schedule of product administration, Rash; Inappropriate schedule of product administration, Rash More
rash; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consum... rash; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 24-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash (Verbatim: rash) and incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the rash was not resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK receipt date: 27-APR-2025 Consumer was the reporter, stated that he received his first dose of Shingrix on 24th August 2024 in the left arm. Consumer forgot to get his second dose of Shingrix in the recommended interval of 2 to 6 Months. Consumer stated he will have the second dose administered this week. Consumer stated that he broke out in a rash on the back of one leg and went to urgent care and Shingles was ruled out by the doctor. Consumer stated now the rash has spread to the other leg and was on both front and back of legs. Consumer stated the vaccine was administered at Pharmacy. No further information was provided. More
2835047 19 F FL 04/09/2025 HEP
HEP
HEP
HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 CT3Z7
CT3Z7
CT3Z7
UNK
UNK
UNK
Antinuclear antibody increased, Arthralgia, Blood potassium increased, Condition... Antinuclear antibody increased, Arthralgia, Blood potassium increased, Condition aggravated, Eosinophil count increased; Incomplete course of vaccination, Incorrect route of product administration, Paraesthesia, Peripheral swelling, Product administered at inappropriate site; Rash, Rash erythematous, Rheumatoid arthritis, Rheumatoid factor positive; Antinuclear antibody increased, Arthralgia, Blood potassium increased, Condition aggravated, Eosinophil count increased; Incomplete course of vaccination, Incorrect route of product administration, Paraesthesia, Peripheral swelling, Product administered at inappropriate site; Rash, Rash erythematous, Rheumatoid arthritis, Rheumatoid factor positive More
Rheumatoid Arthritis also came back abnormal; the patient began to experience a rash; tingling, pins... Rheumatoid Arthritis also came back abnormal; the patient began to experience a rash; tingling, pins and needles, paresthesia; joint pain in the knees, ankles, wrists; redness; Swelling; Potassium level was elevated; ANA panel came back abnormal; Eosinophils were elevated; The patient has not had further doses of ENGERIX-B; The patient received ENGERIX B ID in the left forearm; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 19-year-old female patient who received HBV (Engerix B adult) (batch number CT3Z7) for prophylaxis. Co-suspect products included HBV (Engerix B adult) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 06-NOV-2024, the patient received the 1st dose of Engerix B adult (intradermal, left arm). On an unknown date, the patient received the 2nd dose of Engerix B adult. On 06-NOV-2024, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B adult, the patient experienced wrong route of administration (Verbatim: The patient received ENGERIX B ID in the left forearm). On an unknown date, the patient experienced rheumatoid arthritis (Verbatim: Rheumatoid Arthritis also came back abnormal) (serious criteria GSK medically significant), rash (Verbatim: the patient began to experience a rash), tingling (Verbatim: tingling, pins and needles, paresthesia), knee pain (Verbatim: joint pain in the knees, ankles, wrists), erythema (Verbatim: redness), swelling (Verbatim: Swelling), potassium increased (Verbatim: Potassium level was elevated), antinuclear antibody (Verbatim: ANA panel came back abnormal), eosinophil count increased (Verbatim: Eosinophils were elevated) and incomplete course of vaccination (Verbatim: The patient has not had further doses of ENGERIX-B). The patient was treated with prednisone. On 06-NOV-2024, the outcome of the wrong route of administration was not applicable. The outcome of the rheumatoid arthritis was not reported and the outcome of the rash, tingling, knee pain, erythema and swelling were not resolved and the outcome of the potassium increased, antinuclear antibody and eosinophil count increased were unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the rheumatoid arthritis, rash, tingling, knee pain, erythema, swelling, potassium increased, antinuclear antibody and eosinophil count increased to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device. The company considered the rheumatoid arthritis to be unrelated to Engerix B adult and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the rash, tingling, knee pain, erythema, swelling, potassium increased, antinuclear antibody and eosinophil count increased to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 27-MAR-2025 The reporter was the mother of the patient. The patient received the first dose of Engerix b on November 6, 2024. The patient received Engerix b intradermal (ID) in the left forearm which led to wrong route of administration. The patient began to experienced a rash (the rash was redness and was not raised) and tingling, pins and needles, paresthesia, in the fingers on both hands. The patient also experienced joint pain in the knees, ankles, wrists. The redness, swelling, and tingling in the patient's fingers comes and goes, but seems to be more persistent lately. The joint pain was primarily in the wrist at this time. The patient had been treated with prednisone and an antihistamine. The patient had an Antinuclear antibody (ANA) done in December 2024 or January 2025. The Antinuclear antibody (ANA) was negative, but the Potassium level was elevated and the Absolute Eosinophils were elevated. The patient had blood work repeated about one month ago in which the Antinuclear antibody (ANA) panel came back abnormal and lab work for Rheumatoid Arthritis also came back abnormal. The patient was scheduled to see a Rheumatologist in April. The patient had not had further doses of Engerix b. Till the time of reporting, the patient did not receive 2nd dose of engerix b, which led to incomplete course of vaccination.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK vaccine Engerix B adult and Engerix B PRE-FILLED SYRINGE DEVICE . More
2835048 45 F 04/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Burning sensation, Dizziness, Dyspnoea, Dysstasia, Flatulence; Nausea, Pyrexia, ... Burning sensation, Dizziness, Dyspnoea, Dysstasia, Flatulence; Nausea, Pyrexia, Vertigo, Visual impairment More
Nausea; Vertigo dizziness; Gas in stomach; Fever chills; Unable stand up; Labored breathing; Burning... Nausea; Vertigo dizziness; Gas in stomach; Fever chills; Unable stand up; Labored breathing; Burning neck; Vision abnormal; This non-serious case was reported by a consumer and described the occurrence of nausea in a 45-year-old female patient who received Herpes zoster (Shingrix) (expiry date MAR-2025) for prophylaxis. The patient's past medical history included meningitis, encephalitis, seizure, stroke and transient ischemic attack. Concurrent medical conditions included sleep disturbance, diabetes, systemic lupus erythematosus, rheumatoid arthritis and balance difficulty. Concomitant products included zolpidem. On 27-MAR-2025, the patient received Shingrix. On 27-MAR-2025, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), vertigo (Verbatim: Vertigo dizziness), gas in stomach (Verbatim: Gas in stomach), fever chills (Verbatim: Fever chills), difficulty in standing (Verbatim: Unable stand up), labored breathing (Verbatim: Labored breathing), burning sensation (Verbatim: Burning neck) and abnormal vision (Verbatim: Vision abnormal). The outcome of the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision were not resolved. It was unknown if the reporter considered the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision to be related to Shingrix. It was unknown if the company considered the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision to be related to Shingrix. Additional Information: GSK Receipt Date: 28-MAR-2025 The patient self reported this case for herself. Patient was a woman with diabetes and some autoimmune conditions that physicians were still investigating, which were connected to lupus and rheumatoid arthritis. In the past, patient had experienced serious health issues, including meningitis, encephalitis, seizures, and a stroke at the age of six. More recently, she had a transient ischemic attack (TIA) in 2020 and had been dealing with balance problems. Symptoms of Fever chills were treated. More
2835049 65 M NJ 04/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Condition aggravated, Tinnitus Condition aggravated, Tinnitus
his Tennitus has gotten worse; This non-serious case was reported by a consumer via call center repr... his Tennitus has gotten worse; This non-serious case was reported by a consumer via call center representative and described the occurrence of tinnitus aggravated in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included arthritis (Arthritis), anxiety (Anxiety) and tinnitus (on his left ear). Concomitant products included omeprazole (Prilosec), gabapentin and mirtazapine (Remeron). On 19-MAR-2025, the patient received Arexvy. On 20-MAR-2025, 1 days after receiving Arexvy, the patient experienced tinnitus aggravated (Verbatim: his Tennitus has gotten worse). The outcome of the tinnitus aggravated was not resolved. It was unknown if the reporter considered the tinnitus aggravated to be related to Arexvy. It was unknown if the company considered the tinnitus aggravated to be related to Arexvy. Additional Information: GSK Receipt Date: 28-MAR-2025 The patient has a history of Tinnitus on his left ear. Patient reports that he received Arexvy on 3/19/2025. Since receiving the vaccine, his Tinnitus has gotten worse. More
2835050 M OH 04/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
the patient received a total of 0.94 ml of Shingrix on a single day; received 0.44 ml; This non-seri... the patient received a total of 0.94 ml of Shingrix on a single day; received 0.44 ml; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a male 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 .5 ml and the 1st dose of Shingrix .44 ml. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced overdose (Verbatim: the patient received a total of 0.94 ml of Shingrix on a single day) and incomplete dose administered (Verbatim: received 0.44 ml). The outcome of the overdose and incomplete dose administered were not applicable. Additional Information: GSK Receipt Date: 28-MAR-2025 The pharmacist reported that what was the next steps if a patient only received 0.44 milliliter of the first dose, which led to incomplete dose administered. The product was then identified as Shingrix. She was driving at the time of the outbound call and therefore did not have the access to the patient's date of birth or other information such as the lot number. She stated that he did some research on center of disease control website and immunization organization which indicated that the dose should be re administered thus she called the patient back to the pharmacy and administer 0.5 milliliter. Therefore, the patient received a total of 0.94 milliliter of Shingrix on a single day, which led to overdose. No further information available. Pharmacist was aware that safety may follow up with her to collect more details. More
2835051 F CA 04/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 A274J
Injection site mass Injection site mass
develop a BB like bump on the injection site; This non-serious case was reported by a other health p... develop a BB like bump on the injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number A274J) for prophylaxis. On 03-MAR-2025, the patient received the 1st dose of Bexsero (right arm). On 03-MAR-2025, less than a day after receiving Bexsero, the patient experienced injection site swelling (Verbatim: develop a BB like bump on the injection site). The outcome of the injection site swelling was resolving. The reporter considered the injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-MAR-2025 The mother of patient was a Medical Assistant. The patient had small BB like bump at the injection site and was reported as worsened. It had gone down a little but the bump still was there. More
2835052 TX 04/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
the other only received the liquid adjuvant; the other only received the liquid adjuvant; This non-s... the other only received the liquid adjuvant; the other only received the liquid adjuvant; This non-serious case was reported by a nurse via patient support programs and described the occurrence of inappropriate preparation of medication in a adult patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 28-MAR-2025, the patient received the 1st dose of Arexvy. On 28-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: the other only received the liquid adjuvant) and inappropriate dose of vaccine administered (Verbatim: the other only received the liquid adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-MAR-2025 The two older adult patients was vaccinated with first dose of Arexvy vaccine, one with mixed components and the other only received the liquid adjuvant. The clinic was unsure which patient received the full dose and which patient received partial dose. The patients were a married couple. The Medical Assistant in the clinic administered a correct dose of Arexvy for one patient and the other only received the adjuvant liquid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2835053 78 F MS 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 X3M3D
Incorrect route of product administration Incorrect route of product administration
a patient received Priorix intramuscular instead of subcutaneously; Priorix received to patient 78 y... a patient received Priorix intramuscular instead of subcutaneously; Priorix received to patient 78 year old; 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 a 78-year-old female patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis. On 27-MAR-2025, the patient received Priorix (intramuscular, left arm) .5 ml. On 27-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: a patient received Priorix intramuscular instead of subcutaneously) and inappropriate age at vaccine administration (Verbatim: Priorix received to patient 78 year old). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration 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: 31-MAR-2025 On 27 MAR 2025, a patient received Priorix intramuscularly instead of subcutaneously which led to Subcutaneous injection formulation administered by other route. The patient was 78 year old female and received Priorix which led to Inappropriate age at vaccine administration. More
2835054 F 04/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 XX9N4
Incorrect route of product administration Incorrect route of product administration
patient received Priorix by the intramuscular route instead of subcutaneously; Adult patient receive... patient received Priorix by the intramuscular route instead of subcutaneously; Adult patient received priorix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a adult female patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis. On 29-MAR-2025, the patient received Priorix (intramuscular). On 29-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient received Priorix by the intramuscular route instead of subcutaneously) and inappropriate age at vaccine administration (Verbatim: Adult patient received priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration 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: 31-MAR-2025 The patient self reported this case for herself. An adult female patient received Priorix on 29th March 2025 by the intramuscular route instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route and Inappropriate age at vaccine administration. More
2835055 8 F FL 04/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
Extra dose administered; This non-serious case was reported by a other health professional via call ... Extra dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-year-old female patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received the 1st dose of Havrix on unknown date) and Havrix (received the 2nd dose of Havrix on unknown date). On 31-MAR-2025, the patient received the 3rd dose of Havrix. On 31-MAR-2025, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 31-MAR-2025 The Healthcare professional reported that a third Havrix dose was administered on the day of reporting to an 8 year old female patient, which led to extra dose administered. More
2835056 F FL 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Paraesthesia Paraesthesia
Tingling fingers; This non-serious case was reported by a physician via sales rep and described the ... Tingling fingers; This non-serious case was reported by a physician via sales rep and described the occurrence of tingling of extremity in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (right deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: Tingling fingers). The outcome of the tingling of extremity was resolved. The reporter considered the tingling of extremity to be related to Shingrix. The company considered the tingling of extremity to be related to Shingrix. Additional Information: GSK Receipt Date: 31-MAR-2025 The patient received a dose of Shingrix and experienced tingling fingers which was not serious. No other products were received by the patient. More
2835057 M 04/09/2025 RVX
 UNKNOWN MANUFACTURER
 PK9C5
Arthralgia, Incorrect dose administered Arthralgia, Incorrect dose administered
Arthralgia; 1ml RSV vaccine was given; This non-serious case was reported by a consumer and describe... Arthralgia; 1ml RSV vaccine was given; This non-serious case was reported by a consumer and described the occurrence of arthralgia in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number PK9C5) for prophylaxis. Concurrent medical conditions included diabetes and colitis. Concomitant products included azathioprine (Imuran), metformin hydrochloride (Medformin), atorvastatin calcium (Lipitor), balsalazide, mirabegron and esomeprazole. On 16-NOV-2024, the patient received RSV vaccine 1 ml. On 16-NOV-2024, an unknown time after receiving RSV vaccine, the patient experienced overdose (Verbatim: 1ml RSV vaccine was given). On 20-NOV-2024, the patient experienced arthralgia (Verbatim: Arthralgia). The outcome of the arthralgia was not resolved and the outcome of the overdose was not applicable. It was unknown if the reporter considered the arthralgia to be related to RSV vaccine. It was unknown if the company considered the arthralgia to be related to RSV vaccine. Additional Information: GSK Receipt Date: 01-APR-2025 Consumer reported that he took the RSV vaccine and experienced arthralgia. Patient received 1ml of RSV vaccine which led to overdose. More
2835058 52 F 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
Patient had several cases of shingles, then got first vaccine and then got shingles again before sec... Patient had several cases of shingles, then got first vaccine and then got shingles again before second dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Patient had several cases of shingles). On 01-JUN-2024, the patient received the 1st dose of Shingles vaccine (left deltoid). On 09-SEP-2024, 100 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Patient had several cases of shingles, then got first vaccine and then got shingles again before second dose). The outcome of the shingles was resolved. The reporter considered the shingles to be unrelated to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date : 01-APR-2025 Patient had several cases of shingles, then got first vaccine and then got shingles again before second dose. More
2835059 F 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain, Pain in extremity Pain, Pain in extremity
Arm pain after shot for 6 days; Body aches the first 24 hours; This non-serious case was reported by... Arm pain after shot for 6 days; Body aches the first 24 hours; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28-MAR-2025, the patient received Shingrix (left deltoid). On 28-MAR-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm pain after shot for 6 days) and general body pain (Verbatim: Body aches the first 24 hours). On 03-APR-2025, the outcome of the pain in arm was resolved (duration 6 days). The outcome of the general body pain was resolved (duration 24 hrs). The reporter considered the pain in arm and general body pain to be related to Shingrix. The company considered the pain in arm and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The reporter reported that the patient received a subsequent dose of Shingrix vaccine and experienced sore arm and body aches and had arm pain after shot for 6 days and the body aches for the first 24 hours More
2835060 77 M 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
swelling at injection site; redness at the injections site; pain at the injection site; This non-ser... swelling at injection site; redness at the injections site; pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 17-MAR-2025, the patient received the 1st dose of Shingrix (left arm). On 17-MAR-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injections site) and injection site pain (Verbatim: pain at the injection site). On 17-MAR-2025, the patient experienced injection site swelling (Verbatim: swelling at injection site). On 20-MAR-2023, the outcome of the injection site erythema and injection site pain were resolved (duration 3 days). On 20-MAR-2025, the outcome of the injection site swelling was resolved (duration 3 days). It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix. Additional Information: GSK receipt date: 03-APR-2025 The patient reported that after receiving the 1st dose of Shingrix vaccine he experienced pain, swelling, redness at the injection site for 4 days then was completely recovered. The batch number and expiry date of Shingles vaccine were unknown. More
2835061 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
If I didn't get a second shingrix vaccine (it's been 2 years); This non-serious case was r... If I didn't get a second shingrix vaccine (it's been 2 years); 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 (Shingrix) for prophylaxis. Previously administered products included Shingrix (On an unknown date, the patient received 1st dose). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: If I didn't get a second shingrix vaccine (it's been 2 years)). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 18-MAR-2025 The reporter asked if the he/she didn't get a second Shingrix vaccine (it's been 2 years) should he/she start over and get two with appropriate time between the two. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. More
2835062 04/09/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Nerve injury, Ophthalmic herpes zoster, Pain, Temperature intoler... Herpes zoster, Nerve injury, Ophthalmic herpes zoster, Pain, Temperature intolerance; Vaccination failure More
Still have horrible nerve damage in my eye forehead, ear, side to center of skull; hard to deal with... Still have horrible nerve damage in my eye forehead, ear, side to center of skull; hard to deal with the heat; Suspected Vaccination failure; got the worse case shingles the right side of my head the whole quarter from my eye all the way back; 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. The patient's past medical history included shingles (several times, usually just a little patch on neck or shoulder), back pain (bit of pain in back) and shoulder pain (bit of pain in back up to shoulder). On an unknown date, the patient received Shingles vaccine. On 26-NOV-2024, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the worse case shingles the right side of my head the whole quarter from my eye all the way back). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Still have horrible nerve damage in my eye forehead, ear, side to center of skull) and skin warm (Verbatim: hard to deal with the heat). The outcome of the vaccination failure, shingles and skin warm were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and skin warm 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, post herpetic neuralgia and skin warm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles several times, usually just a little patch on neck or shoulder and the patient could always felt them coming on with a bit of pain in his/her back up to shoulder. Then the patient got the vaccine a couple years ago and got the worse case of shingles and that had been a nightmare and the right side of head the whole quarter from eye all the way back. The patient still had horrible nerve damage in his/her eye, forehead, ear, side to center of skull and felt like a little guy in there with a pick axe trying to get out. It was very hard to deal with the heat and the pain and had been 4 months and still in pain. Nothing helped and stated he/she wouldn't wish this on anyone. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2835063 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
3 years since i got the first, can i go ahead now and get the second shot; This non-serious case was... 3 years since i got the first, can i go ahead now and get the second shot; 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 (Shingrix) for prophylaxis. Previously administered products included Shingrix (received the 1st dose of Shingrix 3 years ago). 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: 3 years since i got the first, can i go ahead now and get the second shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 19-MAR-2025 The reporter reported that it had been 3 years since got the first, could he/she go ahead now and get the second shot or do need to start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835064 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
What if i miss my second dose of shingrix, can i still get it; This non-serious case was reported by... What if i miss my second dose of shingrix, can i still get it; 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 (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). 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: What if i miss my second dose of shingrix, can i still get it). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 19-MAR-2025 The case was received from the patient via (Shingrix GSK) The reporter asked what if he/she miss his/her second dose of Shingrix, could he/she still get it. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination. More
2835065 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Oral herpes Oral herpes
broke out in cold sores; This non-serious case was reported by a consumer via interactive digital me... broke out in cold sores; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold sores in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, 24 hrs after receiving Shingles vaccine, the patient experienced cold sores (Verbatim: broke out in cold sores). The outcome of the cold sores was not reported. It was unknown if the reporter considered the cold sores to be related to Shingles vaccine. It was unknown if the company considered the cold sores to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the 2nd vaccine 2 days ago in March 2025 and broke out in cold sores within 24 hours. Patient was glad that the patient got the vaccine, but someone was the first person that has mentioned this side effect that patient could find. More
2835066 04/09/2025 FLUX
VARZOS
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Bedridden, Chills, Headache, Malaise, Pyrexia; Bedridden, Chills, Headache, Mala... Bedridden, Chills, Headache, Malaise, Pyrexia; Bedridden, Chills, Headache, Malaise, Pyrexia More
feeling the worst; severe chills; Within a few hours I had a horrible headache; Fever; bedridden; Th... feeling the worst; severe chills; Within a few hours I had a horrible headache; Fever; bedridden; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine. In MAR-2025, less than a week after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced chills (Verbatim: severe chills), headache (Verbatim: Within a few hours I had a horrible headache) and fever (Verbatim: Fever). On an unknown date, the patient experienced bedridden (Verbatim: bedridden) and feeling abnormal (Verbatim: feeling the worst). The outcome of the chills, headache, fever and feeling abnormal were not reported and the outcome of the bedridden was resolved (duration 3 days). It was unknown if the reporter considered the chills, headache, fever, bedridden and feeling abnormal to be related to Shingrix. It was unknown if the company considered the chills, headache, fever, bedridden and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter reported that two dose Shingrix vaccine was in short supply here when it was first introduced. The reporter knew he/she wanted to get protected b/c he/she had heard so many stories about how painful shingles was. The reporter was in and happened to notice a sign at the pharmacy announcing they had the Shingrix vaccine in stock. The patient spoke with the pharmacist and told him the reporter was planning to get the flu shot the next day. The reporter asked him if he/she take the first Shingrix vaccine today and the flu shot tomorrow would that cause problems for the reporter. He said it would be fine, so reporter took the shot. The next day at the reporter told the nurse he/she had just had the first Shingrix shot the previous day and asked if the reporter should wait to get a flu shot. She told me it would be fine to take the flu shot now, so the reporter did. The reporter should have listened to his/her gut instead of the two professionals. Within a few hours the reporter had a horrible headache then severe chills. The reporter spent the next three days in bed, feeling the worst the reporter had ever felt. The reporter had fever reached 103๏ฟฝ. So a word to the wise, did not make the same mistake reporter did. More
2835067 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
Pain; This non-serious case was reported by a consumer via interactive digital media and described t... Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included pain (Pain was excruciating). Previously administered products included Covid-19 vaccine with an associated reaction of herpes zoster. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient got 1 month after second shot of first Covid vaccine. Got 3 in a row. Out of work more than a month. Pain was excruciating. Right after patient healed got the vaccine. Knock on wood nothing since, sounds like had the same pain but different reasons for getting it. More
2835068 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
first shingrix shot in 2021 but didn't get the second one until 2024; This non-serious case was... first shingrix shot in 2021 but didn't get the second one until 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021). 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: first shingrix shot in 2021 but didn't get the second one until 2024). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 24-MAR-2025 The patient had a chat with that GlaxoSmithKline chat bot. The patient had a questioned regarding Shingrix vaccine. The chatbot replay to visitor the GlaxoSmithKline makes medicines and vaccines that need a prescription they cannot give medical advice it was important to talk with doctor or other healthcare provider for guidance based on your medical history. The patient talked chat specialist pharmacist. The patient stated that he/she had received first Shingrix shot in 2021 but did not get the second one until 2024. The chat specialist replay to the visitor that the GlaxoSmithKline was very interested in learning more about this potential adverse event and comments will be forwarded to our safety department, who may contact you for additional information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835069 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain, Pyrexia Pain, Pyrexia
The new vaccine caused me some aches and fever; The new vaccine caused me some aches; This non-serio... The new vaccine caused me some aches and fever; The new vaccine caused me some aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever (Verbatim: The new vaccine caused me some aches and fever) and pain (Verbatim: The new vaccine caused me some aches). The outcome of the fever and pain were resolved. It was unknown if the reporter considered the fever and pain to be related to Shingles vaccine. It was unknown if the company considered the fever and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that it was up to you, since Shingles was not contagious, without direct contact to the fluids. If you have not had chicken pox, you were probably good, but 1 in 3 people get shingles and your chances increase as you get older. The new vaccine caused the reporter some aches and fever for a few hours but he/she would do it again anytime. Even a mild case of shingles was horrid. More
2835070 04/09/2025 PPV
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Erythema, Pain; Erythema, Pain Erythema, Pain; Erythema, Pain
I am still red; I amd still red and hurting; This non-serious case was reported by a consumer via in... I am still red; I amd still red and hurting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. In MAR-2025, the patient received Shingles vaccine. On an unknown date, the patient received Pneumococcal vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced erythema (Verbatim: I am still red) and pain (Verbatim: I amd still red and hurting). The outcome of the erythema and pain were not resolved. It was unknown if the reporter considered the erythema and pain to be related to Shingles vaccine. It was unknown if the company considered the erythema and pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-MAR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got shot last Tuesday along with the pneumonia shot in the same arm and I am still red and hurting. Better than getting the sicknesses but patient was not expecting such reaction. It was reported that the patient suffered from pneumonia after receiving pneumonia vaccine. It was unknown if the reporter considered the adverse events to be related to pneumonia vaccine. More
2835071 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Ophthalmic herpes zoster, Pain, Vaccination failure Ophthalmic herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; still got the shingles/had them on my eye my eye; This serious case w... Suspected vaccination failure; still got the shingles/had them on my eye my eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: still got the shingles/had them on my eye my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 22-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shot for the shingles and still got the shingles and they did hurt, had them on the eye and eye still bothers. 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. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
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