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
2838909 50 M DC 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 47N3Y
Product storage error Product storage error
Maladministration of Shingrix after a temperature excursion; This non-serious case was reported by a... Maladministration of Shingrix after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 47N3Y, expiry date 20-MAR-2027) for prophylaxis. On 22-APR-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Maladministration of Shingrix after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 24-APR-2025 The Shingrix was exposed to -8C for 6 hours on 22nd April 2025. After this temperature excursion, Shingrix was administered to a patient, which led to incorrect storage of drug. The reporter consented to follow up. More
2838910 2 M UT 04/30/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 l5229
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
accidental administration of Boostrix instead of Infanrix; accidental administration of Boostrix; ac... accidental administration of Boostrix instead of Infanrix; accidental administration of Boostrix; accidental administration of Boostrix to 2 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number l5229, expiry date 19-APR-2027) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Dtap vaccine (received 3 doses of Dtap series on an unknown date). On 24-APR-2025, the patient received Boostrix. On an unknown date, the patient received Infanrix. On 24-APR-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: accidental administration of Boostrix instead of Infanrix), accidental underdose (Verbatim: accidental administration of Boostrix) and inappropriate age at vaccine administration (Verbatim: accidental administration of Boostrix to 2 year old). The outcome of the wrong vaccine administered, accidental underdose 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: 24-APR-2025 A registered nurse called in to request data about the accidental administration of Boostrix instead of Infanrix as the fourth dose in the Dtap series for a patient, which led to wrong vaccine administered, accidental underdose and inappropriate age at vaccine administration. First the requested safety data and then they requested recommendations. The vaccine administration facility was the same as primary reporter. More
2838911 110 F MO 04/30/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 34mf9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
10 year-old female patient that on 4/17/2025 received Kinrix; This non-serious case was reported by ... 10 year-old female patient that on 4/17/2025 received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis. Concomitant products included Proquad and Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 17-APR-2025, the patient received Kinrix. On 17-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 10 year-old female patient that on 4/17/2025 received Kinrix). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-APR-2025 Medical Assistant had a 10 year-old patient that received Kinrix , which led to inappropriate age at vaccine administration. The patient also received Proquad and Engerix-B. There was no vaccination records. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. More
2838912 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult p... Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transfers a pharmacy technician that calls to asked about dosage/schedule for ten adult's patients that were maladministered with pediatric doses of the Havrix vaccine. The reporter reported that the adult patient received pediatric dose which led to, adult use of a child product and accidental underdose. The reporter had a questioned was there any guidance/advice on this situation or no vaccination date, vaccine detail or patient demographics detail was provided from the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient More
2838913 M TX 04/30/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2443
Inappropriate schedule of product administration Inappropriate schedule of product administration
late second dose of Twinrix was administered; This non-serious case was reported by a other health p... late second dose of Twinrix was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis. Previously administered products included Twinrix (Patient received first dose on 12-JUL-2024). On 25-APR-2025, the patient received the 2nd dose of Twinrix. On 25-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose of Twinrix was administered). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-APR-2025 Pharmacist reported that a late second dose of Twinrix was administered to a patient. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2838914 70 F 04/30/2025 COVID19
 MODERNA
 3030373
COVID-19, Drug ineffective, Interchange of vaccine products, Smear test COVID-19, Drug ineffective, Interchange of vaccine products, Smear test
The patient had COVID; Have COVID; Interchange of vaccine products; This spontaneous case was report... The patient had COVID; Have COVID; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient had COVID), DRUG INEFFECTIVE (Have COVID) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030373) for COVID-19 immunisation. Previously administered products included for Immunisation: FLU VACCINE VII (Lot: 1204201, Dose number -Uknown, single shot, Patient was 62-year-old) on 10-Sep-2012, Pneumococcal vaccine (As dose 2) on 07-Dec-2022, FLU VACCINE VII on 11-Sep-2023, Zoster (dose 1, single) on 03-Oct-2023, Zoster (dose 2 and single) on 03-Dec-2023; for Immunization: Pneucon (Patient was 62-year-old, Dose 1, Lot: H010515, Pneucon) on 10-Sep-2012, flu vaccine (the patient was 63-year-old, Dose number-Unknown and single shot. Lot: 1307601) on 07-Oct-2013; for COVID-19 immunization: BNT162b2 (Dose 1 and Batch Number: EN5318) on 28-Jan-2021; for COVID-19 immunisation: BNT162b2 (Dose 2, Batch Number: EN6201) on 18-Feb-2021, BNT162b2 (Dose 3, Batch Number: FF2589, booster) on 27-Sep-2021, BNT162b2 (Dose 4, Batch Number: FM0698, Booster) on 08-Mar-2022, BNT162b2 omi ba.4-5 (Dose 5, Batch Number: Unknown and Booster) on 08-Nov-2022. Past adverse reactions to the above products included No adverse effect with BNT162b2, BNT162b2, BNT162b2, BNT162b2, BNT162b2 omi ba.4-5, FLU VACCINE VII, FLU VACCINE VII, Pneucon, Pneumococcal vaccine, Zoster, Zoster and flu vaccine. Concomitant products included Influenza vaccine (Flu vaccine VII) from 11-Dec-2024 to an unknown date for Immunisation. On 03-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 03-Nov-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) (seriousness criterion medically significant). On 01-Mar-2025, the patient experienced COVID-19 (The patient had COVID) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Have COVID) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment, at a dose of unknown. At the time of the report, COVID-19 (The patient had COVID), DRUG INEFFECTIVE (Have COVID) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear test: Positive. It was reported that patient was not allergies, patient had no important medical conditions, and patient had no previous vaccine reactions. It was reported that the patient had Covid. She was too sick, and all by herself. The patient was never this sick in her life and she had total seven Covid-19 vaccine shots. The patient was not allergic to any previous vaccination, medications, food or other products and there were no other diagnosed illnesses and chronic health conditions was reported for patient. It was reported that the patient did not take any other medications within 2 weeks prior to the event onset. This case was linked to MOD-2025-784897, MOD-2025-784897 (Patient Link).; Reporter's Comments: As primary schedule was not administrated with moderna vaccine, Drug ineffective event was assessed as not related. The benefit -risk relationship of product is not affected by this report. More
2838915 CA 04/30/2025 RSV
 PFIZER\WYETH
Needle issue Needle issue
The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate ... The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off; The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), NEEDLE ISSUE (non-serious), outcome "unknown" and all described as "The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off". Causality for "the act-o-vial, they had a problem with it being really hard to push down; the needle also separate from that; needle breaking off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2838929 13 F AZ 04/30/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 973K4
Expired product administered, No adverse event Expired product administered, No adverse event
Vaccine was given on 4/17/25, but medication expired on 4/7/25. Member/guardian was informed of expi... Vaccine was given on 4/17/25, but medication expired on 4/7/25. Member/guardian was informed of expired vaccine administration. No adverse reactions were reported. Member will be re-vaccinated with new vaccine. More
2838930 69 F NV 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 K2BB7
Arthralgia, Burning sensation, Influenza like illness, Malaise, Paraesthesia Arthralgia, Burning sensation, Influenza like illness, Malaise, Paraesthesia
On evening of vaccination, started to feel very sick with strong joint pain. This felt like a very s... On evening of vaccination, started to feel very sick with strong joint pain. This felt like a very strong case of the flu; it persisted for 2 days. Since receiving the shot, I also feel a painful tingle around half of my left ankle (where the foot folds toward the lower leg; not on the heel side). It's a disagreeable, localized, but not very strong pain, best described as a burning or needling, that is most pronounced at bedtime and in the morning when I get up. There is no rash associated with it. The skin is not dry or otherwise impacted. I do not use any ointment or lidocain cream on the area, as pain is bearable and does not prevent me from falling asleep. More
2838932 4 M MI 04/30/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8383AB
Y010292
Erythema, Muscle oedema, Skin warm; Erythema, Muscle oedema, Skin warm Erythema, Muscle oedema, Skin warm; Erythema, Muscle oedema, Skin warm
Erythema, edema and increased warmth in right deltoid area. Erythema, edema and increased warmth in right deltoid area.
2838970 61 F IL 04/30/2025 MMR
MMR
VARZOS
VARZOS
 MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Arthralgia, Balance disorder, Inflammation, Lymphadenopathy, Musculoskeletal dis... Arthralgia, Balance disorder, Inflammation, Lymphadenopathy, Musculoskeletal discomfort; Skin discolouration; Arthralgia, Balance disorder, Inflammation, Lymphadenopathy, Musculoskeletal discomfort; Skin discolouration More
Caller also mentioned having inflammation from the SHINGRIX vaccine, affecting her balance.; Caller ... Caller also mentioned having inflammation from the SHINGRIX vaccine, affecting her balance.; Caller also mentioned having inflammation from the SHINGRIX vaccine, affecting her balance.; then last night her neck was bothering her even more, then she noticed her glands were swollen and her lower jaw was feeling "sensitive".; She also mentioned having a "dot" on her neck that looks like a "bug bite" in the area of her swollen glands on her skin.; She also mentioned having achey joints in her fingers.; This spontaneous report was received from a consumer and refers to herself, a 61-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included type I diabetes. She did not have a spleen and was sensitive to SULFA drugs, mold and cat dander. Concomitant medications included long and short term insulin, and two hormone replacement medications: estrogen and progesterone . On 02-Apr-2025 at 02:00 PM, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #, expiration date, route of administration, exact dose and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. On an unspecified date, she was also vaccinated with shingrix. On 02-Apr-2025 (on the day of the shot), the patient's neck felt tight, then last night her neck was bothering her even more, then she noticed her glands were swollen and her lower jaw was feeling sensitive (lymphadenopathy). On an unspecified date in April 2025, she also mentioned having a dot on her neck that looks like a bug bite in the area of her swollen glands on her skin (skin lesion). She also mentioned having achy joints in her fingers (arthralgia). On an unspecified date, she also mentioned having inflammation from the shingrix vaccine, affecting her balance (inflammation; balance disorder). No additional adverse event (AE) or product quality complaint (PQC) was reported. The outcome of the adverse events was reported as not recovered. The causal relationship between the adverse events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported. The causal relationship between the adverse events and Shingrix was not reported, with the exception of inflammation for which it was considered related. Lot # is being requested and will be submitted if received. More
2838971 17 F TX 04/30/2025 HPV9
HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Y018398
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No adverse effects were reported; the second extra dose (dose number 5) was on 3/4/2025; The first e... No adverse effects were reported; the second extra dose (dose number 5) was on 3/4/2025; The first extra dose (dose number 4) was on 6/2/2023; This spontaneous report was received from a nurse concerning a 20-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On an unspecified date in approximately 2020, when she was 17-year-old, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) dose number 1, 1 dosage form (route of administration, anatomical location, lot # and expiration date were not reported). On unspecified dates, she received the doses 2 and 3 of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form each (route of administration, anatomical location, lot # and expiration date were not reported), completing the vaccination series. Then, on 06-Feb-2023, the patient was administered a 4th dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form (route of administration, anatomical location, lot # and expiration date were not reported) (extra dose administered). Additionally, on 04-Mar-2025, the patient received another dose of Human Papillomavirus 9-valent Vaccine, Recombinant, lot #Y018398, expiration date: 04-Nov-2026, dose number 5, 0.5 mL administered by a health professional (route of administration and anatomical location were not reported) (extra dose administered). All vaccine doses were administered as prophylaxis. It was also reported that patient did not recall her administration history, when she consented to the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) series again on 06-Feb-2023. No adverse effects were reported (no adverse event.) Additional lot #s are being requested and will be submitted if received. More
2838972 F 04/30/2025 HPV9
 MERCK & CO. INC.
Lymphadenopathy Lymphadenopathy
patient complained of enlarged lymph node after receiving GARDASIL 9.; This spontaneous report was r... patient complained of enlarged lymph node after receiving GARDASIL 9.; This spontaneous report was received from a/an Consumer or other non health professional (Field-Based Employee [FBE]) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection (exact dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unspecified day in January 2025 (reported as about 3 months ago), the patient experienced enlarged lymph node after receiving suspect vaccine. At the reporting time, the outcome of enlarged lymph node was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) regarding the event was assessed as not applicable. The causal relationship between the event of enlarged lymph node and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Lot # is being requested and will be submitted if received. More
2838973 F 04/30/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Arthralgia, Lymphadenopathy; Arthralgia, Lymphadenopathy; Arthralgia, Lymphadeno... Arthralgia, Lymphadenopathy; Arthralgia, Lymphadenopathy; Arthralgia, Lymphadenopathy More
Nurse reported the day after the last dose experiencing pain in her right clavicle; Nurse reported t... Nurse reported the day after the last dose experiencing pain in her right clavicle; Nurse reported the day after the last dose experienced enlarged lymph nodes; This spontaneous report was received from a nurse and refers to herself, a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first, second and third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) administered for prophylaxis (strength, exact quantity volume, lot #, expiration date, route and anatomical site of administration were not reported). On an unknown date, the day after the last dose, the patient experiencing pain in her right clavicle (Pain) and enlarged lymph nodes. The patient also reported that her daughter also received this vaccine and did not experience any symptoms. At the reporting time, the patient recovered from the events. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant was not provided. More
2838974 PA 04/30/2025 RV5
 MERCK & CO. INC.
 2091232
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No other AE.; third dose of ROTATEQ past the recommended age.; This spontaneous report was received... No other AE.; third dose of ROTATEQ past the recommended age.; This spontaneous report was received from a health care professional referring to a 9-months-old patient, gender not reported. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On 29-APR-2025, at the age of 9 months, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent Oral solution (ROTATEQ) liquid, (valid lot number 2091232, with an expiration date on 17-APR-2026) administered orally for prophylaxis. (Product administered to patient of inappropriate age). More
2838975 0.25 F 04/30/2025 HIBV
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MEN
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Anion gap, Band neutrophil percentage increased, Blood chloride normal, Blood cr... Anion gap, Band neutrophil percentage increased, Blood chloride normal, Blood creatinine normal, Blood culture negative; Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased; Carbon dioxide normal, Chest X-ray abnormal, Cough, Diarrhoea, Differential white blood cell count; Full blood count, Haematocrit normal, Haemoglobin normal, Hypochromasia, Hypophagia; Hypoxia, Lung consolidation, Lymphocyte percentage, Mean cell volume normal, Monocyte percentage increased; Myelocyte percentage increased, Neutrophil percentage decreased, Platelet count increased, Platelet morphology normal, Pneumonia; Polychromasia, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal; Respiratory distress, Respiratory symptom, Respirovirus test positive, Reticulocyte count increased, Rhinorrhoea; Upper respiratory tract infection, Urine output decreased, Viral infection, White blood cell count increased; Anion gap, Band neutrophil percentage increased, Blood chloride normal, Blood creatinine normal, Blood culture negative; Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased; Carbon dioxide normal, Chest X-ray abnormal, Cough, Diarrhoea, Differential white blood cell count; Full blood count, Haematocrit normal, Haemoglobin normal, Hypochromasia, Hypophagia; Hypoxia, Lung consolidation, Lymphocyte percentage, Mean cell volume normal, Monocyte percentage increased; Myelocyte percentage increased, Neutrophil percentage decreased, Platelet count increased, Platelet morphology normal, Pneumonia; Polychromasia, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal; Respiratory distress, Respiratory symptom, Respirovirus test positive, Reticulocyte count increased, Rhinorrhoea; Upper respiratory tract infection, Urine output decreased, Viral infection, White blood cell count increased; Anion gap, Band neutrophil percentage increased, Blood chloride normal, Blood creatinine normal, Blood culture negative; Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased; Carbon dioxide normal, Chest X-ray abnormal, Cough, Diarrhoea, Differential white blood cell count; Full blood count, Haematocrit normal, Haemoglobin normal, Hypochromasia, Hypophagia; Hypoxia, Lung consolidation, Lymphocyte percentage, Mean cell volume normal, Monocyte percentage increased; Myelocyte percentage increased, Neutrophil percentage decreased, Platelet count increased, Platelet morphology normal, Pneumonia; Polychromasia, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal; Respiratory distress, Respiratory symptom, Respirovirus test positive, Reticulocyte count increased, Rhinorrhoea; Upper respiratory tract infection, Urine output decreased, Viral infection, White blood cell count increased; Anion gap, Band neutrophil percentage increased, Blood chloride normal, Blood creatinine normal, Blood culture negative; Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased; Carbon dioxide normal, Chest X-ray abnormal, Cough, Diarrhoea, Differential white blood cell count; Full blood count, Haematocrit normal, Haemoglobin normal, Hypochromasia, Hypophagia; Hypoxia, Lung consolidation, Lymphocyte percentage, Mean cell volume normal, Monocyte percentage increased; Myelocyte percentage increased, Neutrophil percentage decreased, Platelet count increased, Platelet morphology normal, Pneumonia; Polychromasia, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal; Respiratory distress, Respiratory symptom, Respirovirus test positive, Reticulocyte count increased, Rhinorrhoea; Upper respiratory tract infection, Urine output decreased, Viral infection, White blood cell count increased; Anion gap, Band neutrophil percentage increased, Blood chloride normal, Blood creatinine normal, Blood culture negative; Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased; Carbon dioxide normal, Chest X-ray abnormal, Cough, Diarrhoea, Differential white blood cell count; Full blood count, Haematocrit normal, Haemoglobin normal, Hypochromasia, Hypophagia; Hypoxia, Lung consolidation, Lymphocyte percentage, Mean cell volume normal, Monocyte percentage increased; Myelocyte percentage increased, Neutrophil percentage decreased, Platelet count increased, Platelet morphology normal, Pneumonia; Polychromasia, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal; Respiratory distress, Respiratory symptom, Respirovirus test positive, Reticulocyte count increased, Rhinorrhoea; Upper respiratory tract infection, Urine output decreased, Viral infection, White blood cell count increased More
Viral Syndrome; Pneumonia; This 8-month-old female subject was enrolled in a blinded study titled Ph... Viral Syndrome; Pneumonia; This 8-month-old female subject was enrolled in a blinded study titled Phase IIIB, Observer-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 07-JAN-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 07-JAN-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 02-NOV-2018, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 07-JAN-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 07-JAN-2019, for prophylaxis. On 16-MAR-2019, 68 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13 and Hiberix and 134 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 pneumonia (Verbatim: Pneumonia). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 viral syndrome (Verbatim: Viral Syndrome) on 23-MAR-2019 with serious criteria of hospitalization. The subject was treated with zinc oxide, salbutamol (Albuterol), oxygen, cefotaxime sodium (Omnicef), sodium chloride, sodium chloride (Normal Saline), paracetamol (Tylenol Infants), ibuprofen (Children'S Motrin) and ceftriaxone. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13 and Hiberix was no change. The outcome of pneumonia was resolved on 02-APR-2019. The outcome(s) of the additional event(s) included viral syndrome (resolved on 02-APR-2019). Relevant Tests: On 25-Mar-2019 Myelocytes percent was 1 percent (normal range0-0), PLTS, BLD,QL,MAN was increased, PLTS MORPH was normal, Polychromasia was 1 plus normal range n/a, Dacrocytes, BLD QL, LMICRO was 1 plus normal range n/a, diff Panel MAN DIFF was normal normal range n/a, blood culture result showed no growth (normal range no growth), ANION GAP4 SERPL was 12 normal range 5-16mEq/L, GLUCOSE was 102 normal range 60-159 md/dL, CRATININE was less than 0.20 normal range 0.20-0.40 mg/dL. On 27-Mar-2019 Myelocytes percent was 3 percent (normal range0-0), PLTS, BLD,QL,MAN was confirmed normal range n/a, PLTS MORPH was (normal ranges normal), Hypochromia was 1 plus normal range n/a, Toxic Granuels, Bld QL, Micro was 2 plus normal range n/a, diff Panel MAN DIFF was normal normal range n/a, blood culture result showed no growth (normal range no growth), WBC MANUAL DIFFERENTIAL, REFLUX was abnormal normal range normal, CBC W/AUTOMATED DIFFERENTIAL was abnormal normal range normal. On 25Mar2019 X-Ray chest performed findings showed "right upper lobe consolidation with air brochograms and possible synpneumonic effusion". On 28-Mar-2019 ParaInfluenza Virus 3 RNA, PCR exam Findings result showed, "Positive". normal findings would be negative.. Diagnostic results (reference ranges are provided in parenthesis if available): Band neutrophil count- 25-MAR-2019 16 percent, (0.00-5.00) and 27-MAR-2019 5 percent, (0.00-5.00). Blood chloride- 25-MAR-2019 98 mEq/L, (100.00-111.00). Blood potassium- 25-MAR-2019 4.8 mEq/L, (3.50-5.30). Blood sodium- 25-MAR-2019 137 mEq/L, (135.00-145.00). Blood urea- 25-MAR-2019 7 mg/dL, (7.00-27.00). C-reactive protein- 25-MAR-2019 15.6 mg/dL, (0.00-0.90) and 27-MAR-2019 7.3 mg/dL, (0.00-0.90). Carbon dioxide- 25-MAR-2019 27 mEq/L, (20.00-24.00). Haematocrit- 25-MAR-2019 10.9 g/dL, (10.50-13.50) and 27-MAR-2019 11.5 g/dL, (10.50-13.50). Haemoglobin- 25-MAR-2019 33 percent, (33.00-39.00) and 27-MAR-2019 35 percent, (33.00-39.00). Lymphocyte percentage- 25-MAR-2019 31 percent, (20.00-70.00) and 27-MAR-2019 28 percent, (20.00-70.00). Mean cell volume- 25-MAR-2019 82 fL, (70.00-86.00) and 27-MAR-2019 83 fL, (70.00-86.00). Monocyte percentage- 25-MAR-2019 6 percent, (0.00-12.00) and 27-MAR-2019 9 percent, (0.00-12.00). Neutrophil percentage- 25-MAR-2019 46 percent, (16.00-60.00) and 27-MAR-2019 55 percent, (16.00-60.00). Platelet count- 25-MAR-2019 502 K/uL, (140.00-400.00) and 27-MAR-2019 458 K/uL, (140.00-400.00). Red blood cell count- 25-MAR-2019 4.03 M/uL, (4.00-5.20) and 27-MAR-2019 4.22 M/uL, (4.00-5.20). Red blood cell sedimentation rate- 25-MAR-2019 85 mm/hr, (0.00-20.00). Red cell distribution width- 25-MAR-2019 13.2 percent, (12.00-16.50) and 27-MAR-2019 13.2 percent, (12.00-16.50). White blood cell count- 25-MAR-2019 21.7 K/uL, (6.00-17.00) and 27-MAR-2019 18.6 K/uL, (6.00-17.00). The investigator considered that there was no reasonable possibility that the pneumonia and viral syndrome may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13 and Hiberix. The company considered that there was no reasonable possibility that the pneumonia and viral syndrome may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13 and Hiberix. Additional Information: GSK receipt date: 08-MAY-2019 Eight month old with coughing and fevers that started on 16 Mar 2019. She was seen by her primary doctor on 20 Mar 2019 and was diagnosed with an upper respiratory infection, no medications prescribed at this time, Mom was instructed to use a humidifier and give Tylenol or Motrin to reduce fevers. She returned to the clinic on 23 Mar 2019 for continuing fevers, cough, rhinorrhea and diarrhea. Per Mom her oral intake had decreased, though the physician diagnosed her with ongoing upper respiratory symptoms and viral syndrome. Due to worsening symptoms of cough, persistent fevers and decrease urine output she was advised by a physician to get care in the Emergency room on 25 Mar 2019. In the Emergency room she presented with respiratory distress and hypoxia requiring oxygen via nasal cannula. The child was admitted to the hospital with the diagnosis of pneumonia. Also labs were drawn and blood cultures were taken. While in the hospital she required only the first night oxygen and weaned herself to room air with good saturations. But she required several days of additional hospitalization for poor oral intake and large diarrhea output. Intravenous hydration was started, antibiotics were given and Tylenol and Motrin was administered for fevers and pain. On 30 Mar 2019, the child was discharged home, as her "stool output had decreased, she was taking fluids orally without problems and did not need oxygen" to maintain saturations. A blood culture was drawn on 27 Mar 2019 that showed "no growth to date" on the day of discharge. The child went home and finished off her course of antibiotics. By 02 Apr 2019, she was playful and interactive without any respiratory issues or diarrhea, per mom. Follow-up information received on 06-Aug-2024 The subject received biogaria protectis baby at a dosage of 5 drops daily oral from 29-MAR-2019 00:00 to 30-MAR-2019 00:00 for Diarrhoea. The subject received D5 Sodium Chloride 0.9% Potassium Chloride 20 meq/L at a dosage of 5 ml CO intravenously from 29-MAR-2019 to 30-MAR-2019 for maintain IV patency. Later, received at a dosage of 28 ml CO intravenously from 26-MAR-2019 to 29-MAR-2019 for Hydration. Summary of changes: Treatment medication Ceftriaxone details (frequency) updated. Follow-up information received on 30-AUG-2024 Summary of changes: Event Diarrhea deleted, seriousness GSK Medically Significant for event Pneumonia was removed and narrative updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Pneumonia and Viral infection, 68 days after receiving 3rd dose of Bexsero, Hiberix and DTPa-HBV-IPV and 134 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 8-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility and alternative etiology (ParaInfluenza Virus 3 RNA, PCR exam Findings result "Positive"). More
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2838976 F 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Skin ulcer Skin ulcer
sores on body; sores that itch; This non-serious case was reported by a consumer via call center rep... sores on body; sores that itch; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin ulcer in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced skin ulcer (Verbatim: sores on body) and pruritus (Verbatim: sores that itch). The outcome of the skin ulcer and pruritus were not resolved. It was unknown if the reporter considered the skin ulcer and pruritus to be related to Shingrix. It was unknown if the company considered the skin ulcer and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 23-APR-2025 The case was self reported by patient. She was vaccinated with her first dose of Shingrix a few weeks back and about a week after vaccination she has sores on her body and the sores are itchy. The sores are located on her legs and her back near her neck. The consumer declined to provide any demographic information or information pertaining to vaccination. No further information was provided/obtained. More
2838977 F 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Pain and redness at injection site that is still worsening after two days; Pain and redness at injec... Pain and redness at injection site that is still worsening after two days; Pain and redness at injection site that is still worsening after two days; This non-serious case was reported by a consumer and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypothyroidism and blood cholesterol increased. Concomitant products included atorvastatin calcium (Atorvastatin) and levothyroxine sodium (Levothyroxine). On 25-APR-2025, the patient received Shingrix .5 ml. On 25-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Pain and redness at injection site that is still worsening after two days) and injection site pain (Verbatim: Pain and redness at injection site that is still worsening after two days). The outcome of the injection site erythema and injection site pain were not resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix. It was unknown if the company considered the injection site erythema and injection site pain to be related to Shingrix. Additional Information: GSK receipt date: 27-APR-2025 The patient experienced pain and redness at injection site that was still worsening after two days. These symptoms were not treated. More
2838978 F 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; a bout of shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; a bout of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: a bout of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 21-APR-2025 The reporter states that she saw that female patient had received the Shingrix vaccine and subsequently experienced a bout of shingles. The reporter does not know any further information about the patient or the event. The reporter had no further information on this report. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with US2025AMR051346, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix US-GSK-US2025AMR051346:Same reportr/Different patient More
2838979 M KY 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
experienced arm soreness after his first dose of SHINGRIX; This non-serious case was reported by a n... experienced arm soreness after his first dose of SHINGRIX; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 71-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 pain in arm (Verbatim: experienced arm soreness after his first dose of SHINGRIX). The outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 28-APR-2025 The nurse reported that a patient experienced arm soreness after his first dose of Shingrix.; Sender's Comments: US-GSK-US2025051113:SAME REPORTER US-GSK-US2025051111:SAME REPORTER More
2838980 61 F NC 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
soreness on her left arm; This non-serious case was reported by a consumer via call center represent... soreness on her left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included hydrochlorothiazide. On 24-JAN-2025, the patient received the 1st dose of Shingrix. On 25-JAN-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: soreness on her left arm). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK receipt date: 28-APR-2025 The patient reported that she experiencing soreness on her left arm after receiving the first dose of Shingrix vaccine. The batch number and expiry date was unknown. More
2838981 04/30/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Feeling abnormal, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; ... Feeling abnormal, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; Feeling abnormal, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure More
It impacted left eye; contracted shingles across the left side of face; suspected vaccination failur... It impacted left eye; contracted shingles across the left side of face; suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included immune system disorder. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: contracted shingles across the left side of face). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It impacted left eye) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were resolving. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had two Shingles shots over the years, and 10 weeks ago (from the date of reporting) the patient contracted shingles across the left side of her/his face. The patient had been working too hard (author), and her/his low immune system was a factor. The patient had never been so miserable. In 2025, it (shingles) impacted her/his left eye, but patient saw an ophthalmologist and it was okay. He/she thanked the stars. It was slowly improving. The patient was told rest was key to recovery, so he/she was resting in the afternoons. The patient had been feeling sorry for herself/himself. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding ophthalmic herpes zoster and facial herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease; Concurrent medical conditions included immune system disorder) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). More
2838982 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Sleep disorder, Vaccination failure Herpes zoster, Pain, Sleep disorder, Vaccination failure
Suspected vaccination failure; got a small episode of Shingles; I could not sleep; This serious case... Suspected vaccination failure; got a small episode of Shingles; I could not sleep; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got a small episode of Shingles) and difficulty sleeping (Verbatim: I could not sleep). The outcome of the vaccination failure, shingles and difficulty sleeping were not reported. It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and difficulty sleeping to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got the vaccine. Then several years after patient got the vaccine, got a small episode of Shingles. Patient indicated that it was painful and he/she could not sleep. Also stated it would have been horrible if he/she had not been vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR016049:same patient differen suspect More
2838983 F 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
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 female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 21-APR-2025 The reporter stated that she saw that two women had received the Shingrix vaccine and subsequently experienced a bout of shingles. The reporter does not know any further information about the patients or the events. Reporter had no further information on this report. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025051090 reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025051090:Same reportr/Different patient More
2838984 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
Shingles vaccine Does hurt; This non-serious case was reported by a consumer via interactive digital... Shingles vaccine Does hurt; 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. 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: Shingles vaccine Does hurt ). 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: 23-APR-2025 This case was reported by a patient via interactive digital media. The Shingles vaccine did hurt but having Shingles vaccine hurts worse than running through a under a wire fence. More
2838985 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
made me sick; This non-serious case was reported by a consumer via interactive digital media and des... made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: made me sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK receipt date: 28-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that after a Shingrix vaccination patient experienced sickness. More
2838986 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
had a shingles shot 5 years ago do i need to restart again; This non-serious case was reported by a ... had a shingles shot 5 years ago do i need to restart again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received Shingles shot 5 years ago on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: had a shingles shot 5 years ago do i need to restart again). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. Consumer reported that he/she had a Shingles shot 5 years ago and want to ask do he/she need to restart again. Till the time of reporting, the patient did not receive 2nd dose of Shingles shot, which led to an incomplete course of vaccination. More
2838987 F 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
My mom got shingles each time she got the vaccine; This non-serious case was reported by a consumer ... My mom got shingles each time she got the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: My mom got shingles each time she got the vaccine). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Linked case(s) involving the same patient: US2021AMR184987 Additional Information: GSK Receipt Date : 24-APR-2025 The patient got shingles each time she got the vaccine which tells me not to get the vaccine.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR184987:same reporter, case created for 1st dose More
2838988 F CA 04/30/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
hasn't received any other doses since; This non-serious case was reported by a pharmacist via c... hasn't received any other doses since; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Previously administered products included Menveo (received a first dose on 20-JUL-2021, lot no AMXA517A). On an unknown date, the patient did not receive the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incomplete course of vaccination (Verbatim: hasn't received any other doses since). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 23-APR-2025 The pharmacist reported that a patient received a first dose of Menveo 4 years ago and hasn't received any other doses since. The pharmacist mentioned patient required now to complete the Menveo schedule due to a soliris infusion. Till the time of reporting, the patient did not receive 2nd dose of Menveo, which led to incomplete course of vaccination. More
2838989 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Adult use of child product; This non-serious c... Maladministration of pediatric dose on adult patient; Adult use of child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of child product). The outcome of the accidental 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-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050556:same reporter/different patient More
2838990 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Adult use of child product; This non-serious c... Maladministration of pediatric dose on adult patient; Adult use of child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of child product). The outcome of the accidental 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-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050556:same reporter/different patient More
2838991 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult p... Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050551:same reporter/different patient US-GSK-US2025050553:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050559:same reporter/different patient US-GSK-US2025050561:same reporter/different patient US-GSK-US2025050563:same reporter/different patient US-GSK-US2025050566:same reporter/different patient More
2838992 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult p... Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050559:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050553:same reporter/different patient US-GSK-US2025050551:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050561:same reporter/different patient US-GSK-US2025050563:same reporter/different patient US-GSK-US2025050566:same reporter/different patient More
2838993 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult p... Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050559:same reporter/different patient More
2838994 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious... Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the accidental 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-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050556:same reporter/different patient More
2838995 78 M NC 04/30/2025 COVID19
 MODERNA
 034F21A
Bell's palsy, Borrelia test negative, Facial paralysis, Herpes simplex test... Bell's palsy, Borrelia test negative, Facial paralysis, Herpes simplex test negative, Magnetic resonance imaging head normal More
February 12, 2022 R sided facial droop and sensation changes, forehead muscle paralysis, presented t... February 12, 2022 R sided facial droop and sensation changes, forehead muscle paralysis, presented to this same facility's ER , diagnosed with Bell's Palsy and sent with antiviral, steroids, about 1 month out had near resolution of facial droop. More
2838996 74 M IA 04/30/2025 COVID19
 MODERNA
 3043159
Death Death
Passed away Passed away
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2838997 85 F MI 04/30/2025 COVID19
 MODERNA
 3043823
Cough, Oropharyngeal pain Cough, Oropharyngeal pain
Sore throat and coughing to the point have to leave the room when talking to people starting the nex... Sore throat and coughing to the point have to leave the room when talking to people starting the next day after the shot. She was healthy and not sick before the shot. She wen tot he urgent care and they said to not take cough syrup but to go to pharmacy to ask what hey recommend. Sore throat has gone away. More
2838998 75 M GA 04/30/2025 COVID19
 MODERNA
 3043823
Expired product administered Expired product administered
Patient given vaccine dose that had exceeded its BUD Patient given vaccine dose that had exceeded its BUD
2838999 73 F GA 04/30/2025 COVID19
 MODERNA
 3043823
Expired product administered Expired product administered
Patient given vaccine dose that had exceeded its BUD Patient given vaccine dose that had exceeded its BUD
2839000 56 F FL 04/30/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Skin discolouration Skin discolouration
Patient's husband reported larg red marks that appeared on patient's thighs 3-4 days after... Patient's husband reported larg red marks that appeared on patient's thighs 3-4 days after the vaccine. No fever, no pain, only minor itching. More
2839001 4 F NY 04/30/2025 MMR
 MERCK & CO. INC.
 XO28353
Lymphadenopathy, Pyrexia, Rash, Skin lesion, Vomiting Lymphadenopathy, Pyrexia, Rash, Skin lesion, Vomiting
MOM REPORTED SHE BROKE OUT IN A RASH ON 4/11/25. SHE WAS SEEN IN OFFICE ON 04/22/2025, RASH HAD RES... MOM REPORTED SHE BROKE OUT IN A RASH ON 4/11/25. SHE WAS SEEN IN OFFICE ON 04/22/2025, RASH HAD RESOLVED BUT SHE HAD SWOLLEN LYPM NODE IN NECK AND HAD VOMITED ONCE. DEVELOPED A HIGH FEVER, 104 F, DAY 12 AFTER MMR THEN ON DAY 13 BROKE OUT IN RASH THAT STARTED AT HARILINE, SPREAD DOWN FACE AND ONTO TRUNK WITH SORES INSIDE OF MOUTH . THEY WERE SORE CIRCULAR LESIONS INSIDE HER CHEEK WITH A SLIGHT WHITE TINGE. AT TIME OF APPOINTMENT WITH DOCTOR THEY WERE ALREADY RESOLVING. More
2839002 77 F GA 04/30/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient... Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate. More
2839003 70 F GA 04/30/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient... Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate. More
2839004 14 M TX 04/30/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8361AA
X449Y
Pallor, Syncope; Pallor, Syncope Pallor, Syncope; Pallor, Syncope
Patient received MCV4 & TDap. Patient stared at the wall, became pale, then fainted while sittin... Patient received MCV4 & TDap. Patient stared at the wall, became pale, then fainted while sitting in chair. Patient leaned towards nurse on right side. Noted skin warm and clammy. Patient awoke in approximately 30 seconds, he stated he could not see or hear, then stated he hears weird noises. Laid patient on a mat on his left side after complaints of dizziness. Asked nurse to assist with next patient and obtained an ice pack from Nurse. This nurse obtained VS, placed cool towel on back of neck, ice pack on forehead, later provided water. Patient returned to baseline at 1604, he denied dizziness and stated he felt like his normal self. Color normal for ethnicuty, gait steady. Mom stated this has never happened before but has been complaining of dizziness and light-headedness for a few weeks. Provided resource list of clinics and encouraged to follow up with PCP. Vital signs % 1553: 108/60, HR-51, 94% RA, RR-18. 1556: HR-62, 98% RA. 1604: 110162, HR-67, 97%-RA, RR-18. More
2839005 OH 04/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious... Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the accidental 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-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050558:same reporter/different patient More
2839006 77 M GA 04/30/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient... Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate. More
2839007 77 M GA 04/30/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient... Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate. More
2839008 65 F TX 04/30/2025 PNC21
 MERCK & CO. INC.
 Y011819
Erythema, Pain, Pain in extremity, Pruritus Erythema, Pain, Pain in extremity, Pruritus
PT SAID SHE STARTED TO EXPERIENCE REDNESS, ITCHING, SWELLING AND PAIN RADIATING DOWN THE ARM AND I... PT SAID SHE STARTED TO EXPERIENCE REDNESS, ITCHING, SWELLING AND PAIN RADIATING DOWN THE ARM AND IS GETTING WORSE. SHE HAS BEEN APPLYING COLD PACKS FOR 15 MINUTES A T A TIME, BUT THIS IS NOT HELPING. More
2839009 68 F GA 04/30/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient... Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate. More
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