🏥 VAERS Vaccine Data Browser

🔒 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.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 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 "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 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:

  • ✅ Early warning system for potential safety signals
  • ✅ Open and transparent - publicly accessible
  • ✅ Accepts all reports regardless of likelihood of causation
  • ✅ Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ 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?

⚠️ 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
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2817474 4 M OK 12/23/2024 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y002099
Y002099
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional adverse event; HCP called to report TE on PROQUAD. HCP stated that the PROQUAD was sto... No additional adverse event; HCP called to report TE on PROQUAD. HCP stated that the PROQUAD was stored in the refrigerator and administered to multiple patients. Original AE 02722046 filed on 12/13/2024. At the time of the original report (12/13/2024), patient information was n; This spontaneous report was received from medical assistant and refers to a 4-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #Y002099, expiration date: 09-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration (Product storage error). No additional adverse event was reported. More
2817069 4 U OK 12/19/2024 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y002099
Y002099
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE; PROQUAD was stored in the refrigerator and administered to multiple patients/unsup... No additional AE; PROQUAD was stored in the refrigerator and administered to multiple patients/unsupported PROQUAD was administered; This spontaneous report was received from a Medical Assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), dose description "not reported", lot #Y002099, expiration date: 09-JUL-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided), after vaccine being stored in refrigerator (Product storage error). No reported signs/symptoms of adverse effects. No additional adverse event. This is one of the several reports from the same reporter. More
2815670 24 F TX 12/12/2024 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LN5496
UNK
Exposure during pregnancy; Exposure during pregnancy, Product use issue Exposure during pregnancy; Exposure during pregnancy, Product use issue
34 weeks pregnant, contact patient for more information I am unsure 34 weeks pregnant, contact patient for more information I am unsure
2820204 84 F OH 01/09/2025 COVID19
 MODERNA
 3043823
Cerebrovascular accident, Facial paralysis, Seizure Cerebrovascular accident, Facial paralysis, Seizure
At approximately 2:30 AM, the patient began having symptoms of possible stroke. She had drooping of... At approximately 2:30 AM, the patient began having symptoms of possible stroke. She had drooping of the face and then some mild seizures as well. Her daughter was taking her to the hospital today. More
2820205 73 M NC 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given a second dose of RSV vaccine 369 days after an initial dose (1st dose - Abrysvo on... Patient was given a second dose of RSV vaccine 369 days after an initial dose (1st dose - Abrysvo on 1/5/24, 2nd dose - Arexvy on 1/8/25). The patient has not reported any side effects at this time. More
2820206 65 F OR 01/09/2025 PNC20
TDAP
 PFIZER\WYETH
SANOFI PASTEUR
 LC5483
3CA22C1
Injection site erythema, Injection site pain; Injection site erythema, Injection... Injection site erythema, Injection site pain; Injection site erythema, Injection site pain More
Patient received a vaccine in her left upper arm last week. About 3 to 4 days later it began to get... Patient received a vaccine in her left upper arm last week. About 3 to 4 days later it began to get red and painful. The redness is spreading up up and down her arm. She denies fevers, sweats or chills. There is some pain in the area. More
2820214 76 F GA 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
There is no adverse event. Patient had already received this vaccine on 10/7/23. She requested anoth... There is no adverse event. Patient had already received this vaccine on 10/7/23. She requested another not remembering getting the first one. More
2820215 1.67 M HI 01/09/2025 HIBV
 SANOFI PASTEUR
 UK008AA
Extra dose administered, No adverse event Extra dose administered, No adverse event
Administered ActHiB to Right Vastus Lateralis. No symptoms/adverse reactions occurred while in offic... Administered ActHiB to Right Vastus Lateralis. No symptoms/adverse reactions occurred while in office and at home. Mother notified immediately. More
2820216 84 F GA 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Vaccination error. Patient had already received RSV vaccine on 12/19/2023. GRITs was not updated, pr... Vaccination error. Patient had already received RSV vaccine on 12/19/2023. GRITs was not updated, prescriber recommended. We as well as the patient did not realize that she had already received it. More
2820217 75 F 01/09/2025 FLU3
 SEQIRUS, INC.
Extra dose administered Extra dose administered
pt had inadvertently received 2 doses of the high dose of the flu vaccine once in september and agai... pt had inadvertently received 2 doses of the high dose of the flu vaccine once in september and again in november More
2820218 81 M GA 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Vaccination Error: Patient had already received RSV vaccine on 12/19/2023. Record was not updated. P... Vaccination Error: Patient had already received RSV vaccine on 12/19/2023. Record was not updated. Prescriber hence recommended. We and the patient did not realize that he had already received at pharmacy. More
2820219 48 F OH 01/09/2025 COVID19
 MODERNA
Atrial fibrillation, Electrocardiogram Atrial fibrillation, Electrocardiogram
Atrial fibrillation w rapid ventricular response Atrial fibrillation w rapid ventricular response
✓ ✓
2820220 18 F TX 01/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 PB5JA
Dizziness, Loss of consciousness Dizziness, Loss of consciousness
After administrating the RPH a HEP-A the patient was waiting for proof and then her dad stated that ... After administrating the RPH a HEP-A the patient was waiting for proof and then her dad stated that she is complaining of dizziness. The tech that was completing the paper let the patient they could have a seat. As the RPH completed a vaccine for another pt a loud thud was heard. The RPH immediately came out of the room the pt was unconscious. The RPH went back to the room to get the epi pen but before it could be administered the pt awoke and was alert. We called 911 and had the pt wait with her parents to be checked out. While the waiting for EMS pt was given a water and a dum dum candy. When EMS arrived she was taken take out to the ambulance for further evaluation. More
2820221 17 F WA 01/09/2025 HPV9
 MERCK & CO. INC.
 Y007991
Dizziness, Syncope Dizziness, Syncope
Patient experienced a syncopal episode immediately after receiving HPV vaccine. (Her mom was present... Patient experienced a syncopal episode immediately after receiving HPV vaccine. (Her mom was present) patient became very pale, said "I feel dizzy," then fainted. I placed an ice pack on her neck and staff assisted her to a wheel chair to get her in bed. The bed was placed in Trendelenburg position. Once patient was alert enough, she was able to drink some water and eat a few crackers. I checked her vital signs three times during this situation. She felt better after about 35 minutes, her blood pressure improved, and she was able to go home in stable condition. I advised her to eat and rest this evening and contact our 24 hr nurse number this evening if any concerns. I also sent an FYI message to her PCP. More
2820222 49 F CA 01/09/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 028A21A
028A21A
028A21A
0165B21A
0165B21A
0165B21A
027L621A
027L621A
027L621A
Carpal tunnel syndrome, Dyspepsia, Endoscopy upper gastrointestinal tract, Impai... Carpal tunnel syndrome, Dyspepsia, Endoscopy upper gastrointestinal tract, Impaired work ability, Laboratory test; Magnetic resonance imaging, Nerve conduction studies, Pain in extremity, Peripheral swelling, Rheumatoid arthritis; Ultrasound scan, X-ray limb; Carpal tunnel syndrome, Dyspepsia, Endoscopy upper gastrointestinal tract, Impaired work ability, Laboratory test; Magnetic resonance imaging, Nerve conduction studies, Pain in extremity, Peripheral swelling, Rheumatoid arthritis; Ultrasound scan, X-ray limb; Carpal tunnel syndrome, Dyspepsia, Endoscopy upper gastrointestinal tract, Impaired work ability, Laboratory test; Magnetic resonance imaging, Nerve conduction studies, Pain in extremity, Peripheral swelling, Rheumatoid arthritis; Ultrasound scan, X-ray limb More
I was diagnosed with RA in January 2024. I had symptoms leading up to the diagnosis during 2022 and ... I was diagnosed with RA in January 2024. I had symptoms leading up to the diagnosis during 2022 and 2023. Shortly after the shot I had to see a GI MD - for slow digestion a symptom of RA. He scoped my esophogus and eventually prescribed metoclopramide. At that time I did not know if could be a symptom of RA. During late 22 and all of 23 I suffered from 1 and then 2 swollen fingers with no known cause. In 2024 more of my digits swelled and I had uncontrolled pain throughout my hands. My RA MD has tried me on 2-3 different courses and combinations of therapy. More
✓
2820223 78 M FL 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255t2
Extra dose administered Extra dose administered
Patient was given another dose of Arexvy, but the patient has already received a dose on 1/9/24. Pat... Patient was given another dose of Arexvy, but the patient has already received a dose on 1/9/24. Patient was contacted by the pharmacist when the discovery of the second dose of the vaccination was discovered through our Immunization Review. More
2820224 65 F FL 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
Patient received a second dose of Arexvy - reported no adverse effects besides a sore arm. Patient received a second dose of Arexvy - reported no adverse effects besides a sore arm.
2820225 71 F FL 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Patient received a second dose of Arexvy - original dose in 2023 Patient received a second dose of Arexvy - original dose in 2023
2820226 74 F FL 01/09/2025 FLU3
FLU3
PNC20
PNC20
 SEQIRUS, INC.
SEQIRUS, INC.
PFIZER\WYETH
PFIZER\WYETH
 388488
388488
lc5482
lc5482
Asthenia, Chills, Delusion, Gait inability, Headache; Injection site swelling, P... Asthenia, Chills, Delusion, Gait inability, Headache; Injection site swelling, Pain, Pyrexia, Swelling; Asthenia, Chills, Delusion, Gait inability, Headache; Injection site swelling, Pain, Pyrexia, Swelling More
Patient reported high fever, chills, swollen shoulder, body aches, weakness ("couldn't wal... Patient reported high fever, chills, swollen shoulder, body aches, weakness ("couldn't walk"), delusions, headaches. Symptoms started in 2 hours. Swollen site of injection for a few days More
2820235 11 M CA 01/09/2025 FLU3
HPV9
MNQ
TDAP
 SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 U8518DA
X024650
U8375AA
U8232AA
Injection site cellulitis, Injection site erythema, Injection site pain, Injecti... Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Right upper arm, redness, swelling and pain. Mother reported warm to touch. Redness surround almost ... Right upper arm, redness, swelling and pain. Mother reported warm to touch. Redness surround almost entire deltoid. Diagnosed with Rt upper extremity cellulitis. treated with Keflex 250 mg/5ml - 20 ml by mouth 2 times daily x 10 days and Ibuprofen 200mg as needed for pain Follow up apt. More
2819837 U 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Guillain-Barre syndrome Guillain-Barre syndrome
Guillain Barre Syndrome; This serious case was reported by a consumer and described the occurrence o... Guillain Barre Syndrome; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 24-DEC-2024 The two patient developed guillain barre syndrome after their second dose of Shingrix. This case was linked with case US2024AMR163730 reported by the same reporter, for different patient.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2024AMR163730:Same reporter More
2819838 U 01/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Tinnitus Tinnitus
Annoying sound; This non-serious case was reported by a consumer and described the occurrence of ear... Annoying sound; This non-serious case was reported by a consumer and described the occurrence of ear discomfort in a 45-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ear discomfort (Verbatim: Annoying sound). The outcome of the ear discomfort was not resolved. It was unknown if the reporter considered the ear discomfort to be related to RSV vaccine. It was unknown if the company considered the ear discomfort to be related to RSV vaccine. Additional Information: GSK Receipt Date: 09-DEC-2024 The patient had annoying sound after RSV vaccine. The symptoms were not treated. More
2819839 U 01/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Irritability Irritability
Annoyance; This non-serious case was reported by a consumer and described the occurrence of feeling ... Annoyance; This non-serious case was reported by a consumer and described the occurrence of feeling irritated in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced feeling irritated (Verbatim: Annoyance). The outcome of the feeling irritated was resolving. It was unknown if the reporter considered the feeling irritated to be related to RSV vaccine. It was unknown if the company considered the feeling irritated to be related to RSV vaccine. Additional Information: GSK Receipt Date: 09-DEC-2024 The patient experienced annoyance. More
2819841 U MA 01/08/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
HCP reported that the patient has not received the second or third doses of the ENGERIX-B since Octo... HCP reported that the patient has not received the second or third doses of the ENGERIX-B since October; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in a adult patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (1st dose received in October 2024). On an unknown date, the patient did not received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: HCP reported that the patient has not received the second or third doses of the ENGERIX-B since October). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 14-DEC-2024 The reporter called to report an adverse event regarding the Engerix-B vaccine. The reporter stated that an adult patient had received the Engerix- B vaccine in October. The reporter reported that the patient had not received the second or third doses of the Engerix-B since October. The reporter stated that the patient was going to receive the second and third doses of the Recombivax HB vaccine in order to complete the vaccination series. No additional adverse event or product quality complain was reported. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B , which led to incomplete course of vaccination. More
2819842 F TX 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and... Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose at least 14 months ago). 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: Late 2nd dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 09-DEC-2024 The pharmacist reported that he/she had a patient who received the 1st dose of the Shingrix, more than a year ago. The reporter knew it was a 2 dose series, did they need to repeat the whole series again. The healthcare professional did not have any patient data nor vaccine information. The pharmacist also mentioned that the 1st dose was administer at least 14 months ago, but no more than 2 years, however, she did not share any specific date. The pharmacist mentioned that she estimated that the patient was 70 years old, but never confirmed the date of birth. More
2819843 9 F PA 01/08/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 ZJ3G3
Expired product administered, Inappropriate schedule of product administration Expired product administered, Inappropriate schedule of product administration
expired dose administered; 2nd dose received late; This non-serious case was reported by a other hea... expired dose administered; 2nd dose received late; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-year-old female patient who received HAV (Havrix) (batch number 2X2EJ, expiry date 14-OCT-2024) and (batch number ZJ3G3) for prophylaxis. Previously administered products included Hepatitis A (received 1st dose on 08th September 2021). On 10-DEC-2024, the patient received the 2nd dose of Havrix. On 10-DEC-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired dose administered) and drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the expired vaccine used and drug dose administration interval too long were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 11-DEC-2024 The clinical supervisor explained that an expired dose of Havrix was administered to a patient which led to, expired vaccine used. The patient got a first dose of Hepatitis A (unknown brand name) vaccine back on 08th September 2021, but caller did not have expiration date for the first vaccine. The patient received 2nd dose of Havrix, later than the recommended interval, which led to lengthening of vaccinations schedule More
2819844 F MA 01/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
received an extra dose of Arexvy; This non-serious case was reported by a pharmacist via call center... received an extra dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (received 1st dose in March 2024). Concurrent medical conditions included psoriasis and hypertension. In DEC-2024, the patient received the 2nd dose of Arexvy. In DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received an extra dose of Arexvy). The outcome of the extra dose administered was unknown. Additional Information: GSK receipt date: 16-DEC-2024 and 17-DEC-2024 The patient was given two doses of the Arexvy vaccine, which led to extra dose administered. More
2819845 17 M GA 01/08/2025 MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS

Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
on same visit the patient received 2 doses of Menveo; This non-serious case was reported by a other ... on same visit the patient received 2 doses of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 06-DEC-2024, the patient received Menveo and Menveo. On 06-DEC-2024, an unknown time after receiving Menveo and Menveo, the patient experienced overdose (Verbatim: on same visit the patient received 2 doses of Menveo). The outcome of the overdose was unknown. Additional Information: GSK Receipt Date: 09-DEC-2024 The physician's assistant reported that he/she had a patient that got the same vaccine twice and according to reporter, on the same visit, that was done as the patient received one dose of Bexsero and two doses of Menveo, which led to overdose. The Vaccine Administration Facility was the same as Primary Reporter. More
2819846 F AZ 01/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Rash, Urticaria Rash, Urticaria
Experienced rash; Experienced hives; This non-serious case was reported by a pharmacist via call cen... Experienced rash; Experienced hives; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Concurrent medical conditions included egg allergy. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced rash (Verbatim: Experienced rash) and hives (Verbatim: Experienced hives). The outcome of the rash and hives were resolved. It was unknown if the reporter considered the rash and hives to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the rash and hives to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-DEC-2024 The patient was allergic to egg and approximately 20 years ago they got a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (unknown brand name) and experienced rash and hives, that was currently solved. The reporter did not have a specific date of administration, lot number or expiration date for the vaccine, and they did not know if it was the first and only dose of a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine. More
2819847 1.17 M UT 01/08/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 D2LP3
Expired product administered Expired product administered
an expired dose of Priorix was administered to a patient; This non-serious case was reported by a nu... an expired dose of Priorix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-month-old male patient who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis. On 11-DEC-2024, the patient received Priorix. On 11-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: an expired dose of Priorix was administered to a patient). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 11-DEC-2024 The nurse reported that an expired dose of Priorix was administered to a patient which led to, expired vaccine used. The nurse that administered the vaccine observed the expiration date on the diluent instead of the expiration on the lyophilized or box. The reporter reported an expired dose of the vaccine was given, did not mentioned anything about it being only the diluent. The vaccine administration facility was the same as primary reporter. More
2819849 50 M WI 01/08/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6207
N/A
Depression, Injury, Pain, Sudden death, Surgery; Depression, Injury, Pain, Sudde... Depression, Injury, Pain, Sudden death, Surgery; Depression, Injury, Pain, Sudden death, Surgery More
Online report of sudden death for mid 50's male EUA countermeasure recipient. Victim was a musi... Online report of sudden death for mid 50's male EUA countermeasure recipient. Victim was a musician. A copy of vax card after DOSE1 was obtained. Based on the victims extensive international travel I believe he received the 2nd inoculation. DOSE#1 Date 03/10/21 LOT#EN6207. Victim was under the care of Acupuncture around 12/12/23. On 09/10/24 his social media post indicate he received a surgical procedure. It seems victim had some type of injury that caused chronic pain that required pain killers and acupuncture or chiropractic care. Victim also posted about 3-month depression in December 2023. Victim consumed alcohol, seemed to be high BMI and physically active based on online photos. More
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2819888 28 U NC 01/08/2025 VARCEL
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
a consumer received one dose of a varicella vaccine on 1/19/1996. The consumer has not received a 2n... a consumer received one dose of a varicella vaccine on 1/19/1996. The consumer has not received a 2nd dose at this time.; no adverse event; This spontaneous report was received from a registered pharmacist referring to a 29 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On 19-JAN-1996, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, dose number, route, lot#, expiration date and anatomical location were not provided) for prophylaxis. The patient had not received a second dose at this time (incomplete course of vaccination). The patient was planning to receive another dose of varicella virus vaccine live (oka/merck)(VARIVAX) on 02-JAN-2025 (also reported as: "today". No adverse event reported. More
2819889 U KY 01/08/2025 PNC15
 MERCK & CO. INC.
 y002643
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report... No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker, and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the vaccine pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot#y002643 has been verified to be a valid lot number, expiration date: 04-OCT-2026) had a temperature excursion of 46.6F for 1 hour 55 minutes. There was no previous temperature excursion. On 31-DEC-2024, the patient was vaccinated with above pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (1 dose) for prophylaxis (strength, and route of administration were not provided) (product storage error). No additional adverse event (no adverse event) was reported. More
2819890 U NY 01/08/2025 RV5
 MERCK & CO. INC.
 2003166
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs; Caller reported ROTATEQ administered after temperature excursion. Temperature 55.... No additional AEs; Caller reported ROTATEQ administered after temperature excursion. Temperature 55.9F; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-JAN-2025, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 0.5 milliliter, administered orally, lot # 2003166, expiration date 06-SEP-2025. Improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) experienced excursion with temperature reported as 55.9 degrees Fahrenheit for 4 hours (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported. More
2819891 U KY 01/08/2025 PNC15
 MERCK & CO. INC.
 Y002643
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; The healthcare worker is reporting that a patient received improper... No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 31-DEC-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered as the first dose for prophylaxis (lot number reported as Y002643, which has been verified as valid, expiration date reported and validated as 04-OCT-2026) (strength, dose, route of administration, and anatomical site of injection were not provided). The administered dose was exposed to a temperature excursion of 46.6 Fahrenheit degrees (F) for 1 hour and 55 minutes. There was no previous excursion. No additional adverse events were reported. No further information provided. More
2819892 5 U GA 01/08/2025 MMRV
 MERCK & CO. INC.
 Y013580
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP called and reported possible inadvertent administrations of MMR-II, VARIVAX, a... No additional AE; HCP called and reported possible inadvertent administrations of MMR-II, VARIVAX, and PROQUAD after a temperature excursion that occurred on 23DEC2024.; This spontaneous report has been received from a nurse and refers to a unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided. On 23-DEC-2024, the vaccines had a temperature excursion (time, temperature and prior excursions were unknown). On an unknown date, the patients were vaccinated with an improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) injection (lot numbers Y013132 with expiration date: 30-JUL-2026 and X027903 with expiration date of 04-DEC-2025, both has been verified to be valid lot numbers for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live) administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided), with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot numbers Y010373 with expiration date:05-JUN-2026 and Y011712 with expiration date of 02-JUL-2026, both has been verified to be valid lot numbers for varicella virus vaccine live [Oka/Merck]) administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live live recombinant Human albumin (rHA) (PROQUAD) injection (lot numbers Y013577 with expiration date: 03-FEB-2026 and Y016872 with expiration date of reported as 04-JUL-2026, but upon internal validation was stablished as 07-APR-2026, both has been verified to be valid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live) administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error). This is a non-valid case due to the lack of patients' identifiers. Follow-up information was received on 03-JAN-2025. The patient's identifiers were provided, and they were a 5-year-old patient. The reporter stated that varicella virus vaccine live (Oka/Merck) (VARIVAX) was not administered, and only measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) were administered. The product of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) was stored in recommend range and no adverse event was being filed. On 30-DEC-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection lot # Y013580 and expiration date reported as and confirmed to be 03-FEB-2026 (temperature excursion [T/E]: current: 31-DEC-2024: 17.0F 1 hour 45 minutes 0 seconds; previous: 8.00F 0 hours 45 minutes and 12.0F 0 hours 50 minutes) (product storage error). No additional adverse event (AE) and no product quality complaint (PQC) was reported (no adverse event). More
2819893 U KY 01/08/2025 PNC15
 MERCK & CO. INC.
 Y002643
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; The healthcare worker is reporting that a patient received improper... No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 30-DEC-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered as the first dose for prophylaxis (lot number reported as Y002643, which has been verified as valid, expiration date reported and validated as 04-OCT-2026) (strength, dose, route of administration, and anatomical site of injection were not provided). The administered dose was exposed to a temperature excursion of 46.6 Fahrenheit degrees (F) for 1 hour and 55 minutes (Product storage error). There was no previous excursion. No additional adverse events were reported. No further information provided. More
2819894 U IL 01/08/2025 MMRV
 MERCK & CO. INC.
 Y010306
Extra dose administered, No adverse event Extra dose administered, No adverse event
No additional AE; reported that a dose of PROQUAD was administered to a patient on 12/2/2024 and ano... No additional AE; reported that a dose of PROQUAD was administered to a patient on 12/2/2024 and another dose of PROQUAD (Same Lot Number) was administered to the patient on 12/10/2024; This spontaneous report has been received from Other Health Professional regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 02-DEC-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, then on 10-DEC-2024, the patient received the second dose (Extra dose administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), both doses administered as prophylaxism lot number Y010306 which was determined to be valid, with an expiration date on 01-DEC-2025 (doses, routes of administration, and anatomical sites of injection were not reported). No additional adverse events were reported in the patient. More
2819895 0.33 M 01/08/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
HIBV
HIBV
PNC13
PNC13
PNC13
PNC13
RV1
RV1
RV1
RV1
UNK
UNK
UNK
UNK
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Abdominal X-ray, Blood bicarbonate decreased, Blood glucose decreased, Crying, D... Abdominal X-ray, Blood bicarbonate decreased, Blood glucose decreased, Crying, Decreased activity; Dehydration, Erythema, Faeces discoloured, Gastroenteritis, Gastrointestinal sounds abnormal; Hypersomnia, Hypophagia, Infantile diarrhoea, Infantile vomiting, Otitis media; Tympanic membrane disorder; Abdominal X-ray, Blood bicarbonate decreased, Blood glucose decreased, Crying, Decreased activity; Dehydration, Erythema, Faeces discoloured, Gastroenteritis, Gastrointestinal sounds abnormal; Hypersomnia, Hypophagia, Infantile diarrhoea, Infantile vomiting, Otitis media; Tympanic membrane disorder; Abdominal X-ray, Blood bicarbonate decreased, Blood glucose decreased, Crying, Decreased activity; Dehydration, Erythema, Faeces discoloured, Gastroenteritis, Gastrointestinal sounds abnormal; Hypersomnia, Hypophagia, Infantile diarrhoea, Infantile vomiting, Otitis media; Tympanic membrane disorder; Abdominal X-ray, Blood bicarbonate decreased, Blood glucose decreased, Crying, Decreased activity; Dehydration, Erythema, Faeces discoloured, Gastroenteritis, Gastrointestinal sounds abnormal; Hypersomnia, Hypophagia, Infantile diarrhoea, Infantile vomiting, Otitis media; Tympanic membrane disorder; Abdominal X-ray, Blood bicarbonate decreased, Blood glucose decreased, Crying, Decreased activity; Dehydration, Erythema, Faeces discoloured, Gastroenteritis, Gastrointestinal sounds abnormal; Hypersomnia, Hypophagia, Infantile diarrhoea, Infantile vomiting, Otitis media; Tympanic membrane disorder More
Gastroenteritis; Dehydration; This 10-month-old male subject was enrolled in a blinded study. The su... Gastroenteritis; Dehydration; This 10-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 14-SEP-2023, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 14-SEP-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 14-SEP-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 14-SEP-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 10-JUL-2023, for prophylaxis. On 05-JAN-2024, 113 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV and Hiberix and 179 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 gastroenteritis (Verbatim: Gastroenteritis). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 dehydration (Verbatim: Dehydration) on 05-JAN-2024 with serious criteria of hospitalization. The subject was treated with sodium chloride, ondansetron, ibuprofen, glucose (Dextrose) and ranitidine hydrochloride (Mylanta). The action taken with Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation was no change. The outcome of gastroenteritis was resolved on 15-JAN-2024. The outcome(s) of the additional event(s) included dehydration (resolved on 09-JAN-2024). Relevant Tests: Due to low bicarb and decreased glucose, patient was admitted for IV fluids. On an unknown date in Jan 2024 X-ray Impression showed, Nonobstructive bowel gas pattern. Small amount of stool in the colon. Couple of scattered air-fluid levels in a nonspecific pattern are noted on the decubitus view. No pneumoperitoneum, No pneumatosis, No portal venous gas. No calcifications. Lung bases are clear. Osseous structures are unremarkable. The investigator considered that there was no reasonable possibility that the gastroenteritis and dehydration may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the gastroenteritis and dehydration may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. GSK receipt date: 09-JAN-2024, 10-JAN-2024 and 15-JAN-2024. Parent reported onset of vomiting and diarrhea on 05Jan2024. Subject presented to the ER (Emergency room) on 08Jan2024 and was subsequently admitted for gastroenteritis and dehydration. Subject was admitted on 08Jan2024 and was discharged on 09Jan2024. Per the hospital record, subject presented with diarrhea and vomiting and one wet diaper that day. Subject had been pulling at right ear. Subject had persistent OM in the right ear and received Ceftriaxone on 12/31 and Jan. 1. Crying at home like he was in pain. Diarrhea and vomiting since 1/5. Other family members have had it. Decreased activity, increased sleep and decreased PO on 08Jan2024. History of persistent otitis media, no chronic illness, never hospitalized. PE noted Frequent crying at home today. Dull TM left ear. Decreased bowel sounds. Erythematous diaper area, liquid yellow stool. Remainder of exam normal. Follow up information received on 21-MAR-2024 Summary of changes: Dose updated as unknown for Mylanta Follow up information received on 08-JUL-2024 Summary of changes: General narrative comment updated. Follow up information received on 23-OCT-2024 Summary of changes: Outcome of event was updated from Not Recovered/ Not Resolved to Recovered/Resolved for Gastroenteritis and Dehydration Event end date updated for Gastroenteritis was 15-Jan-2024 and for Dehydration was 5-Jan-2024, Narrative was updated Follow up information received on 06-NOV-2024, 11-NOV-2024 Summary of changes: General narrative comments updated. Follow up information received on 06-JAN-2025 Summary of changes: Treatment drug name updated Dextrose to Dextrose 5%. Upon internal review the case was updated on: 08-Jan-2025 : The suspect product mmR and virvax removed.; Sender's Comments: A case of Gastroenteritis and Dehydration, 113 days after receiving 3rd dose of Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV and Hiberix, 179 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 10-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. More
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2819896 M 01/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Tinnitus Tinnitus
Triggers tinnitus; This non-serious case was reported by a consumer and described the occurrence of ... Triggers tinnitus; This non-serious case was reported by a consumer and described the occurrence of tinnitus in a 67-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced tinnitus (Verbatim: Triggers tinnitus). The outcome of the tinnitus was not resolved. It was unknown if the reporter considered the tinnitus to be related to RSV vaccine. It was unknown if the company considered the tinnitus to be related to RSV vaccine. Additional Information: GSK Receipt Date: 12-DEC-2024 The patient self-reported this case. The patient received RSV vaccine and stated that vaccine triggered tinnitus and was impossible to avoid except by never watching TV and the symptoms were not treated More
2819897 U CA 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect dose administered, Product preparation issue Incorrect dose administered, Product preparation issue
Antigen was not reconstituted with adjuvant; Antigen was not reconstituted with adjuvant; This non-s... Antigen was not reconstituted with adjuvant; Antigen was not reconstituted with adjuvant; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Antigen was not reconstituted with adjuvant) and inappropriate dose of vaccine administered (Verbatim: Antigen was not reconstituted with adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 18-DEC-2024 The pharmacist reported the patient had Shingrix vaccine and for antigen was not reconstituted with adjuvant, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered More
2819898 U 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain Herpes zoster, Pain
Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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 shingles (Verbatim: Shingles). The outcome of the shingles was resolved (duration 1 week). 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: 09-DEC-2024 This case was reported by a patient via interactive digital media. Reporter indicated it was so horrible. Reporter had it 3 times but only with pain, no rash. The pain was horrible. Reporter got vaccinated with 1 dose because the reaction was horrible also for a week. The follow-up could not be possible as no contact details were available. More
2819899 M 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Dizziness, Feeling abnormal Dizziness, Feeling abnormal
Very sick; Shingrix shot kicked to butt; Felt bad; This non-serious case was reported by a physician... Very sick; Shingrix shot kicked to butt; Felt bad; This non-serious case was reported by a physician via market research programs and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: Very sick), feeling unwell (Verbatim: Shingrix shot kicked to butt) and feeling bad (Verbatim: Felt bad). The outcome of the sickness was resolved and the outcome of the feeling unwell and feeling bad were not reported. The reporter considered the sickness to be related to Shingrix. It was unknown if the reporter considered the feeling unwell and feeling bad to be related to Shingrix. The company considered the sickness to be related to Shingrix. It was unknown if the company considered the feeling unwell and feeling bad to be related to Shingrix. Additional Information: GSK Receipt Date: 11-DEC-2024 The reporter reported that pretty early when Shingrix came out, the patient jumped on it and got it in the next week in the morning huddle where the plan out the day, he said by the way know the literature as chances of bad reaction was 2 percent with Shingrix. The reporter said he took Shingrix shot last week and it kicked to butt, very sick felt so badly so missed work and did not go to work the next day. More
2819900 U 01/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Cough Cough
coughing their hearts out; This non-serious case was reported by a consumer via interactive digital ... coughing their hearts out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: coughing their hearts out). The outcome of the cough was not reported. It was unknown if the reporter considered the cough to be related to RSV vaccine. It was unknown if the company considered the cough to be related to RSV vaccine. Additional Information: GSK Receipt Date: 09-DEC-2024 This case was reported by a patient via interactive digital media. Consumer reported that he/she had met a lot of older people coughing their hearts out, after taking the RSV vaccine. The follow-up could not be possible as no contact details were available. More
2819901 M TN 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster Herpes zoster
Shingles; This non-serious case was reported by a physician via sales rep and described the occurren... Shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. 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: 12-DEC-2024 The patient had developed shingles about one week after taking a dose of Shingrix (the reporter believed that it was first of two dose series). No other patient information was provided at the time of discussion. More
2819902 F NC 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 354M3
Incomplete course of vaccination Incomplete course of vaccination
patient the vaccine dripped out of the collar of the syringe resulting in an incomplete dose; This n... patient the vaccine dripped out of the collar of the syringe resulting in an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis. On 08-DEC-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: patient the vaccine dripped out of the collar of the syringe resulting in an incomplete dose). The outcome of the incomplete dose administered was unknown. Additional Information: GSK Receipt Date: 09-DEC-2024 The pharmacist called to report while administering the second dose of Shingrix to a patient the vaccine dripped out of the collar of the syringe resulting in an incomplete dose. The Vaccine Administration Facility is the same as Primary Reporter. The reporter reported that no product quality complaint involved in this case since Shingrix was packed without syringes or needles. More
2819903 F PA 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Cough, Myalgia, Pyrexia, Respiratory tract congestion Chills, Cough, Myalgia, Pyrexia, Respiratory tract congestion
Congestion; Muscle aches; chills; cough; fever; This non-serious case was reported by a consumer via... Congestion; Muscle aches; chills; cough; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of nasal congestion in a adult 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, 2 days after receiving Shingrix, the patient experienced nasal congestion (Verbatim: Congestion), muscle pain (Verbatim: Muscle aches), chills (Verbatim: chills), cough (Verbatim: cough) and fever (Verbatim: fever). The outcome of the nasal congestion, muscle pain, chills, cough and fever were unknown. It was unknown if the reporter considered the nasal congestion, muscle pain, chills, cough and fever to be related to Shingrix. It was unknown if the company considered the nasal congestion, muscle pain, chills, cough and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 09-DEC-2024 The patient self-reported this case for herself. Customer (patient) reported that 2 days after she received the first Shingrix dose she started to experience cough, fever, chills, muscle aches, congestion. More
2819904 F 01/08/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Inappropriate schedule of product administration, Product use in ... Herpes zoster, Inappropriate schedule of product administration, Product use in unapproved indication, Skin lesion; Herpes zoster, Inappropriate schedule of product administration, Product use in unapproved indication, Skin lesion More
shingles; received a 2nd dose on 11/7/2024 after first daose administered in mar 2024; shingles in M... shingles; received a 2nd dose on 11/7/2024 after first daose administered in mar 2024; shingles in March of 2024 and was vaccinated shortly thereafter, while the existing lesions were still active; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 07-NOV-2024, the patient received the 2nd dose of Shingrix. On 01-MAR-2024, the patient received the 1st dose of Shingrix. On 01-MAR-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: shingles in March of 2024 and was vaccinated shortly thereafter, while the existing lesions were still active). On 07-NOV-2024, the patient experienced drug dose administration interval too long (Verbatim: received a 2nd dose on 11/7/2024 after first daose administered in mar 2024). On 27-NOV-2024, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles, drug dose administration interval too long and drug use for unapproved indication were unknown. It was unknown if the reporter considered the shingles to be related 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: 09-DEC-2024 The consumer reports that she experienced shingles in March of 2024 and was vaccinated shortly thereafter, while the existing lesions were still active, which led drug use for unapproved indication. The patient received 2nd dose of Shingrix and experienced full blown shingles just three weeks after that shot. The patient received 2nd dose at longer time than recommended, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up. More
2819905 4 F OK 01/08/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration, Wrong product administered Inappropriate schedule of product administration, Wrong product administered
Pediarix instead of Kinrix; inappropriate schedule of vaccine administered; This non-serious case wa... Pediarix instead of Kinrix; inappropriate schedule of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis. On 15-NOV-2024, the patient received Pediarix. On an unknown date, the patient did not receive Kinrix. On 15-NOV-2024, immediately after receiving Pediarix and not applicable after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Pediarix instead of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: inappropriate schedule of vaccine administered). The outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:09-DEC-2024 Nurse reported that a 4-year-old female patient received Pediarix instead of Kinrix which led to wrong vaccine administered and inappropriate schedule of vaccine administered. Considering this last Pediarix shot, patient had 5 Dtaps, 3 IPV doses and 3 hep B doses. More
2819906 50 F TX 01/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 KB2YT
Incorrect route of product administration, Local reaction Incorrect route of product administration, Local reaction
localized reaction in arm; administered the Shingrix Vaccine Subcutaneously instead of intramuscula... localized reaction in arm; administered the Shingrix Vaccine Subcutaneously instead of intramuscular; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number KB2YT, expiry date 29-OCT-2026) for prophylaxis. On 04-DEC-2024, the patient received the 1st dose of Shingrix (subcutaneous, left arm). On 04-DEC-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered the Shingrix Vaccine Subcutaneously instead of intramuscular). On an unknown date, the patient experienced local reaction (Verbatim: LOCALIZED REACTION IN LEFT ARM). The outcome of the intramuscular formulation administered by other route and local reaction were unknown. It was unknown if the reporter considered the local reaction to be related to Shingrix. It was unknown if the company considered the local reaction to be related to Shingrix. Additional Information: GSK receipt date: 09-DEC-2024 The reporter reported that patient had administered the Shingrix Vaccine Subcutaneously instead of Intramuscularly which lead to intramuscular formulation administered by other route. The patient had a localized reaction, but physician wanted to double check, as there any information to pass along to the patient about whether or not patient would need to re-do the vaccine. More
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