🏥 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 💀 🏥 🚑 ♿ ⚠️
2839512 78 F TX 05/05/2025 COVID19
 MODERNA
 3042646
Fatigue, Hypersomnia, Lethargy, Pyrexia Fatigue, Hypersomnia, Lethargy, Pyrexia
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient reported... Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient reported SEs after last Covid dose which were described as 'slept a lot, and felt like I had a fever.', Other Vaccines: VaccineTypeBrand: Fluzone High-Dose Trivalent; Manufacturer: Sanofi-Pasteur; LotNumber: UT8463DA; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 09/07/2024 More
2839513 69 F CA 05/05/2025 COVID19
 MODERNA
 8080750
Injection site swelling, Nausea Injection site swelling, Nausea
Site: Swelling at Injection Site-Medium, Systemic: Nausea-Medium Site: Swelling at Injection Site-Medium, Systemic: Nausea-Medium
2839514 78 F NC 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 53XH9
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injecti... Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Small amount of redness and swelling below injection site. No discharge. Pt not running a fever that she is aware of. Counseled to take Tylenol, monitor for increase in swelling and redness and follow up with PCP. Informed pt we would call and check on her this weekend. More
2839515 52 M FL 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5816082311
Product preparation issue Product preparation issue
Systemic: Unconstituted diluent-Mild Systemic: Unconstituted diluent-Mild
2839516 AL 05/05/2025 MMRV
 MERCK & CO. INC.
 X023316
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; Inbound call received from a nurse who said a patient received a dose of PROQUAD a... No adverse event; Inbound call received from a nurse who said a patient received a dose of PROQUAD after it was improperly stored after a Temperature excursion. The dose was administered on 10MAR2025, prior to the expiry date. No patient name or additional informatio; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 10-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with sterile diluent (BAXTER STERILE DILUENT), lot #X023316, expiration date: 19-Mar-2025, administered for prophylaxis (dose, route od administration and anatomical site of injection were not reported). The vaccine administered experienced a temprature excursion of -10.1C for 3 hours and 40 minutes (Product storage error). No additional information was provided to further clarify the details, no previous temperature excursions and no additional adverse events were reported (no adverse events). This case is non-valid due to no patients' identifiers. More
2839517 62 M NJ 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55th4
Herpes zoster, Neuralgia, Rash Herpes zoster, Neuralgia, Rash
Systemic: Herpes rash on abdomen and arm. Nerve pain-Severe, Additional Details: Patient developed a... Systemic: Herpes rash on abdomen and arm. Nerve pain-Severe, Additional Details: Patient developed a rash along abdomen and arm and is being treated for nerve pain and shingles by MD, Other Vaccines: VaccineTypeBrand: shingrix; Manufacturer: glaxo smith kline biologicals; LotNumber: 55th4; Route: intra muscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN More
2839518 66 F CA 05/05/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 lx2497
lx2497
Dysphagia, Eye swelling, Mouth swelling, Paraesthesia, Pruritus; Rash, Swelling ... Dysphagia, Eye swelling, Mouth swelling, Paraesthesia, Pruritus; Rash, Swelling face, Swollen tongue, Throat tightness More
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify:... Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild More
2839519 16 F TX 05/05/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 A2B72
Dizziness, Nausea, Pallor Dizziness, Nausea, Pallor
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: Patient age 16 ... Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: Patient age 16 came in for 2nd of Priorix and Engerix vaccine. she stated on the Vaccine screening and consent form that she does get dizzy and faint after a vaccine. I had asked if this happened with the first two doses and she said no. After giving the vaccines i had patient sit down and wait and assessed her for any adverse effects. Patient started to get dizzy and looked pale. I took her blood pressure which was 106/63, patient also felt nauseous but felt better afterwards, Other Vaccines: VaccineTypeBrand: Priorix MMR; Manufacturer: Glaxosmithkline; LotNumber: XX9N4; Route: Left upper Arm; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Engerix BPEdi; Manufacturer: Glaxosmithkline; LotNumber: 7nx57; Route: LEft Deltoid; BodySite: ; Dose: ; VaxDate: UNKNOWN More
2839520 86 F CT 05/05/2025 RSV
 PFIZER\WYETH
 LG9828
Extra dose administered, No adverse event Extra dose administered, No adverse event
SECOND DOSE OF RSV VACCINE ADMINISTERED. NOT NEEDED UNDER CURRENT RECOMMENDATIONS. NO ADVERSE REACTI... SECOND DOSE OF RSV VACCINE ADMINISTERED. NOT NEEDED UNDER CURRENT RECOMMENDATIONS. NO ADVERSE REACTION REPORTED. More
2839521 66 F CA 05/05/2025 PNC20
 PFIZER\WYETH
 LX2497
Burning sensation, Injection site indentation, Injection site pain, Rash Burning sensation, Injection site indentation, Injection site pain, Rash
Patient is experiencing a sharp/dull pain and an indentation at injection site. Patient also has a r... Patient is experiencing a sharp/dull pain and an indentation at injection site. Patient also has a rash that burns. More
2839522 5 F WA 05/05/2025 DTAPHEPBIP
HEP
HEPA
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 x9ep5
42b22
y012227
y015991
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Hep B was administered although it was already part of the pediarix combo vaccine. Hep B was administered although it was already part of the pediarix combo vaccine.
2839523 1.25 M KY 05/05/2025 DTAPIPVHIB
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UK225AB
LX4484
Lip swelling, Urticaria; Lip swelling, Urticaria Lip swelling, Urticaria; Lip swelling, Urticaria
Hives and swelling to lip. Put on Benadryl. Still with some swelling to lip the next day. Hives and swelling to lip. Put on Benadryl. Still with some swelling to lip the next day.
2839524 0.67 F WI 05/05/2025 MMR
 MERCK & CO. INC.
 Y015834
Injection site erythema, Injection site irritation Injection site erythema, Injection site irritation
Injection given to left leg without incident. VIS given to mother. Rechecked after 10 minutes at 1... Injection given to left leg without incident. VIS given to mother. Rechecked after 10 minutes at 150 pm and injection site red and irritated. No rash to site, or to chest, stomach,arms, legs or back. Ice pack placed on leg will review with PCP. Rechecked at 2 pm with PCP. Ok to watch for a few more minutes. Rechecked at 212 pm. Site remains red. NO rash, trouble breathing, tongue swelling, lip swelling or other reaction. More
2839525 41 F GA 05/05/2025 ANTH
 EMERGENT BIOSOLUTIONS
 300216A
Injection site discolouration, Injection site erythema, Injection site swelling Injection site discolouration, Injection site erythema, Injection site swelling
Pt experienced her upper Rt arm was slightly erythematic, distally swollen to her elbow, with lines ... Pt experienced her upper Rt arm was slightly erythematic, distally swollen to her elbow, with lines of delineation. Patient showed me a picture of her arm the day after the vaccine, in which her whole upper extremity was erythematic, swollen and had a white poc mark where the injection was given More
2839526 12 M TN 05/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M77CC
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient did not have an adverse reaction Patient did not have an adverse reaction
2839527 4 F CA 05/05/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Erythema, Peripheral swelling Erythema, Peripheral swelling
Red thigh swollen and red. Prescribed ointment. Red thigh swollen and red. Prescribed ointment.
2839528 0.5 F IL 05/05/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient had Kinrix ordered instead of Pediarix. Patient received Kinrix and had no adverse reaction ... Patient had Kinrix ordered instead of Pediarix. Patient received Kinrix and had no adverse reaction noted while in office. MA realized after administration, Pediarix should have been ordered instead. More
2839530 71 F 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
pain, redness and swelling at injection site. Redness and swelling has increased in size over the l... pain, redness and swelling at injection site. Redness and swelling has increased in size over the last 5 days More
2839531 58 M FL 05/05/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
Vaccine is supposed to be given subcutaneously but was given intramuscularly instead Vaccine is supposed to be given subcutaneously but was given intramuscularly instead
2839532 0.58 F NM 05/05/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U7947AA
LK6653
2081735
Blood gases abnormal, Full blood count abnormal, Metabolic function test abnorma... Blood gases abnormal, Full blood count abnormal, Metabolic function test abnormal, Seizure, Urine analysis abnormal; Blood gases abnormal, Full blood count abnormal, Metabolic function test abnormal, Seizure, Urine analysis abnormal; Blood gases abnormal, Full blood count abnormal, Metabolic function test abnormal, Seizure, Urine analysis abnormal More
seizure occurred approx 3 hours post- vaccines, pt evaluated in ER seizure occurred approx 3 hours post- vaccines, pt evaluated in ER
2839533 11 F CO 05/05/2025 COVID19
 MODERNA
 3043023
No adverse event, Product storage error No adverse event, Product storage error
Upon visit the vaccine was found in the refrigerator and should have been in the freezer. No issues ... Upon visit the vaccine was found in the refrigerator and should have been in the freezer. No issues or symptoms reported by patient. More
2839534 13 M MO 05/05/2025 DTAP
 SANOFI PASTEUR
 3CA20C1
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was supposed to be getting a tdap and a dtap was entered into the system by a student of Dr. Patient was supposed to be getting a tdap and a dtap was entered into the system by a student of Dr.
2839535 10 F CO 05/05/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Product storage error Product storage error
Upon visit the vaccine was in the freezer and should have been in the refrigerator. Upon visit the vaccine was in the freezer and should have been in the refrigerator.
2839536 50 F AZ 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L944
Influenza like illness, Injection site erythema, Injection site warmth Influenza like illness, Injection site erythema, Injection site warmth
Patient stated she a dime size red area appeared around the site of injection approximately 2 days a... Patient stated she a dime size red area appeared around the site of injection approximately 2 days after she received the vaccine. On the third day, the red area was twice the size and hot to the touch. Patient also experienced flu like symptoms for about four days. Patient took Benadryl last night but she stated she did not think it helped. More
2839537 0.17 F TX 05/05/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7767AA
Crying, Injection site pain, Injection site swelling, Injection site warmth Crying, Injection site pain, Injection site swelling, Injection site warmth
Patient developed adverse symptoms approx. 1 hour after administration. became inconsolable and had ... Patient developed adverse symptoms approx. 1 hour after administration. became inconsolable and had radiating heat, swelling, and pain at injection site. patient given tylenol upon onset of symptoms without improvement after 10min. patient taken by mom to ED. Father notified this clinic More
2839538 0.5 F NY 05/05/2025 DTAPIPVHIB
HEP
PNC20
RV5
 SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 UK149AB
Y009551
LK6655
2051965
Culture wound, Skin lesion, Skin ulcer; Culture wound, Skin lesion, Skin ulcer; ... Culture wound, Skin lesion, Skin ulcer; Culture wound, Skin lesion, Skin ulcer; Culture wound, Skin lesion, Skin ulcer; Culture wound, Skin lesion, Skin ulcer More
Ulcerated skin lesion developed within 48hrs of receiving the Prevnar 20 vaccine in left thigh. Ski... Ulcerated skin lesion developed within 48hrs of receiving the Prevnar 20 vaccine in left thigh. Skin culture obtained. Started Mupirocin Ointment. Consider oral antibiotics if not improving. More
2839539 54 M WA 05/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 58160-0823-11
58160-0823-11
Chills, Injection site pain, Malaise, Myalgia, Oropharyngeal discomfort; Pharyng... Chills, Injection site pain, Malaise, Myalgia, Oropharyngeal discomfort; Pharyngeal inflammation, Sputum discoloured More
On day of injection, mild to moderate soreness at injection site. No erythmea or nother symptoms. Ne... On day of injection, mild to moderate soreness at injection site. No erythmea or nother symptoms. Next morning, slight throat discomfort, which intensified over the next 24 hours. Overnight, symptoms included severe sore throat, inflammed pharynx, slight green phlegm (to the point of raspy breathing), no fever (97.1), there was chills/shivering, no shortness of breath, there was malaise and moderate diffuse myalgia. Symptoms improved vastly within about 6 hours of peak with supportive care and rest at home. More
2839540 M SC 05/05/2025 PNC21
 MERCK & CO. INC.
Injection site pain, Lethargy, Pyrexia, Sinus headache Injection site pain, Lethargy, Pyrexia, Sinus headache
about 8 hours after vaccination he began to have what he described as mild to moderate non-serious a... about 8 hours after vaccination he began to have what he described as mild to moderate non-serious adverse reactions of sinus headache, pain at injection site; pain at injection site; feeling feverish but no fever; lethargy; This spontaneous report was received from a physician and refers to a 70-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported. On 01-May-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection, 0.5 mL, administered as prophylaxis (strength, Lot No., expiration date, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided). On the same date (01-May-2025, reported as about 8 hours after vaccination) he experienced as mild to moderate non-serious adverse reactions of sinus headache, pain at injection site (vaccination site pain), feeling feverish but no fever (pyrexia) and lethargy. At the reporting time, the patient was recovering from all the events The causal relationship between all the events with the suspect vaccine was not reported. More
2839542 OK 05/05/2025 HPV9
 MERCK & CO. INC.
 X019625
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE reported; A nurse called to report a 15 year old patient received an expired dose o... No additional AE reported; A nurse called to report a 15 year old patient received an expired dose of GARDASIL 9 ON 01MAY2025. The caller declined to answer any additional questions. No additional information provided. No additional AE reported. No PQC.; This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 01-May-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), lot #X019625, expiration date: 23-Apr-2025, administered for prophylaxis (dose, route of administration and anatomical site of injection) (expired product administered). No additional information and no additional adverse events were provided (no adverse event). More
2839543 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Senso... Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Sensory disturbance More
got shingles 2 weeks later. I refused the 2nd shot. In my eye, temple, head area.; had nerve sensati... got shingles 2 weeks later. I refused the 2nd shot. In my eye, temple, head area.; had nerve sensations for months after; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: got shingles 2 weeks later. I refused the 2nd shot. In my eye, temple, head area.) (serious criteria GSK medically significant) and sensory disturbance (Verbatim: had nerve sensations for months after). The outcome of the ophthalmic herpes zoster was not reported and the outcome of the sensory disturbance was resolved. It was unknown if the reporter considered the ophthalmic herpes zoster and sensory disturbance to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the sensory disturbance to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that had the first shot, got shingles 2 weeks later. The reporter refused the 2nd shot, the patient had experienced in his/her eye, temple, head area. The patient lived on the couch over 2 months and had to see doctor and eye doctor. The patient looked like a monster, even after the poxs were gone the patient had nerve sensations for months after.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2839544 61 F TX 05/05/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 T75MP
Pain in extremity Pain in extremity
left arm and complains of worse pain than last year; This non-serious case was reported by a contact... left arm and complains of worse pain than last year; This non-serious case was reported by a contact via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number T75MP) for prophylaxis. On 20-SEP-2024, the patient received FluLaval 2024-2025 season (intramuscular, left arm). On 20-SEP-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced pain in arm (Verbatim: left arm and complains of worse pain than last year). The outcome of the pain in arm was not resolved. The reporter considered the pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The company considered the pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 21-MAR-2025 Reporter reported that she had patient that received Flulaval on 20th September 2024 in the left arm and complained of worse pain than last year. More
2839545 F NJ 05/05/2025 FLUX
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Pain in extremity, X-ray limb normal Arthralgia, Pain in extremity, X-ray limb normal
left arm and pain; shoulder pain; This non-serious case was reported by a consumer via call center r... left arm and pain; shoulder pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received belimumab (Benlysta) (batch number Unknown) for systemic lupus erythematosus. Co-suspect products included Flu unspecified (Flu vaccine) for flu prevention. On an unknown date, the patient started Benlysta. In NOV-2024, the patient received Flu vaccine. In DEC-2024, an unknown time after receiving Benlysta and Flu vaccine, the patient experienced pain in arm (Verbatim: left arm and pain) and shoulder pain (Verbatim: shoulder pain). The action taken with Benlysta and Flu vaccine was unknown. The outcome of the pain in arm and shoulder pain were not resolved. It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Benlysta and Flu vaccine. Linked case(s) involving the same patient: US2020237640 GSK receipt date: 07-APR-2025 This case was received from Consumer. Caller was the patient and experienced user of Benlysta IV for LUPUS SLE, for 3 to 4 years. Caller reports she received her flu vaccine in Nov 2024 in her left arm. Caller reports in Dec 2024 for left arm and shoulder was very painful and was still persisting to this day. Caller read the Benlysta can cause extremity pain. She was not sure if the Benlysta or the Flu shot maybe what was causing the arm pain. Caller went to Urgent Care in Feb 2025 due to the left arm and shoulder pain. They took an x-ray and nothing was broken. Caller can supply a complete list of other medications she takes.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR207413:same reporter US-GLAXOSMITHKLINE-US2020237640:same Patient/ new case is created because of time gape. More
2839546 48 F 05/05/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Cardiac stress test, Cardiac valve disease, Echocardiogram abnormal, Electrocard... Cardiac stress test, Cardiac valve disease, Echocardiogram abnormal, Electrocardiogram ambulatory normal, Pain; Product administered to patient of inappropriate age, Schirmer's test abnormal; Cardiac stress test, Cardiac valve disease, Echocardiogram abnormal, Electrocardiogram ambulatory normal, Pain; Product administered to patient of inappropriate age, Schirmer's test abnormal More
Pain in the area of previous shingles; Inappropriate age at vaccine administration; Inappropriate ag... Pain in the area of previous shingles; Inappropriate age at vaccine administration; Inappropriate age at vaccine administration; This non-serious case was reported by a consumer and described the occurrence of pain in a 48-year-old female patient who received Herpes zoster (Shingrix) for varicella zoster. Co-suspect products included Herpes zoster (Shingrix) for varicella zoster, Ocrelizumab (Ocrevus) for prophylaxis and Ocrelizumab (Ocrevus) for prophylaxis. The patient's past medical history included shingles (Shingles on 9th July 2020 lasting for 4 months), corneal erosion (7/01-10/01), iritis (7/01), myopia, astigmatism, presbyopia, cataract (2022), sjogren's, hypertension, tachycardia and chest tightness. Previously administered products included Valtrex (tarted Valtrex within hours of Shingles). Additional patient notes included Low grade squamous epithelial lesion on Pap, squamous metaplasia, koilocytotic atypia on colpo, high risk HPV+ (not 16 & 1Heme Iron deficiency, Endocrine: Metabolic syndrome, Hgb A1c 6.1, Metformin side effect Hyperlipidemia, started Atorvastatin, Hashimoto's thyroiditis /Hypothyroid-on and off Synthroid (see lab list)Febrile seizures, Arachnoid cyst T4 (Windsock type) Multiple sclerosis, C4 & C6 lesions, multi small brain lesions Musculoskeletal: lumbar T score -1.35, hip T score -0.02 NSAID's, Ice R hip pain stiff mid 20's, pain early 30's, inject, R knee effusion, L Biceps tendinitis, Melanonychia. On 28-JAN-2021, the patient received the 1st dose of Shingrix. On 27-APR-2021, the patient received the 2nd dose of Shingrix. On 20-OCT-2022, the patient received the 1st dose of Ocrevus. On 24-OCT-2024, the patient received the 2nd dose of Ocrevus. On 28-JAN-2021, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 27-APR-2021, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 21-OCT-2024, the patient experienced pain (Verbatim: Pain in the area of previous shingles). The patient was treated with valaciclovir hydrochloride (Valtrex) and aciclovir sodium (Acyclovir). (Dechallenge was negative). (Dechallenge was negative). On 22-JAN-2025, the outcome of the pain was resolved with sequelae (duration 3 months 1 day). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable. It was unknown if the reporter considered the pain to be related to Shingrix and Shingrix. It was unknown if the company considered the pain to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 11-APR-2025 The patient had shingles starting on 9th July 2020 and lasting 4 months. The patient started Valtrex within hours. The patient was only 48 at the time she took Shingrix and had quite the ordeal getting it before age 50, but did finally manage to get it in early 2021 as noted which led to inappropriate age at vaccine administration. The patient started Ocrevus on 20th October 2022. The doe of 21st October 2024 dose was delayed because of pain in the area of previous shingles. The Valtrex was again started within hours, 1g TID for 7 days, and pain lasted for 3 months. Ocrevus was given on 24th October 2024 and early in the morning on 10th April 2025, she awoke with pain in the same dermatome. The next Ocrevus dose was in 2 weeks. The patient started 800mg acyclovir 5 times a day in liquid suspension this afternoon. More
2839547 IL 05/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Pain in extremity, Pyrexia Pain in extremity, Pyrexia
Fever; pain in limbs; This non-serious case was reported by a physician via call center representati... Fever; pain in limbs; This non-serious case was reported by a physician via call center representative and described the occurrence of fever in a specified number of patients who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced fever (Verbatim: Fever) and pain in limb (Verbatim: pain in limbs). The outcome of the fever and pain in limb were unknown. It was unknown if the reporter considered the fever and pain in limb to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the fever and pain in limb to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 21-APR-2025 The physician stated that two patients developed fever and pain in limbs after their first dose of Bexsero. The reporter did not have any patient identifiers at that time.; Sender's Comments: US-GSK-US2025047867:same reporter More
2839548 M OH 05/05/2025 RVX
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Erythema, Pruritus, Swelling, Urticaria; Erythema, Pruritus, Swelling, Urticaria Erythema, Pruritus, Swelling, Urticaria; Erythema, Pruritus, Swelling, Urticaria
Hives; Swelling; Itching; Redness/ redness keeps going down the arm; This non-serious case was repor... Hives; Swelling; Itching; Redness/ redness keeps going down the arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 15-APR-2025, the patient received Shingles vaccine (left arm) and RSV vaccine (left arm). On 18-APR-2025, 3 days after receiving Shingles vaccine and RSV vaccine, the patient experienced erythema of extremities (Verbatim: Redness/ redness keeps going down the arm). On an unknown date, the patient experienced hives (Verbatim: Hives), swelling (Verbatim: Swelling) and pruritus (Verbatim: Itching). The outcome of the hives, erythema of extremities, swelling and pruritus were not resolved. It was unknown if the reporter considered the hives, erythema of extremities, swelling and pruritus to be related to Shingles vaccine and RSV vaccine. It was unknown if the company considered the hives, erythema of extremities, swelling and pruritus to be related to Shingles vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 21-APR-2025 The patient received the Shingles Vaccine and the RSV Vaccine on Tuesday, 15 April, 2025. Both vaccines were injected in the Left arm. The patient was unable to provide the manufacturer or brand names of either vaccine. It was not disclosed if the Shingles vaccine was the first or second dose. On Friday, 18 April 2025 the patient began to notice redness. And since this time has been experiencing hives, swelling, and itching. The redness kept going down the arm.. More
2839549 57 F NC 05/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Chills, Diarrhoea, Headache, Inappropriate schedule of product administration, I... Chills, Diarrhoea, Headache, Inappropriate schedule of product administration, Influenza like illness; Insomnia, Sinus pain More
Shivering; Headache; Sinus pain; Diarrhea; Insomnia; Flu like symptoms; Inappropriate schedule of va... Shivering; Headache; Sinus pain; Diarrhea; Insomnia; Flu like symptoms; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received her first dose of vaccine in 2017). On 16-APR-2025, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 16-APR-2025, an unknown time after receiving Shingrix, the patient experienced shivering (Verbatim: Shivering), headache (Verbatim: Headache), sinus pain (Verbatim: Sinus pain), diarrhea (Verbatim: Diarrhea), insomnia (Verbatim: Insomnia), influenza-like symptoms (Verbatim: Flu like symptoms) and drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). On 21-APR-2025, the outcome of the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms were resolved (duration 5 days). The outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms to be related to Shingrix. Additional Information: GSK receipt date: 22-APR-2025 The reporter was the patient who received her first dose of vaccine in 2017 and received the second dose of vaccine on 16th April 2025 in her left arm. Reporter did not had lot number or any information to identify the vaccines. The reporter identified or called the vaccine as Shingrix. The reporter stated after the second dose of vaccine she had shivering, headache, sinus pain, diarrhea, insomnia and flu like symptoms immediately after vaccination. The symptoms lasted 5 days after the second vaccine then resolved. More
2839550 F VA 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not yet received the second dose; This non-serious case was reported by a consumer via call cent... has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (Received Zostavax 22 April 2013), Shingrix (The patient received the first dose of shingrix on 15 August 2018, 50mcg, intramuscularly.) and Methotrexate (had a history of taking Methotrexate for arthritis and unclear if arthritis was a preexisting condition, patient had been off of Methotrexate for 3 weeks). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 23-APR-2025 The patient had not yet received the second dose. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. More
2839551 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not had the second dose; This non-serious case was reported by a consumer via call center repres... has not had the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received 1st dose of Shingrix, intramuscularly injection to deltoid in May 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not had the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 23-APR-2025 The patient reported that she had her first dose of Shingrix in March of 2024. She did not had the second dose, which was due between May, 2024 and September 2024. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. More
2839552 71 M NM 05/05/2025 PPV
PPV
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Abdominal pain upper, Chest pain, Chills, Dyspnoea, General physical condition a... Abdominal pain upper, Chest pain, Chills, Dyspnoea, General physical condition abnormal; Haematemesis, Influenza, Pyrexia, Throat irritation, Throat tightness; Abdominal pain upper, Chest pain, Chills, Dyspnoea, General physical condition abnormal; Haematemesis, Influenza, Pyrexia, Throat irritation, Throat tightness More
Fever; Chills; Body pain; Stomach pain; Chest pain; Cannot breathe/ his throat closes up; Spit up bl... Fever; Chills; Body pain; Stomach pain; Chest pain; Cannot breathe/ his throat closes up; Spit up blood; Flu symptoms like cold; Irritated throat; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date). On 22-APR-2025, the patient received the 2nd dose of Shingrix (right arm) and Pneumococcal vaccine (left arm). On 22-APR-2025, an unknown time after receiving Shingrix and Pneumococcal vaccine, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), general body pain (Verbatim: Body pain), stomach pain (Verbatim: Stomach pain), chest pain (Verbatim: Chest pain), difficulty breathing (Verbatim: Cannot breathe/ his throat closes up), sputum bloody (Verbatim: Spit up blood), cold (Verbatim: Flu symptoms like cold) and throat irritation (Verbatim: Irritated throat). The outcome of the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation were not resolved. It was unknown if the reporter considered the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation to be related to Shingrix and Pneumococcal vaccine. It was unknown if the company considered the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation to be related to Shingrix and Pneumococcal vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 The reporter is the wife calling on behalf of her husband who was a male patient that received his second dose of Shingrix a day before reporting, 22-APR-2025, in his right arm, and reported that ever since he received the vaccine, he had had a lot of fever, chills, body pain, stomach pain, chest pain, and flu symptoms like a cold. The reporter also reported that when the patient was sleeping, he felt like he cannot breathe, his throat closes, and he had to spit up blood it was so irritated. The reporter stated that the patient was still experiencing all the above reported adverse events on the day of reporting, 23-APR-2025. The reporter also reported that the patient received his Pneumonia Vaccine at the same time as his second Shingrix vaccine, but in his left arm. The reporter had no paperwork from either vaccine. More
2839553 TX 05/05/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Rotavirus infection, Vaccination failure Rotavirus infection, Vaccination failure
Suspected vaccination failure; breakthrough Rotavirus cases after administration with Rotarix with m... Suspected vaccination failure; breakthrough Rotavirus cases after administration with Rotarix with multiple patients; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and rotavirus infection (Verbatim: breakthrough Rotavirus cases after administration with Rotarix with multiple patients) (serious criteria other: Serious as per reporter). The outcome of the vaccination failure was not reported and the outcome of the rotavirus infection was unknown. The reporter considered the vaccination failure and rotavirus infection to be related to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. The company considered the vaccination failure and rotavirus infection to be unrelated to Rotavirus vaccine and Rotarix Unspecified Oral Administation 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 : 24-APR-2025 Clinical lead reported breakthrough Rotavirus cases after administration with Rotarix with multiple patients. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE. Rotavirus is an unlisted event which is considered unrelated to GSK vaccine Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE. More
2839554 M VA 05/05/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Blister, Blister rupture, Chest pain, Herpes zoster, Pain; Vaccination failure; ... Blister, Blister rupture, Chest pain, Herpes zoster, Pain; Vaccination failure; Blister, Blister rupture, Chest pain, Herpes zoster, Pain; Vaccination failure More
Suspected vaccination failure; shingles/ blisters on his right side of neck/ somewhat painful; This ... Suspected vaccination failure; shingles/ blisters on his right side of neck/ somewhat painful; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). On 20-APR-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/ blisters on his right side of neck/ somewhat painful). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 24-APR-2025 The reporter called and stated he was a healthcare professional that had taken both Shingrix vaccine and on Sunday, noticed 2 blisters on his right side of neck that erupted and was ongoing. On Monday, (21-APR-2025) on the right side of the chest was somewhat painful and was ongoing. On Thursday, (24-APR-2025) reporter went to the doctor and was diagnosed with shingles. All the shingles vaccines that were administered to patient, this was a normal occurrence. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2839555 F 05/05/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Myalgia, Pain in extremity Myalgia, Pain in extremity
Arm pain, and muscular pain; Arm pain, and muscular pain; This non-serious case was reported by a co... Arm pain, and muscular pain; Arm pain, and muscular pain; This non-serious case was reported by a consumer and described the occurrence of myalgia upper extremities in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included ulcerative colitis and anxiety. Concomitant products included mesalazine (Lialda), alprazolam (Xanax) and zolpidem tartrate (Zopidem). On 25-APR-2025, the patient received RSV vaccine. On 25-APR-2025, less than a day after receiving RSV vaccine, the patient experienced myalgia upper extremities (Verbatim: Arm pain, and muscular pain) and pain in arm (Verbatim: Arm pain, and muscular pain). The outcome of the myalgia upper extremities and pain in arm were not resolved. It was unknown if the reporter considered the myalgia upper extremities and pain in arm to be related to RSV vaccine. It was unknown if the company considered the myalgia upper extremities and pain in arm to be related to RSV vaccine. Additional Information: GSK Receipt Date: 28-APR-2025 The reporter reported that had ulcerated colitis being treated with a drug that impairs immune system been in total remission for this same 13 year. The patient received RSV vaccine and experienced mild to moderate arm pain from any vaccine, but this was the worst yet. More
2839556 05/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
Shingles; This non-serious case was reported by a consumer via call center representative and descri... Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 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 shingles (Verbatim: Shingles). The outcome of the shingles was unknown. 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: 01-MAY-2025 The reporter reported a friend of his developed shingles after receiving the first dose of Shingrix. More
2839557 05/05/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Cough, Feeling abnormal, Respiratory syncytial virus infection, Vaccination fail... Cough, Feeling abnormal, Respiratory syncytial virus infection, Vaccination failure More
Feeling miserable; Suspected vaccination failure; here I am on March 20 for Easter with RVS; This se... Feeling miserable; Suspected vaccination failure; here I am on March 20 for Easter with RVS; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 03-JAN-2025, the patient received RSV vaccine. On 20-MAR-2025, 76 days after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: here I am on March 20 for Easter with RVS). On an unknown date, the patient experienced feeling miserable (Verbatim: Feeling miserable). The outcome of the vaccination failure and feeling miserable were not reported and the outcome of the respiratory syncytial virus infection was not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and feeling miserable to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection and feeling miserable to be related to RSV vaccine. Additional Information: GSK receipt date: 21-APR-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine on January 3 and here on March 20 for Easter with RVS. Patient asked why? Patient was feeling very miserable and coughing like never coughed before. Patient did breathing treatments every 4 hours and keeping track of breathe saturation levels making sure it does not drop below 90 if it does patient had to go directly to hospital. Patient asked if the vaccine worth getting it or not. This case was considered as suspected vaccination failure as laboratory confirmation regarding RSV 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 laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
2839558 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; now suffer with shingles today as I type; This serious case was repor... Suspected Vaccination failure; now suffer with shingles today as I type; 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, between 1 and 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now suffer with shingles today as I type). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-APR-2025 This case was reported by a patient via interactive digital media. The patient got vaccinated 2 years ago on the 30th of this month and now suffered with shingles today as I type This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2839559 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; got the vaccine as an adult and still got shingles; This serious case... Suspected vaccination failure; got the vaccine as an adult and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (had as a kid). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the vaccine as an adult and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 24-APR-2025 This case was reported by a patient via interactive digital media. The patient had chicken pox as a kid, got the vaccine as an adult and still got shingles. The patient thought that his/her case wasn't as bad as some get, because he/she had the vaccine shot. The patient suggested to get vaccinated, if did not want shingles. The patient had a mild case but was painful. 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. More
2839560 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Blister, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure Blister, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Suspected vaccination failure; still got shingles recently; and still had some nerve pain in should... Suspected vaccination failure; still got shingles recently; and still had some nerve pain in shoulder, neck and the back of my head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles recently) and post herpetic neuralgia (Verbatim: and still had some nerve pain in shoulder, neck and the back of my head). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got the vaccine and still got shingles recently. Reporter reported didn't had a lot of blisters but the pain was horrible and still had some nerve pain in shoulder, neck and the back of my head. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2839561 05/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nervous system disorder Nervous system disorder
neurologically compromised; This non-serious case was reported by a consumer via interactive digital... neurologically compromised; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of neurological disorder nos in a specified number of patients 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 neurological disorder nos (Verbatim: neurologically compromised). Shingles vaccine was discontinued. The outcome of the neurological disorder nos was resolved (duration 2 weeks). It was unknown if the reporter considered the neurological disorder nos to be related to Shingles vaccine. It was unknown if the company considered the neurological disorder nos to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that these comments would drive reporter to the vaccination but 2 of reporter best friends had horrible reactions to the vaccination, that being neurologically compromised for about 2 weeks. It was bad, one phoned her doctor and said do not take the second vaccination. More
2839562 05/05/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Deafness unilateral, Neuralgia, Nodule, Pruritus, Pyrexia; Vaccination failure, ... Deafness unilateral, Neuralgia, Nodule, Pruritus, Pyrexia; Vaccination failure, Visual impairment, Vomiting, Zoster sine herpete More
Suspected vaccination failure; lost my hearing in my right ear; went blind in my right eye; shingles... Suspected vaccination failure; lost my hearing in my right ear; went blind in my right eye; shingles; I throw up yellow stuff; I get knots all over my body; it hurts my nerves in my body; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), hearing loss unilateral (Verbatim: lost my hearing in my right ear) (serious criteria GSK medically significant), blind right eye (Verbatim: went blind in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: shingles), vomiting (Verbatim: I throw up yellow stuff), nodule (Verbatim: I get knots all over my body) and post herpetic neuralgia (Verbatim: it hurts my nerves in my body). The outcome of the vaccination failure, hearing loss unilateral, blind right eye and vomiting were not reported and the outcome of the shingles, nodule and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, hearing loss unilateral, blind right eye, shingles, vomiting, nodule and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure, hearing loss unilateral and blind right eye to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, vomiting, nodule and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient had taken vaccine and thought he/she was going to die. Patient threw up yellow stuff, had run, and a high fever for three days. He/she came down with shingles, but they never appeared came out. He/she had been on medication for five years now. He/she had also nearly gone blind in his/her right eye and lost hearing in his/her right ear. Patient had developed knots all over his/her body and itching. The physician had said it was affecting the nerves in his/her body. He/she had felt like it was killing him/her from the inside out. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Blindness unilateral Deafness unilaterial are unlisted event which is considered unrelated to GSK Shingles vaccine. More
2839563 05/05/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had both Shingles shots and still got shingles a year later the suffering was horrible. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2) More
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