πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2830875 40 M VA 03/12/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 035C
035C
035C
027C
027C
027C
035C
035C
035C
027C
027C
027C
Brain fog, Cardiac disorder, Chronic fatigue syndrome, Heart rate increased, Hyp... Brain fog, Cardiac disorder, Chronic fatigue syndrome, Heart rate increased, Hypertension; Hypoaesthesia, Laboratory test, Malaise, Muscle spasms, Pain; Paraesthesia; Brain fog, Cardiac disorder, Chronic fatigue syndrome, Heart rate increased, Hypertension; Hypoaesthesia, Laboratory test, Malaise, Muscle spasms, Pain; Paraesthesia; Brain fog, Cardiac disorder, Chronic fatigue syndrome, Heart rate increased, Hypertension; Hypoaesthesia, Laboratory test, Malaise, Muscle spasms, Pain; Paraesthesia; Brain fog, Cardiac disorder, Chronic fatigue syndrome, Heart rate increased, Hypertension; Hypoaesthesia, Laboratory test, Malaise, Muscle spasms, Pain; Paraesthesia More
The list is lengthy and it's the same diverse group of symptoms that have been commonly reporte... The list is lengthy and it's the same diverse group of symptoms that have been commonly reported by thousands of injured people. Heart issues, excessive heart rate, high blood pressure, numbness in various body part, tingling sensation. Extensive chronic fatigue syndrom, exercise induced Post Exterional Malaise. Brain Fog. Adverse reactions appeared to occur shortly after 2nd Moderna Vaccine which I recieved on 10/13/2021. As you should all be aware right now there are no know treatments. I have tried to get into a coupld of long covid/vaccine injury studies but have been unae to since they have so many patients. This is my story: I am writing this letter to let you know about my journey from being what More
βœ“
2830876 51 F NJ 03/12/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Haemorrhage, Pharyngeal swelling, Urticaria; Haemorrhage, Pharyngeal swelling, U... Haemorrhage, Pharyngeal swelling, Urticaria; Haemorrhage, Pharyngeal swelling, Urticaria More
Hemorrhage for 27 days Hives entire body swelling in throat . I asked multiple times to address thi... Hemorrhage for 27 days Hives entire body swelling in throat . I asked multiple times to address this it took three trips back to the er the bleeding was ignored . I was given multiple steroid injections IM in both upper thighs . More
2830877 64 F NC 03/12/2025 PNC20
 PFIZER\WYETH
 lc5482
Injection site dermatitis, Rash erythematous Injection site dermatitis, Rash erythematous
Patient developed contact dermatitis in an area very close to the injection site. The red rash devel... Patient developed contact dermatitis in an area very close to the injection site. The red rash developed the following day and per our phone call today (3/12/25) the rash has went away. More
2830878 24 F NY 03/12/2025 JEV1
 INTERCELL AG
 JEV23K07E
Rash Rash
Client developed full body rash one hour after receiving vaccine Client developed full body rash one hour after receiving vaccine
2830879 5 M UT 03/12/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Expired product administered Expired product administered
Vaccine was administered after beyond use date. Vaccine was administered after beyond use date.
2830880 9 F UT 03/12/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LN302
UT8514JA
Expired product administered; Expired product administered Expired product administered; Expired product administered
Covid-19 Vaccine given after beyond use date. Covid-19 Vaccine given after beyond use date.
2830881 0.17 M OH 03/12/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U7907AA
LC5483
Y005907
Cough, Death, Pyrexia; Cough, Death, Pyrexia; Cough, Death, Pyrexia Cough, Death, Pyrexia; Cough, Death, Pyrexia; Cough, Death, Pyrexia
Patient found deceased by mother on 02/04/25. Fever started on 02/01/25 and patient woke up with cou... Patient found deceased by mother on 02/04/25. Fever started on 02/01/25 and patient woke up with cough on 02/02/25. More
βœ“
2830882 4 M TX 03/12/2025 DTAPIPV
DTAPIPV
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 4L454
4L454
Y018156
Y018156
Cough, Erythema, Measles antibody positive, Rash, Rash erythematous; Respiratory... Cough, Erythema, Measles antibody positive, Rash, Rash erythematous; Respiratory tract congestion; Cough, Erythema, Measles antibody positive, Rash, Rash erythematous; Respiratory tract congestion More
Redness to patient's cheeks noted on 3/6/2025. Generalized erythematous rash noted on 3/8/25 wh... Redness to patient's cheeks noted on 3/6/2025. Generalized erythematous rash noted on 3/8/25 when seen in ER. Mom also reported a temperature of 99 on 3/8 in addition to cough/congestion. On call Pediatrician had concerns about possible Parvovirus. However, wanted to rule out possible Measles infection. Measles antibodies and Meales PCR was obtained. PCP spoke with patient's father on 3/12/25 and it was noted that patient's rash had improved. More
2830883 4 F FL 03/12/2025 DTAP
MMRV
UNK
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
UNKNOWN MANUFACTURER


Erythema, Mobility decreased, Pain, Swelling, Vomiting; Erythema, Mobility decre... Erythema, Mobility decreased, Pain, Swelling, Vomiting; Erythema, Mobility decreased, Pain, Swelling, Vomiting; Erythema, Mobility decreased, Pain, Swelling, Vomiting More
Vomiting, redness, swelling, extreme pain to the point she can?t move her arm Vomiting, redness, swelling, extreme pain to the point she can?t move her arm
2830884 60 F CA 03/12/2025 COVID19
 PFIZER\BIONTECH
 FM9992
Biopsy skin abnormal, Skin cancer Biopsy skin abnormal, Skin cancer
I did not tolerate 2 booster biopsy, skin cancer I did not tolerate 2 booster biopsy, skin cancer
2830885 53 F OK 03/12/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 235D2
JS254
Injection site mass, Injection site scab, Injection site vesicles, Pain in extre... Injection site mass, Injection site scab, Injection site vesicles, Pain in extremity, Skin exfoliation; Injection site mass, Injection site scab, Injection site vesicles, Pain in extremity, Skin exfoliation More
Patient said that her arm got extremely sore, Had knots below the skin for each site on left arm, ev... Patient said that her arm got extremely sore, Had knots below the skin for each site on left arm, eventually a blister formed on her arm midway between injections sites that when she bathed the skin came off on the rag, and caused a sore that scabbed up afterwards. When she came into on 3/12/25 to have me look at her arm, the scab was present but the are was not red. Patient stated that the arm never got red just really sore. More
2830886 65 M MA 03/12/2025 PNC21
 MERCK & CO. INC.
 Y019158
Syringe issue Syringe issue
The vaccine syringe leaked even though the needle was applied correctly. The full amount of vaccine ... The vaccine syringe leaked even though the needle was applied correctly. The full amount of vaccine was discharged out above the needle. I have had this happen to a lesser degree with two other vaccine administrations of CapVaxive (e.g. I was giving the vaccine and noticed a small leak, and had to get a new needle and reapply it). More
2830887 1.25 F 03/12/2025 COVID19
DTAP
FLU3
HIBV
 MODERNA
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.



Rash; Rash; Rash; Rash Rash; Rash; Rash; Rash
viral exanthem like rash mostly head, neck and abdomen viral exanthem like rash mostly head, neck and abdomen
2830888 18 F NC 03/12/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 944917
Cellulitis, Immediate post-injection reaction, Swelling Cellulitis, Immediate post-injection reaction, Swelling
Pt was given the vaccine on 10 MAR 2025 at about 0820 and was told to wait 15 minutes in the waiting... Pt was given the vaccine on 10 MAR 2025 at about 0820 and was told to wait 15 minutes in the waiting room following vaccine. She states she noticed swelling immediately after receiving vaccine but did not bring it to the attention of clinic staff and left. Pt reported to the clinic the following day 11MAR2025 at around 1300 for treatment and was seen by an Independent Duty Corpsman. More
2830889 10 M UT 03/12/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Expired product administered Expired product administered
Vaccine administered after beyond use date. Vaccine administered after beyond use date.
2830890 61 F ND 03/12/2025 SMALL
SMALL
SMALL
SMALL
SMALL
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS




3X97J
3X97J
3X97J
3X97J
3X97J
Asthenia, Chills, Dysstasia, Headache, Injection site erythema; Injection site p... Asthenia, Chills, Dysstasia, Headache, Injection site erythema; Injection site pruritus, Injection site reaction, Injection site warmth, Nausea, Pain in extremity; Rash macular, Somnolence, Vomiting; Headache, Hypersomnia, Malaise, Mobility decreased, Nausea; Rash macular, Skin warm, Vomiting; Asthenia, Chills, Dysstasia, Headache, Injection site erythema; Injection site pruritus, Injection site reaction, Injection site warmth, Nausea, Pain in extremity; Rash macular, Somnolence, Vomiting; Headache, Hypersomnia, Malaise, Mobility decreased, Nausea; Rash macular, Skin warm, Vomiting More
It started March 5th with a sore arm. During the night I started to feel nausea. The following day... It started March 5th with a sore arm. During the night I started to feel nausea. The following day complete weekness difficulty getting off the couch. I slept most of the day. I also had chills and a terrible headache. I did end up throwing up, but it may be due to ibuprofen taken for headache. On March 8th my arm became blothcy, itchy, and warm near the injection site. By that evening it was one large red area around injection site (appoximately 5 inches diameter) and still warm. My arm still itches but is no longer red. More
2830891 26 F NC 03/12/2025 MMR
 MERCK & CO. INC.
 Y010372
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Employee received the MMR on 3/7/2025. Developed swollen, raised area to right upper arm. Employee c... Employee received the MMR on 3/7/2025. Developed swollen, raised area to right upper arm. Employee came to work on 3/10 with the area of the arm marked with swelling. Swelling and redness started to decrease. More
2830892 17 F NC 03/12/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Z29P4
Z29P4
Blood glucose normal, Eye pain, Haemoglobin normal, Headache, SARS-CoV-2 test ne... Blood glucose normal, Eye pain, Haemoglobin normal, Headache, SARS-CoV-2 test negative; Streptococcus test negative More
HEADACHE AND LEFT EYE PAIN X5 DAYS RESULTING IN 2 OFFICE VISITS. HAS FOLLOW UP APPT ON 3/14/25 TO RE... HEADACHE AND LEFT EYE PAIN X5 DAYS RESULTING IN 2 OFFICE VISITS. HAS FOLLOW UP APPT ON 3/14/25 TO RECHECK SYMPTOMS More
2830893 71 M FL 03/12/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN


Arthritis, Asthenia, Condition aggravated, Conjunctivitis, Inflammation; Joint d... Arthritis, Asthenia, Condition aggravated, Conjunctivitis, Inflammation; Joint dislocation, Muscle spasms, Musculoskeletal stiffness, Myalgia, Pain; Tremor, Urethritis More
Acute and subsequently/still chronic conjunctivitis, chronic urethritis, chronic arthritis (more phy... Acute and subsequently/still chronic conjunctivitis, chronic urethritis, chronic arthritis (more physically impactive than minor acute arthritis occasionally flaring up over years past after physical activity and now, since my vaccination, with significantly more and more widespread inflammation, stiffness, pain, and some subluxation in case of some fingers) even without any physical activity to provoke such substantial arthritis), chronic muscle pain, weakness, tremors (occasionally more like spasms), and slowed/diminished recovery than previously characteristic over lifetime from physical use - predominantly in lower extremities and back area. More
2830894 1 M TX 03/12/2025 DTAPIPV
 SANOFI PASTEUR
 U7838AA
No adverse event, Wrong product administered No adverse event, Wrong product administered
Quadracel accidently given at 1 year check up. Vaccines ordered were MMR, Varicella and Hepatitis A.... Quadracel accidently given at 1 year check up. Vaccines ordered were MMR, Varicella and Hepatitis A. MMR and Varicella given correctly, no Hepatitis A administered, will return to clinic for first dose of Hepatitis A at 15 month check up. Confirmed with provider of any side effects, if any, no side effects that should be present. Made Mother aware of incident explained no side effects should be present from vaccine. Reviewed report with Lead MA, Practice Manager, and Provider. More
2830895 13 M WI 03/12/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9PG49
No adverse event No adverse event
there were no adverse events there were no adverse events
2830896 0.5 F TX 03/12/2025 DTAPHEPBIP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 X9EP5
42B22
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Two vaccines with Hep B given to patient Two vaccines with Hep B given to patient
2830897 68 M TN 03/12/2025 MMRV
 MERCK & CO. INC.
 y008787
Wrong product administered Wrong product administered
Patient was given MMRV vaccine by mistake. Was meant to get MMR vaccine. Patient was given MMRV vaccine by mistake. Was meant to get MMR vaccine.
2830898 25 F CA 03/12/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945660
Asthenia, Feeling hot, Headache Asthenia, Feeling hot, Headache
patient started to experience fever-like symptoms, severe headache and weakness. patient started to experience fever-like symptoms, severe headache and weakness.
2830899 12 M CA 03/12/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 7GF79
X449Y
Injection site erythema, Injection site rash, Injection site warmth; Injection s... Injection site erythema, Injection site rash, Injection site warmth; Injection site erythema, Injection site rash, Injection site warmth More
mom states started with a small rash at the injection site on 03/11 and today 03/12 more redness and... mom states started with a small rash at the injection site on 03/11 and today 03/12 more redness and warm to touch. no pain. More
2830900 6 F CO 03/12/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Expired product administered Expired product administered
Vaccine was beyond BUD date when administered Vaccine was beyond BUD date when administered
2830902 65 M AK 03/12/2025 COVID19
COVID19
 MODERNA
MODERNA
 041J21A
041J21A
Aortic aneurysm, Asthenia, Computerised tomogram, Dysarthria, Hemiparesis; Labor... Aortic aneurysm, Asthenia, Computerised tomogram, Dysarthria, Hemiparesis; Laboratory test, Magnetic resonance imaging normal, Peripheral swelling, Scan with contrast, Tremor More
pt states a couple weeks after he got the second injection he started having tremors that were prima... pt states a couple weeks after he got the second injection he started having tremors that were primarily in the right hand and arm. Then noticed partial paralysis in the right side of his body in the right arm and leg. He has extreme weakness. He developed slurred speech that became worse. He then had swelling of the right arm and leg and left foot. He had a MRI that was negative. They couldn't find evidence of any strokes or tumors. He is now seeing 2 neurologist. Dr. and Dr.. He also has to see a cardiologist now since they have discovered he has a enlarged aortic aorta. Dr. at the Heart Institute. He continues to follow up with specialists to see if he can ever recover. More
βœ“ βœ“
2830903 62 F SC 03/12/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Arthralgia, Neck pain, Pain in extremity, Vaccination site bruising Arthralgia, Neck pain, Pain in extremity, Vaccination site bruising
Patient had bruising at vaccination site along with arm/shoulder/neck pain. Patient had bruising at vaccination site along with arm/shoulder/neck pain.
2830904 42 M IN 03/12/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 lj5283
lj5283
Chills, Injection site pain, Injection site pruritus, Injection site rash, Injec... Chills, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth; Nausea, Vomiting More
rash near the injection site with itching, warmth, pain. Associated Nausea, vomiting and chills. Sta... rash near the injection site with itching, warmth, pain. Associated Nausea, vomiting and chills. Started a few days after vaccine. More
2830905 36 F IA 03/12/2025 COVID19
MMR
 PFIZER\BIONTECH
MERCK & CO. INC.
 LM2223
X05827
Expired product administered; Expired product administered Expired product administered; Expired product administered
covid vaccine administered on 3/12/25 had expiration date of 3/11/2025 covid vaccine administered on 3/12/25 had expiration date of 3/11/2025
2830906 53 F MA 03/12/2025 COVID19
COVID19
 MODERNA
MODERNA

Arthralgia, Fatigue, Impaired work ability, Inflammation, Joint stiffness; Pain ... Arthralgia, Fatigue, Impaired work ability, Inflammation, Joint stiffness; Pain in extremity, Rheumatoid arthritis, Swelling More
Had 2nd Moderna COVID19 vaccine on 4-14-2021. Symptoms related to rheumatoid arthritis started somet... Had 2nd Moderna COVID19 vaccine on 4-14-2021. Symptoms related to rheumatoid arthritis started sometime in April, noticed pain in both wrists. This progressed into worse pain and inflammation throughout fingers, wrists, toes, becoming severe and with joint stiffness, swelling, and exhaustion. Saw a rheumatologist in June 2021 and was diagnosed with rheumatoid arthritis. Have tried several medications to treat the RA over the course of these last few years with limited success as still experiencing moderate to severe rheumatoid arthritis. Had to resign from my teaching position. Have not been able to play the piano or other musical instruments since April 2021. I was a music teacher and musician and have not been able to work. More
βœ“
2830907 10 M NV 03/12/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered Expired product administered
vaccine was administered after BUD which was 11/13/24. vaccine was administered after BUD which was 11/13/24.
2830908 7 F NV 03/12/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered Expired product administered
vaccine was administered after BUD which was 11/13/24 vaccine was administered after BUD which was 11/13/24
2830909 11 F NV 03/12/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered Expired product administered
vaccine was administered after BUD which was 11/13/24 vaccine was administered after BUD which was 11/13/24
2830910 78 F TN 03/12/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LM3XG
LM3XG
Fatigue, Headache, Injection site reaction, Injection site swelling, Injection s... Fatigue, Headache, Injection site reaction, Injection site swelling, Injection site warmth; Pyrexia, Rash pruritic More
Patient had typical fever, fatigue and headache for 2 days. Patient complaint was over a rash locate... Patient had typical fever, fatigue and headache for 2 days. Patient complaint was over a rash located below the inject site and wrapping around the arm. Rash was warm, red, itchy and had some swelling under the skin. More
2830911 8 M NV 03/12/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered Expired product administered
vaccine was administered after BUD which was 11/13/24 vaccine was administered after BUD which was 11/13/24
2830912 0.5 M FL 03/12/2025 DTPPVHBHPB
DTPPVHBHPB
FLU3
FLU3
PNC20
PNC20
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 U7970BA
U7970BA
UT8423LA
UT8423LA
LJ5282
LJ5282
Y014318
Y014318
Blood culture, C-reactive protein, Culture urine, Dyskinesia, Dyspnoea; Full blo... Blood culture, C-reactive protein, Culture urine, Dyskinesia, Dyspnoea; Full blood count, Inflammatory marker test, Respiratory pathogen panel; Blood culture, C-reactive protein, Culture urine, Dyskinesia, Dyspnoea; Full blood count, Inflammatory marker test, Respiratory pathogen panel; Blood culture, C-reactive protein, Culture urine, Dyskinesia, Dyspnoea; Full blood count, Inflammatory marker test, Respiratory pathogen panel; Blood culture, C-reactive protein, Culture urine, Dyskinesia, Dyspnoea; Full blood count, Inflammatory marker test, Respiratory pathogen panel More
As described by grandmother, child was having involuntary movements. As described by grandmother, child was having involuntary movements.
2830913 11 M ID 03/12/2025 DTAP
IPV
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
 9PT2F
W1C751M
48361AA
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Vaccines were given to patient on 01/02/25, DTP was administered instead of the Tdap. Patient shoul... Vaccines were given to patient on 01/02/25, DTP was administered instead of the Tdap. Patient should have not received the DTP since he had the exceeded the maximum age. Patient tolerated well in office, no adverse reaction and no report as of right now from patient. More
2830917 F CA 03/12/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Blood immunoglobulin G abnormal, Inappropriate schedule of product administratio... Blood immunoglobulin G abnormal, Inappropriate schedule of product administration; Blood immunoglobulin G abnormal, Inappropriate schedule of product administration More
her IGG is negative; FBE stated that the HCP has a patient that received 2 doses of VARIVAX 4 weeks ... her IGG is negative; FBE stated that the HCP has a patient that received 2 doses of VARIVAX 4 weeks apart, but her IGG is negative.; This spontaneous report was received from a Pharmacist regarding a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On unknown dates, the patient was vaccinated with the first and second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection, 0.5 mL, administered as prophylaxis (route of administration, lot number and expiration date were not reported for any of the doses), which were reconstituted with sterile diluent (BAXTER STERILE DILUENT) (dose, indication, expiration date, and lot number were not reported). The two mentioned vaccines were administered 4 weeks apart (Inappropriate schedule of product administration), but on an unknown date, her Immunoglubulin G (IGG) was negative (Blood immunoglobulin G abnormal). At the time of the report, the outcome of the events was unknown. The causal relationship between Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) and sterile diluent ((BAXTER STERILE DILUENT), regarding the event of Blood immunoglobulin G abnormal was not reported. No other information was available. More
2830918 1 M MI 03/12/2025 MMR
 MERCK & CO. INC.
 Y011484
No adverse event, Syringe issue No adverse event, Syringe issue
No adverse event; syringe of MMRII leaked while administering vaccine to a patient; MMRII leaked whi... No adverse event; syringe of MMRII leaked while administering vaccine to a patient; MMRII leaked while administering vaccine to a patient/partial vaccination; MMRII leaked while administering vaccine to a patient/partial vaccination; This spontaneous report was received from a nurse on 25-FEB-2025 and refers to a 1-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-FEB-2025, while administering the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #Y011484, expiration date: 27-JUN-2026) with the sterile diluent (DILUENT MRK) (lot #2031277, expiration date: 18-DEC-2026) to the patient, the syringe (25G, 5/8in) leaked (Syringe issue, Poor quality device used). The leakage occurred between the Luer Lock and syringe barrel. The syringe needle was attached or being attached to the syringe tip when the leaking occurred. There was no difficulty trying to attach the needle. There was nothing that was visible that could explain why the leaking occurred. Photos and product were not available for retrieval as product was disposed after partial vaccination (Accidental underdose). No additional information provided. No adverse event (AE) or product quality complaint (PQC) reported (No adverse event). At the reporting time, the outcome of the events was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was reported as not applicable. More
2830919 52 F MI 03/12/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011819
Y011819
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No side effects or symptoms reported; received a second dose of CAPVAXIVE. HCP states the patient re... No side effects or symptoms reported; received a second dose of CAPVAXIVE. HCP states the patient received their first dose on 10/21/2024 and received their second dose 02/25/2025; This spontaneous report was received from a pharmacist and refers to a 52-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-OCT-2024, the patient was vaccinated with a first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection 168 mcg/ml (lot #Y011819, expiration date: 01-OCT-2025), 0.5 ml for prophylaxis by health professional (route of administration was not reported). On 25-FEB-2025, the patient was vaccinated with a second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection 168 mcg/ml (lot #Y011819, expiration date: 01-OCT-2025), 0.5 mL for prophylaxis by health professional (route of administration was not reported) (Extra dose administered). No side effects or symptoms reported. No additional information provided. No additional adverse event (AE) or product quality complaint (PQC). At the reporting time, the outcome of the event was unknown. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02759920-02759919 , CLIC number : , ESTAR number : , IRMS number : 500UW00000UfrwnYAB|03032025230058|1459 , Central date : 2025-03-04 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2258801 , MNSC case number : 02759920 , MNSC interaction number : 02759919 , Integration log UniqueID : 500UW00000UfrwnYAB|03032025230058|1459 , Service cloud CaseID : 500UW00000UfrwnYAB More
2830923 16 M TX 03/12/2025 HPV9
 MERCK & CO. INC.
 Y018389
Extra dose administered, No adverse event Extra dose administered, No adverse event
No additional AE; HCP called to report a patient received a third dose of GARDASIL 9 after competiti... No additional AE; HCP called to report a patient received a third dose of GARDASIL 9 after competition of the two-dose series on February 19, 2019. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.; This spontaneous report was received from medical assistant and refers to 16-year-old male patient. The patient's medical history was not reported. His drug history included Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-FEB-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (valid lot #Y018389, expiration date: 04-NOV-2026) 0.5 mL. On 28-FEB-2025, the patient received a third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) after competition of the two-dose series on 19-FEB-2019. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.. On an unknown date, the patient experienced No additional AE. At the reporting time, the outcome of HCP called to report a patient received a third dose of GARDASIL 9 after competition of the two-dose series on February 19, 2019. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC. and No additional AE was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. More
2830924 F CA 03/12/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
Y014182
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
no side effects or symptoms reported. No Additional AE/ No PQC.; patient received their second dose ... no side effects or symptoms reported. No Additional AE/ No PQC.; patient received their second dose of VARIVAX too early at 3 years and 8 months old; This spontaneous report was received from a certified medical assistant and refers to a 3 years and 8 months female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unknown date approximately in 2022 (reported as at approximately 12 months of age), the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck)(VARIVAX) (dose, lot #, expiration date, route and site of administration were not reported) reconstituted with sterile diluent (lot # and expiration date were not reported) for prophylaxis. On 29-JAN-2025, at the age of 3 years and 8 months, the patient was vaccinated too early with the second dose of Varicella Virus Vaccine Live (Oka-Merck)(VARIVAX) 0.5 ml, lot # Y014182 was confirmed to be valid, expiration date 20-AUG-2026 (route and site of administration were not reported) reconstituted with sterile diluent (lot # and expiration date were not reported) for prophylaxis. More
2830925 M TX 03/12/2025 BCG
BCG
BCG
BCG
BCG
BCG
BCG
BCG
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR







Acid fast bacilli infection, Biopsy brain abnormal, Biopsy liver abnormal, Blind... Acid fast bacilli infection, Biopsy brain abnormal, Biopsy liver abnormal, Blindness, Bone marrow transplant; C-reactive protein increased, CSF culture negative, Chemokine increased, Culture wound positive, Deficiency of the interleukin-1 receptor antagonist; Disseminated Bacillus Calmette-Guerin infection, Exophthalmos, Eyelid tumour, Failure to thrive, Graft versus host disease; Immune reconstitution inflammatory syndrome, Inflammatory marker test, Interleukin-2 receptor increased, Intracranial mass, Irritability; Liver injury, Macrophages increased, Magnetic resonance imaging head abnormal, Malnutrition, Mycobacterium test positive; Neutrophil count increased, Night sweats, Ophthalmoplegia, Osteomyelitis acute, Osteomyelitis chronic; Pustule, Pyrexia, Scan with contrast abnormal, Serum ferritin increased, Transaminases increased; Tuberculosis, Wound More
Immune Reconstitution Inflammatory Syndrome associated with disseminated infection derived from prio... Immune Reconstitution Inflammatory Syndrome associated with disseminated infection derived from prior BCG vaccination; Immune Reconstitution Inflammatory Syndrome associated with disseminated infection derived from prior BCG vaccination; Literature Report. This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 5-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included dominant IFN-?R1 deficiency. Concomitant therapies were not reported. On an unknown date, the patient started therapy with BCG (BCG VACCINE USP), administered by percutaneous route (lot # and expiration date were not reported) for the treatment of prevention of Tuberculosis. A 5-year-old boy with autosomal dominant IFN-?R1 deficiency (frameshift mutation c819_822 del TAAT) and disseminated mycobacterial infection was referred to institution for evaluation and treatment. He had received BCG vaccination at birth and presented at 2 years of age with recurrent fevers, night sweats, failure to thrive, and a rapidly progressive right upper eyelid mass extending into the orbital space and causing significant right eye proptosis. He was treated for presumptive tuberculosis for positive acid-fast bacilli (AFB) stain and culture, without treatment response, and had progression of disease with ongoing fevers, recurrent pustular skin lesions, and worsening protein calorie malnutrition, ultimately leading to the diagnosis of IFN-?R1 deficiency. He was referred to institution for management and initiation of adjuvant IFN-? therapy. Initial evaluation revealed a febrile, irritable child with large open wounds involving the entire calvarium, severe right eye proptosis exposing the entire globe and periorbital soft tissues along with associated ophthalmoplegia and loss of vision. On an unknown date, magnetic resonance imaging (MRI) of the brain and orbits with contrast demonstrated a heterogeneously enhancing, irregularly shaped mass centered around the lesser and greater wings of the right sphenoid bone involving the right pterygoid fossa, extending into the orbit, compromising the optic nerve and intracranially, invading the anterior cranial fossa and suprasellar cistern. The intracranial component of the mass had surrounding vasogenic edema and marked mass effect. There was also irregular moth-eaten destruction of the calvarium and the frontal, parietal, and temporal bones extending circumferentially with epidural thickening mainly at the convexities. On an unknown date, biopsies of the cranium revealed acute on chronic osteomyelitis with soft tissue involvement and numerous AFB. Foamy macrophages and neutrophils were seen without classic granuloma formation. On an unknown date, cerebrospinal fluid cultures were negative for bacteria, mycobacterial, fungal, and viral pathogens. On an unknown date, wound culture revealed M. tuberculosis complex, which on genetic testing was speciated as Mycobacterium bovis BCG strain, consistent with disseminated infection derived from prior BCG vaccination. The antimycobacterial treatment was modified to isoniazid, rifampin, ethambutol, moxifloxacin, clofazimine, and linezolid, and IFN- ? (titrated up to 1.4 mcg/kg/dose) three times per week with good treatment response. After 16 months of therapy, he had resolution of constitutional symptoms and improved nutritional status with markedly decreased burden of disease. On an unknown date, MR imaging showed decreased size of the intracranial enhancing component and healing of skull lesions and associated epidural involvement. However, a complete cure for the infection was not achieved. The patient underwent haploidentical bone marrow transplantation from his mother for correction of the underlying immunodeficiency and ultimate cure of the BCG infection. He received a reduced toxicity, busulfan-based (total exposure 48 mg*h/L) myeloablative conditioning with low-dose total body irradiation (TBI) (200 cGy) without serotherapy. Graft-versus host disease (GVHD) prophylaxis was accomplished with posttransplant cyclophosphamide, tacrolimus, and mycophenolate mofetil. IFN-? was discontinued prior to the conditioning while antimycobacterial drugs (isoniazid, ethambutol, clofazimine, and moxifloxacin) were continued. Linezolid was stopped prior to the transplant cell infusion. He was also empirically started on eltrombopag, with the intention of facilitating engraftment. Viral and antifungal prophylaxis were added. Neutrophil and platelet engraftment occurred on Days +17 and +24, respectively The patient's post-HCT course (Days +60 to +150) was complicated by intermittent low-grade fevers and multiple erythematous nodules arising from the forehead and calvarium draining purulent and necrotic material. During this period, the patient's head circumference gradually increased by 6 cm. On an unknown date, MRI of the brain showed multiple subgaleal complex solid and cystic rim-enhancing lesions, in association with small defects of the outer skull tables involving the right temporalis muscle and bifrontal scalp. The patient remained neurologically intact. The diagnosis of Immune Reconstitution Inflammatory Syndrome (IRIS) was made based upon worsening clinical symptoms and radiological imaging alongside repetitive negative microbiological investigations and correction of the patient's underlying immune defect as evidenced by full (> 98%) donor chimerism in whole blood. Functional studies demonstrated normal monocyte STAT 1 phosphorylation and strong polyfunctional cytokine responses to TB antigens by flow cytometry. Inflammatory biomarkers were measured serially with findings of increased C-reactive protein (CRP), ferritin, and IL2SR indicating T cell activation . CXCL9 was also measured at Days +111 and +173 with elevated values of 207 and 521 pg/mL (reference range = 121 pg/mL) consistent with downstream IFN-? signaling. The patient was managed with supportive care, and symptoms of IRIS began to resolve by Day +150 with a resolution of fevers followed by a gradual decrease in head circumference to baseline. On Day+190, the patient developed a sudden increase in transaminases without cholestasis. His antimycobacterial regimen was discontinued. Liver biopsy revealed mild duct injury and periportal inflammatory infiltrates consistent with GVHD and rare non-necrotizing poorly formed granulomas with negative AFB Fite and ZiehlοΏ½Neelsen stains suspicious of resolving mycobacterial IRIS. The patient was treated for GVHD with tacrolimus and prednisolone (2 mg/kg/day), which were later transitioned to ruxolitinib 2.5 mg twice daily. All immunosuppression was discontinued after 10 months of therapy. He is now approximately 4 years post-HCT and has been doing well off antimicrobials and immunosuppressive medications. At the reporting time, the patient was recovering from IRIS and disseminated BCG infection. The action taken with suspect therapy was reported as not applicable. The authors considered the events to be related to suspect therapy. Upon internal review, the events IRIS and disseminated BCG infection were determined to be medically significant. Patient was hospitalized for both events, as he was admitted to the institution. A copy of the published article is attached as further documentation of the patient's experience. More
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2830926 SC 03/12/2025 VARCEL
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y010045
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 adverse event, Product storage error More
No adverse event; improper storage of prouct in use; improper storage of product in use; This sponta... No adverse event; improper storage of prouct in use; improper storage of product in use; This spontaneous report was received from a pharmacist referring to a patient of unknon age and gender. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection for prophylaxis, 0.5 milliliters, subcutaneously, lot number Y010045 which has been verified to be valid, expiration date reported and validated as 29-MAY-2026. The vaccine was reconstituted with sterile diluent Solution for injection (BAXTER STERILE DILUENT) The administered dose of the vaccine was stored at 59.4 Farenheit (F), during one hour and 30 minutes. There were not previous temperature excursions for which details were unknown. There were no symptoms reported. More
2830927 5 F NE 03/12/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Wrong dose; Received at 5 year of age; This non-serious case was reported by a other health professi... Wrong dose; Received at 5 year of age; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received Hib (Hiberix) for prophylaxis. On 05-MAR-2025, the patient received Hiberix. On 05-MAR-2025, an unknown time after receiving Hiberix, the patient experienced wrong vaccine administered (Verbatim: Wrong dose) and inappropriate age at vaccine administration (Verbatim: Received at 5 year of age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAR-2025 The health care professional reported that a patient received wrong dose of vaccine, which led to wrong vaccine administered. The patient received a dose of Hiberix at an inappropriate age, which led to inappropriate age at vaccine administration. More
2830928 F 03/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Deafness, Herpes zoster, Laboratory test, Vaccination failure Deafness, Herpes zoster, Laboratory test, Vaccination failure
Suspected vaccination failure; lost my hearing; shingles; This serious case was reported by a consum... Suspected vaccination failure; lost my hearing; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), hearing loss (Verbatim: lost my hearing) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure, hearing loss and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The reporter considered the hearing loss to be related to Shingrix. The company considered the vaccination failure and hearing loss to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that she got Shingrix vaccine and she experienced shingles and loss of hearing. They made go to all the test and it cost patient to find out by her old fashion physician. Consumer stated that if you don't need shingle shot you already have shingles and getting the shot was useless. 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. 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 vaccine Shingrix. Deafness is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2830929 F 03/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; within 3 months I got shingles.; This serious case was reported by a ... Suspected vaccination failure; within 3 months I got shingles.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: within 3 months I got shingles.). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The patient got live virus shingles shot and within 3 months the patient had shingles. The follow-up could not be possible as no contact details were available. 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: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. 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
2830930 03/12/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Nerve injury, Ophthalmic herpes zoster, Optic nerve injury, Vacci... Herpes zoster, Nerve injury, Ophthalmic herpes zoster, Optic nerve injury, Vaccination failure; Herpes zoster, Nerve injury, Ophthalmic herpes zoster, Optic nerve injury, Vaccination failure More
Suspected vaccination failure; got shingles after I got the second vac, in the face and in my right ... Suspected vaccination failure; got shingles after I got the second vac, in the face and in my right eye; nerve damage in my eye; got shingles after I got the second vac, in the face and in my right eye; nerve damage in parts of my forehead; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: got shingles after I got the second vac, in the face and in my right eye) (serious criteria GSK medically significant), optic nerve damage (Verbatim: nerve damage in my eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: got shingles after I got the second vac, in the face and in my right eye) and post herpetic neuralgia (Verbatim: nerve damage in parts of my forehead). The outcome of the vaccination failure, ophthalmic herpes zoster and facial herpes zoster were not reported and the outcome of the optic nerve damage and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, optic nerve damage, facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, ophthalmic herpes zoster and optic nerve damage to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles after got the second dose of Shingles vaccine, in the face and in The right eye. That was three years ago and still have nerve damage in eye and parts of forehead. The patient would not want to do that again. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. Optic nerve injury is an unlisted event which is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. More
2830931 03/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I just got the shingles; This serious case was reported by a consumer... Suspected vaccination failure; I just got the 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. In AUG-2024, 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: I just got the shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 05-MAR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got the vaccine last August 2024 and just got the shingles. Patient stated that started meds on the day of reporting. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
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