🏥 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 💀 🏥 🚑 ♿ ⚠️
2823272 7 F CA 01/28/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 L7373
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
MENINGOCOCCAL MCV4O (MENVEO) - 1 VIAL given to 7 year old patient. no symptoms reported. no treatmen... MENINGOCOCCAL MCV4O (MENVEO) - 1 VIAL given to 7 year old patient. no symptoms reported. no treatment. More
2823273 50 F MN 01/28/2025 HPV9
HPV9
VARZOS
VARZOS
 MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Chills, Fatigue, Headache, Lethargy, Myalgia; Pyrexia; Chills, Fatigue, Headache... Chills, Fatigue, Headache, Lethargy, Myalgia; Pyrexia; Chills, Fatigue, Headache, Lethargy, Myalgia; Pyrexia More
headache, chills, fever, lethargic/fatigue, muscle aches/pain headache, chills, fever, lethargic/fatigue, muscle aches/pain
2823274 66 F NM 01/28/2025 COVID19
 MODERNA
 3043501
Fatigue, Headache Fatigue, Headache
Patient stated that she had a headache that would not go away for a week. She also experienced mor... Patient stated that she had a headache that would not go away for a week. She also experienced more fatigue than usual. She stated that the headache is gone and she does not require follow up medical attention but thought it best to report it. More
2823275 84 M MN 01/28/2025 COVID19
 MODERNA
 036C21A
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2823276 34 F ND 01/28/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 A5573
Exposure during pregnancy, No adverse event, Wrong product administered Exposure during pregnancy, No adverse event, Wrong product administered
Patient was meant to receive pregnancy dose of Tdap and received DTaP instead. No adverse events rep... Patient was meant to receive pregnancy dose of Tdap and received DTaP instead. No adverse events reported by patient. Estimated delivery date is 4/9/25. More
2823277 11 M MI 01/28/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Product preparation issue Product preparation issue
Patient received 0.3ml undiluted dose Patient received 0.3ml undiluted dose
2823278 12 M AZ 01/28/2025 HPV9
 MERCK & CO. INC.
 X024560
Erythema, Limb mass Erythema, Limb mass
Child had a knot on left arm and some redness. Child had a knot on left arm and some redness.
2823279 17 M WI 01/28/2025 FLU3
FLU3
MNQ
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 LE355
LE355
3L339
3L339
Hypersomnia, Mobility decreased, Nausea, Pain, Pyrexia; Swelling face, Throat ti... Hypersomnia, Mobility decreased, Nausea, Pain, Pyrexia; Swelling face, Throat tightness; Hypersomnia, Mobility decreased, Nausea, Pain, Pyrexia; Swelling face, Throat tightness More
The evening following vaccination, the patient developed symptoms of fever to 102-103, throat tightn... The evening following vaccination, the patient developed symptoms of fever to 102-103, throat tightness, facial swelling, and body aches. The mother gave him a dose of Benadryl and he had improvement in swelling. The mother reports they had a home pulse oximeter and felt like his oxygen level was in the high 80s. However he did not go to the urgent care or ER for evaluation. The family is concerned about a possible allergic reaction. Our triage nurse recorded the following..."Called mom. and she states they had a really bad weekend, flu/Men B. She thinks he had an allergic RXN- had every sx on the handout. High fever , could barley lift his arm- extremely painful- difficulty with PJ's. Saturday slept all day 102.7 fever. Felt tightening in throat and Saturday night had face swelling, fever came down with compresses and alternating Tylenol and Ibuprofen. No antihistamine. Very nauseated. Today no fever, still throat tightness and slightly puffy face. Kept him home today. No diarrhea. Arm is better today. Pulse OX on Saturday read 73-83, felt SOB - book said he was still in the normal range. Pulse OX yesterday was 93% and 97% today. Told mom I think he needs to be seen- placed on hold and relayed the above and he states he should be seen in UC. Recommended that he be seen in UC given the ongoing throat tightness and puffy face- may need steroid/antihistamines- mom asked if she could just give him Benadryl- needs documentation of symptoms- should be seen- mom plans to take to clinic. Patient states that throat feels tighter then yesterday but is not SOB- can hear him talking and mom said he is breathing thru his nose. She is asking for letter for school- in case she forgets to ask at UC. " More
2823280 25 F ID 01/28/2025 COVID19
 PFIZER\BIONTECH
 EN6208
Computerised tomogram thorax normal, Head discomfort, Musculoskeletal discomfort... Computerised tomogram thorax normal, Head discomfort, Musculoskeletal discomfort, Tinnitus More
Tinnitus in both ears. Unknown how many days it started after vaccine. Head and neck pressure that ... Tinnitus in both ears. Unknown how many days it started after vaccine. Head and neck pressure that started after that and has never gone away. Had CT chest done in 2024 to look at vasculature that did not show any abnormality. Still affected by tinnitus and this head/neck pressure. More
2823281 50 M FL 01/28/2025 PNC20
 PFIZER\WYETH
 pfr lg5579
Extra dose administered Extra dose administered
Pt was administered 2nd Prevnar20 3 years after receiving first one Pt was administered 2nd Prevnar20 3 years after receiving first one
2823283 2 M IL 01/28/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Expired product administered Expired product administered
immunization administered past beyond use date. called manufacture was beyond use 1 day. reviewed wi... immunization administered past beyond use date. called manufacture was beyond use 1 day. reviewed with provider ok to readminister 1-2 months mother notified More
2823284 5 M IL 01/28/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Expired product administered Expired product administered
immunization administered past beyond use date. called manufacture was beyond use 1 day. reviewed wi... immunization administered past beyond use date. called manufacture was beyond use 1 day. reviewed with provider ok to readminister 1-2 months mother notified More
2823285 67 F PA 01/28/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 LN5485
LN5485
Chest pain, Cough, Decreased appetite, Fatigue, Feeling of body temperature chan... Chest pain, Cough, Decreased appetite, Fatigue, Feeling of body temperature change; Headache, Malaise More
SUNDAY NIGHT, THEY GOT VERY TIRED SLEPT FROM 6 TO MONDAY . APPETITE LOSS, CHEST IS IN PAIN WHEN THEY... SUNDAY NIGHT, THEY GOT VERY TIRED SLEPT FROM 6 TO MONDAY . APPETITE LOSS, CHEST IS IN PAIN WHEN THEY COUGH, HOLE IN HEART HURTS WHEN THEY COUGH, HAVE FLUTUATING TIMES OF BEING TOO COLD, AND BEING TOO HOT. They feel sick, took two tylenols on the 27th, had no effect. patient also says they have headache, since the time they got their vaccine. More
2823286 7 M 01/28/2025 FLU3
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
 79K45
M23G5
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 More
Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients a... Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 7 when he received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10. More
2823287 9 F 01/28/2025 MNQ
PPV
 NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 M23G5
X022827
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients a... Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 9 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10. More
2823288 80 M FL 01/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
duplicate vaccine duplicate vaccine
2823289 66 F OH 01/28/2025 PNC21
 MERCK & CO. INC.
 Y013009
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Patient received the vaccine on 1/2/25 and notified me of her arm and shoulder hurting on 1/27/25. I... Patient received the vaccine on 1/2/25 and notified me of her arm and shoulder hurting on 1/27/25. I told her to try Voltaren gel and a Lidocaine patch. She tried a lidocaine patch and it did help for awhile. She is going to the doctor 1/29/25. More
2823290 28 M 01/28/2025 COVID19
 MODERNA
 3043823
Expired product administered Expired product administered
vaccine given past the beyond use date of 01/16/25 vaccine given past the beyond use date of 01/16/25
2823335 F WA 01/28/2025 HPV9
 MERCK & CO. INC.
 Y012864
Extra dose administered, No adverse event Extra dose administered, No adverse event
No additional adverse event was reported; HCP called to report a patient received a fourth dose of G... No additional adverse event was reported; HCP called to report a patient received a fourth dose of GARDASIL 9 after completing a 3-dose-series in 2022 ( exact date unknown). No side effects or symptoms reported. No additional information reported. No additional AE/ No PQC.; This spontaneous report was received from physician assistant and refers to a 26-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 23-JAN-2025, the patient was vaccinated withfourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, lot #Y012864, expiration date: 29-MAY-2026, administered for prophylaxis (strength, and route of administration were not provided) after completing third dose series in unknown date in 2022 (Extra dose administered). No additional adverse event was provided. More
2823336 5 F OH 01/28/2025 MMR
 MERCK & CO. INC.
 X002058
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse side effects were reported; HCP called to report that a patient had been administered MMR... No adverse side effects were reported; HCP called to report that a patient had been administered MMR II after the expiration date. Administered 1/21/2025, expired 1/19/2025.; This spontaneous report has been received from a nurse regarding a 5-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 21-JAN-2025 (also reported as 24-JAN-2025), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered for prophylaxis, (lot number reported as X002058, expiration date reported and validated as 19-JAN-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not provided) (Expired product administered). No adverse side effects were reported. More
2823337 U IL 01/28/2025 MMRV
 MERCK & CO. INC.
 X018584
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; HBP calling on behalf of Physician with a report of an adverse event regarding an ... No additional AE; HBP calling on behalf of Physician with a report of an adverse event regarding an expired dose of PROQUAD that was inadvertently administered to a patient. HBP stated that the PROQUAD had a labeled expiration date of 1/5/2025 and was administered o; This spontaneous report was received from a Health business professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 17-JAN-2025, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA[recombinant human albumin]) (PROQUAD) injection, 0.5 milliliter, administered as prophylaxis (Lot No. X018584 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 05-JAN-2025) (strength, dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided)(expired product administered). No additional adverse event was reported (no adverse event) More
2823338 0.17 F CO 01/28/2025 VARCEL
 MERCK & CO. INC.
 Y011712
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
no side effects or symptoms have been reported; HCP called to report a dose of VARIVAX was administe... no side effects or symptoms have been reported; HCP called to report a dose of VARIVAX was administered to a 2-month-old patient. no side effects or symptoms have been reported. No Additional information provided. No AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 2-month-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided. On 08-NOV-2024 the 2-month-old patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # Y011712 and expiration date 02-JUL-2026, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age). No side effects or symptoms have been reported (o adverse event). More
2823339 71 F TX 01/28/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 X4EA5
X4EA5
Areflexia, Dysphagia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia; Im... Areflexia, Dysphagia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia; Immunoglobulin therapy, Loss of personal independence in daily activities, Mobility decreased More
Guillain Barre syndrome; This serious case was reported by a consumer via sales rep and described th... Guillain Barre syndrome; This serious case was reported by a consumer via sales rep and described the occurrence of guillain barre syndrome in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X4EA5, expiry date 16-OCT-2025) for prophylaxis. On 19-DEC-2024, the patient received the 1st dose of Arexvy. On 30-DEC-2024, 11 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins. The outcome of the guillain barre syndrome was not resolved. The reporter considered the guillain barre syndrome to be related to Arexvy. The company considered the guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 13-JAN-2025 The patient was in hospital for Guillain Barre syndrome and Guillain Barre syndrome was reported as worsened. Patient was vaccinated with Arexvy and went to emergency room on 31st December 2024. The patient had completed 5 treatments of IVIG and still in hospital. Patient was unable to walk and had no feeling/reflexes in legs, unable to move right arm/hand and could not feed herself and on thickened liquids due to swallowing issues.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy. More
✓
2823340 U 01/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; I have the shingles; This serious case was reported by a consumer via... Suspected vaccination failure; I have 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. 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: I have the shingles). The patient was treated with lidocaine. 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 and 21-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles, the patient had received shots of shingles vaccine. Thankful mild case but the pain was horrible, the reporter could not take pain medication. The patient was using lidocaine cream. This case was considered as suspected vaccination failure as details regarding 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, 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
2823341 U 01/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Pruritus, Vaccination failure; Herpes zoster, Pain, Pruritu... Herpes zoster, Pain, Pruritus, Vaccination failure; Herpes zoster, Pain, Pruritus, Vaccination failure More
Suspected vaccination failure; Got shingles/ very painful and itchy; This serious case was reported ... Suspected vaccination failure; Got shingles/ very painful and itchy; 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) and shingles (Verbatim: Got shingles/ very painful and itchy). 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 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: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient got the shot and the booster of shingles vaccine. The patient got shingles and had it for 10 days so far. The patient reported it to be very painful and itchy. This case was considered as suspected vaccination failure as details regarding, 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine 1 and Shingles vaccine 2. More
2823342 U 01/28/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected Vaccination failure; I got SHINGLES anyways; This serious case was reported by a consumer ... Suspected Vaccination failure; I got SHINGLES anyways; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included chemotherapy (User was going through chemotherapy when they contracted shingles.). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got SHINGLES anyways). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 Reporter commented that they got the shingles vaccine but got shingles anyway. Reporter was went through chemotherapy when they contracted shingles. Reporter got a SHINGLES vaccine. It was TWO shots. Reporter got SHINGLES anyways because of the chemo BUT it was mild. No big deal from what he/she heard it was painful. Pharmacist said it was minor because he/she Did had the SHINGLES vaccine. Would had been way worse. So he/she was grateful. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2. More
2823343 F PA 01/28/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 T74KG
Cutaneous vasculitis, Erythema Cutaneous vasculitis, Erythema
suspected leukocytoclastic vasculitis; red spots on legs; This serious case was reported by a consum... suspected leukocytoclastic vasculitis; red spots on legs; This serious case was reported by a consumer via call center representative and described the occurrence of leukocytoclastic vasculitis in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T74KG) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, 7 days after receiving Fluarix 2024-2025 season, the patient experienced leukocytoclastic vasculitis (Verbatim: suspected leukocytoclastic vasculitis) (serious criteria GSK medically significant) and red spotty rash (Verbatim: red spots on legs). The outcome of the leukocytoclastic vasculitis was not reported and the outcome of the red spotty rash was unknown. It was unknown if the reporter considered the leukocytoclastic vasculitis and red spotty rash to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the leukocytoclastic vasculitis to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the red spotty rash to be related to Fluarix 2024-2025 season and Fluarix 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: 14-JAN-2025 Reporter was the patient's father. Patient developed red spots on the legs 7 days after receiving the Fluarix vaccine. Reporter suspected that the patient developed Leukocytoclastic vasculitis (LCV).; Sender's Comments: Cutaneous vasculitis is an unlisted event which is considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE. More
2823344 F 01/28/2025 COVID19
 JANSSEN
Aortic aneurysm, Diarrhoea, Diverticulitis, Rheumatoid arthritis, Unevaluable ev... Aortic aneurysm, Diarrhoea, Diverticulitis, Rheumatoid arthritis, Unevaluable event More
thoracic aortic aneurysm; rheumatoid arthritis; diverticulitis recurrent; she was brain dead since h... thoracic aortic aneurysm; rheumatoid arthritis; diverticulitis recurrent; she was brain dead since heart surgery; chronic diarrhea; This spontaneous report received from a consumer by a business partner (Pfizer Inc.) on 13-Jan-2025 was received by Johnson and Johnson Innovative Medicine on 13-Jan-2025 and concerned a 66 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's past medical history included: thyroidectomy and radiation, and concurrent conditions included: giant cell arteritis, polymyalgia rheumatica, hiatal hernia, barrett's esophagus, and diverticulitis. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. Non-company products included: metoprolol succinate (tablet, route of admin not reported, batch number not reported) 100 milligram(s), once daily, administered on Aug-2023 to end date not provided and (tablet, route of admin not reported, batch number not reported) 50 milligram(s), once daily, administered on 2024 to end date not provided, for blood pressure and to beat heart harder. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included: morphine for pain; ketamine for pain., armour thyroid (Started in Summer 2015 after a thyroidectomy and radiation treatment). On an unspecified date, the patient experienced thoracic aortic aneurysm, rheumatoid arthritis, diverticulitis recurrent, she was brain dead since heart surgery, and chronic diarrhea. (dose series 1) She had a thoracic aortic aneurysm and stated that this was the reason for her surgery. Stated that she was diagnosed with thoracic aortic aneurysm after having the Covid vaccine. Stated that it was the Johnson Johnson Covid vaccine and she took it in Nov-2020. She had to get it for her job. Her initial prescribing physician is not aware of this. She saw another physician outside of the prescribing physician after her surgery. The metoprolol tablet was prescribed after the patient's heart surgery. The chronic diarrhea started gradually after her surgery around the clock. She was on metoprolol for 10-11 months and she has had chronic diarrhea in that time frame. She also had a hernia and a problem with her esophagus. She said that within 12 hours after stopping the metoprolol the diarrhea cleared up. They put her on it for her blood pressure and to make her heart beat harder because she had ascending aorta replacement. Her diarrhea started in the clinic right after surgery and stated that was not diarrhea at that time and was just soft and loose stool. Said that she was astonished that she could goto the bathroom because of the pain meds she was taking were morphine and ketamine. The patient's hiatal hernia and barrett's esophagus was prior to use of metoprolol. During the course of the period on the metoprolol , caller also had had diverticulitis 3 times during that period. She only had it once prior to that at age 12 years old. She never had it again until after her heart surgery and that is what made her research it. She said that she was brain dead and said that brain deadness was since having heart surgery. On 15-Aug-2023 was the date of her surgery and by 18-Aug-2023-19-Aug-2023 she was starting to have diarrhea. This was all while on heavy opioids which usually creates the opposite problem. The diarrhea resolved within hours after stopping the metoprolol. Thinks it stopped in Hours of stopping the medciation in Oct-2024 or around the 01-Nov-2024 and was placed back on Amlodipine and HCTZ. Hindsight is 20/20, she did not put all of this together until last yearuntil she went off of the metoprolol on her own. Unsure if diverticulitis occurred prior to surgery. Does not remember the dates of the diverticulitis, but said that 2 occurred in early 2024 and one of them occurred in Fall 2023 after her surgery. She was scheduled to see a Gastroenterologist and when she stopped the metoprolol Succinate ER, the diarrhea stopped and she did not follow up with the gastroenterologist. The action taken with janssen covid-19 vaccine was not applicable and treatment with metoprolol succinate was withdrawn on an unspecified date. The outcome of thoracic aortic aneurysm, rheumatoid arthritis, diverticulitis recurrent and she was brain dead since heart surgery was not reported. The patient recovered from chronic diarrhea on an unspecified date. This report was serious (other medically important condition).; Sender's Comments: V0; Aortic aneurysm, Diverticulitis, Rheumatoid arthritis, Unevaluable event; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. More
2823345 66 F CA 01/28/2025 COVID19
 PFIZER\BIONTECH
Gait disturbance, Gout, Hypoaesthesia, Pain in extremity, Vein disorder Gait disturbance, Gout, Hypoaesthesia, Pain in extremity, Vein disorder
treated for gout; my leg still wobble, numb and hurts; my leg still wobble, numb and hurts; vein rep... treated for gout; my leg still wobble, numb and hurts; my leg still wobble, numb and hurts; vein replacement; instant leg pain; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. A 67-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for atrial fibrillation; LISINOPRIL taken for atrial fibrillation; XARELTO taken for atrial fibrillation. Vaccination history included: bnt162b2 (dose 1, single; left arm), administration date: 22Dec2020, when the patient was 65-year-old, for covid-19 immunization; bnt162b2 (dose 2, single; intramuscular; left arm), administration date: 11Jan2021, when the patient was 65-year-old, for covid-19 immunization, reaction(s): "CHF", "taste/ want my taste back", "grinding teeth", "interrupting sleep", "nauseating", "kidney damage", "wobble right leg"; bnt162b2 (dose 3 (booster), single; left arm), administration date: 11Dec2021, when the patient was 66-year-old, for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "unknown", described as "instant leg pain"; VEIN DISORDER (medically significant) with onset Feb2023, outcome "unknown", described as "vein replacement"; GOUT (non-serious), outcome "unknown", described as "treated for gout"; HYPOAESTHESIA (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "my leg still wobble, numb and hurts". The events "vein replacement", "instant leg pain", "treated for gout" and "my leg still wobble, numb and hurts" required physician office visit. Therapeutic measures were taken as a result of vein disorder, pain in extremity, gout, hypoaesthesia, gait disturbance. Clinical course: In Dec2022, the patient had instant leg pain. Treated for gout. In Feb2023, vein replacement, felt ok, but neurologist still cannot figure out why leg still wobble, numb, and hurt. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400163246 same patient, different dose/AE; More
2823346 F 01/28/2025 COVID19
 PFIZER\BIONTECH
Headache Headache
Slight Headache; This is a spontaneous report received from a Consumer or other non HCP from License... Slight Headache; This is a spontaneous report received from a Consumer or other non HCP from License Party. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), since 01Aug2024 (ongoing)) at 300 mg weekly, subcutaneous for asthma. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL; BUDESONIDE; BREO ELLIPTA; VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; SPIRIVA; MAGNESIUM OXIDE; VITAMIN D [COLECALCIFEROL]; CALCIUM CARBONATE. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight Headache". The action taken for dupilumab was dosage not changed. Additional information: It was reported that, "the patient asking if okay to inject Dupixent the day after her Covid vaccine. I advised no issue. The patient has a slight headache after getting vaccine. Batch/lot number is not provided, and it cannot be obtained. More
2823369 14 U CA 01/28/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
HCP wanted to know if patient started vaccination series at 14 years of age, if they come in at 15, ... HCP wanted to know if patient started vaccination series at 14 years of age, if they come in at 15, what is recommended for the series.; No additional AE; This spontaneous report was received from a pharmacist and refers to a 15-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (also reported as at 14 years of age), the patient started vaccination series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Healthcare professional (HCP) wanted to know if patient come in at 15, what was recommended for the vaccination series (Inappropriate schedule of product administration). No additional adverse event was reported. Lot # is being requested and will be submitted if received. More
2823370 U PA 01/28/2025 PPV
 MERCK & CO. INC.
 X014729
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event; Nurse calling to report inadvertently administering an expired dose of PNEUMOVAX 2... No adverse event; Nurse calling to report inadvertently administering an expired dose of PNEUMOVAX 23. vaccine expired on 11/22/2024 and was administered on 1/22/2025.; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 22-JAN-2025, the patient was inadvertently vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, prefilled syringe, administered for prophylaxis (lot number X014729 has been verified to be a valid number for pneumococcal 23v polysaccharide vaccine [PNEUMOVAX23], expiration date 22-NOV-2024; dose, anatomical site of injection and route of administration were not provided) (Expired product administered). It was reported that the product did not underwent temperature excursion. No additional information or adverse event was reported for the patient. More
2823371 F PA 01/28/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 W026152
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE/No symptoms reported; HCP calling regarding GARDASIL-9 dosing schedule for a 13 yea... No additional AE/No symptoms reported; HCP calling regarding GARDASIL-9 dosing schedule for a 13 year old female patient. Caller stated that the third dose was administered a "little after" 6 months.; This spontaneous report was received from a consumer and refers to a 13-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 an unknown date and on an unknown date in 2024, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), respectively. On 21-JAN-2025, the patient was vaccinated with the third dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W026152, expiration date: 29-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). Reporter stated that this third dose was administered a "little after" 6 months (Inappropriate schedule of product administration). No symptoms reported. No further information was provided. Lot # is being requested and will be submitted if received. More
2823372 F 01/28/2025 COVID19
COVID19
FLU3
FLU3
RSV
RSV
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SEQIRUS, INC.
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
33T4PAB0B1
33T4PAB0B1
5H1GY99SAY
5H1GY99SAY
Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personal... Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personality change, Vomiting; Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personality change, Vomiting; Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personality change, Vomiting More
Injection site bruising; Feeling abnormal/ out of it/ feeling terrible; Malaise; Nausea; Personality... Injection site bruising; Feeling abnormal/ out of it/ feeling terrible; Malaise; Nausea; Personality change/ persona began to decline; Vomiting; This serious case was reported by a consumer via other manufacturer and described the occurrence of injection site bruising in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5H1GY99SAY) for prophylaxis. Co-suspect products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for prophylaxis and Influenza vaccine inact sAg 3v (Fluad) (batch number 33T4PAB0B1) for prophylaxis. The patient's past medical history included chronic obstructive pulmonary disease (COPD) and restless legs syndrome. Concurrent medical conditions included seasonal allergy (possible). Concomitant products included umeclidinium bromide (Incruse Ellipta), pramipexole, potassium chloride and acetylsalicylic acid (Baby Aspirin). On 19-NOV-2024, the patient received Arexvy (intramuscular, left arm), the 1st dose of Novavax COVID-19 Vaccine (intramuscular, left arm) .5 ml and Fluad (intramuscular, right arm). On 21-NOV-2024, 2 days after receiving Arexvy, the patient experienced injection site bruising (Verbatim: Injection site bruising) (serious criteria hospitalization), feeling abnormal (Verbatim: Feeling abnormal/ out of it/ feeling terrible) (serious criteria hospitalization), malaise (Verbatim: Malaise) (serious criteria hospitalization), nausea (Verbatim: Nausea) (serious criteria hospitalization), personality change (Verbatim: Personality change/ persona began to decline) (serious criteria hospitalization) and vomiting (Verbatim: Vomiting) (serious criteria hospitalization). The outcome of the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting were not resolved. It was unknown if the reporter considered the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting to be related to Arexvy. The company considered the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 13-JAN-2025 The patient was vaccinated with Arexvy, Fluad and Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula), lot number was reported as JIRJ22I041PQLNM on 19 Nov 2024. On 21-Nov-2024, on 3rd day after vaccination the patient experienced feeling abnormal, injection site bruising, malaise, nausea, personality change and vomiting. A discrepancy was identified in the source document where Novavax lot number JIRJ22I041PQLNM was not captured in the structured field as this lot number does not pertain to Novavax. However, this case was processed as confirmed exposure to Nuvaxovid as Novavax was mentioned under the Manufacturer section of the source document. Patient received three vaccines, RSV and covid in left arm and flu in the right arm. On day 1 patient was fine, by day 3 patient had developed a bruise where RSV shot was given and began to feel nausea and out of it. Vomited once, and experienced nausea. Over the course of ten days patient's persona began to decline. Her husband decided to take her to the hospital after several days of feeling terrible. They had been trying blood tests to try to figure out what has been going on, with no clear diagnosis. The patient had been in hospital since Saturday or Sunday at this point. They were suspecting possible carbon monoxide excess per husband as they have patient on a cpap machine. She had been feeling less nauseated, although she was still in hospital under medical care. The bruise had turned to a purple at this point. The event feeling abnormal, injection site bruising, malaise, nausea, personality change, and vomiting was reported as serious. Based on the spontaneous nature of the report, the causal relationship between the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) and feeling abnormal, injection site bruising, malaise, nausea, personality change, and vomiting was considered possible. It was unknown if the reporter considered the feeling abnormal, injection site bruising, malaise, nausea, personality change and vomiting to be related to Fluad.; Sender's Comments: Malaise and Nausea are listed events which, due to the following criteria (Suspected carbon monoxide excess patient was on a cpap machine and insufficient information provided about the clinical description) are considered unrelated to GSK vaccine Arexvy. Injection site bruising, Feeling abnormal, Personality change and Vomiting are unlisted events which are considered unrelated to GSK vaccine Arexvy. More
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2823373 M 01/28/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
tested positive for covid; tested positive for covid; This is a spontaneous report received from a C... tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 81-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jan2025, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jan2025) Positive, notes: tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. No follow-up attempts are possible. More
2823375 8 F 01/28/2025 MNQ
PPV
 NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 M23G5
X022827
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Menveo - 1 vial was ordered by Physician and given by RN, but is meant for patients aged 10-55 years... Menveo - 1 vial was ordered by Physician and given by RN, but is meant for patients aged 10-55 years, and this patient was 8 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10. More
2823376 5 M 01/28/2025 MNQ
PPV
 NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 M23G5
X022827
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients a... Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 5 when he received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10. More
2823377 4 F 01/28/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 LN75D
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients a... Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 5 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10. More
2823378 71 F OR 01/28/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 388468
388468
388468
Arthralgia, Decreased appetite, Fatigue, Gait disturbance, Laboratory test norma... Arthralgia, Decreased appetite, Fatigue, Gait disturbance, Laboratory test normal; Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain, Pain in extremity, Polymyalgia rheumatica; Red blood cell sedimentation rate normal More
9-10-2024 awoke to stiff neck, painful arms and hips. Cannot raise my arms above my head without ext... 9-10-2024 awoke to stiff neck, painful arms and hips. Cannot raise my arms above my head without extreme pain. Arms feel like they are being ripped off when I try to raise them up. Massage helps a little. Heat helps a bit.. I can't dress myself and have a hard time bathing and walking up stairs or for very far. Huge fatigue and loss of appetite. My cardiologist says not to use Ibuprofin since I have had a cardiac issue and a stent put in. Oxycodone takes away about 10% of my pain. Doctor tested for PMR but the test came back negative, Doctor started me on Prednisone 20mg tapering down to 5mg. 50 to 60% pain relief, but when tapering off, the pain comes back. When the pain started shortly after the Flu vaccine, I talked to my doctor and he assurred me that the vaccine is not the problem but, I have taken several flu shots over the the last several decades with no problems but, the Senior flu vaccine is the only thing that was different and now I have PMR and I can't get off the Predisone without the pain returning. I am still working with my doctor to see about maybe taking a bigger dose but I am gaining weight at an alarming pace for the Prednisone, but what else can I do? This is not what I want but waht now? More
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2823379 2 F 01/28/2025 MNQ
PPV
 NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 M23G5
X022827
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients a... Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 2 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10. More
2823380 83 F FL 01/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Injection site erythema Injection site erythema
LARGE RED RING AROUND THE VACCINATION SITE LARGE RED RING AROUND THE VACCINATION SITE
2823400 6 M CA 01/28/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient is 7 years old and was prescribed Menveo liquid form, as he was traveling. Per CDC guideline... Patient is 7 years old and was prescribed Menveo liquid form, as he was traveling. Per CDC guidelines, it must be given for ages 10+ More
2823401 4 M KY 01/28/2025 DTAPIPV
HEPA
HIBV
MMRV
PNC15
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 5g23d
dn273
x022981
y015990
y005465
Rash; Rash; Rash; Rash; Rash Rash; Rash; Rash; Rash; Rash
Mom reports pt started getting rash on bilateral thighs & abdomen around 5pm, called clinic and ... Mom reports pt started getting rash on bilateral thighs & abdomen around 5pm, called clinic and told her to return to clinic to allow him to be assessed by provider. Rash appeared to be hives. No wheezing noted on auscultation. Pt given Benadryl prior to arriving at clinic. Benadryl & prednisolone RX sent into pharmacy. More
2823402 89 F FL 01/28/2025 PNC20
 PFIZER\WYETH
 lg5576
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given a Prevnar 20 shot on 01/27/25, It was realized on 01/28/25 patient had received th... Patient was given a Prevnar 20 shot on 01/27/25, It was realized on 01/28/25 patient had received the shot in 09/2023 and a second dose was not needed. Spoke with patient on 01/28/25 and she had no adverse effects. More
2823403 75 F FL 01/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Additional dose of Arexvy vaccine was administered outside of clinical guideline recommendations. Pa... Additional dose of Arexvy vaccine was administered outside of clinical guideline recommendations. Patient received one dose of Arexvy on 1/11/24, and this additional dose on 1/26/25 More
2823404 61 F FL 01/28/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Inflammation Arthralgia, Inflammation
Pain, in shoulder after initial vaccination Pain, in shoulder after initial vaccination
2823405 69 F SD 01/28/2025 PNC21
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y011819
XN575
Injection site erythema; Injection site erythema Injection site erythema; Injection site erythema
Three days after vaccine given an oval area of redness developed on arm where shot was given, now sp... Three days after vaccine given an oval area of redness developed on arm where shot was given, now spreading toward elbow. I referred patient to provider to seek care More
2823406 0.5 F CA 01/28/2025 HIBV
 MERCK & CO. INC.
 X020942
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
PedvaxHIB given at the incorrect time. No adverse reactions noted. PedvaxHIB given at the incorrect time. No adverse reactions noted.
2823407 53 F CA 01/28/2025 COVID19
COVID19
VARZOS
VARZOS
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 ln0588
ln0588
g97y2
g97y2
Immediate post-injection reaction, Injection site erythema, Injection site haemo... Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling; Product administered at inappropriate site; Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling; Product administered at inappropriate site More
Patient reports that the shot was given very high on the arm. Red, painful rash at injection site wi... Patient reports that the shot was given very high on the arm. Red, painful rash at injection site with swelling. Patient reports openly bleeding for multiple hours after vaccine but is not on blood thinners. Patient states there was a very large amount of pain for ~3 days after shot, that started immediately on injection. More
2823408 65 F GA 01/28/2025 PNC20
 PFIZER\WYETH
 lg5575
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient inappropriately received a 2nd Prevnar 20 vaccine. No adverse events reported. Patient inappropriately received a 2nd Prevnar 20 vaccine. No adverse events reported.
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