🏥 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 💀 🏥 🚑 ♿ ⚠️
2835922 54 F NM 04/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L944
Injection site rash, Injection site swelling Injection site rash, Injection site swelling
Swelling at injection site and rash developed 7 days later per patient Swelling at injection site and rash developed 7 days later per patient
2835923 61 F IL 04/13/2025 PNC21
 MERCK & CO. INC.
 Y011819
Erythema, Pain in extremity Erythema, Pain in extremity
CUSTOMER CAME IN WITH LOCAL REACTION LEFT ARM- SORENESS REDNESS AND PAIN CUSTOMER CAME IN WITH LOCAL REACTION LEFT ARM- SORENESS REDNESS AND PAIN
2835924 36 F WA 04/13/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN




Activated partial thromboplastin time, Alopecia, Antiphospholipid antibodies, Bl... Activated partial thromboplastin time, Alopecia, Antiphospholipid antibodies, Blood glucose fluctuation, Blood thyroid stimulating hormone; Brain natriuretic peptide, Contusion, Echocardiogram, Epistaxis, Exophthalmos; Full blood count, Gingival bleeding, Glycosylated haemoglobin, Metabolic function test, Myalgia; Oedema, Palpitations, Platelet function test, Prothrombin level, Rheumatoid factor; Thyroxine free, Urine analysis More
Bloody noses repeatedly, extensive bruises face, neck, arms, chest, abdomen, back, buttocks, legs. ... Bloody noses repeatedly, extensive bruises face, neck, arms, chest, abdomen, back, buttocks, legs. Bleeding gums while talking, eating or drinking. Bilateral pitting edema lower legs. Hair loss, muscle pains. Blood sugar crashes. Bulging eyes repeatedly. Racing heart rate. More
2835925 87 F NM 04/13/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Immediate post-injection reaction, Injection site mass Immediate post-injection reaction, Injection site mass
IMMEDIATE LUMP UNDER SKIN AT INJECTION SITE, COLD COMPRESS IMMEDIATE LUMP UNDER SKIN AT INJECTION SITE, COLD COMPRESS
2835926 59 F TX 04/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7349L
Injection site pain, Injection site swelling, Injection site warmth, Pyrexia Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Patient reported mild fever for more than 1 day but went away after she took some OTC ibuprofen. Her... Patient reported mild fever for more than 1 day but went away after she took some OTC ibuprofen. Her arm got swollen around the site of injection and kept getting bigger. It felt warm to the touch but not very painful. Patient took OTC ibuprofen and cold compress but it still not improved. More
2835927 71 F MS 04/13/2025 FLU3
 SANOFI PASTEUR
 u8521da
Erythema, Peripheral swelling Erythema, Peripheral swelling
Patient reported red and swollen arm. Patient received vaccine on 4/10/25 and reaction progressed. P... Patient reported red and swollen arm. Patient received vaccine on 4/10/25 and reaction progressed. Patient report reaction to pharmacy 4/13/25. I advise patient to try Benadryl for the reaction and to follow up with her md provider. More
2835928 1.5 M GA 04/13/2025 PNC15
PNC15
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y010035
Y010035
Y011017
Y011017
Body temperature increased, Decreased appetite, Erythema, Palatal ulcer, Rash; R... Body temperature increased, Decreased appetite, Erythema, Palatal ulcer, Rash; Rash pustular, Scab, Skin lesion, Vomiting; Body temperature increased, Decreased appetite, Erythema, Palatal ulcer, Rash; Rash pustular, Scab, Skin lesion, Vomiting More
04 April 2025: 18 month old received Varivax (dose 1) and PCV-15 (dose 3) 09 April 2025: T102.8, em... 04 April 2025: 18 month old received Varivax (dose 1) and PCV-15 (dose 3) 09 April 2025: T102.8, emesis x 2, rash to neck and back; decreased appetite. Father reported that he had "varicella" 2 weeks ago, was evaluated at another hospital. 10 April 2025: presented to ED, afebrile with exam performed and documented by NP; noted "shallow ulcerations to palate, generalized vesicopustular rash to face, trunk, and extremities, sparing palms and soles". Discharged 10 April 2025 11 April 2025: represented to ED with continued temp of 102, responds to antipyretics and recurs. Evaluated by MD. Parents reported lesions started on back. Lesions have a red base, vesiculopustular, scabbing, pruritic. Decreased appetite. Administered diphenhydramine; one palatal ulcer noted; lesions diffuse over trunk, extremities, face, near eyes, no scleral or conjunctival involvement. Discharged 11 April 2025. Per my assessment as the hospital epidemiologist, I recommended reporting to VAERS as it is unclear if this is wild-type varicella from exposure to the father or varicella-vaccine associated. No diagnostic testing was done at either ED encounter. PCP declined to complete the VAERS form, as by report, he did not feel that the child's lesions and ED presentations x 2 were vaccine associated. More
2835929 55 F CA 04/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 KB2YT
Magnetic resonance imaging, Pain in extremity Magnetic resonance imaging, Pain in extremity
injected and developed severe left arm pain afterwards that persisted for up to greater than 1 month injected and developed severe left arm pain afterwards that persisted for up to greater than 1 month
2835879 F IA 04/12/2025 HEP
HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Hepatitis B antibody negative; Hepatitis B antibody negative; Hepatitis B antibo... Hepatitis B antibody negative; Hepatitis B antibody negative; Hepatitis B antibody negative More
Caller had a question about RECOMBIVAX HB. Pharmacist stated that he has an employee that had receiv... Caller had a question about RECOMBIVAX HB. Pharmacist stated that he has an employee that had received 3 doses of RECOMBIVAX HB in the past and the titer showed below threshold. Consent was obtained to follow up with the HCP. No additional AE/PQC.; This spontaneous report was received from a pharmacist and refers to a 24-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, the patient was vaccinated with the first, second and third dose of with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), solution for injection (lot # and expiration date were not reported) for Prophylaxis. On an unknown date, the Pharmacist stated that he had an employee that had received 3 doses of the vaccine, and the titer showed below threshold. At the reporting time, the outcome of the event was not reported. The causal relationship between the event and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was unknown. More
2835880 PA 04/12/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Incorrect dose administered, No adverse event, Wrong product administered; Incor... Incorrect dose administered, No adverse event, Wrong product administered; Incorrect dose administered, No adverse event, Wrong product administered More
administer an MMR vaccine with the VARIVAX, but instead administered PROQUAD and VARIVAX to a patien... administer an MMR vaccine with the VARIVAX, but instead administered PROQUAD and VARIVAX to a patient in the same visit; administered PROQUAD and VARIVAX to a patient in the same visit; No additional adverse events were reported.; This spontaneous report was received from a Nurse Practitioner and refers to a 1-year-old patient of unknown gender. The patient's medical history, concurrent condition, concomitant therapies and drug reactions/allergies were not reported. On an unknown date, the nurse was supposed to administered Measles, Mumps and Rubella vaccine with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), but instead, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 1 dosage form (dosage regimen, anatomical location, route of administration, lot # and expiration date were not reported) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 1 dosage form (dosage regimen, anatomical location, route of administration, lot # and expiration date were not reported) (wrong product administered) (overdose), which were diluted with sterile diluent (expiration date and lot # were not reported) and administered as prophylaxis in the same visit. No additional information was provided. No additional adverse events were reported (no adverse event.) Lot # is being requested and will be submitted if received. More
2835881 M FL 04/12/2025 HPV9
 MERCK & CO. INC.
Erythema, Pruritus, Rash, Skin warm, Urticaria Erythema, Pruritus, Rash, Skin warm, Urticaria
General Rash; Itchiness; possible hives; Redness to Cheeks that were Warm to touch; This spontaneous... General Rash; Itchiness; possible hives; Redness to Cheeks that were Warm to touch; This spontaneous report was received from a Physician and refers to a 13-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included Environmental allergies. Concomitant therapies were not reported. On 28-FEB-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) solution for injection (lot #, dose, route of administration, anatomical location of vaccine and expiration date were not reported) for Prophylaxis. On 28-FEBB-2025, experienced general rash, itchiness and redness to cheeks that were "warm to touch" after receiving first dose, additionally, he experienced rash and redness approximately one hour after receiving injection. Patient was given a dose of Fexofenadine (ALLEGRA) on the same day. The reporter said that the symptoms continued a second day and was given a second dose of Fexofenadine (ALLEGRA). The reporter stated that on the third day patient came into clinic for consultation and remnants of a rash and "possible hives" were seen. No other findings were notice. At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown. More
2835882 4 VA 04/12/2025 VARCEL
 MERCK & CO. INC.
 X007373
Expired product administered Expired product administered
No additional AE; HCP called in to report that an expired dose of VARIVAX was administered.; This sp... No additional AE; HCP called in to report that an expired dose of VARIVAX was administered.; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Mar-2025, the patient was vaccinated with an expire dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X007373, expiration date: 12-Mar-2025) 0.5 mL (strength and anatomical location not provided) for prophylaxis, diluted with sterile diluent (MERCK STERILE DILUENT), (lot #2087420, expiration date: 21-Jan-2027) 0.5 mL for an unknown indication. o symptoms reported. No additional information available More
2835883 F NY 04/12/2025 PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
PPV
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

















Anti-ganglioside antibody positive, Autoantibody test, CSF glucose normal, CSF n... Anti-ganglioside antibody positive, Autoantibody test, CSF glucose normal, CSF neutrophil count increased, CSF protein increased; CSF white blood cell count increased, Coma, Diplopia, Electroencephalogram abnormal, Encephalopathy; Endotracheal intubation, Headache, Immunoglobulin therapy, Inflammatory marker test, Intensive care; Laboratory test, Magnetic resonance imaging head abnormal, Meningitis, Miller Fisher syndrome, Myelofibrosis; Paraesthesia, Pleocytosis, Respiratory failure, Scan with contrast abnormal, Venogram normal; Vertebral artery occlusion, White matter lesion; Anti-ganglioside antibody positive, Autoantibody test, CSF glucose normal, CSF neutrophil count increased, CSF protein increased; CSF white blood cell count increased, Coma, Diplopia, Electroencephalogram abnormal, Encephalopathy; Endotracheal intubation, Headache, Immunoglobulin therapy, Inflammatory marker test, Intensive care; Laboratory test, Magnetic resonance imaging head abnormal, Meningitis, Miller Fisher syndrome, Myelofibrosis; Paraesthesia, Pleocytosis, Respiratory failure, Scan with contrast abnormal, Venogram normal; Vertebral artery occlusion, White matter lesion; Anti-ganglioside antibody positive, Autoantibody test, CSF glucose normal, CSF neutrophil count increased, CSF protein increased; CSF white blood cell count increased, Coma, Diplopia, Electroencephalogram abnormal, Encephalopathy; Endotracheal intubation, Headache, Immunoglobulin therapy, Inflammatory marker test, Intensive care; Laboratory test, Magnetic resonance imaging head abnormal, Meningitis, Miller Fisher syndrome, Myelofibrosis; Paraesthesia, Pleocytosis, Respiratory failure, Scan with contrast abnormal, Venogram normal; Vertebral artery occlusion, White matter lesion More
Miller Fisher Syndrome; This literature marketed report was received from the authors in a published... Miller Fisher Syndrome; This literature marketed report was received from the authors in a published literature article, concerning a 70-year-old female patient. Information regarding the patients' concurrent conditions, medical history or concomitant medications was not provided. On unknown dates, the patient was vaccinated with an unspecified pneumococcal vaccine (Manufacturer unknown) for prophylaxis (strength, route of administration, lot # and expiration date were not reported). 8 days after receiving the vaccine, the patient presented to the emergency room with headache, diplopia, and limb paresthesia. Initial neuroimaging showed white matter disease and segmental occlusion of the distal left vertebral artery with reconstitution. Lumbar puncture (LP) was performed, and cerebrospinal fluid showed elevated WBCs with neutrophil predominance, elevated protein and normal glucose. Additional autoimmune, inflammatory and paraneoplastic workup was sent while broad-spectrum antimicrobial treatment for suspected meningitis was initiated. She was subsequently intubated for worsening encephalopathy and hypoxic, hypercapnic respiratory failure and admitted to the Intensive Care Unit. MRI/MRV Brain was negative. EEG showed Delta- Theta coma. Serial neurological exams revealed coma with ocular square wave jerks. Repeat MRI Brain with and without contrast was suspicious for bilateral hippocampal enhancement thought to be possible brainstem or limbic encephalitis. LP was repeated with resolving pleocytosis, and subsequent exam showed purposeful vertical eye movements. Intravenous immunoglobulin was initiated and GM1 antibody test returned positive, confirming the suspicion of post-PV MF syndrome. The outcome of the event was unknown. The event was considered related to the pneumococcal vaccine. More
✓
2835884 M 04/12/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
extra dose administered; No adverse event; This spontaneous report was received from other healthcar... extra dose administered; No adverse event; This spontaneous report was received from other healthcare professional and refers to a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unspecified date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2022, the patient received the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On unknown date, the patient's physician recommended patient to receive a booster dose so he recently received one additional dose (fourth) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis (extra dose administered). The primary reporter did not think one booster dose would help patient and is asking if patient should receive two more doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). No adverse event reported. More
2835885 F FL 04/12/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Sharing Paxlovid; Sharing Paxlovid; This is a spontaneous report received from a Consumer or other n... Sharing Paxlovid; Sharing Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown) and as dose 7 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Sharing Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID. Clinical course: The patient's husband reported that "All 7 of our injections have been Pfizer products. we didn't get the very last updated, maybe that's why we got nailed this time it was pretty bad.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500043426 same reporter/product/event, different patients; More
2835886 M FL 04/12/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ... COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 68-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown) and as dose 7 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was taking Paxlovid as treatment. The patient reported that "All 7 of our injections have been Pfizer products. we didn't get the very last updated, maybe that's why we got nailed this time it was pretty bad." More
2835894 4 M LA 04/12/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5g23d
Erythema Erythema
1 cm area of redness and erythema 1 cm area of redness and erythema
2835895 60 M OH 04/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Hypoaesthesia Hypoaesthesia
patient had facial numbness around cheeks and mouth, patient was monitored for 30 minutes and hydrat... patient had facial numbness around cheeks and mouth, patient was monitored for 30 minutes and hydrated with bottled water, still had numbness and went to ER for further checks because numbness was still present but patient reported no additional adverse events More
2835896 78 F PA 04/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Joint swelling, Muscle spasms, Pain in extremity Joint swelling, Muscle spasms, Pain in extremity
Patient experienced leg cramps progressing to extreme leg pain. Patient went to the emergency room ... Patient experienced leg cramps progressing to extreme leg pain. Patient went to the emergency room with her husband. Notes swelling of knee, administered Gabapentin and Norco and released. Told not to receive the 2nd dose in two months. Upon checking with patient on 4-11-2025 she was doing much better and pain had resolved. More
2835897 69 F NY 04/12/2025 COVID19
UNK
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Rash, Rash pruritic, Skin exfoliation; Rash, Rash pruritic, Skin exfoliation Rash, Rash pruritic, Skin exfoliation; Rash, Rash pruritic, Skin exfoliation
intensely itchy rash with bumps on left side of face, spreading to left side of neck, lasting 10 day... intensely itchy rash with bumps on left side of face, spreading to left side of neck, lasting 10 days, followed by pealing skin. two days later, similar reaction on left side of knee, ongoing More
2835898 81 M GA 04/12/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 7KD5B
Balance disorder, Fall, Feeling drunk, Gait disturbance Balance disorder, Fall, Feeling drunk, Gait disturbance
Patient called the pharmacy today 4-12-2025 concerned that he had an adverse reaction from the Tdap ... Patient called the pharmacy today 4-12-2025 concerned that he had an adverse reaction from the Tdap vaccine he received on 4-11-2025. He said about 2 hours post vaccination he was out in his yard picking up limbs and all at once he became unbalanced and felt like he was drunk. He said he fell 3 times trying staggering to get back to his house. I asked did he hurt himself when he fell and he said no. He said he went inside and sit in his recliner and after about 2 hour he was feeling fine. Patient said he feels fine today as well. More
2835899 74 F WI 04/12/2025 RSV
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LN5487
74NC9
Erythema, Skin irritation, Skin weeping; Erythema, Skin irritation, Skin weeping Erythema, Skin irritation, Skin weeping; Erythema, Skin irritation, Skin weeping
Patient called and stated that she had a red, irritated mark near her navel and that her belly butto... Patient called and stated that she had a red, irritated mark near her navel and that her belly button was oozing a little bit and had an odor. More
2835900 59 F OH 04/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 HM9NS
Injection site erythema, Injection site rash, Pain in extremity, Sleep disorder Injection site erythema, Injection site rash, Pain in extremity, Sleep disorder
Patient Got vaccine 4/10/25 at 11:10am, Woke up on 4/11/25 with red rash around injection site. Pain... Patient Got vaccine 4/10/25 at 11:10am, Woke up on 4/11/25 with red rash around injection site. Pain when lay on arm hard to sleep. Today 4/12/25 Rash about 3-4 inches in diameter circle around injection site. Advised patient to mark rash and watch for change in size, pain, itch or temperature(heat). Patient will use cool compresses, benadryl, tylenol or ibuprofen as needed and see MD or ED if gets worse. More
2835901 60 M WI 04/12/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Arthralgia, Bone pain, Chills, Hyperhidrosis, Joint noise; Joint swelling, Myalg... Arthralgia, Bone pain, Chills, Hyperhidrosis, Joint noise; Joint swelling, Myalgia, Pyrexia, Tremor More
Shaking fevers (103 f), chills, sweats, severe arthralgias, myalgias, and bone pain. Swollen knees w... Shaking fevers (103 f), chills, sweats, severe arthralgias, myalgias, and bone pain. Swollen knees with pain & crepitus. More
2835902 1 F GA 04/12/2025 MMR
 MERCK & CO. INC.
 Y013131
Pyrexia, Rash morbilliform Pyrexia, Rash morbilliform
Fever and diffuse measles like rash. Fever started day after vaccine Tmax 39.2, low grade fevers for... Fever and diffuse measles like rash. Fever started day after vaccine Tmax 39.2, low grade fevers for 36-48 hours after the high fever. Rash started day 9, worsened throughout the week and resolved day 15 post vaccine. More
2835903 55 M IL 04/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Migraine Migraine
I have had a migraine headache for 6 days now starting on the second day of getting the vaccine dose... I have had a migraine headache for 6 days now starting on the second day of getting the vaccine dose. I have had migraines before but every other time they were gone by the 3rd to 4th day. More
2835904 72 F WV 04/12/2025 PNC21
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
 y019158
u8115aa
Injection site haemorrhage; Injection site haemorrhage Injection site haemorrhage; Injection site haemorrhage
Patient reports to pharmacy that "both vaccines bled, and that I have never had a vaccine that ... Patient reports to pharmacy that "both vaccines bled, and that I have never had a vaccine that has bled before. It covered both bandages." Patient reported to facility compliance and complaint line. More
2835905 79 M TX 04/12/2025 PNC20
 PFIZER\WYETH
 LK6651
Injection site mass, Injection site rash, Rash erythematous Injection site mass, Injection site rash, Rash erythematous
Patient came in today 4-12-2025. Patient had red- spotted rash that has been traveling down his left... Patient came in today 4-12-2025. Patient had red- spotted rash that has been traveling down his left arm where shot was given. Rash does not hurt or itch but patient felt knot. Patient is to follow up with Dr. More
2835906 76 F ME 04/12/2025 PNC21
 MERCK & CO. INC.
 y019058
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Hot, red, swollen arm at injection site. Hot, red, swollen arm at injection site.
2835907 59 M CO 04/12/2025 COVID19
 PFIZER\BIONTECH
 lt7425
Underdose Underdose
Administered Pediatric COVID-19 vaccine to an adult. Could not reach him to correct error. Administered Pediatric COVID-19 vaccine to an adult. Could not reach him to correct error.
2835908 84 M TX 04/12/2025 COVID19
 MODERNA
Death, Myocardial infarction Death, Myocardial infarction
Death from heart attack. Death from heart attack.
✓
2835909 72 M NV 04/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Loss of personal independence in daily activities, Pain in extremity, Sleep diso... Loss of personal independence in daily activities, Pain in extremity, Sleep disorder More
Patient came in the pharmacy on 4/12/2025 stating that he received the vaccination last month and th... Patient came in the pharmacy on 4/12/2025 stating that he received the vaccination last month and that his left arm continued to hurt and that the pain extended toward the neck area and this prohibited him from doing normal daily activities and also cause loss of sleep. Patient has been taking aleve over the counter but the pain did not go resolve More
2835910 65 F CO 04/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7349L / HM9N5
Lymphadenopathy, Vaccination site swelling Lymphadenopathy, Vaccination site swelling
Swelling in left are and red striations above vaccination site. Swelling in lymph nodes near armpit Swelling in left are and red striations above vaccination site. Swelling in lymph nodes near armpit
2835911 4 M MA 04/12/2025 COVID19
 PFIZER\BIONTECH
 FJ8762
Myocardial infarction Myocardial infarction
Heart Attack Heart Attack
✓ ✓
2835706 47 F TX 04/11/2025 HPV9
 MERCK & CO. INC.
 Y014510
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No symptoms.; one dose of GARDASIL 9 was administered to a patient who is 47 years old; This spontan... No symptoms.; one dose of GARDASIL 9 was administered to a patient who is 47 years old; This spontaneous report was received from a nurse concerning to a 47-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported. On 26-DEC-2024, the patient was vaccinated with one dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled syringe, lot #Y014510, expiration date: 01-Nov-2026, 0.5 mL (dosage regimen, anatomical location and route of administration were not reported) administered as prophylaxis (product administered to patient of inappropriate age.) On 26-Dec-2024, the patient experienced one dose of GARDASIL 9 was administered to a patient who is 47 years old. There were no symptoms (no adverse event.) More
2835720 75 F CA 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Hyperhidrosis, Nausea, Vertigo Chills, Hyperhidrosis, Nausea, Vertigo
chills; sweat; vertigo; nausea; This non-serious case was reported by a consumer via call center rep... chills; sweat; vertigo; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 26-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 27-MAR-2025, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: chills), sweating (Verbatim: sweat), vertigo (Verbatim: vertigo) and nausea (Verbatim: nausea). On 28-MAR-2025, the outcome of the chills, sweating, vertigo and nausea were resolved (duration 1 day). It was unknown if the reporter considered the chills, sweating, vertigo and nausea to be related to Shingrix. It was unknown if the company considered the chills, sweating, vertigo and nausea to be related to Shingrix. Additional Information: GSK Receipt Date: 27-MAR-2025 Reporter called and stated she received her 1st of 2 vaccines for Shingrix on 26-MAR-2025 and within 24 hours the reporter started having chills, sweat, vertigo and nausea that lasted around 24 hours before completely resolving. More
2835721 F 04/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
Priorix administered IM instead of subcutaneously; This non-serious case was reported by a pharmacis... Priorix administered IM instead of subcutaneously; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 4N222) for prophylaxis. On 31-MAR-2025, the patient received Priorix (intramuscular, right arm). On 31-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix administered IM instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 05-APR-2025 Priorix administered intramuscularly instead of subcutaneously which led to Subcutaneous injection formulation administered by other route. More
2835722 M GA 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain Herpes zoster, Pain
I took your vaccine and about a week later I got shingles; This non-serious case was reported by a c... I took your vaccine and about a week later I got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: I took your vaccine and about a week later I got shingles). The outcome of the shingles was resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 04-APR-2025 The reporter reported that the patient received the vaccine and about a week later he got shingles. He had never had shingles. He was never warned he might get shingles after he took the shingles shot. He was not very happy about this. It was the most painful of anything he ever experienced. The shingles attack occurred on his right butt cheek. He was in pain for 3 days. The doctor gave him a cream to use. It helped a little. He asked, why was not he warned. He was pretty old and had pain like that was a surprise. He could believe, he was the first to get shingles from vaccine. He did not care whether vaccine was live or dead. No one would ever convince him those two events were not connected. If he was going to get shingles it would had happened during one of his decades. It would not had happened one-week after taking a vaccine. He had already talked to 3 of his doctors and they were puzzled. That did not mean he was wrong. It happened to him, on his butt. It was painful. If he had not taken the vaccine he seriously doubt he would ever had heard the word shingles. 2024 was a bad medical year. He was fine now. It was been a few months. More
2835723 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; 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: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-APR-2025 The case was received from the patient via interactive digital media. The patient asked he/she had the vaccine so why did he/she get shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2835724 DE 04/11/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK043AA
No adverse event, Product preparation issue, Underdose No adverse event, Product preparation issue, Underdose
patient was given an incomplete dose of PENTACEL that was not mixed together correctly, it was missi... patient was given an incomplete dose of PENTACEL that was not mixed together correctly, it was missing HIB with no reported adverse event; Initial information received on 08-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age and unknown gender patient who experienced patient was given an incomplete dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] that was not mixed together correctly, it was missing hib with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an incomplete 1ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection frequency -once (strength-unknown) (lot UK043AA, expiry date- 31-Aug-2025) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) that was not mixed together correctly, it was missing hib with no reported adverse event (single component of a two-component product administered) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2835743 82 M TX 04/11/2025 FLU3
 SEQIRUS, INC.
 P100713529
Confusional state, Feeling abnormal Confusional state, Feeling abnormal
Patient was confused and dazed. Patient was confused and dazed.
2835744 60 M TX 04/11/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7776AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No Symptoms. No Symptoms.
2835784 7 M MD 04/11/2025 MMRV
 MERCK & CO. INC.
 X022919
No adverse event, Product preparation error No adverse event, Product preparation error
No adverse event; HCP called to report a patient received an expired dose of PROQUAD. caller states... No adverse event; HCP called to report a patient received an expired dose of PROQUAD. caller states the product expired 03/12/2025 and was administered to one patient 03/14/2025.; This spontaneous report was received from a Nurse and refers to a 7-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 14-Mar-2025, the patient was vaccinated with an expiry dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X022919, expiration date: 12-Mar-2025), 0.5 mL (strength, dose, and anatomical location not provided) for prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT) 0.5 mL (indication, expiration date, and lot # were not reported). No side effects or symptoms have been reported. More
2835785 F NY 04/11/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Not Reported
Not Reported
Cellulitis, Injection site erythema, Injection site induration, Injection site p... Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling; Pyrexia More
HCP diagnosed as cellulitis; Patient came back to clinic 03/18/2025 with complaint of injection sit... HCP diagnosed as cellulitis; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch.; This spontaneous report was received from a Nurse and refers to a(n) 49-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 12-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), formulation: injection (lot #, expiration date, exact dose, route of administration, anatomical location and indication were not provided). On an unknown exact date in March 2025, the patient experienced cellulitis, vaccination site erythema, vaccination site induration, vaccination site pain, vaccination site swelling. Patient came back to clinic 10-Mar-2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch. Patient was prescribed Benadryl and topical cortisone cream for symptoms as well as CEPHALEXIN. HCP diagnosed as cellulitis. On the same date, body temperature was 97.8 F, oxygen saturation was 99 %, heart rate showed 71 (units not provided), blood pressure showed 126/75 (units not provided). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided. More
2835786 F TX 04/11/2025 PNC21
 MERCK & CO. INC.
Injection site erythema Injection site erythema
Received from the AE Self-Service Portal: Report submitted by Merck Employee Provider stated today ... Received from the AE Self-Service Portal: Report submitted by Merck Employee Provider stated today that this patient experienced 7-10 days of redness at the injection site after receiving a dose of Capvaxive. "Case assigned/processed; This spontaneous report was received from a physical assistant and refers to a(n) 50-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 exact day in January 2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On an unknown exact day in January 2025, the patient experienced vaccination site erythema (experienced 7-10 days of redness at the injection site after receiving a dose of vaccine). At the reporting time, the outcome of the event was unknown. The causal relationship between the event of vaccination site erythema and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided. More
2835787 F LA 04/11/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


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; Inappropriate schedule of product administration, No adverse event More
HCP called to report a female patient received third dose of GARDASIL 9 late according to vaccinatio... HCP called to report a female patient received third dose of GARDASIL 9 late according to vaccination schedule. Caller did not have exact dates but states the first and second dose were administered appropriately according to the vaccination schedule; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (expiration date, and lot # were not reported) for prophylaxis. According to the reporter, the first and second dose were administered appropriately according to the vaccination schedule, but the third dose was administered later than the recommended 6 months (the nurse did not have exact dates) (Inappropriate schedule of product administration). No adverse events were reported. Lot is being requested and will be submitted if received. More
2835788 NY 04/11/2025 PNC15
 MERCK & CO. INC.
 Y010035
No adverse event, Syringe issue No adverse event, Syringe issue
No adverse event; Poor quality device used; LPN calling to report increased pressure irregularity of... No adverse event; Poor quality device used; LPN calling to report increased pressure irregularity of VAXNEUVNACE prefilled syringe while administering vaccine to a 15-month-old patient. Caller stated vaccine was being given to a 15-month-old patient in the thigh when the injection experienced; Device leakage; This spontaneous report was received from a nurse and refers to a(n) 15-month-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 09-Apr-2025, the patient was vaccinated with the dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), formulation: injection, lot #Y010035, expiration date: 17-Feb-2027, 0.5 mL, administered in thigh (route of administration and site of administration were not provided) for prophylaxis. The reporter stated that vaccine was being given to a 15-month-old patient in the thigh when the injection experienced resistance to the point that nurse "couldn't push anymore". Reporter stated that the needle was removed from patient at that point the rest of the medication squirted out of the syringe with no force (poor quality device used, device leakage). Patient was given vaccine however did not receive full dose (vaccine underdose). No additional adverse event reported (no adverse event). More
2835789 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Guillain-Barre syndrome Guillain-Barre syndrome
I got GBS from the shingles shot; This serious case was reported by a consumer via interactive digit... I got GBS from the shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: I got GBS from the shingles shot) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got the Guillain-Barre syndrome from the shingles shot. The follow-up could not be possible as no contact details were available. This case has been linked with US2022AMR134320, reported by same reporter; Sender's Comments: Guillain-Barre syndrome is a listed event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK Shingles vaccine. US-GLAXOSMITHKLINE-US2022AMR134320:same reporter More
2835790 M 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Peripheral swelling Peripheral swelling
Swelling arm; This non-serious case was reported by a consumer via sales rep and described the occur... Swelling arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of swelling arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 13-SEP-2024, the patient received the 1st dose of Shingrix (left deltoid). On 17-SEP-2024, 4 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling arm). On 24-SEP-2024, the outcome of the swelling arm was resolved. The reporter considered the swelling arm to be related to Shingrix. The company considered the swelling arm to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The patient self reported this case for himself. Patient had swelling greater than 100 mm took 7 to 10 days to resolve. More
2835791 57 F CA 04/11/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Rash; Herpes zoster; Rash; Herpes zoster Rash; Herpes zoster; Rash; Herpes zoster
she developed a rash on her lower back; This non-serious case was reported by a consumer via call ce... she developed a rash on her lower back; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included insomnia, depression, bipolar ii disorder and seasonal allergy. Concomitant products included eszopiclone (Lunesta), venlafaxine hydrochloride (Effexor), olanzapine (Zyprexa) and clarithromycin (Claritin). On 29-MAR-2025, the patient received the 1st dose of Shingrix. On 29-MAR-2025, less than a day after receiving Shingrix, the patient experienced rash (Verbatim: she developed a rash on her lower back). The outcome of the rash was resolving. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK receipt date: 03-APR-2025 The patient is the reporter. The patient developed a rash on her lower back after receiving the first dose of Shingrix. More
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