🏥 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 💀 🏥 🚑 ♿ ⚠️
2795569 65 F MD 10/03/2024 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Antinuclear antibody, Blood thyroid stimulating hormone, C-reactive protein, Fat... Antinuclear antibody, Blood thyroid stimulating hormone, C-reactive protein, Fatigue, Full blood count; Metabolic function test, Myalgia, Red blood cell sedimentation rate, Rheumatoid factor, Swelling face; Erythema, Facial paralysis, Pruritus, Skin exfoliation, Swelling face More
facial swelling myalgia fatigue facial swelling myalgia fatigue
2820367 F TN 01/10/2025 RSV
 PFIZER\WYETH
Injection site pain, Injection site pruritus Injection site pain, Injection site pruritus
very sore injection site for over a week/then less sore but able to use arm; itching at the injectio... very sore injection site for over a week/then less sore but able to use arm; itching at the injection site; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Dec2024 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PRURITUS (disability) with onset 20Dec2024 at 16:00, outcome "recovering", described as "itching at the injection site"; VACCINATION SITE PAIN (disability) with onset 20Dec2024 at 16:00, outcome "recovering", described as "very sore injection site for over a week/then less sore but able to use arm". Therapeutic measures were taken as a result of vaccination site pain, vaccination site pruritus. Additional information: very sore injection site for over a week. Then less sore but able to use arm. Then itching at the injection site. This is the very worst injection i have ever received. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
✓
2820368 F 01/10/2025 COVID19
 PFIZER\BIONTECH
Allergy to vaccine, Autoimmune disorder, COVID-19, Condition aggravated, Drug in... Allergy to vaccine, Autoimmune disorder, COVID-19, Condition aggravated, Drug ineffective More
she had Covid; she had Covid; autoimmune disease reactivated; autoimmune disease reactivated; Is it ... she had Covid; she had Covid; autoimmune disease reactivated; autoimmune disease reactivated; Is it similar ingredients to Pfizer Covid Vaccine because she is allergic to them; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had Covid"; AUTOIMMUNE DISORDER (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "autoimmune disease reactivated"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Is it similar ingredients to Pfizer Covid Vaccine because she is allergic to them". Clinical course: She said that she had the Pfizer Covid-19 vaccine before. After a year, she had Covid and her autoimmune disease reactivated. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2820369 M 01/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
he just had Covid 19, he went to the ER; he just had Covid 19, he went to the ER; This is a spontane... he just had Covid 19, he went to the ER; he just had Covid 19, he went to the ER; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he just had Covid 19, he went to the ER". The event "he just had covid 19, he went to the er" required emergency room visit. The patient stated he just had Covid 19. He went to the ER and the doctor would not give him nirmatrelvir, ritonavir (PAXLOVID) because he said the patient had all of his vaccinations and was updated on his boosters. The physician said recent study's showed it would be more detrimental to take nirmatrelvir, ritonavir. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2820370 F PA 01/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure, Weight COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Got Covid after having been vaccinated; Got Covid after having been vaccinated; This is a spontaneou... Got Covid after having been vaccinated; Got Covid after having been vaccinated; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient got vaccinated past fall. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT; ABILIFY. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2025, outcome "unknown" and all described as "Got Covid after having been vaccinated". The event "got covid after having been vaccinated" required physician office visit. The patient went to the doctor on Friday 03Dec2024. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2025) Positive; Weight: (unspecified date) 160 lbs, notes: Could be a little more. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started PAXLOVID on Saturday 04Jan2025. The patient was already on fourth day of taking her medication. Clinical course: On Monday night last week (30Dec2024), the patient got exposed to covid. She didn't test until 03Jan2025 and it came back positive. The lot number for BNT162b2 omicron (kp.2), was not provided and will be requested during follow up. More
2820371 M PA 01/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
Got Covid after receiving Covid Vaccine; Got Covid after receiving Covid Vaccine; This is a spontane... Got Covid after receiving Covid Vaccine; Got Covid after receiving Covid Vaccine; This is a spontaneous report and received from Consumer or other non HCPs. A 78-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN taken for low density lipoprotein; FLOMAX [TAMSULOSIN HYDROCHLORIDE] taken for prostatic disorder, bladder disorder; DUTASTERIDE taken for prostatic disorder. Past drug history included: Covid-19 vaccine for COVID-19 immunization, notes: DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2024, outcome "unknown" and all described as "Got Covid after receiving Covid Vaccine". Clinical course: The patient (reporter's husband) was exposed to COVID on 30Dec2024. It was confirmed that the patient was vaccinated with the Pfizer COVID vaccine (vaccinated again in the fall). The patient developed COVID after receiving the COVID vaccine. The reporter stated that the patient he had to "come off" of atorvastatin. The patient was treated with nirmatrelvir, ritonavir. The patient had finished the nirmatrelvir, ritonavir dose the night before the initial report. The patient also had to make a modification of tamsulosin hydrochloride; he had to reduce the dose. The patient was attempting to see if still he was still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820372 M PA 01/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 antibody test COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Got Covid after having been vaccinated; Got Covid after having been vaccinated; This is a spontaneou... Got Covid after having been vaccinated; Got Covid after having been vaccinated; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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) all with onset 30Dec2024, outcome "unknown" and all described as "Got Covid after having been vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820374 F 01/10/2025 PNC13
 PFIZER\WYETH
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Inappropriate dose of vaccine administered; This is a spontaneous report received from an Other HCP,... Inappropriate dose of vaccine administered; This is a spontaneous report received from an Other HCP, Program ID. A 36-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Mar2020 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "asplenia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (Dose 1; single), administration date: Sep2013, for immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset Mar2020, outcome "unknown", described as "Inappropriate dose of vaccine administered". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2820375 58 F 01/10/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza like illness, Nasal polyps, Productive cough, Sinusitis, Tachycardia Influenza like illness, Nasal polyps, Productive cough, Sinusitis, Tachycardia
got sick after having a flu shot in Nov-2024; developing flu like symptoms, and had mucus in her lun... got sick after having a flu shot in Nov-2024; developing flu like symptoms, and had mucus in her lungs; developing flu like symptoms, and had mucus in her lungs; adult patient is taking dupixent for sinusitis with no reported adverse event; tachycardia in which her heart rate went up to 160 at rest; vaginal yeast infections; immune system was affected by the medicine; Initial information received on 12-Sep-2024 was processed as non-case and upon follow-up received on 02-Jan-2025, the case became valid as an unsolicited valid non-serious case received from a patient. This case involves a 58 years old female patient who had tachycardia in which her heart rate went up to 160 at rest, got sick after having a flu shot in nov-2024, developed flu like symptoms, and had mucus in her lungs, vaginal yeast infections while being treated with Dupilumab [Dupixent] delivered via Dupilumab singledose prefilled pen and Influenza vaccine and adult patient was taking dupixent for sinusitis with nasal polyps with no reported adverse event directly linked to product use in unapproved indication. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included mepolizumab (nucala). On 24-Jul-2024, the patient started taking Dupilumab solution for injection of strength 300mg/2ml at a dose of 600 mg once as loading dose and since then on unknown date 2024 the patient started 300 mg maintenance dose every other week (QOW) subcutaneously via Dupilumab singledose prefilled pen for Asthma, sinusitis with nasal polyps (product use in unapproved indication) (same day latency) (unknown batch number and expiry date). In Nov-2024, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported (unknown dose, route, strength for prophylactic vaccination). In Nov-2024 the patient developed a non-serious event tachycardia in which her heart rate went up to 160 at rest (tachycardia) (approximately 5 months latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine. In Nov-2024 the patient developed a non-serious event got sick after having a flu shot in nov-2024 (illness) (approximately 5 months latency following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine. In Nov-2024 the patient developed a non-serious event developing flu like symptoms and had mucus in her lungs (influenza like illness) (productive cough) (approximately 5 months latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine. In 2024 the patient developed a non-serious vaginal yeast infections event (vulvovaginal mycotic infection) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine. In 2024 the patient developed a non-serious event "immune system was affected by the medicine" (immune system disorder) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine. Information regarding batch number and expiry date corresponding to one at the time of event occurrence was requested. It was reported additional information was received on 02-Jan-2025 patient reported she had several health issues within the past 2 months, in which she got sick after having a flu shot in Nov-2024. she reports developing flu like symptoms, and had mucus in her lungs and her doctor of medicine (md) prescribed antibiotics. she was concerned that her immune system was affected by the medicine. she reported within that time frame she missed a dose and delayed another dose by one week due to being sick. she did not had a flare up in her symptoms due to the missed/delayed doses. she also had been getting more vaginal yeast infections (unknown onset). she also had tachycardia in which her heart rate went up to 160 at rest. this occurred a couple days after she was feeling better from her illness. md is not aware. Relevant laboratory test results included: Heart rate - On an unknown date: [160 at rest] Action taken with dupilumab: Drug withdrawn in 2024 for influenza like illness, productive cough, illness and unknown for tachycardia, vulvovaginal mycotic infection, immune system disorder. And with influenza vaccine: unknown for influenza like illness, productive cough, illness, tachycardia, vulvovaginal mycotic infection, immune system disorder. Corrective treatment: Antibiotic (unspecified) for influenza like illness, productive cough, illness and not reported for tachycardia, vulvovaginal mycotic infection, immune system disorder. At time of reporting, the outcome was Unknown for tachycardia, vulvovaginal mycotic infection, immune system disorder and Recovering / Resolving for influenza like illness, productive cough, illness. 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
2820376 47 M 01/10/2025 FLUX
 UNKNOWN MANUFACTURER
Chills, Malaise, Myopia, Pleural effusion, Vision blurred Chills, Malaise, Myopia, Pleural effusion, Vision blurred
patient reports he is also near sighted; sick; experienced fluid in his chest and chills; experience... patient reports he is also near sighted; sick; experienced fluid in his chest and chills; experienced fluid in his chest and chills; reports blurred vision; Initial information on 26-Dec-2024 regarding an unsolicited valid non-serious case received from a patient. This case involves a 50-year-old male patient who was near sighted, sick, experienced fluid in his chest and chills and reports blurred vision while treated with DUPILUMAB [DUPIXENT] delivered via pre-filled syringe and after receiving influenza vaccine. The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided. At the time of the event, the patient had ongoing Pre-diabetes. On an unknown date in Sep-2021, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 600 mg 1X subcutaneously, strength: 300Mg/2ML followed by 300 mg QOW subcutaneously for Asthma and Nasal polyps via pre-filled syringe. On an unknown date in 2024, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). On an unknown date the patient developed a non-serious event "patient reports he is also near sighted" (myopia) (unknown latency) following the first dose intake (with an unknown batch number, expiry date) of DUPILUMAB and INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the first dose intake (with an unknown batch number, expiry date) of DUPILUMAB and INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "experienced fluid in his chest and chills" (pleural effusion), (chills) (unknown latency) following the first dose intake (with an unknown batch number, expiry date) of DUPILUMAB and INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "reports blurred vision" (vision blurred) (unknown latency) following the first dose intake (with an unknown batch number, expiry date) of DUPILUMAB and INFLUENZA VACCINE. Information on batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "the patient he was diagnosed with pre -diabetes 2-3 years ago. he reports no change in his pre -diabetes symptoms since the start of therapy. patient reports blurred vision, onset 1-2 years ago. md not aware. patient reports he is also near sighted and wears reading glasses. patient reports getting sick after the influenza vaccine he received in the fall of 2024. he experienced fluid in his chest and chills. The (doctor of medicine) md prescribed an antibiotic." Action taken: no action taken for all events for DUPILUMAB and not applicable for all events for influenza vaccine. Corrective treatment: wears reading glasses for myopia; unspecified antibiotic for pleural effusion, chills and not reported for other events. At time of reporting, the outcome was Unknown for all events. More
2820377 0.75 M CA 01/10/2025 IPV
 SANOFI PASTEUR
 X1C891M
Rash, Rash erythematous, Urticaria Rash, Rash erythematous, Urticaria
developed rash all over his body from his neck to his genital area; hives with red rash with dotted ... developed rash all over his body from his neck to his genital area; hives with red rash with dotted red spots; hives with red rash with dotted red spots; Initial information received on 06-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old male patient who developed rash all over his body from his neck to his genital area, hives with red rash with dotted red spots after receiving poliomyelitis vaccine (INACTIVATED) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jan-2025, the patient received 0.5 ml of dose 1 dose of IPV (VERO) Suspension for injection with standard strength (expiry date- 31-Oct-2026 and lot X1C891M) once via intramuscular route in the right vastus lateralis as Immunization. On 04-Jan-2025 the patient developed rash all over his body from his neck to his genital area (rash) and hives with red rash with dotted red spots (urticaria) (rash macular) (latency- 1 day) following the administration of IPV (VERO). Reportedly, the mother of the patient mentioned that the rashes went away on their own. No other vaccines. The next once was supposed to be on 31-Jan-2025. Action taken was not applicable. No corrective treatment was received for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date in January 2025 for the events. More
2820378 U PA 01/10/2025 FLU3
 SANOFI PASTEUR
 UT8437AA
No adverse event, Product storage error No adverse event, Product storage error
administered this Fluzone prior to being aware that there had been a temperature excursion (with no ... administered this Fluzone prior to being aware that there had been a temperature excursion (with no reported adverse event); Initial information received on 18-Dec-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves an unknown age and unknown gender patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone HD] prior to being aware that there had been a temperature excursion (with no reported adverse event). The patient's past medical history, medical treatment(s), Conocmitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength) with lot UT8437AA and expiry date 30-Jun-2025 via unknown route in unknown administration site for immunization prior to being aware that there had been a temperature excursion (with no reported adverse event) (poor quality product administered) (Latency same day). Reportedly, reporter stated that one of our work clinics refrigerators was out of range for a while before it was discovered. Total time out of range: 261 hours (10 days 21 hours) Highest Temp: 12.7C. 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
2820379 F FL 01/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 388477
388477
Lip disorder, Lip erythema, Lip pruritus, Mass, Nausea; Rash, Somnolence Lip disorder, Lip erythema, Lip pruritus, Mass, Nausea; Rash, Somnolence
Queasy; Skin rashes; Got breakout; Pea-sized bumps on biceps, stomch, back side of arm, bottom lip; ... Queasy; Skin rashes; Got breakout; Pea-sized bumps on biceps, stomch, back side of arm, bottom lip; Bumps on bottom lip, they were itchy; Bumps on bottom lip, they were pink; Sleepy; This spontaneous case initially received on 31-Dec-2024, was reported by a non health professional and concerns an elderly female patient. At the time of the event the patient had diabetes. Concomitant medication: refer to appropriate report section, Zenofibrate. Administration of company suspect drug(s): On 26-Dec-2024, the patient received Fluad (TIV) for Influenza immunization, Dose regimen: .5 ml, route of administration and anatomical location were not reported. Lot number: 388477. Non-company suspect drugs: Benadryl (Diphenhydramine hydrochloride), Indication: Bumps on bottom lip, they were itchy, Bumps on bottom lip, they were pink, Got breakout, Pea-sized bumps on biceps, stomch, back side of arm, bottom lip, Skin rashes. Adverse reactions/events and outcomes: On 27-Dec-2024, the patient experienced Skin rashes (outcome: Not recovered / Not resolved), Got breakout (outcome: Not recovered / Not resolved), Pea-sized bumps on biceps, stomch, back side of arm, bottom lip (outcome: Not recovered / Not resolved), Bumps on bottom lip, they were itchy (outcome: Not recovered / Not resolved), Bumps on bottom lip, they were pink (outcome: Not recovered / Not resolved). On 30-Dec-2024, the patient experienced Queasy (outcome: Not recovered / Not resolved). On Dec-2024, the patient experienced Sleepy (outcome: Not Reported). Patient had breakouts and a rash. Patient had pea-sized bumps on biceps, stomach, back side of arm, the one in the front and back of the neck were painful and the size of 50cent pieces. Patient had bumps on my bottom lip, they were itchy, pink, and in the middle they get redder and redder, it was not really like a blister. Patient talked to the Pharmacy, they recommended Benadryl but made patient sleepy. Patient spoke to the doctor, and they wanted patient to got to the emergency room (ER), but patient didn't do that. The patient woke up about 3 o'clock. Patient had to put Caladryl on her neck. Patient was feeling a bit queasy last night (30-Dec-2024). Fluad (TIV) action taken: Not Applicable Treatment medication: Benadryl, Caladryl Reporter's assessment: The reporter considered the events as non-serious and causality was not reported. ; Reporter's Comments: All events were considered related. More
2820380 U PA 01/10/2025 FLUX
 UNKNOWN MANUFACTURER
 No batch number
Acoustic stimulation tests abnormal, Hearing aid user, Hypoacusis Acoustic stimulation tests abnormal, Hearing aid user, Hypoacusis
Lost 60 percent hearing in the left ear / To day hearing is now 56% loss; This spontaneous case init... Lost 60 percent hearing in the left ear / To day hearing is now 56% loss; This spontaneous case initially received on 04-Jan-2025 (with additionally information also received on 06-Jan-2025 and 07-Jan-2025), was reported by a non health professional and concerns a patient of unknown age/gender. No medical history or concomitant medications were reported. Administration of company suspect drug(s): On 09-Oct-2024, the patient received Influenza virus vaccine for an unknown indication, dose regimen not reported, route of administration and anatomical location not reported, Lot number: not reported but will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 13-Oct-2024, the patient experienced Lost 60 percent hearing in the left ear / To day hearing is now 56% loss (Medically Significant, outcome: Not Reported). The patient stated that on 09-Oct had the vaccination as noted. Four days later (13-Oct-2024) lost 60 percent hearing in the left ear. To day of notification (04-Jan-2025), hearing was now 56% loss. Have gained 20% back. May the patient would get it all back when vaccine left the immune system which would be Mar-2025 or Apr-2025. Currently spent thousands today on hearing aids. At ENT 03-Jan-2025. Hearing aids. As of 06-Jan-2025 would not work out for patient. Planned to return them. Hearing test done. Remarkably had come up 20% in injured ear. From 36% hearing to now 56 %. Quite curious in 8 weeks. Felt when vaccine left immune end of Mar-2025 may receive the hearing back The patient was waiting flu vaccine leaving immune system and also said that never again would take it. No more vaccines. Influenza virus vaccine action taken: Not Applicable Non-medication treatment: hearing aid Reporter assessment: the reporter did not provide a seriousness and causality assessment for the event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes.Related due to plausible temporal relationship of 4 days post vaccination. More
2820388 1 U 01/10/2025 MMR
 MERCK & CO. INC.
 Y010372
Injection site erythema, Product administered to patient of inappropriate age Injection site erythema, Product administered to patient of inappropriate age
Redness at the injection site; inappropriate age at vaccine administration; This spontaneous report ... Redness at the injection site; inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to a below 12-months-old patient, gender was not provided. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided. On an unknown date, at the age of below 12 months (Inappropriate age at vaccine administration), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y010372, with expiration date not provided but upon internal validations established as 05-JUN-2026). On an unknown date, the patient experienced redness at the injection site (Injection site erythema). It was not reported if the patient sought medical attention, received any treatment, or if the patient had laboratory diagnostics or studies performed for this adverse event. At the time of the reporting, the outcome of the event was unknown. The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live therapy type (M-M-R II) was not provided. More
2820389 5 F NY 01/10/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 996624
996624
Abdominal pain upper, Decreased appetite, Dizziness, Headache, Malaise; Pyrexia,... Abdominal pain upper, Decreased appetite, Dizziness, Headache, Malaise; Pyrexia, Respiratory viral panel, Viral test negative More
Child spiked high fevers 104 over next 24-hrs headache stomach ache malaise dizziness poor appetite Child spiked high fevers 104 over next 24-hrs headache stomach ache malaise dizziness poor appetite
2820390 60 F 01/10/2025 COVID19
 PFIZER\BIONTECH
 LM2216
Immune thrombocytopenia Immune thrombocytopenia
immune thrombocytopenia immune thrombocytopenia
2820391 69 F MO 01/10/2025 COVID19
 MODERNA
 3043823
Pulmonary embolism Pulmonary embolism
Patient reports that on 12/29 she developed a blood clot that went to her lungs. She was admitted to... Patient reports that on 12/29 she developed a blood clot that went to her lungs. She was admitted to the hospital on 12/29 and was treated for a pulmonary embolism with a heparin drip and then discharged on 12/31/24. More
✓ ✓
2820392 19 F PA 01/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LP1780
LP1780
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient received 2 doses of Pfizer COVID-19 vaccine in error Patient received 2 doses of Pfizer COVID-19 vaccine in error
2820393 65 M PA 01/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 t92hk
Chills, Impaired work ability, Nausea, Pyrexia, Rash Chills, Impaired work ability, Nausea, Pyrexia, Rash
Patient said 10 to 14 days after receiving the Shingrix vaccine he had a rash develop on his arm and... Patient said 10 to 14 days after receiving the Shingrix vaccine he had a rash develop on his arm and trunk, high fever with chills, nausea, and was unable to work for 3 to 5 days. More
2820394 76 M 01/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ga99k
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse event just didn't need an additional dose. No adverse event just didn't need an additional dose.
2820395 12 F OR 01/10/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 3CA22C1
3CA22C1
Crying, Discomfort, Dizziness, Erythema, Facial pain; Posture abnormal Crying, Discomfort, Dizziness, Erythema, Facial pain; Posture abnormal
Administered vaccine to client, then one to her younger sister. Completed documentation, then went t... Administered vaccine to client, then one to her younger sister. Completed documentation, then went to front desk to hand over paperwork. Heard younger sister crying and returned to room to find client slumping over a chair, with her dad assisting her. Dad said she had stood up, said she felt dizzy, and then slumped over. Dad assisted client onto exam table. Client crying and said the right side of her face hurt; slight redness noted there. She complained of no other injuries . Over the next 20 minutes, head of exam table was raised gradually, and client was given a bottle of water. Cold pack also given for face, although client said it was uncomfortable and took it off after a few minutes. After about half an hour, client walked to waiting area accompanied by dad and myself. She sat down for another 5 minutes, then left. More
2820412 8 M CO 01/10/2025 COVID19
 PFIZER\BIONTECH
 LM2211
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
No adverse event, patient given adult dose instead of child dose. Patient has tolerated fine. No adverse event, patient given adult dose instead of child dose. Patient has tolerated fine.
2820413 74 M PA 01/10/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 LN5463
LN5463
Anal incontinence, Atrial fibrillation, Electrocardiogram, Fatigue, Lymphadenopa... Anal incontinence, Atrial fibrillation, Electrocardiogram, Fatigue, Lymphadenopathy; Malaise, Mobility decreased, Nausea, Vomiting More
After receiving Abrysvo vaccination the patient reported feeling tired and then sick. He laid down a... After receiving Abrysvo vaccination the patient reported feeling tired and then sick. He laid down and eventually became nauseous but could not move himself to the bathroom, so he used a nearby trashcan instead. Pt reported having to go to the bathroom 25 times which unfortunately resulted in him soiling himself. He called the hospital. His son recommended that he get there via ambulance for his safety. Pt stated that he felt his life was in danger. At the hospital pt discovered that he was experiencing atrial fibrillations due to severe vomiting. Pt was put on fluids. Pt is currently laying down in bed recovering. More
2820414 10 F UT 01/10/2025 COVID19
 PFIZER\BIONTECH
 LN0588
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Covid Comirnaty vaccine (12yr and up) given to patient that is 10years old. Once realized, patient&... Covid Comirnaty vaccine (12yr and up) given to patient that is 10years old. Once realized, patient's father notified and he stated that she is fine, not having any adverse symptoms and he was not concerned. Pt is 10years old and weighs around 170lbs More
2820415 80 F FL 01/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered, No adverse event Extra dose administered, No adverse event
no adverse event, but second vaccine given in error no adverse event, but second vaccine given in error
2820416 22 F TN 01/10/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0180
EW0180
EW0180
EW0172
EW0172
EW0172
FP7140
FP7140
FP7140
Anti-GAD antibody, Autoantibody test, Blood glucose, Decreased appetite, Fatigue... Anti-GAD antibody, Autoantibody test, Blood glucose, Decreased appetite, Fatigue; Glycosylated haemoglobin, Insomnia, Pollakiuria, Somnolence, Thirst; Weight decreased; Anti-GAD antibody, Autoantibody test, Blood glucose, Decreased appetite, Fatigue; Glycosylated haemoglobin, Insomnia, Pollakiuria, Somnolence, Thirst; Weight decreased; Anti-GAD antibody, Autoantibody test, Blood glucose, Decreased appetite, Fatigue; Glycosylated haemoglobin, Insomnia, Pollakiuria, Somnolence, Thirst; Weight decreased More
Weight loss, increased thirst, trouble staying awake, fatigue, decreased appetite, frequent urinatio... Weight loss, increased thirst, trouble staying awake, fatigue, decreased appetite, frequent urination, difficulty sleeping. More
✓
2820417 52 F MI 01/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 L2ZK2
L2ZK2
Chills, Lymphadenopathy, Malaise, Pain, Pyrexia; Rash, Rash erythematous, Rash v... Chills, Lymphadenopathy, Malaise, Pain, Pyrexia; Rash, Rash erythematous, Rash vesicular, Sensitive skin More
Within a few hours of receiving the Shingrix vaccine in her left deltoid she felt a bit ill with fe... Within a few hours of receiving the Shingrix vaccine in her left deltoid she felt a bit ill with fevers and chills. The next day she initially felt a little bit better. Later that night she woke up with a burning pain on the medial side of her right arm around the elbow. There was a small palpable epitrochlear lymph node. Skin on the arm was extremely sensitive to light touch but no rash developed on her arm. The following day, she developed a rash on the right lateral ribs. Rash was a cluster of vesicles on erythematous base in a single dermatome on the side of the chest. More
2820418 65 F HI 01/10/2025 PNC20
 PFIZER\WYETH
 lg5577
Erythema, Tenderness Erythema, Tenderness
patient complained of redness and tenderness in arn patient complained of redness and tenderness in arn
2820510 25 F IL 01/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 A4P56
Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
RSV Arexvy vaccine was administered to a 34 week 1 day pregnant female that was due on 2/19/25. Phys... RSV Arexvy vaccine was administered to a 34 week 1 day pregnant female that was due on 2/19/25. Physician was immediately informed, patient was informed, patients OB GYN was informed. next OB appt is 1/23/25 No adverse effects noted Pregnancy Hx G2 Estimated date of delivery 2/19/25 More
2834408 M LA 01/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Abdominal pain, Flank pain Abdominal pain, Flank pain
Abdomen right side pain; Flank area pain; 1st dose on 02Jul2024 and the 2nd on 14Aug2024 of Engerix ... Abdomen right side pain; Flank area pain; 1st dose on 02Jul2024 and the 2nd on 14Aug2024 of Engerix B; This non-serious case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 49-year-old male patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B with an associated reaction of abdominal pain (received 1st dose on 02-JUL-2024, for tolerance of 1st dose of Engerix B , refer case US2024156174). On 14-AUG-2024, the patient received the 2nd dose of Engerix B. On 14-AUG-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 02Jul2024 and the 2nd on 14Aug2024 of Engerix B). On an unknown date, the patient experienced abdominal pain (Verbatim: Abdomen right side pain) and flank pain (Verbatim: Flank area pain). The outcome of the abdominal pain, flank pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the abdominal pain and flank pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the abdominal pain and flank pain to be related to Engerix B and Engerix B 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. Linked case(s) involving the same patient:US2024156174 Additional Information: GSK Receipt Date: 11-DEC-2024 The reporter reported that patient had received Engerix B in an urgent care facility but he did not know the lot number and expiry dates The right side pain in abdomen and flank area came back after receiving second dose of Engerix B The patient received 2nd dose of Engerix B later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments: US-GSK-US2024156174:1 st dose More
2820020 1.08 M MO 01/09/2025 VARCEL
 MERCK & CO. INC.
 Y011015
Extra dose administered, No adverse event Extra dose administered, No adverse event
No additional AE; They intended to give this patient one Varivax vaccine and one MMR II vaccine. The... No additional AE; They intended to give this patient one Varivax vaccine and one MMR II vaccine. They accidentally however gave two Varivax vaccinations in the patient's left leg; They intended to give this patient one Varivax vaccine and one MMR II vaccine. They accidentally however gave two Varivax vaccinations in the patient's left leg; This spontaneous report was received from an other health care professional and refers to a 13-month-old male patient. The patient's historical medications, medical history, concurrent conditions, and concomitant medications were not reported. On 27-DEC-2024 at 16:30, the patient was accidentally vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck)(VARIVAX) Subcutaneous Injection, both doses administered in his left leg, lot number: Y011015 and expiration date reported as 18-JUN-2026 (strength, dose, and route of administration were not reported) as prophylaxis. The intention was giving this patient one varicella virus vaccine live (Oka/Merck)(VARIVAX) vaccine and one Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine. No adverse events had been reported by the patient's family thus far. More
2820021 11 M NM 01/09/2025 HPV9
 MERCK & CO. INC.
Loss of consciousness, Syncope Loss of consciousness, Syncope
passed out in the hallway/fainted after exiting the patient room; This spontaneous report has been r... passed out in the hallway/fainted after exiting the patient room; This spontaneous report has been received from a medical assistant via company employee referring to a 11-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided. In approximately October 2024 (reported as approximately 3 months ago), the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered by a health professional at a pediatric clinic for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). On the same day after receiving the injection, the patient waited 15 minutes and then fainted after exiting the patient room (also reported as passed out in the hallway of the clinic) (Syncope). On an unknown date, the patient recovered from the event. No additional adverse event (AE) or product quality complaint (PQC). The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. Upon internal review, the event of syncope was determined to be medically significant. Lot # is being requested and will be submitted if received. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2501USA001362:0279790/02729790 US-009507513-2501USA001339:0279790/02729790 More
2820022 U LA 01/09/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
Y010656
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No adverse event; Caller reported patient received 1st GARDASIL 9 vaccine on 10/31/2024, 2nd dose on... No adverse event; Caller reported patient received 1st GARDASIL 9 vaccine on 10/31/2024, 2nd dose on 12/23/2024 and 3rd dose on 1/6/2025.; This spontaneous report was received from a pharmacist referring to a patient, age and gender was not reported. Information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided. On 31-OCT-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis 0.5 ml (route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). On 23-DEC-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis 0.5 ml (route of administration, vaccination scheme frequency, anatomical location, were not reported, valid lot number Y010656 with an expiration date on 29-NOV-2026). On 06-JAN-2025, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis 0.5 ml (route of administration, vaccination scheme frequency, anatomical location, were not reported, valid lot number Y010656 with an expiration date on 29-NOV-2026) (Inappropriate schedule of product administration). There was not adverse event reported. More
2820023 1 F TN 01/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 LG722
Expired product administered Expired product administered
patient was administered with expired vaccine; This non-serious case was reported by a nurse via cal... patient was administered with expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received MMR (Priorix) (batch number LG722, expiry date 01-DEC-2024) for prophylaxis. On 11-DEC-2024, the patient received the 1st dose of Priorix. On 11-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient was administered with expired vaccine). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-DEC-2024 Nurse reported a patient was administered her first dose of Priorix, which had already expired, which led to an expired vaccine used. Nurse called to inquire if the dose needs to be repeated after 28 days like other MMR vaccines would be if given after expiration. At the time of reporting, dose has not been repeated. The vaccine administration facility was same as primary reporter. More
2820026 52 F DC 01/09/2025 PNC20
 PFIZER\WYETH
Confusional state, Dizziness, Headache, Vision blurred Confusional state, Dizziness, Headache, Vision blurred
Dizziness, blurry vision, intense headache, confusion - resurrected concussion symptoms from past Dizziness, blurry vision, intense headache, confusion - resurrected concussion symptoms from past
2820028 U 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Cough, Respiratory tract congestion, Rhinorrhoea, Sneezing Cough, Respiratory tract congestion, Rhinorrhoea, Sneezing
congestion; runny nose; little sneezing; coughing; This non-serious case was reported by a consumer ... congestion; runny nose; little sneezing; coughing; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nasal congestion in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. In DEC-2024, an unknown time after receiving Arexvy, the patient experienced nasal congestion (Verbatim: congestion), runny nose (Verbatim: runny nose), sneezing (Verbatim: little sneezing) and cough (Verbatim: coughing). The outcome of the nasal congestion, runny nose, sneezing and cough were not reported. It was unknown if the reporter considered the nasal congestion, runny nose, sneezing and cough to be related to Arexvy. It was unknown if the company considered the nasal congestion, runny nose, sneezing and cough to be related to Arexvy. Additional Information: GSK receipt date: 16-DEC-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter reported that he/she went to lunch last Saturday on (14-December-2024) and he/she mentioned that he/she experienced congestion, runny nose, a little sneezing and coughing a little, same thing on 16th December 2024. More
2820029 M CO 01/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 D2LP3
Expired product administered Expired product administered
patient accidentally received an expired dose of Priorix; This non-serious case was reported by a ot... patient accidentally received an expired dose of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis. On 12-DEC-2024, the patient received the 1st dose of Priorix. On 12-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient accidentally received an expired dose of Priorix). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-DEC-2024 A medical assistant was called to report that a patient accidentally received an expired dose of Priorix, which led to expired vaccine used. The reporter wished to know if there was any data and recommendations. They were provided patient and vaccine data, declining to receive follow-up. More
2820030 F MS 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect dose administered, Product preparation issue Incorrect dose administered, Product preparation issue
received the Arexvy adjuvant only; received the Arexvy adjuvant only; This non-serious case was repo... received the Arexvy adjuvant only; received the Arexvy adjuvant only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 17-DEC-2024, the patient received Arexvy. On 17-DEC-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received the Arexvy adjuvant only) and inappropriate dose of vaccine administered (Verbatim: received the Arexvy adjuvant only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 18-DEC-2024 The pharmacist reported that yesterday (day before reporting) a patient received the Arexvy adjuvant only, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist immediately realized the error, then administer a fully reconstituted Arexvy vaccine to the patient. The reporter did not have the date of birth of the patient at the time of the call. More
2820031 78 F WA 01/09/2025 COVID19
 PFIZER\BIONTECH
 EP6955
Blindness unilateral, Eye pain, Scleral disorder Blindness unilateral, Eye pain, Scleral disorder
red spot on while of eye appeared causing pain and Overtime blindness, blind in her left eye; red sp... red spot on while of eye appeared causing pain and Overtime blindness, blind in her left eye; red spot on white of eye appeared causing pain and overtime blindness, blind in her left eye; red spot on white of eye appeared causing pain and overtime blindness, blind in her left eye; This is a spontaneous report received from an Other HCP, Program ID:. A 78-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, 0.3 ml single (Lot number: EP6955) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6199, Anatomical Location: Arm Left), administration date: 03Mar2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "blindness/ totally blind in her left eye", "Severe pain in stomach", "Burning sensation", "too sick", "Joints ached could not walk", "Joints ached could not walk", "Could not sleep due to pain and Burning", "Could not sleep due to pain and Burning/constant pain", "red spot on while of eye appeared causing pain and Overtime blindness", "red spot on white of eye appeared causing pain and Overtime blindness", "diarrhea", "Rheumatoid arthritis", "ready to commit suicide", "accused of being a druggie", "Long covid", "maybe has 10 percent vision in the right", "very angry", "stress eating", "can't sleep/no sleep", "overweight", "crabby", "often falls", "has limited use of her hands that do not bend", "heart murmur", "changes in hair/hair loss", "itchy/irritated skin", "weak", "stomach irritated". The following information was reported: SCLERAL DISORDER (disability) with onset 01Jun2021, outcome "not recovered", described as "red spot on while of eye appeared causing pain and Overtime blindness, blind in her left eye"; BLINDNESS UNILATERAL (disability, medically significant), EYE PAIN (disability) all with onset 01Jun2021, outcome "not recovered" and all described as "red spot on white of eye appeared causing pain and overtime blindness, blind in her left eye".; Sender's Comments: The events scleral disorder, and eye pain are conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. As there is limited information in the case provided, the causal association between the event blindness unilateral and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202400031157 same patient/product, different dose/event;US-PFIZER INC-202300334093 same patient/vaccine, different dose/events;US-PFIZER INC-202400057571 same patient/product, different dose/event; More
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2820035 77 F IL 01/09/2025 COVID19
 PFIZER\BIONTECH
 LP1780
Injection site bruising, Injection site pain, Pain Injection site bruising, Injection site pain, Pain
Bruising @ injection site. Painful arm which hindered arm movement. Injection site located in correc... Bruising @ injection site. Painful arm which hindered arm movement. Injection site located in correct deltoid muscle position. Intermittent pain, not constant. Pain with or without movement. Not every day. Not radiating down arm or in shoulder. pinching pain @ injection site. Patient has called pharmacy almost every day since vaccination explaining issue with arm pain. We have counseled her on resting arm, icing injection site, taking Tylenol for pain. Patient also came back to pharmacy I visually inspected injection site. I saw a very pale blue bruise. Injection site looked at correct location at middle of deltoid muscle. She was advised to call her MD, which she did not. She did try to make apt at urgent care but was denied. We continue to counsel her daily on steps to relax arm, ice injection site and take Tylenol for pain. Pt is content and says pain is not everyday. There is no radiating pain down arm or in shoulder. Pain come and goes and is not dependent on movement. Pt states it is a pinching feeling at injection site. Pt calls almost daily and states the same facts. Ends conversation saying that we are so kind and she is grateful for all that we do for her. More
2820036 38 M NH 01/09/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 TH9NR
KX5LM
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Scheduled for #2 Men B vaccine: Men A administerd. Over 30 d and #2. Men B vaccine also administered... Scheduled for #2 Men B vaccine: Men A administerd. Over 30 d and #2. Men B vaccine also administered. More
2820037 F CA 01/09/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 XM42T
XM42T
Blood test, Computerised tomogram head, Electric shock sensation, Facial paralys... Blood test, Computerised tomogram head, Electric shock sensation, Facial paralysis, Foaming at mouth; Loss of consciousness, Malaise, Seizure, Vomiting More
First started to feel sick, then started to foam at mouth which lead to vomiting. Witnessed loosing ... First started to feel sick, then started to foam at mouth which lead to vomiting. Witnessed loosing facial tone, then looked like she left her self. Next she started to convulse. While this was going on I felt 3 different times on L. side of face similar to shocks, then passed out for several seconds. More
2820038 67 M CA 01/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 XM427
Blood test normal, Chest discomfort, Chest pain, Hypoaesthesia Blood test normal, Chest discomfort, Chest pain, Hypoaesthesia
- Sharp chest pain on/off - Pressure on chest - L. Arm numb. - E.R. Visit - no heart attack occurrin... - Sharp chest pain on/off - Pressure on chest - L. Arm numb. - E.R. Visit - no heart attack occurring unk. Diagnosis More
2820039 0.33 M NM 01/09/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U7899AA
HR3650
5N2AN
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Pentacel ordered but Vaxelis administered Pentacel ordered but Vaxelis administered
2820040 4 M NM 01/09/2025 DTAP
IPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
 5ST5M
W1B511M
Y010930
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Kinrix ordered but administered Infanrix and Polio vaccine as separate injections to patient Kinrix ordered but administered Infanrix and Polio vaccine as separate injections to patient
2820041 2 M MI 01/09/2025 COVID19
DTPPVHBHPB
FLU3
HEPA
PNC20
 PFIZER\BIONTECH
MSP VACCINE COMPANY
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 LP1776
U7921AA
24PL5
A3X2K
LC5483
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; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Patient is 2 years old and a Covid vaccine for 12y+ was given in error. Patient tolerated vaccine we... Patient is 2 years old and a Covid vaccine for 12y+ was given in error. Patient tolerated vaccine well and not signs or symptoms of an adverse event at time of administration. More
2820042 0.42 M NM 01/09/2025 DTAP
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 5ST5M
HN5980
2032349
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Vaxelis ordered but Infanrix administered on 11/4/24. Other components administered on 12/9/24. Vaxelis ordered but Infanrix administered on 11/4/24. Other components administered on 12/9/24.
2820043 0.58 M NM 01/09/2025 DTAPIPV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 42Y93
HN2630
2032345
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Kinrix administered instead of Vaxelis. Hib and Hep B vaccines administered on 12/19/24. Kinrix administered instead of Vaxelis. Hib and Hep B vaccines administered on 12/19/24.
2820044 0.42 F MI 01/09/2025 DTPPVHBHPB
FLU3
PNC20
 MSP VACCINE COMPANY
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 U7921AA
24PL5
LC5483
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Patient is 5 months old and received a Flulaval flu vaccine licensed for 6 months and older. No sign... Patient is 5 months old and received a Flulaval flu vaccine licensed for 6 months and older. No signs or symptoms of adverse event at time of administration. More
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