🏥 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 💀 🏥 🚑 ♿ ⚠️
2824321 F IN 02/03/2025 DTAP
DTAP
 SANOFI PASTEUR
UNKNOWN MANUFACTURER
 3CA25C1
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
accidentally given Dtap instead of Tdap with no reported adverse event; Initial information received... accidentally given Dtap instead of Tdap with no reported adverse event; Initial information received on 30-Jan-2025 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 25 years old female patient where patient was accidentally given diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] instead of diphtheria, tetanus and acellular pertussis vaccine 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 a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot 3CA25C1 via intramuscular route in the right arm (dose, frequency, route, strength and expiration date: not provided) for Immunisation and patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, frequency, route, strength and expiration date: not provided) for Immunisation and accidentally given dtap instead of tdap with no reported adverse event (wrong product administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. 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
2824322 68 F 02/03/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 No batch number
No batch number
Arthralgia, Back pain, Coccydynia, Dyspnoea, Fear; Mobility decreased, Spinal pa... Arthralgia, Back pain, Coccydynia, Dyspnoea, Fear; Mobility decreased, Spinal pain More
The incident scared me to death; Excruciating pain in my back (spine) running from shoulders to tail... The incident scared me to death; Excruciating pain in my back (spine) running from shoulders to tailbone; Difficulty breathing; Could not move; This spontaneous case, initially received on 23-Jan-2025, was reported by a non health professional and concerns an elderly female patient. No medical history and allergy information were reported. Concomitant medication: refer to appropriate report section. There was no product complaint associated with this case. Administration of company suspect drug: On 27-Dec-2024, the patient received Fluad (TIV) for unknown indication, Dose regimen and route of administration: not reported, Anatomical location: left arm. Lot number: No batch number available but would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 27-Dec-2024, the patient experienced Excruciating pain in my back (spine) running from shoulders to tailbone (outcome: Recovered / Resolved, stop date: 27-Dec-2024), Difficulty breathing (outcome: Unknown), Could not move (outcome: Unknown). On an unknown date, the patient experienced The incident scared me to death (outcome: Unknown). The patient wrote to report an adverse reaction to the vaccine she received. She received her vaccine at a pharmacy on 27-Dec-2024. She walked to her car after received her injection in the left arm. When she got to her car she had excruciating pain in her back (spine) running from her shoulders to her tailbone. It was so intense she could not move and had difficulty breathing. Then after a few minutes She started having periods of relief. After about 5-10 minutes all of the pain had subsided. She had waited now several weeks to see if she would have any other symptoms. She had not had any further symptoms. She had not had an adverse reaction to any previous vaccines in her life. The incident scared her to death. Now she did not know if she could take a vaccination. She would not want anything worse than what she experienced to happen. Fluad (TIV) action taken: Not Applicable Reporter assessment: The reporter assessed the events as non serious and did not provide a causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes in view of close temporal association (while walking back to car after vaccination). More
2824343 U VA 02/03/2025 MMR
MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
y012074
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 More
No additional AEs were reported; Nurse reported that a patient received MMR II and VARIVAX on 12/2/2... No additional AEs were reported; Nurse reported that a patient received MMR II and VARIVAX on 12/2/2024 and received PROQUAD on 1/30/2025; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, past drug reactions and allergies were not reported. On 02-DEC-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection; and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection; both administered for prophylaxis (dose, lot number, expiration date, anatomical site of injection and route of administration were not provided for any of the mentioned doses). On 30-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dosage form, administered for prophylaxis (lot number Y012074 has been verified to be a valid number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [PROQUAD], expiration date 05-JAN-2026; exact dose, anatomical site of injection and route of administration were not provided) (Extra dose administered). No additional adverse events (AEs) were reported for the patient (No adverse event). No further information was provided. More
2824344 M VT 02/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Received First Dose in Aug 2024, and Received Second Dose Jan 2025; Initial report received on 13-Ja... Received First Dose in Aug 2024, and Received Second Dose Jan 2025; Initial report received on 13-Jan-2025. A consumer reported that he, a male, (race, ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Aug-2024 and received the second dose on 13-Jan-2025. No medical history or concomitant medications were reported. In Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (NDC #43528-002-01, lot #, expiration date, and , site not reported) intramuscularly. On 13-Jan-2025, the patient received dose 2 of HEPLISAV-B intramuscularly. No adverse reactions were reported. No additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2824345 F VA 02/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 944942
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
17 Year Old Received 1st Dose of HEPLISAV-B; Initial report received on 13-Jan-2025. A pharmacist r... 17 Year Old Received 1st Dose of HEPLISAV-B; Initial report received on 13-Jan-2025. A pharmacist reported that a 17-year-old female patient (race, ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when she was 17 years old. No medical history or concomitant medications were reported. On 02-Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #944942, expiration date 07-Jan-2027, NDC # 43528-0003-05) intramuscularly in the right deltoid. The patient was 17 years old at the time. No adverse effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2824346 F NY 02/03/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
 944942
944942
Back pain, Blister, Headache, Meningism, Neck pain; Rash vesicular Back pain, Blister, Headache, Meningism, Neck pain; Rash vesicular
Has not received second dose of HEPLISAV-B yet; Neck Pain; Back Pain; Severe Headache; Herpetic Rash... Has not received second dose of HEPLISAV-B yet; Neck Pain; Back Pain; Severe Headache; Herpetic Rash (Water Blisters); Meningitis Like Reaction; Initial report received on 13-Jan-2025. A pharmacist reported that a 48-year-old female patient (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed a herpetic rash, water blisters, severe headache, neck pain, back pain and a meningitis-type of reaction. At the time of the report, the patient has not had the second dose in the series yet. The patient is allergic to non-steroidal anti-inflammatory (NSAID) medications and aspirin. On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 944942, expiration date 03-Jan-2027, NDC # 43528-0003-05)] intramuscularly in the left arm. On 23-Aug-2024, one day after receiving HEPLISAV-B, the patient had reactions like a herpetic rash, water blisters, and a severe headache. The water blisters lasted two days. The patient had neck, back, and head pain for one month. The patient stated the reaction was like a meningitis-type of reaction. On-13-Jan-2025, the patient presented to the pharmacy wanting to receive the second dose in the series. As of the date of this report, the patient has not received the second dose of the HEPLISAV-B series. The patient was advised by the pharmacist that she will need to obtain the next dose under "medical supervision." No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2824347 F NE 02/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
Had The First Dose, and Have Not Had The Second Dose; Initial report received on 17-Jan-2025. A c... Had The First Dose, and Have Not Had The Second Dose; Initial report received on 17-Jan-2025. A consumer reported that she, a female (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet. No medical history was reported. No medical history or concomitant medications were reported. On 22-Nov-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, and NDC #, not reported)] intramuscularly. At the time of this report, the patient has not received the second dose yet. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2824348 50 M FL 02/03/2025 COVID19
 MODERNA
Overdose, Polyarthritis Overdose, Polyarthritis
Autoimmune polyarthritis/inflammation; Vaccine overdose; This spontaneous case was reported by a pat... Autoimmune polyarthritis/inflammation; Vaccine overdose; This spontaneous case was reported by a patient and describes the occurrence of POLYARTHRITIS (Autoimmune polyarthritis/inflammation) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gluten sensitivity (I developed a gluten allergy a few months after this event). On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 milliliter. On 21-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Vaccine overdose). On 06-Oct-2022, the patient experienced POLYARTHRITIS (Autoimmune polyarthritis/inflammation) (seriousness criterion medically significant). At the time of the report, POLYARTHRITIS (Autoimmune polyarthritis/inflammation) had not resolved and OVERDOSE (Vaccine overdose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patient developed a significant autoimmune polyarthritis/inflammation. He had been on many different unsuccessful medical therapies and surgical interventions.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report. More
2824349 U CA 02/03/2025 RSV
 PFIZER\WYETH
Device breakage Device breakage
Lower cap broke off the diluent; little plastic on the luer lock and the piece on the glass it came ... Lower cap broke off the diluent; little plastic on the luer lock and the piece on the glass it came off; This is a spontaneous report received from a Pharmacist from product quality group, Program ID. No patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation, Device Lot Number: HN8587, Device Expiration Date: 01Sep2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "Lower cap broke off the diluent"; DEVICE ISSUE (non-serious), outcome "unknown", described as "little plastic on the luer lock and the piece on the glass it came off". Additional information: NDC Number: 0069-0250-01. Causality for "lower cap broke off the diluent" and "little plastic on the luer lock and the piece on the glass it came off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2824350 U VA 02/03/2025 COVID19
 PFIZER\BIONTECH
Cardiac disorder, Myocardial infarction, Type 2 diabetes mellitus Cardiac disorder, Myocardial infarction, Type 2 diabetes mellitus
Type 2 diabetes; heart attack; cardiac issues; This is a spontaneous report received from a Consumer... Type 2 diabetes; heart attack; cardiac issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An 81-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 8 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "Type 2 diabetes"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "cardiac issues". Therapeutic measures were taken as a result of myocardial infarction, cardiac disorder. Clinical course: Patient has received all 10 of the Pfizer COVID vaccines and boosters with the last most recent in Sep2024. Patient was 81 years old and have Type 2 diabetes and cardiac issues to include having a heart attack in Nov2023 and implant of a stent and then the implant of a cardiac defibrillator in Aug2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2824353 68 F AK 02/03/2025 RSV
 PFIZER\WYETH
 ln5486
Extra dose administered Extra dose administered
Patient received Abrysvo, after having received Arexvy the year prior. Patient received Abrysvo, after having received Arexvy the year prior.
2824354 69 F NY 02/03/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH





Activated partial thromboplastin time normal, Beta-2 glycoprotein antibody negat... Activated partial thromboplastin time normal, Beta-2 glycoprotein antibody negative, Blood immunoglobulin G normal, Blood immunoglobulin M, Brain natriuretic peptide normal; Bronchial secretion retention, Cardiolipin antibody, Chest X-ray abnormal, Colonoscopy normal, Computerised tomogram thorax abnormal; Computerised tomogram thorax normal, Deep vein thrombosis, Emphysema, Glomerular filtration rate normal, Hepatic cyst; Metabolic function test, Peripheral swelling, Positron emission tomogram abnormal, Prothrombin time normal, Pulmonary mass; Scan with contrast abnormal, Skin discolouration, Superficial vein thrombosis, Troponin normal, Ultrasound Doppler abnormal; White blood cell count increased More
DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish d... DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish discolorationof left leg from ankle to groin. Symptoms were present for appoximately 2 weeks. More
2824355 89 M CA 02/03/2025 COVID19
COVID19
FLU3
FLU3
RSV
RSV
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LN0588
LN0588
U8527AA
U8527AA
J9493
J9493
Asthenia, Dysarthria, Endotracheal intubation, Eyelid ptosis, Fatigue; Immunoglo... Asthenia, Dysarthria, Endotracheal intubation, Eyelid ptosis, Fatigue; Immunoglobulin therapy, Myasthenia gravis, Respiratory failure; Asthenia, Dysarthria, Endotracheal intubation, Eyelid ptosis, Fatigue; Immunoglobulin therapy, Myasthenia gravis, Respiratory failure; Asthenia, Dysarthria, Endotracheal intubation, Eyelid ptosis, Fatigue; Immunoglobulin therapy, Myasthenia gravis, Respiratory failure More
Patient developed left eyelid droop, trouble talking, weakness and fatigue. Myasthenia gravis was th... Patient developed left eyelid droop, trouble talking, weakness and fatigue. Myasthenia gravis was the diagnosis and patient started on IVIG after stroke was ruled out. Ended up with respiratory failure leading to intubation. More
✓
2824361 41 F NV 02/03/2025 COVID19
COVID19
 JANSSEN
JANSSEN

Blood test, Deep vein thrombosis, Platelet count decreased, Pulmonary embolism, ... Blood test, Deep vein thrombosis, Platelet count decreased, Pulmonary embolism, Thrombosis; Thrombosis with thrombocytopenia syndrome More
TTS TTS
✓ ✓ ✓
2824362 52 M WI 02/03/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 lm7786
tfaa2439
Paraesthesia; Paraesthesia Paraesthesia; Paraesthesia
Patient received dose on a Thursday. Patient began feeling side effect on Saturday of tingling along... Patient received dose on a Thursday. Patient began feeling side effect on Saturday of tingling along the left arm from shoulder to hand. More
2824363 1.33 M MT 02/03/2025 DTAPIPV
 SANOFI PASTEUR
 5H95B
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
The combo vaccine was given DTAP/IPV versus the scheduled DTAP. This was found on inventory. Patient... The combo vaccine was given DTAP/IPV versus the scheduled DTAP. This was found on inventory. Patient did not have any adverse events noted per mother when informed. More
2824364 12 F OR 02/03/2025 TDAP
 SANOFI PASTEUR
 3CA30C1
Asthenia, Syncope Asthenia, Syncope
Patient was given vaccine and 5-6 minutes later, pt began to walk out the exam room and felt suddenl... Patient was given vaccine and 5-6 minutes later, pt began to walk out the exam room and felt suddenly weak. Pt collapse without losing consciousness, shortly after pt was monitored for 15 minutes and given juice to take home. Parents were present during exam. More
2824365 11 M AZ 02/03/2025 HPV9
MENB
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Y012864
99G34
4K7JP
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Patient was given the Meningococcal B instead MCV4 ACWY. I spoke with provider NP and she said it�... Patient was given the Meningococcal B instead MCV4 ACWY. I spoke with provider NP and she said it's okay that Men B was given early he will get second those when he is 16, but pt does need MCV4 per school protocol. I called mom to let her know about the incident, mom was okay, and we scheduled a nurse visit so he can get the correct vaccine. More
2824366 79 M SC 02/03/2025 PNC20
 PFIZER\WYETH
 LC5485
Extra dose administered Extra dose administered
The pharmacist administered an additional dose of Prevnar 20 even though patient has already receive... The pharmacist administered an additional dose of Prevnar 20 even though patient has already received dose in 7/31/24. More
2824367 79 F SC 02/03/2025 PNC20
 PFIZER\WYETH
 LC5485
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pharmacist administered additional dose of Prevnar 20 even though patient received dose on 7/31/24. ... Pharmacist administered additional dose of Prevnar 20 even though patient received dose on 7/31/24. No reported adverse events associated with double dose per patient. More
2824368 31 M TX 02/03/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FR2583
FR2583
Cough, Headache, Nausea, Oropharyngeal pain; Cough, Headache, Nausea, Oropharyng... Cough, Headache, Nausea, Oropharyngeal pain; Cough, Headache, Nausea, Oropharyngeal pain More
Coughing, Nausea, Head- Ache, Sore Throat Coughing, Nausea, Head- Ache, Sore Throat
2824086 31 M RI 02/02/2025 FLU3
 SEQIRUS, INC.
 AW1620A
Mobility decreased, Pain Mobility decreased, Pain
Extreme pain causing limited mobility for approximately one month after immunization which subsided ... Extreme pain causing limited mobility for approximately one month after immunization which subsided lighty to pain when raising arm in pressing motion or pulling light weights across body or over head. More
✓
2824087 1.58 M CA 02/02/2025 HIBV
IPV
 MERCK & CO. INC.
SANOFI PASTEUR

Hypersensitivity, Lip swelling, Pruritus, Swelling face, Urticaria; Hypersensiti... Hypersensitivity, Lip swelling, Pruritus, Swelling face, Urticaria; Hypersensitivity, Lip swelling, Pruritus, Swelling face, Urticaria More
3 hours after vaccination, pt started to have an allergic reaction at home with hives, itchiness and... 3 hours after vaccination, pt started to have an allergic reaction at home with hives, itchiness and facial swelling. We gave benedryl and proceeded to the emergency department due to lip swelling. He was given more Benedryl, steroids and discharged with prescriptions for Benedryl, 3 day course of steroids and epi pens. He continued on the Benedryl as needed for another day and completed the course of steroids. More
2824088 53 F KS 02/02/2025 COVID19
 MODERNA
Cough, Fatigue, Wheezing Cough, Fatigue, Wheezing
Wheezing, cough, tiredness Wheezing, cough, tiredness
2824089 92 F OH 02/02/2025 COVID19
COVID19
FLU3
FLU3
PNC20
PNC20
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
 00069-2432-10
00069-2432-10
49281-0124-65
49281-0124-65
00005-2000-10
00005-2000-10
Blood test, Cardiac failure congestive, Computerised tomogram, Laboratory test, ... Blood test, Cardiac failure congestive, Computerised tomogram, Laboratory test, Pneumonia; Sepsis; Blood test, Cardiac failure congestive, Computerised tomogram, Laboratory test, Pneumonia; Sepsis; Blood test, Cardiac failure congestive, Computerised tomogram, Laboratory test, Pneumonia; Sepsis More
None stated. None stated.
✓ ✓
2824090 70 F FL 02/02/2025 PNC20
 PFIZER\WYETH
 lj5283
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient did not report any issues after vaccination; however this is a duplication. Patient just rec... Patient did not report any issues after vaccination; however this is a duplication. Patient just received a dose of Prevnar 20 on 12/03/2024 so they were not eligible for vaccination on 1/31/2025. It was overlooked when we searched state Shots and pt did not remember getting it in December More
2824091 53 F OH 02/02/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 lc5482
f9x49
Rash, Swelling face, Swelling of eyelid; Rash, Swelling face, Swelling of eyelid Rash, Swelling face, Swelling of eyelid; Rash, Swelling face, Swelling of eyelid
patient had a rash that broke out on forehead and some facial swelling, especially right eyelid patient had a rash that broke out on forehead and some facial swelling, especially right eyelid
2824092 39 M GA 02/02/2025 ANTH
ANTH
 EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS

Blood test, Disorientation, Dizziness, Hepatic enzyme increased, Hypertension; N... Blood test, Disorientation, Dizziness, Hepatic enzyme increased, Hypertension; Neuropathy peripheral, Retinal disorder, Sleep apnoea syndrome, Type 2 diabetes mellitus More
Dizziness disorientation. Dizziness disorientation.
✓ ✓ ✓
2824093 87 M 02/02/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Arexvy vaccine was give twice to the same patient Arexvy vaccine was give twice to the same patient
2824094 86 F 02/02/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Arexvy was given twice to the same patient Arexvy was given twice to the same patient
2824095 54 F GA 02/02/2025 PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y01300901003
Y01300901003
Y01300901003
Chills, Injection site erythema, Injection site pain, Injection site reaction, I... Chills, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling; Injection site warmth, Oral herpes, Peripheral swelling, Pruritus, Pyrexia; Rash, Rash pruritic More
1/27/25 - Soreness & Redness at injection site; 1/28/25 - Itchy, Chills & Feverish; 1/29/25 ... 1/27/25 - Soreness & Redness at injection site; 1/28/25 - Itchy, Chills & Feverish; 1/29/25 - Swelling, redness, hotness, and itchy rash at injection site; 1/30/25 - Cold sore on outer right nostril; 1/31/25 - Swelling & rash spreading down to bicep; 2/1/15 - Swelling and rash down to elbow. 2/2/25 - Swelling past elbow & Itchy rash More
2824096 64 F 02/02/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3553T
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient received two doses of Boostrix 6 months apart patient received two doses of Boostrix 6 months apart
2824097 88 F 02/02/2025 COVID19
 MODERNA
 3043823
Fatigue, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea, Vision blur... Fatigue, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea, Vision blurred More
patient reported that symptoms occurred 1 day after vaccination. she reports symptoms of a cold such... patient reported that symptoms occurred 1 day after vaccination. she reports symptoms of a cold such as runny nose, congestion, and fatigue. she also reported having blurry vision that has continued. More
2824098 77 F IL 02/02/2025 COVID19
 MODERNA
 3042439
Joint swelling, Pain in extremity, Product administered at inappropriate site Joint swelling, Pain in extremity, Product administered at inappropriate site
Arm was initially sore and swollen. Patient states that the injection was administered too high in t... Arm was initially sore and swollen. Patient states that the injection was administered too high in the deltoid muscle and did hit the bone. Patient did not see any doctor in regards to the extreme soreness. Patient went to seek advice from her local pharmacy a few times after 4 months of getting vaccine and was told that the soreness would go away, but it did not. More
2824099 95 F AZ 02/02/2025 PNC21
 MERCK & CO. INC.
 y013009
Cellulitis Cellulitis
cellulitis cellulitis
2824100 82 F GA 02/02/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Blood glucose normal, Death, Resuscitation, Wheezing Blood glucose normal, Death, Resuscitation, Wheezing
11-30-2024 resident was found at 0620 with audible wheezing. Blood glucose testing performed, with r... 11-30-2024 resident was found at 0620 with audible wheezing. Blood glucose testing performed, with results of 65. PRN Albuterol jet nebulizer treatment administered. O2 saturation 93% ; pulse 96; respirations 22. At 0635 patient had no vital signs, CPR begun, 911 called and resident was pronounced at 0729. More
✓
2824101 42 F OR 02/02/2025 COVID19
 NOVAVAX
 3044143
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
The pt was given the moderna 6 month-11 yrs dose instead of spikevax The pt was given the moderna 6 month-11 yrs dose instead of spikevax
2824102 75 F 02/02/2025 RSV
 PFIZER\WYETH
Dizziness, Injection site erythema, Injection site swelling Dizziness, Injection site erythema, Injection site swelling
On the first day of vaccination, pt called to express she experienced redness and swelling at the in... On the first day of vaccination, pt called to express she experienced redness and swelling at the injection site. She also started to experience some dizziness on the next day. Her symptoms have since improved and she is feeling much better. More
2824103 64 F GA 02/02/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LP1776
LP1776
Death, Dyspnoea, Hallucination, Moaning, Resuscitation; Urinary tract infection Death, Dyspnoea, Hallucination, Moaning, Resuscitation; Urinary tract infection
11-26-2024 resident was diagnosed with a UTI and med prescribed for treatment. 11-27-2024 Resident w... 11-26-2024 resident was diagnosed with a UTI and med prescribed for treatment. 11-27-2024 Resident was noted lying in bed moaning. Resident denied being in pain, resident was talking to person not in the room. Later on in the day resident was noted to have SOB. O2 was placed on resident and during the night an order obtained to transfer resident to hospital for observation during. On 11-28-2024 resident was transferred from hospital to hospital. During transport CPR was initiated. Resident was pronounced at the hospital on 11-28-2024, time unknown. More
✓
2824104 72 F MO 02/02/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 N9595
Injection site pain, Pain Injection site pain, Pain
Achiness, soreness, throbbing, pain at injection site lasting more than 10 days Achiness, soreness, throbbing, pain at injection site lasting more than 10 days
2824105 5 F 02/02/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 C5981AB
C5981AB
Decreased appetite, Erythema, Lethargy, Mobility decreased, Pain in extremity; P... Decreased appetite, Erythema, Lethargy, Mobility decreased, Pain in extremity; Peripheral swelling, Pyrexia, Tenderness More
Swelling, redness tender and sore arm from shoulder to elbow. Unable to move arm 2x day following va... Swelling, redness tender and sore arm from shoulder to elbow. Unable to move arm 2x day following vaccine. Mild fever 38.1. X1 day following vaccine. Lethargy, loss of appetite. Following two days redness and swelling continues to grow and spread. More
2824138 69 F CA 02/02/2025 COVID19
RSV
 PFIZER\BIONTECH
PFIZER\WYETH
 ln0588
hy1813
Musculoskeletal stiffness, Skin discolouration; Musculoskeletal stiffness, Skin ... Musculoskeletal stiffness, Skin discolouration; Musculoskeletal stiffness, Skin discolouration More
PATIENT COMPLAIN THAT HER RIGHT IS STIFF AND CANNOT MOVE AROUND. AREA LOOKS PURPLE AND IT HAS BEEN 2... PATIENT COMPLAIN THAT HER RIGHT IS STIFF AND CANNOT MOVE AROUND. AREA LOOKS PURPLE AND IT HAS BEEN 2 WEEKS More
2824139 72 F WA 02/02/2025 COVID19
FLU3
PNC20
TDAP
 PFIZER\BIONTECH
SANOFI PASTEUR
PFIZER\WYETH
SANOFI PASTEUR
 LM7786
U8521AA
LG5577
U8339BA
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa... Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm More
On 2/2/2025 patient states she started experiencing redness and swelling of the left arm the evening... On 2/2/2025 patient states she started experiencing redness and swelling of the left arm the evening of the vaccination (1/27/2025). Patient reported (2/2/2025) that the swelling and redness was going around her whole arm and was painful and warm to touch. Advised patient to mark around area to make sure the redness wasn't spreading and to follow up with provider to determine next steps. More
2824140 36 M 02/02/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00553
Extra dose administered Extra dose administered
Patient administered a 5th, unnecessary dose of RabAbert for post-exposure secondary to a cat scratc... Patient administered a 5th, unnecessary dose of RabAbert for post-exposure secondary to a cat scratch. Only 4 post-exposure doses recommended in immunocompetent patient. More
2824141 1.5 F CO 02/02/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
MMR
MMR
MMR
MMR
VARCEL
VARCEL
VARCEL
VARCEL
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
MMR
MMR
MMR
MMR
PNC13
PNC13
PNC13
PNC13
VARCEL
VARCEL
VARCEL
VARCEL
MMR
MMR
MMR
MMR
VARCEL
VARCEL
VARCEL
VARCEL
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.











U7623AA
U7623AA
U7623AA
U7623AA
Y004117
Y004117
Y004117
Y004117
LJ5283
LJ5283
LJ5283
LJ5283
Y013350
Y013350
Y013350
Y013350
Decreased appetite, Extra dose administered, Inappropriate schedule of product a... Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia; Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability; Malaise, Pyrexia, Rash, Vomiting; Pyrexia; Pyrexia More
Measels 8/5/24; 1/31/25 ? should be birth and 4-5 years old Chicken pox 8/5/24; 1/31/25 ? should be... Measels 8/5/24; 1/31/25 ? should be birth and 4-5 years old Chicken pox 8/5/24; 1/31/25 ? should be birth and 4-5 years old Combo ? Dtap, hib, HepB 9/23; 11/23; 1/2024; 10/31/24; 1/31/25 ? 4-5 years old (this last dose was not needed, and Dr. had given her the previous dose) Medical records from another state were provided prior to first appointment, per clinic request. A paper copy of vaccine records was also brought to the first appointment, 10/31/2024. During the appointment on 1/31/25 the provider, Dr., said patient was due for 4 shots as well as a Flu Shot. Patient had already received a flu shot plus booster, as such the flu shot was declined. The provider was 35 mins late to the appointment and was very rushed. She kept referring to Patient as ?he? and also kept thinking that she was in for 15 month well check, instead of the 18 month well check. The evening of 1/31/25 Patient was generally not feeling well with a low grade fever. By 6pm she developed a rash on her chest, face, and inner thighs. The hotline was consulted and symptoms were managed with OTC medication. The day of 2/1/25 Patient continued to be unwell, generally fussy, poor appetite, and vomited mid day. She developed a high fever >103 later in the day, as well as a reoccurrence of the rash on her chest and face. The fever was controlled with OTC medications The hotline was consulted multiple times. It was discovered that Patient was improperly dosed with MMR, Chicken Pox, and the combo. 2/2/25 Patient woke up and was doing better. Temperature was 98-99 deg F for the morning. She took a nap and again developed a fever of 101.6 in the afternoon. Fever was managed with OTC meds and the hotline was consulted again, as Patient was seeming improved, but quickly developed another fever. Dr. recommended that we follow up with a pediatrician tomorrow, 2/3/25 morning (he said he would be speaking with Dr. and recommended we call at 730AM to make an appointment with him) Patient is sleeping as I complete this form. She still had a fever of 101 tonight when she went to bed, despite tylenol and ibuprofen dosage. Hotline provider was Dr.- very helpful Provider that administered unnecessary vaccinees: Dr. More
✓ ✓
2824142 32 F FL 02/02/2025 COVID19
 MODERNA
 011L20A
Peripartum cardiomyopathy Peripartum cardiomyopathy
Peripartum Cardiomyopathy Peripartum Cardiomyopathy
✓ ✓ ✓
2824047 32 F VA 02/01/2025 HPV9
 MERCK & CO. INC.
Tachycardia Tachycardia
The patient experienced tachycardia later at night.; This spontaneous report was received from Other... The patient experienced tachycardia later at night.; This spontaneous report was received from Other Health Professional and referred to a 32-years-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 started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, (strength, dose, frequency, scheme, lot #, expiry date, route of administration, anatomical location, and indication were not provided). On an unknown date, the same date of the vaccination later at night, the patient experienced tachycardia. On an unknown date, the patient recovered from the tachycardia. The reporter considered tachycardia to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but could be related to the fact that the patient "works night shift". Lot number is being requested and will be submitted if received. More
2824048 12 U FL 02/01/2025 HPV9
 MERCK & CO. INC.
 X005579
No adverse event, Product storage error No adverse event, Product storage error
the patient did not report any adverse issues or side effects related to the administration of the e... the patient did not report any adverse issues or side effects related to the administration of the expired dose; a patient was inadvertently administered an expired dose of GARDASIL 9 (lot: X005579 expiration: 11/30/2024) on 01/28/2025.; This spontaneous report was received from a other health professional and refers to a 12-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 28-JAN-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #X005579, expiration date: 30-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The vaccine had never been exposed to any temperature excursions and the patient did not report any adverse issues or side effects related to the administration of the expired dose. No other information available. More
2824049 U MD 02/01/2025 MMRV
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Nurse called and reported a patient that received their second dose of PROQUAD ten days before the a... Nurse called and reported a patient that received their second dose of PROQUAD ten days before the age of 4 years old.; No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 3-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter (ml) per dose, administer(inappropriate schedule of product administered). Limited patient demographics was provided by reporter. No additional information was known by reporter. No additional adverse event (AE). More
2824050 U NM 02/01/2025 HEP
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
No adverse event; administration of a pediatric dose of RECOMBIVAX HB to an adult patient over 20 ye... No adverse event; administration of a pediatric dose of RECOMBIVAX HB to an adult patient over 20 years of age. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a pharmacist referring to an adult patient) reported as over 20-year-old). Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On 29-JAN-2025, the patient was vaccinated with a pediatric dose of hepatitis B vaccine (Recombinant) (RECOMBIVAX HB) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported) (Inappropriate dose of vaccine administered). No additional adverse event was reported. More
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