๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2825249 U 02/07/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still got them/Shingles; This serious case was reported by a consumer... Suspected vaccination failure; still got them/Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got my shingle shots and still got them). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-JAN-2025 This case was reported by a patient via interactive digital media. At the time of reporting patient stated that he/she got shingle shots and still got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2825250 U 02/07/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 25-JAN-2025 This case was reported by a patient via interactive digital media. At the time of reporting patient stated that he/she got the shots and had shingles right now. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2825251 M 02/07/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; he got the shingles; This serious case was reported by a consumer via... suspected vaccination failure; he got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he got the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. Reporter's husband got the Shingles shot and a few years later he got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2825252 U 02/07/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Malaise, Pyrexia Malaise, Pyrexia
Ive never been so sick in my life; 104 temp for days; This non-serious case was reported by a consum... Ive never been so sick in my life; 104 temp for days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Ive never been so sick in my life) and fever (Verbatim: 104 temp for days). The outcome of the sickness was not reported and the outcome of the fever was resolved. It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine. It was unknown if the company considered the sickness and fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-FEB-2025 The case was received from the patient via interactive digital media. The reporter had never been so sick in his/her life. The reporter reported that the second vaccine nearly killed him/her. The reporter had 104 temperature for days. The reporter thought the first dose was bad, but the second shot was horrible. The reporter reported that beware and plan round being sick. More
2825253 U 02/07/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
UNK
Fatigue Fatigue
tiredness; This non-serious case was reported by a consumer via interactive digital media and descri... tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: tiredness). The outcome of the tiredness was not reported. It was unknown if the reporter considered the tiredness to be related to Arexvy. It was unknown if the company considered the tiredness to be related to Arexvy. Additional Information: GSK receipt date: 03-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had received a dose Arexvy vaccine and experienced tiredness. The reporter had a question how long was tiredness. More
2825255 75 M ME 02/07/2025 COVID19
MODERNA
3044202
Chest tube insertion, Computerised tomogram thorax abnormal, Dyspnoea, Pneumotho... Chest tube insertion, Computerised tomogram thorax abnormal, Dyspnoea, Pneumothorax spontaneous, Pulmonary embolism More
presented with progressive shortness of breath, found to have spontaneous pneumothorax and pulmonary... presented with progressive shortness of breath, found to have spontaneous pneumothorax and pulmonary emboli superimposed on his chronic interstitial lung disease More
โœ“ โœ“
2825256 17 F MA 02/07/2025 FLU3
SEQIRUS, INC.
388532
Product substitution error Product substitution error
Private vaccine supplied influenza vaccine given instead of state supplied influenza vaccine. Corre... Private vaccine supplied influenza vaccine given instead of state supplied influenza vaccine. Correct vaccine, correct dose, just incorrect stock. More
2825257 50 F NC 02/07/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
7ZM55
Injection site rash, Pain, Pain in extremity, Peripheral swelling Injection site rash, Pain, Pain in extremity, Peripheral swelling
Patient reported a sore arm that was painful to move and swelling. A large red rash around 4-4.5 in... Patient reported a sore arm that was painful to move and swelling. A large red rash around 4-4.5 inches in diameter was reported around the vaccination site. Patient did not report a fever, but was concerned about cellulitis More
2825258 73 F MI 02/07/2025 COVID19
PFIZER\BIONTECH
GH9703
COVID-19 pneumonia, Dyspnoea, Hypoxia, Respiratory failure COVID-19 pneumonia, Dyspnoea, Hypoxia, Respiratory failure
Name: Medical Record #: Age: 75 y.o. DOB: Admit date: 1/28/2025 Discharge date: 1/31/2025... Name: Medical Record #: Age: 75 y.o. DOB: Admit date: 1/28/2025 Discharge date: 1/31/2025 Attending Physician at the Time of Discharge: DO Primary Care Physician: DO Reason for Admission: hypoxia Brief Summary of Hospital Stay: 75 y.o. female with ESRD on hemodialysis presented to ED with difficulty breathing. Admitted with covid infection causing acute hypoxic respiratory insufficiency. She was started on dexamethasone with gradual improvement. She underwent usual hemodialysis while admitted. Problem list: Acute respiratory insufficiency with hypoxia due to covid pneumonia -dexamethasone through 2/4 -guaifenesin, incentive spirometry, mobilize ESRD on hemodialysis -T/Th/Sat Coronary artery disease -aspirin, atorvastatin -metoprolol, Imdur Hypertension -amlodipine Diabetes mellitus type 2 -increase tresiba to 15U while on decadron, back to 8U after -home humalog Hypothyroid -levothyroxine Although leaving today, this patient will require ongoing assessment and treatment, with adjustments to the plan as appropriate. Medicine is complicated and unforseen changes in status may occur. Discharged to Home. More
โœ“
2825259 59 F MI 02/07/2025 FLU3
SEQIRUS, INC.
388487
Incorrect dose administered Incorrect dose administered
Patient was incorrectly given a High dose influenza vaccine instead of a regular dose influenza vacc... Patient was incorrectly given a High dose influenza vaccine instead of a regular dose influenza vaccination for the season. More
2825260 55 F MI 02/07/2025 COVID19
MODERNA
004M20A
COVID-19, Chest X-ray normal, Haemodialysis, Nausea, Vomiting COVID-19, Chest X-ray normal, Haemodialysis, Nausea, Vomiting
Name: Medical Record #: Age: 59 y.o. DOB: Admit date: 2/1/2025 Discharge date: 02/03/2025 ... Name: Medical Record #: Age: 59 y.o. DOB: Admit date: 2/1/2025 Discharge date: 02/03/2025 Admitting Physician: MD Attending Physician at the Time of Discharge: MD Primary Care Physician: PAC Reason for Admission: Nausea/vomiting Hospital Course: This is a 59-year-old female with significant history of ESRD on HD TTS, type 2 diabetes, and hypertension who presented due to intractable nausea/vomiting. Workup was significant for COVID-19 infection. Nausea and vomiting improved with antiemetic therapy. Patient was not hypoxemic during hospitalization. Chest x-ray did not demonstrate any infiltrates. Patient was started on remdesivir while inpatient. Prior to discharge, patient was able to ambulate and did not desaturate. Hemodialysis schedule was kept while inpatient. Disposition upon discharge is stable and improving. Patient was discharged with Tessalon Perles and Atrovent for supportive care for COVID-19 infection. Patient was provided with a work note per her request. Discharged to Home. More
โœ“
2825261 75 M MI 02/07/2025 COVID19
COVID19
COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
FE3590
FE3590
FE3590
FE3590
Atrial flutter, Bundle branch block left, Bundle branch block right, COVID-19, C... Atrial flutter, Bundle branch block left, Bundle branch block right, COVID-19, Cardioversion; Chest X-ray normal, Cough, Dyspnoea, Electrocardiogram QRS complex prolonged, Electrocardiogram T wave abnormal; Hypokalaemia, Influenza, Influenza A virus test positive, SARS-CoV-2 test positive, Supraventricular tachycardia; Troponin increased More
Name: Age: 78 y.o. Admit date: 1/30/2025 Discharge date: Feb 3, 2025 Attending Physician at t... Name: Age: 78 y.o. Admit date: 1/30/2025 Discharge date: Feb 3, 2025 Attending Physician at the Time of Discharge: MD Reason for Admission: Patient presenting with shortness of breath and cough for 2 weeks. HR at clinic was in the 170s so he was sent to the ER. ER lab workup notable for stable CKD, initial troponin elevated at 31 (delta of negative 4). RVP positive for both Flu A and COVID. Initial EKG noted SVT with wide QRS tachycardia, RBBB and LAFB (bifascicular block) and T wave abnormality (possible inferior ischemia). CXR unremarkable. Patient given adenosine and initially converted to NSR. Patient then went back into SVT, amiodarone bolus given with conversion to NSR. Patient again flipped into SVT, cardiology consulted and recommended amiodarone drip and admission. Brief Summary of Hospital Stay: Principal Problem: Paroxysmal SVT (supraventricular tachycardia) / flutter with RVR. Likely due to viral infections with COVID and Flu. Did not have much resolution with IV amio and currently on low dose bblocker. Cards had given Dig push x2 and HR has settled and is now NSR> Conitnue lopressor. On eliquis. CXR neg. F/u Cardiologist Dr. Influenza A - on Tamiflu. Mucinex. Encourage IS, flutter. COVID infection - no hypoxia and chest clear. No need for steroids/remdesevir unless hypoxia. Hypokalemia - replaced. Active Problems: Chronic renal insufficiency -CKD 3a - stable. Benign paroxysmal positional vertigo Dyslipidemia associated with type 2 diabetes mellitus - on statin. Essential hypertension - monitor BP. Hypothyroid - TSH ok. On synthroid. Malignant neoplasm of prostate - stable. On flomax. Diabetes mellitus - BS stable. Resume home meds. The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home. More
โœ“
2825262 75 M AR 02/07/2025 COVID19
COVID19
MODERNA
MODERNA


COVID-19, Death, Dyspnoea, Intensive care, Pulse absent; Respiratory arrest COVID-19, Death, Dyspnoea, Intensive care, Pulse absent; Respiratory arrest
Admit to hospital 2/6/2025 with COVID. Symptoms shortness of breath.. Increased oxygen needs. Patien... Admit to hospital 2/6/2025 with COVID. Symptoms shortness of breath.. Increased oxygen needs. Patient stopoped breathing and no pulse. Transfer to ICU. Expired 2/7 2:25 More
โœ“ โœ“
2825263 59 F NY 02/07/2025 COVID19
COVID19
COVID19
MODERNA
MODERNA
MODERNA
025J20A
025J20A
025J20A
Atrial fibrillation, Cardiac hypertrophy, Cardiac stress test, Cardiomyopathy, D... Atrial fibrillation, Cardiac hypertrophy, Cardiac stress test, Cardiomyopathy, Dizziness; Echocardiogram, Electrocardiogram, Heart rate irregular, Left ventricular hypertrophy, Loss of consciousness; Magnetic resonance imaging heart More
after taking my second dose i started feeling light headed off and on but didnot think it was covid ... after taking my second dose i started feeling light headed off and on but didnot think it was covid vaccine. I was always healthy. I had to get booster and it was even worse. I ended up passing out . I went to drs in january 2023 and she recomended me see a cardiologist. After getting EKg, heart ultrasound and MRI i found out i had Cadiomyopathy hypertrophic. irregular heart beat and thickening in left valve. Never had issues before More
2825264 11 F IN 02/07/2025 MNQ
SANOFI PASTEUR
U8194AA
Dizziness, Loss of consciousness Dizziness, Loss of consciousness
PT WAS TERRIFIED OF NEEDLES. SAID SHE WOULD THROW UP, GAGGED BUT DIDN'T THROW UP. SAID SHE WOUL... PT WAS TERRIFIED OF NEEDLES. SAID SHE WOULD THROW UP, GAGGED BUT DIDN'T THROW UP. SAID SHE WOULD PASS OUT. AFTER 20 MINUTES OF TRYING TO CALM HER, THE VACCINE WAS ADMINISTERED. ABOUT A MINUTE LATER SHE PASSED OUT IN MOM'S ARMS. I LAID HER ON THE FLOOR AND ELEVATED HER FEET. CHECK HER BREATHING WHICH WAS FINE. WAS GETTING THE SMELLING SALTS WHEN SHE WOKE UP AND ASKED WHY SHE WAS ON THE FLOOR. SHE ASKED FOR A DRINK, GAVE HER A BOTTLE OF WATER. AFTER A COUPLE MINUTES I ALLLOWED TO SIT UP ON THE FLOOR. SHE WAS A LITTLE DIZZY SO SHE STAYED THERE FOR SEVERAL MINUTES THEN MOVED TO A CHAIR. I GAVE HER SOME CHOCOLATE CANDY. AFTER ABOUT 15 MINUTES SHE WAS FEELING WELL ENOUGH TO WALK AND LEAVE. More
2825265 0.5 M NE 02/07/2025 DTAPHEPBIP
GLAXOSMITHKLINE BIOLOGICALS
TC47K
Dysstasia, Injection site nodule Dysstasia, Injection site nodule
leg has a knot at the injection site, infant will not stand on the left leg leg has a knot at the injection site, infant will not stand on the left leg
2825266 67 M CT 02/07/2025 COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
30155BA
30155BA
Balance disorder, Computerised tomogram head abnormal, Headache, Ischaemic strok... Balance disorder, Computerised tomogram head abnormal, Headache, Ischaemic stroke, Malaise; Nausea More
11/18 started feeling sick, lost balance, severe headache, nausea , 11/19went to urgent care -sent t... 11/18 started feeling sick, lost balance, severe headache, nausea , 11/19went to urgent care -sent to ED . In ED on 11/19 was diagnosed with stoke More
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2825267 32 F TX 02/07/2025 FLU3
SEQIRUS, INC.
AW1664A
Arthralgia, Limb injury, Product administered at inappropriate site, X-ray limb Arthralgia, Limb injury, Product administered at inappropriate site, X-ray limb
1. Injury of right shoulder Received influenza vaccine on November 16, 2024 at clinic. Since then, ... 1. Injury of right shoulder Received influenza vaccine on November 16, 2024 at clinic. Since then, pt developed chronic right shoulder pain. Denied any skin changes. Otherwise, denies any previous shoulder injury/procedures. Exam today otherwise, unremarkable. No TTP around injection site. No skin changes. Pt does recall an unusual higher injection site. - will obtain right shoulder plain film to r/o any bony abnormality - referral sent to physical therapy for evaluation - clinical presentation suggestive of SIRVA (shoulder injury related to vaccine administration), which is not a contraindication for receiving flu vaccine, rather the medical staff may have given the vaccine at the subdeltoid bursa - f/u with me in February 2025 for re-assessment - return precautions provided Ordered: Referral Request 2.0 - More
2825268 8 M CO 02/07/2025 HEPA
VARCEL
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
T5727
Y011017
Circumstance or information capable of leading to medication error; Circumstance... Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error More
Pt received un-needed vaccines due to getting confused with another pt. Mother was notified of event... Pt received un-needed vaccines due to getting confused with another pt. Mother was notified of event, and spoke with provider after receiving vaccines. More
2825269 1 F PA 02/07/2025 VARCEL
MERCK & CO. INC.
Y004555
Culture wound negative, Herpes simplex test negative, Rash, Rash vesicular, Vari... Culture wound negative, Herpes simplex test negative, Rash, Rash vesicular, Varicella virus test positive More
On 2/4 started with vesicular rash on left arm which spread down the left arm to left hand On 2/4 started with vesicular rash on left arm which spread down the left arm to left hand
2825270 64 F MT 02/07/2025 PNC20
PFIZER\WYETH
0005-2000-02
Rash, Rash pruritic Rash, Rash pruritic
The only reaction I have had as of today is a small and some what itchy rash on parts of my right an... The only reaction I have had as of today is a small and some what itchy rash on parts of my right and left leg, under my left breast, as well as my left side of my abdomen. Also small amount on my lower back. I felt fine after I received Prevnar 20 vaccine and I feel fine now. The rash is bothersome but not painful. More
2825271 11 M NC 02/07/2025 HEPA
HPV9
MNQ
TDAP
MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
Y011731
Y008119
7GF79
3RE73
Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection s... Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection site rash, Injection site warmth, Rash, Rash erythematous; Injection site rash, Injection site warmth, Rash, Rash erythematous More
rt upper arm noted with red rash above injection site and warm to touch. cheeks also red with raised... rt upper arm noted with red rash above injection site and warm to touch. cheeks also red with raised rash. ice pack applied to arm. 15 minute recheck by provider revealed arm rash almost gone and no longer warm to touch but cheeks still red. No difficulty breathing. mom states after rash started that she thinks she remembers that child had the same reaction to Hep A vaccine when he received the 1st dose. Provider instructed mom to give a zyrtec before bed. More
2825272 0.42 M NE 02/07/2025 DTAPHEPBIP
GLAXOSMITHKLINE BIOLOGICALS
TC47K
Injection site erythema, Pyrexia Injection site erythema, Pyrexia
mother states pt has little red spots at injection sites- has fever of 105 (over) mother states pt has little red spots at injection sites- has fever of 105 (over)
2825273 29 F VT 02/07/2025 HPV9
TDAP
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
Y000205
CX4HL
Erythema, Injection site induration, Pruritus, Skin disorder, Swelling; Erythema... Erythema, Injection site induration, Pruritus, Skin disorder, Swelling; Erythema, Injection site induration, Pruritus, Skin disorder, Swelling More
Patient reports "red bulls' eye (similar to Lyme disease), bubbling up under the skin, swe... Patient reports "red bulls' eye (similar to Lyme disease), bubbling up under the skin, swelling, itchiness, that lasted about a week hen went away. Now, there is a hard feeling under the skin that is the size of a pea that can be felt, on the left side of the arm at the injection site." Patient believes this is from the HPV vaccine, however, the TDAP vaccine was recorded as being given on this site. Patient declines any fevers, chills. Used Hydrocortisone cream on the area. Declined ED/EC visit. More
2825274 37 M 02/07/2025 FLU3
FLU3
HEPA
HEPA
IPV
IPV
TDAP
TDAP
VARCEL
VARCEL
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
p224h
p224h
2345b
2345b
x1c891m
x1c891m
u8232aa
u8232aa
y007637
y007637
Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; S... Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope; Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia; Syncope More
Pt stated he had intermittent fever for 2 days 1/24/2025 to 1/25/2025, mild shortness of breath only... Pt stated he had intermittent fever for 2 days 1/24/2025 to 1/25/2025, mild shortness of breath only one day on 1/24/2025, and some swelling on his left arm from 1/24/2025 to 1/27/2025. Pt stated he had one episode of fainting on 1/26/2025 in the morning. Pt stated at the ER, he had lab drawn, chest xray, and was told by the doctor all the results were normal. Pt stated he was told by the ER doctor that he had reaction due to receiving multiple vaccinations and he was not told of any allergic reaction. More
2825275 0.83 M DE 02/07/2025 COVID19
PFIZER\BIONTECH
LN8272
Inappropriate schedule of product administration Inappropriate schedule of product administration
third dose of Covid-19 vaccine administered one month too early. This dose, therefore, dose not coun... third dose of Covid-19 vaccine administered one month too early. This dose, therefore, dose not count towards the primary series. Discussed and informed parents of administration error on 2/7/2025. More
2825276 57 F ID 02/07/2025 PNC20
VARZOS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS


Chills, Pain in extremity, Restlessness; Chills, Pain in extremity, Restlessness Chills, Pain in extremity, Restlessness; Chills, Pain in extremity, Restlessness
Pain in arm, shivering all night, super restless, I took Tylenol last night and this morning more ma... Pain in arm, shivering all night, super restless, I took Tylenol last night and this morning more manageable but still there More
2825277 18 F CO 02/07/2025 HEP
GLAXOSMITHKLINE BIOLOGICALS
42B22
Wrong product administered Wrong product administered
Patient given the incorrect vaccine Patient given the incorrect vaccine
2825278 16 M CO 02/07/2025 HEP
GLAXOSMITHKLINE BIOLOGICALS
42B22
Wrong product administered Wrong product administered
Incorrect vaccine given Incorrect vaccine given
2825279 11 M FL 02/07/2025 MNQ
TDAP
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
X4T99
9YB4G
Injection site discharge, Injection site induration, Injection site pain, Inject... Injection site discharge, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth; Injection site discharge, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth More
Patient noticed a small bump on left deltoid, mom popped it and it drained clear water. Since then a... Patient noticed a small bump on left deltoid, mom popped it and it drained clear water. Since then area has been tender, hard to palpated with distinct localized area. Area warm and hard to touch, induration. Per patient, was painful until this morning. Denies pain when provider touch. Start mupirocin 2 % topical ointment 1 application 2 times a day for 15 days Start clindamycin HCL 300 mg capsule 150 mg 3 times a day as directed for 5 days More
2825280 F IN 02/07/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS

Injection site pain Injection site pain
Pain in injection area; This non-serious case was reported by a consumer via call center representat... Pain in injection area; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in injection area). The outcome of the injection site pain was resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 Patient was the reporter. Patient received her 1st Shingrix vaccine in October 2023 in the right arm and has had intense pain since receiving the vaccine. Patient stated she received the 2nd vaccine in January 2024 in the left arm and had not had any pain. Patient had reached out to her health professional and the pain was ongoing. More
2825281 78 M IA 02/07/2025 COVID19
PFIZER\BIONTECH
LP1776
Abdominal distension, Arthralgia, Injection site bruising, Injection site discol... Abdominal distension, Arthralgia, Injection site bruising, Injection site discolouration, Malaise More
Client reports pain and swelling at injection site along with some malaise starting after vaccinatio... Client reports pain and swelling at injection site along with some malaise starting after vaccination on 12/18/24. Developed bruising to injection area. Client used analgesics and ice to area. Client stopped in to office today to show left arm to staff. Left upper arm has old bruising- yellow/purple in color. No warmth or redness known. Area of swelling closer to inner area just above elbow is noted by this author but he states that is not a new issue since vaccination. Reports no further discomfort but was concerned as bruising, although appears to be dissipating, remains after >45 days. Advised to continue to monitor and utilize heat/ice if necessary. See healthcare provider if concerns persist or symptoms worsen. Will discuss further COVID vaccinations with his healthcare provider and this agency. Patient verbalizes understanding, agrees with plan of care and intends to comply. More
2825282 75 F OH 02/07/2025 COVID19
COVID19
FLU3
FLU3
RSV
RSV
COVID19
COVID19
FLU3
FLU3
RSV
RSV
NOVAVAX
NOVAVAX
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH












Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursit... Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint fluid drainage, Joint swelling; Bursitis, Joint swelling More
Don?t know that elbow bursitis is a reaction. Swelling of elbow. It was drained today and Medrol w... Don?t know that elbow bursitis is a reaction. Swelling of elbow. It was drained today and Medrol was prescribed. More
2825283 4 F AK 02/07/2025 DTAPIPV
MMR
VARCEL
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
5H95B
X011431
Y013350
Product storage error; Product storage error; Product storage error Product storage error; Product storage error; Product storage error
Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vacc... Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use. This did not include MMR and Variceela More
2825284 77 F FL 02/07/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
JB272A
Extra dose administered, No adverse event Extra dose administered, No adverse event
It was discovered after the fact that this patient had already received a dose if the Arexvy vaccine... It was discovered after the fact that this patient had already received a dose if the Arexvy vaccine on 10/05/2023. Patient has not had any adverse reactions and is aware that she received two doses and does not ever need another dose. More
2825285 42 F AK 02/07/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
CX4HL
Product storage error Product storage error
Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vacc... Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use. More
2825286 30 M 02/07/2025 COVID19
NOVAVAX
6024MF020
Expired product administered Expired product administered
Expired vaccine administered. Vaccine was expired by 3 days. Expired vaccine administered. Vaccine was expired by 3 days.
2825287 0.33 M SC 02/07/2025 HIBV
HIBV
IPV
IPV
RV5
RV5
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
UK016AC
UK016AC
W1C741M
W1C741M
Y011483
Y011483
C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram he... C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram head normal, Full blood count, Intensive care; Laboratory test normal, Leukocytosis, Respiratory viral panel, Seizure like phenomena, White blood cell count increased; C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram head normal, Full blood count, Intensive care; Laboratory test normal, Leukocytosis, Respiratory viral panel, Seizure like phenomena, White blood cell count increased; C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram head normal, Full blood count, Intensive care; Laboratory test normal, Leukocytosis, Respiratory viral panel, Seizure like phenomena, White blood cell count increased More
Less than 24h after receiving vaccines, infant began having seizure like activity. He was admitted t... Less than 24h after receiving vaccines, infant began having seizure like activity. He was admitted to ICU. More
โœ“ โœ“
2825288 85 F MI 02/07/2025 DTAP
GLAXOSMITHKLINE BIOLOGICALS
BH57H
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
None, nurse was supposed to give a Tdap and instead gave a Dtap None, nurse was supposed to give a Tdap and instead gave a Dtap
2825289 91 F FL 02/07/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
52z52
No adverse event No adverse event
n/a nothing reported from patient or her daughter when called n/a nothing reported from patient or her daughter when called
2825290 0.33 M CT 02/07/2025 DTAPIPV
HIBV
PNC20
RV5
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.
42Y93
UK0422A
HH590
2032353
Agitation, Infant irritability, Product administered to patient of inappropriate... Agitation, Infant irritability, Product administered to patient of inappropriate age; Agitation, Infant irritability, Product administered to patient of inappropriate age; Agitation, Infant irritability, Product administered to patient of inappropriate age; Agitation, Infant irritability, Product administered to patient of inappropriate age More
Patient received 1 dose of DTAP-IVP Kinrix which is designated for ages 4-6 and he is 4 months old. ... Patient received 1 dose of DTAP-IVP Kinrix which is designated for ages 4-6 and he is 4 months old. The error was not known until 01/24/25 when I spoke with the physician when it did not appear on patient's medical record, (technical issues on the facilitie's part). I contacted GSK, obtained the following information: Inadvertent use of Kinrix in children younger then 4 years, immunogenicity & safety. I then phoned mother of child, informed her of the error and common side effects, agitation and irritabiity. She reported the patient had experienced these. I notified her that the doses were valid and would not need to be repeated and to call for further concerns. Today, she reports the patient is fine, doing well and had no further adverse side effects. More
2825291 1.33 F CA 02/07/2025 DTAP
GLAXOSMITHKLINE BIOLOGICALS
9KB9G
Erythema, Injection site erythema, Peripheral swelling, Rash Erythema, Injection site erythema, Peripheral swelling, Rash
localized erythema on Left thigh, followed by erythema and swelling extending to Left foot and then ... localized erythema on Left thigh, followed by erythema and swelling extending to Left foot and then to Right foot and then diffuse rash to trunk/ body More
2825292 0.58 M MI 02/07/2025 DTAPIPVHIB
PNC21
RV5
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
UJ202AA
Y011819
2032352
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
PCV 21 given instead of PCV 15 PCV 21 given instead of PCV 15
2825293 11 M ID 02/07/2025 MNQ
TDAP
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
7GF79
3CA17C1
Dizziness, Pallor; Dizziness, Pallor Dizziness, Pallor; Dizziness, Pallor
Patient had a Meningococcal vaccine and a T-dap vaccine today. After those vaccines, patient became... Patient had a Meningococcal vaccine and a T-dap vaccine today. After those vaccines, patient became light headed and pale. He did not LOC at all. He laid down for about 15 min and then started feeling better. His mother stated that he works him self up before vaccines and this is probably the issue. Dr. evaluated the patient and felt like he was doing much better after the 15 min and assessment was done by MD. Tried to call the patient's mother to check up on him. No answer, but I left a message to call us back for an update .RN More
2825294 82 F AL 02/07/2025 FLU3
PNC20
SEQIRUS, INC.
PFIZER\WYETH
388478
LG5573
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient received Prevnar 20 and had already received this shot 12/28/2022 and 8/1/2023 but shots did... Patient received Prevnar 20 and had already received this shot 12/28/2022 and 8/1/2023 but shots did not show on immprint. More
2825295 1 M AR 02/07/2025 VARCEL
MERCK & CO. INC.
Y013347
Erythema, Induration, Skin lesion, Skin warm Erythema, Induration, Skin lesion, Skin warm
Patient is a 13 m.o. male brought by mother presenting with a red, hard area to the leg. He got sho... Patient is a 13 m.o. male brought by mother presenting with a red, hard area to the leg. He got shots (12 mos) about 11 days ago and mom not sure if it was in the exact same area but he had a smaller lesion up until 4 days ago, then it worsened and got red, warm. More
2825296 86 F PA 02/07/2025 COVID19
MODERNA
3043835
Injection site pain, Injection site reaction, Limb discomfort, Pain, Tenderness Injection site pain, Injection site reaction, Limb discomfort, Pain, Tenderness
Heaviness and pain in deltoid at site of vaccination. Raising arm hurts, touching arm hurts, and ev... Heaviness and pain in deltoid at site of vaccination. Raising arm hurts, touching arm hurts, and even just sitting still it aches. Hot water bottle did not help. She's had it against all night, It didn't help. She also took 2 Tylenol last night cause it was so painful but it didn't help. More
2825297 82 F ID 02/07/2025 FLU3
SANOFI PASTEUR
49281-124-65
Injection site pain, Shoulder injury related to vaccine administration, X-ray li... Injection site pain, Shoulder injury related to vaccine administration, X-ray limb More
shoulder injury related to vaccine administration (SIRVA) S49.80xA, pain in the left deltoid startin... shoulder injury related to vaccine administration (SIRVA) S49.80xA, pain in the left deltoid starting about 48 hours after vaccination and persisting, no other apparent cause. More
2825298 U AZ 02/07/2025 HIBV
GLAXOSMITHKLINE BIOLOGICALS
4777F
Product preparation issue Product preparation issue
only been administered with the saline solution; only been administered with the saline solution; Th... only been administered with the saline solution; only been administered with the saline solution; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: only been administered with the saline solution) and inappropriate dose of vaccine administered (Verbatim: only been administered with the saline solution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Reporter stated that six different patients received a Hiberix vaccine and two of them had only been administered with the saline solution. Reporter did not know which were the two patients that received the full dose. Vaccination date was asked, nevertheless the reporter mentioned it occurred between September and December of last year (twenty-twenty four). They asked about any concerning information regarding safety, or if they have to readminister those two doses. No patient demographics were provided and no further information was provided. The patients received only saline solution of Hiberix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2825299 2 M WI 02/07/2025 COVID19
FLU3
PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
LN8272
2XK44
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
No adverse events known to date No adverse events known to date