🏥 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 💀 🏥 🚑 ♿ ⚠️
2829262 60 F WA 03/04/2025 PNC21
 MERCK & CO. INC.
 Y011819
Rash Rash
rash; Information has been received from Business Partner/CRO on 12-Feb-2025. This spontaneous repo... rash; Information has been received from Business Partner/CRO on 12-Feb-2025. This spontaneous report was received from a/an Pharmacist and refers to a(n) 60-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-Feb-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Solution for injection (lot #Y011819, expiration date: 01-Oct-2025) 0.5 mL (0.5ml/dose), administered by Intramuscular route. On an unknown date, the patient started therapy with . The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), for the treatment of Age over 50 years old. On 03-Feb-2025, the patient experienced rash. At the reporting time, the patient was recovering from rash. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of rash and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. More
2829263 M UT 03/04/2025 PNC21
 MERCK & CO. INC.
Chills, Fatigue, Malaise, Tremor Chills, Fatigue, Malaise, Tremor
Physician reported he has been sick all day and had to cancel his patient appointments; severe react... Physician reported he has been sick all day and had to cancel his patient appointments; severe reaction to include chills with shaking, and fatigue.; severe reaction to include chills with shaking, and fatigue.; severe reaction to include chills with shaking, and fatigue; This spontaneous report has been received from a physician and refers to himself, a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Feb-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported/unknown by the reporter). On that same date, the patient experienced severe reaction to include chills with shaking (tremor), and fatigue. On an unknown date, the patient experienced he has been sick all day and had to cancel his patient appointments. At the reporting time, the patient had not recovered from all the events. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. No additional information is expected. More
2829264 ME 03/04/2025 HPV9
 MERCK & CO. INC.
 X019862
Product storage error Product storage error
No additional EAE/PQC; 3 doses of GARDASIL-9 were administered to a patient after a temperature excu... No additional EAE/PQC; 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion; This spontaneous report was received from a nurse regarding to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with 3 doses series of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number X019862 (lot number X019862 had been verified to be valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine [yeast], expiration date was not provided, but upon an internal validation, established as 14-FEB-2025) (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis. The nurse stated that the 3 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) were administered to a patient after a temperature excursion (temperature: unknown, only knows it was above 46 F with time frame for longer than 1600 hours. There was previous temperature excursion, details unknown). No further information was available from the HCP. Consent to contact the physician was provided. No additional adverse event (AE)/product quality complaint (PQC). More
2829265 M TX 03/04/2025 DTPPVHBHPB
HEP
 MSP VACCINE COMPANY
MERCK & CO. INC.
 U7899AA
X027728
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
no adverse event; Medical assistant calling to report a patient was inadvertently administered both ... no adverse event; Medical assistant calling to report a patient was inadvertently administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day on 12/20/2024. No symptoms reported as of now, however caller states they have not followed up with the parents; This spontaneous report was received from a medical assistant concerning a 2-month-old male patient. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On 20-DEC-2024, the patient was inadvertently administered both the Hepatitis B Vaccine (Recombinant) (lot #X027728, expiration date: 16-Oct-2026) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (+) Inactivated Poliovirus (+) Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B Vaccine (VAXELIS), Unknown (lot #U7899AA, expiration date: 31-Aug-2026). Both administered as prophylaxis (route, dose, anatomical site were not reported) (vaccine overdose). No symptoms reported as of now, however the reporter stated that they have not followed up with the parents to confirm. The patient's next appointment would be on 20-FEB-2025. No additional details were provided. The operator of device was healthcare professional.; Reporter's Comments: Keywords : BP More
2829266 F KY 03/04/2025 PPV
 MERCK & CO. INC.
 X018278
Expired product administered, No adverse event Expired product administered, No adverse event
not experienced any ill effects; Expired Pneumovax 23 was administered; This spontaneous report was ... not experienced any ill effects; Expired Pneumovax 23 was administered; This spontaneous report was received from an other healthcare profession via vendor and refers to a 72-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 12-FEB-2025, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) lot # X018278 was confirmed to be valid, expiration date 24-NOV-2024, for prophylaxis (dose, route and site of administration were not reported). The patient had no ill effects. More
2829267 NY 03/04/2025 HPV9
 MERCK & CO. INC.
 Y007322
No adverse event, Syringe issue No adverse event, Syringe issue
No additional AEs/PQC reported; Caller reports GARDASIL 9 PFS leaked during administration and pati... No additional AEs/PQC reported; Caller reports GARDASIL 9 PFS leaked during administration and patient did not receive full dose.; GARDASIL 9 PFS leaked during administration and patient did not receive full dose.; Caller reports GARDASIL 9 PFS leaked during administration and patient did not receive full dose.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-FEB-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (valid lot number Y007322, expiration date: 18-AUG-2026) intramuscular injection for prophylaxis (dose, dose number, anatomical location, route of administration was not provided) and was leaked during administration and patient did not receive full dose ( product leakage, poor quality device used, accidental underdose). No other information provided. No additional adverse event (AE) reported. More
2829268 77 M KY 03/04/2025 PPV
 MERCK & CO. INC.
 X018278
Expired product administered, No adverse event Expired product administered, No adverse event
the patients have not experienced any ill effects; This office manager reports that expired PNEUMOVA... the patients have not experienced any ill effects; This office manager reports that expired PNEUMOVAX 23 was administered to two patients on 12Feb2025.; This spontaneous report has been received from a regarding a health professional regarding a 77-year-old male patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 12-FEB-2025, the patient received Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for prophylaxis, lot number X018278 which has been verified to be valid, expiration date reported and validated as 24-NOV-2024 (scheme, dose, strength, anatomical site, route of administration not provided) (expired vaccine used). The patient have not experienced any ill effects (no adverse event). More
2829269 HI 03/04/2025 HPV9
RV5
UNK
UNK
UNK
UNK
UNK
 MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Y008119
2032354
y008119
y010035
y008119
Y008338
Y009341
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
improper storage of product in use; no adverse event; Information has been received from Business Pa... improper storage of product in use; no adverse event; Information has been received from Business Partner/CRO on 18-Feb-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with unknown dosage. On an unknown date, the patient started therapy with unknown dosage. On an unknown date, the patient started therapy with . On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y008119, expiration date: 18-Jun-2026), dose number 1,. On an unknown date, the patient started therapy with Hepatitis A Vaccine, Inactivated (lot #Y008338, expiration date: 26-Nov-2025), dose number 1, 0.5 mL (0.5ml),. On an unknown date, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2032354, expiration date: 12-Nov-2025), dose number 1, (2ml),. On an unknown date, the patient started therapy with Hepatitis A Vaccine, Inactivated (VAQTA (25 U/0.5 ML)), (lot #y008119, expiration date: 18-Jun-2026), dose number 1, (0.5ml),. On an unknown date, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y009341, expiration date: 24-Nov-2025), dose number 1, (2ml),. On an unknown date, the patient started therapy with Pneumococcal 15-valent Conjugate Vaccine (lot #y010035, expiration date: 17-Feb-2027), dose number 1, 0.5 mL (0.5ml),. On an unknown date, the patient started therapy with Hepatitis A Vaccine, Inactivated (VAQTA (25 U/0.5 ML)), (lot #y008119, expiration date: 18-Jun-2026), dose number 1, 0.5 mL. The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis. The patient started therapy with Hepatitis A Vaccine, Inactivated for the treatment of prophylaxis. The patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), for the treatment of prophylaxis. The patient started therapy with Hepatitis A Vaccine, Inactivated (VAQTA (25 U/0.5 ML)), for the treatment of prophylaxis. The patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), for the treatment of prophylaxis. The patient started therapy with Pneumococcal 15-valent Conjugate Vaccine for the treatment of prophylaxis. The patient started therapy with for the treatment of prophylaxis. The patient started therapy with Hepatitis A Vaccine, Inactivated (VAQTA (25 U/0.5 ML)), for the treatment of prophylaxis. The patient started therapy with for the treatment of prophylaxis. On an unknown date, the patient experienced no adverse event. On an unknown date, the patient experienced improper storage of product in use. At the reporting time, the outcome of no adverse event and improper storage of product in use was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant. nHepatitis A Vaccine, Inactivated. nRotavirus Vaccine, Live, Oral, Pentavalent. nHepatitis A Vaccine, Inactivated. nRotavirus Vaccine, Live, Oral, Pentavalent. nPneumococcal 15-valent Conjugate Vaccine and Hepatitis A Vaccine, Inactivated was reported as not applicable. More
2829270 UT 03/04/2025 HEP
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
No symptoms reported. No additional adverse event reported.; adult patient who was inadvertently adm... No symptoms reported. No additional adverse event reported.; adult patient who was inadvertently administered a pediatric dose of RECOMBIVAXHB; This spontaneous report was received from a certified medical assistant and refers to an adult patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 19-FEB-2025, the patient was inadvertently administered a pediatric dose of hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection, 0.5 ml for prophylaxis (lot #, expiration date, route and site of administration were not provided). No symptoms reported. No additional adverse event reported. More
2829271 CO 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product dose omission issue Product dose omission issue
The patient took the three doses of Vivotif, and missed the fourth dose; Case reference number US-BN... The patient took the three doses of Vivotif, and missed the fourth dose; Case reference number US-BN-2024-001983 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV23-1245) on 03-Jun-2024 and concerns a patient of unspecified demographics. The patient's relevant medical history and concomitant medication details were not provided. On unspecified dates, the patient took three doses of Vivotif (batch number: unknown), at unknown doses, or routes of administration, for an unknown indication. On an unspecified date, as reported it was one week since last dose of Vivotif, the patient missed fourth dose of Vivotif (explicitly coded as 'missed dose'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from Bavarian Nordic on 04-Jun-2024 included reporter name updated.; Reporter's Comments: A patient of unspecified demographics missed fourth dose of Vivotif. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified demographics missed fourth dose of Vivotif. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829272 F CO 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004008
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient taken first three doses of Vivotif sequentially; Case reference number US-BN-2024-001984 is ... Patient taken first three doses of Vivotif sequentially; Case reference number US-BN-2024-001984 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-1240) on 03-Jun-2024 and concerns a 76-year-old female patient. The patient did not have no notable medical history and other medications. The patient's concomitant medications included TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). On 28-May-2024, the patient took first dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use for pre travel. On 29-May-2024, one day after the first dose, the patient took second dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered'). On 30-May-2024, two days after the first dose, the patient took third dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered'). On 01-Jun-2024, four days after the first dose, the patient took fourth dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported medication error occurred during the administration, it happened at home as the patient did not read the instructions after taking medication at home. On 31 May 2024 the patient went to take fourth dose and observed that the directions said every other day. *At the time of follow up report, the patient did not experience any adverse event due to Vivotif.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Additional information received from a nurse via Med Communication on 04-Jun-2024: included additional reference number (USBAV24-1257). Additional information received from Med Communication on 06-Jun-2024: included confirmation that the suspect product is Vivotif. Follow up information received from a nurse on 18-Jun-2024: New information included added patient demographic details (patient initials and age), concomitant product TDAP, Vivotif dosage information and confirmation on patient medical history, medication error, contributing factors that led to the event during the administration of Vivotif. Follow up information received from a nurse on 08-Jul-2024: New information included confirmation that the patient did not experience any adverse events.; Reporter's Comments: A 76-year-old female patient took the second dose of Vivotif one day after the first dose, at a dose reported as four capsules, via oral use which is considered as inappropriate schedule of vaccine administered. Two days after the first dose, the patient took third dose of Vivotif, which is also considered as inappropriate schedule of vaccine administered. On the day four after the first dose, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. The patient did not experience any adverse event due to Vivotif. The patient did not have notable medical history and other medications, and concomitant medications included TDAP. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 76-year-old female patient took the second dose of Vivotif one day after the first dose, at a dose reported as four capsules, via oral use which is considered as inappropriate schedule of vaccine administered. Two days after the first dose, the patient took third dose of Vivotif, which is also considered as inappropriate schedule of vaccine administered. On the day four after the first dose, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. The patient did not experience any adverse event due to Vivotif. The patient did not have notable medical history and other medications, and concomitant medications included TDAP. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829273 M MA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient took third dose of Vivotif 12 hours later (on day six instead on day five); Case reference n... Patient took third dose of Vivotif 12 hours later (on day six instead on day five); Case reference number US-BN-2024-001980 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV23-1229) on 03-Jun-2024 and concerns a male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, reported as day one, the patient took first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for typhoid immunisation. On unspecified date, reported as day three, the patient took second dose of Vivotif (batch number: unknown), at an unknown dose, orally. On unspecified date, reported as day six and as 12 hours late, the patient took third dose of Vivotif instead on day five (batch number: Unknown), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A male patient of unspecified age took third dose of Vivotif six and as 12 hours late, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age took third dose of Vivotif six and as 12 hours late, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829274 F WA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient took first two doses of Vivotif, two days in row; Case reference number US-BN-2024-00198... The patient took first two doses of Vivotif, two days in row; Case reference number US-BN-2024-001982 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV23-1231) on 03-Jun-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medication details were not provided. On unspecified days, as reported two days in a row, the patient took the first and the second dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from Med Communications on 03-Jun-2024 included Vivotif indication and new reference number (USBAV23-1227).; Reporter's Comments: A female patient of unspecified age took the first and the second dose of Vivotif, two days in a row, at unknown dose, orally, for typhoid immunization which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took the first and the second dose of Vivotif, two days in a row, at unknown dose, orally, for typhoid immunization which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829275 F VA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004041
Incomplete course of vaccination, Product storage error Incomplete course of vaccination, Product storage error
The patient did not take fourth dose of Vivotif on scheduled date; The finale capsule of Vivotif was... The patient did not take fourth dose of Vivotif on scheduled date; The finale capsule of Vivotif was unrefrigerated for 16 hours at potentially room temperature; Case reference number US-BN-2024-002002 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1297) on 06-Jun-2024 and concerns 18-years-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient received first, second and third dose of Vivotif (batch number: 3004041), at unknown dose, orally, for immunization against disease caused by salmonella typhi. On an unspecified date, reported as yesterday, the patient was due for final fourth dose of Vivotif, and didn't take it (explicitly coded as 'Inappropriate schedule of vaccine administered'). As reported, the final capsule was unrefrigerated for 16 hours, and it was unknown if it was at room temperature, because the patient travelled and potentially that the temperature could be above room temperature (explicitly coded as 'Product storage error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: An 18-years-old female patient was due for final fourth dose of Vivotif, and didn't take it which is considered as inappropriate schedule of vaccine administered. Reportedly, the final capsule was unrefrigerated for 16 hours, and it was unknown if it was at room temperature, because the patient travelled and potentially that the temperature could be above room temperature which is considered as product storage error. Inappropriate schedule of product administration and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An 18-years-old female patient was due for final fourth dose of Vivotif, and didn't take it which is considered as inappropriate schedule of vaccine administered. Reportedly, the final capsule was unrefrigerated for 16 hours, and it was unknown if it was at room temperature, because the patient travelled and potentially that the temperature could be above room temperature which is considered as product storage error. Inappropriate schedule of product administration and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious. More
2829276 IL 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product storage error Product storage error
Patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it'... Patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration; Patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration; Case reference number US-BN-2024-002001 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1292) on 06-Jun-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication was not reported. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first dose of Vivotif, at an unknown dose, via oral use for unknown indication. Reportedly, patient took their first Vivotif dose which has been for more than 24 hours out of refrigeration which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender took the first dose of Vivotif, at an unknown dose, via oral use for unknown indication. Reportedly, patient took their first Vivotif dose which has been for more than 24 hours out of refrigeration which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829277 OR 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient took two doses of Vivotif consecutively, instead of taking the first two doses every other d... Patient took two doses of Vivotif consecutively, instead of taking the first two doses every other day; Case reference number US-BN-2024-002019 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1309) on 07-Jun-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication were not provided. On 06-Jun-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. On 07-Jun-2024, one day after the first dose the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the second dose of Vivotif, one day after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender took the second dose of Vivotif, one day after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829278 0.58 M MI 03/04/2025 COVID19
 MODERNA
 3043000
Expired product administered Expired product administered
Patient received an expired dose of covid. The Date of expiration written on the box 2/26/25, D... Patient received an expired dose of covid. The Date of expiration written on the box 2/26/25, Dose was given on 2/28/25, After speaking with Immunization, TIme out was taken and addressed. Plan was discussed to make sure that the expiration dates are looked at more thoroughly to make sure they are removed from inventory. We discussed getting "expire first" stickers to make it more noticeable to staff. More
2829279 57 F WV 03/04/2025 COVID19
COVID19
 MODERNA
MODERNA
 013L20A
013L20A
Cough, Face and mouth X-ray, Headache, Impaired quality of life, Pulmonary funct... Cough, Face and mouth X-ray, Headache, Impaired quality of life, Pulmonary function test; Smoke sensitivity, Throat irritation More
Nothing at first then I developed a strong sense of smell and cough. I smell things no one else smel... Nothing at first then I developed a strong sense of smell and cough. I smell things no one else smells. I can get a headache from this but not always. It can make me cough, but not always. I get a burning in my throat from some smells. It has affected my life completely. Ongoing! More
2829280 77 M IA 03/04/2025 COVID19
 MODERNA
 3043159
Death Death
Death Death
✓
2829281 83 M IA 03/04/2025 COVID19
 MODERNA
 3043159
Death Death
Death Death
✓
2829282 59 M IA 03/04/2025 COVID19
 MODERNA
Death Death
Death Death
✓
2829283 42 M TX 03/04/2025 COVID19
 MODERNA
 022521a
Cardiac operation, Chest discomfort, Coronary artery bypass, Fatigue Cardiac operation, Chest discomfort, Coronary artery bypass, Fatigue
tightness in the chest, fatigue tightness in the chest, fatigue
✓
2829284 61 M VA 03/04/2025 FLU3
 SEQIRUS, INC.
 388474
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Patient was intended to receive the standard flu vaccine but instead was administered the fluad high... Patient was intended to receive the standard flu vaccine but instead was administered the fluad high dose vaccine. No adverse effects reported. More
2829285 12 F NY 03/04/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 7NX57
Extra dose administered Extra dose administered
Pt given Hep B as the 3rd dose but it was an extra 4th dose 4 weeks after dose#3. Dose#3 given at a... Pt given Hep B as the 3rd dose but it was an extra 4th dose 4 weeks after dose#3. Dose#3 given at another facility. More
2829286 8 M NY 03/04/2025 HEPA
 MERCK & CO. INC.
 Y012227
Inappropriate schedule of product administration Inappropriate schedule of product administration
Pt given Hep A dose without realizing that dose was given 1 mo prior. Pt given Hep A dose without realizing that dose was given 1 mo prior.
2829287 11 F NC 03/04/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8256AB
U8015AA
Injection site erythema, Injection site swelling, Injection site warmth, Urticar... Injection site erythema, Injection site swelling, Injection site warmth, Urticaria; Injection site erythema, Injection site swelling, Injection site warmth, Urticaria More
Redness, warmth and swelling down the majority of her upper left arm that is still there after 1 wee... Redness, warmth and swelling down the majority of her upper left arm that is still there after 1 week. Mom stated it looked like hives. Denies fever. More
2829288 F 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient took two doses of Vivotif and missed to receive third dose; Case reference number US-BN-2024... Patient took two doses of Vivotif and missed to receive third dose; Case reference number US-BN-2024-002043 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1342) on 11-Jun-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. On 06-Jun-2024, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose, via oral use, prior to travel on 27 Jun 2024. On 08-Jun-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown) at unknown dose, via oral use. As reported, patient took two doses of Vivotif and missed to receive third dose (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age took two doses of Vivotif and missed to receive third dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took two doses of Vivotif and missed to receive third dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829289 27 M OH 03/04/2025 COVID19
COVID19
 MODERNA
MODERNA

Alopecia, Condition aggravated, Dry skin, Eczema, Immunodeficiency; Insomnia, Re... Alopecia, Condition aggravated, Dry skin, Eczema, Immunodeficiency; Insomnia, Restless legs syndrome, Skin exfoliation, Skin injury More
Cause eczema which was only on small section of arm and calf?s of both legs, to take up 85% of my en... Cause eczema which was only on small section of arm and calf?s of both legs, to take up 85% of my entire body. Severely dry and damaged skin that resulted in loss of massive amounts of skin from touch alone. Loss of hair across entire body. Insomnia, restless leg syndrome, compromised immune system. The treatment and medications I?m currently on are triamcinolone and Dupixent, which I cannot afford and my doctor states I will most likely be on this medication for the rest of my life More
✓
2829290 11 M NC 03/04/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8256AB
U8115AA
Erythema, Injection site erythema, Injection site pain, Injection site swelling;... Erythema, Injection site erythema, Injection site pain, Injection site swelling; Erythema, Injection site erythema, Injection site pain, Injection site swelling More
Tdap and Menquadfi vaccines were given on the afternoon of 02/21/25. The next day, the spot around ... Tdap and Menquadfi vaccines were given on the afternoon of 02/21/25. The next day, the spot around the vaccines were red and swollen. Tender to touch. Redness spreading down the arm some. No wheezing, respiratory distress or lip/tongue swelling. Denies fevers. More
2829292 7 F MA 03/04/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9KB9G
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse reactions noted No adverse reactions noted
2829293 4 M TX 03/04/2025 DTAPIPV
DTAPIPV
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 Y49B2
Y49B2
Y010306
Y010306
Blood creatine phosphokinase normal, Blood lactic acid normal, Erythema, Pain in... Blood creatine phosphokinase normal, Blood lactic acid normal, Erythema, Pain in extremity, Peripheral swelling; Red blood cell sedimentation rate increased, White blood cell count normal, X-ray limb normal, X-ray normal; Blood creatine phosphokinase normal, Blood lactic acid normal, Erythema, Pain in extremity, Peripheral swelling; Red blood cell sedimentation rate increased, White blood cell count normal, X-ray limb normal, X-ray normal More
Per ER records and Parents: Pt had kinrix and proquad 02/28/2025. About 1 hour after the injections ... Per ER records and Parents: Pt had kinrix and proquad 02/28/2025. About 1 hour after the injections the patients arm began to swell and get red. 03/01/2025 the pt was complaining that his arm was hurting very bad. The swelling had increased and so had the redness. *triage assessment stated pt complains of pain appears in no apparent distress, swelling and redness noted.* Vitals Pulse: 94, Resp: 24, Temp: 98.3, O2: 99% on RA. Was given IV Ancef, IV Decadron, and IV Benadryl. Swelling had decreased by time of discharge and pt was sent home with prescriptions for Benadryl, Prednisolone sodium Phosphate 5mg/5ml (to take 10 ml PO QD for 5 days), Cefdinir 250mg/5ml (to take 3.5 ml PO BID for 10 days), and Diclofenac Sodium 1% topical gel (to apply 4 grams QID to single elbow, wrist or hand). More
2829294 14 M MI 03/04/2025 MMRV
 MERCK & CO. INC.
 Y014306
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
At the time of vaccination the staff was told the child's DOB was 2012 and that he was 12 years... At the time of vaccination the staff was told the child's DOB was 2012 and that he was 12 years old so a Proquad was administered. It was determined after vaccination that his DOB is 2010 and the child was 14 which is outside the range for the vaccine. More
2829295 0.75 M MD 03/04/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Incorrect dose administered, Infant irritability Incorrect dose administered, Infant irritability
Patient was to receive a diluted dosage due to age but instead received 0.3mL. Provider spoke with f... Patient was to receive a diluted dosage due to age but instead received 0.3mL. Provider spoke with father at end of day on signs and symptoms to look out for over the weekend. Spoke with father and patient had been fussy all weekend but no other symptoms. More
2829296 27 F PA 03/04/2025 HPV9
 MERCK & CO. INC.
 W031448
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was accidentally given an expired dose of Gardisal 9. It was expired on 2/12/2025. Pt was no... Patient was accidentally given an expired dose of Gardisal 9. It was expired on 2/12/2025. Pt was notified immediately while still on site. Merck was contacted and informed us that there was no need of revaccination. Patient did not have any adverse reaction to this vaccine. More
2829297 34 F FL 03/04/2025 COVID19
COVID19
 MODERNA
MODERNA

Bedridden, Central nervous system lesion, Gait disturbance, Laboratory test norm... Bedridden, Central nervous system lesion, Gait disturbance, Laboratory test normal, Lumbar puncture normal; Magnetic resonance imaging head abnormal, Paraesthesia, Spinal pain, Weight decreased More
There were no signs until this happened: In September of 2021, after the first shot, I started havin... There were no signs until this happened: In September of 2021, after the first shot, I started having a tingling feeling go from three of my fingers (pinky, ring and middle only) and go up my arms to about my arm pits. After the second dose, in October 2021, I started feeling a tingling band feeling around my waist as if I had on a corset on. This feeling went away after 2 years of being bed ridden. Tingles took over my entire body and my left me not being able to walk on my own and rapid weight loss. There was also an excruciating pain coming from the base of my spine. I am now taking Gabapentin in order to fully walk, function, and have less pain in my spine. More
✓
2829298 33 F TX 03/04/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 025b21a
025b21a
025b21a
025b21a
0048b21a
0048b21a
0048b21a
0048b21a
Arthralgia, Axillary mass, Bacterial infection, Biopsy breast, Biopsy breast abn... Arthralgia, Axillary mass, Bacterial infection, Biopsy breast, Biopsy breast abnormal; Breast abscess, Breast discomfort, Breast inflammation, Breast mass, Breast operation; Breast pain, Drain placement, Erythema, Joint stiffness, Mammogram; Oropharyngeal pain, Pain, Plasma cell mastitis, Ultrasound breast abnormal; Arthralgia, Axillary mass, Bacterial infection, Biopsy breast, Biopsy breast abnormal; Breast abscess, Breast discomfort, Breast inflammation, Breast mass, Breast operation; Breast pain, Drain placement, Erythema, Joint stiffness, Mammogram; Oropharyngeal pain, Pain, Plasma cell mastitis, Ultrasound breast abnormal; Arthralgia, Axillary mass, Bacterial infection, Biopsy breast, Biopsy breast abnormal; Breast abscess, Breast discomfort, Breast inflammation, Breast mass, Breast operation; Breast pain, Drain placement, Erythema, Joint stiffness, Mammogram; Oropharyngeal pain, Pain, Plasma cell mastitis, Ultrasound breast abnormal More
Idiopathic Granulomatous Mastitis Idiopathic Granulomatous Mastitis
✓
2829299 62 F NV 03/04/2025 PNC20
 PFIZER\WYETH
 LC5483
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pt inadvertently received extra dose of vaccine, no symptoms of adverse reactions. No treatment req... Pt inadvertently received extra dose of vaccine, no symptoms of adverse reactions. No treatment required. More
2829300 1 M CA 03/04/2025 DTPPVHBHPB
HIBV
 MSP VACCINE COMPANY
SANOFI PASTEUR
 U&(21AA
UK168AC
Extra dose administered, No adverse event, Wrong product administered; Extra dos... Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered More
Vaccine administration error- VAXELIS inadvertently administered instead of PREVNAR 20 resulting in ... Vaccine administration error- VAXELIS inadvertently administered instead of PREVNAR 20 resulting in patient then received 2 HIBS on same day and extra doses of VAXELIS . Last dose of VAXELIS administered on 10/15/2024. Spoke to Parent on 3/4/2025- she reports no fever, no leg swelling, no other concerning signs or symptoms More
2829301 62 M CA 03/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 KB2YT
Loss of consciousness, Syncope Loss of consciousness, Syncope
Patient fainted about 1 minute after administering vaccination. Regained consciousness and then fain... Patient fainted about 1 minute after administering vaccination. Regained consciousness and then fainted again, upon which time I contacted 911. measuring his BP it was 60/39 pulse 52. The paramedics arrived within 4 minutes and took him away to the ER. More
2829302 4 F MS 03/04/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 Y49BZ
Y01077
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
REDNESS, SWELLING, WARMTH, AND PAIN AT INJECTION SITE 18.5 HOURS AFTER VACCINES GIVEN. MOTHER TREATE... REDNESS, SWELLING, WARMTH, AND PAIN AT INJECTION SITE 18.5 HOURS AFTER VACCINES GIVEN. MOTHER TREATED AT HOME WITH PO BENADRYL LIQUID 5ML COUPLE DOSES. INSTRUCTED AFTER VISIT - COOL COMPRESSES, TYLENOL OR IBUPROFEN PRN ANY PAIN OR SWELLING, FU PRN. SEEN IN CLINIC TODAY 3/4/25 FOR CHECK OF REACTION. IMPROVED BUT STILL SOME REDNESS AND SLIGHT SWELLING, NO FURTHER WARMTH OR PAIN OR ANY FURTHER SYMPTOMS. More
2829303 72 F MN 03/04/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 011M20A
025A21A
001M21A
Cough, Diarrhoea, Dizziness, SARS-CoV-2 test; Cough, Diarrhoea, Dizziness, SARS-... Cough, Diarrhoea, Dizziness, SARS-CoV-2 test; Cough, Diarrhoea, Dizziness, SARS-CoV-2 test; Cough, Diarrhoea, Dizziness, SARS-CoV-2 test More
Cough, diarrhea, dizzy Cough, diarrhea, dizzy
2829304 M 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Sinusitis Sinusitis
Sinus infection; Case reference number US-BN-2024-002045 is a spontaneous case initially received fr... Sinus infection; Case reference number US-BN-2024-002045 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1331) on 11-Jun-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient took a dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, the patient completed the dosing with Vivotif. On an unspecified date, unknown amount of time after the dose of Vivotif, the patient had sinus infection and needs to begin a round of antibiotics for a sinus infection. At the time of the initial report, the outcome of the event sinus infection was unknown. The reporter assessed seriousness for the event sinus infection as non-serious and assessed the causality as possible for the event sinus infection. No further information was provided.; Reporter's Comments: A male patient of unknown age had a non-serious event of sinus infection an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Sinusitis is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication were not provided. The outcome of the event sinus infection was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age had a non-serious event of sinus infection an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Sinusitis is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication were not provided. The outcome of the event sinus infection was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as non-serious. More
2829305 76 F VA 03/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4h7ny
Injection site rash Injection site rash
A rash developed from injection site down arm to the bend of the arm. The rash began the day after ... A rash developed from injection site down arm to the bend of the arm. The rash began the day after the injection and lasted for 3 days. More
2829306 37 F VA 03/04/2025 TDAP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8352BA
U8352BA
U8352BA
Activated partial thromboplastin time, Blood fibrinogen, Crossmatch, Disseminate... Activated partial thromboplastin time, Blood fibrinogen, Crossmatch, Disseminated intravascular coagulation, Exposure during pregnancy; Foetal death, Full blood count, International normalised ratio, Metabolic function test, Pathology test; Premature separation of placenta, Prothrombin time, Reflex test More
Patient administered Adacel 2/25/25 and office, patient was admitted to hospital 2/26/25 for Placent... Patient administered Adacel 2/25/25 and office, patient was admitted to hospital 2/26/25 for Placenta Abruption with IUFD and DIC. She was admitted at 36w3d More
✓
2829307 62 F MI 03/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 YZ9CY
Pruritus, Pyrexia, Somnolence Pruritus, Pyrexia, Somnolence
Patient reported itching, fever, sleepiness shortly after receiving vaccination and for the 4 days f... Patient reported itching, fever, sleepiness shortly after receiving vaccination and for the 4 days following vaccination. Patient reported symptoms to doctor who advised OTC medications. Patient reported relief after taking Benadryl and Tylenol. More
2829308 20 F OR 03/04/2025 COVID19
 MODERNA
 3044091
No adverse event, Underdose No adverse event, Underdose
Reporting administration error. MA administered COVID Moderna Vaccine 6m-11y to 20 year old patient.... Reporting administration error. MA administered COVID Moderna Vaccine 6m-11y to 20 year old patient. No adverse event, signs, or symptoms have been reported. More
2829309 63 M FL 03/04/2025 PNC20
 PFIZER\WYETH
 LK6650
Decreased appetite, Dizziness, Nausea, Pyrexia Decreased appetite, Dizziness, Nausea, Pyrexia
Patient's daughter called pharmacy and stated that the patient was feeling dizzy, nauseous, and... Patient's daughter called pharmacy and stated that the patient was feeling dizzy, nauseous, and had a fever. She also stated he did not have an appetite and did not eat all day. More
2829310 44 M CA 03/04/2025 CHIK
CHIK
 VALNEVA USA, INC.
VALNEVA USA, INC.
 24b011
24b011
Angiogram, C-reactive protein, Full blood count, Headache, Magnetic resonance im... Angiogram, C-reactive protein, Full blood count, Headache, Magnetic resonance imaging head; Muscle spasms, Pyrexia, Respiratory viral panel, Scan with contrast More
severe bilateral headache and neck spasms beginning approximately 70 hours post vaccination. Increas... severe bilateral headache and neck spasms beginning approximately 70 hours post vaccination. Increasing fever peaking at 103.1 degrees. Fever lasted for 48 hours. Treatment was palliative support of IV fluids, compazine, magnesium, torridol, acetemetaphine More
2829311 57 M NY 03/04/2025 TYP
 SANOFI PASTEUR
 x1A261M
Injection site pain Injection site pain
patient reporting that has continued pain at injection site for over a month, at first he though it ... patient reporting that has continued pain at injection site for over a month, at first he though it was a pulled muscle but then realized it was related to the vaccine More
2829312 22 M MD 03/04/2025 COVID19
COVID19
 MODERNA
MODERNA
 031B21A
022C21A
Endotracheal intubation, Intensive care, Laboratory test normal, Magnetic resona... Endotracheal intubation, Intensive care, Laboratory test normal, Magnetic resonance imaging normal, Status epilepticus; Endotracheal intubation, Intensive care, Laboratory test normal, Magnetic resonance imaging normal, Status epilepticus More
Episodes of status epilepticus, generally occurring every 3 months. Hospitalization required on man... Episodes of status epilepticus, generally occurring every 3 months. Hospitalization required on many occasions, including overnight monitoring and ICU stay requiring intubation and sedation to stop the seizures. Patient requires ongoing monitoring by a neurologist and daily anti-seizure medications. Multiple tests, including MRI show no causation for the sudden onset of seizures and prior to the C19 vaccine, patient had no health conditions. More
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