🏥 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 💀 🏥 🚑 ♿ ⚠️
2803606 82 M CA 10/29/2024 YF
YF
YF
YF
YF
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR



UK117AA
Hypotension, Intensive care, Liver function test increased, Neurological symptom... Hypotension, Intensive care, Liver function test increased, Neurological symptom, Thrombocytopenia; Systemic inflammatory response syndrome; Hypotension, Intensive care, Liver function test increased, Neurological symptom, Thrombocytopenia; Systemic inflammatory response syndrome; Unevaluable event More
thrombocytopenia; hypotensive; got elevated LFTs; neurological changes; Initial information received... thrombocytopenia; hypotensive; got elevated LFTs; neurological changes; Initial information received on 22-Oct-2024 regarding an unsolicited valid serious case received from a physician. This case involves a 82 years old male patient who experienced hypotensive, got elevated LFTs (liver function test), neurological changes and thrombocytopenia after receiving yellow fever vaccine - [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 mg dose of yellow fever vaccine - US Solution for injection with standard strength (lot number and expiry date not reported) once via subcutaneous route in unknown administration site for Immunization. On an unknown date the patient was hypotensive (hypotension), got elevated lfts (liver function test increased), neurological changes (nervous system disorder) and thrombocytopenia (latency- 5 days) following the administration of yellow fever vaccine -. Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Physician reported that patient had an adverse effect 5 days after receiving YF-VAX. Physician stated that it seems like patient had got that visceral Visceral Topic Disease from it. Now, the patient was in the ICU (Intensive Care Unit). Patient was hypotensive. Patient had got elevated LFTs, abnormal crowning function, and thrombocytopenia. Patient had neurological changes as well. Patient was hypotensive and mild [unconfirmed] lysis. Patient was still in the ICU right now as per physician. Physician said that patient got the YF-VAX in preparation because he was leaving the country. Patient was being treated by the Doctor. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness criteria: The patient was hospitalized for all the events and medically significant for thrombocytopenia.; Sender's Comments: Sanofi company comment dated 29-Oct-2024: This case involves a 82 years old male patient who experienced hypotensive, got elevated LFTs (liver function test), neurological changes and thrombocytopenia after receiving yellow fever vaccine - [YF-VAX]. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed More
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2830932 03/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; experineced shingles 3 times; This serious case was reported by a con... Suspected vaccination failure; experineced shingles 3 times; 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: experineced shingles 3 times). 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: 09-MAR-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated for shingles and have had shingles 3 times since then. 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. More
2830933 M OH 03/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3939H2S
Extra dose administered Extra dose administered
Extra dose/ third dose administered; This non-serious case was reported by a other health profession... Extra dose/ third dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 3939H2S, expiry date 10-MAR-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 19-FEB-2020) and Shingrix (received 2nd dose on 06-AUG-2020). On 18-FEB-2025, the patient received the 3rd dose of Shingrix. On 18-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose/ third dose administered). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 04-MAR-2025 The Vaccine Administration Facility is the same as Primary Reporter The Practice Director called to enquire if there was any issue with a patient that had the complete schedule for Shingrix vaccine, and received an extra dose (third dose) a few weeks ago. The patient had received the 3rd dose of Shingrix, which had led to extra dose administered. More
2830934 53 M NV 03/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93kk4
Inappropriate schedule of product administration Inappropriate schedule of product administration
Shingrix early second dose; This non-serious case was reported by a pharmacist via call center repre... Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 93kk4, expiry date 31-JAN-2027) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 06-FEB-2025, the patient received the 2nd dose of Shingrix. On 06-FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 05-MAR-2025 The pharmacist reported a patient received the first dose of Shingrix on 13th January 2025. The patient was not immunocompromised. The reporter consented to follow up. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule. More
2830935 73 M 03/12/2025 COVID19
 MODERNA
Fatigue, Feeling abnormal, Initial insomnia Fatigue, Feeling abnormal, Initial insomnia
around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest... around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while; Extreme tiredness/started getting extremely tired in the afternoon; around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while; This spontaneous case was reported by a patient and describes the occurrence of INITIAL INSOMNIA (around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while), FATIGUE (Extreme tiredness/started getting extremely tired in the afternoon) and FEELING ABNORMAL (around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while) in a 73-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer-BioNTech COVID-19 Vaccine (Dose 2) in 2021, Pfizer-BioNTech COVID-19 Vaccine (Dose 1) in 2021, Pfizer-BioNTech COVID-19 Vaccine (Dose 3) in 2022, Pfizer-BioNTech COVID-19 Vaccine (Dose 4) in 2022 and Pfizer-BioNTech COVID-19 Vaccine (Dose 5) in 2023. Past adverse reactions to the above products included No adverse effect with Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine. In October 2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INITIAL INSOMNIA (around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while), FATIGUE (Extreme tiredness/started getting extremely tired in the afternoon) and FEELING ABNORMAL (around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while). At the time of the report, INITIAL INSOMNIA (around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while), FATIGUE (Extreme tiredness/started getting extremely tired in the afternoon) and FEELING ABNORMAL (around lunch time it seems like I am zapped, I can never fall asleep but I have to lay down and rest for a while) outcome was unknown. Concomitant medication was not provided. Patient took 6 shots of COVID-19 Vaccine, after 6th shot of vaccine and from the last two weeks started experiencing extreme tiredness in the afternoon. Patient was not sure if that was form Pfizer covid 19 vaccine or due to old age. She got up in the mornings and did her normal stuff and around lunch time it seems like she was zapped. She could never fall asleep but had to lay down and rest for a while, it had been going on for couple of weeks. She did not know what was going on and will be visiting her heart doctor. Initially patient received a couple of vaccines in each year for first two years and then taper off in the last couple of years, she had got only one per year in 2023 and 2024. Treatment information was not reported. More
2830936 F 03/12/2025 COVID19
 MODERNA
Herpes zoster Herpes zoster
she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got ... she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.). At the time of the report, HERPES ZOSTER (she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-783038 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783038:Master case (B-G) More
2830937 F CA 03/12/2025 COVID19
 MODERNA
Malaise, Vaccination site pain Malaise, Vaccination site pain
Like I was, I for like 24 hours I was very um. kind of sickish; the shot when she put the needle in ... Like I was, I for like 24 hours I was very um. kind of sickish; the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Like I was, I for like 24 hours I was very um. kind of sickish) and VACCINATION SITE PAIN (the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised and Lung disorder NOS. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (Like I was, I for like 24 hours I was very um. kind of sickish) and VACCINATION SITE PAIN (the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain). At the time of the report, MALAISE (Like I was, I for like 24 hours I was very um. kind of sickish) and VACCINATION SITE PAIN (the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain) outcome was unknown. No concomitant medications were reported. It was reported that the patient had medical history of rare disease. Administration date was reported as a couple of months ago. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2025: Non-significant follow-up received, and reference number added On 20-Feb-2025: Upon internal review on 12-Mar-2025, significant correction was performed to update suspect product coding from COVID-19 vaccine to Spikevax NOS. More
2830938 F 03/12/2025 COVID19
COVID19
 MODERNA
MODERNA

Arthralgia, Body temperature, Illness, Insomnia, Mobility decreased; Pyrexia, Tr... Arthralgia, Body temperature, Illness, Insomnia, Mobility decreased; Pyrexia, Tremor More
has been really sick; couldn't sleep last night because the shaking was so bad; couldn't s... has been really sick; couldn't sleep last night because the shaking was so bad; couldn't sleep last night because the shaking was so bad; Caller can't really move the arm that much on the right side; Caller's joints hurt on 'that side' badly; Caller took temperature and it was 103'F; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side) and ARTHRALGIA (Caller's joints hurt on 'that side' badly) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side), ARTHRALGIA (Caller's joints hurt on 'that side' badly) and PYREXIA (Caller took temperature and it was 103'F). At the time of the report, ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side), ARTHRALGIA (Caller's joints hurt on 'that side' badly) and PYREXIA (Caller took temperature and it was 103'F) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2025, Body temperature: 103 degree fahrenheit. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No Concomitant medications provided by the reporter. It was reported that post vaccination patient was felt really sick, and patient was unable to sleep because she experienced a bad shook last night and her joints hurt on the site of vaccination very badly. Patient was unable to move the arm that much on the right side. No treatment medications provided by the reporter. More
2830939 67 M 03/12/2025 COVID19
 MODERNA
 939905
Cardiac failure, Nervous system disorder, Sleep apnoea syndrome Cardiac failure, Nervous system disorder, Sleep apnoea syndrome
heart failure; neurological disease; sleep apnea; This spontaneous case was reported by a patient an... heart failure; neurological disease; sleep apnea; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE (heart failure) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 939905) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Sep-2023, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On 29-Sep-2021, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (neurological disease) and SLEEP APNOEA SYNDROME (sleep apnea). At the time of the report, CARDIAC FAILURE (heart failure), NERVOUS SYSTEM DISORDER (neurological disease) and SLEEP APNOEA SYNDROME (sleep apnea) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown. For mRNA-1273 (Spikevax) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2830940 03/12/2025 PPV
 UNKNOWN MANUFACTURER
Drug ineffective, Pneumococcal infection Drug ineffective, Pneumococcal infection
pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinat... pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown", described as "5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "pneumococcal infection". It was stated that the reporter was hoping to submit an adverse reporting through this route as he/she believes this to be a unique situation. He/she had a clinical meeting with a pediatric infectious disease physician. She is the Director of the newly established Vaccine Center of Excellence and recently has come back in the last year and a half after practicing for 18 years. During their introductory discussion, she elaborated that upon returning, she has witnessed 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (unsure if every child received every dose in the series). She said she had not seen this many cases during her entire tenure, so she had sought to get serotyping and see if anyone is following these cases. She stated she is having trouble with anyone showing interest in this and finds no one researching this area (ie- are we following pediatrics who received PCV13 and then get IPD or PNA? Should pediatric patients who received PCV13 get a booster of PCV20?). She said most research is in pediatrics age < 5 years and is struggling with serotyping and follow up given these patients are over the age of 5 years. The local departments of health utilize a lab in (name) and these cases do not fit their criteria as the patients are over 5 years of age. The adverse event here is the high number of potential breakthrough cases of invasive pneumococcal disease in (name) (she stated one was serotype 3) OR potentially cases of pneumococcal infection that could be covered with PCV20 in patients who received PCV13. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results, vaccination schedule, patient age, medical history and concomitant medications are needed for full medical assessment. More
2830941 11 M 03/12/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Overdose, Product administered to patient of inappropriate age, Pyrexia Overdose, Product administered to patient of inappropriate age, Pyrexia
The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old; The Co... The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old; The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old; fever that lasted for 30 minutes; This is a spontaneous report received from a Nurse from medical information team. An 11-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Feb2025 as dose number unknown, single (Lot number: LP1776, Expiration Date: 26Apr2025) at the age of 11 years for covid-19 immunisation. The patient didn't receive BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 08Feb2025, outcome "unknown" and all described as "The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old"; PYREXIA (non-serious) with onset 2025, outcome "recovered" (2025), described as "fever that lasted for 30 minutes". Additional information: Inadvertent administration of higher than the recommended dose of 10 mcg in 5 through 11 years of age. The reporter stated the mother of the patient or the parent of the patient reported that after the injection the patient experienced fever that lasted for 30 minutes. More
2830942 M AZ 03/12/2025 COVID19
 PFIZER\BIONTECH
Chills, Pyrexia Chills, Pyrexia
just got minor chills and fever; just got minor chills and fever; This is a spontaneous report recei... just got minor chills and fever; just got minor chills and fever; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "just got minor chills and fever". Additional information: stated when got the shot it was no big deal. Patient had gotten all the covid vaccines. Patient always had covid vaccine from Pfizer. When patient previous vaccines he had little reactions. Haven't had anything go bad, just got minor chills and fever. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500052280 Same reporter, different patient/drug/AE; More
2830943 M AZ 03/12/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP. A 73-... got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "pulse" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal, pulse abnormal, start date: 2023 (ongoing); ATORVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization, reaction(s): "little reactions"; Bnt162b2 (DOSE 2), for Covid-19 Immunization, reaction(s): "little reactions"; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for Covid-19 Immunization, reaction(s): "little reactions". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "got COVID". The patient reported he had all the boosters and vaccine before (always had COVID vaccine from Pfizer). He then added, that missed one booster and got COVID in Jul2024 and was pretty sick.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500052280 Same reporter, different patient, drug and AE;US-PFIZER INC-202500052080 Same patient, different dose and event; More
2830945 F NY 03/12/2025 PNC20
 PFIZER\WYETH
Chills, Pyrexia Chills, Pyrexia
chills; fever; This is a spontaneous report received from an Other HCP from a sales representative. ... chills; fever; This is a spontaneous report received from an Other HCP from a sales representative. A female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Mar2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 10Mar2025, outcome "unknown"; PYREXIA (non-serious) with onset 10Mar2025, outcome "unknown", described as "fever". It was unknown if therapeutic measures were taken as a result of chills, pyrexia. Additional information: Patient experienced chills and fever after vaccination with Prevnar 20. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2830946 03/12/2025 PPV
 UNKNOWN MANUFACTURER
Drug ineffective, Pneumococcal infection Drug ineffective, Pneumococcal infection
pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinat... pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown", described as "5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "pneumococcal infection". It was stated that the reporter was hoping to submit an adverse reporting through this route as he/she believes this to be a unique situation. He/she had a clinical meeting with a pediatric infectious disease physician. She is the Director of the newly established Vaccine Center of Excellence and recently has come back in the last year and a half after practicing for 18 years. During their introductory discussion, she elaborated that upon returning, she has witnessed 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (unsure if every child received every dose in the series). She said she had not seen this many cases during her entire tenure, so she had sought to get serotyping and see if anyone is following these cases. She stated she is having trouble with anyone showing interest in this and finds no one researching this area (ie- are we following pediatrics who received PCV13 and then get IPD or PNA? Should pediatric patients who received PCV13 get a booster of PCV20?). She said most research is in pediatrics age < 5 years and is struggling with serotyping and follow up given these patients are over the age of 5 years. The local departments of health utilize a lab in (name) and these cases do not fit their criteria as the patients are over 5 years of age. The adverse event here is the high number of potential breakthrough cases of invasive pneumococcal disease in (name) (she stated one was serotype 3) OR potentially cases of pneumococcal infection that could be covered with PCV20 in patients who received PCV13. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results, vaccination schedule, patient age, medical history and concomitant medications are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-PV202500026859 same reporter/drug/event, different patient; More
2830947 03/12/2025 PPV
 UNKNOWN MANUFACTURER
Drug ineffective, Pneumococcal infection Drug ineffective, Pneumococcal infection
pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinat... pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown", described as "5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "pneumococcal infection". It was stated that the reporter was hoping to submit an adverse reporting through this route as he/she believes this to be a unique situation. He/she had a clinical meeting with a pediatric infectious disease physician. She is the Director of the newly established Vaccine Center of Excellence and recently has come back in the last year and a half after practicing for 18 years. During their introductory discussion, she elaborated that upon returning, she has witnessed 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (unsure if every child received every dose in the series). She said she had not seen this many cases during her entire tenure, so she had sought to get serotyping and see if anyone is following these cases. She stated she is having trouble with anyone showing interest in this and finds no one researching this area (ie- are we following pediatrics who received PCV13 and then get IPD or PNA? Should pediatric patients who received PCV13 get a booster of PCV20?). She said most research is in pediatrics age < 5 years and is struggling with serotyping and follow up given these patients are over the age of 5 years. The local departments of health utilize a lab in (name) and these cases do not fit their criteria as the patients are over 5 years of age. The adverse event here is the high number of potential breakthrough cases of invasive pneumococcal disease in (name) (she stated one was serotype 3) OR potentially cases of pneumococcal infection that could be covered with PCV20 in patients who received PCV13. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results, vaccination schedule, patient age, medical history and concomitant medications are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-PV202500026859 same reporter/drug/event, different patient; More
2830948 03/12/2025 PPV
 UNKNOWN MANUFACTURER
Drug ineffective, Pneumococcal infection Drug ineffective, Pneumococcal infection
pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinat... pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown", described as "5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "pneumococcal infection". It was stated that the reporter was hoping to submit an adverse reporting through this route as he/she believes this to be a unique situation. He/she had a clinical meeting with a pediatric infectious disease physician. She is the Director of the newly established Vaccine Center and recently has come back in the last year and a half after practicing for 18 years. During their introductory discussion, she elaborated that upon returning, she has witnessed 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (unsure if every child received every dose in the series). She said she had not seen this many cases during her entire tenure, so she had sought to get serotyping and see if anyone is following these cases. She stated she is having trouble with anyone showing interest in this and finds no one researching this area (ie- are we following pediatrics who received PCV13 and then get IPD or PNA? Should pediatric patients who received PCV13 get a booster of PCV20?). She said most research is in pediatrics age < 5 years and is struggling with serotyping and follow up given these patients are over the age of 5 years. The local departments of health utilize a lab in (name) and these cases do not fit their criteria as the patients are over 5 years of age. The adverse event here is the high number of potential breakthrough cases of invasive pneumococcal disease in (name) (she stated one was serotype 3) OR potentially cases of pneumococcal infection that could be covered with PCV20 in patients who received PCV13. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results, vaccination schedule, patient age, medical history and concomitant medications are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-PV202500026859 same reporter/drug/event, different patient; More
2830949 WA 03/12/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Covid After Shots; Covid After Shots; This is a spontaneous report received from a Consumer or other... Covid After Shots; Covid After Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 77-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series complete), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2025, outcome "unknown", COVID-19 (medically significant) with onset 2025, outcome "not recovered" and all described as "Covid After Shots". The event "covid after shots" required emergency room visit. The patient was diagnosed with Covid last night at the doctor's office. Patient went to get his/her prescription and they said patient needed to call the emergency room where the patient went last night and have the doctor call them. Patient was sick and made so many calls. Patient was not at his/her best right now. Patient stated, "Covid is not a walk in the park." Patient have had every single one of our wonderful shots and patient was thanking and wondering as what would he/she be feeling like otherwise. Patient stated, "This is the time when a person that's sick needs somebody to give them a hand...". While looking for a prescription from their doctors office, the patient was given a nose spray that came in a bottle. Patient was not feeling good. More
2830950 69 NY 03/12/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
I had COVID again; I had COVID again; got Covid; The initial case was missing the following minimum ... I had COVID again; I had COVID again; got Covid; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 13Feb2024, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "osteoarthritis" (unspecified if ongoing); "rheumatory arthritis" (unspecified if ongoing); "immune system very weak" (unspecified if ongoing). The patient was on an expensive medication to keep the patient's rheumatory arthritis from overcoming the patient and that left the patient's immune system very weak. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Nov2023, outcome "recovered", described as "got Covid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2024, outcome "recovered" and all described as "I had COVID again". The patient got the vaccine on 18Nov2023 and tested positive for COVID on 20Nov2023 and took PAXLOVID. Unbeknownst to the patient, s/he got very sick, didn't know what s/he had, couldn't believe anything. Tested positive for COVID for a second time 20Jan2024 and was on PAXLOVID again. That's how easy the patient succumb to things. PAXLOVID had helped the patient and patient's doctor prescribed it so patient can get over Covid because otherwise it could do great harm to his/her body. The patient did not have a problem right now. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2830951 03/12/2025 PPV
 UNKNOWN MANUFACTURER
Drug ineffective, Pneumococcal infection Drug ineffective, Pneumococcal infection
pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinat... pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown", described as "5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "pneumococcal infection". It was stated that the reporter was hoping to submit an adverse reporting through this route as he/she believes this to be a unique situation. He/she had a clinical meeting with a pediatric infectious disease physician. She is the Director of the newly established Vaccine Center of Excellence and recently has come back in the last year and a half after practicing for 18 years. During their introductory discussion, she elaborated that upon returning, she has witnessed 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (unsure if every child received every dose in the series). She said she had not seen this many cases during her entire tenure, so she had sought to get serotyping and see if anyone is following these cases. She stated she is having trouble with anyone showing interest in this and finds no one researching this area (ie- are we following pediatrics who received PCV13 and then get IPD or PNA? Should pediatric patients who received PCV13 get a booster of PCV20?). She said most research is in pediatrics age < 5 years and is struggling with serotyping and follow up given these patients are over the age of 5 years. The local departments of health utilize a lab in (name) and these cases do not fit their criteria as the patients are over 5 years of age. The adverse event here is the high number of potential breakthrough cases of invasive pneumococcal disease in (name) (she stated one was serotype 3) OR potentially cases of pneumococcal infection that could be covered with PCV20 in patients who received PCV13. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results, vaccination schedule, patient age, medical history and concomitant medications are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-202500051963 same reporter/drug/event, different patient;US-PFIZER INC-202500055171 same reporter/drug/event, different patient;US-PFIZER INC-202500055170 same reporter/drug/event, different patient;US-PFIZER INC-202500055169 same reporter/drug/event, different patient; More
2830952 03/12/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
all these shots doesn't help; COVID; This is a spontaneous report received from a Consumer or o... all these shots doesn't help; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 08Feb2024, outcome "unknown", described as "COVID"; DRUG INEFFECTIVE (medically significant) with onset 08Feb2024, outcome "unknown", described as "all these shots doesn't help". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was ordered to take Paxlovid. The patient came down with COVID this morning; symptoms started last night." Later in the call, patient guess getting all these shots doesn't help. Patient has had every COVID shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2830953 88 M NJ 03/12/2025 DTAP
 SANOFI PASTEUR
 3CA25C1
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Daptacel on an 88-year-old patient with no reported adverse event; Initial information received on 1... Daptacel on an 88-year-old patient with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 88 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 27-Feb-2025, the patient received standard dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the left arm for Immunization (product administered to patient of inappropriate age) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2830954 1 03/12/2025 DTAPIPVHIB
 SANOFI PASTEUR
No adverse event, Product preparation issue No adverse event, Product preparation issue
child was administered pentacel, but the polio portion was given without being mixed with the hib po... child was administered pentacel, but the polio portion was given without being mixed with the hib portion with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 1 years old and unknown gender patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but the polio portion was given without being mixed with the hib portion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) but the polio portion was given without being mixed with the hib portion with no reported adverse event (single component of a two component product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. Reportedly,They want to ensure that this is safe and that the patient will not experience any side effects. Per SRD (Standard Reference Data) informed that Pentacel vaccine components should not be used separately. However, if the DTaP-IPV (Diphtheria, tetanus, and pertussis inactivated poliovirus) liquid component was administered separately it would count as a valid DTaP and IPV dose. Additionally informed that any dose of Act-HIB reconstituted with a diluent other than specific Act-HIB diluent should not be counted as valid and must be repeated. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2830955 4 F MD 03/12/2025 DTAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR

No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
The patient was given Tdap [ADACEL] instead of DTaP [DAPTACEL] as the fifth dose in the supposed 5 d... The patient was given Tdap [ADACEL] instead of DTaP [DAPTACEL] as the fifth dose in the supposed 5 dose-series of DTaP with no reported adverse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient who was given tdap (Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine) [adacel] instead of dtap (Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine) [daptacel] as the fifth dose in the supposed 5 dose-series of dtap with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose 5 of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for immunization instead of dtap [daptacel] as the fifth dose in the supposed 5 dose-series of dtap with no reported adverse event (wrong product administered) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2830956 M 03/12/2025 UNK
 UNKNOWN MANUFACTURER
 946624
Influenza, Influenza A virus test positive, Oropharyngeal pain, Pyrexia, Vaccina... Influenza, Influenza A virus test positive, Oropharyngeal pain, Pyrexia, Vaccination failure More
Vaccination failure; Fever broke; Severe sore throat; Flu virus type A; This spontaneous case, initi... Vaccination failure; Fever broke; Severe sore throat; Flu virus type A; This spontaneous case, initially received on 03-Mar-2025, was reported by a non health professional and concerns an adult male patient. Administration of company suspect drug: On 22-Oct-2024, the patient received Flucelvax (TIV) for Indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Anatomical location: Left Deltoid. Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 21-Feb-2025, the patient experienced Flu virus type A (Medically Significant, outcome: Not Reported). Associated symptoms included: Fever broke , Severe sore throat. On unknown date, the patient experienced Flu virus type A after receiving Flucelvax/Vaccination failure (Medically Significant, outcome: Not Reported) It was reported that 25-Feb-2025, severe sore throat subsided. Source of infection was not known for certain. Possibly obtained at a sporting event on 19-Feb-2025. Flu was verified by swab on 24-Feb-2025. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality of the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. For influenza and vaccination failure, patient tested positive within 21 to 180 day time period and also tested positive to Influenza A on swab. Furthermore, A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated. More
2830978 F 03/12/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Balance disorder, Gait inability, Guillain-Barre syndrome, Loss of personal inde... Balance disorder, Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities, Mobility decreased; Nerve injury More
90 percent bed ridden; unable to walk; unable to function; balance issues; Guillain-Barre syndrome; ... 90 percent bed ridden; unable to walk; unable to function; balance issues; Guillain-Barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant and other: Serious as per reporter), bedridden (Verbatim: 90 percent bed ridden), unable to walk (Verbatim: unable to walk), performance status decreased (Verbatim: unable to function) and balance difficulty (Verbatim: balance issues). The outcome of the guillain barre syndrome was unknown (duration 2 days) and the outcome of the bedridden, unable to walk, performance status decreased and balance difficulty were not reported. The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the bedridden, unable to walk, performance status decreased and balance difficulty to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the bedridden, unable to walk, performance status decreased and balance difficulty to be related to Shingrix. Additional Information: GSK Receipt Date : 09-MAR-2025 This case was reported by a patient via interactive digital media. Patient developed Guillain-Barre syndrome (GBS) after receiving the first shingles shot. As a result, she was 90 percent bedridden, unable to walk or function. She had to re-learn to walk, dealing with balance issues, and it was a long three year journey. Her physician had recommended the vaccine after she recovered from shingles to prevent a recurrence, but the vaccination was worse and caused nerve damage. she should have never taken the shot.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix More
2830979 M TX 03/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 BP74J
Adverse event, Dementia, Extra dose administered Adverse event, Dementia, Extra dose administered
accidentally administered a third dose of Shingrix on March 4th 2025; suffered from dementia; This s... accidentally administered a third dose of Shingrix on March 4th 2025; suffered from dementia; This serious case was reported by a pharmacist via call center representative and described the occurrence of dementia in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number BP74J, expiry date 15-NOV-2026) for prophylaxis. Previously administered products included Shingrix (received 2 doses on an unknown date). On 04-MAR-2025, the patient received the 3rd dose of Shingrix. On 04-MAR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: accidentally administered a third dose of Shingrix on March 4th 2025). In MAR-2025, the patient experienced dementia (Verbatim: suffered from dementia) (serious criteria GSK medically significant). The outcome of the dementia was not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the dementia to be related to Shingrix. The company considered the dementia to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-MAR-2025 The patient was accidentally administered a third dose of Shingrix, which led to extra dose administered. The reporter mentioning that the patient suffered from dementia and that they were experiencing undisclosed adverse events. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Dementia is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2830980 03/12/2025 PNC20
 PFIZER\WYETH
Feeling abnormal, Urticaria Feeling abnormal, Urticaria
Felt kind of abnormal; Breaking out in hives; This is a spontaneous report received from a Consumer ... Felt kind of abnormal; Breaking out in hives; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt kind of abnormal "; URTICARIA (non-serious), outcome "unknown", described as "Breaking out in hives". Additional information: the patient stated, "I got a pneumonia shot on Friday and I am 62. So, I did not get the one for 65 and above and I felt kind of (redated) over the weekend which you know okay, but now I am breaking out in hives." The patient described the vaccine as "it's pneumonia, for pneumonia." The patient was 'under impression' it was the Pfizer vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2830982 F NC 03/12/2025 UNK
 UNKNOWN MANUFACTURER
 946624
Influenza, Influenza A virus test positive, Vaccination failure Influenza, Influenza A virus test positive, Vaccination failure
The patient tested positive for Flu A; Vaccination failure; This spontaneous case, initially receive... The patient tested positive for Flu A; Vaccination failure; This spontaneous case, initially received on 28-Feb-2025, was reported by a non health professional and concerns a female patient. Medical History and concomitant medication were reported as unknown. There was no allergy information reported. There was no product complaint associated with this case. Administration of company suspect drug: On 02-Oct-2024, the patient received Flucelvax (TIV) for Active immunization against influenza disease., Dose Regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Deltoid, Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 22-Feb-2025, The patient tested positive for Flu A (Medically Significant, outcome: Unknown). On an unknown date in 2025, the patient had Vaccination failure (Outcome: Not reported) On 22-Feb-2025, the patient went to urgent care where she tested positive for Flu. She was given the flu shot at work. Flu was not verified by nasal swab. Back to work by 25-Feb-2025. Didn't know how she got this, no one in the family had the flu. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event was reported as unknown. Reporter's assessment: The reporter assessed the seriousness as unknown and causality assessment was not reported for event The patient tested positive for Flu A. The reporter did not provide the seriousness and causality assessment of the event Vaccination failure.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. For influenza and vaccination failure, patient tested positive within 21 to 180 day time period. Furthermore, A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated. More
2830984 78 M PA 03/12/2025 COVID19
FLU3
RSV
VARZOS
 MODERNA
SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 3043335
UT8419CA
LN5482
445TK
Expired product administered; Expired product administered; Expired product admi... Expired product administered; Expired product administered; Expired product administered; Expired product administered More
This was a vaccine administration error. The patient did not report any adverse effects. The dose of... This was a vaccine administration error. The patient did not report any adverse effects. The dose of Shingrix administered 11/8/2024 was the patient's 3rd dose of Shingrix. The series was completed by the facility, who did not report administered vaccines to the Immunization Electronic Registry System at the time of this error. More
2830985 68 F NM 03/12/2025 PNC20
 PFIZER\WYETH
 LG5577
Rash, Rash erythematous, Rash papular, Rash pruritic Rash, Rash erythematous, Rash papular, Rash pruritic
Patient had a rash and itching and was very painful and red and swollen patient apply Benadryl cream... Patient had a rash and itching and was very painful and red and swollen patient apply Benadryl cream and took acetaminophen symptoms for about 10 days and has gotten better More
2830986 0.58 M IL 03/12/2025 RSV
 MODERNA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
none none
2830987 2 F MN 03/12/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 HR4RB
Incorrect dose administered Incorrect dose administered
Pediatric patient given adult Havrix 1440 Elisa units/dose (hepatitis A vaccine) by GSK for hepatiti... Pediatric patient given adult Havrix 1440 Elisa units/dose (hepatitis A vaccine) by GSK for hepatitis A vaccine. Patient was to receive dose of pediatric Hepatitis A vaccine (Havrix 720 Elisa units/dose by GSK). More
2831041 66 F CA 03/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 TY7MZ
Feeling cold, Headache, Nausea, Paraesthesia, Paraesthesia oral Feeling cold, Headache, Nausea, Paraesthesia, Paraesthesia oral
Within 10 minutes of administration, patient experienced tingling in arm and on tongue, headache, an... Within 10 minutes of administration, patient experienced tingling in arm and on tongue, headache, and nausea. Sensation on tongue diminished, but then lips started tingling . Patient had a sip of water and walked around a bit, then staff was notified. Slight headache persisted as did nausea and arm felt cold. Patient was offered benadryl, but initially declined. Stated odd sensation at back of throat subsiding, no difficulty breathing or throat closing down. Legs felt weak . When offered benadryl again, patient agreed and received 10 ml of the dye free childrens liquid (25 mg dose.) Patient was told to check with her physician before receiving the next dose. Patient stayed in waiting room for a bit longer, then did some shopping in the store. Patient checked back with the pharmacy to inform staff she felt well enough (not impaired) and was going to go home. Patient was given the bottle of liquid Benadryl at no charge to have on hand. A little after 1 pm, the pharmacist called the patient at home and was informed patient arrived safely home and was feeling much more "like normal." The patient did not feel strongly either way about a VAERS report, but decided that reporting her experience may benefit others. Patient open to phone calls about her other supplements and any other pertinent information. More
2831042 17 F IA 03/12/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2YS34
Expired product administered Expired product administered
Patient administered Havrix 720 EL.U/0.5ml dose on 3/11/25 that had an expiration date of 3/2/25. Pa... Patient administered Havrix 720 EL.U/0.5ml dose on 3/11/25 that had an expiration date of 3/2/25. Patient was given expired vaccine for dose and will be re-vaccinated as considering the dose void. More
2831043 66 F WA 03/12/2025 COVID19
 MODERNA
 032fz1a
Product administered at inappropriate site, Rotator cuff repair, Rotator cuff sy... Product administered at inappropriate site, Rotator cuff repair, Rotator cuff syndrome, Shoulder injury related to vaccine administration More
Ended up with sirva. Torn cuff and had 2 surgeries to try and repair the torn cuff. Ended up with sirva. Torn cuff and had 2 surgeries to try and repair the torn cuff.
✓
2831044 65 F NJ 03/12/2025 PNC20
 PFIZER\WYETH
Injection site erythema Injection site erythema
Redness from injection site extending down about eight inches sideways about six inches. Redness from injection site extending down about eight inches sideways about six inches.
2831045 13 F GA 03/12/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Cough, Dizziness, Dysphonia, Headache, Injection site pain; Oropharyngeal pain Cough, Dizziness, Dysphonia, Headache, Injection site pain; Oropharyngeal pain
Dizziness, lightheaded, headache, sore throat, hoarseness, dry cough, injection site pain Dizziness, lightheaded, headache, sore throat, hoarseness, dry cough, injection site pain
2831046 65 F CO 03/12/2025 PNC20
 PFIZER\WYETH
 LK6651
Musculoskeletal stiffness, Pain, Rash, Rash pruritic Musculoskeletal stiffness, Pain, Rash, Rash pruritic
Patient received vaccine in afternoon 3/11/25. Patient called on 3/12/25 9:30am stating she develope... Patient received vaccine in afternoon 3/11/25. Patient called on 3/12/25 9:30am stating she developed an itchy rash on vaccinated arm and neck. In pain and neck felt stiff. Instructed pt to contact medical professional to be seen as it sounded like a form of allergic reaction More
2831047 60 F TX 03/12/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
NONE. PATIENT IS FINE NO ADVERSE REACTION WAS ENCOUNTERED, PATIENT WAS GIVEN 3RD DOSE IN 52 DAYS, RE... NONE. PATIENT IS FINE NO ADVERSE REACTION WAS ENCOUNTERED, PATIENT WAS GIVEN 3RD DOSE IN 52 DAYS, RECOMMENDED 5 MONTHS BETWEEN 2 ND AND 3RD DOSE. More
2831064 9 F OR 03/12/2025 HEPA
HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 C24B9
C24B9
KH2BD
Y013073
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Received 2 doses of Hepatitis A vaccine. Patient asymptomatic. No treatment needed. Received 2 doses of Hepatitis A vaccine. Patient asymptomatic. No treatment needed.
2830539 0.17 M 03/11/2025 RV5
 MERCK & CO. INC.
Faeces discoloured, No adverse event, Product dose omission issue Faeces discoloured, No adverse event, Product dose omission issue
patient missed their second dose of ROTATEQ; green poop; This spontaneous report was received from a... patient missed their second dose of ROTATEQ; green poop; This spontaneous report was received from a consumer referring her son as a 2-month-old male patient. His medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 11-NOV-2024, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral liquid, dose number 1, 1 dosage form administered by Oral route (po) (lot # and expiration date were not reported) as prophylaxis (reported as "rotavirus.") On unspecified date in November 2024, the patient had "green poop" (faeces discoloured) following first vaccination, which lasted for "about a week or two". Then on an unspecified date in November 2024, he recovered from the event. Patient's mother reported that the patient missed his second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) on 11-JAN-2025 (product dose omission issue). No symptoms or side effects were reported by the patient's mother for the patient missing the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). No further information reported by the patient's mother. The causal relationship between faeces discoloured and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown as patient's mother was unsure if that was because of the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ.) Additional information was not expected. More
2830540 OK 03/11/2025 HPV9
 MERCK & CO. INC.
 Y010656
No adverse event, Product administered to patient of inappropriate age, Wrong pa... No adverse event, Product administered to patient of inappropriate age, Wrong patient More
No additional AE; infant patient was inadvertently administered an adolescent dose of GARDASIL 9 tod... No additional AE; infant patient was inadvertently administered an adolescent dose of GARDASIL 9 today, 3/3/2025, that was meant for their older sibling; Medical Assistant calling with a report of an adverse event regarding GARDASIL 9. Medical assistant stated that an infant patient was inadvertently administered an adolescent dose of GARDASIL 9 today, 3/3/2025, that was meant for their older sibling; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported, past drug reactions and allergies were not reported. On 03-MAR-2025, the infant patient was inadvertently vaccinated with an adolescent dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL, Two or Three dose series, indicated as prophylaxis (lot number Y010656 has been verified to be a valid number for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date: 29-Nov-2026; formulation route of administration and anatomical site of injection were not provided) that was meant for their older sibling who was of age to received their first dose (Product administered to patient of inappropriate age, Wrong patient received product). The reporter confirmed the patient involved has not experienced any medical concerns or symptoms after the administration (No adverse event). More
2830551 57 F TX 03/11/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 Receipt does no
Receipt does no
Dizziness, Fatigue, Injection site pain, Injection site swelling, Nausea; Rash Dizziness, Fatigue, Injection site pain, Injection site swelling, Nausea; Rash
Rash on left arm appeared 22 hours after injection and persists 56 hours after injection. Injection ... Rash on left arm appeared 22 hours after injection and persists 56 hours after injection. Injection site pain and swelling appeared 4 hours after injection and began to resolve 48 hours after injection. Fatigue, dizziness, and nausea appeared 22 hours after injection and resolved 48 hours after injection. More
2830552 4 F CA 03/11/2025 DTAP
DTAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 223Y9
223Y9
Erythema, Injected limb mobility decreased, Injection site erythema, Injection s... Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Injection site warmth More
Vaccine given on a Friday afternoon. At about 12 hrs after vaccination we noted some redness around ... Vaccine given on a Friday afternoon. At about 12 hrs after vaccination we noted some redness around injection site. At 18 hours it increased in redness and was swollen.. At 24 hours injection site increased in redness. It became raised, itchy, painful to touch and hot to touch. It became hard for the child to move her arm. By 36 hours redness spread to cover whole upper extremity wrapping around arm . It continued to be painful, hot to touch, raised and itchy. Child given oral Benadryl. Completed a Video visit where provider believed it was cellulite and recommended antibiotics. Delayed giving antibiotics. Gave one dose of abx before seeing pediatrician. Pediatrician advised to stop abx as likely was not antibiotics and a localized reaction to the vaccine More
2830567 50 F FL 03/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site pain Injection site pain
The patient states that her arm (Right Arm) is sore at the injection site; This non-serious case was... The patient states that her arm (Right Arm) is sore at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 05-MAR-2025, the patient received the 1st dose of Shingles vaccine (right arm). In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: The patient states that her arm (Right Arm) is sore at the injection site). The outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine. It was unknown if the company considered the injection site pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 06-MAR-2025 The patient received the Shingles vaccine the day before reporting at a local pharmacy. The patient stated that her arm (right Arm) was sore at the injection site. More
2830568 M 03/11/2025 COVID19
COVID19
 MODERNA
MODERNA

Anosmia, Brain fog, Illness, Immunisation reaction, Insomnia; Tinnitus Anosmia, Brain fog, Illness, Immunisation reaction, Insomnia; Tinnitus
Patient began a 1 1/2-year battle with sickness, never had Covid, the vaccines made sick; still suff... Patient began a 1 1/2-year battle with sickness, never had Covid, the vaccines made sick; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Patient began a 1 1/2-year battle with sickness, never had Covid, the vaccines made sick), INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient began a 1 1/2-year battle with sickness, never had Covid, the vaccines made sick), INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues). At the time of the report, ILLNESS (Patient began a 1 1/2-year battle with sickness, never had Covid, the vaccines made sick), INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) had not resolved. No concomitant medications were reported. It was reported that the patient received moderna vaccine on Sep-2023 and Sep-2024. At the time of reporting patient was still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues. Patient wanted to learn why the vaccines made so ill. No treatment medications were reported. This case was linked to MOD-2025-782823 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2830573 62 F FL 03/11/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.

Emotional distress, Feeling hot, Laboratory test, Magnetic resonance imaging, Pa... Emotional distress, Feeling hot, Laboratory test, Magnetic resonance imaging, Pain; Periarthritis, Rotator cuff syndrome More
Turn rotator cuff; Frozen shoulder; warm rush sensation through her chest; agony; pain; she could no... Turn rotator cuff; Frozen shoulder; warm rush sensation through her chest; agony; pain; she could not raise her arm; This spontaneous report has been received from a consumer regarding a 62-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Dexmethylphenidate hydrochloride (FOCALIN), Tramadol hydrochloride, and anti depressant. On 06-JAN-2022 at about 10:00, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On that same date at around 11:30, the patient was standing and experienced a warm rush sensation through her chest (Feeling hot). That night, the patient went to raise her arms to put a shirt on and she could not raise her arm (Vaccination site movement impairment). The reporter stated that she had been dealing with this pain ever since (Pain), and she was in agony for the first 18 months (Emotional distress). On an unknown date in 2023, the patient recovered from the event of emotional distress. On an unknown date, the patient experienced frozen shoulder (Periarthritis) and turn rotator cuff (Rotator cuff syndrome). She stated that she had been to many different healthcare professionals (HCP) including neurologists, pain management, physical therapists, orthopedics, and a psychiatrist, and that all the HCPs want to do is ''cut''. Also, it was reported that some of the treatments have included physical therapy and pain management injections but that the pain persists, and that the patient has gotten ''every test in the book'' including magnetic resonance imaging (MRI). She mentioned that the vaccine di work because she has not gotten sick since she got it back in 2022. At the time of the reporting, the patient had not recovered from the events of pain, rotator cuff syndrome, and periarthritis. The outcome of the events of vaccination site movement impairment and feeling hot was unknown. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not reported. More
2830574 M TX 03/11/2025 MMRV
 MERCK & CO. INC.
 Y009348
Device connection issue, Underdose Device connection issue, Underdose
the PFS leaked from around the leurlock during administration; Initial caller was medical assistant ... the PFS leaked from around the leurlock during administration; Initial caller was medical assistant who then placed MD on phone. HCP reported PQC for Sterile Diluent PFS. Caller states the PFS leaked from around the leurlock during administration and then the needle and leurlock broke off when engaging the saf; syringe leak; This spontaneous report was received from a physician referring to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD), injection for prophylaxis, 0.5 milliliter, intramuscularly, lot number Y009348 which has been verified to be valid, expiration date reported and validated as 11-NOV-2025 (anatomical location, scheme and strength not provided) with sterile diluent solution for injection, lot number 1973529 which is an invalid lot number, expiration date 03-MAR-2026. On 20-FEB-2025, the prefilled syringe leaked from around the leurlock during administration. The reporter stated that the prefilled syringe leaked from around the leurlock during administration and then the needle and leurlock broke off when engaging the safety cap (poor quality deice used) (accidental underdose). Follow-up was received from reporter on 24-FEB-2025. The needle and leur lock broke off from the syringe. The louer lock itself was still inact and attached to the needle. The reporter confirmed needle detached from louer lock while engaging safety cap. It was not difficult to attach the needle but she could not get a good seal. More
2830575 PR 03/11/2025 VARCEL
 MERCK & CO. INC.
 Y015108
Product storage error Product storage error
Caller reported VARIVAX administered after temperature excursion. No other information provided.; Th... Caller reported VARIVAX administered after temperature excursion. No other information provided.; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 07-FEB-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection (VARIVAX) 0.5 milliliter (mL) administered as prophylaxis Lot No. Y015108 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 06-SEP-2026 (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) that was reconstituted with an sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot number, expiration date and route of administration was not provided (product storage error), after a temperature excursion of -2.1 degree Celsius (C) (-2.1C) during a time frame of 6 hours 45 minutes and 0 seconds. No previous temperature excursion was reported. This is one of several reports received from the same reporter. More
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