🏥 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 💀 🏥 🚑 ♿ ⚠️
2852539 M TX 08/04/2025 FLUX
 UNKNOWN MANUFACTURER
Dyspnoea Dyspnoea
Reported Symptoms: 10013963: DYSPNEA; Narrative: Other Relevant HX: Other DYSPNEA. Reported Symptoms: 10013963: DYSPNEA; Narrative: Other Relevant HX: Other DYSPNEA.
2852540 72 M SC 08/04/2025 COVID19
 MODERNA
 3031281
Limb mass, Peripheral swelling, Thrombosis Limb mass, Peripheral swelling, Thrombosis
Reported Symptoms: 10043607: THROMBOSIS; Narrative: 12/17/24 - Pt presented to ED with c/o right low... Reported Symptoms: 10043607: THROMBOSIS; Narrative: 12/17/24 - Pt presented to ED with c/o right lower extremity swelling and pain since 5:30 pm today. Pt does have history of DVT/PE on Eliquis. No calf tenderness noted to extremity. Pt currently on Eliquis 2.5mg twice daily. Pt stated he felt a knot in his leg earlier today and began to have some swelling in the anterior medical region. ED provider noted some tenderness and swelling. Venous duplex ordered to rule out DVT. Imaging shows bilateral femoral clots (chronic) and SVT in left leg below the knee. Apixaban 10mg BID x 7d, then 5mg BID for at least 6 months was prescribed. 11/5/24 - Nurse documented Pt had DVT after each Covid vaccine. Other Relevant HX: PMH: Hypertension, peripheral neuropathy, PE, diabetes, anxiety, hyperlipidemia, depression, CVA Other: THROMBOSIS More
2852541 64 M TX 08/04/2025 FLUX
 UNKNOWN MANUFACTURER
Dyspnoea Dyspnoea
Reported Symptoms: 10013963: DYSPNEA; Narrative: Other Relevant HX: Other: Dyspnea Reported Symptoms: 10013963: DYSPNEA; Narrative: Other Relevant HX: Other: Dyspnea
2852542 M MN 08/04/2025 COVID19
 PFIZER\BIONTECH
 unknown
Joint swelling, Renal impairment Joint swelling, Renal impairment
Reported Symptoms: 10017474:FUNCTION KIDNEY DECREASED; 10033556:PALPITATION; 10042697:SWELLING OF KN... Reported Symptoms: 10017474:FUNCTION KIDNEY DECREASED; 10033556:PALPITATION; 10042697:SWELLING OF KNEES; Narrative: Unknown-Patient reported getting vaccine outside the facility Other Relevant HX: Other: knee swelling and decreased kidney function More
2852586 FL 08/04/2025 VARCEL
 MERCK & CO. INC.
 Z004455
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; VARIVAX involved in temperature excursion has been administered; This spontaneous ... No additional AE; VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from other health professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 10-JUL-2025, the patient was vaccinated with dose of varicella virus vaccine live (Oka-Merck) (VARIVAX) (1 dose, lot # Z004455, expiration date: 13-FEB-2027; dose number, strength, formulation, route and anatomical site were unknown) for prophylaxis, which was involved in temperature excursion and was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date and lot # were not reported) (product storage error). No additional adverse event (no adverse event). The storage temperature of the vaccine was reported as 36.5 degrees Fahrenheit (F) for a time frame of 2 hours and 21 minutes. There was no previous temperature excursion. This is one of the reports from the same reporter (link# 2309177, 2309273, 2309187, 2308972, 2309098, 2309074, 2308927, 2309681). More
2852587 12 F MI 08/04/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More
HCP reported patient received 1st dose of GARDASIL 9 at 12 years old and did not return for 2nd dose... HCP reported patient received 1st dose of GARDASIL 9 at 12 years old and did not return for 2nd dose until she was "20 something" years old.; No additional AE/PQC reported.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, at 12 years old, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. On an unknown date, when the patient was approximately 20 years old, she vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis (inappropriate schedule of product administration). No other information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event). More
2852588 KY 08/04/2025 VARCEL
 MERCK & CO. INC.
 Y006523
No adverse event, Product storage error No adverse event, Product storage error
No additional information provided. No additional AE; Pharmacist calling to report inadvertently adm... No additional information provided. No additional AE; Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-APR-2025, the patient was inadvertently vaccinated with an improperly storage dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y006523 [which has been verified to be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 25-MAR-2026, administered for prophylaxis (strength, dosage, route and anatomical site or administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The reporter stated that the vaccine was "issued" to the facility on 09-AUG-2024 and was inadvertently stored in the refrigerated throughout administrations (Product storage error). He refused to perform a temperature excursion assessment stating assessment has already been performed. No additional adverse event (No adverse event). This is one of several reports received from the same reporter. More
2852589 0.5 CA 08/04/2025 MMR
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE; HCP called regarding spacing of ROTATEQ and MMR II. HCP had a 6 month and 21 day ... No additional AE; HCP called regarding spacing of ROTATEQ and MMR II. HCP had a 6 month and 21 day old patient in the office who received MMR II on 7/1/2025 and requested information on administering ROTATEQ today, 7/10/2025. See request case 02836659. No additiona; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 01-Jul-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Powder and solvent for solution for injection (dose, route of administration, anatomical location, lot #, and expiration date were not reported) as prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not provided) (Product administered to patient of inappropriate age). The reporter requested information on administering Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) today. No additional adverse events were provided. More
2852590 F UT 08/04/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.

Arthralgia, Asthenia, Myalgia, Pain, Pyrexia; Arthralgia, Asthenia, Myalgia, Pai... Arthralgia, Asthenia, Myalgia, Pain, Pyrexia; Arthralgia, Asthenia, Myalgia, Pain, Pyrexia More
titers were low; fever; muscle pain; Weakness; Joint pain; This spontaneous report was received from... titers were low; fever; muscle pain; Weakness; Joint pain; This spontaneous report was received from an other health professional on 31-Jul-2025, referring to a 38-year-old female patient. The patient's medical history included shingles. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown day, the patient was vaccinated with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Her other health care profession (HCP) informed her that her "titers were low" so the HCP informed the patient to receive another dose (Antibody test negative). She did not have any symptoms following the first time she received Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). On 21-Jul-2025, the patient was vaccinated with the second dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5mL (lot # and expiration date were not reported) as prophylaxis (also reported as pneumonia, conflicting information). On the same date (reported as about 12 hours later after vaccination) (it was also stated it could have been on 22-Jul-2025, conflicting information), she experienced side effects. She was experiencing body, muscle and joint pains (Myalgia, Arthralgia) and also reported that she had a fever as well (Pyrexia). these symptoms have not gone away, and have only been getting worse and worse. She felt "very weak" (Asthenia) and that she can't even lift anything out of her fridge. She emphasized that the joint and muscle pain were the worst side effect, and the patient stated that she "can't move without being in excruciating pain". She "wasn't surprised" and she had these side effects because her body "reacted strangely to everything". These symptoms have been "way more painful" than previous shingles. At the reporting time, the patient had not recovered from muscle pain, weakness, joint pain and fever. At the reporting time, the outcome of titers was low was unknown. The action taken with the suspect vaccine was not applicable. No other symptoms or side effects reported. No further information reported by patient. The causal relationship between the event of titers were low and Pneumococcal Vaccine, Polyvalent (23-valent) was unknown. The causal relationship between the events of muscle pain, weakness, joint pain and fever and Pneumococcal Vaccine, Polyvalent (23-valent) was related. Batch/lot number is being requested and will be submitted if received. More
2852591 64 F NV 08/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Bronchitis, COVID-19, Ear infection, Influenza, Sinusitis Bronchitis, COVID-19, Ear infection, Influenza, Sinusitis
COVID-19; Flu; Sinus infection; Bronchitis; Ear infection; This non-serious case was reported by a c... COVID-19; Flu; Sinus infection; Bronchitis; Ear infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included the patient having other conditions. On 17-FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19 (Verbatim: COVID-19), influenza (Verbatim: Flu), sinus infection (Verbatim: Sinus infection), bronchitis (Verbatim: Bronchitis) and ear infection (Verbatim: Ear infection). The outcome of the covid-19, influenza, sinus infection, bronchitis and ear infection were unknown. It was unknown if the reporter considered the covid-19, influenza, sinus infection, bronchitis and ear infection to be related to Shingrix. It was unknown if the company considered the covid-19, influenza, sinus infection, bronchitis and ear infection to be related to Shingrix. Additional Information: GSK receipt date: 18-JUL-2025 The patient received first shot of Shingrix and had experienced covid, flu, sinus infection, and ear infections on the past 6 months. The reason for no batch or lot number of Shingrix was discarded. More
2852592 TX 08/04/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 222h3
Product preparation issue Product preparation issue
accidentally administered the PRIORIX diluent on unknown date; accidentally administered the PRIORIX... accidentally administered the PRIORIX diluent on unknown date; accidentally administered the PRIORIX diluent on unknown date; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 222h3) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally administered the PRIORIX diluent on unknown date) and inappropriate dose of vaccine administered (Verbatim: accidentally administered the PRIORIX diluent on unknown date). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter was the HCP (nurse manager) who stated that a patient was accidentally administered the Priorix diluent on unknown date which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was then given the correct reconstituted vaccine. The healthcare professional to call back with more information. More
2852593 M 08/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
he missed his second dose; This non-serious case was reported by a consumer via call center represen... he missed his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: he missed his second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-JUL-2025 The patient self-reported this case. The patient missed his second dose of Shingrix, and he was wondering if he even had the first dose administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination More
2852594 08/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Erythema, Peripheral swelling Erythema, Peripheral swelling
My arm swelled up from shoulder to elbow and redness; redness; This non-serious case was reported by... My arm swelled up from shoulder to elbow and redness; redness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: My arm swelled up from shoulder to elbow and redness) and erythema (Verbatim: redness). The outcome of the swelling arm and erythema were not reported. It was unknown if the reporter considered the swelling arm and erythema to be related to Shingles vaccine. It was unknown if the company considered the swelling arm and erythema to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-JUL-2025 This case was reported by a patient via interactive digital media. The reporter was ask if you had the two shot vaccination, did you ever have to get another round. The patient had Shingles vaccine and had a reaction to the second dose, the arm swelled up from shoulder to elbow and redness. More
2852595 08/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Fatigue Fatigue
super tired with the first; This non-serious case was reported by a consumer via interactive digital... super tired with the first; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included anemia. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: super tired with the first). The outcome of the tiredness was not reported. It was unknown if the reporter considered the tiredness to be related to Shingles vaccine. It was unknown if the company considered the tiredness to be related to Shingles vaccine. Additional Information: GSK receipt date: 17-JUL-2025 This case was received from the patient via interactive digital media. The patient had one more to go. The patient was super tired with the first, but he/she also had anemia so, go figure. The patient found entertaining, the alliteration, shout and share that everyone surely should get their shingles shot and not shy away like a shady shrimp. More
2852596 74 F PA 08/04/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Condition aggravated Arthralgia, Condition aggravated
Herpes zoster/ shingles; Bad joint pain for while on the therapy/ She Just Had RSV vaccine and state... Herpes zoster/ shingles; Bad joint pain for while on the therapy/ She Just Had RSV vaccine and states that's causing her profound joint pain; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included dupilumab (Dupixent) solution for injection in pre-filled pen (batch number 4F573A, expiry date 31-DEC-2026) for prurigo nodularis. Concurrent medical conditions included joint pain (bad joint pain for while on the therapy), prurigo nodularis and drug allergy (was allergic to Penicillin VK 500 mg tablet, Celebrex 400 mg capsule). Concomitant products included oxygen. On 29-MAY-2025, the patient received RSV vaccine. On an unknown date, the patient started Dupixent (subcutaneous). On an unknown date, an unknown time after receiving RSV vaccine and Dupixent, the patient experienced shingles (Verbatim: Herpes zoster/ shingles) and arthralgia aggravated (Verbatim: Bad joint pain for while on the therapy/ She Just Had RSV vaccine and states that's causing her profound joint pain). The action taken with Dupixent was unknown. The outcome of the shingles was unknown and the outcome of the arthralgia aggravated was resolving. It was unknown if the reporter considered the shingles and arthralgia aggravated to be related to RSV vaccine and Dupixent. It was unknown if the company considered the shingles and arthralgia aggravated to be related to RSV vaccine and Dupixent. Additional Information: GSK Receipt Date: 18-JUL-2025 On an unknown date, the patient started taking Dupilumab solution for injection, strength 300mg/2ml at a dose of 300 mg every other week (QOW) subcutaneously via Dupilumab single dose prefilled pen. The patient received a dose of suspect RSV vaccine via unknown formulation, route and administration site. On an unknown date the patient developed a non-serious event bad joint pain for while on the therapy of Dupilumab or she just had RSV vaccine and stated that was causing her profound joint pain (arthralgia) unknown latency following the first dose intake of Dupilumab and of RSV vaccine. On an unknown date the patient developed a non-serious event shingles (herpes zoster) unknown latency following the first dose intake of Dupilumab and of RSV vaccine. The patient stated that she was just now beginning to recover from it and reported she had shingles. No other details provided. Action taken with Dupilumab (Dupixent) was unknown for arthralgia and no action taken for the event herpes zoster. Action taken with RSV Vaccine was not applicable for arthralgia and unknown for the event herpes zoster. It was not reported if the patient received a corrective treatment for arthralgia and herpes zoster. Additional information was received on 24-Jun-2025 from patient included additional event (herpes zoster) and clinical course. More
2852597 08/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Limb mass, Pain Limb mass, Pain
it was so painful too; lump on arm was so painful; This non-serious case was reported by a consumer ... it was so painful too; lump on arm was so painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: it was so painful too) and local swelling (Verbatim: lump on arm was so painful). The outcome of the injection site pain and local swelling were not reported. It was unknown if the reporter considered the injection site pain and local swelling to be related to Shingles vaccine. It was unknown if the company considered the injection site pain and local swelling to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-JUL-2025 This case was reported by a patient via interactive digital media. The patient stated still need to get the second vaccine. The patient received Shingles vaccine, and it was so painful too, but he/she did not want shingles either The patient was not sick but the lump on arm was so painful, and it was like that for over a month. More
2852598 08/04/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; Had my shoot and now for 2 weeks or more have the symptoms of RSV; Th... Suspected vaccination failure; Had my shoot and now for 2 weeks or more have the symptoms of RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Had my shoot and now for 2 weeks or more have the symptoms of RSV). The outcome of the vaccination failure was not reported, and the outcome of the respiratory syncytial virus infection was not resolved. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 23-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the shot and now (at the time of reporting) for 2 weeks or more had the symptoms of respiratory syncytial virus (RSV). The reporter wanted to know if anyone else. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
2852599 08/04/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
effects except a very sore arm for about 3 days; This non-serious case was reported by a consumer vi... effects except a very sore arm for about 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: effects except a very sore arm for about 3 days). The outcome of the pain in arm was resolved (duration 3 days). It was unknown if the reporter considered the pain in arm to be related to RSV vaccine. It was unknown if the company considered the pain in arm to be related to RSV vaccine. Additional Information: GSK receipt date: 22-JUL-2025 This case was reported by a patient via interactive digital media. The patient had no effects except a very sore arm for about 3 days. The patient was fine at the time of reporting. More
2852600 08/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Got my shingles shot and I still got it; This serious case was report... Suspected vaccination failure; Got my shingles shot and I still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got my shingles shot and I still got it). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-JUL-2025 This case was reported by a patient via interactive digital media. The patient got shingles shot but still got it and it hurt like hell, also said that was lucky that got the shot. The reporter stated that it was not going to hurt as bad but to still just like hell. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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
2852601 08/04/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise, Upper respiratory tract infection Malaise, Upper respiratory tract infection
bad upper respiratory infection; This non-serious case was reported by a consumer via interactive di... bad upper respiratory infection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of upper respiratory tract infection in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included sinus disorder (patient's sinuses are a mess). On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced upper respiratory tract infection (Verbatim: bad upper respiratory infection). The outcome of the upper respiratory tract infection was not reported. It was unknown if the reporter considered the upper respiratory tract infection to be related to RSV vaccine. It was unknown if the company considered the upper respiratory tract infection to be related to RSV vaccine. Additional Information: GSK receipt date: 25-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine but felt that he/she had a really bad upper respiratory infection. The patient felt like crap and his/her sinuses were a mess. More
2852602 17 F KY 08/04/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 A5AD4
Product storage error Product storage error
Administration of Bexsero after it was activated for an unknown time; This non-serious case was repo... Administration of Bexsero after it was activated for an unknown time; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number A5AD4, expiry date 31-JAN-2027) for prophylaxis. On 16-JUL-2025, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Administration of Bexsero after it was activated for an unknown time). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 18-JUL-2025 A practice manager called in to request data about the validity and safety of a dose of Bexsero after the prefilled syringe had been storage for an unknown amount of time, either minutes or days, and then administered to a 17-year-old, which led incorrect storage drug. More
2852603 M NY 08/04/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Intercepted product prescribing error Intercepted product prescribing error
Possible administration to a 30 YO PX; This non-serious case was reported by a pharmacist via call c... Possible administration to a 30 YO PX; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 30-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Pneumonia vaccine (received pneumonia vaccine on an unknown date). Concomitant products included iptacopan hydrochloride monohydrate (Fabhalta). On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: Possible administration to a 30 YO PX). The outcome of the intercepted drug prescribing error was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-JUL-2025 Pharmacist reported that they had a patient, who was 30 years old and he was on a medication, the medication was called Fabhalta. It affected the immune system and lower the ability to fight infection, so as part of him being on this medication, he needs to be vaccinated for strepto pneumonia and meningitis. He already got his pneumonia vaccine, they went to do the meningitis and the doctor sent the prescription, you know the Menveo and then the Bexsero. But the problem was that Bexsero, and all the Meningococcal B, all have an age for 10 to 25 years old in their indication, so he was 30. The healthcare professional mentioned that they have not administer the Bexsero vaccine to the patient, however, as this was prescribed by patient seems that the patient will receive the vaccine at the age of 30 years old which led to intercepted product prescribing error. More
2852604 1 M NM 08/04/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
A 15-year-old male patient received two doses of the vaccine 14 years ago, 1 month apart instead of ... A 15-year-old male patient received two doses of the vaccine 14 years ago, 1 month apart instead of between 6 to 12 months later as recommended; 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 15-year-old male patient who received HAV (Havrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact (Havrix). On 01-JAN-2011, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: A 15-year-old male patient received two doses of the vaccine 14 years ago, 1 month apart instead of between 6 to 12 months later as recommended). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 The pharmacist called to get assistance on the Havrix vaccine series. A 15-year-old male patient received two doses of the vaccine 14 years ago, 1 month apart instead of between 6 to 12 months later as recommended which led to shortening of vaccination schedule. The reporter called to know if a new second dose should be administered or if the complete series was required again. Not enough information was collected for this adverse event. The pharmacist refused to provide more information. More
2852605 18 F IL 08/04/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH

Interchange of vaccine products; Interchange of vaccine products Interchange of vaccine products; Interchange of vaccine products
a female patient received Trumeba at age 17 and Bexsero at age 18; This non-serious case was reporte... a female patient received Trumeba at age 17 and Bexsero at age 18; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero and Trumenba. On an unknown date, an unknown time after receiving Bexsero and Trumenba, the patient experienced interchange of vaccine products (Verbatim: a female patient received Trumeba at age 17 and Bexsero at age 18). The outcome of the interchange of vaccine products was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUL-2025 The nurse reported that a female patient received Trumeba at age 17 and Bexsero at age 18 which led to interchange of vaccine products. Nowadays patient was 20 years. More
2852606 31 M FL 08/04/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered, Product administered to patient of inappropriate age, P... Extra dose administered, Product administered to patient of inappropriate age, Product preparation issue More
Active ingredient not added to diluent; Administration over the recommended age; Inappropriate age a... Active ingredient not added to diluent; Administration over the recommended age; Inappropriate age at vaccine administration; Extra dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 31-year-old male patient who received MMR (Priorix) for prophylaxis. Previously administered products included Priorix (received 2 doses on an unknown date). On an unknown date, the patient received the 3rd dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Active ingredient not added to diluent), inappropriate dose of vaccine administered (Verbatim: Administration over the recommended age), inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration) and extra dose administered (Verbatim: Extra dose administered). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, inappropriate age at vaccine administration and extra dose administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: The pharmacist reported that the possible administration of Priorix vaccine with received only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received 3 doses of Priorix vaccine, which led to extra dose administered The patient received dose of Priorix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. More
2852607 F MT 08/04/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient who wanted to finish Twinrix schedule in a month, however Twinrix first dose was on 7/11/202... patient who wanted to finish Twinrix schedule in a month, however Twinrix first dose was on 7/11/2025 and Twinrix second dose was on 2nd 7/23/2025.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 23-JUL-2025, the patient received the 2nd dose of Twinrix. On 23-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient who wanted to finish Twinrix schedule in a month, however Twinrix first dose was on 7/11/2025 and Twinrix second dose was on 2nd 7/23/2025.). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-JUL-2025 The pharmacist had an adult female patient who wanted to finish Twinrix schedule in a month, however Twinrix first dose was on 11th July 2025 and Twinrix second dose was on 2nd 23rd July 2025 which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. More
2852608 M CA 08/04/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I was diagnosed with Covid this morning; I was diagnosed with Covid this morning; This is a spontane... I was diagnosed with Covid this morning; I was diagnosed with Covid this morning; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jul2025, outcome "unknown" and all described as "I was diagnosed with Covid this morning". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient reported, patient has a prescription for a Paxlovid at this time and patient reported had all his vaccines from Pfizer, all his Covid vaccines (Clarified as Covid-19 vaccine) from Pfizer. Clarified if patient had Covid now and prescribed with Paxlovid for that reported as yes. Patient reported was diagnosed with Covid this morning. The first time he got it to the stadium, when there was, people were going to get the vaccines here in withheld in the Stadium, here in withheld and he thought the second one, he thought it was in withheld, thought he got 2 in withheld and got another one or 2 in withheld. Did not have lot information, he was at the pharmacy and the card was at home. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2852609 F 08/04/2025 PNC20
 PFIZER\WYETH
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Patient experienced local site reaction of erythema, extended warmth and redness; Patient experience... Patient experienced local site reaction of erythema, extended warmth and redness; Patient experienced local site reaction of erythema, extended warmth and redness; This is a spontaneous report received from a Nurse from a sales representative. A 58-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "Patient experienced local site reaction of erythema, extended warmth and redness". Therapeutic measures were taken as a result of vaccination site warmth, vaccination site erythema. Additional information: Patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting., the patient did not received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting, the patient not taking any other medications within 2 weeks of the event starting. Treatment received for the adverse event with Ice and Recommended Ibuprofen and Zyrtec. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2852610 08/04/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Dizziness, Headache, Malaise, Neck pain, Ocular discomfort; Tinnitus Dizziness, Headache, Malaise, Neck pain, Ocular discomfort; Tinnitus
eye pressure; humming in head; head and neck aches; feel like I have a fever but didn't; dizzin... eye pressure; humming in head; head and neck aches; feel like I have a fever but didn't; dizziness; head and neck aches; This is a spontaneous report received from a Consumer or other non HCP. 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. The following information was reported: DIZZINESS (non-serious) with onset 20Jan2024, outcome "not recovered"; OCULAR DISCOMFORT (non-serious) with onset 20Jan2024, outcome "not recovered", described as "eye pressure"; MALAISE (non-serious) with onset 20Jan2024, outcome "not recovered", described as "feel like I have a fever but didn't"; NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 20Jan2024, outcome "not recovered" and all described as "head and neck aches"; TINNITUS (non-serious) with onset 20Jan2024, outcome "not recovered", described as "humming in head". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. Additional information: Patient began having symptoms on 20Jan2024 including dizziness, eye pressure, humming in head and felt like patient had a fever but didn't. Also head and neck aches. That never stopped, at times very severe. Had been to 14 doctors, had numerous tests all with good results. Could that be Covid shots patient asked for help. More
2852611 F 08/04/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
covid back in June of this year; covid back in June of this year; This is a spontaneous report recei... covid back in June of this year; covid back in June of this year; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female 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 series completed), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "covid back in June of this year". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient called regarding a follow up questionnaire that she just got another one from Pfizer, both her husband and her (patient) contracted covid back in June of this year (2025) they've both have had all the Pfizer vaccines, the first initial and every update they had every single one and in spite of that she still wearing mask, nevertheless she got covid, and was treated with Paxlovid. It worked right away, by the second day and probably least the 3rd day she felt like she was well, she continued and finish the 5 days, after the 5 days and completed the whole course. 3 days after that she started feeling sick again, now have long covid which is the reason it is continuing the nasal junk that she have been dealing with as well as the other symptoms nevertheless she ended up sick again 3 days after she had finished that she got ill again. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500155436 same reporter/drug/event, different patient; More
2852612 M 08/04/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
contracted covid; contracted covid; This is a spontaneous report received from a Consumer or other n... contracted covid; contracted covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "contracted covid". The patient has had all the Pfizer vaccines, including the first initial and every update; the patient received every single one. Despite this, the patient continued wearing a mask, yet still contracted COVID-19 and was treated with Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500155427 same reporter/drug/event, different patient; More
2852614 11 M IN 08/04/2025 MNQ
 SANOFI PASTEUR
 U8599AA
Injection site erythema, Injection site mass, Injection site swelling Injection site erythema, Injection site mass, Injection site swelling
REDNESS AND SWELLING. KNOT AT INJECTION SITE REDNESS AND SWELLING. KNOT AT INJECTION SITE
2852615 18 M FL 08/04/2025 ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
HEP
HEP
HEP
HEP
HEP
HEP
HEP
HEP
HEP
HEP
HEP
TYP
TYP
TYP
TYP
TYP
TYP
TYP
TYP
TYP
TYP
TYP
YF
YF
YF
YF
YF
YF
YF
YF
YF
YF
YF
 EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 300216A
300216A
300216A
300216A
300216A
300216A
300216A
300216A
300216A
300216A
300216A
CTCT327
CTCT327
CTCT327
CTCT327
CTCT327
CTCT327
CTCT327
CTCT327
CTCT327
CTCT327
CTCT327
X1A271M
X1A271M
X1A271M
X1A271M
X1A271M
X1A271M
X1A271M
X1A271M
X1A271M
X1A271M
X1A271M
UK217AA
UK217AA
UK217AA
UK217AA
UK217AA
UK217AA
UK217AA
UK217AA
UK217AA
UK217AA
UK217AA
Activated partial thromboplastin time normal, Aplastic anaemia, Aspergillus test... Activated partial thromboplastin time normal, Aplastic anaemia, Aspergillus test, Biopsy bone marrow abnormal, Blood beta-D-glucan positive; Blood creatinine normal, Blood culture negative, Blood test abnormal, Bone marrow failure, Chest X-ray normal; Computerised tomogram, Computerised tomogram abnormal, Computerised tomogram head normal, Contusion, Coxiella test; Cryptococcus test, Culture urine negative, Cytomegalovirus test negative, Cytopenia, Epistaxis; Epstein-Barr virus test negative, Febrile neutropenia, Fungal test positive, HIV test negative, Haemoglobin decreased; Hepatitis B surface antigen negative, Hepatitis C antibody negative, Herpes simplex test negative, Human herpes virus 6 serology negative, Immune thrombocytopenia; Immunoglobulin therapy, Incorrect route of product administration, International normalised ratio normal, Laboratory test normal, Leukopenia; Liver function test normal, Lymphadenopathy, Lymphocyte count decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging pelvic; Neutrophil count decreased, Oral contusion, Parvovirus B19 test negative, Pelvic fluid collection, Petechiae; Platelet count decreased, Platelet transfusion, Prothrombin level normal, Pyrexia, Rash; Red blood cell transfusion, Thrombocytopenia, Typhus rickettsia test, Viral test negative, White blood cell count decreased; Activated partial thromboplastin time normal, Aplastic anaemia, Aspergillus test, Biopsy bone marrow abnormal, Blood beta-D-glucan positive; Blood creatinine normal, Blood culture negative, Blood test abnormal, Bone marrow failure, Chest X-ray normal; Computerised tomogram, Computerised tomogram abnormal, Computerised tomogram head normal, Contusion, Coxiella test; Cryptococcus test, Culture urine negative, Cytomegalovirus test negative, Cytopenia, Epistaxis; Epstein-Barr virus test negative, Febrile neutropenia, Fungal test positive, HIV test negative, Haemoglobin decreased; Hepatitis B surface antigen negative, Hepatitis C antibody negative, Herpes simplex test negative, Human herpes virus 6 serology negative, Immune thrombocytopenia; Immunoglobulin therapy, Incorrect route of product administration, International normalised ratio normal, Laboratory test normal, Leukopenia; Liver function test normal, Lymphadenopathy, Lymphocyte count decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging pelvic; Neutrophil count decreased, Oral contusion, Parvovirus B19 test negative, Pelvic fluid collection, Petechiae; Platelet count decreased, Platelet transfusion, Prothrombin level normal, Pyrexia, Rash; Red blood cell transfusion, Thrombocytopenia, Typhus rickettsia test, Viral test negative, White blood cell count decreased; Activated partial thromboplastin time normal, Aplastic anaemia, Aspergillus test, Biopsy bone marrow abnormal, Blood beta-D-glucan positive; Blood creatinine normal, Blood culture negative, Blood test abnormal, Bone marrow failure, Chest X-ray normal; Computerised tomogram, Computerised tomogram abnormal, Computerised tomogram head normal, Contusion, Coxiella test; Cryptococcus test, Culture urine negative, Cytomegalovirus test negative, Cytopenia, Epistaxis; Epstein-Barr virus test negative, Febrile neutropenia, Fungal test positive, HIV test negative, Haemoglobin decreased; Hepatitis B surface antigen negative, Hepatitis C antibody negative, Herpes simplex test negative, Human herpes virus 6 serology negative, Immune thrombocytopenia; Immunoglobulin therapy, Incorrect route of product administration, International normalised ratio normal, Laboratory test normal, Leukopenia; Liver function test normal, Lymphadenopathy, Lymphocyte count decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging pelvic; Neutrophil count decreased, Oral contusion, Parvovirus B19 test negative, Pelvic fluid collection, Petechiae; Platelet count decreased, Platelet transfusion, Prothrombin level normal, Pyrexia, Rash; Red blood cell transfusion, Thrombocytopenia, Typhus rickettsia test, Viral test negative, White blood cell count decreased; Activated partial thromboplastin time normal, Aplastic anaemia, Aspergillus test, Biopsy bone marrow abnormal, Blood beta-D-glucan positive; Blood creatinine normal, Blood culture negative, Blood test abnormal, Bone marrow failure, Chest X-ray normal; Computerised tomogram, Computerised tomogram abnormal, Computerised tomogram head normal, Contusion, Coxiella test; Cryptococcus test, Culture urine negative, Cytomegalovirus test negative, Cytopenia, Epistaxis; Epstein-Barr virus test negative, Febrile neutropenia, Fungal test positive, HIV test negative, Haemoglobin decreased; Hepatitis B surface antigen negative, Hepatitis C antibody negative, Herpes simplex test negative, Human herpes virus 6 serology negative, Immune thrombocytopenia; Immunoglobulin therapy, Incorrect route of product administration, International normalised ratio normal, Laboratory test normal, Leukopenia; Liver function test normal, Lymphadenopathy, Lymphocyte count decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging pelvic; Neutrophil count decreased, Oral contusion, Parvovirus B19 test negative, Pelvic fluid collection, Petechiae; Platelet count decreased, Platelet transfusion, Prothrombin level normal, Pyrexia, Rash; Red blood cell transfusion, Thrombocytopenia, Typhus rickettsia test, Viral test negative, White blood cell count decreased More
18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 ... 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600). More
✓ ✓
2852616 29 F MD 08/04/2025 COVID19
 PFIZER\BIONTECH
Exposure during pregnancy, Premature delivery, Premature labour Exposure during pregnancy, Premature delivery, Premature labour
My wife had her first dose of the vaccine on 9/8/2021 while in her third trimester and went into pre... My wife had her first dose of the vaccine on 9/8/2021 while in her third trimester and went into premature (5.5 weeks early) labor that night, giving birth the following morning (9/9/2021). I would have reported this sooner had I known this system existed. She got her vaccine from the pharmacy, and gave birth next day at the hospital. More
✓
2852617 18 M GA 08/04/2025 HPV9
 MERCK & CO. INC.
Seizure, Syncope Seizure, Syncope
My son was receiving his SECOND dose of the GARDASIL vaccination. As the nurse was pulling out the s... My son was receiving his SECOND dose of the GARDASIL vaccination. As the nurse was pulling out the syringe and placing a bandaid over the injection site, my son fainted and had 3-4 small convulsions. This was NOT due to fear, as he is not afraid of medical situations or vaccinations. He had blood drawn intravenously about five minutes prior to this vaccination for another medical test with no issues or concerns. This appeared to be a reaction to the injection/vaccine, which he did say hurt more than usual injections. He was unconscious for maybe 7 seconds total and regained consciousness. Doctor's office had him continue to lie down for about 10 minutes and drink some juice, then slowly sit up until he was ready to stand and leave. So, far he seems okay one month later. More
2852618 1.42 M FL 08/04/2025 DTAPHEPBIP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Fatigue, Injection site erythema, Injection site induration, Injection site infe... Fatigue, Injection site erythema, Injection site induration, Injection site infection, Injection site pain; Injection site warmth, Irritability, Lymphadenopathy, Speech disorder More
At the time of injection it was red, hot to touch , size of a quarter on 12/14/2022 11am, childrens ... At the time of injection it was red, hot to touch , size of a quarter on 12/14/2022 11am, childrens cranky, tired the evening of 12/14/2022., left thigh began splotches of redness on upper left thigh/ center where shot injected hard like a rock 12/15/2022 7am, splotching turns to solid red circle around injection sight 12/15/2022 10am, the red infected area is growing to completely cover thigh area , hot to touch , painful to touch- child will not allow me to touch it 12/15-12/16 2022 More
✓
2852619 21 M TX 08/04/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00115
Expired product administered, No adverse event Expired product administered, No adverse event
FDP00115 LOT Expired on 20250731; Administered on 20250804; No reaction; Pt monitored for 30 minutes... FDP00115 LOT Expired on 20250731; Administered on 20250804; No reaction; Pt monitored for 30 minutes after administration; Patient and physician notified. More
2852620 61 M IA 08/04/2025 COVID19
 MODERNA
 3043332
Death Death
Resident passed away Resident passed away
✓
2852621 11 F SC 08/04/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Y010656
u8256ba
U8353aa
Hypotension, Presyncope, Tongue discomfort; Hypotension, Presyncope, Tongue disc... Hypotension, Presyncope, Tongue discomfort; Hypotension, Presyncope, Tongue discomfort; Hypotension, Presyncope, Tongue discomfort More
Patient had vagal reponse 5 min after vaccines given, c/o tongue feeling funny, low BP, epi given an... Patient had vagal reponse 5 min after vaccines given, c/o tongue feeling funny, low BP, epi given and EMS called transported to ER. More
2852622 12 M PA 08/04/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 a274j
No adverse event, Product preparation error No adverse event, Product preparation error
Patient presented for meningitis ACWY (menquadfi). Medical Assistant inadvertently administered meni... Patient presented for meningitis ACWY (menquadfi). Medical Assistant inadvertently administered meningitis B (Bexsero). Parent and patient were notified of incorrect administration. As of the time of this report, there were not any adverse reactions or need for treatment. More
2852623 50 F IN 08/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2M7GR
Injection site erythema, Injection site pain, Injection site swelling, Sleep dis... Injection site erythema, Injection site pain, Injection site swelling, Sleep disorder More
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: pt stated she tested for fever but body temp was not elevated-Mild, Systemic: Unable to Sleep-Medium, Additional Details: Pt stated that she felt as if the vaccine stug upon injection. Son reported seeing the vaccinator inject twice. Vaccinator report that upon injection pt jerked/adjusted arm but did not inject twice. Pt arrived the next day with red raised area about size of half dollar coin in the right arm. Upon inspection it appearred that injection site was in the center of muscle in the in the shoulder below the should an appropriate distance. More
2852624 84 F NY 08/04/2025 PNC21
 MERCK & CO. INC.
 z004301
Injection site pain, Injection site pruritus Injection site pain, Injection site pruritus
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium
2852626 48 F CA 08/04/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946906
Pruritus, Rash Pruritus, Rash
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional... Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient did not go into much detail, just mentioned she's picking up TAC crm, prednisone, hydroxyzine due to a reaction she received from vaccine she received a week ago with "bad rash" More
2852627 57 F TX 08/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 gj952
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia More
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ... Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fever-Medium More
2852628 17 F NV 08/04/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 2JS53
Dizziness, Syncope, Unresponsive to stimuli Dizziness, Syncope, Unresponsive to stimuli
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Det... Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: patient was given a meningitis vaccine (menveo) and at 5:28pm (pt was in the car getting ready to leave), the pt fainted while seated in the car per mom and woke up. Pt returned to pharmacy to have blood pressure and heart rate taken. blood pressure was was 107/73 (normal) and heart rate was 71 bpm (normal). Pt fully recovered; pharmacist offered ambulance and mom denied; no ambulance, no 911, nor any other emergency services were called. pt is back to normal now. More
2852629 27 F NY 08/04/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4mg3e
Injection site erythema, Injection site pain, Injection site swelling, Neurologi... Injection site erythema, Injection site pain, Injection site swelling, Neurological symptom, Paraesthesia More
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injecti... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: patient stated "neurologic symptoms" prior to ED/neurologist visit-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Other Vaccines: VaccineTypeBrand: Moderna 2024-2025 Covid; Manufacturer: Moderna; LotNumber: 3046734; Route: IM; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN More
2852630 50 M NJ 08/04/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946062
Injection site pain Injection site pain
Site: Pain at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: capvaxive; Manufacturer: merck... Site: Pain at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: capvaxive; Manufacturer: merck; LotNumber: y019157; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN More
2852631 79 F NY 08/04/2025 PNC20
 PFIZER\WYETH
 lp4946
Injection site erythema, Injection site pruritus, Rash Injection site erythema, Injection site pruritus, Rash
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Ra... Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild More
2852632 12 M NV 08/04/2025 MNQ
 SANOFI PASTEUR
 U8194AA
Dizziness, Syncope, Unresponsive to stimuli Dizziness, Syncope, Unresponsive to stimuli
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for a few seconds. He recovered immediately and verbalized that he became dizzy. Did not sustain any physical injury. Monitored for 15 mins. VS signs were stable. BP=100/65, HR=95/min. O2sat=97%. Patient was ambulatory upon discharge with his mother. , Other Vaccines: VaccineTypeBrand: Tdap; Manufacturer: GSK; LotNumber: H4279; Route: IM; BodySite: left deltoid; Dose: 1; VaxDate: 07/29/2025 More
2852633 42 F FL 08/04/2025 HPV9
 MERCK & CO. INC.
 y008640
Peripheral swelling, Pruritus, Rash, Urticaria Peripheral swelling, Pruritus, Rash, Urticaria
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify... Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: swelling of fingers/hand-Mild, Additional Details: swelling, rash, and hives on lower right hand/fingers and thighs, Other Vaccines: VaccineTypeBrand: fluarix; Manufacturer: ; LotNumber: ; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: heplisav; Manufacturer: ; LotNumber: ; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: pfizer covid; Manufacturer: ; LotNumber: ; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN More
📋 Privacy Policy & Data Disclaimer