🏥 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 💀 🏥 🚑 ♿ ⚠️
2827020 59 F NV 02/19/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LJ5283
LJ5283
Erythema, Injection site erythema, Injection site induration, Injection site pai... Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus; Injection site warmth, Limb discomfort, Skin warm More
Patient with area of confluent erythema along right upper arm, overlying the deltoid area. Spanning ... Patient with area of confluent erythema along right upper arm, overlying the deltoid area. Spanning approximately 10cm in length x 7.5cm in width. Area was marked with surgical marker. -most distal area of induration is slightly tender to touch and warmer than surrounding area -denes fever, chills -states that initially area was very itchy and then redness spread to larger area Patient was in clinic today for flu immunization. After immunization patient notified this RN that she had a question. She notified this RN she was given the pneumonia vaccine last week and now has a reddened area. Patient proceeded to take how other arm out of her sleeve of her jacket and pull up the sleeve of her shirt. The deltoid region of her left arm was exposed where there was a red circle that covered most of her deltoid region. This RN touched patients arm where reddened area was and felt area was warm to touch. There was no other abnormalities and patient denies chills, fever, n/v/d, light headed or dizziness. She notes mild arm discomfort when moving. This RN notified patients PCP who provided this RN with supportive measures for patient and strict instruction to return to clinic if not better in 48 hours. More
2827021 62 M TN 02/19/2025 UNK
 UNKNOWN MANUFACTURER
Dermatitis atopic Dermatitis atopic
Patient reported that the 1st time they started developing skin issues (atopic dermatitis) was with... Patient reported that the 1st time they started developing skin issues (atopic dermatitis) was within about two months after receiving their 2nd dose of the Moderna COVID-19 vaccination. They now require use of over the counter and prescription medications to manage atopic dermatitis. The vaccinations were received at a local pharmacy (not the pharmacy of the reporting RPH) on an unknown date. Patient unable to provide additional specifics on the vaccine details at time of reporting. Any follow-up on this report should be completed by calling the patient directly. More
2827022 M MI 02/19/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Product preparation issue Product preparation issue
Gave three does in one with no diluent Gave three does in one with no diluent
2827023 71 F CT 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Dizziness, Nausea, Pain, Rash Dizziness, Nausea, Pain, Rash
Patient developed a rash on the R abdomen, nausea, dizziness, and R sided pain. Symptoms occurred th... Patient developed a rash on the R abdomen, nausea, dizziness, and R sided pain. Symptoms occurred the day after she was vaccinated with dose #1 of the Shingrix vaccine series. More
2827024 M NY 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Dizziness, Vertigo Dizziness, Vertigo
Dizziness, vertigo Dizziness, vertigo
2827025 F NJ 02/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Biopsy colon abnormal, Colitis microscopic, Colonoscopy abnormal, Diarrhoea, Lab... Biopsy colon abnormal, Colitis microscopic, Colonoscopy abnormal, Diarrhoea, Laboratory test abnormal; Weight decreased More
On Feb 20, 2021, I received my first Covid vaccine (Pfizer). 15 days later, after 2 weeks of watery ... On Feb 20, 2021, I received my first Covid vaccine (Pfizer). 15 days later, after 2 weeks of watery diarrhea and a 15-pound weight loss, I was admitted to the hospital for 6 days. A colonoscopy biopsy revealed microscopic colitis (MC). Pervious routine colonoscopies were normal with 1-2 benign polyps. IV steroids immediately stopped the diarrhea and I was discharged on Budesonide. I never made the association of the vaccine and MC until recently when I came across an article noting the several such cases had been reported. July 28, 2024, I was hospitalized again for 5 days for a recurrence of MC. I was treated with IV steroids and discharged on Prednisone. As soon as I tapered to 5 mg a day, the watery diarrhea returned. I was readmitted 6 weeks later for 12 days. A complete GI workup was done, only positive finding was MC. I am currently tapering off Budesonide. More
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2827026 U 02/19/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 52N4S
Inadvertent injection air bubble Inadvertent injection air bubble
Bexsero (GSK) vaccine - Lot #: 52N4S - product consistently contains air bubble that is not able to ... Bexsero (GSK) vaccine - Lot #: 52N4S - product consistently contains air bubble that is not able to be dislodged through manual manipulation. Air bubble is therefore injected into patient with every dose, or significant volume loss occurs. This has happened with all lots for several months. More
2827027 U 02/19/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 52N4S
Inadvertent injection air bubble Inadvertent injection air bubble
Bexsero (GSK) vaccine - Lot #: 52N4S - product consistently contains air bubble that is not able to ... Bexsero (GSK) vaccine - Lot #: 52N4S - product consistently contains air bubble that is not able to be dislodged through manual manipulation. Air bubble is therefore injected into patient with every dose, or significant volume loss occurs. This has happened with all lots for several months. More
2827029 86 M OH 02/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LN0591
LN0591
Aortic aneurysm, Atrioventricular block, COVID-19, Death, Laboratory test abnorm... Aortic aneurysm, Atrioventricular block, COVID-19, Death, Laboratory test abnormal; Pulmonary mass, SARS-CoV-2 test positive, Sepsis More
Resident admitted to facility for rehab. He had significant fall and was hospitalized where they fou... Resident admitted to facility for rehab. He had significant fall and was hospitalized where they found possible cancer, heart block, sepsis and AAA. He was given the covid vaccine on 02/08/2025. On 02/11/2025, he tested positive for covid. While doing rounds, he was found sitting in his chair. He passed away. More
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2827030 106 F OH 02/19/2025 COVID19
 PFIZER\BIONTECH
 LN0591
Death, Dyspnoea, Feeling abnormal, Oxygen saturation decreased, SARS-CoV-2 test ... Death, Dyspnoea, Feeling abnormal, Oxygen saturation decreased, SARS-CoV-2 test negative More
Resident was given the covid vaccine on 02/08/2025. On 02/09/2025, she developed SOB, "not feel... Resident was given the covid vaccine on 02/08/2025. On 02/09/2025, she developed SOB, "not feeling good" and POX dropped to 78% on RA. She was placed on oxygen and POX came back up to 93%. CXR was refused by family, but aerosol treatments were given with some relief. She was on hospice for heart failure, and she passed away on 02/12/2025. She had no s/s of covid and tested negative on 02/09/2025. Manufacturer/Lot#: Comirnaty LN0591 with exp date of 04/24/2025. More
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2827031 50 F MT 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Diarrhoea, Pain, Pyrexia Diarrhoea, Pain, Pyrexia
Received first dose of Shingrix, 26 Nov 2025 with little to no side effects. Received second dose of... Received first dose of Shingrix, 26 Nov 2025 with little to no side effects. Received second dose of Shingrix 17 Feb 2025 at approximately 3pm. Body aches began at approximately 10pm the day of the vaccination. At 9am on 18 Feb 2025 have 101F fever, body aches and diarrhea. More
2827033 U KS 02/19/2025 RSV
 PFIZER\WYETH
 HA3218
Syringe issue Syringe issue
While Reconstituting product syringe broke off cleanly from vial adaptor. Unable to determine if vac... While Reconstituting product syringe broke off cleanly from vial adaptor. Unable to determine if vaccine was still safe to give. More
2827100 U SC 02/19/2025 HIBV
 MERCK & CO. INC.
 Y006392
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored P... No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored PEDVAXHIB on 2/4/2025 that experienced a TE on 1/31/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case #02749; 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 medications, and previous drug reactions or allergies were not reported. On 04-FEB-2025, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) at a dose of 0.5 milliliter (ml), lot number Y006392 which was determined to be valid, with an expiration date on 08-NOV-2026) as prophylaxis (vaccination scheme, route of administration, and anatomical site of injection were not reported). Administered doses were stored at a temperature of 10.22 degrees Celsius (C), during a time frame of 22 hours and 50 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient. More
2827101 F FL 02/19/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.









Antinuclear antibody positive, Anxiety, Arthralgia, Autonomic nervous system imb... Antinuclear antibody positive, Anxiety, Arthralgia, Autonomic nervous system imbalance, Brain fog; Cognitive disorder, Cough, Disturbance in attention, Dizziness, Dysgraphia; Dyspnoea, Educational problem, Executive dysfunction, Fatigue, Fine motor skill dysfunction; Headache, Impaired work ability, Joint stiffness, Memory impairment, Migraine; Palpitations, Sleep disorder, Speech disorder; Antinuclear antibody positive, Anxiety, Arthralgia, Autonomic nervous system imbalance, Brain fog; Cognitive disorder, Cough, Disturbance in attention, Dizziness, Dysgraphia; Dyspnoea, Educational problem, Executive dysfunction, Fatigue, Fine motor skill dysfunction; Headache, Impaired work ability, Joint stiffness, Memory impairment, Migraine; Palpitations, Sleep disorder, Speech disorder More
autonomic dysfunction SOB coughing headache migraine fatigue sleep disturbance dizziness faint memor... autonomic dysfunction SOB coughing headache migraine fatigue sleep disturbance dizziness faint memory impairment concentration brain frog cognition inability to multitask difficulty speech spelling no focus impaired recall heart palpitation anxiety; autonomic, autoimmune, and neurological injuries; autonomic, autoimmune, and neurological injuries; Plaintiff received her first and second dosage of Gardasil on December 9, 2019 and January 5, 2021.; HPV Vaccination Syndrome; migratory joint pain; stiffness in the joints in her hands and in the neck; has a positive ANA factor; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning an adult female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 09-DEC-2019, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) intramuscular injection and on 05-JAN-2021 with the second dose (dose, frequency, vaccination scheme, anatomical location, route of administration, lot number and expiration date were not reported for both doses) administered for preventing cancer. It has been reported that the pt sustained serious autoimmune, autonomic, and neurological Injuries as a result. It was reported that on an unknown date, after her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, the pt began experiencing chronic shortness of breath and coughing. She began experiencing chronic headaches and chronic migraines, sometimes lasting for days and months with no relief from medications. The pt also began experiencing prolonged general fatigue and sleep disturbances. She sometimes experiences dizziness and the sensation that she would faint. Subsequent to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)vaccinations, the pt began experiencing significant memory impairment, difficulties in concentration, brain fog, difficulties with cognition, inability to multitask, difficulties with speech and spelling, inability to focus, and impaired recall, all which had impacted her both in school and on the job. Following pt's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, she developed migratory joint pain, including stiffness in the joints in her hands and in her neck. She had been seen by a rheumatologist and was tested and has a positive antinuclear antibodies (ANA) factor. She had decreased fine motor movements which made it difficult for her to use her hands, as her fingers did not bend easily. Following the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, the pt had developed chronic heart palpitations with her heart racing. She also developed anxiety because of her worsening medical condition and her inability to function. She was prescribed alprazolam (XANAX) to treat her anxiety. She also was prescribed dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate (ADDERALL) to help with her brain fog and inability to concentrate. Before pt's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, she was healthy and loved to study. As a result of her post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, it had been hard for her to function at her job and complete her post-graduate education. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, pt's collection of symptoms were consistent with human papilloma virus (HPV) Vaccination Syndrome. The underlying, unifying diagnosis would be autonomic dysfunction. As a proximate result of company's fraudulent, false, and misleading statements, omissions, and conduct concerning the safety and efficacy of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). As a direct and proximate result of her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur those losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). All the events were considered as disabling by reporter. Upon internal review, the event of autoimmune disorder was determined to be medically significant. More
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2827102 F MD 02/19/2025 HEPA
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
a 45 year old female received a pediatric/adolescent dose of VAQTA.; No additional AE reported; This... a 45 year old female received a pediatric/adolescent dose of VAQTA.; No additional AE reported; This spontaneous report was received from a medical assistant and refers to a 45-year-old female patient. The patient's medical history, concurrent conditions and Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a pediatric/adolescent dose of Hepatitis A Vaccine, Inactivated (VAQTA), suspension for injection (dose, route, strength, lot # and expiration date were not reported) for prophylaxis (underdose). No additional adverse event reported (no adverse event). Lot# is being requested and will be submitted if received. More
2827103 18 U AL 02/19/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Extra dose administered Extra dose administered
The office mistakenly administered a 3rd dose of Bexsero January 8, 2025; This non-serious case was ... The office mistakenly administered a 3rd dose of Bexsero January 8, 2025; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 18-year-old patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (a patient received two Bexsero doses (one month apart) in 2023) and Bexsero (a patient received two Bexsero doses (one month apart) in 2023). On 08-JAN-2025, the patient received the 3rd dose of Bexsero. On 08-JAN-2025, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: The office mistakenly administered a 3rd dose of Bexsero January 8, 2025). The outcome of the extra dose administered 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: 20-JAN-2025 Nurse reported that a patient received two Bexsero doses (one month apart) in 2023. The office mistakenly administered a 3rd dose of Bexsero January 8, 2025 which led to extra dose administered. More
2827104 F IL 02/19/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M77CC
Myalgia Myalgia
Pain seems to be in the patient's left bicep; This non-serious case was reported by a other hea... Pain seems to be in the patient's left bicep; This non-serious case was reported by a other health professional and described the occurrence of localized muscle pain in a 76-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis. On 30-DEC-2024, the patient received Boostrix (intramuscular) .5 ml. On 30-DEC-2024, an unknown time after receiving Boostrix, the patient experienced localized muscle pain (Verbatim: Pain seems to be in the patient's left bicep). The outcome of the localized muscle pain was not resolved. It was unknown if the reporter considered the localized muscle pain to be related to Boostrix. It was unknown if the company considered the localized muscle pain to be related to Boostrix. Additional Information: GSK receipt date: 13-JAN-2025 Other HCP reported that a patient had muscle pain which seem to be in the patient's left bicep. More
2827105 M AL 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Arthralgia Arthralgia
Severe joint pain was reported as worsened; This non-serious case was reported by a nurse via sales ... Severe joint pain was reported as worsened; This non-serious case was reported by a nurse via sales rep and described the occurrence of joint pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced joint pain (Verbatim: Severe joint pain was reported as worsened). The outcome of the joint pain was not resolved. The reporter considered the joint pain to be related to Shingrix. The company considered the joint pain to be related to Shingrix. Additional Information: GSK Receipt Date: 23-JAN-2025 Severe joint pain was reported as worsened. Patient was otherwise healthy before first dose was administered. A week later, the patient complained of severe joint pain. They were referred to rheumatologist, and the labs were all normal according to the provider. More
2827106 U CA 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injected limb mobility decreased, Pain in extremity Injected limb mobility decreased, Pain in extremity
injected arm still hurts/ pain; injected arm has limited mobility; This non-serious case was reporte... injected arm still hurts/ pain; injected arm has limited mobility; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: injected arm still hurts/ pain) and injected limb mobility decreased (Verbatim: injected arm has limited mobility). The outcome of the pain in arm and injected limb mobility decreased were not resolved. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix. It was unknown if the company considered the pain in arm and injected limb mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2025 Patient was the reporter. Patient had the Shingrix vaccine in October 2024, and his/her injected arm still hurt and had limited mobility. He/she read that he/she was supposed to take pain relievers, but patient was asking whether they need to take it forever. He/she did not want to take the second dose because the pain continued. Patient never had any reaction to any other vaccine, although he/she vaccinated on a recommended schedule for any and all other vaccines. More
2827107 39 F 02/19/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Underdose Underdose
adult female patient received pediatric dose of Engerix B; adult female patient received pediatric d... adult female patient received pediatric dose of Engerix B; adult female patient received pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 39-year-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis. On 17-JAN-2025, the patient received the 3rd dose of Engerix B 10 mcg. On 17-JAN-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: adult female patient received pediatric dose of Engerix B) and underdose (Verbatim: adult female patient received pediatric dose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt date: 22-JAN-2025 The registered nurse reported that an adult female patient received pediatric dose of Engerix B 10 mcg as a third dose which led to underdose and adult use of a child product. More
2827108 U 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration, Incorrect dose administered, P... Inappropriate schedule of product administration, Incorrect dose administered, Product preparation error More
The patient received a prior dose of Shingrix back on September 26th 2023 (unknown lot number and ex... The patient received a prior dose of Shingrix back on September 26th 2023 (unknown lot number and expiration date), and the second dose was given on January 8th 2025.; Second dose was the one who was mixed with a different diluent,; Second dose was the one who was mixed with a different diluent,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 26-SEP-2023). On 08-JAN-2025, the patient received the 2nd dose of Shingrix. On 08-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received a prior dose of Shingrix back on September 26th 2023 (unknown lot number and expiration date), and the second dose was given on January 8th 2025.), wrong solution used in drug reconstitution (Verbatim: Second dose was the one who was mixed with a different diluent,) and inappropriate dose of vaccine administered (Verbatim: Second dose was the one who was mixed with a different diluent,). The outcome of the drug dose administration interval too long, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 24-JAN-2025 The medical assistant reported that a patient received prior dose of Shingrix back on September 26th 2023 (unknown lot number and expiration date), and the second dose was given on January 8th 2025, which led to drug dose administration interval too long. Second dose was the one who was mixed with a different diluent, and the diluent pertains to an MMR vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. More
2827109 U 02/19/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Mobility decreased, Pain in extremity Mobility decreased, Pain in extremity
it hurt like hell/ sore arm; barely move his/her arm for a day; This non-serious case was reported b... it hurt like hell/ sore arm; barely move his/her arm for a day; 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 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 pain in arm (Verbatim: it hurt like hell/ sore arm) and mobility decreased (Verbatim: barely move his/her arm for a day). The outcome of the pain in arm was not reported and the outcome of the mobility decreased was resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR010517 Additional Information: GSK Receipt Date: 25-JAN-2025 This case was reported by a patient via interactive digital media. Patient was the reporter. It was fine for him/her. But of course everyone was different. It was 2 shots and it hurt like hell. Especially the 2nd shot. If he/she recalled, he/she could barely move his/her arm for a day or so. He/she had been vaccinated for shingles for 7 years with no problems other than a sore arm when he/she got the shots. For tolerance to 2nd dose, refer case US2025AMR010517.; Sender's Comments: US-GSK-US2025AMR010517:same patient, second dose More
2827110 F ME 02/19/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient didn't get the 2nd dose (of Twinrix), it's been 2 months since the 1st dose; This ... patient didn't get the 2nd dose (of Twinrix), it's been 2 months since the 1st dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and an unknown time after receiving TWINRIX, the patient experienced incomplete course of vaccination (Verbatim: patient didn't get the 2nd dose (of Twinrix), it's been 2 months since the 1st dose). The outcome of the incomplete course of vaccination 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: 22-JAN-2025 A pharmacist called to inform that a patient did not get the 2nd dose of Twinrix, it's been 2 months since the 1st dose. According to reporter, the 1st dose of Twinrix was administered back on 26th November 2024. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination. More
2827111 U 02/19/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Intercepted product storage error Intercepted product storage error
the products were received by the warehouse at below freezing temperature; This non-serious case was... the products were received by the warehouse at below freezing temperature; This non-serious case was reported by a consumer via sales rep and described the occurrence of intercepted product storage error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product storage error (Verbatim: the products were received by the warehouse at below freezing temperature). The outcome of the intercepted product storage error was not applicable. Additional Information: GSK receipt date: 22-JAN-2025 Reporter stated that a delivery truck that was involved in inclement weather and the products were received by the warehouse at below freezing temperature. Reporter had an invoice detailing the medication on the delivery truck. One of those products was Arexvy, however, quantity was unknown. No further information was known including names of medication on the delivery truck, quantity, or lot numbers. Products were received by the warehouse at below freezing temperature, which led to intercepted product storage error. More
2827112 0.33 F UT 02/19/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 79K45
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
patient was 4 months old at that time), and was administered a FluLaval vaccine; This non-serious ca... patient was 4 months old at that time), and was administered a FluLaval vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 79K45, expiry date 01-JUN-2025) for prophylaxis. On 13-NOV-2024, the patient received FluLaval 2024-2025 season. On 13-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: patient was 4 months old at that time), and was administered a FluLaval vaccine). The outcome of the inappropriate age at vaccine administration was unknown. 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-JAN-2025 The medical assistant reported that a patient who was currently 6 months old was seen in clinic on 13-Nov-2024 (patient was 4 months old at that time), and was administered a FluLaval vaccine, which led to inappropriate age at vaccine administration. At that time no one caught that the patient was too young for the vaccine, now the patient was back in clinic for 6 month visit and the error was discovered. The medical assistant reports the patient was fine and had no reactions. The vaccine administration facility was the same as primary reporter. More
2827113 M CO 02/19/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
a one-year-old patient received a dose of Kinrix.; Kinrix administered instead of Infanrix.; This no... a one-year-old patient received a dose of Kinrix.; Kinrix administered instead of Infanrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 21-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Infanrix. On 21-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a one-year-old patient received a dose of Kinrix.) and wrong vaccine administered (Verbatim: Kinrix administered instead of Infanrix.). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. 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-JAN-2025 The nurse reported that a one-year-old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. Reporter mentioned that the intention was to give Infanrix to that patient instead, which led to wrong vaccine administered. More
2827114 F IA 02/19/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J5T9Z
Wrong product administered Wrong product administered
Mistaken administration of a FLULAVAL instead of a FLUZONE High Dose; This non-serious case was repo... Mistaken administration of a FLULAVAL instead of a FLUZONE High Dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 71-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis. Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) for prophylaxis. On 29-JAN-2025, the patient received FluLaval 2024-2025 season. On an unknown date, the patient received Fluzone high dose. On 29-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: Mistaken administration of a FLULAVAL instead of a FLUZONE High Dose). The outcome of the wrong vaccine administered was unknown. 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: 30-JAN-2025 The reporter reported that a patient mistaken administration of a Flulaval instead of a fluzone high dose in a seventy one year old patient which led to wrong vaccine administered. Vaccination date, vaccine detail and patient demographics were provided from the registered nurse end. No further information was obtained in this call. More
2827115 F CA 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not get the second dose at two to six months; This non-serious case was reported by a physician ... did not get the second dose at two to six months; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received 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. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not get the second dose at two to six months). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 13-FEB-2025 The physician reported that the patient received her first Shingles vaccine and did not get the second dose at two to six months. The reporter did not have a lot number or NDC number and states she does not remember which arm dose was given. She had no side effects from the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination More
2827116 16 F 02/19/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 52X45
Expired product administered Expired product administered
patient should be revaccinated after receiving an expired dose; This non-serious case was reported b... patient should be revaccinated after receiving an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 52X45, expiry date 31-DEC-2024) for prophylaxis. On 17-FEB-2025, the patient received Menveo. On 17-FEB-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient should be revaccinated after receiving an expired dose). The outcome of the expired vaccine used was unknown. Additional Information: GSK receipt date: 17-FEB-2025 The health care provider called to ask if a patient should be revaccinated after receiving an expired dose of Menveo (1 vial) on the day of reporting. The patient recived expired dose of Menveo which led to, expired vaccine used. The Vaccine Administration Facility is the same as Primary Reporter. More
2827117 52 F MD 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
interval between first dose and second dose of Shingrix was too long; This non-serious case was repo... interval between first dose and second dose of Shingrix was too long; 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 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 11-NOV-2022). On 05-NOV-2024, the patient received the 2nd dose of Shingrix. On 05-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: interval between first dose and second dose of Shingrix was too long). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK receipt date: 17-FEB-2025 The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not have lot number or expiration dates for any of the 2 vaccines administered. More
2827118 75 M 02/19/2025 CHIK
 VALNEVA USA, INC.
 24B011
Fatigue, Malaise, Pyrexia Fatigue, Malaise, Pyrexia
Fever; The following information was received from a nurse on 31 Dec 2024. A 75-year-old male recei... Fever; The following information was received from a nurse on 31 Dec 2024. A 75-year-old male received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 24B011) on 13 Dec 2024. Two days later, on 15 Dec 2024, he experineced fever, fatigue and malaise. The outcome of the events was reported as not resolved. Case is linked to case US-INTERCELLP-6625 (wife with same events).; Sender's Comments: Causality assessed as possibly related, as time to onset is plausible (2 days past vaccination) and as Fever and Fatigue are well known for IXCHIQ and Malaise can be seen in the same context as abnormal/ill feeling. All reactions are indicative of a systemic vaccination reaction. More
2827119 F 02/19/2025 CHIK
 VALNEVA USA, INC.
 24B011
Fatigue, Malaise, Pyrexia Fatigue, Malaise, Pyrexia
Fever; The following information was received from a nurse on 31 Dec 2024. A female of unknown age ... Fever; The following information was received from a nurse on 31 Dec 2024. A female of unknown age received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 24B011) on 13 Dec 2024. Two days later, on 15 Dec 2024, she experineced fever, fatigue and malaise. The outcome of the events was reported as not resolved. Case is linked to case US-INTERCELLP-6624 (husband with same events).; Sender's Comments: Causality assessed as possibly related, as time to onset is plausible (2 days past vaccination) and as Fever and Fatigue are well known for IXCHIQ and Malaise can be seen in the same context as abnormal/ill feeling. All reactions are indicative of a systemic vaccination reaction. More
2827120 72 F 02/19/2025 COVID19
 MODERNA
 unknown
Blood pressure measurement, Magnetic resonance imaging head, Pain in extremity, ... Blood pressure measurement, Magnetic resonance imaging head, Pain in extremity, Sinusitis More
it made her arm sore, a "sore muscle"; she also had a sinus infection; This spontaneous ca... it made her arm sore, a "sore muscle"; she also had a sinus infection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (it made her arm sore, a "sore muscle") and SINUSITIS (she also had a sinus infection) in a 72-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. unknown) for COVID-19 prophylaxis. The patient's past medical history included Cataract operation (She had one eye that's good and one eye that isn't but was going to get the other one done.), Colonoscopy (She has had a colonoscopy and a mammogram with the past year : no cancer.) in 2024 and Mammogram (She has had a colonoscopy and a mammogram with the past year : no cancer.) in 2024. Concurrent medical conditions included Spinal stenosis, Ear, nose and throat disorder and Bone densitometry. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (it made her arm sore, a "sore muscle") and SINUSITIS (she also had a sinus infection). At the time of the report, PAIN IN EXTREMITY (it made her arm sore, a "sore muscle") and SINUSITIS (she also had a sinus infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Normal everyday. On an unknown date, Magnetic resonance imaging head: looked for a problem with her left ear vertigo which happened in May. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. No concomitant medications were reported. The patient had been fairly healthy. The patient stated she had received 11 COVID vaccines, and the most recent dose of the Spikevax (2024-2025) had been administered 4 months ago. The vaccine had made her arm sore, a �sore muscle' for a couple of days. The patient stated she had been in the middle of cataract surgery. She had had a sinus infection and had just been getting over it, but other than that, she had not been sick in years. The reporter stated she had had ENT issues and had to get knee surgery. She had had �bone stuff,' but other than that, she had been completely healthy. She had recently had every �test on the planet' the past year. She had had a bone density test with no osteoporosis. The reporter stated that there had been new horrible diseases. No treatment medications were reported. This case was linked to MOD-2023-716619 (Patient Link). More
2827121 78 F OK 02/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EL001SO
EL001SO
Body height, Fatigue, Infection, Interstitial lung disease, Investigation; Malai... Body height, Fatigue, Infection, Interstitial lung disease, Investigation; Malaise, Near death experience, Respiratory arrest, Seasonal allergy More
she had interstitial lung disease.; she was picked up at home in ambulance, was not breathing, was t... she had interstitial lung disease.; she was picked up at home in ambulance, was not breathing, was totally passed out.; she was picked up at home in ambulance, was not breathing, was totally passed out.; did not feel good; tired; big infection/she got infected; allergies related to pollen; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 80-year-old female patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: EL001SO) at the age of 78 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "hysterectomy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE. LOT: EL9264. Administered in arm.), administration date: 05Feb2021, when the patient was 77-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE. LOT: EL9266.), administration date: 26Feb2021, when the patient was 77-year-old, for COVID-19 immunisation. The following information was reported: NEAR DEATH EXPERIENCE (hospitalization, life threatening), RESPIRATORY ARREST (hospitalization, life threatening) all with onset 06Feb2024, outcome "unknown" and all described as "she was picked up at home in ambulance, was not breathing, was totally passed out."; SEASONAL ALLERGY (non-serious) with onset Feb2024, outcome "unknown", described as "allergies related to pollen"; INFECTION (non-serious) with onset Feb2024, outcome "unknown", described as "big infection/she got infected"; INTERSTITIAL LUNG DISEASE (hospitalization) with onset Feb2024, outcome "unknown", described as "she had interstitial lung disease."; MALAISE (non-serious), outcome "unknown", described as "did not feel good"; FATIGUE (non-serious), outcome "unknown", described as "tired". The patient was hospitalized for near death experience, respiratory arrest (start date: Feb2024, hospitalization duration: 8 day(s)); for interstitial lung disease (start date: Feb2024). The clinical course was reported as follows: Patient had never smoked in her life. Had never taken illegal drugs, any of that kind of stuff. Patient reported that she had shrunk 4, 8. Around 06Feb2024, patient was picked up at home in ambulance, was not breathing, was totally passed out. Woke up in hospital, had no way of knowing, did not remember a thing except, being picked up and carried in chair she was sitting in, going down the stairs. Remembered waking up in hospital. Patient was in hospital, in Intensive Care Unit (ICU), 8 days. They were running all kinds of tests, to figure out what was going on. That was how they determined that, she had interstitial lung disease and she received her pills to take, regimen of different kinds, along the way. She did pulmonary rehab for 24 times. Of course, they gave her 3 to 5 years. She did not feel good, it made her tired, it did not feel like doing anything. She was sitting down and would love to go lie down. It was the worst thing she could do. Patient got so out of breath. She tried to get on stationary bike each morning for 3 or 4 minutes, was doing 2 minutes. She could walk to end of yard, to street and back. Patient took vitamins, not every day but, said one a day. Patient had big infection from that Death on arrival (DOA) thing. She had allergies related to pollen. Everything started then, when she got infected. The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) shrunk is 4, 8; tests: (Feb2024) interstitial lung disease. Therapeutic measures were taken as a result of interstitial lung disease. More
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2827122 M SC 02/19/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Drug ineffective COVID-19, Disease recurrence, Drug ineffective
there's still people getting Covid right now, cause I got it again and even after the boosters;... there's still people getting Covid right now, cause I got it again and even after the boosters; Pfizer Product Name: Boosters/ got it again and event after the boosters; Pfizer Product Name: Boosters/ got it again and event after the boosters; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), 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 series of immunization completed manufacturer: Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2023, outcome "unknown" and all described as "Pfizer Product Name: Boosters/ got it again and event after the boosters"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "there's still people getting Covid right now, cause I got it again and even after the boosters". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient has taken Paxlovid before and report being pleased last time took it. Patient reports now being prescribed the medication again. It was further reported that patient had Paxlovid since he had Covid last year (last Christmas, 25Dec2023), not this past Christmas but the year before, and he used Paxlovid and it was described as a miracle drug. Patient stated that his voice was cracking up now and need to take the medication, his wife is at the pharmacy now and need to have those pills or need to take medication; he reported that there's still people getting Covid right now, cause he got it again and even after the boosters. More
2827123 U 02/19/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
COVID; COVID; second time tested positive for COVID; This is a spontaneous report received from a Co... COVID; COVID; second time tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-782175 (Moderna). A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "battled leukemia" (unspecified if ongoing), notes: for close to 10 years and was on a drug trial through. The patient's concomitant medications were not reported. Past drug history included: Protonix, reaction(s): "GERD"; Olmesartan, reaction(s): "high blood pressure", notes: 40 mg once daily; Amlodipine, reaction(s): "high blood pressure", notes: 10 mg once daily The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2023, outcome "recovered", described as "second time tested positive for COVID"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID". The clinical course was reported as follows: The patient tested positive for COVID twice. The first time got COVID, took PAXLOVID and the PAXLOVID gave more side effects than the COVID virus did. The second time tested positive for COVID (at the end of 2023) they attempted to find a smaller/ pediatric dose of PAXLOVID but by the time they found it, no longer had any symptoms. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2827124 M LA 02/19/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
talked someone earlier about Paxlovid/prescription is for her husband/took 3 Pfizer COVID vaccines; ... talked someone earlier about Paxlovid/prescription is for her husband/took 3 Pfizer COVID vaccines; talked someone earlier about Paxlovid/prescription is for her husband/took 3 Pfizer COVID vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 78-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), 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), outcome "unknown" and all described as "talked someone earlier about Paxlovid/prescription is for her husband/took 3 Pfizer COVID vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19. The clinical course was reported as follows: Patient's wife reported that her husband was asleep; he was just at home sick. Reporter and her husband took 3 Pfizer COVID vaccines, last one probably in the fall 2021, Oct2021. More
2827125 M 02/19/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Influenza Influenza
Seasonal influenza; This spontaneous case, initially received on 07-Feb-2025, was reported by a non ... Seasonal influenza; This spontaneous case, initially received on 07-Feb-2025, was reported by a non health professional and concerns a male patient with unknown age. Medical history and concomitant medications were reported as unknown. Administration of company suspect drug: On an unknown date in Oct-2024 or Nov-2024, the patient received Flucelvax (TIV) for Influenza vaccination, Dose regimen: 0.5 ml, route of administration and anatomical location: not reported. Lot number: not reported but would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Jan-2025, the patient experienced Seasonal influenza (Medically Significant, outcome: Not Reported, stop date: 29-Jan-2025). It was reported that In October or November of 2024, the patient received the Flucelvax vaccine and he diagnosed with seasonal influenza on 29-Jan-2025. 'Case was upgraded to serious upon company assessment of the reported event Seasonal influenza clinical significance' Flucelvax (TIV) action taken: Not Applicable Reporter assessment: The reporter considered the event as non-serious and did not provide a causality assessment for event; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association cannot be completely ruled out for the events in view of insufficient information (events onset date, temporality, relevant medical history,nclear etiology). More
2827137 33 F MO 02/19/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 92NK2
Exposure via skin contact, Syringe issue, Underdose Exposure via skin contact, Syringe issue, Underdose
administration of an incomplete Engerix-B dose to an adult patient; an unknown volume of the vaccine... administration of an incomplete Engerix-B dose to an adult patient; an unknown volume of the vaccine dripped over the patient�s arm; an unknown volume of the vaccine dripped over the patient�s arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 33-year-old female patient who received HBV (Engerix B) (batch number 92NK2, expiry date 29-SEP-2026) for prophylaxis. On 26-JAN-2025, the patient received Engerix B. On 26-JAN-2025, an unknown time after receiving Engerix B, the patient experienced incomplete dose administered (Verbatim: administration of an incomplete Engerix-B dose to an adult patient), exposure via skin contact (Verbatim: an unknown volume of the vaccine dripped over the patient�s arm) and inadvertent exposure to vaccine (Verbatim: an unknown volume of the vaccine dripped over the patient�s arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine 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: 27-JAN-2025 A pharmacist called to report the administration of an incomplete Engerix-B dose to a patient, which led to an incomplete dose administration. The pharmacist mentioned that during the administration an unknown volume of the vaccine dripped over the patient's arm, which led to an inadvertent exposure to vaccine and exposure via skin contact. The reporter asked if patient should be revaccinated. More
2827138 0.17 F TX 02/19/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7907AA
Injected limb mobility decreased, Injection site swelling, Irritable bowel syndr... Injected limb mobility decreased, Injection site swelling, Irritable bowel syndrome More
leg swelling, entire leg, unable to move leg, fussy/irritable leg swelling, entire leg, unable to move leg, fussy/irritable
2827139 4 M CA 02/19/2025 DTAPIPV
HEPA
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 42Y93
DN273
Y015989
Dermatitis bullous, Rash papular, Rhinorrhoea, Varicella post vaccine; Dermatiti... Dermatitis bullous, Rash papular, Rhinorrhoea, Varicella post vaccine; Dermatitis bullous, Rash papular, Rhinorrhoea, Varicella post vaccine; Dermatitis bullous, Rash papular, Rhinorrhoea, Varicella post vaccine More
Developed rhinorrhea and papular-vesicular-bullous rash 3d after vaccination - suspect post-vaccinat... Developed rhinorrhea and papular-vesicular-bullous rash 3d after vaccination - suspect post-vaccination varicella More
2827157 74 M NC 02/19/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 HA9CH
Rash Rash
Patient reported to the pharmacy that he developed a rash on his hands and head that began several m... Patient reported to the pharmacy that he developed a rash on his hands and head that began several months after he received the vaccine. He reported it 2 years after the vaccine was given. More
2827158 72 M VA 02/19/2025 COVID19
 PFIZER\BIONTECH
 LN0588
Injection site bruising Injection site bruising
The patient came to the pharmacy on 2/19/25 to show photos of large black and blue bruising around t... The patient came to the pharmacy on 2/19/25 to show photos of large black and blue bruising around the injection site More
2827159 58 F OH 02/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Asthenia, COVID-19, Fatigue, Gait disturbance, Impaired work ability; Loss of co... Asthenia, COVID-19, Fatigue, Gait disturbance, Impaired work ability; Loss of consciousness, Malaise, Pain, Pain in extremity, Pyrexia More
Vaccine given at 4 pm. Drove home which was 30 minutes away. Around 5:30pm I decided to do my workou... Vaccine given at 4 pm. Drove home which was 30 minutes away. Around 5:30pm I decided to do my workout. My arm was sore but nothing to be alarmed about. I did everything for the beginning and standing part. I then went to the floor to do my floor workout. It is a good thing I did. I only remember laying down. I completely passed out. I have never passed out before. I woke up about 30 minutes later and I was sick as a dog. I had a high fever and I hurt from head to toe. I was eating the ibuprofen all weekend and it took about 3 days before I began to feel a little better. I had to miss work. This was the second injection. I did not have any reaction to the first one. I now know I actually had Covid. Since the vaccines, I have had Covid twice. So much for the stupid vaccine. Every time I get it I have adverse symptoms that are long lasting. Especially low or no energy. I find it hard to even go up stairs. Complete fatigue. I still struggle on and off with that without being sick. I know it is a leftover from the vaccines. More
2827160 73 M OR 02/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 544TL
Chills, Flank pain, Renal pain Chills, Flank pain, Renal pain
Chills, uncontrolled shivering and kidney/flank pain. Chills, uncontrolled shivering and kidney/flank pain.
2827161 64 M MO 02/19/2025 COVID19
COVID19
 MODERNA
MODERNA
 008B21A
008B21A
Atrial fibrillation, Balance disorder, Brain fog, Cardiac ablation, Cerebrovascu... Atrial fibrillation, Balance disorder, Brain fog, Cardiac ablation, Cerebrovascular accident; Hypoaesthesia, Sleep apnoea syndrome, Vertigo, Vocal cord paralysis More
Suffered stroke on 8/9/2021. Developed A Fib, sleep apnea, vertigo, paralyzed vocal cord, numbness... Suffered stroke on 8/9/2021. Developed A Fib, sleep apnea, vertigo, paralyzed vocal cord, numbness on left side of body, major balance issues. Spent 3 weeks in the hospital, then had one year of physical therapy. Made significant recovery but still suffer from balance issues, brain fog and numbness on left side of body. More
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2827162 22 M OR 02/19/2025 COVID19
HEP
MMR
TDAP
 PFIZER\BIONTECH
DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 LN0589
944609
Y009782
XN575
Syncope, Urinary incontinence; Syncope, Urinary incontinence; Syncope, Urinary i... Syncope, Urinary incontinence; Syncope, Urinary incontinence; Syncope, Urinary incontinence; Syncope, Urinary incontinence More
Patient fainted and urinated themselves about a minute after completing vaccines Patient fainted and urinated themselves about a minute after completing vaccines
2827163 53 F WI 02/19/2025 TD
TD
 SANOFI PASTEUR
SANOFI PASTEUR

Cervical vertebral fracture, Exercise tolerance decreased, Loss of consciousness... Cervical vertebral fracture, Exercise tolerance decreased, Loss of consciousness, Palpitations, Postural orthostatic tachycardia syndrome; Road traffic accident, Syncope, Wound More
Syncope with exercise and palpitations. I passed out while riding my bicycle and broke my neck etc. ... Syncope with exercise and palpitations. I passed out while riding my bicycle and broke my neck etc. I almost died. I had a POTs type syndrome. I got the TD again this year after a large puncture wound and developed POTs again about 10 days after the shot. I would continually pass out if I tried to exercise or put forth any effort . It is somewhat better now but still lots of palpitations. I was curious to if I had a TD shot just prior to my accident and sure enough I did. I am obviously not ever getting another TD. I had a reaction a long time ago with a drop in B/p lasting a week and thought it was the pertussis component. Apparently not. Feel free to call with ?. I was an ED RN prior to my accident and disability. More
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2827164 52 F VA 02/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FM7553
FM7553
Chills, Erythema, Insomnia, Neutrophil count decreased, Pruritus; Pyrexia, Rash,... Chills, Erythema, Insomnia, Neutrophil count decreased, Pruritus; Pyrexia, Rash, Skin hyperpigmentation, Skin hypertrophy, White blood cell count decreased More
rash, itching, over 90% of body, fever, chills, lack of sleep, thickened skin, hyperpigmentation, er... rash, itching, over 90% of body, fever, chills, lack of sleep, thickened skin, hyperpigmentation, erythemia, White blood cells and nuetrophil levels low - this has been happening from time of vaccine to present day More
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2827165 69 F FL 02/19/2025 FLU3
 SANOFI PASTEUR
Dizziness, Malaise, Nausea, Vomiting Dizziness, Malaise, Nausea, Vomiting
When I woke up Wednesday I was dizzy, rather quickly felt nauseous and within about 3 hours, I was s... When I woke up Wednesday I was dizzy, rather quickly felt nauseous and within about 3 hours, I was sick (vomited.) I continued to be dizzy for the next 3 days and finally felt better on Sunday. (Please note : I am not sure of the exact Flu shot I received but I *think* it was the Seasonal Influenza High-dose Fluzone - but pharmacy would know for sure. I can't call to ask since the Pharmacy is closed now.) More
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