🏥 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 💀 🏥 🚑 ♿ ⚠️
2844659 41 M AZ 06/11/2025 COVID19
 MODERNA
 3046732
Extra dose administered, No adverse event Extra dose administered, No adverse event
No known adverse reaction. Pt received two doses of COVID vaccine. Dose 1: 10/29/2024. Dose 2: 06/11... No known adverse reaction. Pt received two doses of COVID vaccine. Dose 1: 10/29/2024. Dose 2: 06/11/2025 More
2844660 54 M WA 06/11/2025 ANTH
COVID19
 EMERGENT BIOSOLUTIONS
NOVAVAX
4302mf023
Chest pain, Furuncle, Myocardial infarction, Peripheral swelling; Chest pain, Fu... Chest pain, Furuncle, Myocardial infarction, Peripheral swelling; Chest pain, Furuncle, Myocardial infarction, Peripheral swelling More
took ivermectin, metax lotion, colloidal gold water , wormwood , and many other took ivermectin, metax lotion, colloidal gold water , wormwood , and many other
✓ ✓
2844661 78 F NC 06/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received a second dose of a one-dose series. The first dose was administered to the patient... Patient received a second dose of a one-dose series. The first dose was administered to the patient in August of 2023, but not reported to the State Immunization Registry. The second dose was administered on June 6, 2025. Patient reports no adverse effects following the second dose. More
2844662 26 M TX 06/11/2025 COVID19
 PFIZER\BIONTECH
Atrial fibrillation, Cardiac monitoring, Postural orthostatic tachycardia syndro... Atrial fibrillation, Cardiac monitoring, Postural orthostatic tachycardia syndrome More
Onset of POTS and atrial fibrillation Onset of POTS and atrial fibrillation
✓
2844667 8 M CO 06/11/2025 HEP
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 X004819

X024656
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
Improperly stored vaccine administered before it expired.; No additional AE; This spontaneous report... Improperly stored vaccine administered before it expired.; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced a temperature excursion on 19-MAR-2025. Because they did not know that temp TRED 30-16R was temperature. Excursion by power outage in the morning, and they did not know, On 08-APR-2025, the patient was vaccinated with an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X024656, expiration date: 09-APR-2025) (doses and routes of administration, were not reported) with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 66 degrees Fahrenheit for 3 hours. There was no adverse effect reported. No product quality complaint was involved. Follow up information was received from the pharmacist, on 28-MAY-2025. The patient was an 8-years-old boy, who on 24-MAR-2025 (previously reported as 08-APR-2025), received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot # X024656, expiring on 04-SEP-2025 (previously captured as 09-APR-2025), in the right deltoid (dose and route not reported) in a public health clinic/hospital, as required by school. Other vaccines administered on the same day included Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), (lot #X004819, expiration date: 22-May-2025) in Left Deltoid and Diphtheria vaccine toxoid;Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid (QUADRACEL) (lot #U7908AB, expiring on 03-OCT-2025) in the right deltoid. On 19-MAR-2025, the vaccines experienced a temperature excursion of 47 to 77 degrees Fahrenheit for 3 hours, due to digital data logger issue. On 02-MAY-2025, the vaccine's potency was checked and was supported. This is one of several reports form the same source More
2844668 52 F MD 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75D3A
Inappropriate schedule of product administration Inappropriate schedule of product administration
Early 2nd dose.; This non-serious case was reported by a nurse via call center representative and de... Early 2nd dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 75D3A, expiry date 31-MAR-2027) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 02-JUN-2025, the patient received the 2nd dose of Shingrix. On 02-JUN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose.). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK receipt date: 05-JUN-2025 On 05/Jun/2025, a nurse called to inform about the early administration of the 2nd dose of Shingrix to a patient, according to reporter, first dose was given back in 11/Apr/2025, and the 2nd dose was administered on 2/Jun/2025 which led to which led to shortening of vaccinations schedule. More
2844669 M PA 06/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Incomplete Vaccination Schedule; This non-serious case was reported by a pharmacist via call center ... Incomplete Vaccination Schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 2 dosage last year). On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete Vaccination Schedule). 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: 05-JUN-2025 The pharmacist reported Someone called in reference to give a follow-up shot for Twinrix, they didn't get first ones here, so, we did determine it was Twinrix. Now, he is going to show up and he said that the last one he got was over a year ago and he is here to get his Third shot. So, does he have to start the series over again. HCP stated that the patient was new to them. He said that he did not have more information about the patient and previous doses. Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination. More
2844670 0.17 F IA 06/11/2025 RSV
 PFIZER\WYETH
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
There were no adverse effects, i gave a 2 month old patient a RSV vaccine, the database only had one... There were no adverse effects, i gave a 2 month old patient a RSV vaccine, the database only had one option pull up when i typed in RSV, it was the ABRYSVO RSV vaccine, after giving the vaccine i was trying to chart it in our computer and realized i couldn't, so i dug a little deeper and realized this vaccine was for older adults and pregnant women, not infants, so i called the pharmacy, they got ahold of Pfizer and asked what we needed to do/ what side effects would happen, they said the patient could be more fussy then normal,, be sore at injection site, and may run a low grade fever, which normally can happen with any vaccine given, the patient also received 3 other vaccines today so she will probably be sore and more fussy because of all the vaccines. I also informed my manager and the provider i work with about my mistake and they gave me the steps to follow to fill out the correct paperwork. More
2844671 56 F ME 06/11/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Extra dose administered Extra dose administered
Patient was given booster when not immunocompromised or over the age of 65 in anticipation of travel Patient was given booster when not immunocompromised or over the age of 65 in anticipation of travel
2844672 17 M ME 06/11/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Extra dose administered Extra dose administered
Patient was administered booster of Comirnaty but the vaccine was not indicated. Patient not immunoc... Patient was administered booster of Comirnaty but the vaccine was not indicated. Patient not immunocompromised or over 65 More
2844673 12 F PA 06/11/2025 HPV9
 MERCK & CO. INC.
Blood pressure decreased, Dizziness, Nausea, Pallor, Vomiting Blood pressure decreased, Dizziness, Nausea, Pallor, Vomiting
Loss of color in face/pale. Dizziness, Nausea, vomiting, slight drop in blood pressure. Loss of color in face/pale. Dizziness, Nausea, vomiting, slight drop in blood pressure.
2844674 18 M ME 06/11/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Extra dose administered Extra dose administered
Given booster when not indicated in anticipation of family travel. Given booster when not indicated in anticipation of family travel.
2844680 59 F CA 06/11/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LN0588
LN0588
Arthralgia, Impaired driving ability, Injection site pain, Loss of personal inde... Arthralgia, Impaired driving ability, Injection site pain, Loss of personal independence in daily activities, Pain in extremity; Paraesthesia, Rotator cuff syndrome, X-ray limb More
IT BEGAN WITH MINOR ARM PAIN THAT EVENTUALLY WENT TO MY SHOULDER. EACH MORNING WAKING UP TO MY HANDS... IT BEGAN WITH MINOR ARM PAIN THAT EVENTUALLY WENT TO MY SHOULDER. EACH MORNING WAKING UP TO MY HANDS TINGLING AND ARM AND INJECTION SITE SORE AND HURTING. I WAS DIAGNOSED WITH SHOUDLER IMPINGEMENT SYNDRONE. I RECEIVED A CORTISONE SHOT AND 30 DAYS LATER I AM IN THE WORSE PAIN AND AM UNABLE TO PERFORM MY NORMAL DAY TO DAY DUTIES, LIKE DRIVING, PUTTING ON CLOTHES (SHIRT OR DRESS OR NIGHT GOWN). I REACHED OUT TO MY DR TODAY JUNE 10, 2025 AND SHE WANTS ME TO MAKE AN APPOINTMENT FOR PHYSICAL THERAPY. More
2844681 35 F CO 06/11/2025 VARCEL
 MERCK & CO. INC.
 Y015100
Erythema, Pain in extremity, Skin warm Erythema, Pain in extremity, Skin warm
Patient called the pharmacy on 6/11 to report increasing redness that is moving down the arm, pain a... Patient called the pharmacy on 6/11 to report increasing redness that is moving down the arm, pain and hot to the touch. More
2844682 82 M WA 06/11/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Extra dose administered, No adverse event Extra dose administered, No adverse event
no adverse effect. duplicate vaccine. pt had a vaccine one month prior no adverse effect. duplicate vaccine. pt had a vaccine one month prior
2844704 0.17 F WY 06/11/2025 MMRV
 MERCK & CO. INC.
 1973244
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Dose inadvertently administered too early. as of now no adverse reaction Dose inadvertently administered too early. as of now no adverse reaction
2844400 OH 06/10/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 X028353
1973244
Device issue, No adverse event; Device issue, No adverse event Device issue, No adverse event; Device issue, No adverse event
No adverse event; HCP reported PQC for 3 Sterile Diluent PFS that all occurred during one vaccinatio... No adverse event; HCP reported PQC for 3 Sterile Diluent PFS that all occurred during one vaccination visit: Event #1: HCP reports after she diluted MMR II with sterile Diluent PFS. Upon withdrawing the MMR II vaccine back into the PFS- the Barrel of the Sterile D; Syringe issue; Complication of device removal; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-MAY-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) 0.5 ml (lot #X028353, who had been verified to be a valid lot number, expiration date: 11-DEC-2025) administered by Intramuscular route as prophylaxis; sterile diluent (lot #1973244, who had been verified to be a valid lot number, expiration date: 01-MAR-2026). It was reported that the health care professional was administering Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) and the needle and leurlock separated from the barrel of the prefilled syringe (PFS). The needle and leurlock remained in the patient and the PFS separated from the leurlock (Poor quality device used, Syringe issue, Complication of device removal). In addition some information about syringe was reported as: health care professional reported after she diluted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) with sterile Diluent PFS. Upon withdrawing the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) vaccine back into the PFS- the Barrel of the Sterile Diluent separated from the Needle and Leurlock- The Needle and Leurlock remained in the stopper of the vial and the barrel of the PFS was separate. The caller states all components were intact (Not broken) but were just separated. Also, after Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) (not related to #1 or #2 report) was administered. HCP went to engage the safety cap on the needle and the needle and leurlock "Flew across the room". HCP states no injuries from this incident. HCP confirmed there were no broken components- The leurlock and needle separated from the barrel of the PFS. No additional adverse events. More
2844401 F OH 06/10/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Alanine aminotransferase, Antibody test, Aspartate aminotransferase, Autoimmune ... Alanine aminotransferase, Antibody test, Aspartate aminotransferase, Autoimmune hepatitis, Biopsy liver; Blood alkaline phosphatase, Blood bilirubin, Hepatic enzyme, Histology, Investigation; Microscopy, Serology test More
autoimmune hepatitis after receiving a SARS-CoV-2 mRNA vaccine; This is a literature report for the ... autoimmune hepatitis after receiving a SARS-CoV-2 mRNA vaccine; This is a literature report for the following literature source(s). The demographics and clinical characteristics of the patients were presented . The majority of the patients were female (8 of 12; 67%) and (redacted) (9 of 12; 75%), with an age range between 29 and 79 years (redacted, 58 years). Five patients received the mRNA-1273 (Moderna) vaccine and 7 patients received the BNT162b2 (Pfizer BioNTech) vaccine. Ten patients received at least 2 doses of the SARSCoV-2 mRNA vaccines and 2 patients received only 1 dose. Four of 12 patients (33%) had a prior history of liver disease, including jaundice, steatosis, cirrhosis secondary to metabolic dysfunction-associated steatohepatitis complicated by hepatocellular carcinoma, and autoimmune hepatitis. Nine of 12 patients (75%) presented with symptoms including jaundice, pruritus, fever, nausea, fatigue, and epigastric pain. Three of 12 patients (25%) were asymptomatic, and they had all received the BNT162b2 vaccine. Eleven of the 12 patients (92%) had significantly elevated liver enzymes that prompted liver biopsies. Two of the 3 asymptomatic patients (67%) had elevated liver enzymes that were identified on routine laboratory testing for annual wellness visits. The third asymptomatic patient had a history of liver transplantation and mildly elevated alanine transaminase; this biopsy was done as routine follow-up to monitor the liver allograft. Clinical symptoms for the 9 patients began between 1 day and 2 months after receiving the vaccine dose. Two of 12 patients (17%) developed symptoms after the first dose, 5 (42%) developed symptoms after the second dose, and 2 patients (17%) developed symptoms after the third dose. All symptomatic patients (n = 9) and 1 asymptomatic patient had elevated aspartate transaminase and/or alanine transaminase greater than 1000 IU/mL. Positive titers for autoimmune antibodies were detected in all but one of the patients for whom serologic data were available (9 of 10 patients; 90%). Viral serologies available for 9 of 9 patients (100%) were negative. Three of 12 patients (25%) reported new medications: 1 had been prescribed low-dose acetaminophen, opioids, and celecoxib; another was on etonogestrel; and the third was on baby aspirin. However, drug-induced liver injury was considered unlikely after consideration of dosage and timing of the medications by the treating hepatologists. Eight of 12 patients (67%) received steroid treatment and 4 of 12 (33%) received no treatment. Clinical symptoms resolved spontaneously (n = 4) or after steroid therapy (n = 8) between 1 and 3 months after presentation. Normalization of liver enzymes occurred during several months. One patient was eventually diagnosed with autoimmune hepatitis, and another was later diagnosed with celiac disease and sarcoidosis.; Sender's Comments: The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
✓
2844402 AL 06/10/2025 IPV
 SANOFI PASTEUR
 W1C751M
No adverse event, Product storage error No adverse event, Product storage error
ipol was administered after temperature excursion with maximum/lowest temperature reached: 28.6 fah... ipol was administered after temperature excursion with maximum/lowest temperature reached: 28.6 fahrenheit duration 1 hour and 13 minutes with no reported adverse event; Initial information received on 06-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] after temperature excursion with maximum/lowest temperature reached: 28.6 Fahrenheit duration 1 hour and 13 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection, lot W1C751M, expiry date:18-nov-2025,strength not reported via unknown route in unknown administration site for Prophylactic vaccination (immunization) post excursion where maximum/lowest temperature reached: 28.6 Fahrenheit duration 1 hour and 13 minutes with no reported adverse event (poor quality product administered) (unknown latency). Reportedly, human error was not involved; Reason: Unknown. The extended stability data doesn't cover the excursion and product has been administered post excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001\83\EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844414 32 IN 06/10/2025 TDAP
 SANOFI PASTEUR
Off label use Off label use
Intentional Off Label Prescription by HCP: Adacel is prescribed with off label diagnosis code S31.31... Intentional Off Label Prescription by HCP: Adacel is prescribed with off label diagnosis code S31.31XA Laceration without foreignbody of scrotum and testes, initial encounter with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 32 years old and unknown gender patient for whom diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] intentional off label prescription by hcp with off label diagnosis code s31.31xa laceration without foreign body of scrotum and testes, initial encounter with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose (0.5ml) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine; Suspension for injection in pre-filled syringe (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for Laceration without foreign body of scrotum and testes, initial encounter (Scrotal injury) and (Testicular injury); intentional off label prescription by hcp with off label diagnosis code s31.31xa laceration without foreign body of scrotum and testes, initial encounter with no reported adverse event (off label use). (latency: same day) Information on the batch number cannot be requested corresponding to the one at time of event occurrence. Action taken was not applicable. More
2844454 WA 06/10/2025 HPV9
 MERCK & CO. INC.
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
No symptoms reported.; Nurse called and reported that 1 dose of GARDASIL 9 was inadvertently adminis... No symptoms reported.; Nurse called and reported that 1 dose of GARDASIL 9 was inadvertently administered to a 68 year old patient when the patient actually should have received PCV 20. Caller stated this patient had never had any previous HPV vaccinations. Caller stated n; This spontaneous report was received from a nurse and refers to a 68-year-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. The patient had never had any previous human papillomavirus (HPV) vaccinations. On 16-MAY-2025, the patient was inadvertently vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a dose of 1 dosage form (1 dose) (route of administration, anatomical location, lot # and expiration date were not reported) instead of pneumococcal vaccine conj 20v (crm197); the vaccine should have been administered for prophylaxis (Wrong product administered). No patient symptoms had been reported (No adverse event). Lot# is being requested and will be submitted if received. More
2844455 F MO 06/10/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y003883
Y015108
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No additional AE/PQC reported; HCP reported that a husband and wife both received the VARIVAX and PR... No additional AE/PQC reported; HCP reported that a husband and wife both received the VARIVAX and PROQUAD vaccines concomitantly; HCP reported that both patients are adults; This spontaneous report was received from a medical assistant and refers to an adult female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), lot #Y015108, expiration date: 06-Sep-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 20-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y003883, expiration date: 05-Aug-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age, overdose). No additional adverse event reported (no adverse event). More
2844456 M MO 06/10/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y003883
Y015108
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No additional AE/PQC reported; HCP reported that a husband and wife both received the VARIVAX and PR... No additional AE/PQC reported; HCP reported that a husband and wife both received the VARIVAX and PROQUAD vaccines concomitantly; HCP reported that both patients are adults; This spontaneous report was received from a medical assistant and refers to an adult male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), lot #Y015108, expiration date: 06-Sep-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 20-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y003883, expiration date: 05-Aug-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age, overdose). No additional adverse event reported (no adverse event). More
2844457 DE 06/10/2025 HPV9
 MERCK & CO. INC.
 Y015599
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE/PQC; administration of GARDASIL-9 to a patient under 9 years old; This spontaneous ... No additional AE/PQC; administration of GARDASIL-9 to a patient under 9 years old; This spontaneous report was received from a nurse and refers to a 6-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 04-JUN-2025, the patient was administered a dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) lot # Y015599 established as valid, expiration date 10-FEB-2027 (dose, route of administration, anatomical location, indication were not provided) (Product administered to patient of inappropriate age). No adverse events were reported. More
2844458 20 F CO 06/10/2025 HEPA
 MERCK & CO. INC.
No adverse event, Underdose, Wrong product administered No adverse event, Underdose, Wrong product administered
A FBE called on behalf of an HCP to report an AE for VAQTA in which a 0.5mL pediatric dose administe... A FBE called on behalf of an HCP to report an AE for VAQTA in which a 0.5mL pediatric dose administered to an adult patient on an unknown date who should have instead received a 1mL dose. The FBE stated the patient did not experience any other advers; the patient did not experienced any other adverse issues or side effects; This spontaneous report was received from a nurse and refers to a 20-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis; but the patient was administered 0.5 mL (which is the pediatric dose) instead of 1 mL (incorrect dose administered). The patient did not experience any other adverse issue or side effect from the dose administered. More
2844459 9 M VA 06/10/2025 HEPA
 MERCK & CO. INC.
 Y006121
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No Additional AE/ No PQC; Caller states third dose administered was verified to be VAQTA and was not... No Additional AE/ No PQC; Caller states third dose administered was verified to be VAQTA and was noticed to be expired after administered to patient.; This spontaneous report was received from a medical assistant and refers to a(n) 9-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included Hepatitis A vaccine (unknown brand name) (lot # NB759), and Hepatitis A vaccine (unknown brand name) (lot # 77DFK). These vaccines were administered at inappropriate schedule, reported as: patient received two hepatitis A vaccines (unknown brand name) at another facility 5 months apart instead of 6 months as recommended. Concomitant therapies were not reported. On 06-Jun-2025, the patient with the third dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #Y006121, expiration date: 17-May-2025, 0.5 mL administered by intramuscular route for the treatment of vaccination (expired vaccine used). No additional adverse event reported (no adverse event). More
2844460 IL 06/10/2025 HEP
 MERCK & CO. INC.
 W025817
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE/No PQC.; HCP calling to report expired administration of RECOMBIVAX HB on 06/02/202... No additional AE/No PQC.; HCP calling to report expired administration of RECOMBIVAX HB on 06/02/2025. The product was expired on 05/21/2025 with no TEs. No symptoms reported on behalf of patient. Supported outcome delivered verbally per memo. Received consent to contact. No; This spontaneous report was received from a physician and refers to a 10-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-JUN-2025, the patient was vaccinated with an expired vaccine of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (valid lot number W025817, expiration date: 21-MAY-2025) for prophylaxis (dose, dose number, frequency, anatomical location and route of administration were not provided) (expired product administration), no temperature excursion were reported. No symptoms reported on behalf of patient. No additional adverse event (AE) reported. More
2844461 MO 06/10/2025 COVID19
FLUN3
 UNKNOWN MANUFACTURER
MEDIMMUNE VACCINES, INC.

Death; Death Death; Death
Patient is deceased; A solicited report has been received from a other health professional in Patien... Patient is deceased; A solicited report has been received from a other health professional in Patient Support Program. The report concerns a male elderly patient born in 1936 (age 88 years). No medical history was reported. No concomitant products were reported. The patient started treatment with Dapagliflozin (dapagliflozin) (batch number(s) Unknown), on an unknown date for product used for unknown indication. It is unknown if any action was taken with Covid-19 Vaccine (covid-19 vaccine) and Fluenz (influenza vaccine live reassort 3v). The patient died (preferred term: Death) on 22-FEB-2025. The patient died on 22-FEB-2025. It is not known whether an autopsy was performed. The cause of death was unknown. The event was considered serious (Medically Significant and Death). The reporter did not assess causality for patient is deceased.The reporter did not consider that there was a reasonable possibility of a causal relationship between Dapagliflozin and the following event(s): patient is deceased. The company physician did not consider that there was a reasonable possibility of a causal relationship between Dapagliflozin and the following event(s): patient is deceased. The company physician considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): patient is deceased. The company physician considered that there was a reasonable possibility of a causal relationship between Fluenz and the following event(s): patient is deceased. Significant correction on 30-Apr-2025 : coding for the suspect drug influenza has been updated narrative amended,; Sender's Comments: This is a case report of an 88-year-old male patient with reported fatal outcome (Preferred term: Death) in association with covid 19. Cause of death was further not specified. Advanced age could be possibly confounding. Due to limited information on cause of death, circumstances leading to fatal outcome, indication, autopsy details, medical history, concurrent diseases, concomitant medications, etiological and diagnostic workup, other risk factors; the evaluation did not find evidence to exclude a causal relationship between fatal outcome and suspect; Reported Cause(s) of Death: unknown cause of death More
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2844462 M TN 06/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 92NN2
Lymphadenopathy, Peripheral swelling, Swelling Lymphadenopathy, Peripheral swelling, Swelling
Lymphadenopathy worsened; swelling in his neck; swelling in his right arm; This non-serious case was... Lymphadenopathy worsened; swelling in his neck; swelling in his right arm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of lymphadenopathy in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 92NN2, expiry date 30-MAR-2027) for prophylaxis. On 28-MAY-2025, the patient received the 1st dose of Shingrix (right arm). On 01-JUN-2025, 4 days after receiving Shingrix, the patient experienced lymphadenopathy (Verbatim: Lymphadenopathy worsened), neck swelling (Verbatim: swelling in his neck) and swelling arm (Verbatim: swelling in his right arm). The patient was treated with clindamycin. The outcome of the lymphadenopathy, neck swelling and swelling arm were resolving. The reporter considered the lymphadenopathy, neck swelling and swelling arm to be related to Shingrix. The company considered the lymphadenopathy, neck swelling and swelling arm to be related to Shingrix. Additional Information: GSK Receipt Date: 03-JUN-2025 The reporter stated that the patient who received Shingrix and noticed swelling in his right arm and neck on 1st June upon awakening and went to the ER (emergency room). Emergency room attributed to Shingrix. Lymphadenopathy was reported as worsened, and it was not serious. Given 5 day course clindamycin to the patient in emergency room, on 3rd June (on the day of reporting) patient was seen by PCP (primary care physician). Patient reported symptoms were improving. No other products were received by the patient. More
2844463 06/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash macular Rash macular
Blotchy rash; This non-serious case was reported by a consumer via interactive digital media and des... Blotchy rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blotchy rash 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 blotchy rash (Verbatim: Blotchy rash). The outcome of the blotchy rash was not reported. It was unknown if the reporter considered the blotchy rash to be related to Arexvy. It was unknown if the company considered the blotchy rash to be related to Arexvy. Additional Information: GSK receipt date: 03-JUN-2025 The patient reported that glad I received it relief, that I was protected, and had minimum symptoms. Mainly, blotchy rash. More
2844464 F 06/10/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Axonal and demyelinating polyneuropathy, Gait inability, Guillain-Barre syndrome... Axonal and demyelinating polyneuropathy, Gait inability, Guillain-Barre syndrome, Herpes zoster, Hypoaesthesia; Malaise, Vaccination failure; Axonal and demyelinating polyneuropathy, Gait inability, Guillain-Barre syndrome, Herpes zoster, Hypoaesthesia; Malaise, Vaccination failure More
Suspected vaccination failure; she had Guillain-Barre; followed by axonal demyelinating polyneuropat... Suspected vaccination failure; she had Guillain-Barre; followed by axonal demyelinating polyneuropathy; I still get shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In APR-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: she had Guillain-Barre) (serious criteria GSK medically significant), axonal and demyelinating polyneuropathy (Verbatim: followed by axonal demyelinating polyneuropathy) (serious criteria GSK medically significant) and shingles (Verbatim: I still get shingles). The outcome of the vaccination failure, guillain barre syndrome and shingles were unknown and the outcome of the axonal and demyelinating polyneuropathy were not resolved. It was unknown if the reporter considered the vaccination failure, guillain barre syndrome, axonal and demyelinating polyneuropathy and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure, guillain barre syndrome and axonal and demyelinating polyneuropathy to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date : 04-JUN-2025 Reporter reported that patient was she was terribly ill. She had Guillain-Barre followed by axonal demyelinating polyneuropathy. During the call, Member of Public, also mentioned she could not felt her feet, she was crippled and she still got shingles. She claimed that back in 2023 there was no warning that these adverse effects could happened. She indicated that she did not want to share her address. She did not want to answer any further questions. During the conversation she made statements such as she had been crippled by your 'rubbish' vaccination. It was prescribed to her by her doctor because she was getting shingles. Full disclosure would have been good in January 2023 before she had the shot, that would have been good but she did not get it. If she had been told that she could get Guillain-Barre GB or any other ailment she would not have your vaccination. -January 2023 was when she had her first shot there was no [GBS] warning. She did got the second shot in April 2023. The warning on TV about the risk of Guillain-Barre did not come about until about 18 months ago. She was very ill, crippled. She had axonal demyelinating polyneuropathy. She could not felt her feet. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure and Guillain-Barre syndrome are listed events 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 vaccine Shingrix(Dose 1 & 2). Axonal and demyelinating polyneuropathy is an unlisted event which is considered unrelated to GSK vaccine Shingrix(Dose 1 & 2). More
2844465 M 06/10/2025 COVID19
 MODERNA
COVID-19 COVID-19
Patient had covid twice; This spontaneous case was reported by a consumer and describes the occurren... Patient had covid twice; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had covid twice) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had covid twice). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient had covid twice) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication information was not provided. It was reported that the first-time patient had Covid was 3 years ago. The patient was going to die literally even though being tough. The patient was prescribed Paxlovid. The reporter swore to God, that the next day, the reporter did not have Covid. It was like a miracle for the reporter. In the second time of developing Covid when the patient had Paxlovid, it did not work at all. He thought they might have changed the formulation, as it was made somewhere else, or might be he did not take it soon enough. However, he did not know the answer to this. Patient did not have the Pfizer vaccine. Patient waited until day 6 of having Covid, and just thought he had a cold. Patient was more symptomatic with covid that second time. A nurse practitioner prescribed Paxlovid. Patient took the Paxlovid every day and just got sicker and sicker. Patient thought COVID just had to run its course. Patient stated it was disappointing when he got the vaccine and still got Covid for 2-3 times. Everyone in his family had it for 2-3 times. This case was linked to US-MODERNATX, INC.-MOD-2025-787143, US-MODERNATX, INC.-MOD-2025-787169, US-MODERNATX, INC.-MOD-2025-787170 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2025: Live follow up received that contains non-significant information, reference number added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787143:same reporter different patient (Caller's family members) US-MODERNATX, INC.-MOD-2025-787170:same reporter different patient (Caller's oldest brother) US-MODERNATX, INC.-MOD-2025-787169:same reporter different patient (Caller's wife) More
2844466 4 M VA 06/10/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Per patient portal message received from mother of patient: "Patient is having a lot of redness... Per patient portal message received from mother of patient: "Patient is having a lot of redness and swelling at his vaccine location on his right thigh. He seems fine otherwise but the redness is continuing to increase in size and now the center looks bruised and purple. The thigh is hard and hot. We spoke with the team in the immunization clinic as soon as we noticed the redness (about 24 hours after the vaccine) and they suggested hot compresses and Benadryl. I wanted to make sure you were looped in and wondered if you had any other advice as it doesn?t seem to be improving. The picture attached is from the first day of redness. The redness is larger than patient?s hand now and purple in the center." Reporter was the nurse to speak with Mother of patient. More
2844467 43 F VA 06/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 204AZ1A
204AZ1A
Blood smear test normal, Blood test normal, Echocardiogram normal, Lymphadenopat... Blood smear test normal, Blood test normal, Echocardiogram normal, Lymphadenopathy, Lymphoedema; Ultrasound scan normal More
5-6 day post vaccine, I had swelling of lymph nodes under arm pit. Beginning in fall of 2021, inter... 5-6 day post vaccine, I had swelling of lymph nodes under arm pit. Beginning in fall of 2021, intermittent Lymphedema in right lower extremity. Lymphedema became persistent in June 2024. Ruled out DVT, Baker's Cyst, Venous insufficiency, infectious disease (filariasis). I have had no trauma, cancer, or surgery on the limb and do not fit the profile (not overweight, obese or have T2D) for primary or secondary lymphedema. More
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2844468 72 F PA 06/10/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 z004301
z004301
Acne, Arthralgia, Erythema, Peripheral swelling, Pruritus; Skin warm Acne, Arthralgia, Erythema, Peripheral swelling, Pruritus; Skin warm
Hard swollen from shoulder down to elbow. red area approximately 4 inches. Hot to touch, red spot in... Hard swollen from shoulder down to elbow. red area approximately 4 inches. Hot to touch, red spot in middle, achy shoulder, itchiness, fine pimples in red area. More
2844469 65 M PA 06/10/2025 PNC21
 MERCK & CO. INC.
 z004301
Peripheral swelling, Pruritus, Pyrexia, Rash, Rash erythematous Peripheral swelling, Pruritus, Pyrexia, Rash, Rash erythematous
rash width of arm and 2 inches long swollen bright red spots size of pinhead on neck, chest and leg.... rash width of arm and 2 inches long swollen bright red spots size of pinhead on neck, chest and leg. Low grade fever 99.4, itchiness More
2844470 45 F KS 06/10/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LK6655
9N4E7
Arthralgia, Injected limb mobility decreased, Injection site pain, Myalgia, Pain... Arthralgia, Injected limb mobility decreased, Injection site pain, Myalgia, Pain; Arthralgia, Injected limb mobility decreased, Injection site pain, Myalgia, Pain More
Patient presented to clinic for vaccinations, receiving Prevnar20 in right deltoid and Tdap in left ... Patient presented to clinic for vaccinations, receiving Prevnar20 in right deltoid and Tdap in left deltoid on Friday afternoon (5/2). Patient complained of some pain during the injection process of the Prevnar 20 vaccine to her right deltoid. The vaccine was given in full, and she said it felt like a muscle spasm in her arm. Patient left message for clinic later that evening that arm had radiating pain from shoulders to fingertips. Clinic called patient back Monday morning upon seeing message where patient states pain increased around 7:30 pm the evening of 5/2, to the point where she was not able to lift her arm above her head. She stated there was no redness or swelling at the injection site. All of her pain resided in her muscle/joint area. She did not seek further medical attention over the weekend. The provider was notified and called the patient advising that patient needs to come in for an exam if she continues to have issues with range of motion of arm. Patient states no improvement in pain and was scheduled to see provider in clinic on 5/7. Patient encouraged to continue taking ibuprofen as needed, ice, and to seek treatment at the ER if her pain worsened. At visit, patient was prescribed prednisone in the morning for 5 days and to follow up in clinic if still no improvement will plan for EMG. A follow-up message was sent to patient on her improvement however patient stated that symptoms have improved minimally, with pain still in shoulder, triceps and radiating down the arm. Provider has planned to schedule and EMG. More
2844471 70 F NC 06/10/2025 COVID19
 MODERNA
 3044091
No adverse event, Underdose, Wrong product administered No adverse event, Underdose, Wrong product administered
Staff administered the wrong vaccine (0.25mL dose for ages 6 months to 11 years), no signs or sympto... Staff administered the wrong vaccine (0.25mL dose for ages 6 months to 11 years), no signs or symptoms were present. Patient left facility. More
2844472 16 M VA 06/10/2025 HPV9
 MERCK & CO. INC.
 Z002903
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received third HPV Vaccine in error. Notified guardian of this mistake. No adverse side effe... Patient received third HPV Vaccine in error. Notified guardian of this mistake. No adverse side effects from 3 versus 2 doses. More
2844473 84 F PA 06/10/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Pyrexia Pyrexia
Had covid vaccine on 6/9/2025 then developed a fever 102.4 on 6/10/2025 no other symptoms Had covid vaccine on 6/9/2025 then developed a fever 102.4 on 6/10/2025 no other symptoms
2844474 20 F WY 06/10/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945657
Loss of consciousness, Syncope Loss of consciousness, Syncope
Syncope. Patient lost consciousness for about 15 to 20 seconds. Ice pack on back of neck then pati... Syncope. Patient lost consciousness for about 15 to 20 seconds. Ice pack on back of neck then patient was feeling fine afterward. More
2844475 34 F UT 06/10/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y009239
Y009239
Anxiety, Injection site erythema, Injection site swelling, Insomnia, Myalgia; Pa... Anxiety, Injection site erythema, Injection site swelling, Insomnia, Myalgia; Pain in extremity, Paraesthesia, Tachycardia, Tachypnoea More
Red, raised area at injection site, arm pain extending to whole body pain, paresthesia and myalgias ... Red, raised area at injection site, arm pain extending to whole body pain, paresthesia and myalgias in neck, shoulder, deltoid, and left arm; Tachypnea, tachycardia, and anxiety, insomnia. More
2844476 7 M 06/10/2025 TDAP
 SANOFI PASTEUR
Inappropriate schedule of product administration Inappropriate schedule of product administration
Tdap given too early Tdap given too early
2844477 65 F NC 06/10/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 2002626
2002626
Erythema, Headache, Malaise, Oropharyngeal pain, Pain in extremity; Pruritus, Py... Erythema, Headache, Malaise, Oropharyngeal pain, Pain in extremity; Pruritus, Pyrexia More
redness in right arm, spreading up to right axillary area with pain. mild focal itching, arm pain wi... redness in right arm, spreading up to right axillary area with pain. mild focal itching, arm pain with fever of 100, headache, malaise and sore throat. More
2844478 24 F CA 06/10/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5H773
Exposure during pregnancy, No adverse event, Wrong product administered Exposure during pregnancy, No adverse event, Wrong product administered
There were no adverse reactions to the vaccine it's an error giving the pregnant woman the Dtap... There were no adverse reactions to the vaccine it's an error giving the pregnant woman the Dtap instead of the Tdap and the provider was informed after it was given. Pt. is 29 weeks and 6 days estimated delivery date is 08/23/2025 More
2844479 60 F TX 06/10/2025 PNC20
 PFIZER\WYETH
 LJ5280
Erythema, Pain in extremity, Pruritus, Skin warm Erythema, Pain in extremity, Pruritus, Skin warm
Patient received Prevnar vaccine on 06/05/2025 on her left arm. Patient presented to pharmacy on 6/... Patient received Prevnar vaccine on 06/05/2025 on her left arm. Patient presented to pharmacy on 6/10/2025 stating her arm is still sore, swollen, red, itchy, and warm to the touch. Patient does not have fever. I asked patient what has she taken and she said nothing yet. Patient said she also did not massage her arm or apply ice as rph directed her to. Rph advised her to take massage her arm, apply ice, and take ibuprofen to help with swelling and anti-histamine to help with itching. Rph also advised patient to see doctor if symptoms does not improve. More
2844480 78 M 06/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93KK4
Pain Pain
patient said left arm hurts when he raises it patient said left arm hurts when he raises it
2844481 1.42 M 06/10/2025 HEPA
 MERCK & CO. INC.
Inappropriate schedule of product administration Inappropriate schedule of product administration
Dose given too early Dose given too early
2844482 20 F ND 06/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 30/358A
FL3209
Fatigue, Gastrointestinal disorder, Hypertension; Fatigue, Gastrointestinal diso... Fatigue, Gastrointestinal disorder, Hypertension; Fatigue, Gastrointestinal disorder, Hypertension More
Chronic fatigue, blood pressure scare and stomach issues but no one can find a cause. Chronic fatigue, blood pressure scare and stomach issues but no one can find a cause.
2844483 1.25 M 06/10/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Vaccine given too early Vaccine given too early
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