🏥 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 💀 🏥 🚑 ♿ ⚠️
2838160 53 M IL 04/27/2025 COVID19
COVID19
 JANSSEN
JANSSEN
 203AE1A
203AE1A
Cognitive disorder, Dyspnoea, Irritability, Malaise, Rash; Swelling face, Urtica... Cognitive disorder, Dyspnoea, Irritability, Malaise, Rash; Swelling face, Urticaria More
First 48 hours felt sick. The next 6-8 month complete body rash resembling welts. Swelling of face, ... First 48 hours felt sick. The next 6-8 month complete body rash resembling welts. Swelling of face, feeling of not being able to breath. Irritability, inability to think. More
2838161 76 F FL 04/27/2025 COVID19
 MODERNA
Erythema, Swelling, Tenderness Erythema, Swelling, Tenderness
SWELLING, REDNESS, TENDER TO TOUCH. NON- PURLENT CELLULITC FOMATION. SWELLING, REDNESS, TENDER TO TOUCH. NON- PURLENT CELLULITC FOMATION.
2838162 50 F OH 04/27/2025 COVID19
COVID19
 JANSSEN
PFIZER\BIONTECH

Arthropathy, Brain fog, Memory impairment, Myalgia; Arthropathy, Brain fog, Memo... Arthropathy, Brain fog, Memory impairment, Myalgia; Arthropathy, Brain fog, Memory impairment, Myalgia More
Muscle n joint weakness brain fog. Memory loss Muscle n joint weakness brain fog. Memory loss
2838163 67 M IA 04/27/2025 COVID19
 PFIZER\BIONTECH
Tinnitus Tinnitus
Tinnitus, at first subtle and increasing in nature overtime. Tinnitus has been continuous and remain... Tinnitus, at first subtle and increasing in nature overtime. Tinnitus has been continuous and remains today. Sometimes not noticed when particularly active and often can be ignored but always present and varying degrees of irritation. More
2838164 60 M CA 04/27/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 g22gh
Influenza like illness Influenza like illness
Patient has RSV shot 7 days ago and now he stated that he is feeling some flu-like symptoms. Phar... Patient has RSV shot 7 days ago and now he stated that he is feeling some flu-like symptoms. Pharmacist apologized to the patient. Pharmacist advised the patient to see his doctor on Monday if he would like. More
2838165 75 M FL 04/27/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS

Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
PATIENT RECEIVED A SCOND DOSE OF BOOSTRIX IN 9 MONTH PERIOD PATIENT RECEIVED A SCOND DOSE OF BOOSTRIX IN 9 MONTH PERIOD
2838166 66 M GA 04/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N77J2
Injection site pain Injection site pain
Patient stated that he had consistent pain at the injection site for almost 2 weeks Patient stated that he had consistent pain at the injection site for almost 2 weeks
2838167 39 F WA 04/27/2025 HPV9
 MERCK & CO. INC.
 Y000206
Arthralgia, Headache Arthralgia, Headache
Headache and joint pain lasting greater than 1 week Headache and joint pain lasting greater than 1 week
2838214 74 F TX 04/27/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 EL9262
EL9269
30145BA
Biopsy, Death, Malaise, Pancreatic carcinoma; Biopsy, Death, Malaise, Pancreatic... Biopsy, Death, Malaise, Pancreatic carcinoma; Biopsy, Death, Malaise, Pancreatic carcinoma; Biopsy, Death, Malaise, Pancreatic carcinoma More
My mom felt ill after her vaccines, but started to have more symptoms that she didn't talk abou... My mom felt ill after her vaccines, but started to have more symptoms that she didn't talk about. On December 4, 2024 she was finally diagnosed with pancreatic cancer. She was dead by January 3, 2025. More
✓
2838215 51 F CA 04/27/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Arthralgia, Asthenia, Immediate post-injection reaction, Impaired work ability, ... Arthralgia, Asthenia, Immediate post-injection reaction, Impaired work ability, Injected limb mobility decreased; Injection site pain, Pain, Pain in extremity More
I had pain immediately at sit of injection and it has not stopped since. I have loss of range of mot... I had pain immediately at sit of injection and it has not stopped since. I have loss of range of motion, severe pain radiating from my shoulder down to my fingers. It is debilitating as I am right-handed. This is unacceptable and the doctor told me there is nothing to do about it. I now have to live with this constant pain. I am supposed to be finding work and how am I going to work without full use of my dominant arm. More
✓
2838216 63 F MD 04/27/2025 FLU3
 SEQIRUS, INC.
Injection site pain, Pain in extremity Injection site pain, Pain in extremity
Continuous pain in left arm along the shoulder and at the injection site especially at night and fir... Continuous pain in left arm along the shoulder and at the injection site especially at night and first thing in the morning. This is still ongoing now in April 2025 despite use of cold compression, hot compression, Tylenol and Advil. Pain ease with Tylenol and advice but then comes back again. More
2838220 66 F 04/27/2025 PNC21
PNC21
PNC21
PNC21
PNC21
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
PNC21
PNC21
PNC21
PNC21
PNC21
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y01309
Y01309
Y01309
Y01309
Y01309
47N3Y
47N3Y
47N3Y
47N3Y
47N3Y
Deafness bilateral, Laboratory test, Pain in extremity, Scan, Vertigo; Vomiting;... Deafness bilateral, Laboratory test, Pain in extremity, Scan, Vertigo; Vomiting; Asthenia, Audiogram abnormal, Deafness unilateral, Dizziness, Fatigue; Gait disturbance, Impaired work ability, Loss of personal independence in daily activities, Mixed deafness, Mobility decreased; Paraesthesia, Sudden hearing loss, Tinnitus, Tympanometry abnormal, Vertigo; Deafness bilateral, Laboratory test, Pain in extremity, Scan, Vertigo; Vomiting; Asthenia, Audiogram abnormal, Deafness unilateral, Dizziness, Fatigue; Gait disturbance, Impaired work ability, Loss of personal independence in daily activities, Mixed deafness, Mobility decreased; Paraesthesia, Sudden hearing loss, Tinnitus, Tympanometry abnormal, Vertigo; Deafness bilateral, Laboratory test, Pain in extremity, Scan, Vertigo; Vomiting; Asthenia, Audiogram abnormal, Deafness unilateral, Dizziness, Fatigue; Gait disturbance, Impaired work ability, Loss of personal independence in daily activities, Mixed deafness, Mobility decreased; Paraesthesia, Sudden hearing loss, Tinnitus, Tympanometry abnormal, Vertigo; Deafness bilateral, Laboratory test, Pain in extremity, Scan, Vertigo; Vomiting; Asthenia, Audiogram abnormal, Deafness unilateral, Dizziness, Fatigue; Gait disturbance, Impaired work ability, Loss of personal independence in daily activities, Mixed deafness, Mobility decreased; Paraesthesia, Sudden hearing loss, Tinnitus, Tympanometry abnormal, Vertigo More
PT Got vaccine 3/18 and that night had severe pain on arms. When woke up in morning felt explosion i... PT Got vaccine 3/18 and that night had severe pain on arms. When woke up in morning felt explosion in ER and lost hearing in both ears. She had extreme verigo and started vomiting. After 30 to 40min of vomiting called 911. PT taken to ER and had tests and scans completed she was given meclizine. She followed up with her PCP. She has no hearing in the right ear still, but some hearing in the left ear. More
✓
2838132 M 04/26/2025 MMR
VARCEL
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Diarrhoea; Diarrhoea Diarrhoea; Diarrhoea
began experiencing diarrhea and loose stool; This spontaneous report was received from a consumer an... began experiencing diarrhea and loose stool; This spontaneous report was received from a consumer and refers to a 31-year-old male patient. The patient's concurrent conditions included Penicilin allergy. Concomitant therapies and medical history were not reported. On 02-Apr-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (2 injections 6 weeks apart), (dose, route of administration, anatomical site of injection, lot # and expiration date were not reported); and with the second dose of Varicella Virus Vaccine (trade name not reported), (2 injections 6 weeks apart) (dose, route of administration, anatomical site of injection, lot # and expiration date were not reported); both vaccines were reconstituted with sterile diluent (BAXTER STERILE DILUENT) and were administered for prophylaxis. The vaccines were administered around 9:30 and at around 21:00 the patient began experiencing diarrhea and loose stool. The patient worked in a freezer for almost 6 hours and didn't eat or drink after the vaccine administration. Symptoms lessened after food and water were ingested. On 03-Apr-2025, the patient recovered from the event. The causal relationship between the event and the suspect therapies was not reported. More
2838133 IN 04/26/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014305
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 other information provided. No additional AE.; HCP calling to inform PROQUAD administration for a... No other information provided. No additional AE.; HCP calling to inform PROQUAD administration for a patient 17 years old (outside of PI). The PROQUAD was administered on 4/16/25 and patient is not symptomatic.; This spontaneous report was received from a Nurse and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported. On 16-Apr-2025 at the age of 17, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA [recombinant human albumin]) (PROQUAD) administered as prophylaxis (Lot No. Y014305 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported and upon internal validation established as 18 Feb 2026 (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot number, expiration date, route of administration and indication was not provided) (product administered to patient of inappropriate age) No other information provided. No additional adverse event (No adverse event). More
2838134 FL 04/26/2025 MMR
 MERCK & CO. INC.
 W022942
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event; regarding an expired administration of a dose of MMR II; Information has been rece... No adverse event; regarding an expired administration of a dose of MMR II; Information has been received from Business Partner/CRO on 24-Apr-2025. This spontaneous report was received from a/an Nurse and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 16-Apr-2024, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #W022942, expiration date: 05-Apr-2024) 0.5 mL (0.5 mL / Two dose series),. On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), for the treatment of Prophylaxis. On 16-Apr-2024, the patient experienced regarding an expired administration of a dose of MMR II. On an unknown date, the patient experienced No adverse event. At the reporting time, the outcome of regarding an expired administration of a dose of MMR II and No adverse event was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. More
2838135 61 F FL 04/26/2025 PNC20
 PFIZER\WYETH
 LX4483
Injection site erythema, Injection site inflammation, Injection site rash Injection site erythema, Injection site inflammation, Injection site rash
Rash (small bumps) around the injection site, redness, inflammation; Rash (small bumps) around the i... Rash (small bumps) around the injection site, redness, inflammation; Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site; Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site; This is a spontaneous report received from a Nurse. A 61-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Apr2025 as dose number unknown 0.5 ml, single (Lot number: LX4483, Expiration Date: 20Feb2026) at the age of 61 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 15Apr2025, outcome "recovering", described as "Rash (small bumps) around the injection site, redness, inflammation"; VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Apr2025, outcome "recovering" and all described as "Rash (small bumps) around the injection site, redness, inflammation/rash and erythema around injection site". Therapeutic measures were taken as a result of vaccination site inflammation, vaccination site rash, vaccination site erythema. Additional information: The patient did not received any other vaccines on the same date as the vaccine. The patient did received any other vaccines within 4 weeks PRIOR to the vaccine. The patient was taking other medications within 2 weeks of the event starting. Nurse reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physician stated a patient recently reported a side effect that came from one batch, the same lot number. She has done reporting on Pfizer portal and VAERS. Wants to know what to do with that lot. They have it quarantined and out of patient circulation. They purchase through a distributor, and she wants to see what we recommend from manufacturer; she had contacted the distributor to see if they need return it, wait for it to expire or if they can get credit. States the physician is not comfortable using that lot. States she has confirmation numbers for the patients. She also has one patient that had an adverse event with Prevnar 20 back in February with a different lot. They thought it was a one off thing. She had reported that today also online but that is a different lot. More
2838136 57 F FL 04/26/2025 PNC20
 PFIZER\WYETH
 LK6650
Injection site erythema, Injection site oedema, Injection site pain Injection site erythema, Injection site oedema, Injection site pain
Pain at the injection site; Pain at the injection site, edema, erythema; This is a spontaneous repor... Pain at the injection site; Pain at the injection site, edema, erythema; This is a spontaneous report received from a Nurse. A 57-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Feb2025 as dose number unknown, 0.5ml single (Lot number: LK6650, Expiration Date: 31May2026) at the age of 57 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Feb2025, outcome "recovered" (2025), described as "Pain at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 25Feb2025, outcome "recovered" (2025), described as "Pain at the injection site, edema, erythema". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema. Additional information: Patient did not receive any other vaccines on the same date as the vaccine. Patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient was taking any other medications within 2 weeks of the event starting. Reporter seriousness for pain and erythema at the injection site was not serious. Patient had an adverse event with Prevnar 20 back in February with a different lot. They thought it was a one off thing. She had reported that today also online but that was a different lot. It was reported pain and erythema at the injection site was non serious. States this was not reported to her on time. She was going to say patient noted pain and erythema at the injection site the next day, 25Feb2025.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086589 same reporter/product/event, different patient; More
2838137 56 F FL 04/26/2025 PNC20
 PFIZER\WYETH
 LX4483
Injection site erythema, Injection site oedema, Injection site pain Injection site erythema, Injection site oedema, Injection site pain
Erythema, pain at the injection site, and edema.; Erythema, pain at the injection site, and edema.; ... Erythema, pain at the injection site, and edema.; Erythema, pain at the injection site, and edema.; Erythema, pain at the injection site, and edema.; This is a spontaneous report received from a Nurse. A 56-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Apr2025 as dose number unknown (0.5 ml), single (Lot number: LX4483, Expiration Date: Feb2026) at the age of 56 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE OEDEMA (non-serious) all with onset 17Apr2025, outcome "recovering" and all described as "Erythema, pain at the injection site, and edema.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain, vaccination site oedema. Additional information: Patient did not received any other vaccines on the same date as the vaccine and not received any other vaccines within 4 weeks prior to the vaccine. Patient taking other medications within 2 weeks of the event starting. Reported events included erythema, pain at the injection site, and edema. On 22Apr2025, received additional context in which stated report 1 of 4 on patient. She reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physican stated a patient recently reported a side effect that came from one batch, the same lot number. Stated the physician is not comfortable using that lot. 1st patient reported erythema, pain and edema at injection site site left deltoid. Prevnar 20 given on 16Apr2025 and noted erythema, pain and edema at injection site left deltoid on 17Apr2025. Outcome was recovering. Patient has an appointment with her provider today. Seriousness criteria reported as it was mild so she doesn't think significant. It is definitely inconvenient but not life threatening.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086599 same reporter/product/event, different patient.;US-PFIZER INC-202500086566 same reporter/product/event, different patient; More
2838138 59 F FL 04/26/2025 PNC20
 PFIZER\WYETH
 LX4483
Injection site erythema, Injection site oedema, Injection site pain Injection site erythema, Injection site oedema, Injection site pain
Erythema, edema, and pain at the injection site.; Erythema, edema, and pain at the injection site.; ... Erythema, edema, and pain at the injection site.; Erythema, edema, and pain at the injection site.; Erythema, edema, and pain at the injection site.; This is a spontaneous report received from a Nurse. A 59-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Apr2025 as dose number unknown, single (Lot number: LX4483, Expiration Date: Feb2026) at the age of 59 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE OEDEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Apr2025, outcome "recovering" and all described as "Erythema, edema, and pain at the injection site.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site oedema, vaccination site pain. Additional information: The patient did not receive any other vaccines on the same date as the vaccine which is reported. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine which is reported. The patient was taking any other medications within 2 weeks of the event starting. Reporter seriousness for erythema, pain and edema at injection site was not Serious. She reported 3 adverse events related to Prevnar 20 vaccine under the same lot on Pfizer portal. Physican stated a patient recently reported a side effect that came from one batch, the same lot number. Wanted to know what to do with that lot. They have it quarantined and out of patient circulation. Stated the physician was not comfortable using that lot. Stated she has confirmation numbers for the patients. She also has one patient that had an adverse event with Prevnar 20 back in February with a different lot. They thought it was a one off thing. She had reported that today also online but that was a different lot. Patient called and said kind of noticed erythema, pain and edema at injection site the same day into the next day. Caller stated she would say 19Apr2025.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086589 same reporter/product/event, different patient.; More
2838139 52 F LA 04/26/2025 COVID19
 PFIZER\BIONTECH
 EP6955
Cough Cough
Did have cough, about a month, as soon as she did first injection. Cough came back within 45 minutes... Did have cough, about a month, as soon as she did first injection. Cough came back within 45 minutes of first injection Apr2021; This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old female patient received BNT162b2 (COMIRNATY), on 20Mar2021 as dose 1, single (Lot number: EP6955) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Apr2021, outcome "unknown", described as "Did have cough, about a month, as soon as she did first injection. Cough came back within 45 minutes of first injection Apr2021". More
2838140 M FL 04/26/2025 COVID19
 PFIZER\BIONTECH
Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test, Streptococcus tes... Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test, Streptococcus test More
got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP, Progra... got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (previous Pfizer Covid vaccines), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2025, outcome "recovering" and all described as "got Covid". The event "got covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (19Apr2025) slight fever over 100, notes: Saturday; (20Apr2025) fever was at 102 all day, notes: Sunday; SARS-CoV-2 test: (21Apr2025) said patient had Covid; Streptococcus test: (Apr2025) no strep. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was at (withheld) Friday morning and by Saturday night (19Apr2025) he had a slight fever over 100. By Sunday (20Apr2025) his fever was at 102 all day. He took Tylenol and Monday morning didn't have fever when he went to his doctor. The patient went to the doctor Monday morning early (21Apr2025) and got tested and said the patient had Covid. Doctor wrote a prescription for Paxlovid and he picked it up and started taking it on Monday. Got on Paxlovid and that started the up climb to better ness. The patient started feeling a lot better by Tuesday morning. He was starting to feel better within 2 days definitely didn't have severe coughing and nasal dripping. was taking Aleve cold and sinus that helps with dripping. Noticed by would say within 24 hours plus that he noticed a change in the way he was feeling. Feels a lot better today. Still has coughing and some sneezing but not as much. Some phlegm. His doctor said his lungs are clear. He had a sore throat and was tested for strep, no strep. Patient has had all Pfizer Covid vaccines and got Covid. Stated he has had all covid vaccinations from Pfizer because he has had good results with Pfizer vaccinations. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500088756 same reporter drug AE different patient; More
2838145 52 F OH 04/26/2025 PNC21
 MERCK & CO. INC.
 Y013009
Erythema, Pain, Pruritus, Pyrexia, Swelling Erythema, Pain, Pruritus, Pyrexia, Swelling
Visit urgent care on Saturday 4/26 and was given itching cream and antibiotics to take for 7 days Visit urgent care on Saturday 4/26 and was given itching cream and antibiotics to take for 7 days
2838146 32 M KY 04/26/2025 COVID19
 PFIZER\BIONTECH
 LN0591
Expired product administered Expired product administered
Pt is given expired COVID vaccine, no symptoms Pt is given expired COVID vaccine, no symptoms
2838147 33 F KY 04/26/2025 COVID19
 PFIZER\BIONTECH
 LP1780
Expired product administered Expired product administered
Pt is given expired dose of COVID Pt is given expired dose of COVID
2838148 85 M NH 04/26/2025 COVID19
 PFIZER\BIONTECH
 LN0588
Burning sensation, Rash, Rash pruritic Burning sensation, Rash, Rash pruritic
Patient developed a rash on parts of his arm/chest (not around the injection site). It is itchy and ... Patient developed a rash on parts of his arm/chest (not around the injection site). It is itchy and burns, he is headed to urgent care to be assessed from here. More
2838149 26 M IL 04/26/2025 MMR
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 y014095
pg3rp
Dyspnoea; Dyspnoea Dyspnoea; Dyspnoea
Patient came in for MMR vaccine for travel. Patient spoke to doctor about egg allergy and doctor ad... Patient came in for MMR vaccine for travel. Patient spoke to doctor about egg allergy and doctor advised patient to get vaccine even with said allergy (per patient). Patient given MMRII and Boostrix. Sat about 10-15 minutes after vaccine talking to vaccinating technician but came back about 25 minutes after vaccine for Benadryl, then went to ER due to trouble breathing. Patient states in ER for about 2 hours but now released. More
2838150 16 F FL 04/26/2025 MNQ
 SANOFI PASTEUR
 U8375AA
Headache, Pain in extremity, Paraesthesia Headache, Pain in extremity, Paraesthesia
04/09/2025 01:50:02 PM > severe headache started 12 hours after receipt of the meningitis vaccine... 04/09/2025 01:50:02 PM > severe headache started 12 hours after receipt of the meningitis vaccine, reports of migraine type headache, felt a bad headache yesterday, wanted to get picked up from school, also reported arm pain and tingling, was at school today and mom is not sure if she has headache or arm tingling today, I advised mom that if headache or arm tingling is persisting to please schedule an office visit for evaluation 04/11/2025 04:14:48 PM > headache lasted until 4/10, each day headache improved, had headache for 2 days and had headache at school but was able to go to school left arm had tingling shoulder to the wrist until 4/9 in the evening, and soreness left arm ended 4/9 More
2838151 76 M ID 04/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93kk4
Asthenia, Nausea, Pyrexia, Vomiting Asthenia, Nausea, Pyrexia, Vomiting
nausea vomiting , fever , weakness nausea vomiting , fever , weakness
2838152 60 F NJ 04/26/2025 PNC21
 MERCK & CO. INC.
 Y013009
Blood pressure decreased, Erythema, Loss of consciousness, Pyrexia, Swelling Blood pressure decreased, Erythema, Loss of consciousness, Pyrexia, Swelling
Patient states redness/swelling and fever and drop in blood pressure that led to passing out and an ... Patient states redness/swelling and fever and drop in blood pressure that led to passing out and an ER trip. More
2838153 82 F TX 04/26/2025 COVID19
 MODERNA
 8080799
Chills, Malaise, Pyrexia Chills, Malaise, Pyrexia
Patient said she got a fever the night of the immunization and felt sicker. She had cold chills the ... Patient said she got a fever the night of the immunization and felt sicker. She had cold chills the next day but started to feel better the next day in the evening. More
2838154 97 F WV 04/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3X97J
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Patient's caregiver observed redness around the injection site the evening of administering the... Patient's caregiver observed redness around the injection site the evening of administering the vaccine. Today (3 days after administration), the caregiver observed significantly more redness, some swelling, and warm to the touch around the vaccination site. The area of redness today appears to be nearly the size of a softball, but oval in shape going lengthways with the patient's arm. I advised the caregiver to take the patient to the local urgent care (the patient's family did not want her going to the ER). More
2838155 66 M WI 04/26/2025 COVID19
 MODERNA
 304383F
Arthralgia, Inflammation, Myalgia Arthralgia, Inflammation, Myalgia
Whole body muscle and joint pain. Increased and new inflammation of prior injuries. Whole body muscle and joint pain. Increased and new inflammation of prior injuries.
2838156 2.58 F MO 04/26/2025 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
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UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
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Injection site discolouration, Injection site erythema, Injection site induratio... Injection site discolouration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site pallor, Injection site pruritus; Injection site discolouration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site pallor, Injection site pruritus; Injection site discolouration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site pallor, Injection site pruritus; Injection site discolouration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site pallor, Injection site pruritus; Injection site discolouration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site pallor, Injection site pruritus; Injection site discolouration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site pallor, Injection site pruritus More
Patient present with vaccine administrations in bilateral thigh on 04/24/2025. Mother did not bring ... Patient present with vaccine administrations in bilateral thigh on 04/24/2025. Mother did not bring a detailed record, just a general list of what was given. Yesterday she noticed redness surrounding a white central area that was new. Today the redness is larger, hard (not fluctuant) and erythematic. 1+ edema measures 2 inches by 2.75 inches with central pale area that measure 0.5 inch and 2 prominent puncture areas noted. Patient indicates that it is tender to touch and itchy. The other leg has very slight pink area, no edema. Recommended Loratidine 2.5 mg daily and to reach out to PCP to share the reaction. Notified mother that she may get a call for more information, she agreed. More
2838157 0.33 F CA 04/26/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS



Delayed fontanelle closure, Poor feeding infant, Pyrexia, Somnolence; Delayed fo... Delayed fontanelle closure, Poor feeding infant, Pyrexia, Somnolence; Delayed fontanelle closure, Poor feeding infant, Pyrexia, Somnolence; Delayed fontanelle closure, Poor feeding infant, Pyrexia, Somnolence; Delayed fontanelle closure, Poor feeding infant, Pyrexia, Somnolence More
Approximately 18 hours after receiving her 4-month vaccinations, my baby began to experience swellin... Approximately 18 hours after receiving her 4-month vaccinations, my baby began to experience swelling of the anterior fontanelle, fever, drowsiness, and poor appetite. More
2838158 78 F ME 04/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 3X325
Giant cell arteritis, Headache, Malaise, Visual impairment Giant cell arteritis, Headache, Malaise, Visual impairment
Patient felt unwell after the vaccine with intermittent headaches and ultimately was diagnosed with ... Patient felt unwell after the vaccine with intermittent headaches and ultimately was diagnosed with giant cell arteritis with partial vision loss in 8/2024. She was treated with high dose prednisone and one infusion of Actemra. She is currently tapering her prednisone still. She has persistent vision loss but has not had new loss of vision. More
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2838219 3 M NJ 04/26/2025 DTAPHEPBIP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 B5325
DN273
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Administered Pediarix vaccine (DTaP + Hep B + IPV) and patient should have only received DTaP vaccin... Administered Pediarix vaccine (DTaP + Hep B + IPV) and patient should have only received DTaP vaccine. More
2837964 WI 04/25/2025 MMRV
 MERCK & CO. INC.
 Y009347
No adverse event, Product storage error No adverse event, Product storage error
No additional information provided. No additional AE/PQC reported; Nurse calling to report inadverte... No additional information provided. No additional AE/PQC reported; Nurse calling to report inadvertently administering a dose of PROQUAD outside of time frame in the Prescribing Information. Caller stated dose was administered 40 minutes after reconstitution. Caller stated patient reported no symptoms and permission; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 31-MAR-2025, the patient was vaccinated with a outside of time frame of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD), (lot #Y009347 who had been verified to be a valid lot number, expiration date reported and validated as 11-NOV-2025); and sterile diluent (BAXTER STERILE DILUENT), (lot # and expiration date were not reported) as prophylaxis (product storage error). The reporter stated that, dose was administered 40 minutes after reconstitution. No additional adverse events. More
2837965 27 M NY 04/25/2025 HPV9
 MERCK & CO. INC.
 Y010656
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Pharmacist reported that a patient missed his second dose of GARDASIL 9. Product information attache... Pharmacist reported that a patient missed his second dose of GARDASIL 9. Product information attached is related to first dose that was administered on 10/22/2024. No additional information available. No additional AE/no PQC.; No adverse event; This spontaneous report was received from a Pharmacist and refers to a 28-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-OCT-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y010656, expiration date: 29-Nov-2026), dose number 1, 0.5 mL administered by Unknown route for Prophylaxis. On an unknown date, the patient missed his second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Product dose omission issue) No additional adverse event was reported. More
2837966 16 F GA 04/25/2025 HPV9
 MERCK & CO. INC.
 1957404
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP calling to report TE's for GARDASIL 9 advised the vaccine was administere... No additional AE; HCP calling to report TE's for GARDASIL 9 advised the vaccine was administered to a patient on 03/20/2025.; This spontaneous report was received from a medical assistant and refers to a 16-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-Jan-2025, Human Papillomavirus 9-valent Vaccine, Recombinant (GRADASIL 9) (lot #1957404, expiration date: 05-Oct-2025) underwent a temperature excursion with a temperature of 35.8 F and on 30-Jan-2025, 35.6 F during 15 minutes and 10 minutes respectively. On 20-Mar-2025, the patient was vaccinated with this improperly stored vaccine, administered by unknown route as prophylaxis (Product storage error). No additional adverse event (AE). More
2837967 26 M NV 04/25/2025 VARCEL
 MERCK & CO. INC.
 Y015100
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No side effects or symptoms reported. No Additional information provided. No Additional AE/ N; HCP c... No side effects or symptoms reported. No Additional information provided. No Additional AE/ N; HCP called to report a patient received MMR II (03/01/2025) and then received VARIVAX 7 days later (03/07/2025) instead of the recommended 4-week interval.; This spontaneous report was received from a pharmacist and refers to a 26-year-old male patient. The patient's medical history, current conditions and concomitant medications were not reported. On 01-MAR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (strength, dose, anatomical route of administration, lot # and expiration date were not reported); and then on 07-MAR -2025 (reported as 7 days later) instead of the recommended 4 week-interval (inappropriate schedule of product administration), the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5 mL (lot #Y015100 who had been verified to be a valid lot number, expiration date assessed and reported as 06-SEP-2026), both vaccines were administered as prophylaxis. No additional adverse events reported. More
2837968 F GA 04/25/2025 HEPAB
HEPAB
PNC21
PNC21
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 4DS4N
4DS4N
Y011819
Y011819
Injection site erythema, Injection site haemorrhage, Injection site pain, Inject... Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Lethargy, Malaise; Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Lethargy, Malaise More
The left arm injection site demonstrated continuous bleeding; sickness feeling; the entire upper p... The left arm injection site demonstrated continuous bleeding; sickness feeling; the entire upper portion with pain and a little itching; the entire upper portion with pain and a little itching; Lethargy; The patient said that the swelling, redness, and warmth; The left arm showed redness and swelling; The left arm showed redness and swelling; This spontaneous report was received from other health professional regarding to a 64-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-FEB-2025, the patient started therapy with the first dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE), lot number Y011819 (lot number Y011819 had been verified to be valid lot number for, expiration date was not provided, but upon an internal validation, established as 01-OCT-2025), and with hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX), lot number 4DS4N, both administered by intramuscular route in left arm, for prophylaxis. Since 22-FEB-2025, the patient's left arm injection site demonstrated continuous bleeding in comparison to the right arm injection sites per patient. The left arm showed redness and swelling down the entire upper portion with pain and a little itching. The patient said that the swelling, redness, and warmth improved a little after the second night. Lethargy and sickness feeling reported for two days, ibuprofen (MOTRIN) and paracetamol (TYLENOL) was taken by the patient to alleviate the symptoms. The patient stated that she has never experienced any adverse reactions to her previous vaccinations and was contemplating going to the ER the prior day but did not. The reporter visually inspected the sites and redness was present but was much better as per patient. The reporter instructed the patient to take diphenhydramine if the redness or itching continued and to let us know if the areas did not continue to improve. The patient was satisfied with consult about this reaction. On an unspecified date in 2025, the patient recovered from the events. The causal relationship between the events and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) and hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-22 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2827677 , Central date : 2025-04-22 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2837986 47 F NY 04/25/2025 VARCEL
 MERCK & CO. INC.
 Y0155588
Erythema, Pain in extremity, Peripheral swelling Erythema, Pain in extremity, Peripheral swelling
Reported by employee: Left arm painful, red and swollen. Reported by employee: Left arm painful, red and swollen.
2838026 10 M MI 04/25/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Unevaluable event Unevaluable event
none none
2838027 9 M TX 04/25/2025 HEP
MMR
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
Y007613
U8015AA
Immediate post-injection reaction, Lethargy, Vision blurred; Immediate post-inje... Immediate post-injection reaction, Lethargy, Vision blurred; Immediate post-injection reaction, Lethargy, Vision blurred; Immediate post-injection reaction, Lethargy, Vision blurred More
Immediate blurred vision and lethargy, lasting up to 24 hours Immediate blurred vision and lethargy, lasting up to 24 hours
2838028 4 F MA 04/25/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.

Axillary pain, Oedema peripheral, Skin discolouration, Skin lesion, Tenderness; ... Axillary pain, Oedema peripheral, Skin discolouration, Skin lesion, Tenderness; Axillary pain, Oedema peripheral, Skin discolouration, Skin lesion, Tenderness More
4/16 red mark on left arm and reporting left armpit pain, sl swollen and tender, seen in the office ... 4/16 red mark on left arm and reporting left armpit pain, sl swollen and tender, seen in the office 4/24 no longer tender to the touch or with movement. Mark has dulled in color almost looks bruised, no longer arm pit pain. PE dark red blanching, non tender, non palpable confluent oval lesion at longest length about 3 in More
2838029 15 M NC 04/25/2025 HPV9
 MERCK & CO. INC.
 Y015179
Extra dose administered Extra dose administered
A third dose of HPV was given that was not needed. Patient had already received two prior doses of H... A third dose of HPV was given that was not needed. Patient had already received two prior doses of HPV. No noted or observed adverse signs or symptoms. More
2838030 66 M 04/25/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Body temperature increased, Chills, Fatigue, Pain Body temperature increased, Chills, Fatigue, Pain
shivering, achy in neck and lumbar and hips, temp 102.6, fatigue. No previous reaction to all other ... shivering, achy in neck and lumbar and hips, temp 102.6, fatigue. No previous reaction to all other doses and booster in the past. More
2838031 1.17 F PA 04/25/2025 HEPA
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH

Vomiting; Vomiting Vomiting; Vomiting
Vomiting in the car on the way home from the doctor Vomiting in the car on the way home from the doctor
2838032 1 F MD 04/25/2025 COVID19
 PFIZER\BIONTECH
 LN7305
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
Vaccination given with Covid 6m-4yr vial that had been mixed the day before on 04/23/2025. Verified ... Vaccination given with Covid 6m-4yr vial that had been mixed the day before on 04/23/2025. Verified the date on the sheet with the vial was 4/23/2025, 3 doses were mixed, one was given and verified on 04/23/2025, the next dose was marked and verified as given on 04/24/2025. Nurse manager notified immediately after it was noticed, and a few hours after vaccine was administered. Provider was made aware of the incident and notified family. Protocol was updated to waste vial every night before end of shift to ensure it can't happen again in the future. More
2838033 45 M OR 04/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 AK334
Joint swelling, Muscle spasms, Peripheral swelling Joint swelling, Muscle spasms, Peripheral swelling
Swelling of bilateral hands, wrists, lower extremities, sensation of lumbar back spasms. Swelling of bilateral hands, wrists, lower extremities, sensation of lumbar back spasms.
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