🏥 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 💀 🏥 🚑 ♿ ⚠️
2819959 18 M IN 01/08/2025 COVID19
COVID19
FLU3
FLU3
HEPA
HEPA
HPV9
HPV9
MENB
MENB
MMR
MMR
MNQ
MNQ
TDAP
TDAP
VARCEL
VARCEL
MMR
MMR
 PFIZER\BIONTECH
PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 LM2219
LM2219
7KZ9R
7KZ9R
5JA57
5JA57
Y007991
Y007991
52N4S
52N4S
X000177
X000177
FX3ED
FX3ED
CX4HL
CX4HL
Y006522
Y006522
X000177
X000177
Expired product administered; Expired product administered, No adverse event; Ex... Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event; Expired product administered; Expired product administered, No adverse event More
Patient received a dose of MMR on 01/08/2025 that had expired on 01/02/2025. I called Merck, and the... Patient received a dose of MMR on 01/08/2025 that had expired on 01/02/2025. I called Merck, and they stated that they have data supporting the potency of the vaccine. More
2819960 63 M MN 01/08/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2819961 10 F WI 01/08/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 3044091
T75MP
Chest discomfort, Pain in extremity, Pallor, Throat tightness; Chest discomfort,... Chest discomfort, Pain in extremity, Pallor, Throat tightness; Chest discomfort, Pain in extremity, Pallor, Throat tightness More
pale and stated chest felt heavy, thought throat felt tight with some left arm pain pale and stated chest felt heavy, thought throat felt tight with some left arm pain
2819962 80 F WI 01/08/2025 COVID19
 MODERNA
 3043837
Chest discomfort, Dizziness, Feeling abnormal, Pain in extremity Chest discomfort, Dizziness, Feeling abnormal, Pain in extremity
felt "kind of funny," complained of lightheadedness, chest tightness/heaviness, and right ... felt "kind of funny," complained of lightheadedness, chest tightness/heaviness, and right arm pain. More
✓
2819963 23 F CA 01/08/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 TP2F9
Arthralgia, Pain, Paraesthesia, Skin warm Arthralgia, Pain, Paraesthesia, Skin warm
After Vaccination Patient compliant of tingling in left hand on the finger tips. And left minor elb... After Vaccination Patient compliant of tingling in left hand on the finger tips. And left minor elbow pain radiating down towards the hand. tingling subsided after 10 minutes. Patient also stated that left Palm of hand was warm. More
2819964 50 F WI 01/08/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 T75MP
Pruritus, Throat tightness Pruritus, Throat tightness
itchy, tightness in throat itchy, tightness in throat
2819965 9 F KS 01/08/2025 HEPA
IPV
TDAP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 C24B9
W1C831M
U7999AA
Y010373
Lethargy, Pallor, Palpitations; Lethargy, Pallor, Palpitations; Lethargy, Pallor... Lethargy, Pallor, Palpitations; Lethargy, Pallor, Palpitations; Lethargy, Pallor, Palpitations; Lethargy, Pallor, Palpitations More
Child was very nervous prior to receiving vaccines. Tolerated vaccinations well. Nurse stepped away ... Child was very nervous prior to receiving vaccines. Tolerated vaccinations well. Nurse stepped away from the room; returned; child was standing holding chest stated, " Heart racing" Moved child to exam table; elevated her head and lower extremities. Child then appeared pale and lethargic; arousable. V/S B/P 69/40 pulse 64, 02 sat 100%. Child then appeared on the verge of unconsciousness with eyes closed; yet able to arouse. V/S retaken 83/54 pulse 76 02 sat 100%. Within 3-4 minutes Child was alert; color good, V/S 112/66 02 sat 96% pulse 79. Stated she felt better. Nurse Practitioner assessed pt; and spoke with mother; mother stated, " She has done this before because she is very terrified of Shots" Explained to mother; this needs to be communicated with staff everywhere she goes; even for blood draws. Verbalized understanding. More
2819966 70 F IL 01/08/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LM2211
ut8409ea
Arthralgia, Fatigue, Myalgia, Polymyalgia rheumatica; Arthralgia, Fatigue, Myalg... Arthralgia, Fatigue, Myalgia, Polymyalgia rheumatica; Arthralgia, Fatigue, Myalgia, Polymyalgia rheumatica More
Pt first started experience side effects from the vaccines 4 days after the vaccines were administer... Pt first started experience side effects from the vaccines 4 days after the vaccines were administered. Pt experienced exhaustion, muscle pain, joint pain, shoulder pain, and knee pain. More
2819967 0.83 F KS 01/08/2025 DTAPHEPBIP
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 X9EP5
J245K
Product storage error; Product storage error Product storage error; Product storage error
Vaccine deemed not stable due to temp excursion Vaccine deemed not stable due to temp excursion
2819968 2 M VA 01/08/2025 PPV
 MERCK & CO. INC.
 X014729
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse reactions No adverse reactions
2819969 81 F FL 01/08/2025 FLU3
 SANOFI PASTEUR
 ut8470ba
Fall, Pain in extremity, Photopsia, Screaming Fall, Pain in extremity, Photopsia, Screaming
Pt came to pharmacy to request a refill for her Amlodipine refilled and asked for a Flu shot.. Upon ... Pt came to pharmacy to request a refill for her Amlodipine refilled and asked for a Flu shot.. Upon filling the questionnaire, pt answered all questions as (NO) which include "do you get dizzy or faint after a vaccine".. after vaccine was administered; pt was advised to wait for a bit just in case but she objected. and said "I have to leave to take care of my disabled husband".. as she was leaving the pharmacy, Pharmacy staff received a call from the front register indicating patient fell. Pharmacist, pharmacy tech and shift lead approached the patient trying to help her questioning patient; patient said "I was diabetic and my doctor just took me off Metformin.. I did not have anything to eat or drink this morning.. as was leaving the store I saw a flash of light in front of me and I fell". Patient asked team to just help her to get up as she wanted to go home, but as tech was helping her out, she was screaming of pain in her arm and could NOT bare the pain, so team had to call 911 and get her sent to hospital. More
✓
2819970 48 F FL 01/08/2025 COVID19
 JANSSEN
Deafness unilateral, Electric shock sensation, Tinnitus Deafness unilateral, Electric shock sensation, Tinnitus
I and my friend both had shooting electric shock 1 sec pain that migrated around the body for about ... I and my friend both had shooting electric shock 1 sec pain that migrated around the body for about 4-6 weeks after the vaccine. They resolved in both of us. I have had this return briefly one for only a day about a year later but for the last 4 weeks has returned. Neurology has said no MS etc. never has before the vaccine. I also have had a return of tinnitus that became mostly in my left ear that resulted in hearing loss but also in the right ear. The right ear still has tinnitus. None was present before the vaccine. I begin to make multiple autoantibodies after the JnJ including new Anti-TSI, Anti scl-70, HSCrp is 6.11 More
2819971 12 F WA 01/08/2025 MNQ
 SANOFI PASTEUR
 U8361AA
Blood glucose normal, Dizziness, Syncope Blood glucose normal, Dizziness, Syncope
Syncope episode after injection , felt faint, was placed on exam table laying down with elevated leg... Syncope episode after injection , felt faint, was placed on exam table laying down with elevated legs, RN and staff monitored patient until she felt better- juice and water provided-pt had not had any food prior to injection. Patient was discharged in stable condition. More
2819972 50 M TX 01/08/2025 FLU3
 SANOFI PASTEUR
 UT845AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pt given high dose flu not within the age parameters of the high dose limits. Pt gave wrong name an... Pt given high dose flu not within the age parameters of the high dose limits. Pt gave wrong name and birthdate verified by both front desk and myself. I was using interpreter during the visit but when the patient could speak some of the language the interpreter stopped helping. More
2819973 18 M NE 01/08/2025 MENB
MNQ
 PFIZER\WYETH
SANOFI PASTEUR
 GX1463
U8351CA
Chills, Migraine, Vomiting; Chills, Migraine, Vomiting Chills, Migraine, Vomiting; Chills, Migraine, Vomiting
chills, migraine, vomiting chills, migraine, vomiting
2819974 M IL 01/08/2025 COVID19
 PFIZER\BIONTECH
 FJ8757
COVID-19, Drug ineffective COVID-19, Drug ineffective
had covid in June of this year; had covid in June of this year; This is a spontaneous report receive... had covid in June of this year; had covid in June of this year; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 35-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0170, Expiration Date: 22Nov2021), in right arm, on 21May2021 as dose 2, single (Lot number: EW0178, Expiration Date: 22Nov2021), in right arm and as dose 3 (booster), single (Lot number: FJ8757, Expiration Date: 22Nov2021), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had it when was unvaccinated. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "had covid in June of this year".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400329270 same patient, different vaccine dose/event;US-PFIZER INC-202400329386 same patient, different vaccine dose/event; More
2819975 70 M PA 01/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
just tested positive for Covid this morning / I've been with Pfizer since that / I've tak... just tested positive for Covid this morning / I've been with Pfizer since that / I've taken all the shots; just tested positive for Covid this morning / I've been with Pfizer since that / I've taken all the shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "just tested positive for Covid this morning / I've been with Pfizer since that / I've taken all the shots". Additional information: During this inbound call for financial assistance the caller (patient) stated "...I just tested positive for Covid this morning, and my doctor ordered the prescription for me. Now I do have a prescription card from my company, but the problem is the card I downloaded expired at the end of last year." Then at the end of the call the caller stated "...I just hope this gets this thing cleared up, It's not as bad as had it in 2020 but I've been with Pfizer since that, that's for sure, I've taken all the shots, although (inaudible) Covid shots..." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2819976 U MA 01/08/2025 PNC20
 PFIZER\WYETH
Rash erythematous, Rash pruritic Rash erythematous, Rash pruritic
Itchy red rash; Itchy red rash; This is a spontaneous report received from a Pharmacist. An adult p... Itchy red rash; Itchy red rash; This is a spontaneous report received from a Pharmacist. An adult patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious) all with onset Oct2024, outcome "unknown" and all described as "Itchy red rash". Therapeutic measures were taken as a result of rash erythematous, rash pruritic. Additional information: pharmacy said that one of their patients back in October (2024) had gotten a itchy red rash after getting a Prevnar 20 vaccine (adult patient). The patient was given Zyrtec and a topical Benadryl. This adverse reaction that had happened in October (2024). The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2819977 33 F 01/08/2025 RSV
 PFIZER\WYETH
 LN5463
Injection site discomfort, Injection site erythema, Injection site swelling, Lym... Injection site discomfort, Injection site erythema, Injection site swelling, Lymphadenopathy More
swelling, redness and discomfort (like a huge hive) at the site of injection; swelling, redness and ... swelling, redness and discomfort (like a huge hive) at the site of injection; swelling, redness and discomfort (like a huge hive) at the site of injection; swelling, redness and discomfort (like a huge hive) at the site of injection; swelling, redness and discomfort (like a huge hive) at the site of injection; swollen lymph nodes in armpit and side of breast on the side that injection was administered; This is a spontaneous report received from an Other HCP. A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Dec2024 as dose 1, single (Lot number: LN5463) at the age of 33 years for maternal immunisation. The patient's relevant medical history included: "adhesive tape allergy" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). The patient is expected to deliver a baby(s) on 13Feb2025. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE URTICARIA (non-serious), outcome "recovering" and all described as "swelling, redness and discomfort (like a huge hive) at the site of injection"; LYMPHADENOPATHY (non-serious), outcome "recovering", described as "swollen lymph nodes in armpit and side of breast on the side that injection was administered". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site discomfort, vaccination site urticaria, lymphadenopathy. Additional information: Patient was vaccinated on the left side. The patient did not receive any other vaccines on the same date as the ABRYSVO and any other vaccines within 4 weeks PRIOR to the ABRYSVO. More
2819978 57 F TX 01/08/2025 PNC20
 PFIZER\WYETH
 L45575
Feeling abnormal, Loss of personal independence in daily activities, Pain, Swell... Feeling abnormal, Loss of personal independence in daily activities, Pain, Swelling More
Severe pain/terrible pain; swelling; I even can't change my clothes, even can't take showe... Severe pain/terrible pain; swelling; I even can't change my clothes, even can't take shower/Can't do anything work with my left hand; it's really bad feeling; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29Dec2024 as dose number unknown, single (Lot number: L45575, Expiration Date: Mar2026) at the age of 57 years for immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing); METFORMIN taken for glucose tolerance impaired, start date: 2024 (ongoing). The following information was reported: PAIN (non-serious), outcome "not recovered", described as "Severe pain/terrible pain"; SWELLING (non-serious), outcome "not recovered"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I even can't change my clothes, even can't take shower/Can't do anything work with my left hand"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it's really bad feeling". Therapeutic measures were taken as a result of pain, swelling. Additional information: Prevnar 20 is on the routine that patient supposed got her insurance, her doctor told her that she can go and take that vaccine because here the pneumonia is very common, she should prevent herself, so she should take that vaccine. It's normal protocol that she supposed to take that vaccine. Consumer stated about lot number, "They wrote here L45575 or 645575. or maybe it's L or 6 I don't know about their writing." Consumer stated, "There actually I get one of the vaccine from Pharmacy that is pneumonia vaccine, named Prevnar 20. I had a very bad reaction for that vaccine. I am still I get that vaccine, but I still have severe pain, swelling and I concerned my doctor, or the nurse and they said you can take this Ibuprofen. I am taking Ibuprofen 800 mg but still I am having terrible pain today(04Jan2025. I visited a Pharmacy and talk to them. It's a severe reaction or any it's hurting a lot." Consumer stated, "Severe pain. I even can't change my clothes, even can't take shower. I have a severe pain I am taking whenever I am taking 800 mg like in the morning, I took 800 mg Ibuprofen after two three hours it little bit mild but still I can't do anything work with my left hand." Consumer stated, "I feel after few hours little bit relaxed but when I pass like now, I took that medicine at 9 AM. Now I am that time I will say I am having terrible pain but I have to take after 12 hours that medication, I am not allowed to take right away. So, I wait for two like nine ten after passing 12 hour then I take the second dose, it's really bad feeling." Consumer stated, "Do you know anything which I do for to relieve the pain because I go to the Pharmacy and they said you can only do the ice like cold so I took that but it's not work because I am having a terrible pain." More
2819979 F 01/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Caller had covid in 27Aug2024; Caller had covid in 27Aug2024; This is a spontaneous report received ... Caller had covid in 27Aug2024; Caller had covid in 27Aug2024; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization completed), for Covid-19 immunization; Bnt162b2 (Dose number unknown, Booster), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose number unknown, Booster), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2024, outcome "unknown" and all described as "Caller had covid in 27Aug2024". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2819980 58 M HI 01/08/2025 COVID19
 PFIZER\BIONTECH
Blood pressure measurement, Chest discomfort, Hypotension Blood pressure measurement, Chest discomfort, Hypotension
had funny feeling on left chest in the afternoon; hypotension (80/60mmHg); This is a spontaneous rep... had funny feeling on left chest in the afternoon; hypotension (80/60mmHg); This is a spontaneous report received from a Physician from a sales representative. A 58-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 as dose 1; single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "tiredness" (unspecified if ongoing), notes: 1-yr history; "weakness" (unspecified if ongoing), notes: 1-yr history; "numbness" (unspecified if ongoing), notes: 1-yr history; "covid-19", start date: Jun2024 (not ongoing), notes: approx 4 months prior to vaccination; "anxious personality" (unspecified if ongoing); "high mercury" (unspecified if ongoing), notes: received chelation therapy. The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 01Oct2024, outcome "recovered", described as "had funny feeling on left chest in the afternoon"; HYPOTENSION (non-serious) with onset Oct2024, outcome "recovered", described as "hypotension (80/60mmHg)". The events "had funny feeling on left chest in the afternoon" and "hypotension (80/60mmhg)" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, hypotension. Additional information: Received Comirnaty vaccine in morning, had funny feeling on left chest in the afternoon, and went to ER the following day with hypotension (80/60mmHg). Received aspirin, and had echo & cardiologist follow-up. Also f/u 3 months later with neurologist for 1-year history of weakness, numbness, tiredness. He was treated with aspirin. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2819981 F 01/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
recently contracted COVID; recently contracted COVID; This is a spontaneous report received from a C... recently contracted COVID; recently contracted COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "recently contracted COVID". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2819989 F PR 01/08/2025 HPV4
HPV4
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Chills, Condition aggravated, Cough, Depressed mood, Fatigue; Ocular hyperaemia,... Chills, Condition aggravated, Cough, Depressed mood, Fatigue; Ocular hyperaemia, Pain, Pneumonia, Pyrexia, Rash; Chills, Condition aggravated, Cough, Depressed mood, Fatigue; Ocular hyperaemia, Pain, Pneumonia, Pyrexia, Rash More
Pneumonia/cough/fatigue; Product origin unknown; fever; chills; body aches; depressed mood; red eyes... Pneumonia/cough/fatigue; Product origin unknown; fever; chills; body aches; depressed mood; red eyes; rashthat sprouted and spreaded on the thighs, knees, feet and elbows, arms and knuckles; This spontaneous report was received from 37-year-old female patient and refers to herself via Pharmacy. The patient's medical history was not reported. The patient's concurrent conditions included rash, and asthma. Concomitant therapies were not reported. The patient's past medical history/medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On an unknown date in 2024 (also reported as month ago), the patient was vaccinated with HPV vaccine (HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (manufacture not reported), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 01-JAN-2024, the patient started therapy with dupilumab (DUPIXENT) solution for injection, 300 milligram, qow, administered subcutaneously for asthma (strength, lot #, and expiry date were not provided). Both products were delivered via unknown device. After administration of dupilumab (DUPIXENT), the patient developed fever (pyrexia), chills, body aches (pain). Patient reported that she had been depressed for personal reasons (depressed mood) and think thought of hospitalization in a psychiatric facility. Also reported a rash that sprouted and spreaded on the thighs, knees, feet and elbows, arms and knuckles, these symptoms had been present before dupilumab (DUPIXENT) but now they were more pronounced while being treated with dupilumab (DUPIXENT) and HPV vaccine. On unknown date in 2024, the patient experienced red eyes (Ocular hyperemia) (unknown latency). On 08-OCT-2024, the patient experienced pneumonia (latency: 9 month 7days) and was hospitalized due to event pneumonia from 08-OCT-2024 to 15-OCT-2024, she was still recovering and continued with cough and fatigue. It was unknown if the patient experienced any additional symptoms/events. It was not reported corrective treatment for all events. At the time of reporting, the outcome of event ocular hyperemia was reported as recovered in 2024 and the outcome of rest of events was reported as recovering. The action taken with dupilumab (DUPIXENT) was reported as no action taken (dose not changed). The action taken with the HPV vaccine was not applicable. The causal relationship between all events and all suspect products were unknown. Upon internal review, the event Pneumonia was determined to be medically significant. More
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2819990 0.5 U AL 01/08/2025 RV5
 MERCK & CO. INC.
 x028576
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; caller verified the ROTATEQ was administered after the RMPDS case was submitted.; ... No adverse event; caller verified the ROTATEQ was administered after the RMPDS case was submitted.; This spontaneous report was received from a nurse referring to a patient, age and gender was not provided. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On 02-JAN-2025, the patient was vaccinated with an improperly stored dose of rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 ml, for prophylaxis, (route of administration, vaccination scheme frequency, anatomical location was not reported, valid lot number x028576 with an expiration date on 08-OCT-2025). The administered dose of the vaccine experienced a temperature excursion 34.7 degrees Fahrenheit for 24 hours, it was not reported if the information was recorded by a data logger or not. No previous temperature excursion. There was no adverse effect reported. More
2819991 U OH 01/08/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 X024178
Y006523
No adverse event, Product preparation error; No adverse event, Product preparati... No adverse event, Product preparation error; No adverse event, Product preparation error More
No additional AE reported; T/E for STERILE DILUENT. HCP stated wasn't sure if on 12/16/2024 the... No additional AE reported; T/E for STERILE DILUENT. HCP stated wasn't sure if on 12/16/2024 there was a T/E. HCP stated there was no T/E; This spontaneous report was received from a nurse, concerning to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-DEC-2024, a temperature excursion could happened, involving: sterile diluent (BAXTER STERILE DILUENT), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and/or varicella virus vaccine live (oka/merck) (VARIVAX). On the same day, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, and route of administration were not provided; lot #X024178 has been verified to be valid for this vaccine, expiration date reported and confirmed as 14-JUL-2025); varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, and route of administration were not provided; lot #Y006523 has been verified to be valid for this vaccine, expiration date reported and confirmed as 25-MAR-2026); with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion (strength, dose, route of administration, and indication were not provided; Lot # 1940390 has been verified to be valid for this product, expiration date not reported but confirmed as 05-OCT-2025). (Product storage error). No additional adverse event (no adverse event). More
2819992 U NM 01/08/2025 HPV9
 MERCK & CO. INC.
Dizziness Dizziness
felt dizzy and lightheaded; This spontaneous report was received from a medical assistant regarding ... felt dizzy and lightheaded; This spontaneous report was received from a medical assistant regarding an adolescent patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (exact dose, vaccination scheme frequency, lot number, expiration date, anatomical site of injection and route of administration were not provided). Following the vaccination, the patient felt dizzy and lightheaded in the exam room (Dizziness). At the time of the report, the outcome of the event Dizziness was not reported. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of Dizziness was not provided. This is one of 3 reports from the same reporter.; Sender's Comments: US-009507513-2501USA001092: More
2819993 U NM 01/08/2025 HPV9
 MERCK & CO. INC.
Dizziness Dizziness
felt dizzy and lightheaded; This spontaneous report was received from a medical assistant regarding ... felt dizzy and lightheaded; This spontaneous report was received from a medical assistant regarding an adolescent patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (exact dose, vaccination scheme frequency, lot number, expiration date, anatomical site of injection and route of administration were not provided). Following the vaccination, the patient felt dizzy and lightheaded in the exam room (Dizziness). At the time of the report, the outcome of the event Dizziness was not reported. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of Dizziness was not provided. This is one of 3 reports from the same reporter.; Sender's Comments: US-009507513-2501USA001092 More
2819994 M NC 01/08/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH




Alanine aminotransferase, Anion gap, Aspartate aminotransferase, Blood albumin, ... Alanine aminotransferase, Anion gap, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase; Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood glucose; Blood potassium, Blood sodium, Blood urea, COVID-19, Carbon dioxide; Gene mutation identification test, Gene sequencing, Glomerular filtration rate, Hyperkeratosis, Investigation; Metabolic function test, Physical examination, Protein total, SARS-CoV-2 test, Vaccination failure More
COVID-19 infection/ The patient was fully vaccinated prior to infection which, at the time, constitu... COVID-19 infection/ The patient was fully vaccinated prior to infection which, at the time, constituted a total of three vaccine doses; COVID-19 infection/ The patient was fully vaccinated prior to infection which, at the time, constituted a total of three vaccine doses; Aquagenic Syringeal Keratoderma; This is a literature report for the following literature source(s): A 24-year-old male with a history of food allergy anaphylaxis, infection-induced asthma, and atopic dermatitis pruritis presented with a subacute (approximately 2-week) onset of bilateral palmar edema with whitish-colored papules following brief local exposure to water or sweat. The patient denied excessive handwashing. The patient had no history of daily nonsteroidal anti-inflammatory drug (NSAID) use but had a recent 2-week prior history of pm re nata (PRN) ibuprofen use. There was no known family history of atopy, renal disease, pulmonary disease, AF508 cystic fibrosis transmembrane conductance regulator (CFTR) allele mutation, or breast cancer (BRCA) gene mutation. The patient was convalescent for Coronavirus disease 2019 (COVID- 19) 3 months prior, which was successfully treated with a full course of ritonavir-boosted nirmatrelvir (PAXLOVIDTM, Pfizer), resulting in complete recovery without any COVID-19-related hospitalization. The patient was fully vaccinated prior to infection which, at the time, constituted a total of three vaccine doses. Post-COVID self-administered rapid COVID-19 viral antigen tests were negative. The patient denied any post-COVID-19 conditions, also known as post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (PASC) or long COVID. Prior to presentation, the patient obtained photographic documentation of ASK on 2 separate occasions. On presentation, both palms appeared unremarkable; however, upon brief exposure to water for 2 minutes, the clinical signs of ASK became apparent with moderate involvement of the thumb and index fingers. There was no pedal involvement or involvement of other areas. The patient denied pain, discomfort, pruritis, and burning sensation. The patient declined therapeutic intervention, including topical steroids, topical aluminum chloride solution, and antihistamines. Workup for associated conditions was negative. A comprehensive metabolic panel (CMP) was also unremarkable, excluding nephrotic syndrome or other associated renal involvement. Sodium - 139 mmol/L [Standard range (SR): 135-146 mmol/L], Potassium - 4.7 mmol/L (SR: 3.5-5.3 mmol/L), Chloride 103 mmol/L (SR: 98-110 mmol/L), CO2 - 30 mmol/L (SR: 21-31), BUN - 12 mg/dL (SR: 8-24 mg/dL), Glucose - 89 mg/dL (SR: 70-99 mg/dL), Creatinine - 1.04 mg/dL (SR: 0.70 - 1.30 mg/dL), Calcium - 9.4 mg/dL (SR: 8.5-10.5 mg/dL), Total protein - 7.1 g/dL (SR: 6.4 - 8.9 g/L), Albumin - 4.6 g/dL (SR: 3.5 - 5.7 g/L), Total bilirubin - 0.3 mg/dL (SR: 0.0 - 1.0 mg/dL), Alkaline phosphatase - 57 IU/L or U/L (SR: 34 - 104 IU/L or U/L), AST (SGOT) - 18 IU/L (SR: 13 - 39 IU/L or U/L), ALT (SGPT) - 32 IU/L or U/L (SR: 7 - 52 IU/L or U/L), Anion gap - 6 mmol/L (SR: 4 - 14 mmol/L), Est. CFR - >90 ml/min/l.73 m2. Subsequent CFTR gene sequencing and single-gene deletion/duplication analysis returned negative. No pathogenic, likely pathogenic, or variants of uncertain significance on the CFTR gene were identified. Two months later, ASK appeared to have resolved. It could no longer be elicited by exposure to water or sweat, despite numerous attempts. The patient noted disappearance of white plaques and wrinkling after water exposure. Photographs of the improvement were not obtained. No known lifestyle, dietary, or medication-related changes contributed to ASK resolution. One month later, however, ASK returned, initially characterized by palmar edema after water exposure with absence of white plaques and papules. Soon, ASK progressed in severity with development of white plaques and increased palmar area involvement. Physical discomfort with episodes of pruritis was noted. Treatment with 12% topical aluminum chloride to promote palmar anhidrosis did not lead to improvement despite 4 weeks of nightly treatment. As a result, the patient was treated with bilateral palmar botulinum toxin injections. Within 2 weeks following botulinum toxin treatment, complete resolution of ASK occurred. The affected phalangeal surfaces also resolved despite no direct injection to these locations. Conclusions: The authors present a case of ASK in an adult male months following COVID-19 infection without a history of excessive handwashing. Near resolution 2 months after ASK onset was followed by recurrence 1 month later. The patient may have had a predisposition to recurrent ASK due to his history of atopy including atopic dermatitis and food allergy anaphylaxis combined with prior COVID-19 infection and sporadic, short-term NSAID use. It is possible that ASK may be a newly identified condition comprising PASC or long COVID. Clinicians should maintain heightened awareness of ASK in their patients and continue to document cases of this rare and poorly understood condition to improve clinical knowledge, treatment strategies, and future patient outcomes. Amendment: This follow-up report is being submitted to amend previous information: Case was reassessed from invalid to valid.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 NOS cannot be excluded for the event vaccination failure. Aquagenic Syringeal Keratoderma could be secondary to underlying contributory factors including COVID-19 infection. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product 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
2819995 M 01/08/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza virus test positive Influenza virus test positive
tested positive for the flu; Initial information received on 27-Dec-2024 regarding an unsolicited va... tested positive for the flu; Initial information received on 27-Dec-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an unknown age male patient who had tested positive for the flu after receiving vaccine influenza vaccine. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date in November 2024, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (immunization). On an unknown date the patient tested positive for the flu (influenza) (unknown latency) following the administration of influenza vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Reporter stated that, flu vaccine that was given to my son at the Pediatric office back in November. I'd like to obtain more information about the influenza vaccine and the virus strains. I understand that there are four or more strains of mutations out there and your vaccine is a 1:4 ratio, which I am trying to connect the dots. The reason is that my son tested positive for the flu and has been taking Tamiflu for 6 days and has not been better. Relevant laboratory test results included: Influenza virus test - On an unknown date: Positive Action take was not applicable. The patient was treated with oseltamivir phosphate (tamiflu) for Influenza. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. More
2819996 M 01/08/2025 FLUX
 UNKNOWN MANUFACTURER
COVID-19 COVID-19
came down with covid; Initial information received on 31-Dec-2024 regarding an unsolicited valid Soc... came down with covid; Initial information received on 31-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional. This case involves Adult male patient who had came down with covid after receiving Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested. On an unknown date the patient had came down with covid (covid-19) (unknown latency) following the administration of Influenza Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (came down with covid). At time of reporting, the outcome was Unknown for the event came down with covid. More
2819997 F 01/08/2025 FLUX
 UNKNOWN MANUFACTURER
Malaise Malaise
sick; Initial information received on 28-Dec-2024 regarding an unsolicited valid Social Media non-se... sick; Initial information received on 28-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional. This case involves Adult female patient who experienced sick, after receiving vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the patient got sick (malaise) (latency: few days) following the administration of Influenza Vaccine. Reportedly, the patient always got sick a few days after getting the vaccine. Action taken : not applicable. It was not reported if the patient received a corrective treatment for the event (sick). At time of reporting, the outcome was Unknown for the event sick. More
2819998 M 01/08/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza Influenza
when took the vaccine for years, I came down with 2 weeks of flu every time; Initial information rec... when took the vaccine for years, I came down with 2 weeks of flu every time; Initial information received on 10-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a Patient This case involves Adult male patient who reported when he took the Influenza Vaccine for years, he came down with 2 weeks of flu every time. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On an unknown date the patient when took the vaccine for years, he came down with 2 weeks of flu every time (influenza) (unknown latency). Reportedly, Ever since I stopped taking the flu vaccine, I never came down with the flu; When I took the vaccine for years, I came down with 2 weeks of flu every time. Go figure but I'm staying with my track record. Screw the flu vaccine and getting sick. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2819999 1.25 M FL 01/08/2025 HIBV
 SANOFI PASTEUR
 UK148AA
No adverse event, Product preparation error No adverse event, Product preparation error
vaccine was given to patient without the diluent and sterile water was used with no adverse event; v... vaccine was given to patient without the diluent and sterile water was used with no adverse event; vaccine was given to patient without the diluent and sterile water was used with no adverse event; Initial information received on 30-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient to whom HIB (PRP/T) Vaccine [ACT-HIB] was given without the diluent and sterile water was used with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 30-Dec-2024, the patient received a dose 4 with dosage 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK148AA, with unknown, strength and expiry) via unknown route in unknown administration site as immunization without the diluent and sterile water was used with no adverse event (product preparation error) (poor quality product administered) (Latency: same day). 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
2820000 1 F 01/08/2025 HIBV
 SANOFI PASTEUR
 UK008AA
Expired product administered, No adverse event Expired product administered, No adverse event
receiving an expired dose of act-hib with no reported adverse event; Initial information received on... receiving an expired dose of act-hib with no reported adverse event; Initial information received on 02-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old female patient received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and PNEUMOCOCCAL VACCINE 13V for Immunisation. On 02-Jan-2025, the patient received an expired dose of 0.5 ml, 1X (once) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK008AA and expiry 31-Dec-2024) with no reported adverse event (expired product administered) (latency same day) (strength and route: unknown) in the thigh NOS (not specified) for immunization. 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
2820001 13 F OH 01/08/2025 TDAP
 SANOFI PASTEUR
 U7626AA
Expired product administered, No adverse event Expired product administered, No adverse event
provided an expired ADACEL to a patient with no reported adverse event; Initial information received... provided an expired ADACEL to a patient with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old female patient who received an expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Dec-2024, the patient received 0.5 ml of an expired diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection with standard strength (expiry date- 08-Dec-2024 and lot U7626AA) once via intramuscular route in the deltoid NOS (not otherwise specified) as Immunization with no reported adverse event (expired product administered) (latency- same day). 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
2820002 0.33 M ME 01/08/2025 HIBV
 SANOFI PASTEUR
 UK008AA
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to administration of expired ACTHIB vaccine with no reported adverse event; In... inappropriate use due to administration of expired ACTHIB vaccine with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who had administration of expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Quadracel) for Immunisation; Polio vaccine inact 3v (Vero) (Ipol) for Immunisation; Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation; and Rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation. On 03-Jan-2025, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) lot UK008AA, Expiry date: 31-Dec-2024 (Expired product administered) via intramuscular route in the thigh nos(Not specified) (strength was unknown) for Immunization (Latency : same day). 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
2820003 0.33 F CA 01/08/2025 HIBV
 SANOFI PASTEUR
 UK008AA
Expired product administered, No adverse event Expired product administered, No adverse event
expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial informa... expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient with no reported adverse event . The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine live oral 1v (Rotarix) for Immunisation; and Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix) and PCV 20 for Immunisation. On 03-Jan-2025, the patient received a dose 1 of 0.5 ml suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) lot UK008AA, Expiry date: 31-Dec-2024 (expired product administered) (strength was unknown) via intramuscular route in the thigh nos for Immunization. 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
2820004 1.33 M FL 01/08/2025 HIBV
 SANOFI PASTEUR
 UK005AA
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to administration of expired vaccine with no reported adverse event; Initial i... inappropriate use due to administration of expired vaccine with no reported adverse event; Initial information received on 07-Jan-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 16 months old male patient who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis B vaccine; pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20); and varicella zoster vaccine, all for Immunisation. On 06-Jan-2025, the patient received expired unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength with lot UK005AA and expiry date 31-Dec-2024 via unknown route in unknown administration site for Immunization (expired product administered) (Latency same day). Reportedly, Reporter stated that they gave an expired ACT HIB vaccine to a patient yesterday. 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
2820005 1.83 F ID 01/08/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 WF2582
No adverse event No adverse event
No Reaction to report No Reaction to report
2820006 0.33 F CA 01/08/2025 PNC15
RV1
VARCEL
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 Y002643
5N2AN
Y010184
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Varicella was ordered instead of Vaxielis administered in error. We did not know that we made the e... Varicella was ordered instead of Vaxielis administered in error. We did not know that we made the error until our billing department notified us. I contacted my supervisor, notified the ordering provider, and then contacted the patient right away and of the vaccine error. We then scheduled patient to come in to get the correct vaccine. I then reported the incident to our compliance department and now I am reporting it here. More
2820007 21 F CT 01/08/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 8081564
TFAA2439
Loss of consciousness, Syncope; Loss of consciousness, Syncope Loss of consciousness, Syncope; Loss of consciousness, Syncope
pt fainted, but didn't loose consciousness. she usually faints or has dizziness after being str... pt fainted, but didn't loose consciousness. she usually faints or has dizziness after being stressed out or very nervous. she had job interview on Tue 1/7/2025 and very nervous since it's her last semester of college. pt was given a glass of water. she was able to sit by herself on chair while drinking glass of water, then was able to stand up on her own and waited for about 15-20 minutes while her mother was getting her Immunization. More
2820008 70 M FL 01/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
PATIENT ACCIDENTALLY RECEIVED A SECOND DOSE OF AREXVY (1ST DOSE IN DECEMBER 2023 AND 2ND DOSE IN JAN... PATIENT ACCIDENTALLY RECEIVED A SECOND DOSE OF AREXVY (1ST DOSE IN DECEMBER 2023 AND 2ND DOSE IN JANUARY 2025). PATIENT WAS INFORMED BUT LET US KNOW HE HASN'T EXPERIENCED ANY SIDE EFFECTS FROM INADVERTANTLY RECEIVING A SECOND DOSE OF THE VACCINE. More
2820009 73 F TN 01/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Patient received 2 doses of Arexvy; the first being on 1/22/24 and the second on 1/4/25 Patient received 2 doses of Arexvy; the first being on 1/22/24 and the second on 1/4/25
2820010 71 F AL 01/08/2025 PNC20
 PFIZER\WYETH
 LG5577
Extra dose administered Extra dose administered
Patient received an inappropriate dose of Prevnar 20. The patient was vaccinated with Prevnar 20 on ... Patient received an inappropriate dose of Prevnar 20. The patient was vaccinated with Prevnar 20 on 01/07/25 but had previously already been vaccinated on 03/23/23. Record did not have history of the past vaccination. Also, due to the two-year time difference since last immunization, enterprise did not show history of this vaccination on the patient's profile. The patient was also asked about previous vaccinations prior to Prevnar 20 being administered. She did not recall receiving this vaccination in the past. Patient is now aware of inappropriate dose given. She reports no ADRs and is not upset. More
2820012 55 F 01/08/2025 COVID19
FLU3
HEP
IPV
MMR
TDAP
 PFIZER\BIONTECH
SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
 LM7786
UT8415LA
945657
X1C891M
Y008290
U8015AA
Axillary pain, Tenderness; Axillary pain, Tenderness; Axillary pain, Tenderness;... Axillary pain, Tenderness; Axillary pain, Tenderness; Axillary pain, Tenderness; Axillary pain, Tenderness; Axillary pain, Tenderness; Axillary pain, Tenderness More
Patient came to pharmacy saying that her left arm hurts when she puts pressure on it and that it hur... Patient came to pharmacy saying that her left arm hurts when she puts pressure on it and that it hurts under her armpit on 1/7/25 around 3pm. Looked as her armpit area and did not see any signs of swelling or redness. Looked up side effect profile of all vaccines administered on the the left arm and came to conclusion that it may be the Comirnaty vaccine that may have caused the symptoms patient was experiencing since it list axillary tenderness/swelling as possible side effects. Advised patient to use cold compress to help with pain or can take Tylenol if necessary and continue to monitor. If symptoms get worse advise patient to seek medical attention at clinic/ER since patient did not have primary doctor. More
2820024 44 F AZ 01/08/2025 COVID19
 NOVAVAX
Chillblains Chillblains
Covid toes aka chilblains Covid toes aka chilblains
2820025 84 F CA 01/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 A4P5G
Injection site erythema, Injection site pain, Injection site pruritus Injection site erythema, Injection site pain, Injection site pruritus
pt came into pharmacy 5 days after injection to show a red patch about 2.5 inches in diameter on her... pt came into pharmacy 5 days after injection to show a red patch about 2.5 inches in diameter on her left shoulder. non raised, red and patchy. pt described it as burning and itchy. More
2820032 69 F CT 01/08/2025 COVID19
COVID19
 MODERNA
MODERNA
 023M20A
Chemotherapy, Death, Endoscopy; Chemotherapy, Death, Endoscopy Chemotherapy, Death, Endoscopy; Chemotherapy, Death, Endoscopy
Online report of death in EUA medical countermeasure recipient, a 69-year-old female recipient. She ... Online report of death in EUA medical countermeasure recipient, a 69-year-old female recipient. She was receiving intravenous infusions on her hand on 12/4/24 and right forearm on 12/11/24 as a form of cancer treatment at Treatment Center and 04/22/24 victim received endoscopy at Hospital according to social media posts. On her social media post victim stated, "Just like the polio vaccine in 1959". No other post with inoculation info. On 08/12/21 victim posted about FDA decision to allow immune compromised to receive a "booster". Dose#1 Date 02/23/21 LOT#023M20A. VAX card list "MH"location likely hospital. Based on her social media posts she received at least 2 shots if not a third "booster" More
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2820033 1.42 M CA 01/08/2025 HIBV
 SANOFI PASTEUR
 UJ964AD
Expired product administered Expired product administered
Gave Patient Expired HIB vaccine Gave Patient Expired HIB vaccine
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