🏥 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 💀 🏥 🚑 ♿ ⚠️
2853051 83 F NV 08/06/2025 COVID19
 PFIZER\BIONTECH
 LN0589
Blood test, COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure Blood test, COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
she finally caught COVID; she finally caught COVID; This is a spontaneous report received from a Con... she finally caught COVID; she finally caught COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 84-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 as dose 1, single (Lot number: LN0589) at the age of 83 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (ongoing); "next-door neighbor had covid" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] intramuscular taken for immunisation, on 01Nov2024 as dose number unknown, single; RSV VACCINE intramuscular taken for immunisation, in Nov2024 as dose number unknown, single; OMEPRAZOLE taken for gastrooesophageal reflux disease; VITAMINS NOS. Vaccination history included: Covid-19 vaccine (took all of her shots and everything was fine), for covid-19 immunisation.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jul2025, outcome "unknown" and all described as "she finally caught COVID". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown Results, notes: The lab work for COVID, I had a blood test done; (unspecified date) Unknown Results, notes: The lab work for COVID, I had a blood test done; SARS-CoV-2 test: (16Jul2025) Positive, notes: It was about 16Jul, 17Jul and the results were that I had COVID, SARS COVID-19, it was positive; (17Jul2025) Positive, notes: It was about 16Jul, 17Jul and the results were that I had COVID, SARS COVID-19, it was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took all of her shots and everything was fine. Her last shot was in Nov of last year (2024). It slipped her mind to take another one in the next 4, 5, or 6 months, so she was almost 7 or 8 months without having a shot, forgot the latest shot. After 3 years of being successful, the caller's incredible next-door neighbor asked her for a ride, so she gave him a ride, and he was sick. It turned out he had COVID, so for the first time in three or four years, she finally caught COVID.Her doctor gave her Tamiflu, and COVID really knocked her down hard. After the last 30 days of having it, she now needs to know because her flu shot is set for the end of Aug, and she had already planned to get a COVID shot. However, her doctor advised her not to get it because she now has antibodies, but she told them that she's going to get the shot anyway. People who just relied on their antibodies have had COVID two or three times. She took her Pfizer shots and never got it. More
2853052 08/06/2025 PNC20
 PFIZER\WYETH
Erythema, Feeling hot, Mobility decreased, Pain in extremity, Peripheral swellin... Erythema, Feeling hot, Mobility decreased, Pain in extremity, Peripheral swelling More
I am worried about cellulites in the arm; this arm, I could barely lift up; The whole thing hurts ve... I am worried about cellulites in the arm; this arm, I could barely lift up; The whole thing hurts very bad.; It is so red and it feels like there is bubble under the skin and it is very hot.; It is so red and it feels like there is bubble under the skin and it is very hot.; some kind of allergy; my arm is completely swollen and red; my arm is completely swollen and red; This is a spontaneous report received from a Nurse. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: Oct2024, for COVID-19 Immunization, reaction(s): "Drug allergy", "Erythema of extremities", "Extremities hot feeling of", "Swollen arm". The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "I am worried about cellulites in the arm"; INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "unknown", described as "this arm, I could barely lift up"; PAIN (non-serious), outcome "unknown", described as "The whole thing hurts very bad."; FEELING HOT (non-serious), SKIN DISORDER (non-serious), outcome "unknown" and all described as "It is so red and it feels like there is bubble under the skin and it is very hot."; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "some kind of allergy"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "my arm is completely swollen and red". Additional Information: Reporter received Prevnar 20 and now reporter arm was completely swollen and red. Reporter received last fall, the Pfizer COVID vaccine Comirnaty, that one and reporter had a reaction in the other arm. Reporter arm was completely swollen, red and very hot. Reporter need to know what if, ingredients are the same in those vaccines, anything was there Because reporter definitely had some kind of allergy. When paraphrased the concern, consumer stated, Anything that was similar. Reporter looked it up on AI and it does not says if there anything similar between these two. Consumer stated, Okay, yes, well, in the meantime, reporter was going to go to the clinic to get checked about this because this was now two vaccines. The COVID reporter got last fall, October and now, this arm, reporter could barely lift. The whole thing hurts very bad. Reporter was worried about cellulites in the arm. It was so red and it felt like there was bubble under the skin and it was very hot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853053 TX 08/06/2025 PNC20
 PFIZER\WYETH
 LP4948
Product container issue Product container issue
one of the vial was broke; This is a spontaneous report received from an Other HCP from product qual... one of the vial was broke; This is a spontaneous report received from an Other HCP from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LP4948, Expiration Date: 31Aug2026) for immunisation, Device Lot Number: LP4948, Device Expiration Date: 31Aug2026. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "one of the vial was broke". Additional information: A nurse practitioneris calling in regards to Prevnar 20 stated that they open a box of 10 yesterday(on 29Jul2025) and one of the vial is broke. When probed if there was any patient involvement, reporter stated, no, that was not administer. She had actually got the vial here in her office, in her possession. Prevnar 20 in tin, one of the vials arrived broken. Reporter was informed not to discard the product as the report will be forwarded for review by our Quality department.? Reporter stated okay. Reporter stated, a sample of the product available to be returned, she had got it right in front of her and she would not discard it. She will keep it. Reporter stated, packaging sealed and intact. When they opened the box, then they discovered that one because it was brand new tin vial box and so that was the only one that was broken. Reporter stated, no additional lot numbers, this is the only one. Sample not requested due to sharps risk. Product strength and count size dispensed: Reporter stated, "It is the Prevnar 20. It says 1 dose 0.5 ML.". Product NDC# 0005-2000-01. Causality for "one of the vial was broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). More
2853054 82 F CA 08/06/2025 PNC20
 PFIZER\WYETH
 LN4930
Erythema, Inflammation, Pain in extremity, Pruritus, Skin warm Erythema, Inflammation, Pain in extremity, Pruritus, Skin warm
arm pain; redness to upper arm spreading to lower arm; itchy; Inflammation to the upper arm spreadin... arm pain; redness to upper arm spreading to lower arm; itchy; Inflammation to the upper arm spreading through the lower arm; Hot to touch; Swelling; This is a spontaneous report received from a Nurse. An 82-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Jul2025 as dose 1, single (Lot number: LN4930, Expiration Date: 31Jul2026) at the age of 82 years, in left arm for immunisation. The patient's relevant medical history included: "Sulfa Antibiotics: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 2025, outcome "unknown", described as "Hot to touch"; INFLAMMATION (non-serious) with onset 2025, outcome "unknown", described as "Inflammation to the upper arm spreading through the lower arm"; SWELLING (non-serious) with onset 2025, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset 2025, outcome "recovering", described as "arm pain"; PRURITUS (non-serious) with onset 2025, outcome "recovering", described as "itchy"; ERYTHEMA (non-serious) with onset 2025, outcome "recovering", described as "redness to upper arm spreading to lower arm". Therapeutic measures were taken as a result of pain in extremity, erythema, pruritus, inflammation, feeling hot, swelling. Additional information: The vaccine was administered at a doctor's office or urgent care facility. The patient did not receive any other vaccines on the same date as the Prevnar 20 vaccine. The patient did not receive any other vaccines within four weeks prior to receiving the Prevnar 20 vaccine. The patient experienced arm pain and redness in the upper arm, which spread to the lower arm and was occasionally itchy. Treatment orders was placed to shut down inflammation process - Doxycycline, Prednisone, Triamcinolone, Zyrtec. Inflammation to the upper arm spreading through the lower arm, redness, hot to touch, itchiness and swelling. The primary care is already treating the patient. More
2853055 08/06/2025 RSV
 PFIZER\WYETH
Injection site rash Injection site rash
rash in injection site area; This is a spontaneous report received from a Physician from medical inf... rash in injection site area; This is a spontaneous report received from a Physician from medical information team. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash in injection site area". Additional information: The reporter questioned if Abrysvo had shown to cause a rash in injection site area during studies. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2853056 F 08/06/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got Covid; got Covid; This is a spontaneous report and received from Consumer or other non HCPs. A ... got Covid; got Covid; This is a spontaneous report and received from Consumer or other non HCPs. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The event "got covid" required physician office visit. Clinical course: reporter was calling on behalf of wife (patient) and stated that patient got COVID. There was no medicine at the pharmacy that the patient was prescribed (still has not arrived). Reporter wanted to know how much it costs. The patient was sick and laying down. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853057 08/06/2025 RSV
 PFIZER\WYETH
Neurological symptom Neurological symptom
Neurological reaction to the RSV vaccine (Abrysvo Vaccine); This is a spontaneous report received fr... Neurological reaction to the RSV vaccine (Abrysvo Vaccine); This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: NEUROLOGICAL SYMPTOM (hospitalization), outcome "unknown", described as "Neurological reaction to the RSV vaccine (Abrysvo Vaccine)". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
✓
2853058 M MI 08/06/2025 COVID19
 PFIZER\BIONTECH
Psoriasis Psoriasis
Psoriasis after vaccine and has not resolved; This is a spontaneous report received from a Nurse fro... Psoriasis after vaccine and has not resolved; This is a spontaneous report received from a Nurse from a sales representative. An adult male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis after vaccine and has not resolved". It was unknown if therapeutic measures were taken as a result of psoriasis. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853059 F 08/06/2025 COVID19
 PFIZER\BIONTECH
Immune system disorder Immune system disorder
immune system gotten worse; This is a spontaneous report received from a Consumer or other non HCP f... immune system gotten worse; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 69-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reaction to steroid" (unspecified if ongoing); "allergic to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "immune system gotten worse". Additional information: The reporter informed that she has been receiving from Pfizer and the last email she received was from 29July2025. The email said Pfizer wanted to know more about her situation. She informed that she didn't want any more shots because she's done with it and it could've been fatal for her. She informed that she already reported it through (redacted) back in 2021. She was just letting them know she has already recorded this to the (redacted). So she's not sending additional information. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853060 F 08/06/2025 TDAP
 SANOFI PASTEUR
Pain, Pyrexia Pain, Pyrexia
reported that patient experienced: body ache; reported that patient experienced: fever; Initial info... reported that patient experienced: body ache; reported that patient experienced: fever; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult female patient who had body ache and fever after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. The patient's past medical history included Insomnia, Kidney stone and Bladder disorder. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Intervertebral disc disorder, Multiple sclerosis and Nephrolithiasis. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date, the patient developed body ache (pain) and fever (pyrexia) (latency unknown) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. More
2853061 0.75 F DE 08/06/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK040AA
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initia... inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 9 months old female patient who received an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 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 Pneumococcal Vaccine Conj 20v (Crm197) (Pneumococcal Vaccine Conj 20v (Crm197)) for Immunisation. On 01-Aug-2025, the patient received an expired 0.5ml, dose 3 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (once), Suspension for injection, Strength standard, lot UK040AA and expiry date 31-Jul-2025 via intramuscular route in the right thigh for immunization, with no reported adverse event (expired product administered) (Latency Same day). Reportedly, Medical Assistant (MA) had administered a dose of Pentacel vaccine to a patient on 01-Aug-2025, but the vaccine expired on 31-Jul-2025. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853062 M VA 08/06/2025 RAB
 SANOFI PASTEUR
No adverse event, Product prescribing error, Wrong technique in product usage pr... No adverse event, Product prescribing error, Wrong technique in product usage process More
this situation is pre-assessed as an off-label use as per local labelling due to product not adminis... this situation is pre-assessed as an off-label use as per local labelling due to product not administered immediately after reconstitution with no adverse event; the vaccine should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age male patient who was prescribed with Rabies (HDC) vaccine [Imovax Rabies] that should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14 and the product was not administered immediately after reconstitution with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection (expiry date, lot number and strength-unknown) via unknown route in unknown administration site for Immunization was not administered immediately after reconstitution (wrong technique in product usage process) and the vaccine should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14 with no adverse event (product prescribing error). Reportedly- The vaccine must be administered immediately after reconstitution but on their day 7, their vaccine was already reconstituted on the desk. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853063 11 M CA 08/06/2025 MEN
 UNKNOWN MANUFACTURER
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
MENQUADFI was given at an earlier than recommended interval to a patient with no reported adverse ev... MENQUADFI was given at an earlier than recommended interval to a patient with no reported adverse events; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA229437 (cluster case) This case involves a 11 years old male patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] earlier than recommended interval with no reported adverse events. 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, Tetanus vaccine toxoid (AdaCel) for Immunisation. On 19-Feb-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (once), Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation. On 23-Jul-2025, the patient received an extra, unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, (once), Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, earlier than recommended interval with no reported adverse events (extra dose administered) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, The patient was already up to date with the ADACEL while the MENQUADFI was given at an earlier than recommended interval. She explained that the patient has already received both vaccines last 19-Feb-2025 and was given again last 23-Jul-2025. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA229437: More
2853064 11 M CA 08/06/2025 TDAP
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
extra doses of ADACEL was administered with no reported adverse event; Initial information received ... extra doses of ADACEL was administered with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with US-SA-2025SA229198 (cluster case). This case involves a 11 years old male patient who received extra doses of 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. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation. On 19-Feb-2025, the patient received an unknown dose of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Immunization. On 23-Jul-2025 the patient also received an extra dose of the same vaccine (with an unknown batch number and expiry date) via unknown route in unknown administration site for Immunization with no reported adverse event (extra dose administered) (latency- same day). Information on the batch number could not be requested corresponding to the one at time of event occurrence. Reportedly, the patient was already up to date with the ADACEL. Caller refused to provide other information stating the she didn't have it and was not permitted to. She also advised not to be contacted because she didn't have the information regarding the vaccination. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA229198:MENQUADFI More
2853065 19 ID 08/06/2025 MEN
 UNKNOWN MANUFACTURER
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
was prescribed to get 3-doses of MENQUADFI starting back in 2020; that they were to receive one dose... was prescribed to get 3-doses of MENQUADFI starting back in 2020; that they were to receive one dose and then 6- months later the second dose; that the consumer never got the second dose until now in 2025 with no adverse event; Initial information received on 05-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 19 years old and unknown gender patient who was prescribed to get 3-doses of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] starting back in 2020; that they were to receive one dose and then 6- months later the second dose; that the consumer never got the second dose until now in 2025 with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2020, the patient received a dose 1 (at 14 years old) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization. On an unknown date in 2025 patient received a dose 2 of same vaccine with an unknown batch number via unknown route in unknown administration site. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. The patient was prescribed to get 3-doses of menquadfi starting back in 2020; that they were to receive one dose and then 6- months later the second dose; that the consumer never got the second dose until now in 2025 with no adverse event (Routine immunization schedule incomplete) (latency same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853066 65 M CA 08/06/2025 MEN
MMR
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 U8493AA
No adverse event, Product preparation error; No adverse event, Product preparati... No adverse event, Product preparation error; No adverse event, Product preparation error More
A patient was supposed to receive an MMR vaccine. Instead of using the correct diluent for the MMR ... A patient was supposed to receive an MMR vaccine. Instead of using the correct diluent for the MMR vaccine, a medical assistant reconstituted the MMR dose with MenQuadfi with no reported adverse event; Initial information received on 05-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old male patient who was supposed to receive measles vaccine, mumps vaccine, rubella vaccine [MMR], instead of using the correct diluent for the MMR vaccine, a medical assistant reconstituted the MMR dose with meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Aug-2025, the patient was supposed to receive an unknown dose of MMR not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported instead of using the correct diluent for the MMR vaccine, a medical assistant reconstituted the MMR dose with an unknown dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength- unknown, expiry date- 31-MAY-2028 and lot U8493AA) via intramuscular route in unknown administration site for prophylactic vaccination (Immunization) with no reported adverse event (wrong product administered) (latency- same day). Reportedly, the patient was not supposed to get MenQuadfi at all. No other immunizations were there. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853067 2 TX 08/06/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK330AA
No adverse event, Product preparation error No adverse event, Product preparation error
inadvertently administered pentacel powder reconstituted with sterile water only with no reported ad... inadvertently administered pentacel powder reconstituted with sterile water only with no reported adverse event; Initial information received on 05-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 2 years old and unknown gender patient who was inadvertently administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] powder reconstituted with sterile water only with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received dose 4 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine(strength, dose unknown) Powder and suspension for suspension for injection lot UK330AA expiry date-31-Jul-2026 via unknown route in unknown administration site for Immunization, inadvertently administered pentacel powder reconstituted with sterile water only with no reported adverse event (product preparation error) (same day latency). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853072 52 M FL 08/06/2025 MEN
 UNKNOWN MANUFACTURER
No adverse event, Off label use No adverse event, Off label use
MENQUADFI prescribed with off label diagnosis,Acquired absence of spleen with no reported adverse e... MENQUADFI prescribed with off label diagnosis,Acquired absence of spleen with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 52 years old male patient to whom Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was prescribed with off label diagnosis,Acquired absence of spleen with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed with an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site for Acquired absence of spleen (Acquired asplenia) and prescribed with off label diagnosis with no reported adverse event (off label use). Action taken was not applicable. No follow up possible since reporter denied to respond to Sanofi PV Follow up. More
2853073 CA 08/06/2025 DTAP
 SANOFI PASTEUR
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
patient only had 3 Daptacel when they were months- old to 6 years old with no reported adverse event... patient only had 3 Daptacel when they were months- old to 6 years old with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child and unknown gender patient who only had 3 diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] when they were months- old to 6 years old with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received only 3 dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (unknown strength, lot and expiry date) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) when they were months- old to 6 years old with no reported adverse event (routine immunisation schedule incomplete) Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, reporter had questioned about the DTAP and TDAP vaccines. They want to know what to give for a 7 year-old to 10 year-old patient when they are not up do date with vaccine. The patient only had 3 Daptacel when they were months- old to 6 years old. She inquired whether they should give Adacel. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853074 12 F WA 08/06/2025 MNQ
 SANOFI PASTEUR
 U8438AA
Inappropriate schedule of product administration Inappropriate schedule of product administration
I and MA-C checked database for vaccine records, there was no vaccine record found on database, we c... I and MA-C checked database for vaccine records, there was no vaccine record found on database, we checked our records and determine the child was due for her second dose of Meningococcal and HPV, few days after giving the shots, our Supervisor discovered that the child was not due for the second dose of Meningococcal at this time. MA-C called and inform CDC about this, and CDC states this will not cause any harm or adverse reaction to the child, since it almost a year from when she got her first dose, but Patient will still need to get her second dose as at when due . Called Parent several times to inform them about this, no response, left message on voice mail, will continue trying to reach Parent and will send a letter by 8/8/2025, if unable to contact parent on phone. More
2853075 7 M 08/06/2025 DTAP
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No symptoms were reported or adverse reaction No symptoms were reported or adverse reaction
2853076 51 F CA 08/06/2025 RSV
 PFIZER\WYETH
 MD5465
No adverse event, Wrong product administered No adverse event, Wrong product administered
No adverse event was reported. Patient was given the wrong vaccine. Instead of getting the second ... No adverse event was reported. Patient was given the wrong vaccine. Instead of getting the second and final dose of the shingrix, patient got the abrysvo RSV vaccine instead More
2853089 54 F MA 08/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4j
Injection site erythema, Pain in extremity, Peripheral swelling Injection site erythema, Pain in extremity, Peripheral swelling
Patient received first dose on July 21, 2025, she called the pharmacy on august 6, 2025 to report he... Patient received first dose on July 21, 2025, she called the pharmacy on august 6, 2025 to report her arm still had pink spot where vaccine was given. The spot is described as half dollar size. She also stated her arm was in pain for 3 days and swelled . Patient went to doctor yesterday for other condition and forgot to mention to doctor. I told her to follow up with physician before receiving the second dose. More
2853090 53 F AZ 08/06/2025 COVID19
COVID19
 MODERNA
MODERNA

Autonomic nervous system imbalance, Dizziness, Exercise tolerance decreased, Fat... Autonomic nervous system imbalance, Dizziness, Exercise tolerance decreased, Fatigue, Gait disturbance; Heart rate increased More
After several weeks, extreme fatigue, spikes in heart rate, dizziness, difficulty walking, exercise ... After several weeks, extreme fatigue, spikes in heart rate, dizziness, difficulty walking, exercise intolerance. These symptoms have worsened over time. Heat exposure, stress, and overdoing are major triggers. More
✓
2853091 79 M CA 08/06/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 95BJ9
Underdose Underdose
none reported. patient was given the wrong vaccine. Was given the pediatric dose instead of the adu... none reported. patient was given the wrong vaccine. Was given the pediatric dose instead of the adult dose More
2853092 0.33 M ME 08/06/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
PNC20
PNC20
RV1
RV1
RV1
RV1
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8265AA
U8265AA
U8265AA
U8265AA
LN4932
LN4932
LN4932
LN4932
3Z34X
3Z34X
3Z34X
3Z34X
Ascites, Blood albumin decreased, Blood immunoglobulin G decreased, Blood sodium... Ascites, Blood albumin decreased, Blood immunoglobulin G decreased, Blood sodium decreased, Dehydration; Enterocolitis, Gastrointestinal wall thickening, Hypoalbuminaemia, Hypogammaglobulinaemia, Hyponatraemia; Intensive care, Intussusception, Laboratory test normal, Magnetic resonance imaging abdominal abnormal, Magnetic resonance imaging pelvic; Magnetic resonance imaging thoracic abnormal, Pleural effusion, Rotavirus test negative, Ultrasound abdomen normal; Ascites, Blood albumin decreased, Blood immunoglobulin G decreased, Blood sodium decreased, Dehydration; Enterocolitis, Gastrointestinal wall thickening, Hypoalbuminaemia, Hypogammaglobulinaemia, Hyponatraemia; Intensive care, Intussusception, Laboratory test normal, Magnetic resonance imaging abdominal abnormal, Magnetic resonance imaging pelvic; Magnetic resonance imaging thoracic abnormal, Pleural effusion, Rotavirus test negative, Ultrasound abdomen normal; Ascites, Blood albumin decreased, Blood immunoglobulin G decreased, Blood sodium decreased, Dehydration; Enterocolitis, Gastrointestinal wall thickening, Hypoalbuminaemia, Hypogammaglobulinaemia, Hyponatraemia; Intensive care, Intussusception, Laboratory test normal, Magnetic resonance imaging abdominal abnormal, Magnetic resonance imaging pelvic; Magnetic resonance imaging thoracic abnormal, Pleural effusion, Rotavirus test negative, Ultrasound abdomen normal More
Admitted to pediatric ICU early August 2025 with hyponatremic dehydration. MRI with concern for mult... Admitted to pediatric ICU early August 2025 with hyponatremic dehydration. MRI with concern for multiple associated short segment enteroenteric intussusceptions. Subsequent US without intussusception. Also severe hypoalbuminemia, hypogammaglobulinemia. Change in stool started prior to rotavirus vaccine. More
✓
2853093 75 F CA 08/06/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 95BJ9
Underdose Underdose
None reported. Patient was given the pediatric Engerix B and not the adult Engerix B vaccine. None reported. Patient was given the pediatric Engerix B and not the adult Engerix B vaccine.
2853094 1 F CA 08/06/2025 VARCEL
 MERCK & CO. INC.
 Z004245
Circumstance or information capable of leading to medication error, Underdose Circumstance or information capable of leading to medication error, Underdose
Dose 2 of Varicella SQ was ordered by Physician. Administered to right thigh SQ. Dose was 0.5 mg, wh... Dose 2 of Varicella SQ was ordered by Physician. Administered to right thigh SQ. Dose was 0.5 mg, while injecting patient moved which caused some of the vaccine to not be administered. Patient's mother was on the left side and father was standing on the right side of patient during administration. Patient was not harmed though patient did not receive the entire dose of Varicella. More
2853095 4 M NV 08/06/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4l454
z008222
Perioral dermatitis; Perioral dermatitis Perioral dermatitis; Perioral dermatitis
after client left t left the clinic i saw in the registry comments rash after vaccines on MMRV, F... after client left t left the clinic i saw in the registry comments rash after vaccines on MMRV, Father answered no to all screening questions . stated no allergy and no reaction to prior vaccination. Called the father and after seeing registry, He stated patient is playing but notice rash around the mouth. Advise father to bring child to ER More
2853096 17 F TX 08/06/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Vaccination site reaction More
Delayed onset injection site reaction. Raised hive around injection site. Swollen, red and itchy. ... Delayed onset injection site reaction. Raised hive around injection site. Swollen, red and itchy. Increasing in size More
2853097 19 F 08/06/2025 PNC20
 PFIZER\WYETH
 HN2630
Nausea, Weight decreased Nausea, Weight decreased
Pt started with nausea and weight loss that lasted for 6 months after. T Pt started with nausea and weight loss that lasted for 6 months after. T
2852702 GA 08/05/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Z003883
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
HBP confirmed the patient involved did not experience any medical concerns or symptoms after the adm... HBP confirmed the patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored VARIVAX.No additional AE; VARIVAX was exposed to multiple temperature excursions beginning in May 2025 and stated that a dose of the VARIVAX was administered to the patient involved on 6/6/2025; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 06-Jun-2025, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (oka-merck) (VARIVAX) 0.5 mL (dose frequency reported as two dose series) administered as prophylaxis (Lot No. Z003883 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck], expiration date reported and upon internal validation established as 03-Feb-2027) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (Lot No., expiration date and indication were not provided) (Product storage error). Additionally, it was stated that the previous mention vaccine was exposed to multiple temperature excursions beginning in (May 2025). The patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored varicella virus vaccine live (oka-merck) (VARIVAX). No additional adverse event (No adverse event). More
2852716 08/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Still got it; This serious case was reported by a consumer via intera... Suspected vaccination failure; Still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got it). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-JUL-2025 This case was reported by a patient via interactive digital media. Patient stated that they had the vaccine and still got it so why get the shots reporter indicated that they were furious besides had to pay for them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2852717 OR 08/05/2025 HIBV
 SANOFI PASTEUR
No adverse event, Product preparation error No adverse event, Product preparation error
pt received wrong diluent (sterile water) rather than intended diluent (sodium chloride 0.4%) with n... pt received wrong diluent (sterile water) rather than intended diluent (sodium chloride 0.4%) with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] with wrong diluent (sterile water) rather than intended diluent (sodium chloride 0.4%) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Aug-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine with wrong diluent (sterile water) rather than intended diluent (sodium chloride 0.4%),Powder and solvent for solution for injection (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for routine vaccination (Immunisation) with no reported adverse event (product preparation error) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852718 57 M AZ 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NJ374
Pruritus, Rash, Rash erythematous, Rash pruritic, Urticaria Pruritus, Rash, Rash erythematous, Rash pruritic, Urticaria
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: A 58yo male reported red itchy rash ... Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: A 58yo male reported red itchy rash on the chest, stomach, arms and legs two days after received first shot of Shingles vaccine. Other Relevant HX: Two days after vaccine, broke out in rash/hives on trunk and legs. Presented to urgent care. Reports given steroid injection and 5 days of prednisone. Also was using topical triamcinolone cream. Referred to dermatology per ID e-consult recommendations. Meanwhile, ID prescribed another steroid taper via pharmacy. Per telederm assessment, not consistent with a fixed drug eruption or diffused fixed drug eruption and morphologically is more consistent with an eczematous/psoriasiform dermatoses. According to the secure messaging, the patient was using diclofenac gel for this rash it is possible this is causing or contributing to contact dermatitis (irritant versus allergic), unclear what else patient is applying to skin, so instructed patient to stop all current topical products other than what was described in derm consult: 0.1% triamcinolone cream; 12% ammonium lactate lotion; 0.5% CAMPHOR AND MENTHOL LOTION; 10 mg cetirizine. More
2852719 57 M WI 08/05/2025 COVID19
 MODERNA
Swelling, Swollen tongue, Tongue oedema Swelling, Swollen tongue, Tongue oedema
Reported Symptoms: 10014257:EDEMA TONGUE; 10042674:SWELLING; Narrative: Other Relevant HX: Other: SW... Reported Symptoms: 10014257:EDEMA TONGUE; 10042674:SWELLING; Narrative: Other Relevant HX: Other: SWELLING; SWELLING OF TONGUE More
2852720 42 M MI 08/05/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LG5579
LG5579
Animal scratch, Injection site rash, Pruritus, Rash, Rash erythematous; Rash pru... Animal scratch, Injection site rash, Pruritus, Rash, Rash erythematous; Rash pruritic, Urticaria More
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Patient was give... Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Patient was given the Prevnar 20 vaccine in the right deltoid on 2/10/25. He presented to urgent care on 2/14/25 for a rash that began at the injection site on 2/11/25. As of 2/14/25 the rash has progressed to pruritic red bumps on his forearms and lower legs. Per the provider's note in urgent care it appears that the patient was receiving a different type of pneumococcal vaccine every few months. The patient was asked if he had an immunocompromising conditions or knew why he was receiving the vaccine and he was not aware. Patient was also found to have cat scratches on his right forearm, this is reported to not be abnormal for him. Patient was prescribed cetirizine and diphenhydramine. Patient was instructed to talk to his PCP about the indication for receiving the pneumococcal vaccines every few months. Upon further investigation the patient was being offered the vaccine every few months due to a clinical reminder firing from the patient's former alcohol dependence diagnosis (he is currently in remission). The patient refused the previous vaccine inquiries until 2/10/25. Database shows pneumococcal vaccines given on 4/2/18 x3 facilities (PPSV23) and 2/10/25 x1 facility (PCV20). Last year in pneumococcal vaccine history: -2/10/24: received PCV20 -12/10/24: refused all pneumococcal vaccines -10/9/24: refused all pneumococcal vaccines -7/11/24: refused all pneumococcal vaccines -5/1/24: no clinical reminders were firing for vaccines At his 2/19/25 follow-up More
2852721 65 M DC 08/05/2025 RSV
 PFIZER\WYETH
 LG9829
Angioedema, Swollen tongue Angioedema, Swollen tongue
Reported Symptoms: 10002424:ANGIOEDEMA; Narrative: a 65yo male with PMH of Cervical Spondylosis w/ra... Reported Symptoms: 10002424:ANGIOEDEMA; Narrative: a 65yo male with PMH of Cervical Spondylosis w/radiculopathy, Pain in R. Knee, Angioedema (2021), Lumbar Spondylosis, DM, Depressive disorder, Sleep Apnea, CKD, Gout and Exposure to Potentially Hazardous Substance. Per the administering RN's note; on February 11, 2025, the patient received RSV vaccine Pfizer RSV Bivalent, Protein subunit RSVPREF diluent reconstituted 0.5ML, PF, Lot#LG9829, Exp. 10/31/25, NDC#000069034405. Patient was observed by the administering nurse for 15 minutes at which time the nurse reported the patient felt slight swelling of side of the tongue. No rash and no shortness of breath was present. The patient self administered Epi pen in the clinic, PCP assessed the patient and patient remained in the clinic for observation. The patient also took his own prednisone, which he usually does whenever he gets medication reaction, together with epipen. The nurse's note included that the patient has two more epi pen at home. The nurse made follow up phone call and the patient confirmed the symptom has gone down, will take Tylenol for a headache and stating as the RN documented it " I know by the end of the day it will be gone". The ordering physician reported the observed vaccination induced Tongue swelling and updated patient's allergy profile. Other Relevant HX: Other: ANGIOEDEMA OF TONGUE More
2852722 M WI 08/05/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 7554T
Rash Rash
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
2852723 76 M KY 08/05/2025 PPV
 UNKNOWN MANUFACTURER
Rash Rash
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
2852724 64 M TN 08/05/2025 RSV
 PFIZER\WYETH
 LH4511
Device connection issue Device connection issue
Reported Symptoms: 10065066:DEVICE CONNECTION ISSUE; 10069868:DEVICE ISSUE; Narrative: LPN attempted... Reported Symptoms: 10065066:DEVICE CONNECTION ISSUE; 10069868:DEVICE ISSUE; Narrative: LPN attempted to administer an RSV vaccine to a patient and in the reconstitution process of the vaccine kit, the luer locking section of the syringe fell off. LPN tried it a second time with another kit from the same box and lot number and it was defective as well. A third kit was obtained from a different box that had the same lot number and there was no issue with reconstituting the vial with that kit's syringe. The LPN had previous experience in reconstituting the kits. Other Relevant HX: Other: Equipment malfunction - leur lock broke More
2852725 73 M OK 08/05/2025 RSV
 PFIZER\WYETH
 LF9828
Angioedema, Face oedema, Orbital oedema, Pruritus Angioedema, Face oedema, Orbital oedema, Pruritus
Reported Symptoms: 10002424:ANGIOEDEMA; 10037987:PRURITUS; 10054521:ORBITAL EDEMA; Narrative: Patien... Reported Symptoms: 10002424:ANGIOEDEMA; 10037987:PRURITUS; 10054521:ORBITAL EDEMA; Narrative: Patient was contacted by primary care provider 6 days after immunization and he states reaction is fully resolved Other Relevant HX: orbital and facial edema following RSV vaccine Other: orbital edema More
2852726 67 M AZ 08/05/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza like illness, Viral infection Influenza like illness, Viral infection
Reported Symptoms: 10016797:FLU-LIKE SYMPTOMS; Narrative: a 67yo male reported he can't get inf... Reported Symptoms: 10016797:FLU-LIKE SYMPTOMS; Narrative: a 67yo male reported he can't get influenza vaccine due to experiencing severe flu-like symptoms previously. Other Relevant HX: Patient reported had a severe viral illness after flu vaccines. Other: severe flu-like symptom More
2852727 39 F AZ 08/05/2025 FLUX
 UNKNOWN MANUFACTURER
Dyspnoea, Guillain-Barre syndrome Dyspnoea, Guillain-Barre syndrome
Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: A 39yo female reported to physician ... Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: A 39yo female reported to physician unable to get flu vaccines due to Guillain-Barre syndrome with prior vaccines. Patient reported had allergies to influenza vaccine back in March, 2017 with no sx listed, then August 22,2022 reported sx of dyspnea when received influenza vaccine. Other Relevant HX: 39yo female reported a severe sx of Guillain-Barre when received influenza vaccine. Looking back to patient history, had also reported allergies to flue vaccine with no specific symptom listed back in March 16, 2017, Then later reported with sx of dyspnea when received influenza vaccine back in August 22, 2022. Other: Guillain-Barre syndrome More
2852728 69 M GA 08/05/2025 FLUX
 UNKNOWN MANUFACTURER
Pyrexia Pyrexia
Reported Symptoms: 10016558:FEVER; Narrative: Other Relevant HX: Other: FEVER Reported Symptoms: 10016558:FEVER; Narrative: Other Relevant HX: Other: FEVER
2852729 45 M TX 08/05/2025 COVID19
 MODERNA
 3044202
Angina pectoris, Chest pain, Dizziness, Nausea, Vomiting Angina pectoris, Chest pain, Dizziness, Nausea, Vomiting
Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; 10013573:DIZZINESS; 10028813:NAUSEA; ... Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; 10013573:DIZZINESS; 10028813:NAUSEA; 10047700:VOMITING; Narrative: Other Relevant HX: Other: NAUSEA AND VOMITING; CHEST PAIN; DIZZINESS More
2852730 85 M MN 08/05/2025 COVID19
 MODERNA
 unknown
Headache, Malaise, Myalgia Headache, Malaise, Myalgia
Reported Symptoms: 10019211:HEADACHE; 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narr... Reported Symptoms: 10019211:HEADACHE; 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: MUSCLE PAIN; HEADACHE; MALAISE More
2852731 58 M MS 08/05/2025 RSV
 PFIZER\WYETH
 lg9827
Injection site reaction, Peripheral swelling, Rash Injection site reaction, Peripheral swelling, Rash
Reported Symptoms: 10037844:RASH; Narrative: Patient seen by tele urgent care provider. Patient with... Reported Symptoms: 10037844:RASH; Narrative: Patient seen by tele urgent care provider. Patient with swollen arm and sunburn type reaction from shoulder to right elbow. Diagnosed with RSV reaction and received prednisone and loratadine. Other Relevant HX: Other: RASH More
2852732 M DC 08/05/2025 FLUX
 UNKNOWN MANUFACTURER
Cough, Malaise Cough, Malaise
Reported Symptoms: 10011232:COUGHING; Narrative: a 52yr male with PMH of Allergic Rhinitis, GERD, As... Reported Symptoms: 10011232:COUGHING; Narrative: a 52yr male with PMH of Allergic Rhinitis, GERD, Asthma, Migraine, Plantar Fascial Fibromatosis, Knee Pain, Shoulder Pain, low Back pain, ED and Exposure to potentially hazardous substance. On February 20, 2025, staff RN @ 17:43 reported the patient had a history of influenza vaccine induced ADR of sever cough. The report included, "he became very sick after taking the Flu vaccine and had not taken the vaccine since 2009." No other information was provided regarding the vaccine and where, when and by who it was administered. Other Relevant HX: Other: COUGH More
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