🏥 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 💀 🏥 🚑 ♿ ⚠️
2825482 11 U IN 02/10/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
11 year old patient was given Infanrix instead of Boostrix; 11 year old patient was given Infanrix i... 11 year old patient was given Infanrix instead of Boostrix; 11 year old patient was given Infanrix instead of Boostrix; This non-serious case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 11-year-old patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 10-JUN-2024, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 10-JUN-2024, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 11 year old patient was given Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 year old patient was given Infanrix instead of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-FEB-2025 The healthcare professional reported that the patient of an inappropriate age was given Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter asked what actions should they take. More
2825483 51 F MA 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injected limb mobility decreased, Injection site pain, Loss of personal independ... Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Nasopharyngitis, Pharyngitis streptococcal More
She did say that this was affecting the mobility of the injected arm a bit/ has not been doing any p... She did say that this was affecting the mobility of the injected arm a bit/ has not been doing any personal lifting-weight training; pain at the site of shot on my arm/ exact spot hurts on deltoid muscle where the injection was given, not the whole arm, just that spot; cold; strep throat; This non-serious case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 06-SEP-2024, the patient received the 2nd dose of Shingrix (unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: She did say that this was affecting the mobility of the injected arm a bit/ has not been doing any personal lifting-weight training), injection site pain (Verbatim: pain at the site of shot on my arm/ exact spot hurts on deltoid muscle where the injection was given, not the whole arm, just that spot), cold (Verbatim: cold) and streptococcal sore throat (Verbatim: strep throat). The outcome of the injected limb mobility decreased and injection site pain were not resolved and the outcome of the cold and streptococcal sore throat were resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, cold and streptococcal sore throat to be related to Shingrix. It was unknown if the company considered the injected limb mobility decreased, injection site pain, cold and streptococcal sore throat to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JAN-2025 and 13-JAN-2025 The patient self-reported this case for herself. The patient received her second Shingrix shot in September at the physician's office and still dealing with pain at the site of shot on her arm. Her guess was that this should not still be happening. Felt worse recently as she had been dealing with strep throat and some other viral illness. The patient described her experienced a bit more. She said it was weird because her arm seems worsened, when she was sick for example when she had a cold and strep throat before Christmas in 2024. She thought the sickness activated the injected arm pain. She was recovered from the cold and from the strep throat. She said that she mentioned the arm pain to her physician last week in JAN-2025 and her physician said that was because there could be increased inflammation in the body when a person was sick. She said that the exact spot that hurt on her arm was about 4 fingers down from her shoulder in the deltoid muscle where the injection was given, not the whole arm, just that spot. It really hurts now (at the time of reporting), especially when she pressed on it. She recalled that the injected arm did ache for a few days to a week after the injection was given. She did say that this was affected the mobility of the injected arm a bit. The patient said she had not been done any personal lifting (weight training) in about 6 weeks. More
2825484 U 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pruritus, Pyrexia, Vaccination failure Herpes zoster, Pruritus, Pyrexia, Vaccination failure
Suspected vaccination failure; Shingles/itchy spot on the upper back of their right thigh/slight fev... Suspected vaccination failure; Shingles/itchy spot on the upper back of their right thigh/slight fever; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/itchy spot on the upper back of their right thigh/slight fever). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 28-JAN-2025 Patient reported that he/she got Shingles even he/she was vaccinated. Patient stated that he/she woke up with an itchy spot on the upper back of their right thigh, about the size of a half dollar, also had a slight fever. Patient received Valtrex for treatment and it made them feel worse than they did before taking it. 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 herpes zoster 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 completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix. More
2825485 M 02/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Cough, Dyspnoea Cough, Dyspnoea
slight cough; breathing labored frequently; This non-serious case was reported by a consumer via int... slight cough; breathing labored frequently; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. In JAN-2025, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced cough (Verbatim: slight cough) and labored breathing (Verbatim: breathing labored frequently). The outcome of the cough and labored breathing were not reported. It was unknown if the reporter considered the cough and labored breathing to be related to Arexvy. It was unknown if the company considered the cough and labored breathing to be related to Arexvy. Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The patient 's wife reported that her husband got Arexvy shot 6 days ago and had slight cough and breathing labored frequently. She enquired how long it would last. The follow-up could not be possible as no contact details were available More
2825486 U 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pyrexia Pyrexia
fever; This non-serious case was reported by a consumer and described the occurrence of fever in a p... fever; This non-serious case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-JAN-2025, the patient received the 2nd dose of Shingrix. In JAN-2025, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: fever). The outcome of the fever was resolved. It was unknown if the reporter considered the fever to be related to Shingrix. It was unknown if the company considered the fever to be related to Shingrix. Additional Information: GSK Receipt Date: 03-FEB-2025 Patient got second shot of Shingrix and experienced fever. More
2825487 U 02/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; still contracted Shingles on my forehead and scalp; This serious case... Suspected vaccination failure; still contracted Shingles on my forehead and scalp; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In AUG-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still contracted Shingles on my forehead and scalp). 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 Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient got both Shingrix vaccines in 2020 and still contracted shingles on forehead and scalp in August of last year. It did not affect patient 's eye. The course of the disease was not long, which might have been due to the fact that patient had received the 2 doses of Shingrix in 2020. This case was considered as suspected vaccination failure as details regarding time 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2.. More
2825488 U 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
got first shot when turned 50. now turning 55 do have to get the shot again; This non-serious case w... got first shot when turned 50. now turning 55 do have to get the shot again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received when patient turned 50). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got first shot when turned 50. now turning 55 do have to get the shot again). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 At the time of reporting, the patient was turning 55 years. The patient asked did have to get the Shingrix shot again. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. More
2825489 U 02/10/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Injury Injury
I have a vaccine injured son; This non-serious case was reported by a consumer via interactive digit... I have a vaccine injured son; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injury in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injury (Verbatim: I have a vaccine injured son). The outcome of the injury was not reported. It was unknown if the reporter considered the injury to be related to RSV vaccine. It was unknown if the company considered the injury to be related to RSV vaccine. Additional Information: GSK receipt date: 02-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had a vaccine injured son after taking a RSV vaccine. This case had been link with US2025AMR016146, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR016146:same reporter More
2825490 F NC 02/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 J3952
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
the adult dose was given to an 18-year-old; the adult dose was given to an 18-year-old; This non-ser... the adult dose was given to an 18-year-old; the adult dose was given to an 18-year-old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis. On 14-JAN-2025, the patient received the 1st dose of Engerix B adult. On 14-JAN-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: the adult dose was given to an 18-year-old) and overdose (Verbatim: the adult dose was given to an 18-year-old). The outcome of the adult product administered to child and overdose were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-JAN-2025 Pharmacist reported that the adult dose was given to an 18-year-old, which led to adult product administered to child and overdose. According to reporter, it was the 1st dose of the series for such patient. More
2825491 16 M MI 02/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB044A
Product preparation error Product preparation error
a patient received a dose of Menveao with an unapproved diluent; a patient received a dose of Menvea... a patient received a dose of Menveao with an unapproved diluent; a patient received a dose of Menveao with an unapproved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB044A, expiry date 31-JUL-2025) for prophylaxis. Previously administered products included Menveo (1st dose on unknown date). On 15-JAN-2025, the patient received the 2nd dose of Menveo. On 15-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient received a dose of Menveao with an unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: a patient received a dose of Menveao with an unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK receipt date: 17-JAN-2025 Other healthcare professional reported that a patient received a dose of Menveo with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. More
2825492 M OH 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
they have not received a second dose; This non-serious case was reported by a pharmacist via call ce... they have not received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 9 months ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they have not received a second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 29-JAN-2025 The pharmacist reported that a patient got a first dose of Shingrix 9 months ago and they had not received a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2825493 F FL 02/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
A 70 years old female patient received a dose of Arexvy in 2023 and this year the patient received a... A 70 years old female patient received a dose of Arexvy in 2023 and this year the patient received a second dose of Arexvy.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (received 1st dose in 2023 ). On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: A 70 years old female patient received a dose of Arexvy in 2023 and this year the patient received a second dose of Arexvy.). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 31-JAN-2025 The patient received Arexvy in 2023 and now in reporting year the patient received a second dose of Arexvy, which led to extra dose administered. The reporter wanted to know if they had any studies regarding this situation or was there any concern for possible adverse reactions. More
2825494 33 F FL 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 HA5HL
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
gave a 33 years old a Shingrix; supposed to give a varicella vaccine, and they gave a Shingrix inste... gave a 33 years old a Shingrix; supposed to give a varicella vaccine, and they gave a Shingrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-year-old female patient who received Herpes zoster (Shingrix) (batch number HA5HL, expiry date 13-NOV-2026) for prophylaxis. Co-suspect products included Varicella zoster vaccine (Varicella vaccine) for prophylaxis. On 22-JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive Varicella vaccine. On 22-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave a 33 years old a Shingrix) and wrong vaccine administered (Verbatim: supposed to give a varicella vaccine, and they gave a Shingrix instead). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 The nurse had a medical assistant that actually gave a 33 years old patient a Shingrix which led to inappropriate ae at vaccine administration, and he/she need to know if that was gonna harm that patient at all. The nurse reported it was supposed to give a varicella vaccine, and they gave a Shingrix instead which led to wrong vaccine administered. Also, the nurse mentioned that the patient was not immunocompromised. The Vaccine Administration Facility was the same as Primary Reporter. More
2825495 M KS 02/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M77CC
Inappropriate schedule of product administration Inappropriate schedule of product administration
adult patient was administered by mistake another BOOSTRIX dose "...too early; This non-serious... adult patient was administered by mistake another BOOSTRIX dose "...too early; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis. Previously administered products included BOOSTRIX (13-JAN-2020 the patient received a booster dose). On 30-JAN-2025, the patient received Boostrix. On 30-JAN-2025, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: adult patient was administered by mistake another BOOSTRIX dose "...too early). The outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-FEB-2025 Medical Assistant reported the patient was administered by mistake another Boostrix dose too early, which led to shortening of vaccination schedule. The reporter consented to follow up. More
2825496 88 F OR 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient received her second dose of Shingrix 15 days after the first; This non-serious case was repo... patient received her second dose of Shingrix 15 days after the first; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 24-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received her second dose of Shingrix 15 days after the first). The outcome of the drug dose administration interval too short was unknown. Additional Information: GSK Receipt Date : 04-FEB-2025 Pharmacist stated that a patient received her second dose of Shingrix 15 days after the first (earlier than the recommended interval), which led to shortening of vaccine schedule. More
2825497 U MA 02/10/2025 DTAPIPV
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 D947X
42B22
Product storage error; Product storage error Product storage error; Product storage error
vaccines probably administered after above temperature excursions/temperature excursion for Kinrix a... vaccines probably administered after above temperature excursions/temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) (batch number D947X) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 42B22) for prophylaxis. On an unknown date, the patients received Kinrix and Engerix B. On an unknown date, an unknown time after receiving Kinrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: vaccines probably administered after above temperature excursions/temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius). The outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 05-FEB-2025 The office manager called to reported that a temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius which led to, incorrect storage of drug. The reporter also mentioned a prior temperature excursion for those same vaccines of 7 minutes with a maximum temperature of 8.75degreree Celsius already reported in this case. The reporter explained that some of those vaccines were probably administered to patients after the temperature excursions, but she was not sure (no patient details provided by caller). More
2825498 56 F MO 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N35N9
Product preparation issue Product preparation issue
received only the adjuvant portion of Shingrix as a second dose; received only the adjuvant portion ... received only the adjuvant portion of Shingrix as a second dose; received only the adjuvant portion of Shingrix as a second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number N35N9, expiry date 15-NOV-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On 13-JAN-2025, the patient received the 2nd dose of Shingrix. On 13-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant portion of Shingrix as a second dose) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion of Shingrix as a second dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK receipt date: 06-FEB-2025 The medical assistant reported that they accidentally administered only the adjuvant portion of Shingrix to a patient which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient already had the first dose of Shingrix, but for the second dose she only got the adjuvant portion of Shingrix. The reporter had a question what could potentially happened to the patient or any adverse event that they should look for. More
2825499 F 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5Y4TL
Product preparation issue Product preparation issue
patient received only the diluent; patient received only the diluent; This non-serious case was repo... patient received only the diluent; patient received only the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number 5Y4TL, expiry date 31-JAN-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent ) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 A medical assistant called to report that a patient received only the diluent portion of Shingrix. The Healthcare professional asked for recommendations on this situation and if she could get an additional diluent vial. The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2825500 0.33 F OK 02/10/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Kinrix was administered to a 4-month-old patient instead of Pediarix; Kinrix was administered to a 4... Kinrix was administered to a 4-month-old patient instead of Pediarix; Kinrix was administered to a 4-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 27-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Pediarix. On 27-JAN-2025, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was administered to a 4-month-old patient instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4-month-old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-FEB-2025 The Healthcare professional reported that Kinrix was administered to a 4 month old patient instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration. She stated they had always revaccinated after 30 days because it was considered an invalid dose but their nurse stated, they did not had to revaccinate because it was the same dose. The Vaccine Administration Facility is the same as Primary Reporter. More
2825501 F MO 02/10/2025 COVID19
 JANSSEN
Periarthritis Periarthritis
frozen shoulder; This spontaneous report received from a patient concerned a female patient of unspe... frozen shoulder; This spontaneous report received from a patient concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on 2020, additional dosage information included: dose number in series: 1, for prevention of coronavirus. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced frozen shoulder. (dose number in series: 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of frozen shoulder was not reported. The reporter considered the causality between janssen covid-19 vaccine and frozen shoulder as related. Company causality between janssen covid-19 vaccine and frozen shoulder as possible. This report was non-serious. More
2825502 48 M CA 02/10/2025 COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
JANSSEN
 1805020
1805020
Thrombosis; Thrombosis; Thrombosis; Thrombosis Thrombosis; Thrombosis; Thrombosis; Thrombosis
blood clot behind left knee; This spontaneous report received from a consumer concerned a male patie... blood clot behind left knee; This spontaneous report received from a consumer concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805020) dose and frequency not reported, administered on 09-Mar-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. Concomitant medications included: multivitamin [ascorbic acid;calcium pantothenate;colecalciferol;cyanocobalamin;nicotinamide;pyridoxine hydrochloride;retinol;riboflavin;thiamine hydrochloride]; vitamin d3; turmeric +. The patient had no significant medical history prior to receiving vaccine. The patient was feeling bad and convinced him to go to hospital. On an unspecified date, the patient experienced blood clot behind left knee. (dose series 1) The patient was lucky he went in when he did or he could have died. The patient has been on blood thinners since diagnosis (Dabigatran etexilate 150 mg, 2 capsules daily) and inquired about possible reimbursement for medication. Treatment medications included: dabigatran etexilate for blood thinner. The action taken with janssen covid-19 vaccine was not applicable. The outcome of blood clot behind left knee was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: Thrombosis :. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. More
2825503 F CA 02/10/2025 COVID19
 JANSSEN
 Unknown
Cerebral thrombosis, Death, Surgery Cerebral thrombosis, Death, Surgery
death; BLOOD CLOTS in brain; third surgery; This spontaneous report received from a consumer concern... death; BLOOD CLOTS in brain; third surgery; This spontaneous report received from a consumer concerned an 18 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced death, blood clots in brain, and third surgery. (dose series 1) It was reported that the patient had to have 2 surgeries for her blood clot in her brain and on the third surgery the patient died. The patient died around august or september-2021. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable. Reported cause of death was unknown cause of death. The patient died on an unspecified date. The outcome of blood clots in brain and third surgery was not reported. This report was serious (death and other medically important condition).; Sender's Comments: V0: Death and surgery. -. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration. Cerebral thrombosis: 000-. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: unknown cause of death More
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2825504 F AZ 02/10/2025 COVID19
COVID19
 JANSSEN
JANSSEN
 Unknown
Unknown
COVID-19, Cellulitis, Death, Herpes virus infection, Influenza; Pneumonia COVID-19, Cellulitis, Death, Herpes virus infection, Influenza; Pneumonia
possible pneumonia of both lungs; herpes virus that went to the brain; Covid-19; possible cellulitis... possible pneumonia of both lungs; herpes virus that went to the brain; Covid-19; possible cellulitis; influenza B; influenza A; death; This spontaneous report received from a consumer concerned an 81 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. dose series 1. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-Jun-2024, the patient experienced death. On an unspecified date, the patient experienced possible pneumonia of both lungs, covid-19, possible cellulitis, herpes virus that went to the brain, influenza b, and influenza a. (dose series 1) The patient got the vaccine because she was working around elderly people. After the patient received the Covid vaccine, she got real sick. She was in and out of the hospital. Patient had influenza A and B and had herpes virus that went to the brain. The patient contacted Janssen pharmaceuticals and explained her side effects and the caller's side effects. They wrote her a letter and addressed it to her mom. She had pneumonia in both lungs and cellulitis, she thinks. The reporter thinks her mom may have had Covid too. The reporter has all her mom's medical records and also reported, when she was cleaning her mom's home before bringing her home for hospice care, she was going through her mom's mail, and she found the envelope that her mom had addressed to reporter. The patient had already filed a claim. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable. Reported cause of death was unknown cause of death. The outcome of possible pneumonia of both lungs, covid-19, possible cellulitis, herpes virus that went to the brain, influenza b and influenza a was not reported. The patient died on 02-Jun-2024. This report was serious (death and other medically important condition).; Sender's Comments: V0; Death, Herpes simplex and Pneumonia: The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death More
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2825505 56 F CA 02/10/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
 043221A
043221A
043221A
Abdominal pain, Abnormal faeces, Asthenia, Back pain, Chest pain; Diarrhoea, Dys... Abdominal pain, Abnormal faeces, Asthenia, Back pain, Chest pain; Diarrhoea, Dyspnoea, Faeces discoloured, Haematemesis, Haemoptysis; Headache, Nasopharyngeal swab, Nausea, Vomiting More
vomiting with blood; coughing up with large blood clots; pain in back like the lung area; chest pain... vomiting with blood; coughing up with large blood clots; pain in back like the lung area; chest pain; light to dark green stools; abdominal pain; shortness of breath; headache; nausea; weak; diarrhea; stools smell like adhesive band aids; vomiting; This spontaneous report received from a patient concerned a 56 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: 043221A) 0.5 millilitre(s), frequency not reported, administered on 07-Apr-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced vomiting with blood, coughing up with large blood clots, pain in back like the lung area, chest pain, light to dark green stools, abdominal pain, shortness of breath, headache, nausea, weak, diarrhea, stools smell like adhesive band aids, and vomiting. (dose series 1) The patient started having light to dark green stools, abdominal pain, chest pain, shortness of breath, headache, vomiting with blood, nausea, vomiting, coughing up with large blood clots, and pain in her back like the lung area. The patient went to the facility, where they had her go there to get a vaccine and throat culture swab to see if she had Covid. Those came back negative. The patient began having the side effects in June-2021 and they continued until December-2021. The patient's body is still weak, she still has diarrhea, and her stools smell like adhesive band aids. The patient has a severe allergy to adhesive bandages. The patient read that the things in the Johnson and Johnson Covid vaccine said liquid adhesive and chlorophyll were in the Johnson and Johnson Covid vaccine. The patient provided the lot number as 043221A and stated that she thinks it is 221A at the end (043221A). The patient stated that there is not an expiration date written down. It says that she received the vaccine at the pharmacy. On an unspecified date, laboratory data included: throat swab (NR: not provided) covid negative. The action taken with janssen covid-19 vaccine was not applicable. The outcome of vomiting with blood, coughing up with large blood clots, pain in back like the lung area, chest pain, light to dark green stools, abdominal pain, shortness of breath, headache, nausea, weak, diarrhea, stools smell like adhesive band aids and vomiting was not reported. This report was associated with product quality complaints: Product Complaint 90000352871; 90000352871; 90000352871. Investigation Results: This case does not contain product quality issue and the narrative does not describe and/or provide any indication of a product quality issue. Hence, this record will be sent for void in PQMS.. This report was serious (other medically important condition).; Sender's Comments: V0-haematemesis, hemoptysis . Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. More
2825506 87 M CA 02/10/2025 COVID19
COVID19
 MODERNA
MODERNA

COVID-19, Drug hypersensitivity, Illness, Paralysis, Upper respiratory tract inf... COVID-19, Drug hypersensitivity, Illness, Paralysis, Upper respiratory tract infection; Weight, Weight decreased More
Along with allergic recation to Moderna covid-19 booster; Temporary paralysis; Weight loss; Upper re... Along with allergic recation to Moderna covid-19 booster; Temporary paralysis; Weight loss; Upper respiratory tract infection off and on; Battling an illness; Got covid-19 2 years ago; This spontaneous case was reported by a patient and describes the occurrence of DRUG HYPERSENSITIVITY (Along with allergic recation to Moderna covid-19 booster), PARALYSIS (Temporary paralysis) and WEIGHT DECREASED (Weight loss) in an 87-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Dupilumab solution for injection for Atopic dermatitis. Concurrent medical conditions included Atopic dermatitis. On 07-Jun-2023, the patient started Dupilumab (Subcutaneous use) 300 milligram every two weeks. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced COVID-19 (Got covid-19 2 years ago). In March 2024, the patient experienced ILLNESS (Battling an illness). On an unknown date, the patient experienced DRUG HYPERSENSITIVITY (Along with allergic recation to Moderna covid-19 booster) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection off and on). an unknown date, the patient experienced PARALYSIS (Temporary paralysis) (seriousness criterion medically significant) and WEIGHT DECREASED (Weight loss) (seriousness criterion medically significant). At the time of the report, DRUG HYPERSENSITIVITY (Along with allergic recation to Moderna covid-19 booster), PARALYSIS (Temporary paralysis), WEIGHT DECREASED (Weight loss), COVID-19 (Got covid-19 2 years ago) and UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection off and on) outcome was unknown and ILLNESS (Battling an illness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. The patient had no medical history, concomitant disease or risk factor. There was no Lab data results available. On In unknown date, the patient took Moderna Covid-19 vaccine (Elasomeran) With unknown dose, formulation, strength, route, frequency for prophylactic vaccination (immunization). Patient stated that he was battling an illness (illness) for the last 2 months Onset Mar-2024 and latency 9 months approximately with unknown batch and expiry date and he had not been using his dupilumab. The patient had medication on hand and will request a shipment when needed. The patient got covid-19 two years ago, with an onset date of 15-Jun-2023, and a latency period of eight days. Since then, he had experienced intermittent upper respiratory infections, although the onset and latency of these infections were not known. Additionally, the patient had an allergic reaction to the Moderna covid-19 booster, which resulted in temporary neck paralysis and weight loss, with the specifics of onset and latency remaining unclear. The batch and expiry date of the vaccine were also unknown. During the period of temporary paralysis, the patient was unable to took Dupixent and could not recall the exact dates of these events. Action taken includes the withdrawal of a drug in 2024 due to an unspecified illness, another withdrawal for paralysis on an undetermined date, and an unknown case related to drug hypersensitivity. Additionally, there was a noted weight decrease with no action taken for other events associated with dupilumab, while all events related to elasomeran remain unspecified. Reporter causality was unassessable for all events.; Reporter's Comments: Company comment: Treatment with dupilumab remains as a confounder. The benefit-risk relationship of product is not affected by this report. More
2825507 F WA 02/10/2025 PPV
 UNKNOWN MANUFACTURER
Laboratory test normal, Malaise, Pneumonia Laboratory test normal, Malaise, Pneumonia
I have a good taste of pneumonia; I am a very sick woman from your vaccine; This is a spontaneous re... I have a good taste of pneumonia; I am a very sick woman from your vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 91-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Jan2025 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "I have a good taste of pneumonia"; ILLNESS (non-serious), outcome "unknown", described as "I am a very sick woman from your vaccine". The patient underwent the following laboratory tests and procedures: lab work: Normal, notes: Lab work: Consumer stated, "Yes, I had lab work and it was all normal. Therapeutic measures were taken as a result of pneumonia, illness. Additional information: The consumer stated, "I am having a bad reaction from your Pneumococcal Conjugate." When probed for the reactions experienced by the consumer, consumer stated, "What I am experienced is, I have a good taste of pneumonia." The consumer stated, "I am calling about the Pneumococcal Conjugate that you have recently been pushing." When clarified if consumer want to report it, consumer stated, "I am reporting it to Pfizer. I am a very sick woman from your vaccine." The consumer stated, "Yes, I had lab work and it was all normal." The consumer stated, "I am on Azithromycin." The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2825508 M WA 02/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A... Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Clinical course: During an inbound call to complete enrollment for financial assistance, the patient stated, that he was really sick and not feeling good, and wants to do everything over the phone because he was laying down. If he sit, headache like crazy. Patient stated" I can't go on the computer; I'm laying down talking." The agent advised they would need to play the consent recordings. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2825509 U 02/10/2025 DTAP
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
3CA03C3
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
inappropriate use due to inadvertently administered Dtap instead of Tdap with no reported adverse ev... inappropriate use due to inadvertently administered Dtap instead of Tdap with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who experienced inappropriate use due to inadvertently administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine [tdap] with no reported adverse event. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, suspension for injection, lot number: 3CA03C3, expiry date not reported was inadvertently administered dtap instead of received a unknown dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine (tdap) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site both for Immunization. tdap with no reported adverse event (wrong product administered) (latency:same day). Reportedly,Relayed the information to the school nurse which they got a little upset because they just want to make sure the student will not receive an extra dose of what was already given to them.. 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
2825510 0.33 F NY 02/10/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK149AB
Infantile spasms Infantile spasms
diagnosed with infantile spasm; Initial information received on 04-Feb-2025 regarding an unsolicited... diagnosed with infantile spasm; Initial information received on 04-Feb-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 5 months old female patient who was diagnosed with infantile spasm after receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)]. The patient's past vaccination(s) included HEPATITIS B VACCINE on 03-JAN-2025. The patient's past medical history, medical treatment(s) ,concomitant medications and family history were not provided. On 21-Jan-2025, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK149AB, Expiry date; 31-Aug-2025, strength was unknown via intramuscular route in the right thigh for Immunization. On 28-JAN-2025 the patient diagnosed with infantile spasm (infantile spasms) (latency: 7 days) following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (diagnosed with infantile spasm). At time of reporting, the outcome was Unknown for the event diagnosed with infantile spasm. Seriousness Criteria : This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 07-Feb-2025 : This case involves a 5 months old female patient who was diagnosed with infantile spasm after receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed. More
2825511 62 F PA 02/10/2025 FLU3
FLU4
 SANOFI PASTEUR
SANOFI PASTEUR
 U8527BA
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
62-year-old female patient was accidentally administered the Fluzone High-Dose vaccine, rather than ... 62-year-old female patient was accidentally administered the Fluzone High-Dose vaccine, rather than the Fluzone vaccine with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 62 years old female patient to whom had accidentally administered the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], rather than the Influenza Quadrival A-B Vaccine [Fluzone Qiv] with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Oct-2024, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number U8527BA and expiry date: 01-Jun-2025) via intramuscular route in the right deltoid instead of fluzone vaccine with no reported adverse event (wrong product administered) (latency: same day). Reportedly:" At the time the Fluzone High-Dose vaccine was administered, the patient was observed for 20 minutes after getting the vaccine and experienced no adverse effects during that time. As for the reason for the error, the reporter stated that she does not know without talking to the person who administered the vaccine, but if she had to assess the reason, she would say it probably was due to user error related to inexperience, since the person who administered the Fluzone High-Dose vaccine to the patient had not often administered flu vaccines." 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
2825512 0.5 M UT 02/10/2025 HIBV
 SANOFI PASTEUR
 UK0938B
Product preparation error Product preparation error
administered with ACT-HIB/Instead of using the diluent, sterile water was used with no reported adve... administered with ACT-HIB/Instead of using the diluent, sterile water was used with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB]/instead of using the diluent, sterile water was used 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 (Rotavirus vaccine); Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix); and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 21-Jan-2025, the patient received HIB (PRP/T) VACCINE Powder and solvent for solution for injection dose 0.5 ml 1x(once) lot UK0938B expiry 31-Aug-2025 via intramuscular route in vastus lateralis (strength standard) for Immunization/instead of using the diluent, sterile water was used with no reported adverse event (product preparation error) (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
2825513 1.25 F IN 02/10/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK022AA
Extra dose administered, No adverse event Extra dose administered, No adverse event
administration of PENTACEL to a 15-month-old, leading to the administration of an extra IPV dose wit... administration of PENTACEL to a 15-month-old, leading to the administration of an extra IPV dose with no reported AE; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a 15-month-old, leading to the administration of an extra ipv dose with no reported ae (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); and Hepatitis b vaccine (Hepatitis b) for Immunisation. On 30-Jan-2025, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (strength standard) Suspension for injection dose 0.5 ml 1x(once) lot UK022AA expiry-30-Apr-2025 via intramuscular route in the left thigh for Immunization, leading to the administration of an extra ipv dose with no reported ae (extra dose administered) (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
2825514 41 F GA 02/10/2025 PNC21
 MERCK & CO. INC.
 Y013009
Swollen tongue, Urticaria Swollen tongue, Urticaria
Patient complained of hives, swollen tongue. Patient complained of hives, swollen tongue.
2825515 93 M IA 02/10/2025 COVID19
 MODERNA
 3043159
Death Death
Death Death
✓
2825516 75 F IA 02/10/2025 COVID19
 MODERNA
 038C21S
Death Death
Death Death
✓
2825517 1.08 M IN 02/10/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation error Product preparation error
I did not mix the vaccine with the the sterile water as I was not aware there was a mix that needed ... I did not mix the vaccine with the the sterile water as I was not aware there was a mix that needed to be done, I only gave the child the dilutent More
2825518 20 M ME 02/10/2025 MMRV
 MERCK & CO. INC.
 Y010374
Extra dose administered Extra dose administered
Pt was given a 3rd dose in error of MMR njection Pt was given a 3rd dose in error of MMR njection
2825519 11 M MI 02/10/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Expired product administered, No adverse event Expired product administered, No adverse event
There was no adverse reaction the dose he received was expired. There was no adverse reaction the dose he received was expired.
2825520 11 F MI 02/10/2025 HPV9
 MERCK & CO. INC.
 Y007991
Immediate post-injection reaction, Presyncope Immediate post-injection reaction, Presyncope
Patient had 4 total administrations. Patient had her first 3 vaccines without incident, immediately... Patient had 4 total administrations. Patient had her first 3 vaccines without incident, immediately after patient received her HPV vaccine she had a vasovagal response. Ammonia, ice packs and cold wash cloth applied and effective. Patient remained seated with nurse directly in front. Blood pressure and pulses were assessed and documented as follows: 78/45 p 78 at 10:35 am, 84/58 p 77 at 10:43 am, 90/59 p 76 10:52 am. Patient was given a juice pack and chips between vitals monitoring. Patient was stable at this time. Parent and staff member assisted her to her vehicle without complication. More
2825521 70 F CA 02/10/2025 FLU4
 SANOFI PASTEUR
 u8499da
Injection site bruising, Injection site pain, Loss of personal independence in d... Injection site bruising, Injection site pain, Loss of personal independence in daily activities, Pain More
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Additional Details: pa... Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Additional Details: patient states has extreme soreness, was bruised black and blue day after injection and is still in pain, hurts to lift arm and difficult to do day to day activities More
2825522 43 F MA 02/10/2025 PNC21
 MERCK & CO. INC.
 Y013009
Arthralgia, Injection site pain, Mobility decreased, Myalgia, Neuralgia Arthralgia, Injection site pain, Mobility decreased, Myalgia, Neuralgia
Site: Pain at Injection Site-Mild, Additional Details: Patient received capvaxive on Saturday 02/1st... Site: Pain at Injection Site-Mild, Additional Details: Patient received capvaxive on Saturday 02/1st. Patient left a voice mail on Tuesday 02/4th complaing of muscle or nerve pain in neck and sholder. Patient said she can't move her neck and her sholder is hurting. Patient said she saw her pcp and neurologist today (02/4th) and was put on steroids as per patient's voice mail. More
2825523 50 F VA 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74nc9
Headache, Injection site cellulitis, Injection site erythema, Injection site pai... Headache, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling More
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec... Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Headache-Medium, Additional Details: pt thinks the shot was given too low on her arm. resulting in painful injection site. it got severely painful withing day 2-3. redness and swelling got worse and larger area. pain moved down her arm to her elbow. saw doctor who determined she had cellulitus. got an anitbiotic. as of 2/4/25 she is feeling much better More
2825524 57 F AL 02/10/2025 PNC21
 MERCK & CO. INC.
 Y013008
Injection site pain, Scratch Injection site pain, Scratch
Site: Pain at Injection Site-Medium, Systemic: Scratch at injection site after needle came out durin... Site: Pain at Injection Site-Medium, Systemic: Scratch at injection site after needle came out during injection-Medium, Additional Details: The patient jumped when the needle first penetrated into the muscle. When I began to push the plunger she pulled away quite suddenly and the needle came out of her arm and scratched her down her arm about 1.5 inches. I cleaned the area with alcohol wipes and cotton then applied band-aids. I offered to re-administer the vaccine in the other arm but she said she would return later. More
2825525 61 M TX 02/10/2025 COVID19
 MODERNA
 3044646
Limb injury Limb injury
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)- Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
2825526 49 F AL 02/10/2025 COVID19-2
 MODERNA
 8080803
Dizziness, Pyrexia Dizziness, Pyrexia
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Additional Details: pt called sa... Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Additional Details: pt called saying feeling dizzy and having fever got 4 vaccines in total. i think shes just slightly under the weather from all the shots. i told her if not better soon contact physician and recommended antivert for dizziness More
2825527 66 M CA 02/10/2025 FLU4
 SANOFI PASTEUR
 u8519ea
Bell's palsy Bell's palsy
Systemic: Bell's Palsy-Medium, Other Vaccines: VaccineTypeBrand: Prevnar 20; Manufacturer: Pfi... Systemic: Bell's Palsy-Medium, Other Vaccines: VaccineTypeBrand: Prevnar 20; Manufacturer: Pfizer; LotNumber: lg5579; Route: intramuscular; BodySite: ; Dose: 1; VaxDate: 01/27/2025 More
2825528 14 M MA 02/10/2025 COVID19
 PFIZER\BIONTECH
 LN0588
Asthenia, Dizziness, Hypotension, Syncope, Unresponsive to stimuli Asthenia, Dizziness, Hypotension, Syncope, Unresponsive to stimuli
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypo... Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Mom said that he previously did get faint after getting another vaccine (HPV) at PCP's office in the past but did not faint at that time like he did today. She said that he did not have anything to eat or drink today. I reviewed vasovagal syncope precautions with mom and she felt comfortable taking him home as dad was going to be home the rest of the day to be able to watch him., Other Vaccines: VaccineTypeBrand: Influenza; Manufacturer: Seqirus; LotNumber: 946639; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN More
2825529 74 F AZ 02/10/2025 FLUA4
 SEQIRUS, INC.
 388486
Injected limb mobility decreased, Injection site pain Injected limb mobility decreased, Injection site pain
Site: Pain at Injection Site-Medium, Additional Details: Patient reports having limited range of mot... Site: Pain at Injection Site-Medium, Additional Details: Patient reports having limited range of motion with her arm. She is going to follow-up with her PCP. More
2825530 63 F NE 02/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 24M7E
Dizziness, Syncope, Unresponsive to stimuli Dizziness, Syncope, Unresponsive to stimuli
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient said after a day or two from r... Systemic: Fainting / Unresponsive-Medium, Additional Details: patient said after a day or two from recieving the vaccine she said she was light headed and expierenced mild fainting symptoms. Patient was not hospitalized and did not recieve emergency care from our knowledge. More
2825531 86 F NE 02/10/2025 FLUA4
 SEQIRUS, INC.
 370682
Guillain-Barre syndrome, Nervous system disorder Guillain-Barre syndrome, Nervous system disorder
Systemic: Neurological Disorder (diagnosed by MD)-Mild, Additional Details: patient experienced guil... Systemic: Neurological Disorder (diagnosed by MD)-Mild, Additional Details: patient experienced guillan barret syndrome after recieivng both fluad and pfizer vaccine together at the same time. patient did say she went to md and was told she couldn't recieve anymore vaccins from her knowledge. from our knowledge patient was not medicinally treated for the side effect, patient did not have emergency side effect instead the side effects were mild. More
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