๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2702294 F TX 10/26/2023 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH





Myocardial infarction; Death, Malaise; Myocardial infarction; Death, Malaise; Ch... Myocardial infarction; Death, Malaise; Myocardial infarction; Death, Malaise; Chest pain, Death, Lethargy, Malaise, Mobility decreased; Myalgia More
heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other ... heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. A female patient received bnt162b2 (BNT162B2), on 19Nov2021 as dose number unknown, signle (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid issue" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death) with onset 21Nov2021, outcome "fatal", described as "heart attack". The patient date of death was 21Nov2021. Reported cause of death: "heart attack". It was not reported if an autopsy was performed. Additional information: Reporter lost mom (death) due to a covid vaccine she was given on 19Nov2021 and died 21Nov2021. Patient was mostly healthy woman with thyroid issue minimal high cholesterol etc. Patient suffered a heart attack caused by a pfizer vaccine she received states that on her death certificate. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: heart attack More
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2830738 65 F IL 03/11/2025 TDAP
UNK
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 7KD5B
LG5579
MG5S9
Injection site erythema, Injection site pain; Injection site erythema, Injection... Injection site erythema, Injection site pain; Injection site erythema, Injection site pain; Injection site erythema, Injection site pain More
PATIENT REPORTED REDNESS, SWELLING AND TENDER TO TOUCH AT INJECTION SITE. PATIENT WENT TO A CLINIC A... PATIENT REPORTED REDNESS, SWELLING AND TENDER TO TOUCH AT INJECTION SITE. PATIENT WENT TO A CLINIC AND WAS PRESCRIBED ANTIBIOTICS. More
2830739 62 F FL 03/11/2025 FLU3
 SANOFI PASTEUR
 UT8475NA
Pain, Pyrexia Pain, Pyrexia
Fever and body aches. Fever and body aches.
2830740 53 F FL 03/11/2025 PNC20
 PFIZER\WYETH
 LK6650
Extra dose administered Extra dose administered
Patient received an extra dose. 1st dose was received in November of 2022 and then just received ano... Patient received an extra dose. 1st dose was received in November of 2022 and then just received another dose on 3/10/25. More
2830741 28 F WA 03/11/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Pt did not have any adverse reactions. Pt was given a dose with BUD: 02/14/2025 on 02/19/2025. Pt did not have any adverse reactions. Pt was given a dose with BUD: 02/14/2025 on 02/19/2025.
2830742 59 M OR 03/11/2025 COVID19
 MODERNA
 3043024
Underdose Underdose
None, injected childs vaccine instead of adult vaccine. None, injected childs vaccine instead of adult vaccine.
2830743 56 F OR 03/11/2025 COVID19
 MODERNA
 3043024
Underdose Underdose
none, given child vaccine instead of adult vaccine none, given child vaccine instead of adult vaccine
2830744 69 F NJ 03/11/2025 MMR
 MERCK & CO. INC.
 Y007615
Respiratory tract infection, Urinary tract infection Respiratory tract infection, Urinary tract infection
PATIENT STATES THAT BOTH HER AND HER HUSBAND RECEIVED THE VACCINE THE SAME DAY AND TIME AND SUBSEQUE... PATIENT STATES THAT BOTH HER AND HER HUSBAND RECEIVED THE VACCINE THE SAME DAY AND TIME AND SUBSEQUENTLY DEVELOPED A RESPIRATORY INFECTION AND UTI'S. More
2830745 63 F TX 03/11/2025 FLU3
 SEQIRUS, INC.
 391637
Dysphagia, Headache, Pain, Swelling Dysphagia, Headache, Pain, Swelling
PT'S HUSBAND CALLED AND INDICATED THAT THEY THOUGHT SHE WAS HAVING AN ALLERGIC REACTION. PT WA... PT'S HUSBAND CALLED AND INDICATED THAT THEY THOUGHT SHE WAS HAVING AN ALLERGIC REACTION. PT WAS ACHEY AND HAD HEADACHE, BUT ALSO HAD SWELLING AND A BIT OF DIFFUCLTY SWALLOWING. REACTION WAS ALREADY STARTING TO SUBSIDE ON 3-10-25 More
2830746 72 M NJ 03/11/2025 MMR
 MERCK & CO. INC.
 Y007615
Respiratory tract infection, Urinary tract infection Respiratory tract infection, Urinary tract infection
PATIENT AND HIS WIFE BOTH DEVELOPED UTI AND RESPIRATORY INFECTION SUBSEQUENTLY TO TAKING VACCINE. TH... PATIENT AND HIS WIFE BOTH DEVELOPED UTI AND RESPIRATORY INFECTION SUBSEQUENTLY TO TAKING VACCINE. THOUGHT IT WAS ODD THEY BOTH DEVELOPED THEM. More
2830747 82 M MA 03/11/2025 COVID19
 PFIZER\BIONTECH
 EN6203
Erythema, Muscular weakness, Pain in extremity, Paraesthesia, Peripheral swellin... Erythema, Muscular weakness, Pain in extremity, Paraesthesia, Peripheral swelling More
Both hands/ fingers became red and swollen, with pain and paresthesia; weakness in hands. Pain, par... Both hands/ fingers became red and swollen, with pain and paresthesia; weakness in hands. Pain, paresthesia, weakness still present after four years. Rx- Gabapentin; results inconclusive More
2830310 UT 03/10/2025 VARCEL
 MERCK & CO. INC.
 N022977
Expired product administered, No adverse event Expired product administered, No adverse event
No reported signs/symptoms of adverse events.; second dose in the vaccination series on 10/07/2019 a... No reported signs/symptoms of adverse events.; second dose in the vaccination series on 10/07/2019 and the expiration date of VARIVAX was n022977 / 08/23/2019, post expiry date; Information has been received from Business Partner/CRO on 11-Feb-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Oct-2019, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #N022977, expiration date: 23-Aug-2019) (2nd dose),. On 07-Oct-2019, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), for the treatment of Prophylaxis. On 07-Oct-2019, the patient experienced second dose in the vaccination series on 10/07/2019 and the expiration date of VARIVAX was n022977 / 08/23/2019, post expiry date. On an unknown date, the patient experienced No reported signs/symptoms of adverse events.. At the reporting time, the outcome of second dose in the vaccination series on 10/07/2019 and the expiration date of VARIVAX was n022977 / 08/23/2019, post expiry date and No reported signs/symptoms of adverse events. was unknown. The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable. More
2830311 F TX 03/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Disorientation, Feeling abnormal, Nausea, Product administered to patient of ina... Disorientation, Feeling abnormal, Nausea, Product administered to patient of inappropriate age More
Within hours of her second round of the shingrich shot C Became nauseated disoriented; Within hours ... Within hours of her second round of the shingrich shot C Became nauseated disoriented; Within hours of her second round of the shingrich shot C Became nauseated disoriented; It's like she's dying; Well she's 19 years old; Yes, some idiot at a drugstore administered the second shot while she was having an outbreak; This serious case was reported by a consumer and described the occurrence of disorientation in a 19-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced disorientation (Verbatim: Within hours of her second round of the shingrich shot C Became nauseated disoriented) (serious criteria hospitalization), nausea (Verbatim: Within hours of her second round of the shingrich shot C Became nauseated disoriented) (serious criteria hospitalization), feeling abnormal (Verbatim: It's like she's dying), inappropriate age at vaccine administration (Verbatim: Well she's 19 years old) and drug use for unapproved indication (Verbatim: Yes, some idiot at a drugstore administered the second shot while she was having an outbreak). The outcome of the disorientation and nausea were not resolved and the outcome of the feeling abnormal was not reported and the outcome of the inappropriate age at vaccine administration and drug use for unapproved indication were not applicable. It was unknown if the reporter considered the disorientation, nausea and feeling abnormal to be related to Shingrix. The company considered the disorientation to be unrelated to Shingrix. The company considered the nausea to be related to Shingrix. It was unknown if the company considered the feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date : 27-FEB-2025 Patient was in hospital for Within hours of her second round of the shingrich shot. She became nauseated disoriented.Yes, some idiot at a drugstore administered the second shot while she was had an outbreak which led to Drug use for unapproved indication.All the information says did not do this. She had found no information that says oh if by chance you do, here was what needs to be done and this girl was loosed her life. If this thing did not turn around of all things, they assigned a pediatrician to her case. Well she was 19 years old. She did not thought a pediatrician's going to solve this problem. She need help. One doctor said oh he did not thought it had anything to do with the injection. Please she was fine. She got the shot 3 hours later. It was like she was died. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments: Nausea is a listed event which is considered related to GSK vaccine Shingrix. Disorientation is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
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2830312 F 03/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Dacryostenosis acquired, Ophthalmic herpes zoster, Pain Dacryostenosis acquired, Ophthalmic herpes zoster, Pain
tear duct a non-functioning; and got shingles in my left eye; This serious case was reported by a co... tear duct a non-functioning; and got shingles in my left eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a 83-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: and got shingles in my left eye) (serious criteria GSK medically significant) and blocked tear duct (excl congenital) (Verbatim: tear duct a non-functioning). The outcome of the ophthalmic herpes zoster was resolved (duration 4 months) and the outcome of the blocked tear duct (excl congenital) was not reported. The reporter considered the ophthalmic herpes zoster and blocked tear duct (excl congenital) to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster and blocked tear duct (excl congenital) to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 02-MAR-2025 The patient was 83 years old. The reporter reported that definitely get the shot which was done in 2 sessions. The patient got the first one when it was not that affective and got shingles in his/her left eye. It was extremely painful. It took 4 months to clear up plus left his/her tear duct a non-functioning mess. The patient got the current one because if someone has had shingles, there was a good possibility of getting it again when older.; Sender's Comments: Ophthalmic herpes zoster and Dacryostenosis acquired are unlisted events which are considered unrelated to GSK Shingles vaccine. More
2830313 40 F IL 03/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity, Pyrexia Pain in extremity, Pyrexia
Day after second shot she experienced fever; She also experienced arm pain for first 2 days; This no... Day after second shot she experienced fever; She also experienced arm pain for first 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 40-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in September 2024). Concurrent medical conditions included systemic lupus erythematosus, asthma and cytomegalovirus infection (Chronic). Concomitant products included hydroxychloroquine, azathioprine and valaciclovir (Valacyclovir). On 06-FEB-2025, the patient received the 2nd dose of Shingrix (right deltoid). On 07-FEB-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Day after second shot she experienced fever). In FEB-2025, the patient experienced pain in arm (Verbatim: She also experienced arm pain for first 2 days). In FEB-2025, the outcome of the pain in arm was resolved (duration 2 days). The outcome of the fever was not resolved. It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix. It was unknown if the company considered the fever and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 27-FEB-2025 The patient received Shingrix and the day after second shot she experienced fever which was still present. She also experienced arm pain for first 2 days. No other details were provided. More
2830314 68 F CA 03/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Nausea Chills, Nausea
Shivers; Nausea; This non-serious case was reported by a consumer via call center representative and... Shivers; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivers in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included evolocumab (Repatha), glipizide and benazepril. On 28-FEB-2025, the patient received the 1st dose of Shingrix. On 05-MAR-2025, 5 days after receiving Shingrix, the patient experienced shivers (Verbatim: Shivers) and nausea (Verbatim: Nausea). The outcome of the shivers and nausea were unknown. It was unknown if the reporter considered the shivers and nausea to be related to Shingrix. It was unknown if the company considered the shivers and nausea to be related to Shingrix. Additional Information: GSK Receipt Date : 05-MAR-2025. The reporter is the patient. The patient received the first dose of SHINGRIX last Friday at a local pharmacy. About 2 hours ago 3pm ET , on the day of reporting , the patient was began experienced shivers and nausea. More
2830315 61 F CA 03/10/2025 UNK
 UNKNOWN MANUFACTURER
Hypoaesthesia Hypoaesthesia
numbness in the pinky finger, ring finger of left hand /pad area of the hand, up to the tip of both ... numbness in the pinky finger, ring finger of left hand /pad area of the hand, up to the tip of both fingers; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in fingers in a 61-year-old female patient who received Flu unspecified (Influenza 2024-2025 Vaccine) for prophylaxis. On 17-JAN-2025, the patient received Influenza 2024-2025 Vaccine (intercostal, left arm). On 18-JAN-2025, 1 days after receiving Influenza 2024-2025 Vaccine, the patient experienced numbness in fingers (Verbatim: numbness in the pinky finger, ring finger of left hand /pad area of the hand, up to the tip of both fingers). The outcome of the numbness in fingers was not resolved. It was unknown if the reporter considered the numbness in fingers to be related to Influenza 2024-2025 Vaccine. It was unknown if the company considered the numbness in fingers to be related to Influenza 2024-2025 Vaccine. Additional Information: GSK Receipt Date: 06-FEB-2025 The reporter was a female patient that received a GSK Flu vaccine (Influenza 2024-2025 Vaccine). The patient was administered flu vaccine and it was administered in the left arm. The reporter does not know the name of the vaccine or have information of Lot/Exp. The patient was only informed that it is a GSK brand. The patient reported having side effects of numbness. The patient noticed it the following morning after the vaccination day. The patient stated, she have numbness in the pinky finger, ring finger left hand. The patient stated that the numbness was started from the pad area of the hand, up to the tip of both fingers. The patient stated it was not resolved. The patient reported, they never had a symptom prior to this with any vaccine, this was the first time she experienced such events after post vaccination. No additional events were reported. More
2830316 26 F TX 03/10/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 XX9N4
Incorrect route of product administration, Product administered to patient of in... Incorrect route of product administration, Product administered to patient of inappropriate age More
A 26 years old female patient received a dose of Priorix via IM instead of SC.; dose of Priorix via ... A 26 years old female patient received a dose of Priorix via IM instead of SC.; dose of Priorix via IM instead of SC; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 26 years old female patient received a dose of Priorix via IM instead of SC.) and subcutaneous injection formulation administered by other route (Verbatim: dose of Priorix via IM instead of SC). The outcome of the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-FEB-2025 A pharmacist called to report that a 26 years old female patient received a dose of Priorix via intramuscular instead of Subcutaneous which led to Subcutaneous injection formulation administered by other route. Should the patient be revaccinated. The reporter consented to follow up. More
2830317 F IN 03/10/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
Interchange of vaccine products Interchange of vaccine products
they administered a dose of Kinrix to a 3 years 7 months old patient; Different products for primary... they administered a dose of Kinrix to a 3 years 7 months old patient; Different products for primary series; 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 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93) for prophylaxis. Previously administered products included Vaxelis (received 1st dose on 20th April 2023) and Pediarix (received 2nd dose on 11th November 2024). On 25-FEB-2025, the patient received the 3rd dose of Kinrix. On 25-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: they administered a dose of Kinrix to a 3 years 7 months old patient) and inappropriate schedule of vaccine administered (Verbatim: Different products for primary series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:28-FEB-2025 The reporter contacted to request information about how to proceed after a three-year 7 month old patient accidentally received a dose of Kinrix, which led to inappropriate age at vaccine administration. They mentioned that the patient received doses of DtAP and Polio previously, with the first dose being on 20th April 2023, the second dose being on 7th November 2024 and the third dose being the one administered on 25th February 2025, which led to inappropriate schedule of vaccine administered. During the phone call they also requested information about how to space out the different components of Kinrix, and the information was read after letting the health care professional know that this information was in a standard response letter for Pediarix. The reporter asked if there were any grace period or the dose was count as valid. The Vaccine Administration Facility was the same as Primary Reporter. They mentioned that they consented to receive follow up. More
2830318 1.17 F OK 03/10/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Xx33p
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Bexsero dose was given to a 14-month-old patient; This non-serious case was reported by a other heal... Bexsero dose was given to a 14-month-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-month-old female patient who received Men B NVS (Bexsero) (batch number Xx33p, expiry date 31-JAN-2026) for prophylaxis. On 03-MAR-2025, the patient received Bexsero. On 03-MAR-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero dose was given to a 14-month-old patient). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-MAR-2025 Medical assistant calls to reporta Bexsero dose was given to a 14-month-old patient, which led to Inappropriate age at vaccine administration. The reporter consented to follow up via email. More
2830319 03/10/2025 COVID19
 JANSSEN
COVID-19 immunisation, Feeling abnormal COVID-19 immunisation, Feeling abnormal
I will never be the same after the different shots; Revaccination with different covid-19 vaccine; T... I will never be the same after the different shots; Revaccination with different covid-19 vaccine; This spontaneous report received from a patient by a business partner (Pfizer Inc.) on 05-Feb-2025 was received by Johnson and Johnson Innovative Medicine on 05-Feb-2025 and concerned a patient of unspecified age and sex. 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 was previously treated with bnt162b2 and experienced feeling abnormal. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose number series 2, for covid-19 prophylaxis.The batch number was not reported. The company is unable to perform follow-up to request for batch or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced i will never be the same after the different shots and revaccination with different covid-19 vaccine. (dose number series 2). Patient reported that they got that shot and the jj before the 2nd shots and will never be the same after the different shots The action taken with janssen covid-19 vaccine was not applicable. The outcome of i will never be the same after the different shots and revaccination with different covid-19 vaccine was not reported. This report was non-serious. More
2830320 M 03/10/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza Influenza
Only Time I had flu was after I got the flu shot; Initial information received on 27-Feb-2025 regard... Only Time I had flu was after I got the flu shot; Initial information received on 27-Feb-2025 regarding an unsolicited valid non-serious case received from social media. This case involves Adult male patient who had flu after receiving Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer, Solution for Injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. On an unknown date, the patient experienced flu was after he got the flu shot (influenza) (unknown latency). Reportedly, Patient had flu was after he got the flu shot, and he also stated that first shingles shot almost killed him. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2830321 F 03/10/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza Influenza
Had my regular flu shot and still got the flu!; Initial information received on 01-Mar-2025 regardin... Had my regular flu shot and still got the flu!; Initial information received on 01-Mar-2025 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional. This case involves Adult female patient who had got the flu after receiving vaccine influenza vaccine. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date the patient developed had my regular flu shot and still got the flu! (influenza) (unknown latency) following the administration of influenza vaccine. Information on the batch number could not be requested corresponding to the one at time of event occurrence Reportedly, reporter stated that, had my regular flu shot and still got flu. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2830322 20 M 03/10/2025 COVID19
HPV9
MEN
VARCEL
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
UNKNOWN MANUFACTURER
MERCK & CO. INC.
 6024MF016A
1957404
U8370AA
Y005919
Urticaria; Urticaria; Urticaria; Urticaria Urticaria; Urticaria; Urticaria; Urticaria
He developed hives on his right thigh and lower le; Initial information received on 28-Feb-2025 rega... He developed hives on his right thigh and lower le; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious Courtesy case received from a consumer/non-health care professional. This case involves a 20 years adult male patient who had developed hives on his right thigh and lower leg after receiving Varivax (Varicella zoster vaccine live (Oka/Merck)), Gardasil 9 (HPV vaccine VLP rL1 9v (yeast)), Novavax COVID-19 Vaccine(COVID-19 vaccine prot. subunit (NVX CoV 2373)) and Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi]. The patient's past medical history included Headache. The patient's past medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. On 26-Nov-2024, the patient received a dose 2 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) lot U8370AA via intramuscular route in unknown administration site, a dose 3 of suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur Injection lot 6024MF016A via intramuscular route in unknown administration site for COVID-19 Vaccination, a dose 1 of suspect Varivax not produced by Sanofi Pasteur Injection lot Y005919 via intramuscular route in unknown administration site, a dose 1 of suspect Gardasil 9 not produced by Sanofi Pasteur Injection lot 1957404 via intramuscular route in unknown administration site and On 07-Jan-2025 he also received a dose 1 of vaccine 1957404 via intramuscular route in unknown administration site for all Prophylactic vaccination (Immunization) (strength, expiry date was unknown for all the suspects). On 26-NOV-2024 the patient developed hives on his right thigh and lower leg (urticaria) (latency : same day) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine, Novavax COVID-19 Vaccine, Gardasil 9 and Varivax. Action taken was not applicable. The patient was treated with Cetirizine hydrochloride (Zyrtec) for Urticaria. At time of reporting, the outcome was Recovered / Resolved on 26-Nov-2024 for the event he developed hives on his right thigh and lower le. More
2830323 1.58 F CA 03/10/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK110AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
administration of pentacel with only the dtap-IPV component with no reported adverse event; Initial ... administration of pentacel with only the dtap-IPV component with no reported adverse event; Initial information received on 27-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old female patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIBPRP/T) vaccine [Pentacel (Vero)] with only the dtap-ipv component 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 15V (CRM197) [Prevnar 15]; varivax; and measles vaccine, mumps vaccine, rubella vaccine [MMR] all for Immunisation. On 26-Feb-2025, the patient received 0.5 mL (dose 3) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIBPRP/T) vaccine with only the DTaP-IPV component, Suspension for injection, (unknown Strength),expiry date 31-Aug-2025, lot UK110AA via intramuscular route in unknown administration site for immunization (Single component of a two-component product administered) (Latency Same day). Reportedly, She stated that the ACTHIB was left out of the refrigerator overnight, approximately 16 hours and is at room temperature at around 68๏ฟฝF to 77๏ฟฝF. 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
2830324 WV 03/10/2025 FLU3
 SANOFI PASTEUR
 UT8470AA
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient receives two high dose flu vaccines (Fluzone Hd) in one day with no reported adverse event; ... patient receives two high dose flu vaccines (Fluzone Hd) in one day with no reported adverse event; Initial information received on 27-Feb-2025 (with live follow up process together with CSD: 27-Feb-2025) regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient who receives two high dose flu vaccines (fluzone hd) in one day with no reported adverse event after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD]. 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 influenza USP trival A-B high dose subvirion vaccine; Suspension for injection in pre-filled syringe (lot UT8470AA with expiry date 30-Jun-2025) via unknown route in unknown administration site for Immunization (Immunisation), patient receives two high dose flu vaccines (fluzone hd) in one day with no reported adverse event (extra dose administered). Reportedly: nurse inquired what happens when a patient receives two high dose flu vaccines (Fluzone Hd) in one day. She confirmed that this happened to a patient. Administration of extra doses of tetanus toxoid containing vaccines earlier than the recommend interval can increase the risk for hypersensitivity reactions. - Informed caller that this will be escalated to the business hours team who may contact her for further assistance. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. No follow-up is possible as Reporter cannot be contacted by Sanofi. 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
2830325 45 F MA 03/10/2025 YF
 SANOFI PASTEUR
 UK118AA
No adverse event, Product preparation error No adverse event, Product preparation error
Yf-Vax was reconstituted with sterile water instead of supplied diluent with no reported adverse eve... Yf-Vax was reconstituted with sterile water instead of supplied diluent with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 45 years old female patient and reporter stated that yellow fever vaccine - US [YF-VAX] was reconstituted with sterile water instead of supplied diluent 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 typhoid vaccine (typhoid vaccine) and influenza vaccine (influenza), both for Immunisation. On 13-Nov-2024, the patient received standard dose of 0.5 ml of suspect yellow fever vaccine - US Solution for injection lot UK118AA and expiry date 30-Sep-2025 via unknown route in unknown administration site for Immunisation that was reconstituted with sterile water instead of supplied diluent with no reported adverse event (product preparation error) (Latency same day). 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
2830326 10 F AZ 03/10/2025 IPV
 SANOFI PASTEUR
 W1B511M
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion of ipol; max/low temperature reached: 47.1๏ฟฝf duration: 10 mins with no repor... temperature excursion of ipol; max/low temperature reached: 47.1๏ฟฝf duration: 10 mins with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 years old female patient who received IPV (VERO) [IPOL] which was exposed to temperature excursion and max/low temperature reached: 47.1๏ฟฝf duration: 10 mins 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation; Varicella zoster vaccine (Varicella vaccine) for Immunisation; Hepatitis B vaccine for Immunisation; and Hepatitis A Vaccine for Immunisation. On 25-Feb-2025, the patient received 0.5 ml of dose 2 of IPV (VERO) Suspension for injection with standard strength (expiry date- 08-Sep-2025 and lot W1B511M) once via intramuscular route in the left deltoid for Immunization which was exposed to temperature excursion and max/low temperature reached: 47.1๏ฟฝf duration: 10 mins with no reported adverse event (product storage error) (latency- same day). Reportedly, reporter said that they were transferring the vaccines from their AccuVax to their fridge that was 10 feet away. There was no previous excursion. Human error was involved. 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
2830327 1 F IN 03/10/2025 HIBV
 SANOFI PASTEUR
 UK010AA
Expired product administered, No adverse event Expired product administered, No adverse event
expired ACT-HIB given to a patient with no reported adverse event; Initial information received on 0... expired ACT-HIB given to a patient with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 1 years old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] given to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis A vaccine INACT (VAQTA), hepatitis A vaccine (hepatitis A), measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (proquad) and pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20), all for Immunisation. On 03-Mar-2025, the patient received standard dose 4 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection with lot UK010AA and expiry date 28-Feb-2025 via unknown route in unknown administration site for Immunization (expired product administered) (Latency same day). 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
2830328 F GA 03/10/2025 HIBV
 SANOFI PASTEUR
 UK148AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
administered a dose of ACTHIB too early/underaged patient (7-days-old) with no reported adverse even... administered a dose of ACTHIB too early/underaged patient (7-days-old) with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case linked to US-SA-2025SA067436. This case involves a 7 days old female patient who experienced inappropriate use as patient being administered a dose of acthib too early/underaged, was administered act-hib and daptacel with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation. On 02-Mar-2025, the patient received a dose 1 (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection with standard strength (lot UK148AA with expiry date 30-Sep-2025) via intramuscular route in the left thigh for Immunization (Immunisation) and patient administered a dose of acthib too early/underaged patient (7-days-old) with no reported adverse event (product administered to patient of inappropriate age).(latency: same day). 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-2025SA067436:ACT-HIB More
2830329 F GA 03/10/2025 DTAP
 SANOFI PASTEUR
 3CA11C1
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
administered a dose of DAPTACEL too early to underaged patient (7-days-old) with no reported adverse... administered a dose of DAPTACEL too early to underaged patient (7-days-old) with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA067387. This case involves a 7 days old female patient who was administered with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at underage 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 HIB Vaccine Conj (Tet Tox) (ACT-HIB) for Immunisation. On 02-Mar-2025 the patient was administered 0.5ml (once) dose 1 of diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, Standard strength, Expiry date 31-Dec-2025 and lot 3CA11C1 via intramuscular route in the left thigh for immunization too early at underage (7-days-old) with no reported adverse event (product administered to patient of inappropriate age) (Latency same day) 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-2025SA067387:ACT-HIB More
2830330 1.25 CA 03/10/2025 HIBV
 SANOFI PASTEUR
 UJ995AA
Expired product administered, No adverse event Expired product administered, No adverse event
a patient was administered an expired ACTHIB with no reported adverse event; Initial information rec... a patient was administered an expired ACTHIB with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves a 15 months old with unknown gender patient who administered an expired Hib (PRP/T) Vaccine [Act-Hib] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other List of comcomitants vaccines is mentioned On 03-Mar-2025, the patient administered an expired 0.5 ml dose of suspect Hib (PRP/T) Vaccine,Powder and solvent for solution for injection, lot UJ995AA, expiry date: 28-feb-2025,via intramuscular route in the left vastus lateralis for Immunization.with no reported adverse event (expired product administered) (latency: same day). Reportedly,Caller inquired if the vaccine shot was valid after administering an expired ACTHIB. Call was disconnected. 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
2830331 IL 03/10/2025 HIBV
 SANOFI PASTEUR
Expired product administered, No adverse event Expired product administered, No adverse event
received an ACT-HIB vaccine that expired 28-Feb-2025 with no reported adverse event; Initial informa... received an ACT-HIB vaccine that expired 28-Feb-2025 with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] that expired 28-Feb-2025 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 in Mar-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (expiry date 28-Feb-2025) (lot number and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization) with no reported adverse event (expired product administered) (Latency: same day). There will be no information on batch number and expiration date 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
2830332 0.67 F NJ 03/10/2025 UNK
 UNKNOWN MANUFACTURER
 TFAA2429
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
administration of FLUBLOK to a 7 month old patient (with no reported adverse event); Initial informa... administration of FLUBLOK to a 7 month old patient (with no reported adverse event); Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8-month-old female patient who received Influenza trivalent recombinant vaccine [Flublok TIV] (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Mar-2025, the patient received 0.5ml dose of suspect Influenza trivalent recombinant vaccine Solution for injection , once (strength-standard) (lot TFAA2429) (expiry date-30-Jun-2025) via intramuscular route in left leg for Immunization (with no reported adverse event) (product administered to patient of inappropriate age) (latency-same day). Action taken with 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
2830333 0.42 M PA 03/10/2025 HIBV
 SANOFI PASTEUR
 UK113AB
Extra dose administered, No adverse event Extra dose administered, No adverse event
received another set of 6 month vaccines with no reported adverse event; Initial information receive... received another set of 6 month vaccines with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves 5 months old male patient who received another set of 6 month HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix), pneumococcal vaccine conj 7v (CRM197) (Prevnar) and rotavirus vaccine live reassort oral 5 V (Rotateq) for prophylactic vaccintion (Immunisation) On 25-Feb-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine [ACT-HIB], Powder and solvent for solution for injection (lot number UK113AB and expiry date 30-Sep-2025) (Frequency: Possibly 4 times and strength: standard) via intramuscular route in the left thigh for Immunisation with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, Caller is calling because they have a 6 month old male patient and the patient first received the vaccines and then traveled for two months and got vaccines while traveling. When the patient came back for his six-month appointment, his shot record was not clear. He received another set of 6 month vaccines. The patient's dad wants the HCP to call and see if there is any information about adverse reactions to a child being essentially double vaccinated. They are requesting if there's anything that could happen beside redness, swelling of the injection site, fussiness, decreased appetite, fever, and all that stuff. 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
2830334 2 M IL 03/10/2025 HIBV
 SANOFI PASTEUR
 UK010AA
Expired product administered, No adverse event Expired product administered, No adverse event
administration of an expired product (with no reported adverse event); Initial information received ... administration of an expired product (with no reported adverse event); Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who was administrated with expired product HIB (PRP/T) Vaccine [ACT-HIB] (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Mar-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK010AA, expiry date 28-Feb-2025) via intramuscular route in the left thigh for immunisation and administration of an expired product (with no reported adverse event) (expired product administered) (latency same day) Action taken was not applicable. Reportedly, Nurse Manager called asking if the given dose for patient was valid or if another dose must be given after realizing that the vaccine has expired last 28-Feb-2025. 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
2830335 0.33 M MS 03/10/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UJ876AA
Expired product administered, No adverse event Expired product administered, No adverse event
administration of expired pentacel with no reported adverse event; Initial information received on 0... administration of expired pentacel with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who was administered with expired 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 13v (CRM197) (Prevnar 13) for Immunisation. On 27-Jan-2025, the patient received an expired 0.5ml (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) Vaccine, Powder and suspension for suspension for injection, Unknown Strength, Expiry date 19-Mar-2024 and lot UJ876AA via intramuscular route in unknown administration site for Immunization with no reported adverse event (Expired vaccine used) (Latency same day). Reportedly, A nurse called to inform that a patient had been given expired Pentacel. She wanted to get a recommendation of what to do next after this event. Nurse is unsure of the treatment that was provided. They said that patient was fine. 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
2830336 1.25 M MI 03/10/2025 HIBV
 SANOFI PASTEUR
 UK009AB
Expired product administered, No adverse event Expired product administered, No adverse event
15 months old patient was given expired Act HIB with no reported adverse event; Initial information ... 15 months old patient was given expired Act HIB with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves 15 months old male patient who received HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) for prophylactic vaccination (Immunisation). On 04-Mar-2025, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot number UK009AB and expiry date 28-Feb-2025) (frequency: once, strength: standard) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (Latency: same day). 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
2830337 1 F KS 03/10/2025 HIBV
 SANOFI PASTEUR
 UJ992AA
Expired product administered, No adverse event Expired product administered, No adverse event
patient took expired acthib with no reported adverse event; Initial information received on 05-Mar-2... patient took expired acthib with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves 12 months and 18 days old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20), measles vaccine, mumps vaccine, rubella vaccine (MMR); aesculus hippocastanum [varivax] and hepatitis A vaccine (hepatitis A vaccine), all for Immunisation. On 03-Mar-2025, the patient received standard dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection once with lot UJ992AA and expiry date 28-Feb-2025 via intramuscular route in unknown administration site for immunization (expired product administered) (Latency same day) 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
2830344 4 F OR 03/10/2025 MMRV
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Cheilitis, Dark circles under eyes, Ear swelling, Miliaria, Mouth swelling; Peri... Cheilitis, Dark circles under eyes, Ear swelling, Miliaria, Mouth swelling; Periorbital swelling, Pruritus, Rash, Rash papular, Skin exfoliation; Swelling face More
Saturday March 1st began itching head, face, neck chest and eyes puffy , Sunday March 2nd mouth, fac... Saturday March 1st began itching head, face, neck chest and eyes puffy , Sunday March 2nd mouth, face, ear swelling, heat looking rash to face neck chest and upper back rash on neck raised taken to ER given high dose oral steroids and Benadryl with no improvement. Rash spread from head to toe over next day dark circles brown around eyes, white sores to inner lower lip, everywhere rash was peeled More
2830345 53 F KY 03/10/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Chest pain, Dyspnoea, Erythema, Fatigue, Laboratory test; Lymphadenopathy, Neck ... Chest pain, Dyspnoea, Erythema, Fatigue, Laboratory test; Lymphadenopathy, Neck mass, Neck pain, Pain, Palpitations; Productive cough, Pruritus, Sputum discoloured More
Loss of test, tired, egg shape lump and red arm, neck pain, after about a week trouble breathing, ch... Loss of test, tired, egg shape lump and red arm, neck pain, after about a week trouble breathing, chest pain coughing up brown phlegm, heart racing, aching, neck pain, itching in right arm, swollen glands in neck, and right arm out, severe itching right breast. More
2830350 F 03/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Hypoaesthesia, Ophthalmic herpes zoster, Vaccination failure, Vis... Herpes zoster, Hypoaesthesia, Ophthalmic herpes zoster, Vaccination failure, Visual impairment More
Suspected Vaccination failure; little sight in my right eye/shingles from below my right eye; got sh... Suspected Vaccination failure; little sight in my right eye/shingles from below my right eye; got shingles on right side of my face through hair and down neck all on the right side of my head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 77-year-old female 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), ophthalmic herpes zoster (Verbatim: little sight in my right eye/shingles from below my right eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got shingles on right side of my face through hair and down neck all on the right side of my head). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were resolved. The reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. The company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine but at 77 he got shingles from below his right eye over the right side of his face,through his hair and down neck all on the right side of his head. The doctor at emergency room said it would have been much worse if patient had not had the shot. It was bad for 5 or 6 weeks and had very little sight in his right eye and numbness over the right side of his head. The patient stated get the shot it did helped. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2830351 03/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; light case of shingles; This serious case was reported by a consumer ... Suspected vaccination failure; light case of shingles; 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. 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: light case of shingles). 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. 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: 02-MAR-2025 This case was reported by a patient via (Facebook) interactive digital media. Patient reported that if he/she had received the Shingrix vaccination, but had a light case of shingles after the vaccination. Patient asked if he/she repeat the vaccination. 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 vaccine Shingrix. More
2830352 82 F WV 03/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X5T42
Rash Rash
painful rash developing on the arm two weeks after administration of Shingrix first dose.; painful r... painful rash developing on the arm two weeks after administration of Shingrix first dose.; painful rash developing on the arm two weeks after administration of Shingrix first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number X5T42, expiry date 30-JAN-2027) for prophylaxis. On 14-FEB-2025, the patient received the 1st dose of Shingrix. In FEB-2025, 2 weeks after receiving Shingrix, the patient experienced rash (Verbatim: painful rash developing on the arm two weeks after administration of Shingrix first dose.) and pain (Verbatim: painful rash developing on the arm two weeks after administration of Shingrix first dose). The outcome of the rash and pain were unknown. It was unknown if the reporter considered the rash and pain to be related to Shingrix. It was unknown if the company considered the rash and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 28-FEB-2025 Pharmacist reported that a patient had a painful rash developing on the arm two weeks after administration of Shingrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. More
2830353 M DC 03/10/2025 FLUX
 UNKNOWN MANUFACTURER
Dyspnoea, Palpitations Dyspnoea, Palpitations
Reported Symptms: 10013963:DYSPNEA; 10033556:PALPITATION; Narrative: A 53yo female patient with PMH ... Reported Symptms: 10013963:DYSPNEA; 10033556:PALPITATION; Narrative: A 53yo female patient with PMH of HTN, Asthma, Constipation and GERD, presented to the facility to establish care. On October 28, 2024, the staff RN reported the patient had a historical ADR of influenza vaccine induced Palpitations and Dyspnea. No other detailed information regarding the reaction date or treatment and the vaccine, was provided. i.e. ( when, where and by who the vaccine was administered, Mfg, lot#, Exp. date, etc) Last facility influenza immunization record for the patient - Feb. 22, 2019 (Influenza split virus, quadrivalent, PF. ) Other Relevant HX: Other: PALPITATIONS; DYSPNEA More
2830354 F DC 03/10/2025 COVID19
 PFIZER\BIONTECH
Rash Rash
Narrative: A 25 yo female with PMH of GERD, Pain bilateral knee region and Chronic PTSD. On October ... Narrative: A 25 yo female with PMH of GERD, Pain bilateral knee region and Chronic PTSD. On October 25, 2024, the patient presented to PCC to establish care. The clinic's RN reported the patient had a historical ADR of Pfizer Covid-19 vaccine induced rash with the first vaccine and no problem with the subsequent vaccines. No other detailed information was provided regarding treatment or the vaccine, i.e. (where and by who it was administered, the Lot #. Expiration date etc.) The patient has no clinic immunization record. Other Relevant HX: Other: RASH More
2830355 M DC 03/10/2025 FLUX
 UNKNOWN MANUFACTURER
Urticaria Urticaria
Reported Symptoms: 10046735:URTICARIA; Narrative: A 94yo male with PMH of Subarachnoid Hemorrhage, O... Reported Symptoms: 10046735:URTICARIA; Narrative: A 94yo male with PMH of Subarachnoid Hemorrhage, OA, Dilation of Aorta, GERD, Chronic Rhinitis, Cerebral Infraction, HTN, A-Fib, Aortic Regurgitation and Pulmonary HTN. On October 7, 2024, attending Physician reported the patient had a historical ADR of Influenza vaccine induced Urticaria. The patient presented to the facility to establish care No other detailed information provided regarding the treatment for the ADR or the vaccine (i.e. when, where and who administered the vaccine, Mfg, Lot#, Exp. date. No immunization record on influenza vaccine. Other Relevant HX: Other: URTICARIA More
2830356 58 M OH 03/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 YG4SK
Swelling, Urticaria Swelling, Urticaria
Reported Symptoms: 10042674:SWELLING; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTIC... Reported Symptoms: 10042674:SWELLING; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA; Swelling More
2830359 77 M PA 03/10/2025 COVID19
 PFIZER\BIONTECH
 LM2219
Chills Chills
Reported Symptoms: 10008531:CHILLS; Narrative: Other Relevant HX: Other: CHILLS Reported Symptoms: 10008531:CHILLS; Narrative: Other Relevant HX: Other: CHILLS
2830360 92 M FL 03/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 2B74N
Hemiparesis Hemiparesis
Report systems: 10065780:MUSCLE WEAKNESS LEFT-SIDED; Narrative: Patient seen via home-based primary ... Report systems: 10065780:MUSCLE WEAKNESS LEFT-SIDED; Narrative: Patient seen via home-based primary care and received COVID-19 and RSV vaccines. Patients wide contacted provider three days later stating that after the vaccines the patient experienced left-sided weakness (overall weakness on the left side of the body). Wife followed up the next day to report that patient is getting stronger with overall improvements. Other Relevant HX: Other: Left-sided weakness More
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