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
2816600 M 12/17/2024 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Body temperature, Pyrexia; Blood creatinine, Blood creatinine abnormal Body temperature, Pyrexia; Blood creatinine, Blood creatinine abnormal
fever (102 ๏ฟฝF); This is a spontaneous report received from a Pharmacist from medical information t... fever (102 ๏ฟฝF); This is a spontaneous report received from a Pharmacist from medical information team, Program ID. A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "learning disabled" (unspecified if ongoing), notes: found out last Mar he has a genetic disability, MECP2, which is a gene that carries Rhett's, autism; "Rett Syndrome" (unspecified if ongoing); "rectal bleeding" (unspecified if ongoing); "fecal impaction" (unspecified if ongoing); "trouble swallowing" (unspecified if ongoing); "spasticity" (unspecified if ongoing); "autism spectrum" (unspecified if ongoing); "lack of speech" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Simvastatin, start date: 2020, notes: simvastatin 20mg for years and that was discontinued back in Jan or Feb of 2020; Coumadin, reaction(s): "AFib"; Coumadin, reaction(s): "high fever"; Coumadin, reaction(s): "dehydrated"; Atorvastatin, start date: Mar2020, reaction(s): "Rhabdomyolysis"; Aricept, start date: Mar2020, reaction(s): "Rhabdomyolysis", notes: 2 doses, 1 in am and 1 in pm; Aricept, reaction(s): "Weight loss", notes: 2 doses, 1 in am and 1 in pm; Aricept, reaction(s): "Difficulty in walking", notes: 2 doses, 1 in am and 1 in pm; Aricept, reaction(s): "Fecal impaction", notes: 2 doses, 1 in am and 1 in pm; Aricept, reaction(s): "Rectal bleeding", notes: 2 doses, 1 in am and 1 in pm; Aricept, reaction(s): "Drug interaction", notes: 2 doses, 1 in am and 1 in pm; Aricept, start date: Mar2020, reaction(s): "Creatine phosphokinase increased", notes: 2 doses, 1 in am and 1 in pm; Lipitor, reaction(s): "level went up to 6000"; Lipitor, reaction(s): "Drug interaction"; Lipitor, reaction(s): "Rectal bleeding"; Lipitor, reaction(s): "Fecal impaction"; Lipitor, reaction(s): "Difficulty in walking"; Aricept, reaction(s): "Weight loss"; Lipitor, reaction(s): "Rhabdomyolysis". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, time: 15:45), administration date: 04Feb2021, for COVID-19 immunization, reaction(s): "them on Saturday and his kinase was 1015", "he wasn't feeling well", "Nausea", "unable to articulate how he feels due to depressed ability to speak", "Panic", "Anxiety", "high serum creatinine"; Covid-19 vaccine (DOSE 2, SINGLE; unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever (102 ๏ฟฝF)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Caller, a retired pharmacist, wants to know the difference between the Pfizer COVID-19 Booster now that they are about to get to previous vaccines. He mentioned that his son had a reaction when he got the Pfizer Covid-19 booster. He also would like to know if they can interchange Pfizer Covid-19 and Moderna Boosters. Caller would like to know if the Comirnaty vaccines had changed in the last 6 months. His son has a condition that makes him have spasticity and lack of speech. Some doctors say it's Rett's syndrome, some say it's on the autism spectrum. With previous doses of the COVID-19 vaccine, he had high serum creatinine that resolved in a week. Six months ago he got a dose of Pfizer's COVID-19 vaccine and he had a fever (102 ๏ฟฝF). He administered him Tylenol liquid 2 teaspoons in total (one when he noticed the temperature was going up, and then another 4 or 5 hours later) and it went away as the day went on No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2851287 TN 07/25/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Injection site pain, Vaccination failure; Herpes zoster, Injectio... Herpes zoster, Injection site pain, Vaccination failure; Herpes zoster, Injection site pain, Vaccination failure More
Vaccination failure; Shingles; Shot stung at 1st; Shot stung at 2nd; This serious case was reported ... Vaccination failure; Shingles; Shot stung at 1st; Shot stung at 2nd; This serious case was reported by a consumer via call center representative 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. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), injection site pain (Verbatim: Shot stung at 1st) and injection site pain (Verbatim: Shot stung at 2nd). The outcome of the vaccination failure, shingles, injection site pain and injection site pain were not reported. It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and injection site pain to be related to Shingrix. It was unknown if the company considered the shingles and injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 16-JUL-2025 The patient received both doses of Shingrix vaccine a few years ago. The patient had 6 cases of Shingles since vaccination. Not effective for patient. Shot stung at 1st, but tolerate both well. Hope works better for others. This case was considered as suspected vaccination failure as details regarding 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 completion of primary vaccination schedule, time to onset and regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2851288 F 07/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included COVID-19 vaccine (received a COVID-19 vaccine on an unknown date). 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). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be possibly related to Shingrix. Additional Information: GSK receipt date: 18-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his/her aunty had the COVID vaccine, then six months later received the shingles vaccine. After that, she developed shingles the sickest she had ever been. She went back to the physician and said, did not said the vaccine could give him/her shingles and the physician said, oh yeah, that can occur. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix More
2851289 07/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I got the vaccine and still got a mild case of them; This serious cas... Suspected vaccination failure; I got the vaccine and still got a mild case of them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine and still got a mild case of them). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got a mild case of them. The patient thought that you could not get them twice. The virus should be enough prevention and said what was going on with these viruses, get well soon. 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. More
2851290 F FL 07/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
he received dose one of Shingrix in 2019 and has not yet had the 2nd dose; This non-serious case was... he received dose one of Shingrix in 2019 and has not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: he received dose one of Shingrix in 2019 and has not yet had the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 21-JUL-2025 The reporter was an older male who states that he received dose one of Shingrix in 2019 and has not yet had the 2nd dose. He stated that his wife also received her first dose in 2021 and has not yet had the 2nd dose. The reporter did not have patient identifiers for the wife. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with US2025093099, reported by the same reporter.; Sender's Comments: US-GSK-US2025093099:Same reporter,different patient More
2851291 1.5 07/25/2025 TDAP
 UNKNOWN MANUFACTURER
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
administered Tdap instead of DTaP to 18-month-old/ underage administration; administered Tdap instea... administered Tdap instead of DTaP to 18-month-old/ underage administration; administered Tdap instead of DTaP to 18-month-old; 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 18-month-old patient who received (Tdap Vaccine) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine and did not receive DTaP vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: administered Tdap instead of DTaP to 18-month-old/ underage administration) and wrong vaccine administered (Verbatim: administered Tdap instead of DTaP to 18-month-old). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. Additional Information: GSK Receipt Date: 21-OCT-2024 The Tdap vaccine was administered to 18-month-old patient instead of DTaP vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. No other information provided. No specification if Tdap was Boostrix. More
2851292 F FL 07/25/2025 RVX
 UNKNOWN MANUFACTURER
 3Z34X
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
patient older than 15 weeks of age; This non-serious case was reported by a physician via call cente... patient older than 15 weeks of age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Rotavirus vaccine (batch number 3Z34X, expiry date 09-NOV-2026) for prophylaxis. On 15-JUL-2025, the patient received the 1st dose of Rotavirus vaccine. On 15-JUL-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: patient older than 15 weeks of age). 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: 15-JUL-2025 A health care provider reported that a patient older than 15 weeks of age received Rotarix vaccine which led to inappropriate age at vaccine administration. More
2851293 74 F NC 07/25/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 CE9C9
Expired product administered Expired product administered
administered a dose of Arexvy that was expired on July 6th 2025; This non-serious case was reported ... administered a dose of Arexvy that was expired on July 6th 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number CE9C9, expiry date 06-JUL-2025) for prophylaxis. On 15-JUL-2025, the patient received Arexvy. On 15-JUL-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: administered a dose of Arexvy that was expired on July 6th 2025). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 15-JUL-2025 On 15 Jul 2025, a pharmacist called to inform that earlier that day, they had administered a dose of Arexvy that was expired on 06 July 2025 which led to Expired vaccine administered. No further details provided. More
2851294 M TX 07/25/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 A5DP7
Underdose Underdose
underdose; Adult dose to pediatric patient; This non-serious case was reported by a nurse via call c... underdose; Adult dose to pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number A5DP7, expiry date 11-AUG-2027) for prophylaxis. On 15-JUL-2025, the patient received Engerix B adult 1 ml. On 15-JUL-2025, an unknown time after receiving Engerix B adult, the patient experienced underdose (Verbatim: underdose) and adult product administered to child (Verbatim: Adult dose to pediatric patient). The outcome of the underdose and adult product administered to child 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: 16-JUL-2025 The registered nurse gave an adult dose of Engerix-B (1 milliliter) to a 19 year old patient on 15th July 2025 which led to adult product administered to child and underdose. More
2851295 07/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Incomplete course of vaccination Incomplete course of vaccination
Probable late second dose; This non-serious case was reported by a other health professional via cal... Probable late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Probable late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 01-AUG-2024 and 02-AUG-2024 A voicemail was left by a healthcare professional with the following message, a probable late second dose. The patient was not sure if they had a dose of Shingrix administered or not when they consulted their healthcare professional. No further details provided by reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2851296 M TN 07/25/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 E4A39
Expired product administered Expired product administered
an expired dose of Menveo 1-vial was administered; This non-serious case was reported by a pharmacis... an expired dose of Menveo 1-vial was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult male patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis. On 22-JUL-2025, the patient received Menveo. On 22-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: an expired dose of Menveo 1-vial was administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 22-JUL-2025 The pharmacist reported that an expired dose of Menveo 1-vial was administered to the patient, which led to expired vaccine used. The reporter was looking for information regarding expiration date on a vaccine and how long after the expiration date and asked were they good for and efficacy. More
2851297 F 07/25/2025 COVID19
 MODERNA
Mast cell activation syndrome, Weight Mast cell activation syndrome, Weight
Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the ... Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc) (seriousness criterion medically significant). At the time of the report, MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: she used to be 196 lbs and is currently down to 140 lbs.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. In 2020 or 2021, when the first vaccine came out, she took it. She took another one a year later. She had since been sick all the time. She got flare-ups in the forms of hives and rashes. She felt pain in her body and limbs, and they always felt weak. She added that her joints hurt. She went to a dermatologist, but he was not able to diagnose her. She also had ongoing vomiting and diarrhea accompanied by abdominal pain. When she went to the ER, they were not able to tell her what the problem was. She added that she used to be 196 lbs and was currently down to 140 lbs. She was finally diagnosed to have Mast Cell Syndrome. She added that she had mast cells in her stomach. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. This case was linked to MOD-2025-788259 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2851298 F 07/25/2025 COVID19
 UNKNOWN MANUFACTURER
Antibody test, Antibody test negative, Off label use Antibody test, Antibody test negative, Off label use
Antibody levels checked 2 weeks after receiving the half dose are undetectable; She has had only one... Antibody levels checked 2 weeks after receiving the half dose are undetectable; She has had only one half-dose; This non-serious initial spontaneous safety report was reported by a Physician via contact center (MI No. NOV25-00332) and concerns a 44-year-old Female who experienced "ANTIBODY LEVELS CHECKED 2 WEEKS AFTER RECEIVING THE HALF DOSE ARE UNDETECTABLE" and "SHE HAS HAD ONLY ONE HALF-DOSE" on unknown dates after receiving Nuvaxovid on an unknown date. At the time of the report, the outcome of the Antibody test negative was Unknown and Off label use was Recovered/Resolved.; Sender's Comments: This 44-year-old Female experienced Antibody test negative and Off label use after vaccination with Nuvaxovid. The events Antibody test negative and Off label use were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Nuvaxovid and Antibody test negative and Off label use is considered Possible. More
2851299 M 07/25/2025 COVID19
 PFIZER\BIONTECH
Ageusia, Weight decreased Ageusia, Weight decreased
Loss of taste for a few months/Eventually partially return; Attributes 15lb weight loss to this; Thi... Loss of taste for a few months/Eventually partially return; Attributes 15lb weight loss to this; This is a spontaneous report received from a Consumer or other non HCP. An adult male patient received BNT162b2 (BNT162B2 NOS), in Aug2022 as dose number unknown, 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: AGEUSIA (non-serious), outcome "recovering", described as "Loss of taste for a few months/Eventually partially return"; WEIGHT DECREASED (non-serious), outcome "recovering", described as "Attributes 15lb weight loss to this". It was unknown if therapeutic measures were taken as a result of ageusia, weight decreased. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2851300 M 07/25/2025 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. A male patien... Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Clinical course: The caller inquired about a prescription medicine for COVID-19 they saw advertised. The agent explained that Pfizer offers a prescription medication for COVID-19. The caller expressed dissatisfaction with the COVID-19 vaccine's effectiveness and mentioned past experiences with COVID-19. The agent suggested consulting a doctor for more detailed information. Submitted AE as the caller mentioned that patient had Covid and got Pfizer Covid 19 but it does no good to him. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2851301 F TX 07/25/2025 COVID19
 PFIZER\BIONTECH
Blood pressure measurement, COVID-19, Drug ineffective Blood pressure measurement, COVID-19, Drug ineffective
Covid After Pfizer Covid Immunizations; Covid After Pfizer Covid Immunizations; This is a spontaneou... Covid After Pfizer Covid Immunizations; Covid After Pfizer Covid Immunizations; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stress" (unspecified if ongoing); "blood pressure went up" (unspecified if ongoing); "in and out of the hospital" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number unknown, single), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid After Pfizer Covid Immunizations". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: went up. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient reported she was not feeling good. She was at the pharmacy and didn't have insurance for Paxlovid for COVID. Patient stated she haven't been teaching for over a year. She left teaching over a year ago. It was just too stressful then her blood pressure went up. Patient was in and out of the hospital. Patient was provided with her voucher information. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2851302 39 IN 07/25/2025 TDAP
 SANOFI PASTEUR
No adverse event, Off label use No adverse event, Off label use
with off label diagnosis s61.012A; Initial information received on 22-Jul-2025 regarding an unsolici... with off label diagnosis s61.012A; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 39 years old with unknown gender patient who had off label diagnosis s61.012A (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient had an intentional off label prescription by hcp as Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (with an unknown lot number, expiry date and strength) (frequency once; dose 0.5ml) via intramuscular route in unknown administration site was prescribed with off label diagnosis s61.012A Laceration without foreign body of left thumb without damage to nail, initial encounter (Skin laceration) (with no reported adverse event) had off label diagnosis s61.012A (Off label vaccine use) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. No follow up possible since reporter denied to respond to Sanofi PV. More
2851303 F 07/25/2025 FLU3
 SANOFI PASTEUR
Cough, Hypersensitivity, Immediate post-injection reaction, Vision blurred Cough, Hypersensitivity, Immediate post-injection reaction, Vision blurred
immediate bad cough; blurred vision; Allergic reaction; Initial information received on 23-Jul-2025 ... immediate bad cough; blurred vision; Allergic reaction; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an unknown age female patient who had immediate bad cough, blurred vision and allergic reaction after receiving influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone]. 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 influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization). On an unknown date the patient developed immediate bad cough (cough), blurred vision (vision blurred) and allergic reaction (hypersensitivity) (unknown latency). Reportedly, patient developed an immediate bad cough, and blurred vision after receiving fluzone - which went away after about two weeks. Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. More
2851304 PA 07/25/2025 TDAP
 SANOFI PASTEUR
Expired product administered, No adverse event Expired product administered, No adverse event
expired adacel vaccine was given with no reported adverse event; Initial information received on 24-... expired adacel vaccine was given with no reported adverse event; Initial information received on 24-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient of unknown demographics whom expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of expired suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (latency: on same day). Action taken was not applicable. Information regarding batch number and expiry date corresponding to the one at time of event occurrence is requested. 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
2851306 18 F FL 07/25/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 MSD X025115
SK 55N34
SKB XL223
Asthenia, Dizziness, Headache, Vision blurred; Asthenia, Dizziness, Headache, Vi... Asthenia, Dizziness, Headache, Vision blurred; Asthenia, Dizziness, Headache, Vision blurred; Asthenia, Dizziness, Headache, Vision blurred More
Dizziness, headache, blurred vision,weakness Dizziness, headache, blurred vision,weakness
2851314 80 F WA 07/25/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Choking, Cyanosis, Oxygen saturation decreased Choking, Cyanosis, Oxygen saturation decreased
Resident observed choking, lips blue in color, oxygen saturation decreased to <80% on 5 liters ox... Resident observed choking, lips blue in color, oxygen saturation decreased to <80% on 5 liters oxygen More
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2851315 12 M CA 07/25/2025 IPV
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No adverse effects. No adverse effects.
2851316 66 F OH 07/25/2025 PNC20
 PFIZER\WYETH
Injection site erythema Injection site erythema
patient has red flat patch around vaccine site patient has red flat patch around vaccine site
2851317 54 F CA 07/25/2025 TDAP
 SANOFI PASTEUR
Erythema, Injection site pain, Muscle tightness, Peripheral swelling, Pruritus Erythema, Injection site pain, Muscle tightness, Peripheral swelling, Pruritus
as described by patient "arm hurt quite a bit for ~2 days. Days 3-4 were better and by day 5 I ... as described by patient "arm hurt quite a bit for ~2 days. Days 3-4 were better and by day 5 I only noticed soreness if I touched the area where I got the shot. However, on day 6, my arm started to hurt a LOT again in that area and the pain extended many inches around. My shoulders and back got really tense and I had a 99.5 fever which eventually went down to 98.8 (my normal temp is 97.5-98). My husband massaged shoulder area gently for 20mins which helped so I could sleep. Yesterday, day 7, the pain was better but I got a new reaction and 99.5 fever again. My arm swelled up and got reddish and itchy" More
2851318 33 F CA 07/25/2025 COVID19
COVID19
 MODERNA
MODERNA

Amenorrhoea; Amenorrhoea Amenorrhoea; Amenorrhoea
My period stopped entirely for 13 months My period stopped entirely for 13 months
2851319 5 F AZ 07/25/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Injection site erythema, Injection site swelling; Injection site erythema, Injec... Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling More
Huge raised red raise at injection site Huge raised red raise at injection site
2851320 11 M CA 07/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 PG3RP
Feeling cold, Loss of consciousness Feeling cold, Loss of consciousness
The vaccination was given, the young man, went to stand up to leave after the IZ card was filled out... The vaccination was given, the young man, went to stand up to leave after the IZ card was filled out, sat back down and passed out. His father was present. The nurse put an ice pack on his neck under the right ear, and he was laid down on the floor with legs over heart slightly, 911 called, small sip of water given with 2 small packets of sugar added because he hadn't eaten anything all day. A light cover was placed over his arms because he was cold when he started to be clearer. He remained laying down until the paramedics arrived and they took him to the ambulance. At that time, he was alert, able to follow commands, and answer questions in English and speak to his father in their native language. More
2851321 76 F CA 07/25/2025 YF
YF
 SANOFI PASTEUR
SANOFI PASTEUR
 UK218AA
UK218AA
Burning sensation, Headache, Hypoaesthesia, Oral discomfort, Tinnitus; Tongue di... Burning sensation, Headache, Hypoaesthesia, Oral discomfort, Tinnitus; Tongue discomfort More
Patient has underlying L ear tinnitus. July 19 she started having burning sensation and numbness on ... Patient has underlying L ear tinnitus. July 19 she started having burning sensation and numbness on the soles of both feet. The following day she had similar sensation on the palms of her hands. She also had headache, tinnitus worse from baseline and burning feeling of lips and tongue. More
2851322 47 F VA 07/25/2025 COVID19
 JANSSEN
 1808609
Fatigue, Headache, Pain, Pyrexia Fatigue, Headache, Pain, Pyrexia
severe headache, body aches, high fever, extreme fatigue that last 3 days severe headache, body aches, high fever, extreme fatigue that last 3 days
2851323 48 M CA 07/25/2025 YF
 SANOFI PASTEUR
 UK211AA
Injection site erythema, Injection site papule, Injection site plaque Injection site erythema, Injection site papule, Injection site plaque
Developed injection site papules on 7/21, then a large raise erythematous plaque on 7/22 Developed injection site papules on 7/21, then a large raise erythematous plaque on 7/22
2851324 22 M OR 07/25/2025 HPV9
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y020588
37F34
Cold sweat, Dizziness, Syncope; Cold sweat, Dizziness, Syncope Cold sweat, Dizziness, Syncope; Cold sweat, Dizziness, Syncope
Patient has a history of feeling dizzy or fainting from vaccines but this does not happen every time... Patient has a history of feeling dizzy or fainting from vaccines but this does not happen every time. He also has a fear of needles. After patient received vaccines, he waited by the pharmacy for a few minutes and got dizzy and fainted. He regained consciousness very quickly and had cold sweats and clammy. Patient was given a chair to sit on and water and snacks to regain energy. Patient felt better after 30 minutes and left the pharmacy. More
2851325 66 F TX 07/25/2025 PNC21
PNC21
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Z002626
Z002626
39LB7
39LB7
Dizziness, Erythema, Headache, Pruritus, Pyrexia; Rash macular; Dizziness, Eryth... Dizziness, Erythema, Headache, Pruritus, Pyrexia; Rash macular; Dizziness, Erythema, Headache, Pruritus, Pyrexia; Rash macular More
Itchy splotchy red arm along with days of fever, dizziness and headache Itchy splotchy red arm along with days of fever, dizziness and headache
2851326 2 M LA 07/25/2025 DTPPVHBHPB
DTPPVHBHPB
PNC15
PNC15
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.



Abnormal behaviour, Blood test, Crying, Dysstasia, Eating disorder; Fatigue, Gai... Abnormal behaviour, Blood test, Crying, Dysstasia, Eating disorder; Fatigue, Gait disturbance, Seroma, Sleep disorder, Ultrasound scan abnormal; Abnormal behaviour, Blood test, Crying, Dysstasia, Eating disorder; Fatigue, Gait disturbance, Seroma, Sleep disorder, Ultrasound scan abnormal More
About a 20 minute drive from Dr office to home. He was limping when we arrived. Laying up most of th... About a 20 minute drive from Dr office to home. He was limping when we arrived. Laying up most of the day, when he wakes in the morning he is crying and hit the flood not trying to put pressure on his right leg. Brought him back to clinic she says it was an adverse reaction told me to give it a week it should go away. I have been back and forth to hospitals diagnosed with a seroma due to injury.. got a second opinion. Set up for orthopedic and therapy. I can't get any answers. Everyone I talk to gives me the run around and treats it like it's normal! His behavior, eating, and sleeping habits have changed. He is fatigued and still has problems with his right leg More
2851327 53 M 07/25/2025 MMRV
 MERCK & CO. INC.
Skin discolouration Skin discolouration
This was a booster. My first was in the 70?s. My feet and toes have small brown spots everywhere This was a booster. My first was in the 70?s. My feet and toes have small brown spots everywhere
2851328 0.17 M MI 07/25/2025 DTAPHEPBIP
HIBV
PNC15
RV5
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 9C295
YA3G3
Z003633
2139673
Pyrexia; Pyrexia; Pyrexia; Pyrexia Pyrexia; Pyrexia; Pyrexia; Pyrexia
Fever to 39 C approx 2 hours after vaccination. Fever controlled by Tylenol. Fever to 39 C approx 2 hours after vaccination. Fever controlled by Tylenol.
2850916 FL 07/24/2025 MMRV
 MERCK & CO. INC.
 Y010247
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Caller reports product that experienced temperature excursion was administered to ... No additional AE; Caller reports product that experienced temperature excursion was administered to a patient.; This spontaneous report was received from a nurse and refers to a 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. Temperature excursion occurred sometime between 23-JUN-2025 and 30-JUN2025. Temperature, time frame, and previous temperature excursions were unknown. On 24-Jun-2025, the patient received an improper storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Product storage error), (lot #Y010247, expiration date: 30-Nov-2025) for prophylaxis, diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). No adverse event was reported. More
2850917 MO 07/24/2025 VARCEL
 MERCK & CO. INC.
 Y015108
Product storage error Product storage error
No symptoms reported; HCP called to report a temperature excursion for VARIVAX and PROQUAD. HCP repo... No symptoms reported; HCP called to report a temperature excursion for VARIVAX and PROQUAD. HCP reported that VARIVAX and PROQUAD were administered to multiple patients on multiple dates after being improperly stored. This case pertains to one patient who received imprope; This spontaneous report was received from other health professional and refers to a 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 19-Jun-2025, the patient was vaccinated with an improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #Y015108 which has been verified to be a valid number, expiration date reported and validated 06-Sep-2026) 0.5 mL. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) as a prophylaxis (incorrect product storage). The vaccine administered was stored at temperature of 6.3 degrees Fahrenheit (F) for a time frame of 16 minutes. There was no previous temperature excursion. No symptoms reported. This is one of several reports received from the same reporter. More
2850919 72 M FL 07/24/2025 PPV
 MERCK & CO. INC.
Discomfort, Nasopharyngitis, Rhinorrhoea Discomfort, Nasopharyngitis, Rhinorrhoea
he got a cold, felt discomfort, and a runny nose.; This spontaneous report was received from a consu... he got a cold, felt discomfort, and a runny nose.; This spontaneous report was received from a consumer or other non-health professional and refers to a 72-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included atorvastatin calcium (Lipitor), gabapentin, and baclofen. On 07-Jul-2025 (also reported as Monday), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (strength, dose, frequency, lot #, and expiration date were not reported), for indication described as "Vaccine". On 08-Jul-2025 (also reported as Tuesday), the patient got a cold, felt discomfort, and a runny nose. He took vitamin C and drank more water to try to help with the symptoms. Patient no sought medical attention. At the reporting time, the patient had not recovered from the event. The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided. Lot # is being requested and will be submitted if received. More
2850920 F 07/24/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Drug administered to patient of inappropriate age; No additional AE/No PQC; This spontaneous report ... Drug administered to patient of inappropriate age; No additional AE/No PQC; This spontaneous report has been received from a patient and refers to herself as a 67-year-old female patient. The patient's medical history included previous vaccinations, and had a stem cell transplant that "wiped out" all of her previous vaccinations. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) dose number 1 as prophylaxis (dose, scheme, route of administration and anatomical location, lot # and expiration date were not reported). The patient was 67-year-old at the time of reporting (Drug administered to patient of inappropriate age). The patient was asking for financial assistance options with the vaccine. No further details were provided. No additional AE/No PQC. More
2850921 14 F NY 07/24/2025 HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.

Epilepsy, Fatigue, Fear, Seizure; Epilepsy, Fatigue, Fear, Seizure Epilepsy, Fatigue, Fear, Seizure; Epilepsy, Fatigue, Fear, Seizure
fear that one day she will lose her independence because of the seizures; autoimmune and neurologica... fear that one day she will lose her independence because of the seizures; autoimmune and neurological injuries; Diagnosed with various medical conditions; Epilepsy/seizure/focal seizure/fatigue; This initial spontaneous report was received from a Lawyer and patient regarding a case in litigation and refers to a 15-year-old female patient (Pt). The Pt's concurrent conditions, medical history, concomitant medication, drug reactions or allergies were not reported. On an unspecified date (when she was 14 and 15 years old), the Pt was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL); and on an unspecified date in 2021, she received the second dose of the vaccine (lot #, expiration date, strength, route of administration, anatomical location not provided for any dose), for Preventing cervical cancer, after recommendation of Pt's health care provider and agreement with her father. On approximately 17-Feb-2021, less than a month after her second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the Pt had her first seizure and 911 was called. The following week, Pt was seen by a neurologist at the hospital where she was ultimately diagnosed with epilepsy. Her parents reported to the neurologist about recent vaccination and wondered if that caused her the seizure/epilepsy. The Pt had two more seizures in the following months, and as the months progressed, so did her symptoms. Pt was seen by multiple physicians/specialist for seizures and fatigue. The type of seizures was recently identified as focal seizures. As a result of her post-Gardasil symptoms, Pt had been unable to engage in activities that a normal young person would enjoy. Pt was required to take seizure medication to maintain the seizures and experienced daily fatigue. Pt lived with fear that one day she would lose her independence because of the seizures. Based upon her chronic and severe post-Gardasil symptoms, Pt had been diagnosed with various medical conditions/constellation of adverse symptoms/adverse events/complications/injuries, including but not limited to, epilepsy. Pt contended that Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune and neurological injuries. As a proximate result of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, Pt had suffered and continue to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with their autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). At the reporting time, the outcome of all the events was considered as not recovered. The reporter considered all the events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). The reporter considered all the events to be disabling.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-15 , MNSC number : , CLIC number : , ESTAR number : LEGCOL , IRMS number : 68935 , Central date : 2025-07-14 , Classification : DMC, Attachment description : Legal , Safety case number : More
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2850922 WI 07/24/2025 DTAP
DTAPHEPBIP
DTAPIPV
HEP
HEPA
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS






Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Inadvertent Administration of a Vaccine Following Temperature Excursion; This non-serious case was r... Inadvertent Administration of a Vaccine Following Temperature Excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo and Pediarix. On an unknown date, an unknown time after receiving Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration of a Vaccine Following Temperature Excursion). The outcome of the incorrect storage of drug 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:15-JUL-2025 Pharmacist reported that on 11th October 2024 Boostrix, Engerix-B, Havrix, Infanrix, Kinrix, Menveo (no lot number or data on presentation available) and Pediarix were exposed to a lowest temperature of 30.9F for less than 5 minutes. These vaccines have been administered to patients. HCP is trying to determine which are the patients involved. No further information available. No further information available. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. More
2850923 0.17 M NC 07/24/2025 DTAPIPVHIB
 SANOFI PASTEUR
 C5294AA
Epilepsy Epilepsy
epilepsy after taking pentacel; Initial information received on 18-Jul-2025 regarding an unsolicited... epilepsy after taking pentacel; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case is linked to the following cases- US-SA-2025SA209738, US-SA-2025SA209950 and US-SA-2025SA209519. This case involves a 2 months old male patient who had epilepsy after taking Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]. 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); HIB vaccine conj (tet tox) (Act hib) and Polio vaccine inact 3v (Vero) (Ipol) for Immunisation. On 22-Aug-2017 , the patient received 0.5mL (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot C5370AA) via intramuscular route in the left thigh , on 23-Oct-2017, he also received 0.5mL (dose 2) (lot C5374AA) and on 18-Dec-2017, he also received 0.5mL (dose 3) of vaccine (lot C5294AA) (strength standard and frequency once) (expiry date not reported) via intramuscular route in the left vastus lateralis for Immunisation. On an unknown date in Nov-2017, the patient developed epilepsy after taking pentacel (epilepsy) (latency approximately few few days following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine. Action taken was not applicable. A corrective treatment was received for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. Seriousness criteria- The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 22-JUL-2025: This case involves a 2 months old male patient who had epilepsy after taking Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]. Further information regarding allergic history, laboratory investigations, medical history, and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2025SA209738:Act-hib US-SA-2025SA209950:IPOL US-SA-2025SA209519:Daptacel More
2850924 1.58 F TX 07/24/2025 HIBV
 SANOFI PASTEUR
 UK3048A
No adverse event, Product preparation issue No adverse event, Product preparation issue
acthib was administered without reconstitution with no reported ae; Initial information received on ... acthib was administered without reconstitution with no reported ae; Initial information received on 18-Jul-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 HIB (PRP/T) vaccine [ACT-HIB] without reconstitution with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose (dose 1) (dose 2) (dose 3) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot, strength and expiry date not reported) via unknown route in unknown administration site for immunization. On 17-Jul-2025, the patient received an unknown dose (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UK3048A, strength: standard and frequency: once) via unknown route in the thigh nos (not otherwise specified) for immunization without reconstitution 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
2850925 0.25 M NC 07/24/2025 DTAP
 SANOFI PASTEUR
 C5190AA
Epilepsy Epilepsy
epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case r... epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case is linked with the following cases- US-SA-2025SA209950, US-SA-2025SA209738 and US-SA-2025SA209387. This case involves a 3 months old male patient who had epilepsy after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel]. 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), Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) and Polio vaccine inact 3v (Vero) (Ipol) for Immunisation. On 18-Sep-2017, the patient received 0.5mL (dose 1) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot C5190AA) via intramuscular route in the left thigh and on 21-Jun-2021 he also received 0.5mL (dose 2) (lot C5743AA) (strength standard and frequency once) (expiry date unknown) via intramuscular route in the right deltoid for prophylactic vaccination (Immunisation). On an unknown date in Nov-2017, the patient developed epilepsy (epilepsy) (latency approximately two months) following the administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine. 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. Seriousness criteria - The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 22-JUL-2025: This case involves a 3 months old male patient who had epilepsy after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel]. Further information regarding allergic history, laboratory investigations, medical history and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2025SA209387:pentacel US-SA-2025SA209950:IPOL More
2850926 IL 07/24/2025 HIBV
 SANOFI PASTEUR
Product preparation error Product preparation error
inappropriate use due to administration of a vaccine that was reconstituted with a wrong diluent wit... inappropriate use due to administration of a vaccine that was reconstituted with a wrong diluent with no reported adverse event; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with a wrong diluent with no reported adverse event. 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 HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization that was reconstituted with a wrong diluent with no reported adverse event (product preparation error) (latency same day) Reportedly, Nurse stated they are not 100% sure but that they think ActHIB may have been reconstituted with sterile water and given to a patient. The nurse specifically asked if the vaccine was effective and whether it would be harmful to the patient. The nurse also inquired about the manufacturer of ACT-HIB and whether there is a different department the physician needs to speak to other than medical information. The nurse mentioned that they don't need the diluent but are gathering information since they don't have all the details or access to what occurred. The nurse asked if they were to revaccinate, should they administer the exact amount of 0.5 mL after reconstitution. Information on the batch number was requested corresponding to the one at time of event occurrence Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2850934 80 F AZ 07/24/2025 PNC21
 MERCK & CO. INC.
 Z002626
Injection site rash, Rash pruritic, Skin warm Injection site rash, Rash pruritic, Skin warm
Patient came back with upper arm rash near injection site that covered down to elbow. She reported r... Patient came back with upper arm rash near injection site that covered down to elbow. She reported rash was warm and itchy. More
2850935 49 M TX 07/24/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Blister, Blood pressure increased, Dysarthria, Hypoaesthesia oral, Inflammation;... Blister, Blood pressure increased, Dysarthria, Hypoaesthesia oral, Inflammation; Peripheral swelling, Skin exfoliation More
Fingers swollen, palms only were inflamed, itchy. tongue and lips numb with slurred speech, elevate... Fingers swollen, palms only were inflamed, itchy. tongue and lips numb with slurred speech, elevated blood pressure, inflammation in hands subsided and skin sloughed off lime blisters although no manual work to warrant that. More
2850940 0.58 F MS 07/24/2025 DTAP
DTAP
DTAPHEPBIP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
5KR3R
TC47K
TC47K
Bacterial test, Blood pressure decreased, Eczema, Inappropriate schedule of prod... Bacterial test, Blood pressure decreased, Eczema, Inappropriate schedule of product administration, Laboratory test; Loss of consciousness, Psoriasis, Rash morbilliform; Bacterial test, Blood pressure decreased, Eczema, Inappropriate schedule of product administration, Laboratory test; Loss of consciousness, Psoriasis, Rash morbilliform More
Passed out; significant drop in blood pressure; measles like rash/ rash; Psoriasis; Eczema; third do... Passed out; significant drop in blood pressure; measles like rash/ rash; Psoriasis; Eczema; third dose of pediarix was given 9th August 2024/ Inappropriate schedule of vaccine administered; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 7-month-old female patient who received DTPa (Infanrix) (batch number 5KR3R, expiry date 06-FEB-2027) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis. Previously administered products included Pediarix (received 1st dose 0.5 ml intramuscularly on 05-MAR-2024 with batch number 77J49 and expiry date 09-FEB-2026) and Pediarix (received 2nd dose 0.5 ml intramuscularly on 06-MAY-2024 with batch number X9EP5 and expiry date 09-MAR-2026). Additional patient notes included the reporter stated that she had ensured the patient was fever-free for at least two weeks before any of the vaccines were administered. On 30-APR-2025, the patient received Infanrix (intramuscular) .5 ml. On 09-AUG-2024, the patient received the 3rd dose of Pediarix (intramuscular) .5 ml. On 09-AUG-2024, not applicable after receiving Infanrix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: third dose of pediarix was given 9th August 2024/ Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), blood pressure decreased (Verbatim: significant drop in blood pressure), measles-like rash (Verbatim: measles like rash/ rash), psoriasis (Verbatim: Psoriasis) and eczema (Verbatim: Eczema). The outcome of the passed out, blood pressure decreased and measles-like rash were unknown and the outcome of the psoriasis and eczema were not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the passed out, blood pressure decreased, measles-like rash, psoriasis and eczema to be related to Infanrix and Infanrix Pre-Filled Syringe Device. The company considered the passed out to be unrelated to Infanrix and Infanrix Pre-Filled Syringe Device. It was unknown if the company considered the blood pressure decreased, measles-like rash, psoriasis and eczema to be related to Infanrix and Infanrix Pre-Filled Syringe Device. 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: 09-JUL-2025 This case was reported by the mother of the patient. After receiving Infanrix, the patient experienced a significant drop in blood pressure and passed out in 2025. Seven hours later, the patient developed a measles-like rash in 2025. Subsequently, the patient had developed psoriasis along with severe eczema in 2025. The patient underwent diagnostic testing for mast cell activation syndrome (MCAS) and small intestinal bacterial overgrowth (SIBO). The reporter stated that she insured the patient was fever free for a least 2 weeks before any of the vaccines were administered. The patient did not have any other condition and did not receive any other products. The third dose of Pediarix was administered when the patient was 7 months old, which led to an inappropriate schedule of vaccine administered (drug dose administration interval too long).; Sender's Comments: A case of Loss of consciousness, an unknown time after receiving Infanrix and Infanrix Pre-Filled Syringe Device, in a 7-month-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2850941 F 07/24/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Erythema, Fear, Injection site swelling, Pain, Paraesthesia; Pruritus, Skin warm Erythema, Fear, Injection site swelling, Pain, Paraesthesia; Pruritus, Skin warm
Typical pain; Redness; swelling at injection site expanded to bicep area; hot to the touch upper arm... Typical pain; Redness; swelling at injection site expanded to bicep area; hot to the touch upper arm; prickly; Itchy; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for primary prevention. The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis, fibromyalgia and hypertension. Concomitant products included sarilumab (Kevzara), gabapentin, candesartan and leflunomide. On 15-JUL-2025, the patient received the 1st dose of Shingrix. On 15-JUL-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Typical pain), erythema of extremities (Verbatim: Redness), swelling arm (Verbatim: swelling at injection site expanded to bicep area), hot feeling in hand (Verbatim: hot to the touch upper arm), tingling (Verbatim: prickly) and pruritus (Verbatim: Itchy). The patient was treated with prednisone, fexofenadine hydrochloride (Allegra) and doxycycline. The outcome of the pain in arm, erythema of extremities, swelling arm, hot feeling in hand, tingling and pruritus were not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm, hot feeling in hand, tingling and pruritus to be related to Shingrix. It was unknown if the company considered the pain in arm, erythema of extremities, swelling arm, hot feeling in hand, tingling and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 20-JUN-2025 The reporter reported that the patient received Shingrix vaccine and had typical pain, redness and swelling at injection site expanded to bicep area. It has been 6 days and now have constant prickly/itchy/pain, and a very red, swollen and hot to the touch upper arm. The patient have rheumatoid arthritis and fibromyalgia, because had high risk and a previous mild case of shingles. The doctor recommended being vaccinated, none of us expected this reaction. The patient currently being treated with 3 medications to treat this reaction with Prednisone, Allegra, and Doxycycline, but nothing was working. The doctors are not able to diagnose the reaction, the patient fear and would have permanent damage to the arm. The nerves were activated 24/7 throughout the entire red, swollen site. More
2850942 19 F NY 07/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 H4279
Incorrect route of product administration, Product administered at inappropriate... Incorrect route of product administration, Product administered at inappropriate site More
she gave 0.5 mL subcutaneously instead of IM; he gave 0.5 mL subcutaneously instead of IM, she gave ... she gave 0.5 mL subcutaneously instead of IM; he gave 0.5 mL subcutaneously instead of IM, she gave it in the forearm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4279, expiry date 30-AUG-2027) for prophylaxis. On 15-JUL-2025, the patient received Boostrix (subcutaneous, unknown arm) .5 ml. On 15-JUL-2025, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: she gave 0.5 mL subcutaneously instead of IM) and vaccine administered at inappropriate site (Verbatim: he gave 0.5 mL subcutaneously instead of IM, she gave it in the forearm). The outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site 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: 16-JUL-2025 Practice manager reported that called because one of the nurses made an error while giving immunizations, that involved the Boostrix. Reporter mentioned what happened if that she gave the Boostrix 0.5 ml subcutaneously instead of intramuscularly, she gave it in the forearm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. So, reporter wanted to see potential, if being in a different location and potential for anything. The reporter said that to the second line agent that he did not give the complete dose, only 0.5, however according to package insert was the recommended dose. More
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