🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2848967 F AR 07/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Illness Illness
Sick; This non-serious case was reported by a consumer via call center representative and described ... Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in 2024, for tolerance refer linked case US2025079195). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Linked case(s) involving the same patient: US2025079195 Additional Information: GSK Receipt Date: 24-JUN-2025 This case was reported by the parent of the patient. The reporter mentioned that her daughter (patient) had a reaction to Shingrix. When questioned about the event, she was reluctant to provide any information, only saying that her daughter received both doses of Shingrix a few months ago in 2024 and the 2nd shot made her a little sicker in 2024. She did not wish to provide any further information on behalf of her daughter without her daughter's consent.; Sender's Comments: US-GSK-US2025079195:Same patinet dose 1st/ same reporter More
2848968 F 07/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
patient was inadvertently administered just the diluent without the powder; the patient received twi... patient was inadvertently administered just the diluent without the powder; the patient received twice the amount of diluent; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-JUL-2025, the patient received Shingrix. On 01-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently administered just the diluent without the powder) and inappropriate dose of vaccine administered (Verbatim: the patient received twice the amount of diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date:01-JUL-2025 This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media. A patient was inadvertently administered just the diluent without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. When the error was identified, the provider than correctly reconstituted the vaccine and administered it. essentially, the patient received twice the amount of diluent. are there any risks or concerned they should look out for. The reporter did not currently have much information, but he/she could reach out to the health center if it was absolutely necessary. The reporter knew it was an unexpired lot and this occurred. More
2848980 5 M CA 07/09/2025 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER








Allergy to vaccine, Anaphylactic reaction, Anaphylaxis treatment, Crying, Drooli... Allergy to vaccine, Anaphylactic reaction, Anaphylaxis treatment, Crying, Drooling; Dysphagia, Erythema, Eye swelling, Lip swelling, Paraesthesia; Pruritus; Allergy to vaccine, Anaphylactic reaction, Anaphylaxis treatment, Crying, Drooling; Dysphagia, Erythema, Eye swelling, Lip swelling, Paraesthesia; Pruritus; Allergy to vaccine, Anaphylactic reaction, Anaphylaxis treatment, Crying, Drooling; Dysphagia, Erythema, Eye swelling, Lip swelling, Paraesthesia; Pruritus More
Patient received 3 immunization on 12/07/2017. Before we left the office he said his face was tingli... Patient received 3 immunization on 12/07/2017. Before we left the office he said his face was tingling. I thought it was because he was crying. When we got home, which is about 5 minutes from the office, his face, ears, neck, chest and back were red. His lips and eyes were swollen and he started he was itchy all over. I rushed him to the emergency room for his anaphylaxtic reaction. The hospital is right next to the doctors office. By the time we got to the emergency room he was drooling and was having a hard time swallowing. Hospital rushed him back started an IV within minutes and administered IV Epi along with other medications. After a while his swelling went down and we took home steroid medication for continued treatment. We were told never to give him any of those vaccines administered that day. More
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2848983 79 F TX 07/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3J2S2
Rash, Rash macular Rash, Rash macular
rash/ developed a blotchy rash on her chest, left arm, back and left breast; This non-serious case ... rash/ developed a blotchy rash on her chest, left arm, back and left breast; This non-serious case was reported by a consumer via call center representative and described the occurrence of blotchy rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 3J2S2, expiry date 27-MAR-2027) for prophylaxis. The patient's past medical history included hip replacement (left hip in 2019) and shingles (3 dots on her forehead in 2009). Previously administered products included Valtrex (treated with Valtrex in 2009). Concurrent medical conditions included penicillin allergy (in 2019, her physician recommended that she could take oral penicillin but not injected penicillin). On 04-JUN-2025, the patient received the 1st dose of Shingrix (left arm) .5 ml. On 06-JUN-2025, 2 days after receiving Shingrix, the patient experienced blotchy rash (Verbatim: rash/ developed a blotchy rash on her chest, left arm, back and left breast). On 20-JUN-2025, the outcome of the blotchy rash was resolved (duration 14 days). It was unknown if the reporter considered the blotchy rash to be related to Shingrix. It was unknown if the company considered the blotchy rash to be related to Shingrix. Additional Information: GSK Receipt Date: 30-JUN-2025 The patient self-reported this case for herself. The patient developed a blotchy rash on her chest, left arm, back and left breast. The patient stated that the rash resolved in 2 weeks. More
2848984 18 M VA 07/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4BX39
Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age More
first dose taken in 2008 and 2nd dose on 16 Jun 2025; An 18 years old male patient received an adult... first dose taken in 2008 and 2nd dose on 16 Jun 2025; An 18 years old male patient received an adult dose of Engerix-B; An 18 years old male patient received an adult dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 4BX39, expiry date 29-JUL-2027) for prophylaxis. Previously administered products included Engerix B (received first dose in 2008). On 16-JUN-2025, the patient received the 2nd dose of Engerix B adult. On 16-JUN-2025, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: first dose taken in 2008 and 2nd dose on 16 Jun 2025), adult product administered to child (Verbatim: An 18 years old male patient received an adult dose of Engerix-B) and overdose (Verbatim: An 18 years old male patient received an adult dose of Engerix-B). The outcome of the drug dose administration interval too long, adult product administered to child and overdose 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-JUN-2025 On 16 Jun 2025 they administered an adult dose of Engerix-B to a male patient who was 18 years old which led to Adult product administered to child and overdose. The patient received 1 dose in 2008, that was his first dose but did not complete the series. The adult dose of Engerix-B that the patient received today was his second dose which led to Drug dose administration interval too long. More
2848985 M PA 07/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
Extra dose suggested by Physician not yet given; This non-serious case was reported by a pharmacist ... Extra dose suggested by Physician not yet given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted medication error in a elderly male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received second dose on 30 Aug 2022 with lot 5H29X and FA95N) and Shingrix (first one on July 5th, 2022). On an unknown date, the patient did not receive the 3rd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced intercepted medication error (Verbatim: Extra dose suggested by Physician not yet given). The outcome of the intercepted medication error was not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 Pharmacist mentioned that an immunocompetent patient already got 2 doses of Shingrix in another facility, first one on July 5th, 2022, and the second one on August 30th 2022. Physician of the patient noticed that the doses are too close together and suggested to give a third dose but caller did not administer it yet which led to Intercepted medication error, since they wanted to confirm with Glaxo Smith Kline what recommendations they have. More
2848986 F IA 07/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5Y4TL
Product preparation issue Product preparation issue
a patient was given only the diluent portion of the Shingrix vaccine; a patient was given only the d... a patient was given only the diluent portion of the Shingrix vaccine; a patient was given only the diluent portion of the Shingrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 5Y4TL, expiry date 31-JAN-2027) for prophylaxis. On 27-JUN-2025, the patient received Shingrix. On 27-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: a patient was given only the diluent portion of the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: a patient was given only the diluent portion of the Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 30-JUN-2025 Nurse called today June 30, 2025 to report on June 27, 2025 a patient was given only the diluent portion of the Shingrix vaccine, situation was discovered and right after a correctly reconstituted dose was administered to the patient on the same arm which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2848987 07/09/2025 COVID19
 MODERNA
 3046734
Device issue, No adverse event Device issue, No adverse event
white plunger part were disconnected from the rubber part of the plunger; No adverse effect; This sp... white plunger part were disconnected from the rubber part of the plunger; No adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3046734) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. No concomitant medication was reported. It was mentioned that the white plunger part was disconnected from the rubber part of the plunger (this happened when their customer was getting a syringe from the box and plunger fell off and was disconnected). it was reported that filed an adverse event as a possible occupational exposure of the product to the HCP while preparing for administration. The Device problem code for pre-filled syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. No treatment information was reported. More
2849086 AL 07/09/2025 MMRV
 MERCK & CO. INC.
 Z007214
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP called to report TE for PROQUAD with a prior excursion on 6/18/2025 and a curr... No additional AE; HCP called to report TE for PROQUAD with a prior excursion on 6/18/2025 and a current excursion on 07/02/2025 that was administered post excursion to a patient on 07/01/2025. HCP reported that the patient did not experience any adverse side effects f; 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. On 01-Jul-2025, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 ml, once, lot #Z007214, expiration date: 05-Oct-2026) (route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (dose, route of administration, expiration date, and lot # were not reported). Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced temperature excursion of 6.8 Fahrenheit (F) degree for 47 minutes, on 18-Jun-2025. The patient did not experience any adverse side effects from administered dose, no additional adverse event. This is one of several reports from the same reporter. More
2849087 81 F OK 07/09/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
UNK
UNK
Blister, Eye irritation, Eye pain, Eye pruritus, Headache; Herpes zoster, Inappr... Blister, Eye irritation, Eye pain, Eye pruritus, Headache; Herpes zoster, Inappropriate schedule of product administration, Nasal discomfort, Nasal pruritus, Ophthalmic herpes zoster; Rhinalgia, Vaccination failure; Blister, Eye irritation, Eye pain, Eye pruritus, Headache; Herpes zoster, Inappropriate schedule of product administration, Nasal discomfort, Nasal pruritus, Ophthalmic herpes zoster; Rhinalgia, Vaccination failure More
Suspected vaccination failure; shingles got in her eye; shingles in spinal fluid, and the membrane a... Suspected vaccination failure; shingles got in her eye; shingles in spinal fluid, and the membrane around her brain; blisters started on the left forehead/ it looked like shingles/itching, burning, stinging of the left nostril; Headache; first shot but believes it was one month prior to the second shot; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included glaucoma, celiac sprue, essential tremor, panic attack and fever blister. Concomitant products included levothyroxine, propranolol, primidone, famotidine (Pepcid), clonazepam, imipramine, zinc, lysine and valaciclovir hydrochloride (Valtrex). On 23-FEB-2024, the patient received the 2nd dose of Shingrix (unknown arm). In JAN-2024, the patient received the 1st dose of Shingrix. On 23-FEB-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first shot but believes it was one month prior to the second shot). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria hospitalization and GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles got in her eye) (serious criteria hospitalization and GSK medically significant), herpes zoster meningitis (Verbatim: shingles in spinal fluid, and the membrane around her brain) (serious criteria hospitalization and GSK medically significant), facial herpes zoster (Verbatim: blisters started on the left forehead/ it looked like shingles/itching, burning, stinging of the left nostril) and headache (Verbatim: Headache). The patient was treated with aciclovir (Acyclovir), valaciclovir hydrochloride (Valtrex) and valaciclovir (Valacyclovir). The outcome of the vaccination failure was resolving and the outcome of the ophthalmic herpes zoster, herpes zoster meningitis and facial herpes zoster were not resolved and the outcome of the headache was not reported and the outcome of the drug dose administration interval too short was not applicable. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster meningitis, facial herpes zoster and headache to be related to Shingrix and Shingrix. The company considered the vaccination failure, ophthalmic herpes zoster and herpes zoster meningitis to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster and headache to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 26-JUN-2025 The patient had received both shots of Shingrix and does not remember the date of the first shot but she believed that it was one month prior to the second shot which led to drug dose administration interval too short. She cannot recall whether she was injected in the right arm or left arm. She reported that even though she got both shots of Shingrix she now has a bad case of shingles which caused her to be hospitalized for 11 days and was discharged on June 12th. The patient got shingles got in her eye, spinal fluid, and the membrane around her brain. She stated that she went to the emergency room on May 27th because she was having a horrible headache and the shingles blisters had not formed yet. She was given 2 to 3 migraine cocktails. The blisters started showing up and the emergency room, the doctor said it looked like shingles. The blisters started on the left forehead. She was given 27 infusions of acyclovir. Once discharged she was prescribed 5 days of Valtrex and had discarded the Valtrex prescription bottle. The patient mentioned that she was still suffering from shingles her symptoms which were itching, burning, stinging of the left nostril and left eye and currently taking valacyclovir. 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). Ophthalmic herpes zoster and Herpes zoster meningitis are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 & 2) More
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2849089 M TN 07/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Diarrhoea, Injection site reaction, Pain in extremity Diarrhoea, Injection site reaction, Pain in extremity
Injection site breakout; Pain in arm; Diarrhea; This non-serious case was reported by a consumer via... Injection site breakout; Pain in arm; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 69-year-old male 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 received the 2nd dose of Shingrix. On 25-JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site reaction (Verbatim: Injection site breakout), pain in arm (Verbatim: Pain in arm) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site reaction, pain in arm and diarrhea were not resolved. It was unknown if the reporter considered the injection site reaction, pain in arm and diarrhea to be related to Shingrix. It was unknown if the company considered the injection site reaction, pain in arm and diarrhea to be related to Shingrix. Additional Information: GSK receipt date: 30-JUN-2025 The patient reported that he had experienced diarrhea, arm pain, and a breakout at the injection site after receiving the second shot of Shingrix. More
2849090 07/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Diarrhoea Diarrhoea
diarrhea; This non-serious case was reported by a consumer via interactive digital media and describ... diarrhea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: diarrhea). The outcome of the diarrhea was resolved (duration 1 week). It was unknown if the reporter considered the diarrhea to be related to Shingles vaccine. It was unknown if the company considered the diarrhea to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUN-2025 and 02-JUL-2025 This case was reported by a patient via interactive digital media. The side effects of the shot can be rough. The patient got the second shot and had diarrhea for a week. No other information known at this time. More
2849091 07/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 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 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: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 5 days). 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: 25-JUN-2025 This case was reported by a patient via interactive digital media. The patient had shingles after the vaccine, but it lasted five days and had no rash or blisters. It was not a fun five days. 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 completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine. More
2849092 07/09/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2025, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 02-JUL-2025 This case was reported by a patient via interactive digital media. The patient had both shots 4 years ago and now got shingles 4 days ago. This case was considered as suspected vaccination failure since the details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). More
2849093 07/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
Got my first shot and ended up 3 days later with shingles; This non-serious case was reported by a c... Got my first shot and ended up 3 days later with shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got my first shot and ended up 3 days later with shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 03-JUL-2025 This case was reported by a patient via interactive digital media. The patient got his/her first shot and ended up 3 days later with shingles. More
2849094 F NC 07/09/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
received 3rd dose on 13-MAY-2014; Early 2nd dose; This non-serious case was reported by a pharmacist... received 3rd dose on 13-MAY-2014; Early 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 13-MAY-2014, the patient received the 3rd dose of Twinrix. On 22-NOV-2013, the patient received the 2nd dose of Twinrix. On 22-NOV-2013, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). On 13-MAY-2014, the patient experienced drug dose administration interval too long (Verbatim: received 3rd dose on 13-MAY-2014). The outcome of the drug dose administration interval too long and drug dose administration interval too short 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: 27-JUN-2025 The pharmacist called to request information about the possibility of getting Hepatitis B titers to make sure she was covered. The patient received 1st dose of Twinrix on 10-NOV-2013, 2nd dose on 22-NOV-2013 and 3rd dose on 13-MAY-2014 The reporter did not know if those dates were accurate and would get in contact with physician to confirm the dates. The patient was the health care professional and has 65 year of age at the moment. The patient received 2nd dose of Twinrix vaccine earlier than recommended interval, which led to shortening of vaccination schedule. The patient received 3rd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2849095 F KS 07/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3ZE3E
Product preparation issue Product preparation issue
Maladministration of the diluent only; Maladministration of the diluent only; This non-serious case ... Maladministration of the diluent only; Maladministration of the diluent only; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 28-year-old female patient who received MMR (Priorix) (batch number 3ZE3E, expiry date 22-NOV-2028) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the diluent only) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose 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: 30-JUN-2025 The reporter reported that there was maladministration of a Priorix diluent before reconstituting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They request information about what to do. The Vaccine Administration Facility is the same as Primary Reporter More
2849096 M 07/09/2025 CHIK
CHIK
 VALNEVA USA, INC.
VALNEVA USA, INC.
 24I005
24I005
Arthralgia, Diarrhoea, Dyspepsia, Fatigue, Headache; Myalgia, Nausea, Pruritus, ... Arthralgia, Diarrhoea, Dyspepsia, Fatigue, Headache; Myalgia, Nausea, Pruritus, Pyrexia, Vision blurred More
Fatigue; Joint pain; Muscle pain; Fever; Nausea; Headache; Diarrhea; Indigestion; Pruritis; Blurry v... Fatigue; Joint pain; Muscle pain; Fever; Nausea; Headache; Diarrhea; Indigestion; Pruritis; Blurry vision; The following information was received from a consumer on 24 Jun 2025. A 29-year-old male vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV)), batch number 24I005) on an unknown date. Four days after vaccination he developed fatigue, joint and muscle pain, fever, nausea, headache, diarrhea, indigestion, pruritis and blurry vision, which lasted greater than two weeks.; Sender's Comments: Company's medical assessment: The causality was assessed as possibly related for all reported events, as time to onset is plausible (4 days past vaccination) indicative of a systemic vaccination reaction, and as Fatigue, joint and muscle pain, fever, nausea and headache are listed for IXCHIQ according to RSI. No further details were provided and no confounding factors were reported. More
2849097 M CO 07/09/2025 COVID19
 MODERNA
Immunisation reaction, Pain Immunisation reaction, Pain
common mild side effects (e.g., aches); common mild side effects (e.g., aches); This spontaneous cas... common mild side effects (e.g., aches); common mild side effects (e.g., aches); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Cardiac stent placement in 2002 and Interventional procedure (additional intervention a few years ago where more stents were placed). Concurrent medical conditions included Heart disorder (Heart condition). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)). At the time of the report, IMMUNISATION REACTION (common mild side effects (e.g., aches)) outcome was unknown and PAIN (common mild side effects (e.g., aches)) had resolved. No concomitant medication was reported. He was still active and healthy, despite his condition. He had received all recommended Moderna COVID-19 vaccines and boosters for his age group, with no adverse reactions beyond common mild side effects (e.g., aches). The patient did not experience any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787946 (Patient Link). More
2849098 CO 07/09/2025 COVID19
 MODERNA
COVID-19 COVID-19
Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vacc... Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine) (seriousness criterion life threatening). At the time of the report, COVID-19 (Patient now critically ill with COVID-19 after facing the same difficulty accessing the updated vaccine) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-787946 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787946:Friend case More
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2849099 74 M CO 07/09/2025 COVID19
 MODERNA
Immunisation reaction, Pain Immunisation reaction, Pain
common mild side effects (e.g., aches); common mild side effects (e.g., aches); This spontaneous cas... common mild side effects (e.g., aches); common mild side effects (e.g., aches); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Cardiac stent placement in 2002 and Interventional procedure (additional intervention a few years ago where more stents were placed). Concurrent medical conditions included Heart disorder. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (common mild side effects (e.g., aches)) and PAIN (common mild side effects (e.g., aches)). At the time of the report, IMMUNISATION REACTION (common mild side effects (e.g., aches)) outcome was unknown and PAIN (common mild side effects (e.g., aches)) had resolved. No concomitant medication was reported. He was still active and healthy, despite his condition. He had received all recommended Moderna COVID-19 vaccines and boosters for his age group, with no adverse reactions beyond common mild side effects (e.g., aches). Patient had ongoing difficulties accessing the Spikevax 2024-2025 COVID-19 vaccine. Patient had concern that this issue was happening nationwide, not just to him. The patient did not experience any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787949, US-MODERNATX, INC.-MOD-2025-787973 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2025-787948 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787949:Patient 3 (Wife case) US-MODERNATX, INC.-MOD-2025-787973:Friend case More
2849100 M MT 07/09/2025 RSV
 PFIZER\WYETH
 LL8394
Device issue, Underdose Device issue, Underdose
the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered; the plun... the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered; the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered; that there was half of the vaccine left in the syringe.; This is a spontaneous report received from a Pharmacist from medical information team, Program ID: 004756. An 85-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: LL8394, Expiration Date: Feb2026) for immunisation, Device Lot Number: LH6570, Device Expiration Date: Apr2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MECHANICAL ISSUE (non-serious), POOR QUALITY DEVICE USED (non-serious), outcome "unknown" and all described as "the plunger stopped and kept pushing, pulled the needle out and malfunctioned/Administered"; UNDERDOSE (non-serious), outcome "unknown", described as "that there was half of the vaccine left in the syringe.". Additional information: The pharmacist called in with regard to a dosage and administration question on Abrysvo. So, what she said, happened was when she was giving the vaccine to the patient the plunger stop as if it was done like it is normally does. So, when she went to throw it, she felt like there was more vaccine. So, she looked into the sharps container to confirm it and she saw that there was still vaccine left. She estimated that the patient got half of the vaccine. Then she was not able to fully confirm the presentation of the Abrysvo but she said, it is the one with the vial, adaptor." When paraphrased the concern, reporter stated, "I was giving the vaccine the plunger stop as if the vaccine had all been given. The times seemed like it was correct as well. I guess per usual and then as I was throwing it away, you know how like those like, instinctive thing, just kick in. I thought, as it was going in the sharp, saw liquid in there. I confirmed that later, I could see it in the sharp's container that there seemed to be a half a vial or half dose, still there." Causality for "the plunger stopped and kept pushing, pulled the needle out and malfunctioned/administered" and "that there was half of the vaccine left in the syringe." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v. More
2849101 MA 07/09/2025 HIBV
 SANOFI PASTEUR
 UK227AC
No adverse event, Product preparation error No adverse event, Product preparation error
administration of incorrectly reconstituted ACTHIB with sterile water instead of the ACTHIB diluent,... administration of incorrectly reconstituted ACTHIB with sterile water instead of the ACTHIB diluent, with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an unknown age and unknown gender patient who was administered incorrectly reconstituted HIB (PRP/T) vaccine [ACT-HIB] with sterile water instead of the acthib 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) both for prophylactic vaccination (Immunisation). On 01-Jul-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine that was incorrectly reconstituted with sterile water instead of the acthib diluent (formulation: Powder and solvent for solution for injection) (lot UK227AC and expiry date: 30-Jun-2026) (strength: standard and frequency: once) via intramuscular route in the right deltoid for immunisation 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
2849102 1 F FL 07/09/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK194AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
nurse only gave the liquid portion of PENTACEL to a patient with no reported AE; Initial information... nurse only gave the liquid portion of PENTACEL to a patient with no reported AE; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [PENTACEL (VERO)] from a nurse who only gave the liquid portion of it 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) for Immunisation. On 08-Jul-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, lot UK194AA,expiry date:31-Mar-2026,frequency:once, Strength: standard via intramuscular route in the left thigh for immunization,from nurse only gave the liquid portion of of it with no reported adverse event (single component of a two-component 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
2849103 0.33 M CA 07/09/2025 IPV
 SANOFI PASTEUR
 Y1A201M
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received both the Vaxelis and IPOL yesterday, with no reported adverse event; Initial inform... patient received both the Vaxelis and IPOL yesterday, with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who was received both the vaxelis and IPV (VERO) [IPOL] yesterday, 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, HIB vaccine conj (menigococcal protein), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Vaxelis); Rotavirus vaccine live oral 1v (Rotarix) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) all for prophylactic vaccination (Immunisation). On 07-Jul-2025, the patient received a dose of 0.1 ml of suspect IPV (VERO), suspension for injection (lot Y1A201M and expiry date: 31-Jan-2027) (strength: standard and frequency: once) via intramuscular route in the right thigh for immunization and also received vaxelis yesterday with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, The patient's mother did not bring him to the clinic for his 2-month old physical examination, so patient only received his first dose of Vaxelis yesterday. 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-2025SA193061:Vaxelis More
2849104 16 F OH 07/09/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 7MN4C
7MN4C
Chest pain, Dizziness, Electrocardiogram, Feeling hot, Head injury; Hypoaesthesi... Chest pain, Dizziness, Electrocardiogram, Feeling hot, Head injury; Hypoaesthesia, Loss of consciousness, Urine analysis More
After receiving he vaccines patient passed out/blacked out and hit her head. Before we went down she... After receiving he vaccines patient passed out/blacked out and hit her head. Before we went down she said she felt hot, dizzy, and some chest pain. After the nurses woke her up she said her side of face and arm felt numb and still do More
2849105 11 M MA 07/09/2025 DTAP
DTAP
DTAP
MENB
MENB
MENB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 I don?t know -
I don?t know -
I don?t know -
I don?t know
I don?t know
I don?t know
Abdominal pain upper, Abnormal behaviour, Disturbance in attention, Feeling hot,... Abdominal pain upper, Abnormal behaviour, Disturbance in attention, Feeling hot, Headache; Hypersomnia, Physical assault, Psychomotor hyperactivity, Sleep disorder, Staring; Tremor; Abdominal pain upper, Abnormal behaviour, Disturbance in attention, Feeling hot, Headache; Hypersomnia, Physical assault, Psychomotor hyperactivity, Sleep disorder, Staring; Tremor More
Hello Team - I read the note from the vaccine follow up with doctor on Friday. I think more detaile... Hello Team - I read the note from the vaccine follow up with doctor on Friday. I think more detailed information should be in that note. Here is a timeline of events. Patient?s Vaccine Response Timeline Wednesday, June 5, 2025 Vaccines administered: Tdap and meningitis Initial response: Slept a lot afterward (same day) Friday, June 7, 2025 Severe headache You had to leave work to care for him No fever, but he said he ?felt hot? This was the first major neurological-type symptom noted Monday, June 9, 2025 Behavioral incident at school Swore in class - 3x's - uncharacteristic. That afternoon at baseball, he and a teammate took a kid?s hat and dragged it in the dirt and poured contents of a hand warmer package into it. Result: Suspended from baseball Tuesday, June 11, 2025 (approximate) Emotional flag noted Your friend (a para at the school) noticed patient seemed sad and asked if he was okay. Could have been about suspension - but it was notable. Wednesday, June 12, 2025 Extreme stomach pain Patient had to be sent home from school Friday, June 13, 2025 Incident involving another student Patients impulse control was so bad he injured another student at school. When usually he would have restraint - his put his fingers into a students collar bone and caused a red mark. This appears to have escalated school concern. Each day after the vaccine - patient has appeared not to be able to focus, process information or follow simple instructions - looking off into the distance, shaking his head and having no impulse control. As of today - patient?s sleep cycles still remain disrupted and processing,impulse control and hyperactivity remain increased as opposed to where is was on his drs visit where we reported it was much more controlled. Patient was beginning to cook before these vaccines and with his lack of impulse control and ability to focus it?s unsafe for him to do so at this time. Hoping it stabilizes soon. He was doing so well. Thank you for reviewing this progression. More
2849106 10 F MI 07/09/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 U8465CA
Y007991
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
No adverse event noted. No adverse event noted.
2849107 59 F GA 07/09/2025 PNC21
 MERCK & CO. INC.
 Z002626
Injection site pain, Injection site rash, Malaise, Mobility decreased Injection site pain, Injection site rash, Malaise, Mobility decreased
PATIENT FELT VERY ILL A COUPLE DAYS LATER. PATIENT COULD HARDLY MOVE AND GET OUT OF BED. PATIENT ALS... PATIENT FELT VERY ILL A COUPLE DAYS LATER. PATIENT COULD HARDLY MOVE AND GET OUT OF BED. PATIENT ALSO HAD A BAD RASH (REDNESS) ON UPPER LEFT ARM AND IT WAS ALSO VERY SORE. More
2849108 45 M TX 07/09/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA



Amnesia, Brain fog, Brain operation, Cognitive disorder, Impaired work ability; ... Amnesia, Brain fog, Brain operation, Cognitive disorder, Impaired work ability; Memory impairment, Moyamoya disease, Neurological symptom, Pain, Speech disorder; Amnesia, Brain fog, Brain operation, Cognitive disorder, Impaired work ability; Memory impairment, Moyamoya disease, Neurological symptom, Pain, Speech disorder More
Within days of the second shot, I started to have issues with cognition, speech, and memory - simila... Within days of the second shot, I started to have issues with cognition, speech, and memory - similar to 'brain fog'. This continued until I could hardly speak, couldn't remember my name, and was admitted to the hospital with stroke-like symptoms. I was eventually diagnosed with MoyaMoya. I had brain surgery, but was left in extreme pain. 4 years later, I am not able to work and still have bad symptoms. More
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2849110 16 M IN 07/09/2025 MNQ
 SANOFI PASTEUR
 U8369BA
Dizziness, Fall Dizziness, Fall
Patient given vaccine and when they were checking out of the office seemed to become very lightheade... Patient given vaccine and when they were checking out of the office seemed to become very lightheaded and fell to the floor. Assisted patient to room 1 and placed in lying position with feet elevated. Offered juice, crackers. Mother stated client had not eaten breakfast. After juice given and waiting about 15-20 minutes client was well enough to leave after being evaluated by MD. More
2849111 11 M NH 07/09/2025 HPV9
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 Y013565
U8508AA
Heart rate decreased, Loss of consciousness, Pallor, Presyncope; Heart rate decr... Heart rate decreased, Loss of consciousness, Pallor, Presyncope; Heart rate decreased, Loss of consciousness, Pallor, Presyncope More
Vasovagal response after vaccine. Patient had slow pulse, loss of color and temporary loss of consci... Vasovagal response after vaccine. Patient had slow pulse, loss of color and temporary loss of consciousness. More
2849113 20 F TX 07/09/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945658
Arthralgia, Hot flush, Neck pain, Pain in extremity Arthralgia, Hot flush, Neck pain, Pain in extremity
Pain (felt like nerve pain) from left arm across shoulders and also neck. Also feel hot flushes Pain (felt like nerve pain) from left arm across shoulders and also neck. Also feel hot flushes
2849114 45 F 07/09/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 CD44A
D2343
Injection site rash, Rash; Injection site rash, Rash Injection site rash, Rash; Injection site rash, Rash
Patient called in to report a rash that developed on both arms after being vaccinated on 7/2. Per pa... Patient called in to report a rash that developed on both arms after being vaccinated on 7/2. Per patient, the rashes developed on 7/3 around the injection site and continued to grow towards the elbow until patient went to the ER on 7/8 for treatment. More
2849115 54 F MI 07/09/2025 COVID19
COVID19
 MODERNA
MODERNA
 043B21A
043B21A
Asthenia, Brain fog, Dizziness, Headache, Influenza like illness; Loss of person... Asthenia, Brain fog, Dizziness, Headache, Influenza like illness; Loss of personal independence in daily activities, Pyrexia, Tremor, Vomiting More
It was about 2 hours after, I left the pharmacy and I got a real high fever and I started shaking re... It was about 2 hours after, I left the pharmacy and I got a real high fever and I started shaking really bad, I began to throw up. It felt almost like flu symptoms. And that lasted for about 2 days. I got an extreme headache and that lasted the whole time. I felt faint, I was very depleted. And that was about it at first, and then it just kept getting worse as the days and months went past. I was unable to do anything like any activities, i had brain fog really bad. I was just not my self. And i have seen over 30 doctors and only one has put that the COVID vaccine could be related to my symptoms. More
2849116 89 F AR 07/09/2025 COVID19
 MODERNA
 3031632
Breakthrough COVID-19 Breakthrough COVID-19
covid infection after vaccination covid infection after vaccination
2849117 14 M AZ 07/09/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Kinrix was given to a 14 year old. Kinrix is only indicated for ages 4-6. No adverse effects, just ... Kinrix was given to a 14 year old. Kinrix is only indicated for ages 4-6. No adverse effects, just error. At the time we were out of regular polio vaccine. Doctor told the nurse to given Kinrix. Patient was very behind on vaccines, and was needing to catch up. Patient only had 1 dose of polio previously at ate 1 (Pediarix) none since. More
2849118 30 M TX 07/09/2025 COVID19
UNK
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Asthma late onset, Dyspnoea, Electrocardiogram normal, Impaired quality of life,... Asthma late onset, Dyspnoea, Electrocardiogram normal, Impaired quality of life, Pulmonary function test; Asthma late onset, Dyspnoea, Electrocardiogram normal, Impaired quality of life, Pulmonary function test More
2 days after injection, had severe trouble breathing. Went to urgent care, ran oxygen saturation tes... 2 days after injection, had severe trouble breathing. Went to urgent care, ran oxygen saturation tests and EKG, normal levels. Was prescribed a steroid to get passed it. Still had issues post steroids, spoke to primary care physician which referred me to Allergist/Asthma specialists. Have done extensive testing now for my breathing issues, now have severe adult onset asthma, have use daily inhaler (Trelegy Ellipta) and still have trouble breathing some days but it is controlled and on maintenance. Disruptive quality of life, and never had been diagnosed with asthma or asthma-related issues prior to this time period. More
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2849119 16 F TX 07/09/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 Y012776
CD44A
U8375AA
Seizure; Seizure; Seizure Seizure; Seizure; Seizure
CONVULSUION AFTER 10 MINUTES OF VACCINE ADMINISTRATION. PER MOM EPISODE LASTED ABOUT 30 SECONDS. PT ... CONVULSUION AFTER 10 MINUTES OF VACCINE ADMINISTRATION. PER MOM EPISODE LASTED ABOUT 30 SECONDS. PT RESPONSIVE AND ALERT AFTER. More
2849120 M WI 07/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 LX4XP
Basal ganglia infarction, Cyanosis, Dyspnoea, Listless, Magnetic resonance imagi... Basal ganglia infarction, Cyanosis, Dyspnoea, Listless, Magnetic resonance imaging head abnormal More
After hospital discharge following patient's birth, we were home for about an hour when he star... After hospital discharge following patient's birth, we were home for about an hour when he started turning blue and was struggling to breathe. He was ?dusty? and listless. More
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2849121 14 F 07/09/2025 HEP
HEP
TDAP
TDAP
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 7NX57
7NX57
DY3K7
DY3K7
Y015559
Y015559
Chest pain, Dizziness, Dyspnoea, Feeling hot, Headache; Malaise, Nausea; Chest p... Chest pain, Dizziness, Dyspnoea, Feeling hot, Headache; Malaise, Nausea; Chest pain, Dizziness, Dyspnoea, Feeling hot, Headache; Malaise, Nausea; Chest pain, Dizziness, Dyspnoea, Feeling hot, Headache; Malaise, Nausea More
Client received Varicella, Hepatitis B, and Tdap vaccines at 2:56 PM. Prior to administration, clien... Client received Varicella, Hepatitis B, and Tdap vaccines at 2:56 PM. Prior to administration, client had informed RN, that she had eaten lunch approximately ?20 minutes ago? and declined snacks that were offered. PHN provided two ice packs, one for the neck and one for the injection sites. Client returned to the waiting room where her father was waiting and sat down. At approximately 2:59 PM, client?s father notified, OA, that client was not feeling well and requested a cup of water. OA immediately alerted RN, RN , and PHN. RN brought out a mat, and RN assisted client in lying down. Client reported that she was feeling ?dizzy and warm?. At 3:00 PM, RN obtained vital signs (VS) while client was lying down; HR 60, BP 128/69, RR 19. Client was alert and oriented to person, place, and event. She denied experiencing any chest pain, shortness of breath, nausea, or headache and stated that she was ?feeling better?. Client was also engaging in conversation with her father. At 3:05 PM, VS was taken HR 65, BP 119/64, and RR 18. Client expressed that she wanted to sit up and stated, ?I?m okay?. PHN provided another ice pack for client to put on her neck. At 3:10 PM, VS were HR 80, BP 113/71, RR 18. Client was able stand up unassisted and moved to the chair. She denied experiencing any dizziness, nausea, shortness of breath or pain. At 3:12 PM, client reported that she felt okay to walk and left with her father. Client?s gait was steady. Advised client and client?s father to follow up with client?s primary care physician and to seek emergency care if symptoms return, or if client starts experiencing new symptoms. More
2849122 22 M MO 07/09/2025 COVID19
COVID19
 JANSSEN
MODERNA

Fatigue, Headache, Hyposmia, Influenza like illness, Pain; Fatigue, Headache, Hy... Fatigue, Headache, Hyposmia, Influenza like illness, Pain; Fatigue, Headache, Hyposmia, Influenza like illness, Pain More
After being forced to have the two different COVID vaccinations administered in 2021, I noticed fati... After being forced to have the two different COVID vaccinations administered in 2021, I noticed fatigue, headaches, body aches, and severe flu like symptoms over the course of three weeks. Within one week, I noticed limited sense of smell comparatively to before my vaccinations. It is now 2025, and my sense of smell is still limited to pungent or strong odors. More
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2849123 15 M IL 07/09/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK232AB
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
While providing catch up immunizations to a 15 year old patient without any previous immunization re... While providing catch up immunizations to a 15 year old patient without any previous immunization records, a dose of pentacel was incorrectly ordered by the resident physician and approved by the supervising physician (myself). pentacel is not approved for children 15 years old and it also resulted in a dose of DTaP (incorrect) being given to the patient on the same day that they received a dose of Tdap (which was correct). There were no apparent adverse effects at the time of injection and as of 7/3 when I last checked there were also no apparent adverse symptoms or effects on the patient. More
2849124 29 M WA 07/09/2025 COVID19
COVID19
 MODERNA
MODERNA
 013H21B
013H21B
Catheterisation cardiac normal, Echocardiogram, Electrocardiogram normal, Magnet... Catheterisation cardiac normal, Echocardiogram, Electrocardiogram normal, Magnetic resonance imaging heart abnormal, Myopericarditis; Troponin increased, Ventricular hypokinesia More
Admitted to the hospital and diagnosed with myopericarditis without CAD. Treatment started with Col... Admitted to the hospital and diagnosed with myopericarditis without CAD. Treatment started with Colchicine daily and ibuprofen three times daily x 3 month course. More
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2849125 16 F TN 07/09/2025 MENB
MENB
 PFIZER\WYETH
PFIZER\WYETH
 LW8910
LW8910
Blood glucose normal, Fatigue, Gait disturbance, Heart rate decreased, Loss of c... Blood glucose normal, Fatigue, Gait disturbance, Heart rate decreased, Loss of consciousness; Syncope, Tonic convulsion More
Syncope episode directly following vaccines administration. Patient stood up to walk out of room and... Syncope episode directly following vaccines administration. Patient stood up to walk out of room and her gait starting getting un even. Placed on the ground. She did have a small tonic episode and heart rate dropped to the 40s. By fanning patient and scratching head we were able to bring back to consciousness. However directly following event patient kept going in and out of it and was very tired. Heart rate would drop to the mid 40s. Sent by EMS to ER for further eval More
2849126 38 F MN 07/09/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Fatigue, Headache, Injection site erythema, Injection site pain, Injection site ... Fatigue, Headache, Injection site erythema, Injection site pain, Injection site reaction; Injection site warmth, Rash erythematous, Rash macular, Rash papular, Rash pruritic More
Day of vaccine 7/3: Fatigue, headache, exhaustion, injection site pain. 7/4: Fatigue, headache, exha... Day of vaccine 7/3: Fatigue, headache, exhaustion, injection site pain. 7/4: Fatigue, headache, exhaustion, injection site pain (intense). 7/5: Fatigue, headache, injection site pain, injection site redness w/raised red rash that is warm to the touch. 7/6: Fatigue, headache, injection site pain (greatly reduced) with rash disappearing. 7/7-7/8: Fatigue, headache, injection site redness w/large red blotchy rash, very intense itching, warm to the touch. 7/9: Fatigue, headache, injection site redness has gone down, but the intense itching persists. It's still warm to the touch. More
2849127 17 F VA 07/09/2025 MENB
 PFIZER\WYETH
 LW8910
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient in clinic for Well Child Check. Was administered Men B vaccination too early by accident. No... Patient in clinic for Well Child Check. Was administered Men B vaccination too early by accident. No symptoms or adverse effects at this time. Parent and patient were informed of this incident in clinic by provider. More
2849128 1 F PA 07/09/2025 HEPA
MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y013120
X026329
x026320
Irritability, Pyrexia, Skin lesion, Varicella; Irritability, Pyrexia, Skin lesio... Irritability, Pyrexia, Skin lesion, Varicella; Irritability, Pyrexia, Skin lesion, Varicella; Irritability, Pyrexia, Skin lesion, Varicella More
Vaccine induced varicella 5-6 erythematous papular appearing lesions on the buttock (bilaterally).... Vaccine induced varicella 5-6 erythematous papular appearing lesions on the buttock (bilaterally). Low grade fevers, fussy More
2849129 79 M CO 07/09/2025 COVID19
 MODERNA
 B0020
Full blood count, Mental status changes, Metabolic function test Full blood count, Mental status changes, Metabolic function test
Resident is having altered mental status - labs are being drawn at this time Resident is having altered mental status - labs are being drawn at this time
2849130 61 F NC 07/09/2025 HEPAB
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P2443
PJ353
Diplopia, Muscle spasms, Neck pain, Paraesthesia oral; Diplopia, Muscle spasms, ... Diplopia, Muscle spasms, Neck pain, Paraesthesia oral; Diplopia, Muscle spasms, Neck pain, Paraesthesia oral More
Patient developed, tingling in her mouth, double vision, pain in back of her neck and muscle spasms ... Patient developed, tingling in her mouth, double vision, pain in back of her neck and muscle spasms on her back a few hours after vaccine administration. She took Bendaryl OTC, methocarbamol 500 mg and tramadol before she could sleep that night More
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