🏥 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 💀 🏥 🚑 ♿ ⚠️
2841168 F NY 05/15/2025 HPV4
 MERCK & CO. INC.
No adverse event, Product dose omission issue No adverse event, Product dose omission issue
HCP reports she has a 38 year old patient who previously received 2 doses of the GARDASIL series abo... HCP reports she has a 38 year old patient who previously received 2 doses of the GARDASIL series about 18-20 years ago. The patient missed her 3rd dose of GARDASIL and did not complete the vaccine series. No further details. No additional AE/ No PQC.; No additional AE; This spontaneous report was received from a healthcare professional (reported as a certified midwife) regarding a 38-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates (reported as about 18-20 years ago), the patient was vaccinated with the first and second doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), administered as prophylaxis (strengths, doses, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported for any dose). The reporter stated that the patient missed her third dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) and did not complete the vaccine series (Inappropriate schedule of product administration). No additional adverse events were reported. More
2841169 F TX 05/15/2025 MMR
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.

y018154
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No other AE; patient who received a 3rd dose of MMR-II yesterday (13MAY2025) and should've onl... No other AE; patient who received a 3rd dose of MMR-II yesterday (13MAY2025) and should've only received two doses.; This spontaneous report has been received from a consumer or other non-health professional regarding to a 11-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 17-APR-2025, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), then on 13-MAY-2025, then on an unspecified date in 2025, she received the second dose, both at a dose of 0.5 milliliter as prophylaxis (vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not reported). On 13-MAY-2025, the patient received the third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Extra dose administered) at a dose of 0.5 ml, as prophylaxis, lot number y018154 which had been verified to be an invalid number (vaccination scheme, route of administration, and anatomical site of injection, were not reported). No additional adverse events were reported in the patient. More
2841170 47 F CT 05/15/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
She is 47 years old and yesterday, 04-May-2025, she received priorix subcutaneously; This non-serio... She is 47 years old and yesterday, 04-May-2025, she received priorix subcutaneously; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received MMR (Priorix) for prophylaxis. On 04-MAY-2025, the patient received Priorix (subcutaneous). On 04-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: She is 47 years old and yesterday, 04-May-2025, she received priorix subcutaneously). 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: 05-MAY-2025 The reporter was the husband. The patient was the reporter's wife, and She was 47 years old. The reporter did not want to share her exact date of birth or her MD contact information. He did give permission for GSK to contact him via letter but did not want to provide his email address. Consumer reported that yesterday, 04-May-2025, she received Priorix subcutaneously, which led to Inappropriate age at vaccine administration. Reporter did not have access to the lot number because the paperwork she was given did not include the lot number. The reporter was not certain if his wife had prior MMR injections in the past as a child; he assumes that she did. However, she was going to be traveling internationally soon and so it was recommended she receive a Priorix dose prior to travel.; Sender's Comments: US-GSK-US2025055147:same reporter,different patient 1 of 2 report More
2841171 68 F TX 05/15/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection sit... Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site warmth; Rash pruritic; Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site warmth; Rash pruritic More
warmth at injection site; pain at injection site; redness at injection site; Itchy rash; Tiredness/s... warmth at injection site; pain at injection site; redness at injection site; Itchy rash; Tiredness/she felt exhausted; hurting joints; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included ankylosing spondylitis (diagnosed in her mid 20's), covid-19 (positive for Covid after receiving her Covid vaccine) and shingles (diagnosed on 01-AUG-2024 on her buttocks and upper thigh and completely resolved.). Previously administered products included Covid-19 vaccine (received on 10-OCT-2024). On 30-APR-2025, the patient received the 2nd dose of Shingrix (left arm). On 19-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 19-DEC-2024, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced joint pain (Verbatim: hurting joints). On 01-MAY-2025, the patient experienced tiredness (Verbatim: Tiredness/she felt exhausted). On 02-MAY-2025, the patient experienced injection site warmth (Verbatim: warmth at injection site), injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at injection site) and itchy rash (Verbatim: Itchy rash). The patient was treated with clobetasol propionate (Clobetasol). The outcome of the injection site warmth, injection site pain, injection site erythema, itchy rash and joint pain were not resolved and the outcome of the tiredness was resolving. It was unknown if the reporter considered the injection site warmth, injection site pain, injection site erythema, itchy rash and tiredness to be related to Shingrix and Shingrix. It was unknown if the reporter considered the joint pain to be related to Shingrix. It was unknown if the company considered the injection site warmth, injection site pain, injection site erythema, itchy rash and tiredness to be related to Shingrix and Shingrix. It was unknown if the company considered the joint pain to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAY-2025 The patient self-reported this case. The patient received her first Shingrix vaccine in an unknown arm and her second Shingrix vaccine and she felt exhausted and tired which still has not completely resolved, but she was feeling a little better and also had pain at the injection site, it was red and warm to the touch. The patient had a rash that had traveled to her elbow and to the crease of her arm from the injection site and the rash was itchy. The patient had some Clobetasol Ointment left over from when she had shingles that she used on the rash and it seemed to help. The patient had take no meds for this disease, but did say her joints have hurt more since receiving the Shingrix vaccines and the patient will reach out to her HCP for next steps about the rash on her arm. More
2841172 05/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Mammogram, Mobility decreased, Therapeutic response unexpected, X-ray Mammogram, Mobility decreased, Therapeutic response unexpected, X-ray
couldn't even move my arm; when the patient got Shingles shot the next day that pain and burnin... couldn't even move my arm; when the patient got Shingles shot the next day that pain and burning went away; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (that was really hurting and burning under my arm). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: couldn't even move my arm) and unexpected therapeutic effect (Verbatim: when the patient got Shingles shot the next day that pain and burning went away). The outcome of the mobility decreased was not reported and the outcome of the unexpected therapeutic effect was not applicable. It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine. It was unknown if the company considered the mobility decreased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-MAY-2025 This case was reported by a patient via interactive digital media The patient thought that he/she had shingles that was really hurting and burning under my arm and the patient never broke out, but when the patient got Shingles shot the next day that pain and burning went away, which led to unexpected therapeutic benefit. The doctor kept saying it wasn't shingles because the patient didn't break out, but when got the shot that awful pain went away and hasn't come back and couldn't even move my arm without burning sharp pains. The patient had a mammograms and x-rays for muscle strains that we thought it was but I know it was shingles because it was all the symptoms of Shingles The patient had his/her second one now and highly recommend the vaccine on this one and for Pneumonia and said don't do the flu and definitely not the Covid but the patient did do Shingles and the RSV and Pnumonia one More
2841173 05/15/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Headache Headache
having headaches every day; This non-serious case was reported by a consumer via interactive digital... having headaches every day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced headache (Verbatim: having headaches every day). The outcome of the headache was not resolved. It was unknown if the reporter considered the headache to be related to RSV vaccine. It was unknown if the company considered the headache to be related to RSV vaccine. Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. Reporter stated that vaccine my protect but left them having headaches everyday and also stated that miserable going on a second year. More
2841174 M 05/15/2025 VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
Extra dose administered, Herpes zoster, Pain, Vaccination failure; Extra dose ad... Extra dose administered, Herpes zoster, Pain, Vaccination failure; Extra dose administered, Herpes zoster, Pain, Vaccination failure; Extra dose administered, Herpes zoster, Pain, Vaccination failure More
Suspeceted vaccination failure; suffering death with them right now; Extra dose administered; This s... Suspeceted vaccination failure; suffering death with them right now; Extra dose administered; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: suffering death with them right now) (serious criteria life threatening) and extra dose administered (Verbatim: Extra dose administered). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter reported that her husband was suffering death with them right now and had 3 shots. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1, 2 & 3). Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine(Dose 1, 2 & 3). More
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2841175 05/15/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Burning sensation, Herpes zoster, Vaccination failure; Burning sensation, Herpes... Burning sensation, Herpes zoster, Vaccination failure; Burning sensation, Herpes zoster, Vaccination failure More
Suspected Vaccination failure; got shingles 3 times; This serious case was reported by a consumer vi... Suspected Vaccination failure; got shingles 3 times; 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. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 3 times). 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: 10-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the both shingles vaccine and got shingles 3 times. This last time it was really bad, it burned like crazy. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2841176 48 05/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Product administered to patient of inappropriate age, Vaccination... Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure More
Suspected vaccination failure; ot shingles again at 49; got the vaccine at 48; This serious case was... Suspected vaccination failure; ot shingles again at 49; got the vaccine at 48; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 49-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (got a a mild case of shingles at the age of 47 years old). 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), shingles (Verbatim: ot shingles again at 49) and inappropriate age at vaccine administration (Verbatim: got the vaccine at 48). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the inappropriate age at vaccine administration was not applicable. 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: 10-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated he/she got the vaccine at the age of 48-years old, which led to an inappropriate age at vaccine administration and got shingles again at the age of 49-years-old and so far, patient was 50-years of age and was shingles free. 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2841177 05/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nausea, Pain in extremity, Vaccine positive rechallenge Nausea, Pain in extremity, Vaccine positive rechallenge
Arm hurts; a lil nauseous; This non-serious case was reported by a consumer via interactive digital ... Arm hurts; a lil nauseous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st shot on an unknown date, had nausea, For tolerance to 1st dose, refer case US2025AMR058820). 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 pain in arm (Verbatim: Arm hurts) and nausea (Verbatim: a lil nauseous). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm and nausea were not reported. It was unknown if the reporter considered the pain in arm and nausea to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and nausea to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR058820 Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. The patient said that first shot made him/her really sick and just got the second shot and the arm hurts and a lil nauseous but not as bad as the first one by far This case is linked with US2025AMR058820, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR058820:Original Case : US2025AMR058760 More
2841178 05/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I had shingles 3 times even after the shot; This serious case was rep... Suspected vaccination failure; I had shingles 3 times even after the shot; 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 had shingles 3 times even after the shot). 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: 10-MAY-2025 This case was reported by a patient via interactive digital media. The patient had shingles 3 times even after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 Shinglex vaccine. More
2841179 M 05/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Penile blister Penile blister
I have blisters on my penis; This non-serious case was reported by a consumer via interactive digita... I have blisters on my penis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of penile blister in a male 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 penile blister (Verbatim: I have blisters on my penis). The outcome of the penile blister was not reported. It was unknown if the reporter considered the penile blister to be related to Shingles vaccine. It was unknown if the company considered the penile blister to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he had blisters on his penis what do the patient do. More
2841180 17 M MA 05/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 553j7
Expired product administered Expired product administered
patient received Engerix-B on 7-APR-2025 and later it was realized that it expired 28-MAR-2025; This... patient received Engerix-B on 7-APR-2025 and later it was realized that it expired 28-MAR-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HBV (Engerix B pediatric) (batch number 553j7, expiry date 28-MAR-2025) for prophylaxis. On 07-APR-2025, the patient received Engerix B pediatric. On 07-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: patient received Engerix-B on 7-APR-2025 and later it was realized that it expired 28-MAR-2025). The outcome of the expired vaccine used 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 :05-MAY-2025 Pharmacist reported that a 17-year-old patient received Engerix-B on 7-APR-2025 and later it was realized that it expired 28-MAR-2025, which led to Expired vaccine used. The reporter Consented to follow up. More
2841181 M NY 05/15/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
adult patient was given the Priorix vaccine IM instead of SC; This non-serious case was reported by ... adult patient was given the Priorix vaccine IM instead of SC; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 47-year-old male patient who received MMR (Priorix) for prophylaxis. On 23-APR-2025, the patient received Priorix. On 23-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: adult patient was given the Priorix vaccine IM instead of SC). The outcome of the subcutaneous injection formulation administered by other route 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: 05-MAY-2025 A pharmacist reported that an adult patient was given the Priorix vaccine IM instead of SC, which led to subcutaneous injection formulation administered by another route. The pharmacist asked if the dose was valid. The pharmacist did not provided information about Priorix dose. The reporter Consented to follow up. More
2841182 41 M KY 05/15/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
3X937
Interchange of vaccine products; Interchange of vaccine products Interchange of vaccine products; Interchange of vaccine products
Engerix-B Interchangeability with Heplisav; This non-serious case was reported by a nurse via call c... Engerix-B Interchangeability with Heplisav; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 41-year-old male patient who received HBV (Engerix B) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis. On 05-MAY-2025, the patient received the 2nd dose of Engerix B. On 03-APR-2025, the patient received Heplisav b. On 05-MAY-2025, an unknown time after receiving Engerix B, the patient experienced interchange of vaccine products (Verbatim: Engerix-B Interchangeability with Heplisav). The outcome of the interchange of vaccine products 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: 05-MAY-2025 Nurse reported that a patient received Heplisav on April 3rd 2025 and on the day of reporting Engerix B was administered to this patient, which led to interchange of vaccine products. The nurse asked how to proceed with the vaccination in order to complete the Hep B series. More
2841183 M TX 05/15/2025 DTAPHEPBIP
IPV
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 9359N
X1D141M
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Extra dose of IPV component; This non-serious case was reported by a nurse via call center represent... Extra dose of IPV component; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9359N, expiry date 10-OCT-2027) for prophylaxis. Co-suspect products included Polio vaccine inact (Ipv) (batch number X1D141M, expiry date 31-OCT-2026) for prophylaxis. On 05-MAY-2025, the patient received the 1st dose of Pediarix and the 1st dose of Ipv. On 05-MAY-2025, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Extra dose of IPV component). The outcome of the overdose 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: 05-MAY-2025 A registered nurse requested safety data about the administration of both Pediarix and a monovalent IPV vaccine on 05-MAY-2025. The monovalent IPV vaccine was confirmed to not be a GSK product. Patient received Pediarix and monovalent IPV vaccine on the same day, which led to overdose. More
2841184 58 M TX 05/15/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 EF773
HZ9Z9
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Shorter than recommended interval between 2nd and 3rd dose; Longer than recommended interval between... Shorter than recommended interval between 2nd and 3rd dose; Longer than recommended interval between 1st and 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old male patient who received HAB (Twinrix) (batch number EF773, expiry date 09-SEP-2018) for prophylaxis. Co-suspect products included HAB (Twinrix) (batch number EF773, expiry date 09-SEP-2018), (batch number EF77N, expiry date 09-SEP-2018) and (batch number HZ9Z9, expiry date 03-MAR-2017) for prophylaxis. Previously administered products included Twinrix (received 1st dose twinrix on 1st January 2015 with batch number HZ9Z9 and expiry date 3rd March 2017). In APR-2017, the patient received the 3rd dose of Twinrix. On 01-JAN-2017, the patient received the 2nd dose of Twinrix. On 01-JAN-2017, not applicable after receiving Twinrix, 731 days after receiving Twinrix and an unknown time after starting Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval between 1st and 2nd dose). In APR-2017, the patient experienced drug dose administration interval too short (Verbatim: Shorter than recommended interval between 2nd and 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 05-MAY-2025 The physician called to request data regarding the possibility of a schedule variation being used. The patient had received the first dose in January 2015, with lot number HZ9Z9 and expiration date 03rd March 2017. The second dose was administered in January 2017, with lot number EF773 and expiration date 09th September 2018, and the third dose was given in April 2017, with the same lot number EF773 and expiration date 09th September 2018. The physician had only inquired about the shorter than recommended interval between the second and third doses but did not ask about the longer than recommended interval between the first two doses. The interval between the second and third dose was shorter than recommended, which led to Drug dose administration interval too short. The interval between the first and second dose was longer than recommended, which led to Drug dose administration interval too long. More
2841185 24 F PA 05/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 79S54
Expired product administered Expired product administered
Patient not knowing that, the expiration date was 4/4 of 25/ I might just gave it to her like maybe ... Patient not knowing that, the expiration date was 4/4 of 25/ I might just gave it to her like maybe 20 minutes ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis. On 12-MAY-2025, the patient received the 1st dose of Engerix B. On 12-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Patient not knowing that, the expiration date was 4/4 of 25/ I might just gave it to her like maybe 20 minutes ago). The outcome of the expired vaccine used 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: 12-MAY-2025 The certified medical assistant called to report she had given the vaccine to a patient without knowing or realizing that the expiration date was 4th April 2025 which led expired vaccine used. She believed she had administered it approximately 20 minutes prior to the call. She wanted to confirm whether the patient needed to repeat the first dose, as it was a Hepatitis B vaccine. She stated that the patient had just received the first of the three-dose series. More
2841186 M AR 05/15/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
KINRIX over age administration; This non-serious case was reported by a nurse via call center repres... KINRIX over age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. Previously administered products included Dtap (received 3 doses on an unknown date) and IPV (received 2 doses on an unknown date). On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: KINRIX over age administration). 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: 13-MAY-2025 The nurse reported that 7 year old male patient received Kinrix by error, which led to inappropriate age at vaccine administration. Patient already has 3 valid Dtaps and 2 IPVs. More
2841187 37 F 05/15/2025 COVID19
COVID19
 MODERNA
MODERNA

Ear discomfort, Ear disorder, Formication, Immunisation reaction, Otorrhoea; Sin... Ear discomfort, Ear disorder, Formication, Immunisation reaction, Otorrhoea; Sinus disorder More
spiral" or "coil"-like structure under the skin from temple to neck/"odd spirali... spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck; condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications; condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications; ear deformities, fluid movement, and pressure; ear deformities, fluid movement, and pressure; some unidentified issue involving spike protein particles "the size of a pea" and said "it moves to your hair follicles." She mentioned what she is suffering, it's inhumane, and she's "in hell."; This spontaneous case was reported by a non-health professional and describes the occurrence of FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), EAR DISORDER (ear deformities, fluid movement, and pressure), EAR DISCOMFORT (ear deformities, fluid movement, and pressure) and IMMUNISATION REACTION (some unidentified issue involving spike protein particles "the size of a pea" and said "it moves to your hair follicles." She mentioned what she is suffering, it's inhumane, and she's "in hell.") in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Nematodiasis (Nematode infection). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck) (seriousness criterion medically significant), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications) (seriousness criterion medically significant), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications) (seriousness criterion medically significant), EAR DISORDER (ear deformities, fluid movement, and pressure) (seriousness criterion medically significant), EAR DISCOMFORT (ear deformities, fluid movement, and pressure) (seriousness criterion medically significant) and IMMUNISATION REACTION (some unidentified issue involving spike protein particles "the size of a pea" and said "it moves to your hair follicles." She mentioned what she is suffering, it's inhumane, and she's "in hell.") (seriousness criterion medically significant). At the time of the report, FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), EAR DISCOMFORT (ear deformities, fluid movement, and pressure) and IMMUNISATION REACTION (some unidentified issue involving spike protein particles "the size of a pea" and said "it moves to your hair follicles." She mentioned what she is suffering, it's inhumane, and she's "in hell.") had not resolved and OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications) and EAR DISORDER (ear deformities, fluid movement, and pressure) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Patient reported experiencing severe physical symptoms as odd spiraling thing with balls connected to it that had been affecting her for over a year. She said the condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications. Patient mentioned that she had medical scans, biopsy results, doctor orders, and videos/images documenting the issue, although none of the tests picked up what she was experiencing. Patient suggested that the symptoms might be related to a prior nematode infection or potentially linked to a cheap headphone that initially injured her ear. Patient stated that only a QPCR test would be able to identify what's happening. Patient was concerned it could be some unidentified issue involving spike protein particles "the size of a pea" and said "it moves in the hair follicles. Patient mentioned that what she was suffering, was inhumane, and she was in hell." Patient noted a loosening of the tightness in her ear after the vaccination and described it as "something was working," though she emphasized it was still not fully resolved. Patient compared the sensation to "rubber bands" loosening and described visible spiral-like objects matching online images of spike proteins. Patient believed that the vaccine may be impacting or unraveling the condition. It was unknown if the patient experienced any additional symptoms/events. Patient indicated having undergone multiple biopsies and scans and having seen various doctors. Treatment information was not reported. This case was linked to MOD-2025-785865 (Patient Link).; Reporter's Comments: Company comment: Use of earphones and injury is a confounder for the events of ear discomfort, otorrhea and ear disorder. The benefit-risk relationship of product is not affected by this report. More
2841188 05/15/2025 COVID19
 MODERNA
 3043838
Pain in extremity Pain in extremity
Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported... Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. The reporter checked to see if Spikevax lot 2043838 had any quality issues or concerns. No treatment medication was reported. This case contains information for the 3rd patient out of 5 patients. This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live Follow up received that contains non-significant information: Reference added. On 07-May-2025: Live Follow up received that contains non-significant information: Reference added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786107:Master case More
2841189 05/15/2025 COVID19
 MODERNA
 3043838
Pain in extremity Pain in extremity
Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported... Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. The reporter checked to see if Spikevax lot 2043838 had any quality issues or concerns. No treatment medication was reported. This case contains information for the 4th patient out of 5 patients. This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live Follow up received that contains non-significant information: Reference added. On 07-May-2025: Live Follow up received that contains non-significant information: Reference added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786107:Master case More
2841190 05/15/2025 COVID19
 MODERNA
 3043838
Pain in extremity Pain in extremity
Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported... Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. The reporter checked to see if Spikevax lot 2043838 had any quality issues or concerns. No treatment medication was reported. This case contains information for the 5th patient out of 5 patients. This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live Follow up received that contains non-significant information: Reference added. On 07-May-2025: Live Follow up received that contains non-significant information: Reference added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786107:Master case More
2841191 37 F IL 05/15/2025 COVID19
 MODERNA
Ear deformity acquired, Ear discomfort, Formication, Otorrhoea, Sinus disorder Ear deformity acquired, Ear discomfort, Formication, Otorrhoea, Sinus disorder
spiral" or "coil"-like structure under the skin from temple to neck/"odd spirali... spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck; condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications; condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications; ear deformities, fluid movement, and pressure; ear deformities, fluid movement, and pressure; This spontaneous case was reported by a patient and describes the occurrence of FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), EAR DEFORMITY ACQUIRED (ear deformities, fluid movement, and pressure) and EAR DISCOMFORT (ear deformities, fluid movement, and pressure) in a 37-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Ear injury and Nematodiasis (Suspected parasitic infection (possible nematode)/prior nematode infection). In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck) (seriousness criterion medically significant), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications) (seriousness criterion medically significant), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications) (seriousness criterion medically significant), EAR DEFORMITY ACQUIRED (ear deformities, fluid movement, and pressure) (seriousness criterion medically significant) and EAR DISCOMFORT (ear deformities, fluid movement, and pressure) (seriousness criterion medically significant). At the time of the report, FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), EAR DEFORMITY ACQUIRED (ear deformities, fluid movement, and pressure) and EAR DISCOMFORT (ear deformities, fluid movement, and pressure) had not resolved. No concomitant medications were reported. It was reported that patient suggested that the symptoms might be related to a prior nematode infection from the time in Costa Rica or potentially linked to a cheap headphone that initially injured ear hence "injured ear" and suspected parasitic infection (possible nematode)/prior nematode infection. Patient reported experiencing severe physical symptoms as odd spiraling thing with balls connected to it that had been affecting for over a year. She said the condition caused movements under skin like a "boa constrictor" from temple to the base of the neck. It affected ear, pulling it downward, and caused weeping from the eardrum and sinus complications. Patient mentioned that she had medical scans, biopsy results, doctor orders, and videos/images documenting the issue, although none of the tests picked up what she was experiencing. Patient suggested that the symptoms might be related to a prior nematode infection or potentially linked to a cheap headphone that initially injured ear. Patient stated that only a QPCR test would be able to identify what's happening. Patient was concerned it could be some unidentified issue involving spike protein particles "the size of a pea" and said "it moved in the hair follicles. Patient mentioned that what she was suffering, was inhumane, and she was in hell." Patient noted a loosening of the tightness in the ear after the vaccination and described it as "something was working," though she emphasized it was still not fully resolved. Patient compared the sensation to "rubber bands" loosening and described visible spiral-like objects matching online images of spike proteins. Patient believed that the vaccine may be impacting or unraveling the condition. It was unknown if the patient experienced any additional symptoms/events. Patient indicated that undergone multiple biopsies and scans and having seen various doctors. No treatment medications were reported. This case was linked to MOD-2025-786062, MOD-2025-786039 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-May-2025: Live significant follow-up received: Additional reporter, medical history, suspect product, additional events Formication, Sinus disorder, Otorrhoea, Ear disorder, Ear discomfort, narrative and reference numbers were added.; Reporter's Comments: Medical history of prior nematode infection and ear injury secondary to a cheap phone could be confounding factors for the case. The benefit-risk relationship of product is not affected by this report. More
2841192 M AK 05/15/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Blindness transient, Blood pressure measurement, Body temperature, Body temperat... Blindness transient, Blood pressure measurement, Body temperature, Body temperature abnormal, Chest pain; Contrast media allergy, Deafness, Decubitus ulcer, Gait disturbance, Hypotension; Limb discomfort, Pain, Photosensitivity reaction, Polyneuropathy More
pollyneropathy; Lose vision and hearing for 15 seconds when I stand up a few times a day; Lose visio... pollyneropathy; Lose vision and hearing for 15 seconds when I stand up a few times a day; Lose vision and hearing for 15 seconds when I stand up a few times a day; chest pains; Blood pressure is on the low side; Feet got really heavy; Feet got really heavy and almost fell over; have also become allergic to MRI and CT contrast; strange body pains/shocking pain; laying on my bed sore as crap which I have been for the last week; I was in the sun a week ago and for some stupid reason that messed up my body temp and seem to be allergic to it now; That messed up my body temperature/I now wake up with a body temp under 95 degree quite often. 94.1 degree Celsius is the lowest I have seen; This spontaneous case was reported by a patient and describes the occurrence of POLYNEUROPATHY (pollyneropathy), BLINDNESS TRANSIENT (Lose vision and hearing for 15 seconds when I stand up a few times a day) and DEAFNESS (Lose vision and hearing for 15 seconds when I stand up a few times a day) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In April 2025, the patient experienced BODY TEMPERATURE ABNORMAL (That messed up my body temperature/I now wake up with a body temp under 95 degree quite often. 94.1 degree Celsius is the lowest I have seen), DECUBITUS ULCER (laying on my bed sore as crap which I have been for the last week) and PHOTOSENSITIVITY REACTION (I was in the sun a week ago and for some stupid reason that messed up my body temp and seem to be allergic to it now). On an unknown date, the patient experienced POLYNEUROPATHY (pollyneropathy) (seriousness criterion medically significant), BLINDNESS TRANSIENT (Lose vision and hearing for 15 seconds when I stand up a few times a day) (seriousness criterion medically significant), DEAFNESS (Lose vision and hearing for 15 seconds when I stand up a few times a day) (seriousness criterion medically significant), CHEST PAIN (chest pains), HYPOTENSION (Blood pressure is on the low side), LIMB DISCOMFORT (Feet got really heavy), GAIT DISTURBANCE (Feet got really heavy and almost fell over), CONTRAST MEDIA ALLERGY (have also become allergic to MRI and CT contrast) and PAIN (strange body pains/shocking pain). The patient was treated with Gabapentin at an unspecified dose and frequency and Diazepam at a dose of before go to bed (try to keep a month between doses). At the time of the report, POLYNEUROPATHY (pollyneropathy), BLINDNESS TRANSIENT (Lose vision and hearing for 15 seconds when I stand up a few times a day), DEAFNESS (Lose vision and hearing for 15 seconds when I stand up a few times a day), CHEST PAIN (chest pains), BODY TEMPERATURE ABNORMAL (That messed up my body temperature/I now wake up with a body temp under 95 degree quite often. 94.1 degree Celsius is the lowest I have seen), HYPOTENSION (Blood pressure is on the low side), LIMB DISCOMFORT (Feet got really heavy), GAIT DISTURBANCE (Feet got really heavy and almost fell over), DECUBITUS ULCER (laying on my bed sore as crap which I have been for the last week), PHOTOSENSITIVITY REACTION (I was in the sun a week ago and for some stupid reason that messed up my body temp and seem to be allergic to it now), CONTRAST MEDIA ALLERGY (have also become allergic to MRI and CT contrast) and PAIN (strange body pains/shocking pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: General blood pressure is on the low side. On an unknown date, Body temperature: now wake up with a body temp under 95 degree Celsius quite often, 94.1 degree is the lowest. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. Patient knew this was a long shot. He had been through a bunch of doctors. His body had never been the same for 20 minutes after the first Moderna Covid vaccine shot he had. Feet got really heavy and almost fell over. Strange body pains. Chest pains, shocking pains. He was told textbook GBS but never diagnosed. aEMG was Failed. Patient Flew 3000 miles to be treated. They told him something like polyneuropathy and gave a Gabapentin to patient. He was the sole provider for wife and kids. As patient type this complaint, he was laying on bed sore as crap which he had been for the last week because he was in the sun a week ago that messed up body temp and seem to be allergic to it now. Patient also became allergic to MRI and CT contrast. It was always fun to go blind for a few hours. His local doctors very happily told that he had not had MS. He tried to ask about heart and the chest pains when he was at clinic in Feb-2022 with doctor. She literally threw up hands and said patient had to deal with this. Patient was scared. He just wanted to go home after that. This was a glimpse into his crap. A good dose of diazepam before he went to bed normally reset nerves system. He tried to keep a month between doses. He knew that crap was not good. He knew he had not had it as bad as others. But it had and continued to mess up family life. Patient wished he never had gotten the vaccine. He was just trying to survive. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2841193 OH 05/15/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Device breakage Device breakage
A broken flange was observed; The initial case was missing the following minimum criteria: product c... A broken flange was observed; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 08May2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Nurse from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LP1776, Expiration Date: 26Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "A broken flange was observed". Additional information: NDC Number: 00069243210. A broken flange was observed during the evaluation of the returned complaint sample. The reporter considered "a broken flange was observed" not related to BNT162b2 omicron (kp.2). Causality for "a broken flange was observed" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction). More
2841194 05/15/2025 COVID19
 PFIZER\BIONTECH
Asthenia, Dyspnoea, Fatigue, Post-acute COVID-19 syndrome, Pulmonary thrombosis Asthenia, Dyspnoea, Fatigue, Post-acute COVID-19 syndrome, Pulmonary thrombosis
2 blood cloths in my lung; breathing issues; long term Covid; No energy; fatigue; This is a spontane... 2 blood cloths in my lung; breathing issues; long term Covid; No energy; fatigue; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "2 blood cloths in my lung"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing issues"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long term Covid"; ASTHENIA (non-serious), outcome "unknown", described as "No energy"; FATIGUE (non-serious), outcome "unknown". Clinical information: Patient asked, Why did Pfizer Covid vaccine give patient long term Covid fatigue diagnosed by reg doctor and specialist. Patient's life was ruined. No energy and breathing issues was on the world till given new 2023 vaccine in IICU (Intermediate Intensive Care Unit), within a day or so had 2 blood cloths in patient's lung and breathing issues. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2841195 F 05/15/2025 COVID19
 PFIZER\BIONTECH
Illness, Pain in extremity Illness, Pain in extremity
sick; her arm gets very sored.; This is a spontaneous report received from a Consumer or other non H... sick; her arm gets very sored.; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00307 (Novavax). A female patient received BNT162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm gets very sored.". Additional information: Consumer states that possibly they will tweak it for the fall. She states usually it is 36 hours or 2 days that she doesn't feel good. Last time it was 5 days that she couldn't get off of the couch, she was really sick. Pfizer makes her verysick and her arm gets very sored. She gets other vaccines and she doesn't get sick. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2841196 73 F CO 05/15/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Gait disturbance, Musculoskeletal disorder, Neuropathy peripheral, Peripheral sw... Gait disturbance, Musculoskeletal disorder, Neuropathy peripheral, Peripheral swelling More
After about a week, patient had swelling in right hand, neuropathy, and was unable to use her hand f... After about a week, patient had swelling in right hand, neuropathy, and was unable to use her hand for about a week. Patient also reported neuropathy in feet that made it extremely difficult to walk. More
2841197 17 M TX 05/15/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Bell's palsy, Facial paralysis, Neck pain, Paraesthesia Bell's palsy, Facial paralysis, Neck pain, Paraesthesia
Per patient mother, patient had tingling sensation in right arm, pain to back of neck, and right-sid... Per patient mother, patient had tingling sensation in right arm, pain to back of neck, and right-side face drooping. ER visit was advised to mother by PCP for further evaluation. Per mom, provider dx patient with Bells Palsy due to adverse effect from vaccine received at PCP visit. Treatments and other outcomes have not yet been provided. More
2841198 63 M 05/15/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 Z27PB
No adverse event No adverse event
Writer gave vaccine to patient before visit starting. Writer gave vaccines to patient, then 15 minu... Writer gave vaccine to patient before visit starting. Writer gave vaccines to patient, then 15 minutes passed for patient to wait if there was reaction. Writer did not suspect patient having reaction nor did patient mention any symptoms. More
2841199 43 F GA 05/15/2025 HEP
PNC13
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.


Erythema, Pruritus, Rash; Erythema, Pruritus, Rash; Erythema, Pruritus, Rash Erythema, Pruritus, Rash; Erythema, Pruritus, Rash; Erythema, Pruritus, Rash
Redness with itching on back side of right arm where MMR injection given, spreading down arm within ... Redness with itching on back side of right arm where MMR injection given, spreading down arm within 24 hours of vaccination, with patient scratching rash and applying a steroidal type of cream on rash, and taking one dose of Benadryl, within 24 hours of rash. Patient reports rash, itching and redness as decreasing as of 48 hours post vaccination More
2841213 19 F TN 05/15/2025 MMR
 MERCK & CO. INC.
 x026219
No adverse event, Wrong product administered No adverse event, Wrong product administered
MMR accidentally given to patient instead of meningitis vaccine. no reaction. patient given correct ... MMR accidentally given to patient instead of meningitis vaccine. no reaction. patient given correct vaccine 5/15/25 More
2841214 1.58 M CA 05/15/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7829AA
Injection site mass, Injection site pain, Injection site swelling Injection site mass, Injection site pain, Injection site swelling
today, I see 1 cm circular mass left thigh, tender, but initially by report, presented as a large ci... today, I see 1 cm circular mass left thigh, tender, but initially by report, presented as a large circular raised swelling. More
2841215 1.25 M OH 05/15/2025 DTAP
DTAP
DTAP
DTAP
HIBV
HIBV
HIBV
HIBV
MMR
MMR
MMR
MMR
PNC20
PNC20
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 3CA55C1
3CA55C1
3CA55C1
3CA55C1
UK193AA
UK193AA
UK193AA
UK193AA
Y008289
Y008289
Y008289
Y008289
LN4928
LN4928
LN4928
LN4928
Albuminocytological dissociation present, Areflexia, Asthenia, CSF protein incre... Albuminocytological dissociation present, Areflexia, Asthenia, CSF protein increased, CSF white blood cell count negative; Culture negative, Demyelinating polyneuropathy, Diffusion-weighted brain MRI, Gait inability, Guillain-Barre syndrome; Hyporeflexia, Hypotonia, Laboratory test normal, Magnetic resonance imaging abnormal, Nerve conduction studies abnormal; Peripheral sensorimotor neuropathy; Albuminocytological dissociation present, Areflexia, Asthenia, CSF protein increased, CSF white blood cell count negative; Culture negative, Demyelinating polyneuropathy, Diffusion-weighted brain MRI, Gait inability, Guillain-Barre syndrome; Hyporeflexia, Hypotonia, Laboratory test normal, Magnetic resonance imaging abnormal, Nerve conduction studies abnormal; Peripheral sensorimotor neuropathy; Albuminocytological dissociation present, Areflexia, Asthenia, CSF protein increased, CSF white blood cell count negative; Culture negative, Demyelinating polyneuropathy, Diffusion-weighted brain MRI, Gait inability, Guillain-Barre syndrome; Hyporeflexia, Hypotonia, Laboratory test normal, Magnetic resonance imaging abnormal, Nerve conduction studies abnormal; Peripheral sensorimotor neuropathy; Albuminocytological dissociation present, Areflexia, Asthenia, CSF protein increased, CSF white blood cell count negative; Culture negative, Demyelinating polyneuropathy, Diffusion-weighted brain MRI, Gait inability, Guillain-Barre syndrome; Hyporeflexia, Hypotonia, Laboratory test normal, Magnetic resonance imaging abnormal, Nerve conduction studies abnormal; Peripheral sensorimotor neuropathy More
Patient presented with inability to walk starting approximately 3 days after vaccination progressing... Patient presented with inability to walk starting approximately 3 days after vaccination progressing over next 3 weeks. Admitted 5/14/25 and diagnosed with Guillain-Barre-Syndrome on 5/15/25. Diagnosis based on bilateral lower extremity predominant symmetric flaccid weakness, areflexia in lower extremities with hyporeflexia in upper extremities, diffuse spinal root enhancement on post-contrast T1 weighted MRI of the total spine, nerve conduction studies demonstrating primary demyelinating with secondary axon loss sensorimotor polyneuropathy, and albuminocytologic dissociation with CSF protein of 323mg/dL and 0WBC/hpf. Film array and culture are negative. More
✓
2841216 11 F OR 05/15/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Y009051
U8375AA
U8252AA
Discomfort, Urticaria; Discomfort, Urticaria; Discomfort, Urticaria Discomfort, Urticaria; Discomfort, Urticaria; Discomfort, Urticaria
Occurring 17 hours after administration, the patient broke out in full-body hives. No lip swelling o... Occurring 17 hours after administration, the patient broke out in full-body hives. No lip swelling or difficulty breathing. Hives did not start at any specific injection site, they started on the neck. More
2841217 3 M MI 05/15/2025 DTAP
DTAP
HEPA
HEPA
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Don?t have it
Don?t have it
Unknown
Unknown
Circumstance or information capable of leading to medication error, Fear of inje... Circumstance or information capable of leading to medication error, Fear of injection, Gait disturbance, Injection site pain, Injection site rash; Multiple use of single-use product, Underdose, Wrong technique in product usage process; Circumstance or information capable of leading to medication error, Fear of injection, Gait disturbance, Injection site pain, Injection site rash; Multiple use of single-use product, Underdose, Wrong technique in product usage process More
During the time of the vaccinations given my child saw the needle got a little scared so I began to ... During the time of the vaccinations given my child saw the needle got a little scared so I began to hold his hands while soothing him. The M.A who administered the shots straddles his feet to clean injection shot and then gave 1 dose in left thigh(DTP) . Then unstraddled his legs and came over to his left side and began another shot (hep a). While standing on the side of me he accidentally poked my belly and administered me part of the dosage(upon feeling what I felt I looked down and he then was inside my sons thigh with same needle that was in me. He then pulled needle (a little of the medicine that was left van out the syringe. He bandaged both me and my son up. I asked what was I just injected with he said he did not know. I asked office how to report such an event,as I was not trying to get anyone in trouble but needed to report what had happened in case something happens. Once home I noticed soreness on my own stomach and hive had began to form on my way home from the appointment. I took two benedryls. Checked my sons sight and he had multiple bumps around the injection sight on the right thigh where he had been stuck with an used needle. And by nights end complained of his leg hurting and not being able or wanting to walk. I took pictures of both. The next day my own sight was reder in color and swoll. Skin irritated More
✓
2841218 0.75 M CA 05/15/2025 FLU3
 SEQIRUS, INC.
 391418
Rash maculo-papular Rash maculo-papular
generalized maculopapular rash generalized maculopapular rash
2841227 1.5 M CT 05/15/2025 DTAP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 223Y9
Y013120
Erythema, Limb mass, Peripheral swelling, Pruritus; Erythema, Limb mass, Periphe... Erythema, Limb mass, Peripheral swelling, Pruritus; Erythema, Limb mass, Peripheral swelling, Pruritus More
Mom reports leg is red and swollen compared to other leg. She does feel a hard bump under the skin. ... Mom reports leg is red and swollen compared to other leg. She does feel a hard bump under the skin. The leg is itchy. Mom has provided cold compresses and Benadryl with good affect. Patient will be coming to the office for evaluation More
2841228 20 M MA 05/15/2025 MNQ
 SANOFI PASTEUR
 U7827AA
No adverse event, Wrong product administered No adverse event, Wrong product administered
No adverse event patient given wrong vaccine. No adverse event patient given wrong vaccine.
2841229 61 M IA 05/15/2025 PNC21
 MERCK & CO. INC.
 200431
Injection site erythema, Injection site pruritus, Injection site rash Injection site erythema, Injection site pruritus, Injection site rash
Received PCV21 05/09/25 ~ Two days later, developed red, itchy painful rash to area under injection ... Received PCV21 05/09/25 ~ Two days later, developed red, itchy painful rash to area under injection site. Appear more linear, raised erythematous. Approximately 10cm x 6cm. No open sores or lesions. Appears consistent with cellulitis. Treat with cephalexin 500 mg qid x 10 days. More
2841233 11 F CA 05/15/2025 MNQ
MNQ
TDAP
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 XL223
XL223
LX494
LX494
Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus; Skin war... Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus; Skin warm; Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus; Skin warm More
Right arm swelling pain/itch redness induration warmth -> Benadryl & topical steroid given -&... Right arm swelling pain/itch redness induration warmth -> Benadryl & topical steroid given -> still redness -> antibiotic -> did not full scrip after as advised More
2840855 F TX 05/14/2025 UNK
 UNKNOWN MANUFACTURER
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
HCP reports the patient received newborn vaccination Hep B in December when she was born; No additi... HCP reports the patient received newborn vaccination Hep B in December when she was born; No additional AE; This spontaneous report was received from a health care professional referring to a 5 month female patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date when she was born, she was vaccinated with the first dose of Hepatitis B vaccine (Recombinant) suspension for injection for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). On 14-APR-2025, she began the catch-up vaccinations due to being a "no show" at her pediatrician appointments (Inappropriate schedule of product administration) no other events were reported (No adverse event). More
2840856 M 05/14/2025 HPV9
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Patient's mother did not report any symptoms or side effects for the patient./No additional AE... Patient's mother did not report any symptoms or side effects for the patient./No additional AE; Patient's mother reporting an AE for GARDASIL 9 on behalf of the patient. Patient's mother reported that the patient, who is 20 years old, received his first dose of GARDASIL 9 in "August 2024", but the patient never received his second dose. Patie; This spontaneous report was received from the patient's mother and refers to a 20-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In August 2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection (0.5 ml, strength, route, lot number and expiration date were unknown) for prophylaxis. The Patient's mother reported that the patient never received his second dose in 2025 (inappropriate schedule of product administration). The patient's mother did not report any symptoms or side effects for the patient/No additional adverse event (No adverse event). Due to the patient's mother declining to provide further information, no patient information was collected, and no healthcare professional information was collected. More
2840857 MN 05/14/2025 HIBV
 SANOFI PASTEUR
 UK201AC
No adverse event, Product preparation error No adverse event, Product preparation error
vaccine mixed with sterile water instead of the saline diluent with no reported adverse event; Initi... vaccine mixed with sterile water instead of the saline diluent with no reported adverse event; Initial information received on 07-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who received haemophilus type B (HIB) vaccine [ACT-HIB] was mixed with sterile water instead of the saline diluent 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 HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 30-Apr-2026 and lot UK201AC) via unknown route in unknown administration site for Prophylactic Vaccination (Immunization) was mixed with sterile water instead of the saline diluent with no reported adverse event (product preparation error) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2840858 1.33 F CT 05/14/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK022AA
Expired product administered, No adverse event Expired product administered, No adverse event
stated that she gave a dose of pentacel that expired nine days ago with no reported adverse event; I... stated that she gave a dose of pentacel that expired nine days ago with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 16 months old female patient who received dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] that expired nine days ago 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 for Immunisation. On 08-May-2025, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of strength: standard, frequency once with lot UK022AA and expiry date: Apr-2025 via intramuscular route in the left Anterior thigh for immunization that expired nine days ago with no reported adverse event (expired product administered) (Latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2840859 7 M NV 05/14/2025 DTAP
 SANOFI PASTEUR
 3CA20C1
Extra dose administered, No adverse event, Product administered to patient of in... Extra dose administered, No adverse event, Product administered to patient of inappropriate age More
7-year-old patient who received DAPTACEL. It is an extra dose with no reported adverse event; 7-year... 7-year-old patient who received DAPTACEL. It is an extra dose with no reported adverse event; 7-year-old patient who received DAPTACEL. It is an extra dose with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] which was an extra dose with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR); Polio Vaccine Inact (IPV) and varicella zoster vaccine (Varicella Vaccine) all for Immunisation. On 02-Apr-2025, the patient received a dose 6 of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: 3CA20C1; expiry date: 28-Feb-2026; frequency: once; strength: standard) via intramuscular route in the right deltoid for Immunisation which was an extra dose with no reported adverse event (product administered to patient of inappropriate age) (extra dose 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
2840860 MN 05/14/2025 HIBV
 SANOFI PASTEUR
 UK201AC
No adverse event, Product preparation error No adverse event, Product preparation error
administration of a dose of ACT-HIB that was reconstituted with sterile water rather than the diluen... administration of a dose of ACT-HIB that was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient who was administered with a dose of HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in May 2025, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- standard, expiry date- 30-APR-2026 and lot UK201AC) once via unknown route in unknown administration site for Immunization was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event (product preparation error) (same day latency). Reportedly, Caller was stating that they submitted an online request for information on an ACT HIB vaccine. They were looking for information on if the vaccine was reconstituted with sterile water rather than saline. They received some information but were asking if there was any safety information they need to be aware of regarding the vaccine since it was administered to a patient 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
2840861 5 F IN 05/14/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK199AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
pentacel was administered to a patient who is 5 years and 4 months old with no reported ae; Initial ... pentacel was administered to a patient who is 5 years and 4 months old with no reported ae; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a is 5 years and 4 months old female patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) [Proquad] for Immunisation. On 07-May-2025, the patient received 0.5ml dose (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, Strength Standard, lot UK199AA and expiry date: 30-Apr-2026 via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency same day). Reportedly, the patient was due for DTaP and IPV due to which Pentacel (Vero) was administered. No treatment was received by patient. 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
2840862 M WI 05/14/2025 DTAPIPVHIB
 SANOFI PASTEUR
No adverse event, Product preparation issue No adverse event, Product preparation issue
administering pentacel but only the dtap-ipv dose was given with no reported ae; Initial information... administering pentacel but only the dtap-ipv dose was given with no reported ae; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age male patient who recieved Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the dtap-ipv dose was given with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Apr-2025, the patient received an unknown dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine standard strength (lot number, formulation and expiry date-unknown) via unknown route in unknown administration site for Immunization but only the dtap-ipv dose was given with no reported ae (single component of a two-component product administered) (latency-same day). Reportedly- Only the liquid part of PENTACEL was administered. They further asked if they have to revaccinate or when can they give the Hib component. 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-2025SA135316:02514958, 02515969 and 02515973 More
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