🏥 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 💀 🏥 🚑 ♿ ⚠️
2832434 13 F IL 03/20/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
Inbound call from HCP asking about continuing GARDASIL 9 series after the 3rd dose is late. 1st dose... Inbound call from HCP asking about continuing GARDASIL 9 series after the 3rd dose is late. 1st dose 11/14/2019, 2nd dose 7/8/2020 (see request case 02761318). No adverse effects were reported. Unknown Lots and Expiration dates. Caller did not provid; No adverse effects were reported; This spontaneous report was received from a pharmacist and refers to a current 18-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 14-NOV-2019, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (strength, exact dose, route of administration, anatomical location, lot #, and expiration date were not reported). Then on 08-JUL-2020, the patient received the second dose of the suspect vaccine (as described above). Both administered as prophylaxis. Therefore, the third dose was late (inappropriate schedule of vaccine administered). No adverse effects were reported (no adverse event). More
2832435 OK 03/20/2025 HEPA
 MERCK & CO. INC.
 Y008483
Product storage error Product storage error
VFC immunization coordinator calling to report T/E for VAQTA that was administered.; This spontaneou... VFC immunization coordinator calling to report T/E for VAQTA that was administered.; This spontaneous report has been received from a nurse concerns a unspecified age and gender patient. There was no information about medical history, current conditions and concomitant medications. On 03-MAR-2025, the patient was vaccinated with an improper storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) suspension for injection, 2nd dose, lot number Y008483 (who had been verified to be a valid number, expiration date reported and validated as 26-NOV-2025) (exact dose, and anatomical route of administration were not provided). It was reported that the excursion occurred with a temperature of 32.0F with a time frame of 2 hours 12 minutes 0 seconds and there was no information about previous temperature excursion (product storage error). More
2832437 M NY 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Echocardiogram, Electroencephalogram, Pseudostroke Echocardiogram, Electroencephalogram, Pseudostroke
Stroke mimic; This serious case was reported by a consumer via call center representative and descri... Stroke mimic; This serious case was reported by a consumer via call center representative and described the occurrence of stroke mimic in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced stroke mimic (Verbatim: Stroke mimic) (serious criteria hospitalization and GSK medically significant). The outcome of the stroke mimic was unknown. It was unknown if the reporter considered the stroke mimic to be related to Shingrix. The company considered the stroke mimic to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 14-MAR-2025 The case was reported by patient's daughter. Patient had a severe episode which led him to the ER (emergency room) and resulted in his admission to the hospital. They ran all their tests to check for a stroke since it resembled a stroke or TIA (transient ischemic attack). They performed EEG (electroencephalogram) and an echocardiogram. Reporter mentioned to the staff that he had the shingles vaccine, but none of them followed up on that. Reporter's father was not inclined to follow up on that. She had read in the package insert about the syncope warning and had asked, what was the time frame (number of days) in which syncope had been recorded after shingrix so that he could acknowledge that perhaps it was related, because if he went and received the second shot, he might have had a worse reaction, which was hard to imagine. Patient stayed in the hospital for about 24 hours.; Sender's Comments: Pseudostroke is an unlisted event which is considered unrelated to GSK drug Shingrix. More
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2832438 F 03/20/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Condition aggravated, Emotional distress, Gait disturbance, Guillain-Barre syndr... Condition aggravated, Emotional distress, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy; Impaired work ability, Laboratory test abnormal, Loss of personal independence in daily activities, Pain in extremity, Small fibre neuropathy More
Guillain-Barre Syndrome /difficulty walking /Leg pain; physical, emotional, and financial distress; ... Guillain-Barre Syndrome /difficulty walking /Leg pain; physical, emotional, and financial distress; incapacitated for 2 months /resulting in lost income, personal trips/ medical expenses; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cataract operation (had cataract surgery) and respiratory disorder (had respiratory illness). Previously administered products included Shingrix (received 1st dose on 28-NOV-2023). Concurrent medical conditions included small fiber neuropathy (had since 2016). In JAN-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre Syndrome /difficulty walking /Leg pain) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter), emotional distress (Verbatim: physical, emotional, and financial distress) (serious criteria other: Serious as per reporter) and activities of daily living impaired (Verbatim: incapacitated for 2 months /resulting in lost income, personal trips/ medical expenses) (serious criteria other: Serious as per reporter). The patient was treated with IMMUNOGLOBULINS. The outcome of the guillain barre syndrome, emotional distress and activities of daily living impaired were resolving. It was unknown if the reporter considered the guillain barre syndrome, emotional distress and activities of daily living impaired to be related to Shingrix. The company considered the guillain barre syndrome, emotional distress and activities of daily living impaired to be unrelated to Shingrix. Linked case(s) involving the same patient: US2025AMR031874 Additional Information: GSK Receipt Date: 13-MAR-2025 This case was received from the legal department to report the adverse event regarding the Shingrix vaccine. The complainant had filed a complaint against the doctor, intemist/rheumatologist for Reckless Imprudence resulting in Serious Physical Injury. The complaint arised from the administration of a Shingrix vaccine by the respondent in October 2023, which was intended to prevent shingles. The complainant alleged that Doctor, failed to properly inform her of the vaccines potential risks and side effects and did not take her medical history into account before administering the vaccine. The patient received the first dose of the Shingrix vaccine and were no reported issues after the first dose. The patient mentioned having recently experienced a respiratory illhess and undergoing cataract surgery. The patient received the second dose in January 2024, the complainant began experiencing severe pain and difficulty walking, which she promptly reported to doctor. Despite being advised by the doctor to go to the hospital, the complainant's condition worsened, leading to multiple hospital confinements at under the care of various doctors. A diagnosis of small fiber neuropathy secondary to varicella zoster vaccination was made and further treatment was suggested, including expensive intravenous immunoglobulin therapy (IVIG). The complainant later consulted additional neurologists who diagnosed her with Guillain-Barre Syndrome (GBS), a known side effect of the Shingrix vaccine. The respondent (doctor), allegedly failed to properly manage the patients condition, even though she had been informed of the sufferings and inquiries regarding the adverse effects. The doctor also allegedly attempted to refer the complainant to another specialist, instead of addressing the complications caused by the vaccine herself. As a result of the adverse effects, the complainant claimed to have suffered severe physical, emotional, and financial distress. She was incapacitated for over two months, resulting in lost income, personal trips, and significant medical expenses, totaling nearly one million pesos. In counter affidavit the doctor stated that, the complainant has been a patient of hers since 2016. In October 2023, she offered the complainant the recombinant herpes zoster (Shingrix) vaccine as a preventive measure for shingles, which the patient agreed to. After the second dose, the patient complained of leg pain, which was not accompanied by other severe symptoms like weakness, fever or rash. Respondent guided the patient to seek care at the Emergency Room and referred her to her cardiologist and neurologist. Despite the patient's concerns, respondent continued to offer support and coordinated with specialists for further evaluation. After a hospital admission and medical tests, it was determined that complainant had small fiber neuropathy, a condition not unusual in older adults. The Respondent (doctor) clarified that there was no clear medical evidence linking the condition to the vaccine, as small fiber neuropathy had been present in the patient since 2016. The patient condition improved, and she was discharged after receiving pain management. Respondent made efforts to ensure that the complainant received appropriate care, including securing urgent consultations with another neurologist and responding promptly to her concerns, even while traveling. Respondent also reported the case to the vaccine manufacturer (GSK) for investigation into the potential adverse effects of the vaccine. The complaint suggested that doctor actions, or lack thereof, amounted to negligence and inadequate response to a serious medical issue, potentially strengthening the case for reckless imprudence.; Sender's Comments: Guillain-Barre syndrome, Emotional distress and Loss of personal independence in daily activities are unlisted events which are considered unrelated to GSK vaccine Shingrix. US-GSK-US2025AMR031874:same patient case More
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2832439 F FL 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Influenza like illness, Injection site pain Influenza like illness, Injection site pain
feeling like she had the flu with aches; Pain injection site; This non-serious case was reported by ... feeling like she had the flu with aches; Pain injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site) and influenza-like symptoms (Verbatim: feeling like she had the flu with aches). The outcome of the injection site pain was resolved (duration 2 months) and the outcome of the influenza-like symptoms was resolved. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the injection site pain and influenza-like symptoms to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The patient self-reported this case. The patient had received 1st dose of Shingrix vaccine in 2022 and in 2022 due to feeling like she had the flu with aches and pains and pain at the injection site, she did not went back for the second vaccine within the recommended schedule time. The patient stated that she did not remember much about the things she experienced with the first dose. She did remember that the injection site pain lasted for about 2 months before it resolved. The patient did not remember what medications she was taking during the 1st dose in 2022. More
2832440 69 F FL 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Back pain, Neck pain Back pain, Neck pain
Neck pain; lower back pain; This non-serious case was reported by a consumer via call center represe... Neck pain; lower back pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of neck pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose on unknown date). Concurrent medical conditions included chemotherapy, diabetes, seizure, memory deficit, stomach pain and cholesterol. Concomitant products included brigatinib (Alunbrig), vitamin d, insulin lispro (Humalog), insulin glargine (Lantus), levetiracetam, memantine hydrochloride (Memantine), aluminium hydroxide gel, dried, magnesium carbonate (Pepcid) and rosuvastatin calcium (Rosuvastatin). On 03-MAR-2025, the patient received the 2nd dose of Shingrix. On 04-MAR-2025, 1 days after receiving Shingrix, the patient experienced neck pain (Verbatim: Neck pain) and low back pain (Verbatim: lower back pain). The outcome of the neck pain and low back pain were not resolved. It was unknown if the reporter considered the neck pain and low back pain to be related to Shingrix. It was unknown if the company considered the neck pain and low back pain to be related to Shingrix. Additional Information: GSK receipt date: 11-MAR-2025 Patient reported neck and lower back pain after receiving the second dose of Shingrix. More
2832441 CA 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site swelling Injection site swelling
swelling at the injection site; This non-serious case was reported by a pharmacist via call center r... swelling at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site). The outcome of the injection site swelling was unknown. The reporter considered the injection site swelling to be related to Shingrix. The company considered the injection site swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter states within the past 3 months she has administered Shingrix to two patients that had swelling at the injection site. The reporter could not provide the initials, date of birth, gender or lot number for the two individuals. No further information was obtained/provided by health care professional. This was 2 of the 2 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025029066:Same reporter/ different patient More
2832442 F OR 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never got the second dose; This non-serious case was reported by a consumer via call center represen... never got the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient had the first dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-MAR-2025 Patient reported that she had her first dose of Shingrix in 2019 but never got the second dose. Asked if she need to start over, or just have the second dose. Also stated that unfortunately healthcare providers were also unclear of the protocol in this situation and asked about boosters. Till the time of reporting the patient did not receive the second dose of Shingrix, which lead to incomplete course of vaccination. More
2832443 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
internal between 1st dose and 2nd dose was too long; This non-serious case was reported by a consume... internal between 1st dose and 2nd dose was too long; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (recived 1st dose over a year ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: internal between 1st dose and 2nd dose was too long). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 12-MAR-2025 This case was reported by a patient via interactive digital media. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient had a question should he/she get another one 2-6 months from the latest dose. More
2832444 03/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; several people who also got shingles not long after the vaccine; This... Suspected vaccination failure; several people who also got shingles not long after the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: several people who also got shingles not long after the vaccine). 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: 14-MAR-2025 This case was reported by a patient via interactive digital media. The reporter known several people who also got shingles not long after the vaccine (unspecified time period). This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with case US2025AMR031998 reported by the same reporter, for different patient.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR031998:same reporter different patient More
2832445 CA 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
shingrix missed second dose; This non-serious case was reported by a consumer via call center repres... shingrix missed second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose on unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: shingrix missed second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 16-MAR-2025 Patient stated that he/she missed second dose. Asked if they need to take another two doses. Till the time of reporting patient did not receive 2nd dose of vaccine which led to incomplete course of vaccination. More
2832446 F FL 03/20/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255t2
Incorrect dose administered Incorrect dose administered
Partial dose with leakage; This non-serious case was reported by a pharmacist via call center repres... Partial dose with leakage; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 86-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255t2, expiry date 05-DEC-2025) for prophylaxis. On 10-MAR-2025, the patient received the 1st dose of Arexvy. On 10-MAR-2025, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Partial dose with leakage). The outcome of the incomplete dose administered was not applicable. Additional Information: GSK Receipt Date: 10-MAR-2025 A pharmacist called in to request data about the need to readminister a dose of Arexvy after the patient was receiving a dose and recoiled, causing leakage of the vaccine, which led incomplete dose administered. The reporter consented to follow up. More
2832447 62 F OR 03/20/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Blister, Cognitive disorder, Inappropriate schedule of product administration, I... Blister, Cognitive disorder, Inappropriate schedule of product administration, Influenza like illness, Injection site erythema; Muscle strain, Skin discolouration, Skin warm, Swelling, Tenderness More
was like four days of discoloration/color turned to purple/light purple color; the area tender; The ... was like four days of discoloration/color turned to purple/light purple color; the area tender; The patient received the first dose of SHINGRIX in July 2023; red circular rash appeared about 2.5 inches in diameter which was below the injection site; Blisters; Flu-like symptoms; Cognitive dysfunction; color turned to blue; extreme swelling; hot to the touch; strain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in ??-JUL-2023) and Varicella vaccine (received Chicken Pox Vaccine on an unknown date). On 26-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). In FEB-2025, less than a day after receiving Shingrix, the patient experienced swelling (Verbatim: extreme swelling), blister (Verbatim: Blisters) and influenza-like symptoms (Verbatim: Flu-like symptoms). On 26-FEB-2025, the patient experienced injection site rash (Verbatim: red circular rash appeared about 2.5 inches in diameter which was below the injection site) and drug dose administration interval too long (Verbatim: The patient received the first dose of SHINGRIX in July 2023). On an unknown date, the patient experienced feeling hot (Verbatim: hot to the touch), strain (Verbatim: strain), skin discoloration (Verbatim: was like four days of discoloration/color turned to purple/light purple color), blue skin (Verbatim: color turned to blue), cognitive disturbance (Verbatim: Cognitive dysfunction) and tenderness (Verbatim: the area tender). The outcome of the injection site rash and blister were unknown and the outcome of the swelling, feeling hot, strain and cognitive disturbance were resolved (duration 5 days) and the outcome of the skin discoloration and tenderness were not resolved and the outcome of the blue skin was resolved (duration 4 days) and the outcome of the influenza-like symptoms was resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the injection site rash, swelling, feeling hot, strain, skin discoloration, blue skin, blister, influenza-like symptoms, cognitive disturbance and tenderness to be related to Shingrix. It was unknown if the company considered the injection site rash, swelling, feeling hot, strain, skin discoloration, blue skin, blister, influenza-like symptoms, cognitive disturbance and tenderness to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter reported that the patient had extreme swelling and hot to the touch with strain around the bandage site where the pharmacist placed the injection that lasted for 5 days of swelling and heat, that was like four days of discoloration. The patient received the second dose of Shingrix on Wednesday. About 2 hours after the injection, a red circular rash appeared about 2.5 inches in diameter which was below the injection site. During the night swelling appeared and the patient experienced flu-like symptoms The swelling of the injected arm was the size of a large grapefruit. The reporter reported, this area was hot and bright / dark red which lasted for 5 days and the color turned to purple and blue for 3 to 4 more days and the swelling went down. The patient had left the bandage on that was placed by the pharmacist after the shot. During the swelling, blisters appeared around the perimeter of the bandage. The patient also experienced cognitive dysfunction after the shot which last for 5 days. The patient went to Urgent Care for treatment. At the time of reporting, the area tender, was a light purple color and the area is flat. The patient states she never had Chicken Pox. The patient had the Chicken Pox Vaccine. The patient received 2nd dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule. More
2832448 64 M IN 03/20/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call... intramuscular administration of Priorix; 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 64-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 10-MAR-2025, the patient received Priorix (intramuscular). On 10-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix). 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: 11-MAR-2025 The reporter reported that the intramuscular administration of Priorix to patient , which led to subcutaneous injection formulation administered by other route. This was 1 of 3 linked cases , reported by the same reporter.; Sender's Comments: US-GSK-US2025029884:Same reporter/Different patient US-GSK-US2025029889:Same reporter/Different patient More
2832449 67 F 03/20/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 7HG2A
Incorrect route of product administration Incorrect route of product administration
patient that received it was born in 1957; administration via intramuscular; This non-serious case w... patient that received it was born in 1957; administration via intramuscular; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 67-year-old female patient who received MMR (Priorix) (batch number 7HG2A, expiry date 01-JAN-2026) for prophylaxis. On 10-MAR-2025, the patient received Priorix. On 10-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient that received it was born in 1957) and subcutaneous injection formulation administered by other route (Verbatim: administration via intramuscular). The outcome of the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-MAR-2025 Pharmacist wanted to know if the administration via intramuscular of Priorix in a patient was correct or not, but also mention that the patient that received it was born in X. Patient received the vaccine via intramuscular route at the age of 67 years, which led to subcutaneous injection formulation administered by other route and inappropriate age at vaccination. More
2832450 17 F IA 03/20/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2YS34
Expired product administered Expired product administered
administered expired vaccine of Havrix 720; This non-serious case was reported by a pharmacist via c... administered expired vaccine of Havrix 720; 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 female patient who received HAV (Havrix 720) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis. On 11-MAR-2025, the patient received Havrix 720. On 11-MAR-2025, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: administered expired vaccine of Havrix 720). 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: 11-MAR-2025 The registered pharmacist reported that they had a nurse who administer a dose of Havrix 720 unit to a patient on the day of reporting that was expired which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter. More
2832451 TX 03/20/2025 COVID19
 JANSSEN
Adverse event Adverse event
stated that the Covid 19 vaccine "Screwed up my whole body"; This spontaneous report recei... stated that the Covid 19 vaccine "Screwed up my whole body"; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced stated that the covid 19 vaccine "screwed up my whole body". (dose series 1). The patient had multiple complaints surrounding the covid-19 vaccine. The action taken with janssen covid-19 vaccine was not applicable. The outcome of stated that the covid 19 vaccine "screwed up my whole body" was not reported. This report was associated with a product quality complaint: Product Complaint 90000357534. This report was non-serious. More
2832452 F 03/20/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got COVID a month later; got COVID a month later; This is a spontaneous report received from a Physi... got COVID a month later; got COVID a month later; This is a spontaneous report received from a Physician from medical information team. A female patient received BNT162b2 (BNT162B2), in Dec2021 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, latency 1 month after the suspect product(s) administration, outcome "unknown" and all described as "got COVID a month later". Clinical course: the patient took the COVID vaccine BioNTech from Pfizer in Dec2021 and then got COVID infection in Jan2022. So, the patient got COVID the next month. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202500061109 Same patient, Different vaccine dose number and event; More
2832453 19 M UT 03/20/2025 HPV9
MENB
TDAP
TYP
YF
 MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
BERNA BIOTECH, LTD.
SANOFI PASTEUR
 1957407
LF5303
U8339BA
3004086
UK049AA
Eye irritation, Myalgia, Rash; Eye irritation, Myalgia, Rash; Eye irritation, My... Eye irritation, Myalgia, Rash; Eye irritation, Myalgia, Rash; Eye irritation, Myalgia, Rash; Eye irritation, Myalgia, Rash; Eye irritation, Myalgia, Rash More
HAD RINGWORM LOOKING SORE START ABOUT 10-14 DAYS AFTER VACCINATION ON LEFT CHEST BETWEEN ARMPIT AND ... HAD RINGWORM LOOKING SORE START ABOUT 10-14 DAYS AFTER VACCINATION ON LEFT CHEST BETWEEN ARMPIT AND NIPPLE AREA, SPREADING TO RASH THAT CONTINUES TO WORSEN. TRIED TAKING ZYRTEC FOR 2 DAYS BUT DIDN'T NOTICE ANY DIFFERENCE. COMPLAINING OF MUSCLE ACHES BUT GOES TO THE GYM 6 DAYS A WEEK. STATED RASH DOES NOT ITCH. HAS NOT HAD FEVER. ABOUT 7-10 DAYS AGO EXPERIENCED EYE IRRITATION. GIVEN DROPS FOR EYE BY MOM. More
2832454 1 M CO 03/20/2025 MMR
PNC20
RV5
 MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 X026330
HN5980
2032353
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
The patient experienced NO adverse event other than that he inadvertently received RV5 which he was ... The patient experienced NO adverse event other than that he inadvertently received RV5 which he was not due for. The error was noted while the pt./parents were still in the exam room. They were informed of the erro and told not to not expect any adverse symptoms outside what would normally be seen wth this vaccine. Parents were also instructed to report any adverse symtoms and that this nurse would follow-up with them on 03/19/25. I phoned on 03/19/25. I spoke with the child's mother. She informed me the pt. experienced NO adverse effects, stating he was "fine". I instructed her again to notify our agency if there were any adverse symptoms. More
2832455 60 F MI 03/20/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 2FP37
Joint swelling Joint swelling
The patient came to pick up her prescription on 3/20 and said that the RSV vaccination that she rece... The patient came to pick up her prescription on 3/20 and said that the RSV vaccination that she received on 3/1 caused swelling in her left wrist that began on 3/3. It lasted about 2 weeks. I asked if the site of injection was ever red or swollen and she stated that it was not. The issue is now resolved, she just wanted us to know what had occurred. More
2832456 12 M CA 03/20/2025 TDAP
 SANOFI PASTEUR
Abdominal pain upper, Dizziness, Nausea, Syncope, Vomiting Abdominal pain upper, Dizziness, Nausea, Syncope, Vomiting
Tdap, brand unknown (guessed). A few minutes after receiving the vaccine patient complained of stoma... Tdap, brand unknown (guessed). A few minutes after receiving the vaccine patient complained of stomach paid and said he might throw up. I told him to use the garbage can. He got up, vomited in the garbage can, said he was dizzy and then fainted. After that he started to feel better and then vomited a 2nd time about 20 minutes later. More
2832457 67 F 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X5j23
Cerebrovascular accident, Computerised tomogram, Gait inability, Hemiparesis, Ma... Cerebrovascular accident, Computerised tomogram, Gait inability, Hemiparesis, Magnetic resonance imaging More
Per my Patient - patient became unbalanced and was having/ could not walk and and became weak on her... Per my Patient - patient became unbalanced and was having/ could not walk and and became weak on her left side- after multiple test it turned out that patient had a stroke the next day after vaccine- per patient- pt. was seen and contacted their PCP. More
2832458 71 M PA 03/20/2025 COVID19
 MODERNA
 3043823
Expired product administered Expired product administered
Vaccine given 10 days beyond use date Vaccine given 10 days beyond use date
2832459 54 F TX 03/20/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LJ5283
3334Y
Injection site bruising, Injection site erythema, Injection site pain; Injection... Injection site bruising, Injection site erythema, Injection site pain; Injection site bruising, Injection site erythema, Injection site pain More
Patient presented picking up other medications and showed us her arm. Below the site of injection it... Patient presented picking up other medications and showed us her arm. Below the site of injection it seemed red and tender. The back side of the arm looked slightly bruised. More
2832460 54 F CA 03/20/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Chills, Diarrhoea, Dizziness, Fatigue, Headache; Injected limb mobility decrease... Chills, Diarrhoea, Dizziness, Fatigue, Headache; Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus; Injection site rash, Injection site swelling, Injection site warmth, Muscular weakness, Nausea; Pain, Pyrexia, Vomiting More
Fever, chills, headache, severe fatigue, dizziness, severe pain in and weakness in my right arm and ... Fever, chills, headache, severe fatigue, dizziness, severe pain in and weakness in my right arm and shoulder, unable to lift my right arm or lift any objects, diarrhea, nausea, and vomiting, at injection site: redness, discoloration, hot to touch, swelling, pain, rash, and itching. More
2832461 58 F NY 03/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 33FD3
Injection site rash, Rash erythematous Injection site rash, Rash erythematous
Pt noticed a red, inflamed rash approximately the size of a quarter below (unsure of distance from i... Pt noticed a red, inflamed rash approximately the size of a quarter below (unsure of distance from injection site) the button bandage from the shot, covering the injection site on the right arm. Patient noticed rash approx. two days after administration. Patient believes she may have had same reaction on first dose in series but cannot remember due to time between doses (approx 6 months). Patient just reported at date of incident report, unsure of follow up require at the moment but ADR does not seem to be life threatening but was advised if it doesn't improve in 1 to 2 days she should make an appointment with a physician. More
2832462 61 M SC 03/20/2025 HEP
PNC20
 DYNAVAX TECHNOLOGIES CORPORATION
PFIZER\WYETH
 944917
LK6650
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Heplisav Vaccine: no issues, Prevnar vaccine: patient has already received one dose on 10/13/2023. W... Heplisav Vaccine: no issues, Prevnar vaccine: patient has already received one dose on 10/13/2023. We were unaware, which is why he received one outside of dosing interval/recommendation on 03/19/25. Patient did not have any adverse events with this second dose of Prevnar. More
2832463 54 F WI 03/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 304351
304351
Dysarthria, Dysphagia, Headache, Laboratory test, Motor neurone disease; Pain in... Dysarthria, Dysphagia, Headache, Laboratory test, Motor neurone disease; Pain in jaw, Tongue disorder More
First symptom was difficulty with speach, few weeks later, tongue thickness feeling, and some diffic... First symptom was difficulty with speach, few weeks later, tongue thickness feeling, and some difficulty with swallowing pills. (Dysarthria and dysphagia diagnosed) Following month jaw pain and left temple pain. Outcome after seeing primary doctor, ENT, Rheumatology, and finally Nuerolgist- diagnosed with Bulbar Onset Motor Nueron Disease. More
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2832464 12 M CA 03/20/2025 HPV9
 MERCK & CO. INC.
 x024650
Chest pain, Dizziness, Pain in extremity, Throat irritation Chest pain, Dizziness, Pain in extremity, Throat irritation
Per patient verbalized that he felt pain in arm, and was feeling dizzy, and throat and chest hurt. M... Per patient verbalized that he felt pain in arm, and was feeling dizzy, and throat and chest hurt. Mom expressed concern because of the pallor on his face. Treatment was to provide cooling packs, lay down knees bent, monitor vitals. Some throat swelling was noted but no obstruction. Vitals were within normal ranges. Monitored until symptoms improved. Symptoms resolved on their own. No medication was given. More
2832477 68 F AL 03/20/2025 PNC20
 PFIZER\WYETH
 LX4482
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received extra dose of Prevnar 20. Patient had already received prevnar20 back in 12/06/2022... Patient received extra dose of Prevnar 20. Patient had already received prevnar20 back in 12/06/2022 but was not registered. Patient reports no adverse effects at this time. More
2832478 73 F OR 03/20/2025 COVID19
 MODERNA
 NDC: 80777-0110
Fatigue, Injection site pruritus, Nausea, Pain in extremity, Wheezing Fatigue, Injection site pruritus, Nausea, Pain in extremity, Wheezing
Itching around injection site approximately 10 minutes after injection. Aching of upper arm, which I... Itching around injection site approximately 10 minutes after injection. Aching of upper arm, which I consider a normal response developed within a half hour. Fatigue, nausea and mild wheezing developed around 90 minutes later. More
2831833 11 F GA 03/19/2025 FLU3
HPVX
 SANOFI PASTEUR
UNKNOWN MANUFACTURER
 UT8408NA
X025115
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE details reported; Fridge temperature dropped below freezing while office was closed... No additional AE details reported; Fridge temperature dropped below freezing while office was closed; This spontaneous report was received from the vaccine coordinator and refers to a 11-year-old female patient. The patient's medical history included asthma and allergies. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-OCT-2024, the patient was vaccinated with an improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9)(lot #X025115, expiration date: 19-MAY-2026) administered by Intramuscular route; and Influenza vaccine (FLUZONE) (lot #UT8408NA, expiration date: 30-JUN-2025) administered by Intramuscular route (strengths, doses description were not provided) for prophylaxis following a temperature excursion since Fridge temperature dropped below freezing while office was closed. No additional AE details reported. More
2832046 9 M NV 03/19/2025 HPV9
 MERCK & CO. INC.
 2018414
Therapeutic response unexpected Therapeutic response unexpected
HCP states patient has seen a "Significant" improvement in his (non-genital) warts after o... HCP states patient has seen a "Significant" improvement in his (non-genital) warts after one dose of GARDASIL 9. No other informaiton provided. No additional AEs/PQC reported.; This spontaneous report was received from a nurse and refers to a 9-year-old male patient. The patient's medical history, concomitant therapies, drug reactions or allergies were not reported. The patient's concurrent conditions included (non-genital) warts. On 15-NOV-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection (valid lot number 2018414, expiration date: 11-DEC-2025) for prevention of human papillomavirus (HPV) (dose, dose number, vaccination scheme, anatomical location, route of administration were not provided). On 15-NOV-2024, the patient had seen a "significant" improvement in his (non-genital) warts after one dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Therapeutic response unexpected). No other information provided. No additional adverse events reported. At the reporting time, the outcome of the event was not provided. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) not reported. More
2832047 MN 03/19/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product preparation issue Product preparation issue
Administration of the adjuvant portion only; Administration of the adjuvant portion only; This non-s... Administration of the adjuvant portion only; Administration of the adjuvant portion only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the adjuvant portion only) and inappropriate dose of vaccine administered (Verbatim: Administration of the adjuvant portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 10-MAR-2025 Reporter stated that the vaccine was not administered in their facility, what happened if only give the liquid component of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2832048 23 M 03/19/2025 FLUX
 UNKNOWN MANUFACTURER
Cough, Fatigue, Malaise, Swelling face Cough, Fatigue, Malaise, Swelling face
Fatigue; cough; Facial swelling; Sickness; Initial information received on 11-Mar-2025 regarding an ... Fatigue; cough; Facial swelling; Sickness; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 23 years old male patient who had fatigue, sickness, cough and facial swelling after receiving influenza vaccine and corticotropin. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Nephrotic syndrome. Concomitant medications included atorvastatin calcium, furosemide, magnesium oxide; mycophenolate mofetil, olmesartan medoxomil , potassium chloride, prednisone, spironolactone, tacrolimus, ergocalciferol (vitamin d) and omeprazole, all for Product used for unknown indication. On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for vaccine (Immunisation) and cortrophin Gel for injection of strength 1 ml 80 iU (International unit) BIW (twice a week) with lot number 307823 and expiry date 30-Jun-2025 subcutaneous for Nephrotic syndrome. On an unknown date the patient developed a non-serious fatigue, cough and facial swelling (swelling face) (unknown latency) On 28-Oct-2024 the patient developed a non-serious sickness (illness) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence corticotropin (cortrophin) was continued. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for the event fatigue, was Recovered / Resolved on an unknown date for the event cough, was Recovering / Resolving for the event sickness and was Not Recovered / Not Resolved for the event facial swelling. More
2832049 0.42 M AL 03/19/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK194AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
inappropriate use due to only the liquid portion of pentacel was administered to the patient with no... inappropriate use due to only the liquid portion of pentacel was administered to the patient with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse and processed together with live-follow up (10-Mar-2025). This case involves a 5 months old male patient who was administered inappropriately with the liquid portion of 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. On 26-Feb-2025, the patient received 0.5mL of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Suspension for injection (lot number UK194AA expiry date 01-Mar-2026 and strength standard) for immunisation and inappropriately only the liquid portion of pentacel was administered to the patient with no reported adverse event (single component of a two-component product administered) (latency same day). Action taken was not applicable. The age of the patient and dose description of the product was added. Narrative amended accordingly. Reportedly, nurse would like to know if the patient needs to be revaccinated with Pentacel (Vero) or can they administer the ActHib and the vaccination would be completed. 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. Based on data previously received, the following information (duplicate entry for pentacel vero #2 deleted) has been amended. More
2832050 1 F TX 03/19/2025 IPV
 SANOFI PASTEUR
 Y1A201M
No adverse event, Wrong product administered No adverse event, Wrong product administered
accidentally administered 0.1 ml of IPV instead of a PPD skin test to a baby, with no reported adver... accidentally administered 0.1 ml of IPV instead of a PPD skin test to a baby, with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old female patient who experienced accidentally administered IPV (VERO) [IPOL] 0.1 ml of ipv instead of a tuberculin test [Tuberculin Ppd] to a baby,with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation; Varicella zoster vaccine for Immunisation; Hepatitis a vaccine for Immunisation; and Influenza vaccine for Immunisation. On 05-Mar-2025, the patient accidentally received 0.1 ml of suspect IPV (VERO),Suspension for injection, lot Y1A201M, strength: standard, frequency: once, Expiry date:31-Jan-2027 via unknown route in unknown administration site for Immunization instead of a tuberculin test with no reported adverse event (wrong product administered) (latency: same day). Reportedly,verified that ipv's brand name is ipo. Action taken not applicable This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832051 MD 03/19/2025 HIBV
 SANOFI PASTEUR
No adverse event, Product preparation error No adverse event, Product preparation error
inappropriate use due to use of alternate diluent with no reported adverse event; Initial informatio... inappropriate use due to use of alternate diluent with no reported adverse event; Initial information received on 12-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient and is reported inappropriate use of Hib (PRP/T) Vaccine [ACT-HIB] due to use of alternate 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 suspect tHib (PRP/T) Vaccine,Powder and solvent for solution for injection, lot number, strength and expiry date not reported via unknown route in unknown administration site for immunization with use of alternate diluent with no reported adverse event (product preparation error) (latency: same day) Information on the batch number was requested corresponding to the one at time of event occurrence Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832052 FL 03/19/2025 HIBV
 SANOFI PASTEUR
No adverse event, Product preparation error No adverse event, Product preparation error
act-hib diluent was mixed with sterile water with no reported adverse event; Initial information rec... act-hib diluent was mixed with sterile water with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves HIB (PRP/T) vaccine [ACT-HIB] diluent was mixed with sterile water with no reported adverse event. On an unknown date, HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry date-unknown) not reported via unknown route in unknown administration site for Immunization and was mixed with sterile water with no reported adverse event (product preparation error). 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
2832053 0.08 F VA 03/19/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK174AB
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
1-month old patient who was given with PENTACEL by mistake,with no reported adverse event; Initial i... 1-month old patient who was given with PENTACEL by mistake,with no reported adverse event; Initial information received on 17-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 months old female patient who was given with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] by mistake,with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PREVNAR 15 for Immunisation. On 17-Mar-2025, the patient received at dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UK174AB and expiry 31-Mar-2026) by mistake, with no reported adverse event (product administered to patient of inappropriate age) (latency same day) via intramuscular route in right leg for immunization. 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
2832067 48 M CA 03/19/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 016B21A
016B21A
007C21A
007C21A
042J21A
042J21A
Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy, Cerebral ischae... Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy, Cerebral ischaemia, Ejection fraction decreased; Electrocardiogram abnormal, Nervous system disorder, Tachycardia; Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy, Cerebral ischaemia, Ejection fraction decreased; Electrocardiogram abnormal, Nervous system disorder, Tachycardia; Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy, Cerebral ischaemia, Ejection fraction decreased; Electrocardiogram abnormal, Nervous system disorder, Tachycardia More
I lived a healthy and active lifestyle as a former athlete for much of my life. However, after recei... I lived a healthy and active lifestyle as a former athlete for much of my life. However, after receiving the two Moderna COVID-19 shots and the booster in May 2021, I began experiencing severe health issues. Approximately six months after my first shot, I was diagnosed with atrial fibrillation (A-Fib), cardiomyopathy, tachycardia, and congestive heart failure, with an ejection fraction of 15%. These conditions have left me in need of a heart transplant. Additionally, I began suffering from neurological disorders due to decreased blood flow to my brain, which has compounded my health challenges. I am currently 52 years old. More
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2832068 38 F OH 03/19/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA



Abdominal pain, Blood test, Immunodeficiency, Impaired work ability, Loss of per... Abdominal pain, Blood test, Immunodeficiency, Impaired work ability, Loss of personal independence in daily activities; Metastasis, Renal cancer stage IV, Scan, Surgery, X-ray; Abdominal pain, Blood test, Immunodeficiency, Impaired work ability, Loss of personal independence in daily activities; Metastasis, Renal cancer stage IV, Scan, Surgery, X-ray More
I worked full-time and healthcare and I?ve been a single mother for 16 years. I worked third shift s... I worked full-time and healthcare and I?ve been a single mother for 16 years. I worked third shift so I didn?t miss my kids waking hours. I was a football mom. I never stopped. I worked all through the pandemic and I switched jobs to try to avoid the Covid vaccine. I did not want it. Finally made it mandatory, and I had to get it done by a certain date or I was gonna be fired. I have proof of this actually I have a social media post from the day. I got my vaccine. It says well. I got my vaccine today against my will or I was gonna be fired that?s basically what it says . 11 months later, I was diagnosed with stage for renal cancer. I was with my kids at the fireworks on the holiday and the next morning I woke up and I was in so much pain in my abdomen, and I could not even stand up. I worked many shifts up into this day as a nurses aide, which is very very strenuous work. I have suffered so much in the last three years. Mostly the last year, but definitely the full three years almost 3 years. With the first immunotherapy, they tried on me. I look like I was being burnt from the inside out all over my body. The second treatment I tried made my brain swell up caused blindness, I was in a hospital far away from my home because me and my kids had just finished with vacation. I woke up in that hospital. I barely knew I had to learn how to walk by myself again talk normally again I had to learn how to use the bathroom on my own again. It was very humbling and it?s been a very hard recovery to watch. I have lost time with my kids that I will never get back. My life has never been the same since I woke up on July 5, 2022. There is scientific proof that the Covid vaccine causes kidney damage kidney disease, which obviously kidney cancer is kidney disease. I had been to the hospital or urgent cares and had x-rays scans bloodwork and then boom all of a sudden that and nowhere I have stage four cancer and I can never even do my job again. I?m in so much pain every day it?s agonizing. I can?t go to my sons football practices anymore, but I do try to make games . I know the doctors don?t expect me to live too long, but I believe God will bring me through this. I really hope something is done soon because I know with that a shadow of a doubt that that vaccine caused me to have stage four cancer 11 months after I had the Covid vaccine against my will or I was gonna lose my employment as a single mother! I hope there?s help soon! Oh, before I finish, the cancer has spread to multiple places but one of the places it spread to is my ribs and I?ve already had one rib removed. I?ve had a part of my body removed that I will never feel the same again. Now the last scan show that it?s on another rib, we are going to try radiation soon because losing another rib it just seems like too much. Thank you for your time. I just want to add that when I was first diagnosed with stage four renal cancer. All of the doctors were in shock. Everyone that came in contact with me was shocked that I could have cancer that advanced when I had been seen at hospitals, urgent cares and had never been diagnosed with anything near that. The doctors couldn?t believe that at my age at the age of 39 I am 42 now that I had this type of advanced cancer. There is documentation of everything I speak of from above. More
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2832069 31 M TN 03/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6200
EN6200
Cancer screening, Coagulation test, Computerised tomogram, Deep vein thrombosis,... Cancer screening, Coagulation test, Computerised tomogram, Deep vein thrombosis, Pulmonary embolism; Scan with contrast, Thrombectomy, Ultrasound scan, X-ray More
Deep Vein Thrombosis (DVT) in lower left leg; requiring emergency thrombectomy & hospitalization... Deep Vein Thrombosis (DVT) in lower left leg; requiring emergency thrombectomy & hospitalization (6 October 2023); Subsequent pulmonary embolism (roughly 3-4 weeks later) requiring life-long course of anticoagulant medication. More
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2832076 0.5 UT 03/19/2025 HIBV
 MERCK & CO. INC.
 Y003145
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No symptomatic adverse events; the patient received a third dose of PEDVAXHIB at 6 months of age.; T... No symptomatic adverse events; the patient received a third dose of PEDVAXHIB at 6 months of age.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 06-Jan-2025, the patient was vaccinated with a third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) injection (lot #Y003145 has been verified to be a valid lot number, expiration date: 12-Sep-2026; 0.5ml/ series; route and strenght were not provided) for prophylaxis (inappropriate schedule of product administration). No symptomatic adverse events were reported. This is one of the several reports from the same reporter/facility. More
2832077 F 03/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
Shingles; This serious case was reported by a consumer via other manufacturer and described the occu... Shingles; This serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included ruxolitinib phosphate (Jakafi) tablet for product used for unknown indication. On an unknown date, the patient received the 1st dose of Shingrix and Jakafi (oral) 20 mg twice a day (40 mg daily). On 25-FEB-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) (serious criteria clinically significant/intervention required). The patient was treated with valaciclovir. The action taken with Jakafi was unknown. The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 11-MAR-2025 A 66-year-old female patient initiated the use of oral Jakafi (ruxolitinib) 20 mg tablets BID on an unknown date for an unknown indication. The batch/lot number and expiration date were not reported On 25-FEB-2025, at the time of the report, the patient was diagnosed with shingles and was prescribed with valacyclovir to treat it. She was in between her first injection of Shingrix and her second injection of Shingrix when she developed signs of shingles. The outcome of the events was not reported. Concomitant medications were not reported. The Jakafi drug was ongoing. Medical history was not reported. No additional information was provided. Serious spontaneous report Shingles intervention required assessed as listed per the regulatory authority.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2832078 0.08 F 03/19/2025 HIBV
HIBV
HIBV
PNC13
PNC13
PNC13
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Atelectasis, Breath sounds abnormal, Chest X-ray abnormal, Cough, Dyspnoea; Elec... Atelectasis, Breath sounds abnormal, Chest X-ray abnormal, Cough, Dyspnoea; Electrocardiogram abnormal, Influenza virus test negative, Lung consolidation, Lung opacity, Respiratory syncytial virus bronchiolitis; Respiratory syncytial virus test positive, Respiratory tract congestion, Respiratory viral panel, Rhonchi, Sinus tachycardia; Atelectasis, Breath sounds abnormal, Chest X-ray abnormal, Cough, Dyspnoea; Electrocardiogram abnormal, Influenza virus test negative, Lung consolidation, Lung opacity, Respiratory syncytial virus bronchiolitis; Respiratory syncytial virus test positive, Respiratory tract congestion, Respiratory viral panel, Rhonchi, Sinus tachycardia; Atelectasis, Breath sounds abnormal, Chest X-ray abnormal, Cough, Dyspnoea; Electrocardiogram abnormal, Influenza virus test negative, Lung consolidation, Lung opacity, Respiratory syncytial virus bronchiolitis; Respiratory syncytial virus test positive, Respiratory tract congestion, Respiratory viral panel, Rhonchi, Sinus tachycardia; Atelectasis, Breath sounds abnormal, Chest X-ray abnormal, Cough, Dyspnoea; Electrocardiogram abnormal, Influenza virus test negative, Lung consolidation, Lung opacity, Respiratory syncytial virus bronchiolitis; Respiratory syncytial virus test positive, Respiratory tract congestion, Respiratory viral panel, Rhonchi, Sinus tachycardia; Atelectasis, Breath sounds abnormal, Chest X-ray abnormal, Cough, Dyspnoea; Electrocardiogram abnormal, Influenza virus test negative, Lung consolidation, Lung opacity, Respiratory syncytial virus bronchiolitis; Respiratory syncytial virus test positive, Respiratory tract congestion, Respiratory viral panel, Rhonchi, Sinus tachycardia More
Respiratory syncytial virus bronchiolitis; This 3-month-old female subject was enrolled in a blinded... Respiratory syncytial virus bronchiolitis; This 3-month-old female subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular) on 27th July 2018, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 27th July 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 29th September 2018, 64 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed moderate - grade 2 respiratory syncytial virus bronchiolitis. Serious criteria included hospitalization and GSK medically significant. The subject was treated with paracetamol (Tylenol) and 5% dextrose + potassium chloride + 0.9% sodium chloride iv. Bexsero vs Placebo was continued with no change. DTPa-HBV-IPV was continued with no change. Prevnar 13 was continued with no change. Hiberix was continued with no change. Rotarix lyophilized formulation was continued with no change. The outcome of respiratory syncytial virus bronchiolitis was recovered/resolved on 15th October 2018. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Relevant Tests: On 29 Sep 2018, X-ray showed patchy opacity in the right upper to mid lung zone represents atelectasis or consolidation. Diagnostic results (unless otherwise stated, normal values were not provided): On 29th September 2018, Respiratory syncytial virus test result was RSV detected and X-ray result was See text. On 30th September 2018, Electrocardiogram result was normal axis, sinus tachycardia. GSK Receipt Date - 04-OCT-2018 Mother was contacted today 10/4/18 after her missed visit to re-schedule appt. In which she informed us subject was hospitalized for 3 days for RSV. This information was verbally given. Mother does not remember date of admission. Records have been requested and we will follow up when site gets more accurate information. update from hospital records: Patient was admitted 9/29/2018. RVP: RSV+ (confirmed through Respiratory Virus PCR Panel), influenza- and was managed for RSV Bronchiolitis during her stay. She presented on what appears to be day 1 of illness. On admission she appeared to not be in acute respiratory distress although patient was coughing and had labored breathing. On, auscultation, no focal consolidations, no wheezes, although there were bilateral rhonchi in the lower lobes with transmitted upper airway sounds likely from congestion. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchiolitis, 64 days after receiving 1st dose of Bexsero vs Placebo, 1st dose of Prevnar 13, 1st dose of DTPa-HBV-IPV vaccine in pre-filled syringe device injection syringe, 1st dose of Hiberix, 1st dose of Rotarix lyophilized formulation vaccine in oral applicator device co-administered with PCV and routine vaccines in a 3-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering an implausible time to onset and absence of biological plausibility. US-GLAXOSMITHKLINE-US2018181213: More
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2832079 0.33 F 03/19/2025 HIBV
PNC13
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
Chest X-ray normal, Respiratory syncytial virus infection, Respiratory syncytial... Chest X-ray normal, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Chest X-ray normal, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Chest X-ray normal, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Chest X-ray normal, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Chest X-ray normal, Respiratory syncytial virus infection, Respiratory syncytial virus test positive More
Respiratory Syncytial Virus; This 6-month-old female subject was enrolled in a blinded study. The su... Respiratory Syncytial Virus; This 6-month-old female subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 01-NOV-2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 01-NOV-2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 01-NOV-2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 01-NOV-2018, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for an unknown indication. On 05-JAN-2019, 65 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed moderate - grade 2 respiratory syncytial virus infection (Verbatim: Respiratory Syncytial Virus). Serious criteria included hospitalization. The subject was treated with sodium chloride and glucose;potassium chloride (Dextrose;Potassium Chloride). Bexsero vs Placebo was continued with no change. The outcome of respiratory syncytial virus infection was resolved on 11-JAN-2019. Relevant Tests: On an unknown date in Jan2019 Normal Chest x-ray while in hospital; RSV(Respiratory syncytial virus) TEST POSTITVE. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK Receipt Date : 08-Jan-2019 Subject was seen in ER(emergency room) on 06Jan2019 and diagnosed with RSV(respiratory syncytial virus). Subject got worse overnight and came to Clinic and was given a breathing treatment with little improvement so mom was told to watch subject and return if she got any worse. Subject was not improving that afternoon so Mom was told to take her to the the ER and she was admitted. While in hospital subject was given updrafts and IV Fluids. Subject was discharged from Hospital on 09Jan2019. Follow up information received on 10-Feb-2025, 11-Feb-2025 Medication name as reported was Sodium chloride updraft, Little Noses (Sodium Chloride Summary of changes: Lab data updated, Causality of device updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus infection, 65 days after receiving the 2nd doses of Bexsero vs Placebo co-administered with PCV and routine vaccines, Prevnar 13, DTPa-HBV-IPV Hiberix and Rotarix lyophilized formulation, in a 6-month-old male subject. Report is inconsistent with causal relation to the vaccine products, considering the implausible time to onset , absence of biological plausibility and alternative etiology (Respiratory syncytial virus test positive). More
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2832080 0.17 M 03/19/2025 HIBV
HIBV
PNC13
PNC13
UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
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Bronchiolitis, Chest X-ray normal, Condition aggravated, Cough, Nasal congestion... Bronchiolitis, Chest X-ray normal, Condition aggravated, Cough, Nasal congestion; Productive cough, Tachypnoea, Use of accessory respiratory muscles, Wheezing; Bronchiolitis, Chest X-ray normal, Condition aggravated, Cough, Nasal congestion; Productive cough, Tachypnoea, Use of accessory respiratory muscles, Wheezing; Bronchiolitis, Chest X-ray normal, Condition aggravated, Cough, Nasal congestion; Productive cough, Tachypnoea, Use of accessory respiratory muscles, Wheezing; Bronchiolitis, Chest X-ray normal, Condition aggravated, Cough, Nasal congestion; Productive cough, Tachypnoea, Use of accessory respiratory muscles, Wheezing; Bronchiolitis, Chest X-ray normal, Condition aggravated, Cough, Nasal congestion; Productive cough, Tachypnoea, Use of accessory respiratory muscles, Wheezing More
Worsening Acute Viral Bronchiolitis; Worsening Acute Viral Bronchiolitis; This 3-month-old male subj... Worsening Acute Viral Bronchiolitis; Worsening Acute Viral Bronchiolitis; This 3-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 08-MAR-2019, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 08-MAR-2019, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, left thigh) on 08-MAR-2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 08-MAR-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. Concurrent medical conditions included acute bronchiolitis (Viral). On 23-APR-2019, 46 days after receiving Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation, the subject developed severe - grade 3 acute bronchiolitis (Verbatim: Worsening Acute Viral Bronchiolitis). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 condition aggravated (Verbatim: Worsening Acute Viral Bronchiolitis) on 23-APR-2019 with serious criteria of hospitalization. The subject was treated with salbutamol (Albuterol) and dexamethasone (Decadron). The action taken with Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation was no change. The outcome of acute bronchiolitis was resolved on 19-MAY-2019. The outcome(s) of the additional event(s) included condition aggravated (resolved on 19-MAY-2019). Relevant Tests: On 25-Apr-2019 Chest X-ray showed, no cardiopulmonary abnormalities.. Diagnostic results (reference ranges are provided in parenthesis if available): Oxygen saturation-In APR-2019 88% on room air percent:In APR-2019 95 percent:In APR-2019 98 percent:In APR-2019 85 percent and in APR-2019 100 percent. The investigator considered that there was no reasonable possibility that the acute bronchiolitis and condition aggravated may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the acute bronchiolitis and condition aggravated may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. Linked case(s) involving the same subject: US2019090498 Subject seen at PCP (primary care physician) office with cough and wheezing that had worsened starting 23-Apr-2019. Decadron IM (intramuscular) and albuterol inh given at PCP. Oxygen placed at 7L via face mask and oxygen sats up to 95 percent. Subject transferred to hospital via EMS (Emergency medical services). At hospital oxygen sats high 80's. Subject was suctioned and thick secretions removed. Chest Xray done-no cardiopulmonary abnormalities shown. Started on vapotherm oxygen at 6L, 30 percent and oxygen sats increased to 98 percent. Temp 99.6. Placed in contact and droplet isolation. IV (intravenous) saline lock placed. No further updates at this time. The subject was admitted on 25-Apr-2019 and was discharged on 28-Apr-2019. The subject was previously seen in the office on 19-Mar-2019, 25-Mar-2019, and 10-Apr-2019 with symptoms of cough, wheezing and mild contractions that had not resolved. The subject was not recovered as of May 10, 2019 and was scheduled to return to the clinic on May 17, 2019. Subject seen by primary care physician on 17-May-2019. Subject presented with cough, wheezing, and 02 sat of 85 percent. Placed on 02 (oxygen) at 2 liters per minute, increased to 100 percent but still wheezing. Subject transferred by EMS to hospital. Subject had tachypnea in the 60s with subcostal retractions, nasal suctioning with improvement in retractions. Admitted for viral bronchiolitis. Subject was discharged home on 19-May-19 after being stable throughout the day and evening. Nasal congestion and wheezing present. Subject was well appearing and breathing comfortable. Case US2019090498 was identified as a duplicate of US2019075981. All correspondence will be added in the case US2019075981. Follow-up information received on 31-JUL-2024 Summary of changes: Treatment drug (Albuterol) and event condition aggravated Updated. Follow-up information received on 11-Feb-2025 Summary of changes: Treatment medication Albuterol (frequency) updated from prn to Q4H. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Bronchiolitis and Condition aggravated, 46 days after receiving Placebo and 1st dose of DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation in a 3-month-old male subject. Placebo case following unblinding, causality assessment non applicable. Report is inconsistent with causal relation to the vaccine products, considering implausible time to onset, absence of biological plausibility and alternative etiology (concurrent medical condition acute bronchiolitis). US-GLAXOSMITHKLINE-US2019090498: More
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2832081 0.33 M 03/19/2025 HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
MEN
MEN
MEN
MEN
MEN
MEN
MEN
MEN
PNC13
PNC13
PNC13
PNC13
PNC13
PNC13
PNC13
PNC13
UNK
UNK
UNK
UNK
UNK
UNK
UNK
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 UNKNOWN MANUFACTURER
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PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
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Alanine aminotransferase normal, Amylase decreased, Basophil percentage, Blood c... Alanine aminotransferase normal, Amylase decreased, Basophil percentage, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Coagulation factor level normal; Computerised tomogram head abnormal, Craniocerebral injury, Crying, Drug screen negative, Ecchymosis; Eosinophil percentage, Fall, Haematocrit decreased, Haemoglobin normal, Intensive care; Lipase normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased; Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil percentage decreased, Platelet count normal; Red blood cell count normal, Red cell distribution width normal, Skeletal survey normal, Subarachnoid haemorrhage, Urine analysis normal; White blood cell count normal; Alanine aminotransferase normal, Amylase decreased, Basophil percentage, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Coagulation factor level normal; Computerised tomogram head abnormal, Craniocerebral injury, Crying, Drug screen negative, Ecchymosis; Eosinophil percentage, Fall, Haematocrit decreased, Haemoglobin normal, Intensive care; Lipase normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased; Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil percentage decreased, Platelet count normal; Red blood cell count normal, Red cell distribution width normal, Skeletal survey normal, Subarachnoid haemorrhage, Urine analysis normal; White blood cell count normal; Alanine aminotransferase normal, Amylase decreased, Basophil percentage, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Coagulation factor level normal; Computerised tomogram head abnormal, Craniocerebral injury, Crying, Drug screen negative, Ecchymosis; Eosinophil percentage, Fall, Haematocrit decreased, Haemoglobin normal, Intensive care; Lipase normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased; Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil percentage decreased, Platelet count normal; Red blood cell count normal, Red cell distribution width normal, Skeletal survey normal, Subarachnoid haemorrhage, Urine analysis normal; White blood cell count normal; Alanine aminotransferase normal, Amylase decreased, Basophil percentage, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Coagulation factor level normal; Computerised tomogram head abnormal, Craniocerebral injury, Crying, Drug screen negative, Ecchymosis; Eosinophil percentage, Fall, Haematocrit decreased, Haemoglobin normal, Intensive care; Lipase normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased; Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil percentage decreased, Platelet count normal; Red blood cell count normal, Red cell distribution width normal, Skeletal survey normal, Subarachnoid haemorrhage, Urine analysis normal; White blood cell count normal; Alanine aminotransferase normal, Amylase decreased, Basophil percentage, Blood chloride normal, Blood creatine normal; Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Coagulation factor level normal; Computerised tomogram head abnormal, Craniocerebral injury, Crying, Drug screen negative, Ecchymosis; Eosinophil percentage, Fall, Haematocrit decreased, Haemoglobin normal, Intensive care; Lipase normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased; Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil percentage decreased, Platelet count normal; Red blood cell count normal, Red cell distribution width normal, Skeletal survey normal, Subarachnoid haemorrhage, Urine analysis normal; White blood cell count normal More
Subarachnoid hemorrhage; This 5-month-old male subject was enrolled in a blinded study. The subject ... Subarachnoid hemorrhage; This 5-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 27th August 2019, for prophylaxis. On 3rd October 2019 08:33, 37 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed moderate - grade 2 subarachnoid hemorrhage. Serious criteria included hospitalization and GSK medically significant. Bexsero vs Placebo co-administered with PCV and routine vaccines was continued with no change. The outcome of subarachnoid hemorrhage was recovered/resolved on 4th October 2019 14:56. The investigator considered that there was no reasonable possibility that the subarachnoid hemorrhage may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. Relevant Tests: On 03 Oct 2019, Brain CT 3D without Contrast Small amount of high density within the left sylvian fissure consistent with subarachnoid(or less likely subpial) hemorrhage. No significant mass effect. On 03 Oct 2019, Urine toxicology screen for Marijuana, Cocaine Amph/Methamph Barbiturates Methadone Opiates Phencyclidine Benzos ALL Negative. Diagnostic results (unless otherwise stated, normal values were not provided): On 3rd October 2019, Alanine aminotransferase result was 47.00 IU/L (normal low: 17.00, normal high: 63.00), Amylase result was 24.00 IU/L (normal low: 0.00, normal high: 11.00), Basophil percentage result was 1 percent (normal low: 0.00, normal high: 2.00), Basophil percentage result was 1.0 percent (normal low: 0.00, normal high: 2.00), Blood chloride result was 108.00 mmol/L (normal low: 98.00, normal high: 107.00), Blood creatine result was 0.20 mmol/L (normal low: 0.10, normal high: 0.60), Blood glucose result was 89.00 mg/dL (normal low: 57.00, normal high: 117.00), Blood potassium result was 4.20 mmol/L (normal low: 4.10, normal high: 5.30), Blood sodium result was 139 mmol/L (normal low: 136.00, normal high: 146.00), Blood urea result was 6.00 mg/dL (normal low: 6.00, normal high: 18.00), Computerised tomogram head result was see text, Eosinophil percentage result was 2.00 percent (normal low: 0.00, normal high: 3.00), Haematocrit result was 33.90 percent (normal low: 29.00, normal high: 41.00), Haemoglobin result was 11.60 g/dL (normal low: 9.50, normal high: 13.50), Lipase result was 42.00 IU/L (normal low: 73.00, normal high: 393.00), Lymphocyte percentage result was 33.00 percent (normal low: 33.00, normal high: 63.00), Mean cell haemoglobin result was 25.40 pg (normal low: 27.00, normal high: 33.00), Mean cell haemoglobin concentration result was 34.0 g/dL (normal low: 31.00, normal high: 35.00), Mean cell volume result was 74.40 fL (normal low: 74.00, normal high: 108.00), Mean platelet volume result was 7.5 fL (normal low: 6.80, normal high: 10.40), Monocyte count result was 0.58 x10e9/L (normal low: 0.05, normal high: 1.10), Monocyte percentage result was 8 percent (normal low: 5.00, normal high: 12.00), Neutrophil percentage result was 34.00 percent (normal low: 19.00, normal high: 39.00), Platelet count result was 346 (normal low: 156.00, normal high: 359.00), Red blood cell count result was 4.56 (normal low: 3.10, normal high: 4.50), Red cell distribution width result was 12.40 percent (normal low: 11.80, normal high: 15.20), Skeletal survey result was no evidence for acute or healing fractures, Urine analysis result was Normal and White blood cell count result was 7.0 x10e9/L (normal low: 5.00, normal high: 17.00). GSK Receipt Date- 04-OCT-2019 Previously healthy 5 month old presented to Hospital ED evening of 10/3/2019 after closed head injury.Child rolled off a bed falling onto wood floor. Immediately cried no loss of consciousness Normal neuro exam noted area of ecchymosis on temporal scalp CT Scan showed small subarachnoid hemorrhage. Admitted to PICU for medical monitoring. Seen by neurosurgery and trauma team. Had CBC urinalysis urine toxicology screen, clotting factors and skeletal survey all within normal limits. Doing well today may be discharged home. 10/4/2019 15:25 EDT discharged to home. Follow up information received on 11-Mar-2025 End of study Unblinding completed. Upon internal review the case was updated on 17-Mar-2025. Study drugs updated.; Sender's Comments: A case of subarachnoid hemorrhage, 37 days after receiving 2nd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines in a 5-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology of fall based on medical history. US-GLAXOSMITHKLINE-US2019191983: More
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