๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2837370 20 F TX 04/22/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
A 20 years old female patient received a dose of Priorix IM instead of SQ; This non-serious case was... A 20 years old female patient received a dose of Priorix IM instead of SQ; 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 20-year-old female patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A 20 years old female patient received a dose of Priorix IM instead of SQ). 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: 17-APR-2025 Other HCP reported that a patient received Priorix intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route. Reporter asked does it need a revaccination or not. Also asked what do they have to do next. More
2837371 66 F FL 04/22/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 2N795
Incorrect route of product administration Incorrect route of product administration
received a dose of Priorix via intramuscular injection instead of subcutaneously; This non-serious c... received a dose of Priorix via intramuscular injection instead of subcutaneously; 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 66-year-old female patient who received MMR (Priorix) (batch number 2N795, expiry date 13-SEP-2026) for prophylaxis. On 17-APR-2025, the patient received Priorix (intramuscular). On 17-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received a dose of Priorix via intramuscular injection instead of subcutaneously). 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: 18-APR-2025 Pharmacist reported patient received a dose of Priorix via intramuscular injection instead of subcutaneously, which led to subcutaneous injection formulation administered by other route. More
2837372 81 M 04/22/2025 COVID19
 MODERNA
 059M21A
Pain, Vaccination site pain Pain, Vaccination site pain
pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" int... pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head; pain in left shoulder area; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (pain in left shoulder area) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (had Covid-19 approximately on Jan 2022.) in January 2022 and Cardiac stent placement (Patient had heart stents). Previously administered products included for Drug use for unknown indication: EMPAGLIFLOZIN (25 mg), ASCORBIC ACID 2-O-GLUCOSIDE (10 mg 4 tablets a day) and Alogliptin (12.5 mg). Past adverse reactions to the above products included No adverse event with ASCORBIC ACID 2-O-GLUCOSIDE, Alogliptin and EMPAGLIFLOZIN. Concurrent medical conditions included Type 2 diabetes mellitus. On 02-Jun-2022, the patient received fifth dose of mRNA-1273 (Spikevax) (Intramuscular use) .5 milliliter. On 02-Jun-2022, after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE PAIN (pain in left shoulder area). On an unknown date, the patient experienced PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head). The patient was treated with Naproxen at an unspecified dose and frequency. At the time of the report, PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (pain in left shoulder area) had not resolved. No concomitant medications were reported. The patient's age was reported as almost 84 years old. In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number not provided). On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number 030M20A). On 13-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number 038A21A). On 04-Nov-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage 0.5 milliliter (lot number 012F21A). It was reported that his reaction started with the first COVID vaccine back in 2020 and it went worse and worse, and he had 6 shots of Moderna. His pain has moved from his left shoulder area, between the shoulder and neck, and then moved up to 1 inch behind the left ear, 2 inches into the head and down along the hair line in the head. It went worse in the last few weeks. He was unsure if he spoke with HCP regarding how he was feeling, but he mentioned it every time when he received his Covid vaccine. He would like the pain to go away. It was unknown if the patient experienced any additional symptoms or events. This case was linked to US-MODERNATX, INC.-MOD-2023-728819 (Patient Link). More
2837373 81 M 04/22/2025 COVID19-2
 MODERNA
 021HA22A
Pain, Vaccination site pain Pain, Vaccination site pain
pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" int... pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head; pain in left shoulder area; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (pain in left shoulder area) in a 9-decade-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021HA22A) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (approximately on Jan 2022) in January 2022 and Cardiac stent placement (Had heart stents). Previously administered products included for Drug use for unknown indication: ALOGLIPTIN (12.5 mg) and EMPAGLIFLOZIN (25 mg). Past adverse reactions to the above products included No adverse effect with ALOGLIPTIN and EMPAGLIFLOZIN. Concurrent medical conditions included Type 2 diabetes mellitus. On 27-Oct-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (pain in left shoulder area). The patient was treated with Naproxen at an unspecified dose and frequency. At the time of the report, PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (pain in left shoulder area) had not resolved. No concomitant medications were reported. The patient's age was reported as almost 84 years old. Past drug included Glucoside (10 mg 4 tablets a day). In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number not provided). On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number: 030M20A). On 13-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number: 038A21A). On 04-Nov-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage 0.5 milliliter (lot number: 012F21A). On 02-Jun-2022, the patient received fifth dose of mRNA-1273 (Spikevax) (Intramuscular use) 0.5 milliliter (lot number: 059M21A). It was reported that, his reaction started with the first COVID vaccine back in 2020 and it went worse and worse, and he had 6 shots of Moderna. His pain has moved from his left shoulder area, between the shoulder and neck, and then moved up to 1 inch behind the left ear, 2 inches into the head and down along the hair line in the head. It went worse in the last few weeks. He was unsure if he spoke with HCP regarding how he was feeling, but he mentioned it every time when he received his Covid vaccine. He would like the pain to go away. It was unknown if the patient experienced any additional symptoms or events. This case was linked to MOD-2023-728819 (Patient Link). More
2837374 83 M 04/22/2025 COVID19
 MODERNA
 3032233
Pain, Vaccination site pain Pain, Vaccination site pain
Pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" int... Pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head; Pain in left shoulder area; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (Pain in left shoulder area) in a 9-decade-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032233) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (approximately on Jan 2022) in January 2022 and Cardiac stent placement (had heart stents). Previously administered products included for Drug use for unknown indication: ALOGLIPTIN (12.5 mg) and EMPAGLIFLOZIN (25 mg). Past adverse reactions to the above products included No adverse effect with ALOGLIPTIN and EMPAGLIFLOZIN. Concurrent medical conditions included Type 2 diabetes mellitus. On 16-May-2024, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN (Pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (Pain in left shoulder area). The patient was treated with Naproxen at an unspecified dose and frequency. At the time of the report, PAIN (Pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (Pain in left shoulder area) had not resolved. No concomitant medications were reported. The patient's age was reported as almost 84 years old. Past drug included Glucoside (10 mg 4 tablets a day). In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number not provided). On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number 030M20A). On 13-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number 038A21A). On 04-Nov-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage 0.5 milliliter (lot number 012F21A). On 02-Jun-2022, the patient received fifth dose of mRNA-1273 (Spikevax) (Intramuscular use) 0.5 milliliter (lot number 059M21A). On 27-Oct-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 0.5 milliliter (lot number 021HA22A). On 02-NOV-2023, the patient received seventh dose of Spikevax 2023-2024 (Intramuscular use) 0.5 milliliter (lot number not provided). It was reported that his reaction started with the first COVID vaccine back in 2020 and it went worse and worse, and he had 6 shots of Moderna. His pain has moved from his left shoulder area, between the shoulder and neck, and then moved up to 1 inch behind the left ear, 2 inches into the head and down along the hair line in the head. It went worse in the last few weeks. He was unsure if he spoke with HCP regarding how he was feeling, but he mentioned it every time when he received his Covid vaccine. He would like the pain to go away. It was unknown if the patient experienced any additional symptoms or events. This case was linked to MOD-2023-728819 (Patient Link). More
2837375 82 M 04/22/2025 COVID19
 MODERNA
Pain, Vaccination site pain Pain, Vaccination site pain
pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" int... pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head; Pain in left shoulder area; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (Pain in left shoulder area) in a 9-decade-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (approximately on Jan 2022) in January 2022 and Cardiac stent placement (had heart stents). Previously administered products included for Product used for unknown indication: ALOGLIPTIN (12.5 mg) and EMPAGLIFLOZIN (25 mg). Past adverse reactions to the above products included No adverse effect with ALOGLIPTIN and EMPAGLIFLOZIN. Concurrent medical conditions included Type 2 diabetes mellitus. On 02-Nov-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (Pain in left shoulder area). The patient was treated with Naproxen at an unspecified dose and frequency. At the time of the report, PAIN (pain between the shoulder and neck, and has now moved up to 1" behind the left ear, 2" into the head and down along the hair line in the head) and VACCINATION SITE PAIN (Pain in left shoulder area) had not resolved. No concomitant medications were reported. The patient's age was reported as almost 84 years old. Past drug included Glucoside (10 mg 4 tablets a day). In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number 030M20A). On 13-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 0.5 milliliter (lot number 038A21A). On 04-Nov-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage 0.5 milliliter (lot number 012F21A). On 02-Jun-2022, the patient received fifth dose of mRNA-1273 (Spikevax) (Intramuscular use) 0.5 milliliter (lot number 059M21A). On 27-Oct-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 0.5 milliliter (lot number 021HA22A). It was reported that his reaction started with the first COVID vaccine back in 2020 and it went worse and worse, and he had 6 shots of Moderna. His pain has moved from his left shoulder area, between the shoulder and neck, and then moved up to 1 inch behind the left ear, 2 inches into the head and down along the hair line in the head. It went worse in the last few weeks. He was unsure if he spoke with HCP regarding how he was feeling, but he mentioned it every time when he received his Covid vaccine. He would like the pain to go away. It was unknown if the patient experienced any additional symptoms or events. This case was linked to MOD-2023-728819 (Patient Link). More
2837376 M 04/22/2025 COVID19
 MODERNA
COVID-19, Malaise, Sluggishness COVID-19, Malaise, Sluggishness
I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ... I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (I went and got my vaccine and then it started coming on more/Little sluggish for a couple of days/I ended up getting sick) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication information was not provided. Patient and his daughter got COVID. Patient got COVID a while back ago. The first day that he heard that his daughter who was living in a single studio apartment became sick, he went and got his vaccine and then it started coming on more and he ended up getting sick. He got the Paxlovid pills from the physician, took those for 5 days and was fine. He was a little sluggish for a couple of days. His daughter also received the pills. He would get another shot on the day of report to make sure he did not get it again as he heard that the vaccine lasted for about 6 months. More
2837377 F 04/22/2025 COVID19
 MODERNA
Head discomfort, Nervousness Head discomfort, Nervousness
feeling shaken harshly back and forth but not harshly; feeling pressure in their head while driving ... feeling shaken harshly back and forth but not harshly; feeling pressure in their head while driving after receiving vaccine; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (feeling pressure in their head while driving after receiving vaccine) and NERVOUSNESS (feeling shaken harshly back and forth but not harshly) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 16-Apr-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced HEAD DISCOMFORT (feeling pressure in their head while driving after receiving vaccine). On 18-Apr-2025, the patient experienced NERVOUSNESS (feeling shaken harshly back and forth but not harshly). At the time of the report, HEAD DISCOMFORT (feeling pressure in their head while driving after receiving vaccine) had not resolved and NERVOUSNESS (feeling shaken harshly back and forth but not harshly) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that on 16-Apr-2025 and 18-Apr-2025, patient felt a lot of pressure in her head while driving. On 16-Apr-2025, it was resolved after she reached home, but she was afraid to drive again later that day. On 17-Apr-2025, she drove without any problem. Later, on 18-Apr-2025, it happened again while driving. It almost felt like she was shaken back and forth but not harshly. She wanted to know if there was something she should be concerned about. It was unknown if the patient experienced any additional symptoms or events No treatment medications were reported. More
2837378 33 F 04/22/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH

Exposure during pregnancy, Injection site erythema, Injection site pain, Injecti... Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth More
Injection site reaction redness; Injection site reaction: swelling; Injection site reaction: warm; I... Injection site reaction redness; Injection site reaction: swelling; Injection site reaction: warm; Injection site reaction: itching; Injection site reaction: mild pain; gestational_period: 37; gestational_period: 37; This is a spontaneous report received from a Pharmacist. A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Apr2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for maternal immunisation. The patient's relevant medical history included: "Allergy: Sulfa drugs" (unspecified if ongoing). The patient was 37 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05May2025. Concomitant medication(s) included: TDAP taken for immunisation, on 25Mar2025 as dose number unknown, single. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Apr2025 at 10:00, outcome "unknown" and all described as "gestational_period: 37"; VACCINATION SITE ERYTHEMA (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction redness"; VACCINATION SITE PRURITUS (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: itching"; VACCINATION SITE PAIN (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: mild pain"; VACCINATION SITE SWELLING (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: swelling"; VACCINATION SITE WARMTH (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: warm". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pruritus, vaccination site pain. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2837379 74 F GA 04/22/2025 COVID19
 PFIZER\BIONTECH
Hemiparesis, Palpitations, Paraesthesia, Tremor Hemiparesis, Palpitations, Paraesthesia, Tremor
left sided neurological issues, including tremors & tingling, weakness; intermittent heart palpi... left sided neurological issues, including tremors & tingling, weakness; intermittent heart palpitations; left sided neurological issues, including tremors & tingling, weakness; left sided neurological issues, including tremors & tingling, weakness; This is a spontaneous report received from a Physician from a sales representative. A 74-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dsoe 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Nov2024, outcome "not recovered", described as "intermittent heart palpitations"; HEMIPARESIS (medically significant), TREMOR (non-serious), PARAESTHESIA (non-serious) all with onset Nov2024, outcome "not recovered" and all described as "left sided neurological issues, including tremors & tingling, weakness". Therapeutic measures were taken as a result of hemiparesis, palpitations, tremor, paraesthesia. Clinical course: Experiencing intermittent heart palpitations, left sided neurological issues, including tremors & tingling, weakness. Periodic flare-ups of these symptoms. Patient was received Physical therapy as treatment received for the adverse event. Patient was not received any other vaccines on the same date as the vaccine(s) and other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event Hemiparesis and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
2837380 56 F GA 04/22/2025 COVID19
 PFIZER\BIONTECH
 FC3180
Asthenia, Dyspnoea, Ventricular extrasystoles Asthenia, Dyspnoea, Ventricular extrasystoles
Premature Ventricular Contractions - trigeminal pattern; shortness of breath; reduced energy; This i... Premature Ventricular Contractions - trigeminal pattern; shortness of breath; reduced energy; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2021 as dose 2, single (Lot number: FC3180) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism and High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: May2017; HYDROCHLOROTHIAZIDE, start date: Jan2020; LOSARTAN, start date: Sep2020. Past drug history included: Lisinopril, reaction(s): "Hypersensitivity". Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot number: EW0198), administration date: 19Jul2021, for Covid-19 immunisation. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious) with onset 01Oct2022, outcome "not recovered", described as "Premature Ventricular Contractions - trigeminal pattern"; ASTHENIA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "reduced energy"; DYSPNOEA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "shortness of breath". Therapeutic measures were taken as a result of ventricular extrasystoles, dyspnoea, asthenia. Additional information: The patient did not receive any other vaccines on the same date as the vaccine and did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. Reported Event: Not long after taking the vaccines patient got where had shortness of breath and reduced energy. And about a year and a half later it got worse and when went to doctor at the time did an EKG and it was abnormal, so they got an appointment with Dr. with Cardiology and several thousand dollars later was diagnosed with Premature Ventricular Contractions - trigeminal pattern. And on last Doctors appointment two weeks ago every other heartbeat is a PVC. Have been on three different medications to try and control them. The Nurse Practitioner who gave me the first EKG was having the same issue, and she said hers was from the vaccine also. Metroprolol , then Flecainide and now Amiodarone was taken as treatment for events; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500084867 same event, similar drug and different patient.; More
2837381 F OR 04/22/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-Co... COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-CoV-2 test More
27Feb2023 I tested positive for covid, after having all of the vaccines; 27Feb2023 I tested positive... 27Feb2023 I tested positive for covid, after having all of the vaccines; 27Feb2023 I tested positive for covid, after having all of the vaccines; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "muscle problems" (unspecified if ongoing), notes: statins may be causing muscle problems. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "my ears ring"; Aspirin, reaction(s): "Reaction: Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Feb2023, outcome "recovered with sequelae" and all described as "27Feb2023 I tested positive for covid, after having all of the vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: On 27Feb2023 tested positive for covid, after having all of the vaccines. In a day or 2 started on Paxlovid. Patient took it for the prescribed time (5 days) and began to feel better. But the following week (13Mar) covid came back and lasted until the 18th. and experienced a bad taste with the paxlovid, which she expected, but what she didn't expect was the nausea and diarrhea. She had many attacks of both over the next several months. But the attacks got further apart until she don't have the diarrhea very often now. But she still gets the nausea. She honestly doesn't know if it's from the paxlovid or the covid itself; but it began with the paxlovid, so I found this site and am reporting it. OTC anti-diahrrea and prescribe nausea med was prescribed as treatment for the event. Batch/lot number is not provided, and it cannot be obtained. More
2837382 04/22/2025 DTAP
HIBV
 SANOFI PASTEUR
SANOFI PASTEUR

No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue More
n giving Act Hib reconstituted with Daptacel at the 15-month visit with no reported adverse event; I... n giving Act Hib reconstituted with Daptacel at the 15-month visit with no reported adverse event; Initial information received on 15-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at the 15-month visit with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine at the 15-month visit with no reported adverse event (product preparation error) (unknown latency) Information on the batch number could not be requested corresponding to the one at time of event occurrence Reportedly, reporter stated that, I have an account that has been giving Act Hib reconstituted with Daptacel at the 15-month visit. The account has not been using the diluent that comes with Act Hib they have been using Daptacel as the diluent. Nurses state that the rep, 15 years ago, informed them that they could use Daptacel to reconstitute Act Hib. 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
2837383 AR 04/22/2025 DTAP
HIBV
 SANOFI PASTEUR
SANOFI PASTEUR

No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue More
they reconstituted act-hib with Daptacel instead of the provided diluent with no reported adverse ev... they reconstituted act-hib with Daptacel instead of the provided diluent with no reported adverse event; Initial information received on 15-Apr-2025 (with live follow up received on 15-APR-2025) regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine at the 15-month visit with no reported adverse event (product preparation error) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- Caller mentioned that the DTap was Daptacel and the situation has been a practice for years and there were over 2000 patients administered. 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
2837384 42 M WA 04/22/2025 FLU3
 SANOFI PASTEUR
 U8442BA
No adverse event, Product storage error No adverse event, Product storage error
adminsitered post excursion with no adverse event; temperature excursion of fluzone Max/low temperat... adminsitered post excursion with no adverse event; temperature excursion of fluzone Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC Duration: 30minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases- US-SA- 2025SA114290. This case involves a 42 years old male patient who was administered INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] post excursion with no adverse event and temperature excursion of fluzone max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation. On 04-APR-2025 temperature excursion of fluzone max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30minutes with no reported adverse event (product storage error) (unknown latency). On 14-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE Suspension for injection (strength standard) dose 0.5 ml, 1x (once) lot U8442BA expiry date-20-Jun-2025 via intramuscular route in the left deltoid for influenza administered post excursion with no adverse event (poor quality product administered) (latency same day). Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking) and patient did not report any adverse events 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.; Sender's Comments: US-SA-2025SA113376:cluster case US-SA-2025SA114290:Master case More
2837385 58 M WA 04/22/2025 FLU3
 SANOFI PASTEUR
 U8442BA
No adverse event, Product storage error No adverse event, Product storage error
Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC Duration: 30 minutes with no reported adverse even... Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC Duration: 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 58 years old male patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] and the vaccine was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes 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 COVID-19 vaccine for Immunisation. On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (strength- standard, expiry date- 20-JUN-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes with no reported adverse event (product storage error). On 14-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the right deltoid. Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. ; Sender's Comments: US-SA-2025SA114282:cluster case US-SA-2025SA114290: US-SA-2025SA113257: More
2837387 MD 04/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration
Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na๏ฟฝve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837388 MD 04/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration
Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na๏ฟฝve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837389 MD 04/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration
Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na๏ฟฝve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837390 MD 04/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration
Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na๏ฟฝve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837391 MD 04/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration
Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na๏ฟฝve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837392 MD 04/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration
Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na๏ฟฝve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837393 MD 04/22/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration
Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na๏ฟฝve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837394 11 M AZ 04/22/2025 MENB
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 B4J4B
333SK
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Meningococcal B vaccine was given out of the prefered age for vaccination. Age for vaccination is 16... Meningococcal B vaccine was given out of the prefered age for vaccination. Age for vaccination is 16 through 18 years, patient was 11 years old when he got this vaccine. More
2837395 2 F CA 04/22/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 Unknown
Irritability, Pyrexia, Rash Irritability, Pyrexia, Rash
Patient was fussy and irritable starting a few hours after injection. She maintained a fever for abo... Patient was fussy and irritable starting a few hours after injection. She maintained a fever for about 24 hrs, as well as developed a rash all over her body that was lasted several days. More
2837396 2 F CA 04/22/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Genital rash, Hypersensitivity, Rash, Rash pruritic Genital rash, Hypersensitivity, Rash, Rash pruritic
Patient developed fiery painful and itchy rash on torso, spreading to chest, and the worst was in he... Patient developed fiery painful and itchy rash on torso, spreading to chest, and the worst was in her thighs and genital area (she is potty trained and does not wear diapers - could not be ?diaper rash?) Had to dose her with allergy medicine for this allergic reaction More
2837397 7 F CA 04/22/2025 PNC20
 PFIZER\WYETH
 HN5980
No adverse event, Wrong product administered No adverse event, Wrong product administered
NO ADVERSE EVENTS, REPORTING WRONG VACCINE ADMINISTERED BY PROVIDER. NO ADVERSE EVENTS, REPORTING WRONG VACCINE ADMINISTERED BY PROVIDER.
2837398 2 F CA 04/22/2025 DTAP
HEPA
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
PFIZER\WYETH
 223Y9
Y008338
UK169AB
LX2497
Injection site erythema, Injection site rash; Injection site erythema, Injection... Injection site erythema, Injection site rash; Injection site erythema, Injection site rash; Injection site erythema, Injection site rash; Injection site erythema, Injection site rash More
SLIGHTLY RED AND SMALL RASH ON LEFT THIGH FROM DTAP BEING GIVEN SLIGHTLY RED AND SMALL RASH ON LEFT THIGH FROM DTAP BEING GIVEN
2837399 58 F LA 04/22/2025 PNC21
 MERCK & CO. INC.
 Y019158
Cellulitis Cellulitis
PATIENT REPORTS DEVELOPING CELLULITIS AS A RESULT OF THIS VACCINE FOUR DAYS AFTER VACCINATION PATIENT REPORTS DEVELOPING CELLULITIS AS A RESULT OF THIS VACCINE FOUR DAYS AFTER VACCINATION
2837400 1 F WA 04/22/2025 MMR
 MERCK & CO. INC.
 X011431
Expired product administered Expired product administered
Pt was given MMR vaccine that was expired 2 days prior. Expired on 4/19/2025 and given 4/22/2025 Pt was given MMR vaccine that was expired 2 days prior. Expired on 4/19/2025 and given 4/22/2025
2837401 36 F CA 04/22/2025 MMR
 MERCK & CO. INC.
 y014391
Unevaluable event Unevaluable event
Pt brought in rx for MMR vaccine, Shingrix, Twinrix, Boostrix, Prevnar, from Dr. for MMR Pt brought in rx for MMR vaccine, Shingrix, Twinrix, Boostrix, Prevnar, from Dr. for MMR
2837402 56 F FL 04/22/2025 PNC20
 PFIZER\WYETH
 LC5485
Peripheral swelling, Rash Peripheral swelling, Rash
Patient had swelling in left arm and rash in her body Patient had swelling in left arm and rash in her body
2837403 38 F NY 04/22/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8488KA
UT8488KA
Blood test, Magnetic resonance imaging joint, Magnetic resonance imaging neck, P... Blood test, Magnetic resonance imaging joint, Magnetic resonance imaging neck, Pain, Pain in extremity; X-ray limb More
My left arm started hurting about 1 month after that vaccine & still having chronic pain in left... My left arm started hurting about 1 month after that vaccine & still having chronic pain in left arm. I saw NP 12/4/25. & she ordered an x-ray of my left arm & put me on gabapentin on 12/23/24. More
2837414 78 M FL 04/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Extra dose administered, Injection site erythema, Injection site pain Extra dose administered, Injection site erythema, Injection site pain
Patient received a second dose of Arexvy on 4/17/2025. He received a dose previously on 1/24/2024. H... Patient received a second dose of Arexvy on 4/17/2025. He received a dose previously on 1/24/2024. He felt some soreness and redness at the injection site that resolved after 3 days More
2837415 36 F MN 04/22/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Body temperature increased, Pruritus, Urticaria Body temperature increased, Pruritus, Urticaria
Patient began feeling "a little itchy" 2 hrs after administration, 2 hrs after this, her ... Patient began feeling "a little itchy" 2 hrs after administration, 2 hrs after this, her throat began getting itchy, her back and throat was itchy. The next day her she had small hives (not very raised) on her chest, neck, middle of back side. She managed symptoms with oral benadryl daily. Pt reports that whenever she was active and her BP, body temp rises with exertion, she felt the itchiness on neck and arm areas again. She reported these effects to pharmacy 5 days post vaccination. Symptoms are improving with benadryl use, pt will update with any changes. More
2837416 77 F VA 04/22/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Decreased appetite, Dysstasia, Measles antibody positive, Mumps antibody test ne... Decreased appetite, Dysstasia, Measles antibody positive, Mumps antibody test negative, Pyrexia; Rash, Rubella antibody positive, Vertigo More
Low grade fever 99F-100F (<100.4F) started 11 days post-vaccination, lasting 2-3 days, rising to ... Low grade fever 99F-100F (<100.4F) started 11 days post-vaccination, lasting 2-3 days, rising to high-grade fever up to 103F for another 3-5 days, after which diffuse rash appeared and lasted for 4 days with no appetite, followed by another 3-4 days of intense vertigo (patient unable to stand or move without holding onto furniture or walls). She denied any respiratory symptoms and reported a total of ~2 weeks of symptoms that ultimately resolved 3 days before her return to clinic for planned 2nd MMR dose (was scheduled for 4/17/25). After lengthy discussion with RN and consultation with ordering physician, vaccination was postponed and titers were drawn to determine best plan of care. More
2837417 58 F NC 04/22/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 y013009
9l944
Pain in extremity, Paraesthesia; Pain in extremity, Paraesthesia Pain in extremity, Paraesthesia; Pain in extremity, Paraesthesia
Pt reported to the pharmacy with arm soreness reaching from shoulder to wrist with tingling in her f... Pt reported to the pharmacy with arm soreness reaching from shoulder to wrist with tingling in her fingers. She says that the pain started after receiving Shingles and pneumonia vaccines in the left arm 2 weeks ago. Pt was advised to go to the doctors office where she was prescribed naproxen. Pt came back saying that the doctor told her that, based on her own description of where the vaccine was given, the vaccine was given too low and could have caused her problems. More
2837418 66 F LA 04/22/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 y013009
n77j2
Injection site pruritus, Injection site rash, Injection site warmth, Rash erythe... Injection site pruritus, Injection site rash, Injection site warmth, Rash erythematous; Injection site pruritus, Injection site rash, Injection site warmth, Rash erythematous More
red rash on right arm below injection site. hot, itchy red rash on right arm below injection site. hot, itchy
2837419 21 F IL 04/22/2025 HPV9
 MERCK & CO. INC.
Blood glucose, Dizziness, Syncope, Vomiting Blood glucose, Dizziness, Syncope, Vomiting
patient felt lightheaded, and had syncopal episode with vomiting shortly after vaccine. After vomit... patient felt lightheaded, and had syncopal episode with vomiting shortly after vaccine. After vomiting she felt better More
2837420 70 F WA 04/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site bruising, Injection site pain, Pain Injection site bruising, Injection site pain, Pain
BRUSING AT INJECTION SITE, PAIN RADIATING DOWN TO LOWER ARM FOR OVER A WEEK. BRUSING AT INJECTION SITE, PAIN RADIATING DOWN TO LOWER ARM FOR OVER A WEEK.
2837421 14 M IL 04/22/2025 IPV
MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 X1D141M
U8183AA
3CA30C1
Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
Patient accidentally received a duplicate dose of all three vaccines: MedQuafi, Adacel and IPOL. Fir... Patient accidentally received a duplicate dose of all three vaccines: MedQuafi, Adacel and IPOL. First dose administered was 4/17/2025, and second round of doses were administered the next day on 4/18/2025. No adverse signs or symptoms were observed or reported by the patient. The patient's guardian was contacted and informed of the error, and was advised by the physician accordingly, with no additional questions or concerns. More
2837436 0.17 F MT 04/22/2025 DTAPHEPBIP
HIBV
PNC20
RSV
RV5
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
UNKNOWN MANUFACTURER
MERCK & CO. INC.
 ZG273
Y013470
LJ5280
UK309AA
2037483
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
-baby was double dosed on RSV vaccine this season. Baby monitored extra time. No reaction occurred. -baby was double dosed on RSV vaccine this season. Baby monitored extra time. No reaction occurred.
2837437 62 F NH 04/22/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX2497
I5229
Feeling hot, Pain in extremity, Rash; Feeling hot, Pain in extremity, Rash Feeling hot, Pain in extremity, Rash; Feeling hot, Pain in extremity, Rash
Pt presented states her arm hurt, had a rash and was hot Pt presented states her arm hurt, had a rash and was hot
2838218 16 M TX 04/22/2025 MENB
MENB
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
SANOFI PASTEUR
 B4J4B
B4J4B
U8370AA
U8370AA
Blood creatine phosphokinase normal, C-reactive protein increased, Full blood co... Blood creatine phosphokinase normal, C-reactive protein increased, Full blood count normal, Headache, Injected limb mobility decreased; Metabolic function test normal, Nausea, Pain in extremity; Blood creatine phosphokinase normal, C-reactive protein increased, Full blood count normal, Headache, Injected limb mobility decreased; Metabolic function test normal, Nausea, Pain in extremity More
Pain L arm, decreased ROM L arm, nausea, headache. R arm normal. Pain L arm, decreased ROM L arm, nausea, headache. R arm normal.
2836924 NY 04/21/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 3A2KF
Exposure via skin contact, Needle issue, Underdose Exposure via skin contact, Needle issue, Underdose
partial dose of HIBERIX given; Some of the vaccine was dripping down patient arm; Some of it ran dow... partial dose of HIBERIX given; Some of the vaccine was dripping down patient arm; Some of it ran down patient arm; states 3 of the needles popped off and completely detached off the syringe and 1 needle detached during administration; Pharmaceutical product complaint; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a patient who received Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: partial dose of HIBERIX given), inadvertent exposure to vaccine (Verbatim: Some of the vaccine was dripping down patient arm), exposure via skin contact (Verbatim: Some of it ran down patient arm), device connection issue (Verbatim: states 3 of the needles popped off and completely detached off the syringe and 1 needle detached during administration) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the accidental underdose, inadvertent exposure to vaccine, exposure via skin contact, device connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the device connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. It was unknown if the company considered the device connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-APR-2025 The reporter stated that he had another 4 occurrences with Hiberix. He states 3 of the needles popped off and completely detached off the syringe and 1 needle detached during administration. Some of the vaccine was dripping down patient arm which led to inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. Health care professional not sure how much the patient received. He stated that happened about a week ago, no date, no PII, he did not have any information at this time. He stated that all but 1 of the suspect syringes left for return. He stated that all needles were discarded in sharps as well. Picture of unopened needle and suspect product will be sent with this case. Confirmed that all operations were performed appropriately. 3 needle while attaching the second needle for administration and 1 needle during injection detaching or rotating of the luer lok adaptor occurred. Reg 25 g needle was used and no safety on it. Reporter requested to credit total of 4 Hiberix vaccines to GlaxoSmithKline Direct. There was a product complaint to reported of detaching needles from pre-filled syringes. The case had been linked to US2025017219, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025017219:Same reporter More
2836925 56 M NC 04/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 Fj9a7
Rash Rash
Full body rash; This non-serious case was reported by a physician via sales rep and described the oc... Full body rash; This non-serious case was reported by a physician via sales rep and described the occurrence of generalized rash in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number Fj9a7, expiry date 16-JUL-2025) for prophylaxis. On 21-JAN-2025, the patient received the 1st dose of Shingrix. On 24-JAN-2025, 3 days after receiving Shingrix, the patient experienced generalized rash (Verbatim: Full body rash). The outcome of the generalized rash was not resolved. It was unknown if the reporter considered the generalized rash to be related to Shingrix. It was unknown if the company considered the generalized rash to be related to Shingrix. Additional Information: GSK Receipt Date: 14-APR-2025 The patient experienced full body rash. More
2836926 04/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PC5Y3
No adverse event, Product preparation issue No adverse event, Product preparation issue
vaccine was not reconstitied with the adjuvant was just administered; vaccine was not reconstitied w... vaccine was not reconstitied with the adjuvant was just administered; vaccine was not reconstitied with the adjuvant was just administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number PC5Y3, expiry date 30-JAN-2027) for prophylaxis. In APR-2025, the patient received Shingrix (unknown deltoid). In APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: vaccine was not reconstitied with the adjuvant was just administered) and inappropriate dose of vaccine administered (Verbatim: vaccine was not reconstitied with the adjuvant was just administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 There were no symptoms had been reported. Only adjuvant was administered to the patient without having it mixed with the Vaccine Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The health care professional was unaware to whom they administered it too. It was when they were checking on their product quantity, they found out that the vaccine was not reconstituted with the adjuvant and the adjuvant was just administered. Unsure about primary disease because they do not know the patient and usually patient take it as a preventive measures. No further information. More
2836927 54 F IA 04/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3G5T3
Product preparation issue Product preparation issue
Possible adminstration of Diluent only to the pateint; Possible adminstration of Diluent only to the... Possible adminstration of Diluent only to the pateint; Possible adminstration of Diluent only to the pateint; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis. On 02-FEB-2025, the patient received the 2nd dose of Shingrix (right deltoid). On 02-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Possible adminstration of Diluent only to the pateint) and inappropriate dose of vaccine administered (Verbatim: Possible adminstration of Diluent only to the pateint). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 The nurse reported possible administration of diluent only to the patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2024158602, reported by same reporter.; Sender's Comments: US-VIIV HEALTHCARE-US2024158602:same reporter More
2836928 04/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Fatigue, Headache, Injection site erythema, Injection site swelling, Injection s... Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth; Nausea, Pyrexia More
injection site was becoming red; the injection site was swollen; the injection site was hot; fever; ... injection site was becoming red; the injection site was swollen; the injection site was hot; fever; Fatigue; Nausea; headach; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 09-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced injection site erythema (Verbatim: injection site was becoming red), injection site swelling (Verbatim: the injection site was swollen), injection site warmth (Verbatim: the injection site was hot), fever (Verbatim: fever), fatigue (Verbatim: Fatigue), nausea (Verbatim: Nausea) and headache (Verbatim: headach). The outcome of the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache were not reported. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 11-APR-2025 The patient had Shingrix vaccine on 09 Apr 2025 and the injection site was becoming red and hot and swollen. Also running 100.4 fever, fatigue, nausea and headache. They questions was this ok and how likely would patient have such severe symptoms at second shot. More
2836929 04/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
Damn that shot hurt; This non-serious case was reported by a consumer via interactive digital media ... Damn that shot hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Damn that shot hurt). The outcome of the injection site pain was not reported. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 11-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got his/her first shot two months ago. Damn that shot hurt. Fighting to go for second.; Sender's Comments: US-GSK-US2025AMR046350:Same reporter More
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