🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2837929 1 F MT 04/24/2025 DTAPHEPBIP
MMR
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 D252F
X011441
LG5574
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event More
EXPIRED MMR DOSE INADVERTENTLY GIVEN TO PATIENT. DOSE EXPIRED ON 4/19/2025. DOSE WAS GIVEN TO PATIEN... EXPIRED MMR DOSE INADVERTENTLY GIVEN TO PATIENT. DOSE EXPIRED ON 4/19/2025. DOSE WAS GIVEN TO PATIENT ON 4/23/2025. PATIENT'S MOTHER NOTIFIED ON 4/24/2025. PATIENT DOES NOT HAVE ANY ADVERSE REACTIONS. MOTHER NOTIFIED THAT PATIENT WILL RECEIVE AN ADDITIONAL DOSE OF MMR AT NEXT APPOINTMENT IN JUNE. More
2837930 86 M VA 04/24/2025 PNC20
 PFIZER\WYETH
 0005200001
Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus
Pt reported adverse reaction to our office on the afternoon of 04/24/25. He reported that his arm g... Pt reported adverse reaction to our office on the afternoon of 04/24/25. He reported that his arm got red, swollen and itched the following day after getting this immunization on 04/15/25. More
2837931 4 M PA 04/24/2025 MMRV
 MERCK & CO. INC.
 z002986
Erythema, Pruritus, Swelling Erythema, Pruritus, Swelling
itchy, red and swollen itchy, red and swollen
2837932 17 F DE 04/24/2025 MENB
MENB
 PFIZER\WYETH
PFIZER\WYETH
 LF5302
LF5302
Dehydration, Dizziness, Hyperhidrosis, Pallor, Skin warm; Vision blurred Dehydration, Dizziness, Hyperhidrosis, Pallor, Skin warm; Vision blurred
1:32pm- Administered vaccine into left deltoid. Monitored pt for any adverse effects, appeared well,... 1:32pm- Administered vaccine into left deltoid. Monitored pt for any adverse effects, appeared well, denied any dizziness. Patient stood up and denied any adverse effects. LPN escorted patient and mother into waiting room to speak with PSR about scheduling appt and paperwork for when pt turns 18 years old in 2 days. 1:40pm- While standing in front of PSR desk, pt stated she was starting to feel dizzy. Moved pt to sit in chair. Pt appeared very pale and diaphoretic. Body felt hot to touch. Pt reported dizziness was worsening and vision was blurry. LPN immediately alerted RN and Dr. 1:43pm- Moved pt from chair into wheelchair then moved to chair in lactation room and elevated feet. Hooked up to Dinamap, blood pressure cuff applied to right arm along with pulse ox. RN and Dr. present. 1:45pm- Bp 67/28, pulse 53, pulse ox 100%. Gave pt juice box and cheez its, drank entire juice box and ate a few cheez its. Repeated manual blood pressure on left arm, 70/38. Gave pt another juice box and a water bottle. RN and LPN continued to monitor pt. 1:50pm- pt drank all of 2nd juice box and started drinking water. Pt reported dizziness and blurry vision was resolving. RN and LPN continued to monitor pt. 1:55pm- Repeated blood pressure on right arm, 105/72, pulse 72, pulse ox 100%. Dr. made aware. Pt reports she was feeling better, all sx resolved. No longer appeared to be diaphoretic or pale, color returned. Dr. gave verbal permission for pt to go home, advised sx were due to adverse reaction from vaccine, also dehydration. Mother was present for entire time and expressed understanding and felt comfortable taking pt home. RN reviewed proper hydration with pt and encouraged increase hydration and protein before sports practices and games. Pt admits she usually doesn't drink too much. RN and LPN escorted pt and mother to their car. More
2837933 70 F KS 04/24/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 T92HK
T92HK
Arthralgia, Gait disturbance, Pain, Pain in extremity, Paraesthesia; Walking aid... Arthralgia, Gait disturbance, Pain, Pain in extremity, Paraesthesia; Walking aid user, Wheelchair user More
Patient stated shoulder/arm pain was 'excruciating', fingers were tingling. Pain was bad ... Patient stated shoulder/arm pain was 'excruciating', fingers were tingling. Pain was bad enough that patient had to visit an urgent care. Patient was prescribed muscle relaxer (tizanidine) and methylprednisolone dose pack. Patient stated symptoms improved but then got worse again. Had pain on entire right side of body, needed to use a walker and wheelchair as pain made it difficult to walk. Said these symptoms continued for about a month before she had improvement. Patient discussed with her primary care provider however pharmacy was not contacted. Pharmacy first learned of her reaction when contacted to schedule 2nd dose. Pharmacist recommended patient not to received 2nd dose due to severity of reaction after 1st dose. More
2837934 0.33 F CO 04/24/2025 HIBV
 SANOFI PASTEUR
 UK107AB
Product preparation error Product preparation error
The MA reconstituted the vaccine with the incorrect sterile diluent she used sterile water. The MA reconstituted the vaccine with the incorrect sterile diluent she used sterile water.
2837935 11 F MA 04/24/2025 MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8375AA
U8375AA
3CA30C1
3CA30C1
Hypoaesthesia, Injected limb mobility decreased, Injection site reaction, Magnet... Hypoaesthesia, Injected limb mobility decreased, Injection site reaction, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint; Magnetic resonance imaging spinal normal, Muscle oedema, Pain, Pain in extremity, Ultrasound scan normal; Hypoaesthesia, Injected limb mobility decreased, Injection site reaction, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint; Magnetic resonance imaging spinal normal, Muscle oedema, Pain, Pain in extremity, Ultrasound scan normal More
Left arm pain that radiates to hand and fingers. She is experiencing numbness in the arm and has som... Left arm pain that radiates to hand and fingers. She is experiencing numbness in the arm and has some difficulty using the arm. She was evaluated by an Emergency Department physician as well as a Neurologist and Pain specialist. The Gabapentin and steroids that were prescribed do not seem to be effective. More
2837936 68 F FL 04/24/2025 PNC20
 PFIZER\WYETH
 LX4482
Rash Rash
Rash on chest 2 hours post-vaccination Rash on chest 2 hours post-vaccination
2837937 83 F NJ 04/24/2025 COVID19
 PFIZER\BIONTECH
 LN0589
Expired product administered, No adverse event Expired product administered, No adverse event
Patient received an expired COVID vaccine on 4/17/25. The vaccine expired on 4/10/25. There were no ... Patient received an expired COVID vaccine on 4/17/25. The vaccine expired on 4/10/25. There were no adverse effects. Patient notified. More
2837938 75 F WA 04/24/2025 PNC20
 PFIZER\WYETH
 lx2497
Arthralgia Arthralgia
Patient reports a soreness in shoulder that she received a prevanr-20 vaccine. The pain started foll... Patient reports a soreness in shoulder that she received a prevanr-20 vaccine. The pain started follwoing the vaccination and has continued for 2 months. More
2837939 0.17 F CA 04/24/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U8265AA
LC5483
YL9YN
Unevaluable event; Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event; Unevaluable event
N/A N/A
2837940 61 F FL 04/24/2025 COVID19
PNC21
 PFIZER\BIONTECH
MERCK & CO. INC.
 MD3414
Y013009
Cough, Fatigue, Pain, Pyrexia; Cough, Fatigue, Pain, Pyrexia Cough, Fatigue, Pain, Pyrexia; Cough, Fatigue, Pain, Pyrexia
Patient complains of fatigue, bodyache, mild fever, and cough. Patient complains of fatigue, bodyache, mild fever, and cough.
2837949 41 F SC 04/24/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y014059
Y014059
Y014059
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No adverse event; patient was accidently given 3 doses of GARDASIL-9 over a two week period.; This ... No adverse event; patient was accidently given 3 doses of GARDASIL-9 over a two week period.; This spontaneous report was received from a nurse referring to a 41-year-old female patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On 31-MAR-2025, 07-APR-2025 and 14-APR-2025, over a two-week period, the patient received respectively the first, second and third dose of human papillomavirus (GARDASIL 9) injection, as a dose of 0.5 ml for prophylaxis (route of administration, anatomical location was not reported, lot number Y014059 with an expiration date on 20-NOV-2026). (Inappropriate schedule of product administration). There was no adverse effect reported. More
2837950 PA 04/24/2025 VARCEL
 MERCK & CO. INC.
 X010523
Expired product administered Expired product administered
the patient involved has not experienced any medical concerns or symptoms after being administered t... the patient involved has not experienced any medical concerns or symptoms after being administered the expired VARIVAX; Medical Assistant calling to report an adverse event regarding an expired administration of VARIVAX. Medical Assistant stated that a dose of VARIVAX with a labeled expiration date of 4/11/2025 was administered to a patient today, 4/17/2025. Medical; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Apr-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #X010523, expiration date: 11-Apr-2025, 0.5 mL (0.5 mL / Two dose series) (strength, route, and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (details not provided). Medical Assistant confirmed the patient involved has not experienced any medical concerns or symptoms after being administered the expired Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). More
2837951 M TX 04/24/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Wrong product administered Wrong product administered
BEXSERO dose was given to patient on 11-apr 2025 they intended to administer is MenQuadfi; This non-... BEXSERO dose was given to patient on 11-apr 2025 they intended to administer is MenQuadfi; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On 11-APR-2025, the patient received Bexsero (intramuscular) .5 ml. On an unknown date, the patient received Menquadfi. On 11-APR-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: BEXSERO dose was given to patient on 11-apr 2025 they intended to administer is MenQuadfi). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-APR-2025 The nurse reported that a Bexsero dose was given to a patient and stated that the medication they intended to administer was Menquadfi, which led to wrong vaccine administered. More
2837952 M CA 04/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never received his second dose; This non-serious case was reported by a consumer via call center rep... never received his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 26-JUN-2021, in left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received his second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 17-APR-2025 The patient self-reported this case. The patient received his first dose of Shingrix vaccine and never received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2837953 18 M IL 04/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMAB030A
Product preparation error Product preparation error
the patient received the orange topped lyophilized powder diluted with sterile water; This non-serio... the patient received the orange topped lyophilized powder diluted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB030A) for prophylaxis. On 11-APR-2025, the patient received Menveo. On 11-APR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: the patient received the orange topped lyophilized powder diluted with sterile water). The outcome of the wrong solution used in drug reconstitution was not applicable. Additional Information: GSK Receipt Date: 15-APR-2025 The pharmacist asked could tell if both vials of Menveo (2 vial kit) were not administered does the dose need to be repeated. The patient received the orange topped lyophilized powder diluted with sterile water, which led wrong solution used in drug reconstitution. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. More
2837954 PA 04/24/2025 PNC20
 PFIZER\WYETH
Syringe issue Syringe issue
When opened box, one vial was broken it the box; This is a spontaneous report received from a Nurse ... When opened box, one vial was broken it the box; This is a spontaneous report received from a Nurse from product quality group. A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAINER ISSUE (non-serious) with onset 15Apr2025, outcome "unknown", described as "When opened box, one vial was broken it the box". Additional information: The nurse confirmed no patient involvement. She was taking the vaccine out to use and that was when she realized that the pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) was broken. Causality for "when opened box, one vial was broken it the box" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction). The lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein), was not provided and will be requested during follow up. More
2837971 11 F OH 04/24/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 Z53J4
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Incorrect vaccine administered for patient's age Incorrect vaccine administered for patient's age
2837972 0.5 M MS 04/24/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Crying, Dairy intolerance, Eczema, Poor feeding infant, Screaming Crying, Dairy intolerance, Eczema, Poor feeding infant, Screaming
On day after receiving the vaccine in the evening ( about 36 hours after administration) the infant ... On day after receiving the vaccine in the evening ( about 36 hours after administration) the infant cried "like we have never heard before". It was hours of uncontrollable crying. Parents were close to going to ER. They administered Tylenol and it did not help. Went on from 9 PM until 3 AM. Baby would not nurse. Baby just screamed for hours. Baby now exhibits eczema and milk protein intolerance More
2837973 1 M AZ 04/24/2025 HEPA
HEPA
HIBV
HIBV
MMR
MMR
PNC20
PNC20
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 LM99N
LM99N


342RC
342RC
LX4483
LX4483
Y015100
Y015100
Cough, Measles antibody positive, Pyrexia, Rash, Rash maculo-papular; Rhinitis; ... Cough, Measles antibody positive, Pyrexia, Rash, Rash maculo-papular; Rhinitis; Cough, Measles antibody positive, Pyrexia, Rash, Rash maculo-papular; Rhinitis; Cough, Measles antibody positive, Pyrexia, Rash, Rash maculo-papular; Rhinitis; Cough, Measles antibody positive, Pyrexia, Rash, Rash maculo-papular; Rhinitis; Cough, Measles antibody positive, Pyrexia, Rash, Rash maculo-papular; Rhinitis More
Pt. developed a fever on 3/27/25, on 3/29/25, pt developed a maculopapular rash at the hairline on h... Pt. developed a fever on 3/27/25, on 3/29/25, pt developed a maculopapular rash at the hairline on his forehead, and it progressed down his trunk and out to his extremities. Pt also experienced cough and coryza. He was seen in the pediatric ED and suspected of having measles by the clinician. More
2837974 F MS 04/24/2025 PNC20
 PFIZER\WYETH
Eczema, Milk allergy Eczema, Milk allergy
Eczema and dairy intolerance Eczema and dairy intolerance
2837975 73 M FL 04/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 unknown
Diarrhoea, Injection site swelling Diarrhoea, Injection site swelling
Diarrhea all day on the day after the shot (4/25/25) Swelling ad soreness at injection site, ongoing Diarrhea all day on the day after the shot (4/25/25) Swelling ad soreness at injection site, ongoing
2837976 1 M MS 04/24/2025 HEPA
MMR
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH


Condition aggravated, Metabolic function test, Renal impairment, Renal tubular a... Condition aggravated, Metabolic function test, Renal impairment, Renal tubular acidosis; Condition aggravated, Metabolic function test, Renal impairment, Renal tubular acidosis; Condition aggravated, Metabolic function test, Renal impairment, Renal tubular acidosis More
Kidney function worsened requiring increased doses of Bicitra Kidney function worsened requiring increased doses of Bicitra
2837977 0.5 M MS 04/24/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS


Metabolic function test, Renal tubular acidosis, Thyroid function test, Urine an... Metabolic function test, Renal tubular acidosis, Thyroid function test, Urine analysis, Weight decreased; Metabolic function test, Renal tubular acidosis, Thyroid function test, Urine analysis, Weight decreased; Metabolic function test, Renal tubular acidosis, Thyroid function test, Urine analysis, Weight decreased More
Began to lose weight noted at 9 month visit and continued to drop. Was referred and diagnosed with R... Began to lose weight noted at 9 month visit and continued to drop. Was referred and diagnosed with Renal Tubular Acidosis at 11 months More
2837978 15 M 04/24/2025 UNK
 UNKNOWN MANUFACTURER
Syncope Syncope
After administering a vaccine, patient had a syncope. After administering a vaccine, patient had a syncope.
2837979 0.25 M MS 04/24/2025 DTAPIPVHIB
HEP
PNC13
 SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH


Bronchiolitis, Infant irritability, Pyrexia; Bronchiolitis, Infant irritability,... Bronchiolitis, Infant irritability, Pyrexia; Bronchiolitis, Infant irritability, Pyrexia; Bronchiolitis, Infant irritability, Pyrexia More
Fever of 103. Irritable for 3 days. Bronchiolitis non RSV on 12/22/2021 Fever of 103. Irritable for 3 days. Bronchiolitis non RSV on 12/22/2021
2837980 0.17 M MS 04/24/2025 DTAPHEPBIP
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.


Crying, Infant irritability, Poor feeding infant; Crying, Infant irritability, P... Crying, Infant irritability, Poor feeding infant; Crying, Infant irritability, Poor feeding infant; Crying, Infant irritability, Poor feeding infant More
Irritable and cried for many days afterward. Was fussy and not eating well for 2 weeks after the vac... Irritable and cried for many days afterward. Was fussy and not eating well for 2 weeks after the vaccine. Went to hospital and examined and told ok More
2837981 0.58 M MS 04/24/2025 FLU3
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH

Infant irritability, Pyrexia; Infant irritability, Pyrexia Infant irritability, Pyrexia; Infant irritability, Pyrexia
Very fussy. Fever of 101.7 for 24 hours Very fussy. Fever of 101.7 for 24 hours
2837982 5 F OK 04/24/2025 VARCEL
 MERCK & CO. INC.
Injection site erythema, Injection site rash, Injection site reaction, Rash, Urt... Injection site erythema, Injection site rash, Injection site reaction, Rash, Urticaria More
A red welt developed on day two, at the site of injection, about 2 inches in diameter. On day 7, a r... A red welt developed on day two, at the site of injection, about 2 inches in diameter. On day 7, a rash developed down the leg in which the injection was received, across the low back, and partially down the other leg. More
2837983 4 F WA 04/24/2025 COVID19
COVID19
HEPA
HEPA
MMRV
MMRV
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 3044186
3044186
22GP3
22GP3
Y018157
Y018157
Cough, Dermatitis exfoliative generalised, Fatigue, Injection site erythema, Inj... Cough, Dermatitis exfoliative generalised, Fatigue, Injection site erythema, Injection site pruritus; Nausea; Cough, Dermatitis exfoliative generalised, Fatigue, Injection site erythema, Injection site pruritus; Nausea; Cough, Dermatitis exfoliative generalised, Fatigue, Injection site erythema, Injection site pruritus; Nausea More
Child had coughing, redness of injection site followed by itching and erythroderma of face, trunk, l... Child had coughing, redness of injection site followed by itching and erythroderma of face, trunk, less on extremities with some nausea and fatigue within 5 minutes of vaccination. Coughing resolved spontaneously. No wheezing on exam. Benadryl 12.5mg given and epinephrine .015 mg given with improvement of skin redness and itching. Child previously received MMR and Varivax separately without reaction. Vaccine was given in conjunction with first dose of Hepatitis A and COVID. More
2837984 65 F CA 04/24/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX4483
PG3RP
Rash, Rash pruritic; Rash, Rash pruritic Rash, Rash pruritic; Rash, Rash pruritic
Rash on arm, itchiness (Rt) arm. Pt was prescribed Hydrocortisone. Rash on arm, itchiness (Rt) arm. Pt was prescribed Hydrocortisone.
2837985 64 F AZ 04/24/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LX4482
LX4482
Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, H... Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, Hypoaesthesia, Laboratory test normal, Mobility decreased; Pain in extremity, Paraesthesia More
Pt began to experience numbness & tingling in R feet 45 minutes after the vaccine. In evening fi... Pt began to experience numbness & tingling in R feet 45 minutes after the vaccine. In evening fingers in R hand got stuck. Numbness & tingling in R feet has now progressed to pain in R leg. More
2837405 F MS 04/23/2025 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER




















Anion gap increased, Antibody test negative, Blood bicarbonate decreased, Blood ... Anion gap increased, Antibody test negative, Blood bicarbonate decreased, Blood chloride decreased, Blood potassium decreased; Blood sodium decreased, Brain death, Brain herniation, Brain oedema, CNS ventriculitis; CSF glucose decreased, CSF protein increased, Electroencephalogram abnormal, Endotracheal intubation, Haemophilus test positive; Hydrocephalus, Hypochloraemia, Hypokalaemia, Hyponatraemia, Intensive care; Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Meningitis haemophilus, Posturing, Pyrexia; Seizure, Seizure like phenomena, Somnolence, Tachycardia, Total complement activity decreased; Vaccination failure, Vomiting; Anion gap increased, Antibody test negative, Blood bicarbonate decreased, Blood chloride decreased, Blood potassium decreased; Blood sodium decreased, Brain death, Brain herniation, Brain oedema, CNS ventriculitis; CSF glucose decreased, CSF protein increased, Electroencephalogram abnormal, Endotracheal intubation, Haemophilus test positive; Hydrocephalus, Hypochloraemia, Hypokalaemia, Hyponatraemia, Intensive care; Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Meningitis haemophilus, Posturing, Pyrexia; Seizure, Seizure like phenomena, Somnolence, Tachycardia, Total complement activity decreased; Vaccination failure, Vomiting; Anion gap increased, Antibody test negative, Blood bicarbonate decreased, Blood chloride decreased, Blood potassium decreased; Blood sodium decreased, Brain death, Brain herniation, Brain oedema, CNS ventriculitis; CSF glucose decreased, CSF protein increased, Electroencephalogram abnormal, Endotracheal intubation, Haemophilus test positive; Hydrocephalus, Hypochloraemia, Hypokalaemia, Hyponatraemia, Intensive care; Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Meningitis haemophilus, Posturing, Pyrexia; Seizure, Seizure like phenomena, Somnolence, Tachycardia, Total complement activity decreased; Vaccination failure, Vomiting More
Immune evaluation resulted in low antibody titer to Hib despite appropriate vaccination/Immune evalu... Immune evaluation resulted in low antibody titer to Hib despite appropriate vaccination/Immune evaluation resulted in low antibody titer to Hib despite appropriate vaccination; This literature marketed report has been received from the authors of a published article, titled as stated below, referred to 12-month-old female patient. On an unknown dates, the patient was vaccinated with 3 doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Manufacture Unknown), (dose, strength, frequency, vaccination scheme, route, anatomical location, lot number, and expiration date were not reported), administered as prophylaxis. The 12-month-old female with no pertinent medical history on an unknown date, presented to the emergency room for fever and emesis, she was febrile to 101.4�F, tachycardic to 170 and respiratory rate of 50; her initial labs were notable for hyponatremia 127 mmol/L, hypokalemia 3 mmol/L, hypochloremia 90 mmol/L, bicarbonate 14 mmol/L, and anion gap 23 mmol/L. She was admitted to pediatrics for fluid resuscitation and electrolyte management. She became more somnolent and began having seizure-like activity, and posturing; so she was transferred to the Pediatric Intensive Care Unit (PICU) and intubated; an electroencephalogram (EEG) was conducted revealing seizures, and magnetic resonance imaging (MRI) brain revealed meningitis and ventriculitis with hydrocephalus; lumbar puncture findings of purulent cerebrospinal fluid (CSF), protein elevated 368?mg/dL and glucose resulted low less than 2mg/dL; CSF and blood cultures positive for nontypeable haemophilus influenzae (NTHi). Immunological studies later revealed that although she received three Hib vaccines, she had inadequately low levels of antibodies, less than 0.15 mcg/mL, she also had low CH50 complements of less than 12.5?U/mL. It was reported that her decreased complement was likely to be the cause of her susceptibility and lethality of her NTHi meningitis. Unfortunately, despite appropriate antimicrobials and aggressive neuroprotective strategies, she developed severe cerebral edema leading to herniation, underwent brain death testing and was declared brain dead. Her immune evaluation resulted in low antibody titer to Hib despite appropriate vaccination (Vaccine impaired response), and total hemolytic complement (CH50) was undetectable; there was concern that this patient had inherited complete deficiency in either the classical complement pathway or the terminal complement pathway, both are important for protection from NTHi. She appeared to have a specific antibody deficiency to polysaccharide antigens, as seen with her low antibody levels to Hib and Streptococcus pneumoniae. The lack of response to Hib vaccines would not have offered protection against her NTHi. At the time of reporting, the outcome of vaccination failure was unknown. The authors considered the event of vaccination failure as related to the Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Manufacture Unknown). A copy of the published article is attached as further documentation of the patient's experience Additional information is not expected. Literature Citation More
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2837406 NH 04/23/2025 VARCEL
 MERCK & CO. INC.
 Y013347
No adverse event, Product storage error No adverse event, Product storage error
A HCP called to report that a shipment of VARIVAX was received on 02/23/2025 and inadvertently place... A HCP called to report that a shipment of VARIVAX was received on 02/23/2025 and inadvertently placed in the refrigerator until a dose of the VARIVAX was inadvertently administered to a patient on 03/09/2025 in which the improper storage was identifi; The HCP reported that the patient did not experience any adverse issues or side effects from the administered dose.; This spontaneous report has been received from a pharmacist, regarding to a patient of 36-years-old of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored of Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) at a dose of 0.5 milliliters (ml), once, (lot number Y013347, expiration date 02-AUG-2026), with a sterile diluent, solution for injection (lot number 2053173, expiration date 23-MAR-2027) both administered as prophylaxis. The administered dose was stored at a temperature of 41.1 degrees Fahrenheit (F) during a time frame of 14 days (product storage error). There was no previous temperature excursion. No additional side effects were reported in the patients. More
2837407 MD 04/23/2025 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�ve (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
2837408 MD 04/23/2025 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�ve (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
2837409 MD 04/23/2025 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�ve (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
2837410 MD 04/23/2025 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�ve (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
2837411 MD 04/23/2025 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�ve (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
2837412 MD 04/23/2025 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�ve (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
2837413 F 04/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Neuralgia, Paraesthesia oral, Swelling, Urticaria Neuralgia, Paraesthesia oral, Swelling, Urticaria
tingling in lips; Nerve pain in teeth; swelling; Hives; This non-serious case was reported by a cons... tingling in lips; Nerve pain in teeth; swelling; Hives; This non-serious case was reported by a consumer and described the occurrence of tingling lips in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling lips (Verbatim: tingling in lips), nerve pain (Verbatim: Nerve pain in teeth), swelling (Verbatim: swelling) and hives (Verbatim: Hives). The outcome of the tingling lips was not resolved and the outcome of the nerve pain, swelling and hives were resolved with sequelae. It was unknown if the reporter considered the tingling lips, nerve pain, swelling and hives to be related to Shingrix. It was unknown if the company considered the tingling lips, nerve pain, swelling and hives to be related to Shingrix. Additional Information: GSK Receipt Date: 14-APR-2025 The patient never reacted to a vaccine - other than COVID before. It was reported that the patient was really looking for someone to tell if she should get the second shot. The patient didn't want shingles but She was 3 months out from first shot and was still tingly in her lips. (Nerve pain in teeth, tingling in lips and swelling, hives) Were the symptoms treated was reported as no Other Products were reported as no More
2837422 0.33 M WA 04/23/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7899AA
Eye movement disorder, Hypotonia, Unresponsive to stimuli Eye movement disorder, Hypotonia, Unresponsive to stimuli
Approximately 4-5 minutes after vaccine became limp and unresponsive with eyes rolled back into his ... Approximately 4-5 minutes after vaccine became limp and unresponsive with eyes rolled back into his head. He was back to baseline within 30 minutes without residual symptoms. I suspect this is a hypotonic-hyporesponsive episode More
2837433 M 04/23/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Death, Herpes zoster, Organ failure, Scar, Vaccination failure Death, Herpes zoster, Organ failure, Scar, Vaccination failure
Organ failure; Suspected vaccination failure; developed shingles/still had the shingles scars on him... Organ failure; Suspected vaccination failure; developed shingles/still had the shingles scars on him; This serious case was reported by a consumer via interactive digital media and described the occurrence of organ failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced organ failure (Verbatim: Organ failure) (serious criteria death), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles/still had the shingles scars on him). The outcome of the vaccination failure and shingles were not reported. The reported cause of death was organ failure. It was unknown if the reporter considered the organ failure, vaccination failure and shingles to be related to Shingles vaccine. The company considered the organ failure and vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-APR-2025 This case was reported by a patient's wife via interactive digital media. The reporter stated that her late husband developed shingles less than a year after they both were vaccinated. He died of organ failure at about a year out. He still had the shingles scars on him. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Organ failure is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Organ failure More
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2837434 04/23/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise, Respiratory syncytial virus infection, Vaccination failure Malaise, Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; only had it for 3-4 days; This serious case was reported by a consume... Suspected vaccination failure; only had it for 3-4 days; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: only had it for 3-4 days). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The patient had RSV vaccine last year and it was bad but because the patient had been vaccinated only had it for 3 to 4 days. After the vaccination the patient was really sick but only for a few days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
2837435 64 M WA 04/23/2025 FLU3
 SANOFI PASTEUR
 U8442BA
No adverse event, Product storage error No adverse event, Product storage error
Max/low temperature reached: 8.5 �C to 8.8 �C Duration: 30 minutes with no reported adverse even... Max/low temperature reached: 8.5 �C to 8.8 �C 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 was linked to US-SA-2025SA112035 This case involves a 64 years old male patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] which was exposed to temperature excursion where max/low temperature reached: 8.5 �c to 8.8 �c 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. On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (once) (strength- standard, expiry date- 20-Jun-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 �c to 8.8 �c duration: 30 minutes with no reported adverse event (product storage error). On 10-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the right deltoid for immunization. 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-2025SA114290: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA112035:Master case More
2837438 4 M MA 04/23/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8209CB
Y017516
Erythema, Eye swelling; Erythema, Eye swelling Erythema, Eye swelling; Erythema, Eye swelling
Mother called PPA at 2:20 pm to report bilateral eye swelling and one red spot located on the pt... Mother called PPA at 2:20 pm to report bilateral eye swelling and one red spot located on the pt's skin. No SOB, cough or wheeze. Mother advised to have pt seen at the ED. Pt was then seen at ED, Epi-Pen administered and then pt was observed for 5 hours. Pt was then discharged. More
2837439 19 F MA 04/23/2025 HPV9
 MERCK & CO. INC.
 Y010466
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient here for annual well visit. Received an unnecessary 3rd dose of HPV at beginning of visit. P... Patient here for annual well visit. Received an unnecessary 3rd dose of HPV at beginning of visit. Patient did not have any adverse reaction following administration of the vaccine. More
2837465 10 M NY 04/23/2025 COVID19
 PFIZER\BIONTECH
 LM2045
No adverse event, Product storage error No adverse event, Product storage error
vaccine was determined to be out of the optimal temperature range for storage. No symptoms observed ... vaccine was determined to be out of the optimal temperature range for storage. No symptoms observed or reported at time of administration. No additional treatment was required. Pfizer unable to provide viability of vaccinations stored outside of the advised temperature range. Patient and parent was informed and will vaccinate again in the fall. More
2837466 41 F VA 04/23/2025 MMRV
 MERCK & CO. INC.
 Y019464
No adverse event, Underdose No adverse event, Underdose
PATIENT WAS GIVEN A VACCINE MADE FOR PREDIATRICS 12MO-12YRS. THERE WERE NO ADVERSE REACTIONS, NO SID... PATIENT WAS GIVEN A VACCINE MADE FOR PREDIATRICS 12MO-12YRS. THERE WERE NO ADVERSE REACTIONS, NO SIDE AFFECTS, NO SYMPTOMS More
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