πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2684770 76 F MA 09/21/2023 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
H2522
Dizziness; Dizziness, Dysstasia, Gait inability Dizziness; Dizziness, Dysstasia, Gait inability
Dizziness; This non-serious case was reported by a consumer via call center representative and descr... Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 05-SEP-2023, the patient received Arexvy. On 05-SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizziness). The outcome of the dizziness was not resolved. It was unknown if the reporter considered the dizziness to be related to Arexvy. It was unknown if the company considered the dizziness to be related to Arexvy. Additional Information: GSK receipt date: 11-Sept-2023 and 12-Sept-2023 The patient stated that she received Arexvy vaccine around 2 pm and 1 hour later she started feeling dizzy. According to reporter, she still had the dizziness and she tried contacting her physician last week on Friday without success. The patient was very good unfortunately all they were doing was filing a report and she was hoping that she could have more information on having dizziness from this RSV shot and did not know she had called the physician and have not gotten anything back so she will check again. Reporter would like to be contacted by the safety team regarding this concern. The reporter consented to follow-up. More
2836862 53 M FL 04/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EWO171
EWO171
Arthralgia, Asthma, Back pain, Bronchitis, Chest pain; Chronic obstructive pulmo... Arthralgia, Asthma, Back pain, Bronchitis, Chest pain; Chronic obstructive pulmonary disease, Cough, Dyspnoea, Pain More
breathing difficulties; chronic pain especially back & shoulder; chronic pain especially back &a... breathing difficulties; chronic pain especially back & shoulder; chronic pain especially back & shoulder; chronic pain especially back & shoulder; COPD; Bronchitis; Coughing; Cannot stop/devastating cough/still has a lingering cough; Asthma; chest hurting; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2021 as dose 2, single (Lot number: EWO171) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy" (ongoing); "BP" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal; MONTELUKAST taken for hypersensitivity. Vaccination history included: BNT162b2 (DOSE1, SINGLE, Lot number: EWO171, intramuscular), administration date: 18May2021, for COVID-19 immunisation, reaction(s): "Coughing; Cannot stop/devastating cough", "Asthma", "chest hurting", "breathing difficulties", "chronic pain especially back & shoulder", "chronic pain especially back & shoulder", "chronic pain especially back & shoulder", "Bronchitis", "COPD". The following information was reported: ASTHMA (non-serious) with onset 2021, outcome "not recovered"; BRONCHITIS (non-serious) with onset 2021, outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "unknown", described as "COPD"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "Coughing; Cannot stop/devastating cough/still has a lingering cough"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "chest hurting"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing difficulties"; PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "chronic pain especially back & shoulder". The events "coughing; cannot stop/devastating cough/still has a lingering cough", "asthma" and "chest hurting" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320279 same patient, different doses; More
2836863 76 F MO 04/18/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019158
Y019158
Injection site erythema, Injection site pain, Injection site reaction, Injection... Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Skin tightness More
Pt received 1 dose of Capvaxive in her left arm on Monday, 4/14/25. She then presented to the pharma... Pt received 1 dose of Capvaxive in her left arm on Monday, 4/14/25. She then presented to the pharmacy today showing us her arm. She said her symptoms started Monday evening. She presented today with redness and swelling from the top of her left arm, down to almost her elbow. The skin was also warm to the touch and she explained her skin as feeling "tight". She said it is not super painful, but just feels tight and warm. They only thing she has taken for her symptoms was Tylenol OTC. She was not in terrible distress, but was concerned about what to do. I helped her find Benadryl OTC for the reaction and told her to apply a cold compress as well for swelling and discomfort. She could continue to take the Tylenol and/or Ibuprofen for pain control. She only obtained one vaccine that day. She did not mention having any fevers or any other symptoms at this time. I encouraged her to seek medical attention with her PCP or an urgent care to be sure there was not infection d/t the symptoms she presented with. More
2836864 84 F IA 04/18/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 Lx2497
Lx2497
Chest X-ray, Dyspnoea, Echocardiogram, Fibrin D dimer, Intensive care; N-termina... Chest X-ray, Dyspnoea, Echocardiogram, Fibrin D dimer, Intensive care; N-terminal prohormone brain natriuretic peptide, Pulmonary embolism, Troponin increased, Ultrasound Doppler, Ventilation/perfusion scan More
Acute high risk submassive pulmonary embolism. Experienced symptoms of progressive dyspnea beginnin... Acute high risk submassive pulmonary embolism. Experienced symptoms of progressive dyspnea beginning 2 days following vaccine. Admitted to hospital 5 days following vaccine administration. ICU admission, anticoagulation. Outcome: discharged home More
βœ“ βœ“
2836865 1 M MI 04/18/2025 MMRV
 MERCK & CO. INC.
 Y017514
Rash Rash
Rash Rash
2836866 48 F KY 04/18/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 549JB
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient received Hiberix vaccine accidentally instead of the Hepatitis B vaccine, Heplisav-B. Patien... Patient received Hiberix vaccine accidentally instead of the Hepatitis B vaccine, Heplisav-B. Patient notified shortly thereafter of the error and advised to follow up with pharmacy and/or their primary care provider if they have any issues; advised to return whenever able to start Hepatitis B series as intended. No adverse events to report at this time. More
2836867 52 M FL 04/18/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 27LR2
27LR2
UNK
UNK
Herpes zoster, Neuralgia, Rash; Herpes zoster, Rash; Herpes zoster, Neuralgia, R... Herpes zoster, Neuralgia, Rash; Herpes zoster, Rash; Herpes zoster, Neuralgia, Rash; Herpes zoster, Rash More
Patient started with signs and symptoms of shingles about 5 days after the vaccine. He started with ... Patient started with signs and symptoms of shingles about 5 days after the vaccine. He started with the nerve pain in leg and hip and then he had the rash. Patient got diagnosed and treated for shingles by his doctor. He came to reported and also stated that he had a Dupixent dose the day before getting immunized. More
2836868 83 F TX 04/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 92NN2
92NN2
Injection site bruising, Injection site erythema, Injection site pain, Injection... Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash; Nausea, Pain More
PATIENT SORENESS AND NAUSEA DAY OF VACCINATION, NEXT DAY AFTER TAKING MEDICATIONS SORENESS WORSEN, O... PATIENT SORENESS AND NAUSEA DAY OF VACCINATION, NEXT DAY AFTER TAKING MEDICATIONS SORENESS WORSEN, ON SUNDAY PATIENT EXPERIENCED ITCHINESS AND REDNESS ON INJECTION SITE. ON TUESDAY PATIENT NOTICED SEVERE BRUISING A REDNESS AND BURNING GOING DOWN TO THE ELBOW. PATIENT ALSO HAS A RASH BELOW THE INJECTION SITE. More
2836869 67 F IL 04/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site swelling, Product preparation issue Injection site swelling, Product preparation issue
SEVERE SWELLING AT THE INJECTION SITE. PATIENT WAS INJECTED WITH JUST THE DILUENT INSTEAD OF THE COM... SEVERE SWELLING AT THE INJECTION SITE. PATIENT WAS INJECTED WITH JUST THE DILUENT INSTEAD OF THE COMPOUNDED INJECTION More
2836870 54 M IA 04/18/2025 COVID19
 JANSSEN
Cerebrovascular accident, Road traffic accident, Seizure, Spinal fracture, Traum... Cerebrovascular accident, Road traffic accident, Seizure, Spinal fracture, Traumatic fracture More
I got a new job they said i could not work unless i got the vaccine. So i did it, and that was in Se... I got a new job they said i could not work unless i got the vaccine. So i did it, and that was in September in January i started having seizures. on 03/04/25 i had a stroke and seizure while driving and got into an accident and broke my back in 3 places. I have had a told of 8 seizures all together. I am no on medications twice a day that cost over $400. More
βœ“
2836871 M KS 04/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J5T9Z
Infant irritability, Product administered to patient of inappropriate age Infant irritability, Product administered to patient of inappropriate age
No known adverse event. Vaccine given on 4/17/25. Found error on 4/18/25 for vaccine given to child ... No known adverse event. Vaccine given on 4/17/25. Found error on 4/18/25 for vaccine given to child who was not old enough to receive vaccine. Nurse at clinic called and triaged patient. Mother stated child was fussy and had temp of 100 the evening of when child received vaccine. Mother stated patient was given tylenol and has sense not been fussy and the temperature has gone down. Patient did receive other vaccines during this appointment. More
2836872 46 M MD 04/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Allergy to arthropod sting, Aphthous ulcer, Dairy intolerance, Food allergy, Foo... Allergy to arthropod sting, Aphthous ulcer, Dairy intolerance, Food allergy, Food intolerance; Gluten sensitivity More
Persistent kanker sores that couldn?t be treated to conclusion via any other drug than oral steroids... Persistent kanker sores that couldn?t be treated to conclusion via any other drug than oral steroids. His allergies to all foods listed on previous pages occurred post vaccination and had no symptoms prior to it. More
2836873 1 F AL 04/18/2025 DTAP
 SANOFI PASTEUR
 3CA20C1
Cellulitis Cellulitis
cellulitis cellulitis
2836874 79 F IN 04/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9l944
Rash, Rash erythematous Rash, Rash erythematous
Patient began to notice small red bumps on her face the day after vaccination. They have been prese... Patient began to notice small red bumps on her face the day after vaccination. They have been present for over a week and are not itchy or painful. Patient was prescribed mupirocin and hydrocortisone cream to alleviate symptoms. More
2836875 68 F 04/18/2025 MMR
 MERCK & CO. INC.
 y014094
Injection site pain Injection site pain
Patient received MMRII vaccine on left IM on 3/22/25. Today patient came and told that patient has s... Patient received MMRII vaccine on left IM on 3/22/25. Today patient came and told that patient has soreness at the injected side. The pain comes and goes. Other than that, patient is still doing well and no other health concerns. Per patient, patient just has a rotator cuff surgery on the same arm 3 weeks prior to the date she got the vaccination , so it could be pain during healing from surgery . Pharmacist couldn't give vaccine on the other arm because patient has cancer metastasis on right arm. I already counseled patient to use ice packs to help with soreness and take Tylenol incase patient has fever. Patient will have a post-op follow up next month and will check with her doctor to make sure surgical site heals properly. More
2836876 73 F MN 04/18/2025 PNC21
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y019157
D4J9L
Injection site erythema, Injection site induration, Injection site mass, Pain in... Injection site erythema, Injection site induration, Injection site mass, Pain in extremity; Injection site erythema, Injection site induration, Injection site mass, Pain in extremity More
Patient got these two immunizations and a week later on their right arm they were still having a bri... Patient got these two immunizations and a week later on their right arm they were still having a bright red dot on her arm and had a hard lump on her arm from the vaccine. Patient states their arm was sore as well. Patient stated no numbness or tingling and no fevers, redness was just around the vaccine area. More
2836877 84 F MN 04/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood glucose normal, Blood pressure abnormal, Death, Dyspnoea, Facial paralysis... Blood glucose normal, Blood pressure abnormal, Death, Dyspnoea, Facial paralysis; Unresponsive to stimuli More
Resident passed away on 4/16. Resident was on hospice and comfort care. Do not suspect that vaccin... Resident passed away on 4/16. Resident was on hospice and comfort care. Do not suspect that vaccine caused the death, but reporting to VAERS for compliance sake. Resident took her scheduled medication, vitals taken and were as follows: BP :139/72,HR, 90 BPM, oxygen SATS 98%,temperature 98.0 degrees Fahrenheit, and respirations 18 breadth per minute. she then went for PT .The writer was called by staff at 0936 while she was doing therapy. Writer found resident sitting on the wheelchair unresponsive with her mouth drooping to her right side, and assessed the resident EMS contacted at 0938,three nurses present and assessed the resident, vitals taken: Blood sugar 144 mg/dl, HR 50,oxygen sats 90 beats per minute unable to get blood pressure reading, and labored breathing noted. Resident helped in bed ,head of bed elevated and supplemental oxygen administered at 3 liters via nasal cannula. EMT found a heart rate of 10 at arrival, assessed her and then pronounced her dead at 0955.Husband present and stated that he had just talked to her. Nursing administration placed a call to county medical examiner's office for resident status update and the examiner evaluated the status and gave ok to release the body whenever family is done with giving their respects to the mortuary of family choosing. More
βœ“
2836878 61 F LA 04/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 n77j2
Dyspnoea, Urticaria Dyspnoea, Urticaria
patient developed hives about 6 hours after injection, had trouble breathing the next day patient developed hives about 6 hours after injection, had trouble breathing the next day
2836880 NY 04/18/2025 IPV
 SANOFI PASTEUR
 X1D141M
No adverse event, Product storage error No adverse event, Product storage error
maximum/minimum temperature reached: 48 οΏ½f for 30 minutes and Administered post-excursion with no ... maximum/minimum temperature reached: 48 οΏ½f for 30 minutes and Administered post-excursion with no adverse event; Initial information received on 15-Apr-2025 regarding an unsolicited non-valid non-serious case received from other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that exposed to maximum/minimum temperature reached: 48 οΏ½f for 30 minutes with no adverse event On an unknown date, the patient received suspect IPV (VERO) Suspension for injection (Unknown strength) with lot X1D141M and expiry date 31-Oct-2026 via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) that exposed to temperature excursion maximum/minimum temperature reached: 48 οΏ½f for 30 minutes with no reported adverse event (product storage error) (Unknown latency) Reportedly, Human error involved. There were no previous excursion. Extended stability data did not cover the excursion. Fridge door was left open for inventory. 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
2836881 56 F IA 04/18/2025 PNC21
 MERCK & CO. INC.
 y019157
Injection site reaction, Rash erythematous, Urticaria Injection site reaction, Rash erythematous, Urticaria
Patient started to get hives-like reaction the day after the vaccination. red bumps around site of i... Patient started to get hives-like reaction the day after the vaccination. red bumps around site of injection. More
2836882 65 M MN 04/18/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 NZ552
Chills, Headache, Mental impairment, Pain Chills, Headache, Mental impairment, Pain
Headaches, Body aches, Chills, and slow mental processing lasting one week. Headaches, Body aches, Chills, and slow mental processing lasting one week.
2836883 12 F CO 04/18/2025 HPV9
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 z002580
4799g
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
No adverse reactions at the time of this report. Tdap given instead of Menveo. No adverse reactions at the time of this report. Tdap given instead of Menveo.
2836888 80 F FL 04/18/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 JB2A
Extra dose administered Extra dose administered
Patient received a second dose of Arexvy outside of guidelines. Original dose given December 2023. Patient received a second dose of Arexvy outside of guidelines. Original dose given December 2023.
2836889 58 F AL 04/18/2025 MMR
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4N222
4H79Y
Fatigue, Headache; Fatigue, Headache Fatigue, Headache; Fatigue, Headache
Headache, fatigue both starting day after immunizations Headache, fatigue both starting day after immunizations
2836890 56 F AL 04/18/2025 MMR
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 4N222
LC5485
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
unknown - unable to reach patient so will continue to contact her to determine side effects unknown - unable to reach patient so will continue to contact her to determine side effects
2836891 46 M FL 04/18/2025 HPV9
 MERCK & CO. INC.
Intercepted product prescribing error, Product administered to patient of inappr... Intercepted product prescribing error, Product administered to patient of inappropriate age More
employees: pharmacist and manager refused to provide the second dose of the hpv vaccination, for whi... employees: pharmacist and manager refused to provide the second dose of the hpv vaccination, for which my doctor had authorized and pharmacy was provided the authorization when I received the first dose however now these employees and the manager are refusing to provide the second dose of the medication just cause I turned 46 a month ago. They have provide a recommendation brochure form the company who makes the vaccine however I have provided the link and website from the cdc. Well clearly indicates as long as the doctor recommends they?re supposed to provide vaccination and they have refused to provide the oxidation. Therefore, they have refused to provide a medical service. This is a clearly violation of my medical rights. For which I am reporting to the appropriate agencies from the government to report this violation of law. More
2836948 5 M CT 04/18/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Right thigh area red, swollen, warm, Mom to do warm compress. Motrin, Epsom salt soaks Right thigh area red, swollen, warm, Mom to do warm compress. Motrin, Epsom salt soaks
2598233 F 04/17/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH
 EK9231
COVID-19, Drug ineffective; Drug ineffective, Interchange of vaccine products, S... COVID-19, Drug ineffective; Drug ineffective, Interchange of vaccine products, Suspected COVID-19; Drug ineffective, Interchange of vaccine products, Suspected COVID-19; Drug ineffective, Interchange of vaccine products, Suspected COVID-19 More
COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP. A 74-ye... COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EK9231), in arm, as dose 2, single (Lot number: EN6201), in arm and as dose 3 (booster), single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "Pernicious anemia", start date: 1954 (ongoing), notes: congenital verification test 1996, Extreme fatigue.; "Pernicious anemia", start date: 1996 (ongoing); "Osteoarthritis" (ongoing), notes: Joint pain, bone loss, physical therapy 2018, 2021; "Osteoporosis", start date: 2021 (ongoing); "Herpes simplex", start date: 1983 (ongoing), notes: valacyclovir as needed 2021; "Occipital neuralgia", start date: 2020 (ongoing), notes: test conducted; "Mitral valve prolapse", start date: 2021 (ongoing); "HBP" (ongoing); "Blood thinner" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL oral taken for hypertension, start date: 2015 (ongoing); VITAMIN D3 taken for pernicious anaemia, start date: 1996 (ongoing); VITAMIN B12 [CYANOCOBALAMIN] taken for pernicious anaemia, start date: 1996 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for blood disorder, start date: 1996, stop date: 2023; BENADRYL taken for multiple allergies, start date: 2020, stop date: 2021; CALCIUM taken for pernicious anaemia, start date: 1996 (ongoing); BUPROPION. The patient also took other concomitant therapy. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "failure". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2022) Positive. Clinical course: 03Jan2020: illness began following contact with others. No smell, no taste, slight fever, cough recovered in 14 days. 21Jan2020: symptoms recovered in 5 days physician contacted. 28Jan2020: physician diagnosed flu vaccine failure. No covid test available yet. Jun2020: antibodies tested (illegible) negative after 6 month of illness onset trouble breathing at night. Elevated head. Jun2020: hospitalized for extreme dizziness chest pain inability to (illegible). HR 43 BP extremely low diagnosis occipital neuralgia BP meds discontinued discharged to conjugate (illegible) recovery 2 weeks. Jan2021: Relocated to new retirement facility contacted new physician full vaccine completed 23Jan2021. 03Feb2022: Exposure to COVID- at residential facility not monitored by board of health (death rate not monitored either). 06Feb2022: Positive COVID diagnosis by air bio lab. 17Feb2022: COVID to presented contained clinic RN. (no physician available). No treatment recommended except 5-7 days rest after 2 vaccines, recovery in 7 days, bit cough and ear infection lingered one month referred to ENT physician. More
2836454 M NY 04/17/2025 PNC21
 MERCK & CO. INC.
 Y011819
Antibody test abnormal, Staphylococcus test Antibody test abnormal, Staphylococcus test
Blood work was done to address serotype findings. These were not at the level that the patient was e... Blood work was done to address serotype findings. These were not at the level that the patient was expecting based on review of clinical data.; This spontaneous report was received from a male patient of unknown age reporting on himself via company representative. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) (lot #Y011819, expiration date: 01-Oct-2025) administered by unknown route as prophylaxis. Post administration of the vaccine, on 04-Feb-2025, blood work was done to address serotype findings. These were not at the level that the patient was expecting based on review of clinical data (antibody test abnormal). On this date, S Pneumoniae IgG serotype 1 was 30 ug/mL, S Pneumoniae IgG serotype 33F was 1.6 ug/mL, S Pneumoniae IgG serotype 9V was 0.3 ug/mL, S Pneumoniae IgG serotype 19A was unable to perfor due to a reagent issue, S Pneumoniae IgG serotype 18C was 0.5 ug/, S Pneumoniae IgG serotype 15B was 1.1 ug/mL, S Pneumoniae IgG serotype 7F was 3.7 ug/mL, S Pneumoniae IgG serotype 11A was 1.1 ug/mL, S Pneumoniae IgG serotype 10A was 0.2 ug/mL, S Pneumoniae IgG serotype 6B was 1 ug/mL, S Pneumoniae IgG serotype 23F was 0.1 ug/mL, S Pneumoniae IgG serotype 22F was 0.6 ug/mL, S Pneumoniae IgG serotype 20 was 0.5 ug/mL, S Pneumoniae IgG serotype 19F was 0.3 ug/mL, S Pneumoniae IgG serotype 17F was 3.6 ug/mL, S Pneumoniae IgG serotype 14 was 3.9 ug/mL, S Pneumoniae IgG serotype 12F was 0.2 ug/mL, S Pneumoniae IgG serotype 8 was 3.6 ug/mL, S Pneumoniae IgG serotype 4 was 0.1 ug/mL, S Pneumoniae IgG serotype 3 was 0.1 ug/mL, S Pneumoniae IgG serotype 2 was 2.2 ug/mL, S Pneumoniae IgG serotype 5 was less than 0.1 ug/mL, S Pneumoniae IgG serotype 9N was 37.1 ug/mL. At the reporting time, the outcome of this event was unknown. The causal relationship between the event and the suspect vaccine was not provided. More
2836455 ID 04/17/2025 MMRV
 MERCK & CO. INC.
 Y014436
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; The nurse is reporting that a patient received improperly stored va... No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) PROQUAD (y014436 2/22/2026) Temperature: 14.92F Time frame:; This spontaneous report was received from Certified Nursing Assistant (CNA) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-Mar-2025, the patient was vaccinated with and improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(rHA), (lot #Y014436, expiration date: 22-Feb-2026), the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (Dose, route, and anatomical location were not reported) for prophylaxis It was reported that the vaccines had a temperature excursion of 14.92F during a time frame of 1 hour and 40 minutes. There were not previous temperature excursions. No additional adverse events were reported, no further information provided. More
2836457 M NY 04/17/2025 UNK
 UNKNOWN MANUFACTURER
Antibody test negative Antibody test negative
Antibody test negative; This literature marketed report has been received from the authors of a publ... Antibody test negative; This literature marketed report has been received from the authors of a published literature article, and refers to a 33-year-old male patient The patient's medical history included 2 episodes of immune thrombocytopenia (ITP). The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), Solution for injection (indication, expiration date, and lot # were not reported). On an unknown date, the patient experienced Antibody test negative. Immunoglobulin (Ig) gG was 249 mg/dL, IgA was 22 mg/dL, IgM was 25 mg/dL. The was referred to immunology and was found to have a poor pneumococcal vaccine response (only 4 of 23 serotypes became positive). At the reporting time, the outcome of Antibody test negative was unknown. The authors considered the event of Antibody test negative to be related to Pneumococcal Vaccine, Polyvalent (23-valent). More
2836458 IA 04/17/2025 HEP
 MERCK & CO. INC.
 X021478
No adverse event, Underdose No adverse event, Underdose
No symptoms; pediatric dose of RECOMBIVAX HB was administered to an adult patient in error; This spo... No symptoms; pediatric dose of RECOMBIVAX HB was administered to an adult patient in error; This spontaneous report was received from a licensed practical nurse (LPN) concerning an adult patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 04-Apr-2025, the patient was vaccinated in error by a healthcare professional with a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 5 mcg/0.5 mL pre-filled syringe, lot #X021478, expiration date reported as 29-Nov-2025 but upon internal verification established as 18-May-2026, 1 dosage form (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (accidental underdose). It was reported that patient was intending to get Hepatitis b vaccine rHBsAg (yeast) (HEPLISAV B) vaccine. There were no symptoms (no adverse event.) More
2836459 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015101
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 03-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 5.7 degree Fahrenheit for 12 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836460 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015101
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 05-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 5.7 degree Fahrenheit for 30 hours 30 minutes. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836461 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015558
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 13-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6 degree Fahrenheit for 32 hours 30 minutes. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836462 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015558
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 17-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.6 degree Fahrenheit for 58 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836463 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015558
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 17-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.6 degree Fahrenheit for 58 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836464 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015558
Product storage error Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 17-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.6 degree Fahrenheit for 58 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836465 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015101
Product storage error Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 20-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 6.6 degree Fahrenheit for 90 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836466 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015558
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 21-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.8 degree Fahrenheit for 115 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836467 PA 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y015101
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and ... No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 22-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015101, expiration date 06-Sep-2026). The temperature excursion was 6.8 degree Fahrenheit for 127 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter. More
2836469 M FL 04/17/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Cardiac pacemaker insertion; Cardiac pacemaker insertion Cardiac pacemaker insertion; Cardiac pacemaker insertion
pacemaker; This spontaneous report was received from a physician regarding to a 94-year-old male pat... pacemaker; This spontaneous report was received from a physician regarding to a 94-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not reported), as prophylaxis; in combination with sterile diluent (BAXTER STERILE DILUENT) (strength, dose, frequency, lot number, expiration date and indication were not reported). Inbound call was received from physician who had a medical information question on administering a 3rd booster dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) to a 94 year old male who had a pacemaker. After caller disconnected, precautionary AE was identified to due the patient having a pacemaker. Unknown date of when patient received pacemaker and unknown date when patient initially received measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) doses. Because a correlation could not be ruled out, precautionary AE filed. Since HCP had already disconnected, most information was unknown. Permission to contact for follow up is unknown. No additional information available. No additional AE/PQC. At the reporting time, the outcome of pacemaker was unknown. The causal relationship between the event of pacemaker and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and sterile diluent was not provided. Upon an internal review, the event of pacemaker was determined to be medically significant. Lot # is being requested and will be submitted if received. More
2836470 M TX 04/17/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Antibody test positive, Developmental regression, Gait disturbance, Hypersensiti... Antibody test positive, Developmental regression, Gait disturbance, Hypersensitivity, Pyrexia; Rash, Rash erythematous More
fever; his Mump titers were elevated; hypersensitivity reaction to a previous dose of MMR-2; "b... fever; his Mump titers were elevated; hypersensitivity reaction to a previous dose of MMR-2; "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation; Patient had trouble walking; was regressing in speech which he had to receive early intervention services; This spontaneous report was received from a consumer or other non health professional and refers to a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions included autoimmune disease, and immunosuppression. Concomitant therapies were not reported. On 25-Jun-2020, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) for prophylaxis reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). On 01-Jul-2020, the patient experienced hypersensitivity reaction to a previous dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II); "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation (drug hypersensitivity), fever, trouble walking, was regressing in speech which he had to receive early intervention services, his Mump titers were elevated. At the reporting time, the outcome of the events was not reported. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not applicable. The reporter considered the event of hypersensitivity reaction to a previous dose of MMR-2; "big red rash about the size of the palm" from his arm pits to all over his body. Caller stated that it seemed like a full body inflammation to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. The casual relationship between drug hypersensitivity and the suspect vaccine was possibly related. The casual relationship between fever, trouble walking, was regressing in speech which he had to receive early intervention services, his Mump titers were elevated and the suspect vaccine was not reported. More
2836471 NV 04/17/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
y015100
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No side effects or symptoms reported. No Additional AE; HCP called to report a patient received MMR ... No side effects or symptoms reported. No Additional AE; HCP called to report a patient received MMR II (03/01/2025) and then received VARIVAX 7 days later (03/07/2025) instead of the recommended 4-week interval. No side effects or symptoms reported. No Additional information provided. No Additional AE/ N; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 01-MAR-2025, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) and on 07-MAR-2025, with varicella virus vaccine live (Oka-Merck) (VARIVAX) injection, 0.5 ml, lot# Y015100, expiration date: 06-SEP-2026 (dose number, route of administration and anatomical location were not provided), both reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot# and expiration date were not provided), for prophylaxis. The vaccines were administered in 7-day interval instead of recommended 4-week interval (Inappropriate schedule of product administration). No side effects, symptoms or additional adverse event were reported. Lot# is being requested and will be submitted if received. More
2836472 F 04/17/2025 HPV4
 MERCK & CO. INC.
Injection site pain Injection site pain
My daughter was given Gardasil and developed pain at the site of the injection 1 day later. Please l... My daughter was given Gardasil and developed pain at the site of the injection 1 day later. Please let me know if there's other information needed; This spontaneous report was received from a company representative and refers to a female patient of unknown age. The patient's medical history, current conditions, and concomitant therapies was not reported. On an unknown date, the patient was vaccinated Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, anatomical route of administration, lot # and expiration date were not reported) as prophylaxis. The reporter stated that the patient developed pain at the site of the injection 1 day later (exact dates not provided) (vaccination site pain). The outcome of the event vaccination site pain was not reported. The causal relationship between vaccination site pain with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not reported. Lot number is being requested and will be submitted if received. More
2836473 MD 04/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Inappropriate schedule of product administration 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 the following 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 naοΏ½ve (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 (at baseline, median time from diagnosis was 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 (at baseline, median time from diagnosis was 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2836474 M TN 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Guillain-Barre syndrome Guillain-Barre syndrome
developed Guillain Barre syndrome; This serious case was reported by a non-health professional via s... developed Guillain Barre syndrome; This serious case was reported by a non-health professional via sales rep and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillain Barre syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolving. The reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-APR-2025 The patient received in office administration of Shingrix (unknown if this was first or second dose). The reporter stated that, three weeks after administration the patient developed Guillain Barre syndrome. The patient continued to try to recover and is receiving infusion therapy. The causality was believed by the physician office to be related as they could not identify any other precipitating event.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2836475 F 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain, Rash, Vaccination failure Herpes zoster, Pain, Rash, Vaccination failure
Suspected vaccination failure; got shingles; This serious case was reported by a consumer via intera... Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles 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 patient got the vaccine several years ago and currently had shingles. They said patient did not get them that bad. Patient would not wish this pain on worst enemy. They knew about shingles and how excruciating the pain associated with the rash could be. She likes to stay on top of her health, so she did some research. She learned that while not everyone at risk will develop shingles, 99 percent of adults over 50 already have the virus that causes shingles inside their body. Take the first step learn more about the risk of shingles and talk to a pharmacist or doctor. Trademarks were owned by or licensed to the GlaxoSmithKline group of companies. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix More
2836476 M 04/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Testicular swelling Testicular swelling
Swelling of testicles; This non-serious case was reported by a consumer and described the occurrence... Swelling of testicles; This non-serious case was reported by a consumer and described the occurrence of testicular swelling in a 65-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 04-APR-2025, the patient received the 1st dose of Shingles vaccine. On 06-APR-2025, 2 days after receiving Shingles vaccine, the patient experienced testicular swelling (Verbatim: Swelling of testicles). The outcome of the testicular swelling was not resolved. It was unknown if the reporter considered the testicular swelling to be related to Shingles vaccine. It was unknown if the company considered the testicular swelling to be related to Shingles vaccine. Additional Information: GSK receipt date: 07-APR-2025 Patient reported that had swelling of testicles after the first dose of Shingles vaccine. Physician told to patient that the swelling may be a rare side effect of vaccine. More
2836477 55 M 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Oral mucosal eruption, Rash Oral mucosal eruption, Rash
Patient developed rash on one side of face area; Patient developed rash inside mouth; This serious c... Patient developed rash on one side of face area; Patient developed rash inside mouth; This serious case was reported by a physician via sales rep and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included varicella zoster (left varicella zoster). Concurrent medical conditions included gout (gout), hepatitis b (hep b), fatty liver (fatty liver), hyperlipidemia (hyperlipidemia) and gallstones (gall stones). Concomitant products included allopurinol. On 27-MAR-2025, the patient received the 1st dose of Shingrix (left deltoid). On 31-MAR-2025, 4 days after receiving Shingrix, the patient experienced rash (Verbatim: Patient developed rash on one side of face area) (serious criteria other: Serious as per reporter) and rash mouth (Verbatim: Patient developed rash inside mouth) (serious criteria other: Serious as per reporter). The patient was treated with valaciclovir, gabapentin and triamcinolone. On 04-APR-2025, the outcome of the rash and rash mouth were resolved (duration 4 days). It was unknown if the reporter considered the rash and rash mouth to be related to Shingrix. The company considered the rash and rash mouth to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-APR-2025 Patient developed rash on one side of face area and inside mouth 2-3 days after first dose of Shingrix. Patient was started on valacyclovir, gabapentin, triamcinolone, vision check and sent to consult with ophthalmologist .; Sender's Comments: Rash is a listed event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK vaccine Oral mucosal eruption Shingrix. Oral mucosal eruption is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
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