🏥 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 💀 🏥 🚑 ♿ ⚠️
2815233 F 12/10/2024 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH

NDC00069
Back pain, Cardiac flutter, Heart rate, Heart rate irregular, Inflammation; Palp... Back pain, Cardiac flutter, Heart rate, Heart rate irregular, Inflammation; Palpitations, X-ray; Back pain, X-ray More
she started having some back pain/bad pain in my back/I just had a slight backache; inflammation on ... she started having some back pain/bad pain in my back/I just had a slight backache; inflammation on her lower back; having heart irregularities; pounding of the heart and flutter; pounding of the heart and flutter; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 2024, outcome "not recovered", described as "having heart irregularities"; INFLAMMATION (non-serious) with onset 2024, outcome "recovering", described as "inflammation on her lower back"; CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 2024, outcome "not recovered" and all described as "pounding of the heart and flutter"; BACK PAIN (non-serious) with onset 27Oct2024, outcome "recovering", described as "she started having some back pain/bad pain in my back/I just had a slight backache". The events "she started having some back pain/bad pain in my back/i just had a slight backache" and "inflammation on her lower back" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: irregularities, notes: she's having heart irregularities; X-ray: inflammation, notes: I took Xray and said there was inflammation in my back. Therapeutic measures were taken as a result of back pain, inflammation. Clinical course: A 75-year-old female that was administered with Comirnaty for 12 years plus on 30Sep2024 at (name). On 27Oct2024 she started having some back pain and a week later her back pain got worse, and she was prescribed ibuprofen. Pain got even worse, and she was rushed to the emergency room (ER). The doctor said it was inflammation on her lower back and the doctor took an x-ray and gave her muscle relaxant. It has gotten better. Her concern now is that she is having heart irregularities which started about a week ago. She is experiencing pounding of the heart and flutter. She asked for side effects and if her symptoms were listed as part of the side effects of COMIRNATY, agent was able to assist with her inquiry and provided information on myocarditis and pericarditis. Caller did not report myocarditis and pericarditis, but agent provided information on myocarditis and pericarditis since this was her inquiry. She was going to be checked by cardiologist later today. Caller did not provide lot number. Batch/lot number is not provided, and it cannot be obtained. More
2828689 NC 02/27/2025 COVID19
 PFIZER\BIONTECH
Investigation, Thrombosis Investigation, Thrombosis
they discovered 2 blood clots that were not there prior to vaccine; This is a spontaneous report rec... they discovered 2 blood clots that were not there prior to vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 60-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "they discovered 2 blood clots that were not there prior to vaccine". The patient underwent the following laboratory tests and procedures: ATYA test: failed. Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient had originally received the Covid vaccine within a year of the outbreak. In 2023, while in the hospital they discovered 2 blood clots that were not there prior to vaccine. Coumadin was positive in clearing the clots. Patient was just told within the last 2 weeks that he/she failed a test for ATYA test, and going to see Hematologist it does seem that this deadly occurrence did come from the vaccine the patient got. The patient asked what kind of compensation is available for this. Patient just want to live a humble life. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2828690 F OH 02/27/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
I tested myself with the home test, and it said positive; I tested myself with the home test, and it... I tested myself with the home test, and it said positive; I tested myself with the home test, and it said positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 55-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested myself with the home test, and it said positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. More
2828696 71 M 02/27/2025 COVID19
 MODERNA
Gastrointestinal bacterial infection, Gastrointestinal perforation, Headache, Ti... Gastrointestinal bacterial infection, Gastrointestinal perforation, Headache, Tinnitus, Weight decreased More
he went to the gastro and he has holes/he had bacteria in his intestines; tinnitus/The ringing in hi... he went to the gastro and he has holes/he had bacteria in his intestines; tinnitus/The ringing in his ears and the bells in his ears are getting worse; headaches are getting worse; he lost 30 pounds in 30 days. He states he continues to lose weight; he went to the gastro and he has holes/he had bacteria in his intestines; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL PERFORATION (he went to the gastro and he has holes/he had bacteria in his intestines) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cluster headache in 2006 and Traumatic brain injury in 1973. Concurrent medical conditions included Hypothyroidism (inactive thyroid) and Disability (Patient was a disabled). On 11-Aug-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PERFORATION (he went to the gastro and he has holes/he had bacteria in his intestines) (seriousness criterion medically significant), TINNITUS (tinnitus/The ringing in his ears and the bells in his ears are getting worse), HEADACHE (headaches are getting worse), WEIGHT DECREASED (he lost 30 pounds in 30 days. He states he continues to lose weight) and GASTROINTESTINAL BACTERIAL INFECTION (he went to the gastro and he has holes/he had bacteria in his intestines). At the time of the report, GASTROINTESTINAL PERFORATION (he went to the gastro and he has holes/he had bacteria in his intestines), TINNITUS (tinnitus/The ringing in his ears and the bells in his ears are getting worse), HEADACHE (headaches are getting worse) and WEIGHT DECREASED (he lost 30 pounds in 30 days. He states he continues to lose weight) had not resolved and GASTROINTESTINAL BACTERIAL INFECTION (he went to the gastro and he has holes/he had bacteria in his intestines) had resolved. No Concomitant medications provided by the reporter. Suspect product batch number was mentioned as: 017822A or 017B22A. Patient experienced symptom of tinnitus from last two and half year. It was reported that from last 4 months patient experienced worse headache. Patient stated that he was 148 pounds and then he lost 30 pounds in 30 days. He continued to lose weight. He went down to 104 pounds. He stated that he cannot get above 111-112 pounds. Patient went to a boot camp 129 pounds and came out with 165. Patient was stated that he should be the hulk by now, as he ate more carbs. He stated that he went to visit with gastroenterologist, and he had holes that he did not know he had. It was found that patient had bacteria in his intestines and patient took an unspecified treatment medication pill for the Gastrointestinal bacterial infection and the symptom was gone within 7 days. Patient was reported that the only time he did not hear it (ringing in his ears) and the only time he did not feel his headaches was when he went to sleep and when he wakes up, the symptom of ringing in his ears and headache was started for patient. Patient went through CTs, brain scans, MRI's, ultrasounds, thyroid infusion test, blood work, stool samples. But no lab data was available. Patient reported that his concern was related with body weight from last 2.5 years.; Reporter's Comments: Company comment. Etiology of the gastrointestinal perforation (probably based on Helico bacter pylori infection) and lack of information about the date of diagnosis did not confirm positive relationship between gastrointestinal perforation and gastrointestinal infection and vaccination thusevents are assessed as not related. Weight decrease is assessed as not related as it can be related to GI infection. The other events of headache, tinnitus are assessed as related. The benefit-risk relationship of product is not affected by this report. More
2828697 80 F OK 02/27/2025 COVID19
 MODERNA
Asthenia, Blood test, Echocardiogram, Laboratory test Asthenia, Blood test, Echocardiogram, Laboratory test
Next morning, increased weakness overall. Very dramatic. Next morning, increased weakness overall. Very dramatic.
2828698 0.5 F KS 02/27/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 X9EP5
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Patient administered vaccine in clinic and returned to clinic 2 days later with concerns for potenti... Patient administered vaccine in clinic and returned to clinic 2 days later with concerns for potential vaccine reaction. Assessment was done by PCP in which redness and swelling was noted near site of vaccine administration. Patients' family was educated on additional signs and symptoms to watch for and additional fact finding and vaccine education was completed with staff at the clinic. More
2828714 67 F CA 02/27/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Injection site pain, Injection site swelling, Pain Injection site pain, Injection site swelling, Pain
Pain, swelling. Itchiness, and redness in area of injection for about 3 weeks. Then difficulty lifti... Pain, swelling. Itchiness, and redness in area of injection for about 3 weeks. Then difficulty lifting, bending, and weight bearing on left arm accompanied by pain in deltoid down to triceps that lasted 3 months. Gradual reduction in symptoms which occur intermittently at present time. Tenderness with palpation and some movements in areas of pain More
2828715 59 M IL 02/27/2025 PNC21
 MERCK & CO. INC.
 Y011819
Fatigue, Flushing, Headache, Paraesthesia Fatigue, Flushing, Headache, Paraesthesia
FLUSHING HEADACHE FATIGUE TINGLING FLUSHING HEADACHE FATIGUE TINGLING
2828716 66 F TX 02/27/2025 PNC21
 MERCK & CO. INC.
 Y013009
Anaphylactic reaction, Malaise, Peripheral swelling, Swollen tongue Anaphylactic reaction, Malaise, Peripheral swelling, Swollen tongue
Anaphylacic reaction: swelling in tonsils, massive swelling in arm spreading to forearm and close to... Anaphylacic reaction: swelling in tonsils, massive swelling in arm spreading to forearm and close to wrist. Severe malaise. More
2828717 67 F GA 02/27/2025 PNC20
 PFIZER\WYETH
 LG5575
Extra dose administered Extra dose administered
Pt received extra dose of PREVNAR She received a dose 3/5/23 and a second dose that was not needed a... Pt received extra dose of PREVNAR She received a dose 3/5/23 and a second dose that was not needed and given outside CDC guidelines on 2/22/2025 More
2828718 46 F ME 02/27/2025 COVID19
 MODERNA
 3043838
Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Sore arm that progressed to red, swollen, itchy and hot, encompassing majority of bicep/upper ar. Pl... Sore arm that progressed to red, swollen, itchy and hot, encompassing majority of bicep/upper ar. Places on antibiotics 2 days out. More
2828719 65 F TN 02/27/2025 RSV
 PFIZER\WYETH
 hy1813
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient had already received the RSV ( Arexvy ) vaccine in November 2023 and should not have receive... Patient had already received the RSV ( Arexvy ) vaccine in November 2023 and should not have received the Abrysvo per CDC recommendations. The patient has no reported side effects as of now. More
2828720 64 F IL 02/27/2025 PNC20
 PFIZER\WYETH
 lg5579
Dyspnoea, Laboratory test, Myocarditis Dyspnoea, Laboratory test, Myocarditis
Shortness of breath, difficulty breath. Md's suspect myocarditits. Patient still undergoing tes... Shortness of breath, difficulty breath. Md's suspect myocarditits. Patient still undergoing testing More
2828721 10 F CA 02/27/2025 HPV9
 MERCK & CO. INC.
Dizziness, Fatigue, Nausea, Vomiting Dizziness, Fatigue, Nausea, Vomiting
Severe dizziness, nausea, vomiting and fatigue Severe dizziness, nausea, vomiting and fatigue
2828732 1 M GA 02/27/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 5JA57
X014954
Y009956
Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash
1. Fever started day 2 (x 5 days) then resolved and 2. rash --> head to body started day 6 F... 1. Fever started day 2 (x 5 days) then resolved and 2. rash --> head to body started day 6 Fever resolved; Still has rash More
2828733 11 M CA 02/27/2025 MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8259AB
U8259AB
U8352AA
U8352AA
Headache, Injection site erythema, Injection site pain, Injection site swelling,... Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain; Pyrexia; Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain; Pyrexia More
Fever, Headache, body aches the next day. Upper arm (left) swelling, redness, tenderness 13 x 17 cm ... Fever, Headache, body aches the next day. Upper arm (left) swelling, redness, tenderness 13 x 17 cm erythema Mother has pictures More
2828218 MN 02/26/2025 HEPA
 MERCK & CO. INC.
 W038118
Expired product administered Expired product administered
No symptoms reported; Pharmacist calling to report the inadvertent administration of an expired dose... No symptoms reported; Pharmacist calling to report the inadvertent administration of an expired dose of a VAQTA to a patient on 02/18/2025. No symptoms reported and no additional details provided; This spontaneous report has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 18-FEB-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), administered as prophylaxis (lot number reported as W038118, which has been verified as valid, expiration date reported and validated as 06-APR-2024) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported) (Expired product administered). No symptoms reported and no additional details provided. More
2828219 HI 02/26/2025 RV5
 MERCK & CO. INC.
 2051974
No adverse event, Product storage error No adverse event, Product storage error
the patient involved has not reported any medical concerns or symptoms after the administration.; an... the patient involved has not reported any medical concerns or symptoms after the administration.; an improperly stored and administered dose of ROTATEQ. Medical Assistant stated that the dose of ROTATEQ has been exposed to multiple temperature excursions dating back to Decembe; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On 22-FEB-2025, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (2 mL / three dose series, lot#: 2051974, expiration date: 16-NOV-2025; strength was not provided) for prophylaxis by a health care professional. The administered rotavirus vaccine live, pentavalent (ROTATEQ) was improperly stored and was exposed to multiple temperature excursions dating back to December 2024 (product storage error). The patient did not report any medical concerns or symptoms after the vaccination (no adverse event). More
2828220 FL 02/26/2025 MMRV
 MERCK & CO. INC.
 X018574
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; the inadvertent administration of an expired dose of PROQUAD to a 12 month old pat... No additional AE; the inadvertent administration of an expired dose of PROQUAD to a 12 month old patient. Expired on 1/5/2025, administered on 2/24/2025.; This spontaneous report was received from a healthcare professional referring to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On 24-FEB2-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (0.5 ml, lot#: X018574, expiration date: 05-JAN-2025; strength was not provided) by a healthcare professional for prophylaxis inadvertently (expired product administered). No adverse effects were reported. More
2828236 93 F IN 02/26/2025 COVID19
FLU3
RSV
 MODERNA
SANOFI PASTEUR
PFIZER\WYETH


Loss of consciousness; Loss of consciousness; Loss of consciousness Loss of consciousness; Loss of consciousness; Loss of consciousness
Pt passed out the following day after administration, Pt couldn't raise arms to catch fall, Pt ... Pt passed out the following day after administration, Pt couldn't raise arms to catch fall, Pt couldn't reach phone. Pt has been hospitalized ever since. More
✓
2828237 38 F OK 02/26/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA



Asthenia, Blood pressure increased, Chest discomfort, Computerised tomogram head... Asthenia, Blood pressure increased, Chest discomfort, Computerised tomogram head, Dyspnoea; Fatigue, Full blood count, Heart rate increased, Hepatitis viral test, Inflammatory marker increased; Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging head, Mobility decreased, Nausea; Rheumatoid arthritis, Rheumatoid factor increased, Vomiting More
Over time, I began to notice increased blood pressure and my resting heart rate was always over 100.... Over time, I began to notice increased blood pressure and my resting heart rate was always over 100. Walking at an average pace would raise my heart rate to 150. I started getting tired very easily, losing my breath just from things like walking room to room or changing my clothes. On August 19, 2024, I was having a normal day and was sitting when I began to feel weak. Moments later, I could not move at all. My whole body felt paralyzed. I was able to get out the words "911" and "stroke" to my daughter. Long story short, I the ambulance took me to the ER where they couldn't figure it out. I was offered Ativan for an anxiety attack which it was not and I refused. After several hours, I was finally able to move about normally. I had 4 more if these attacks over the next 4 weeks. Since then, my fatigue had reached an all time extreme. I have had multiple issues where I felt like my chest would explode out of my chest because it was breathing so hard. Not from running a marathon, from carrying in groceries. I have had many times where I've become very nauseated such as standing in a long line waiting to vote. I have had times where I did vomit, repeatedly. From just taking a shower without sit breaks. I can no longer cook a quick meal because I become so fatigued from standing longer than a few minutes. My whole life is upside down. My doctor says I have RA, but I have no pain or swelling that I can see anywhere. My inflammation markers and RF factor it through the roof. I'm not able to see a rheumatologist until October 2025. More
✓
2828240 61 F 02/26/2025 HEP
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Twinrix second dose on Sep 5th 2024 and received Engerix-B on Nov 5th 2024; Twinrix - Late second do... Twinrix second dose on Sep 5th 2024 and received Engerix-B on Nov 5th 2024; Twinrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 15-SEP-2022). On 05-SEP-2024, the patient received the 2nd dose of Twinrix. On 05-NOV-2024, the patient received Engerix B. On 05-SEP-2024, an unknown time after receiving Twinrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Twinrix - Late second dose). On 05-NOV-2024, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Twinrix second dose on Sep 5th 2024 and received Engerix-B on Nov 5th 2024). The outcome of the drug dose administration interval too long and inappropriate schedule of vaccine administered were unknown. 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: 03-FEB-2025 The pharmacist reported that a patient received the first dose and second dose on 5th September 2024 of Twinrix series and that patient received a monovalent Hepatitis B vaccine (Engerix-B vaccine) on 5th November 2024, which led to inappropriate schedule of vaccine administered The reporter asked if they could complete the hepatitis A and B series with a Twinrix dose. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2828241 M 02/26/2025 COVID19
 MODERNA
Illness, Lung disorder Illness, Lung disorder
he had a bad reaction and got sick; lung problems; This spontaneous case was reported by a patient a... he had a bad reaction and got sick; lung problems; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (he had a bad reaction and got sick) and LUNG DISORDER (lung problems) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In December 2024, the patient experienced ILLNESS (he had a bad reaction and got sick) and LUNG DISORDER (lung problems). At the time of the report, ILLNESS (he had a bad reaction and got sick) and LUNG DISORDER (lung problems) had not resolved. No concomitant medication was reported. He received vaccine on 5-Dec-2024, right after he had a bad reaction and got sick. As of 22-Feb-2025, he continued to suffer from lung issues. It was unknown if the patient had any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported. More
2828242 34 M NY 02/26/2025 COVID19
 MODERNA
Magnetic resonance imaging, Vertigo Magnetic resonance imaging, Vertigo
Extreme vertigo for 3 months after the vaccine and then on and off until present day Extreme vertigo for 3 months after the vaccine and then on and off until present day
✓ ✓
2828245 34 F NY 02/26/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 4T93R
Fall Fall
Patient received shot, was being counceled on returned for 2nd shot. Upon leaving she fell back and ... Patient received shot, was being counceled on returned for 2nd shot. Upon leaving she fell back and stopped full fall with arm. She lay still then sat up then left after waiting to feel better. She was called after 30 minutes at home, she felt better. More
2828247 51 F MD 02/26/2025 TDAP
 SANOFI PASTEUR
 U8352AA
Vaccination site cellulitis, Vaccination site joint erythema, Vaccination site p... Vaccination site cellulitis, Vaccination site joint erythema, Vaccination site pain, Vaccination site swelling More
Pt developed increased swelling extending distally from vaccine sitefor approxmiately 6 inches with ... Pt developed increased swelling extending distally from vaccine sitefor approxmiately 6 inches with pain and redness, which has been diagnosed as resolving cellulitis. This swelling continued for approxmately 5 to 6 days and has resovled. More
2828248 46 F OH 02/26/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9N4E7
9N4E7
Erythema, Pain, Pruritus, Rash, Skin warm; Swelling Erythema, Pain, Pruritus, Rash, Skin warm; Swelling
itching, warm, red, swollen, painful, rash itching, warm, red, swollen, painful, rash
2828249 77 M NY 02/26/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Ageusia, Anosmia Ageusia, Anosmia
Pt. came to office stating he thinks he is experiencing a S/E from the covid vaccine he received las... Pt. came to office stating he thinks he is experiencing a S/E from the covid vaccine he received last month; he has no sense of smell. Pt states it started slow after vaccine to now when he has lost the sense of smell entirely. He only first reported this S/E today. More
2828304 15 F NY 02/26/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y007197
Y007197
Y007197
Y007197
Exposure during pregnancy, No adverse event, Product use issue; Exposure during ... Exposure during pregnancy, No adverse event, Product use issue; Exposure during pregnancy, Pregnancy test positive; Exposure during pregnancy, No adverse event, Product use issue; Exposure during pregnancy, Pregnancy test positive More
2nd dose of GARDASIL 9 was inadvertently administered to a pregnant woman on 02/10/2025. No reported... 2nd dose of GARDASIL 9 was inadvertently administered to a pregnant woman on 02/10/2025. No reported signs or symptoms of adverse effects. Permission to contact the HCP was given. No additional AE/n; no adverse event; This spontaneous Prospective pregnancy report was received from a physician and refers to a currently 15-year-old female 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 became pregnant (last menstrual period date and due date were not provided). On 10-FEB-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9)(lot #Y007197 was confirmed to be valid, expiration date: 18-AUG-2026) , the dose of was inadvertently administered to a pregnant woman. No reported signs or symptoms of adverse effects (vaccine exposure during pregnancy, no adverse event). The fetal outcome and pregnancy outcome were Unknown. Follow up information has been received from a physician on 25-FEB-2025 via telephone call. The reporter confirmed that she had a patient that was exposed to Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) during pregnancy. No further information provided. More
2828305 0.67 M CA 02/26/2025 UNK
 UNKNOWN MANUFACTURER
Lethargy, Pyrexia, Somnolence, Vomiting Lethargy, Pyrexia, Somnolence, Vomiting
LETHARGY; Pirexia; SOMNOLENCE; Vomiting; This spontaneous report was received from the Health Author... LETHARGY; Pirexia; SOMNOLENCE; Vomiting; This spontaneous report was received from the Health Authority and refers to a(n) 8-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included dairy sensitivity. Concomitant therapies were not reported. On 30-Dec-2024, the patient started therapy with Pneumococcal 15-valent Conjugate Vaccine administered by Intramuscular route (indication, expiration date, and lot # were not reported). On 30-Dec-2024, the patient experienced lethargy, pyrexia, somnolence, and vomiting. At the reporting time, the outcome of lethargy, pyrexia, somnolence and vomiting was unknown. The action taken with Pneumococcal 15-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the events and Pneumococcal 15-valent Conjugate Vaccine not provided. More
2828306 NJ 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; Development of RSV; This serious case was reported by a nurse via cal... Suspected vaccination failure; Development of RSV; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Development of RSV). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK Receipt Date: 18-FEB-2025 The nurse practitioner did not know which dose of the vaccine this was. The infectious diseases nurse practitioner mentioned that they were surprised that the patients in her skilled nursing facilities (SNF) had developed respiratory Syncytial Virus this season despite vaccination. She did not say whether they had received GSK or Pfizer product, but she did say that she had reviewed these patients with their research MD and may look at them more closely because they were surprised to see several cases. It was unexpected to them, so it might have been more than mild illness. there were multiple patients. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 vaccine Arexvy. More
2828307 85 M NJ 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 A2F3R
Arthralgia, Myalgia, Pain Arthralgia, Myalgia, Pain
residual pain in both biceps occurs with movement; residual pain in both Shoulder; General body pain... residual pain in both biceps occurs with movement; residual pain in both Shoulder; General body pain/pain from the neck to both ankles; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number A2F3R, expiry date 26-OCT-2026) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On 07-OCT-2024, the patient received the 2nd dose of Shingrix (left deltoid). On 07-DEC-2024, 61 days after receiving Shingrix, the patient experienced general body pain (Verbatim: General body pain/pain from the neck to both ankles). On an unknown date, the patient experienced muscle pain (Verbatim: residual pain in both biceps occurs with movement) and shoulder pain (Verbatim: residual pain in both Shoulder). The patient was treated with prednisone. The outcome of the general body pain was resolved and the outcome of the muscle pain and shoulder pain were not resolved. It was unknown if the reporter considered the general body pain, muscle pain and shoulder pain to be related to Shingrix. It was unknown if the company considered the general body pain, muscle pain and shoulder pain to be related to Shingrix. Additional Information: GSK Receipt Date: 19-FEB-2025 The patient self-reported this case. The reporter stated that two months after suspect vaccine administration reporter experienced pain from the neck to both ankles. Reporter went to his physician and was prescribed prednisone for the pain. Pain resolved in 2 days after taking Prednisone. Reporter stated that he had residual pain in both shoulders and both biceps that occurs with movement. More
2828308 M NY 02/26/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 x449y
Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia
numbness; tingling radiating from their shoulder to their fingers; This non-serious case was reporte... numbness; tingling radiating from their shoulder to their fingers; This non-serious case was reported by a other health professional and described the occurrence of numbness of upper extremities in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number x449y, expiry date 20-OCT-2026) for prophylaxis. On 26-SEP-2024, the patient received Boostrix (intramuscular) .5 ml. On 26-SEP-2024, less than a day after receiving Boostrix, the patient experienced numbness of upper extremities (Verbatim: numbness) and tingling of extremity (Verbatim: tingling radiating from their shoulder to their fingers). The outcome of the numbness of upper extremities and tingling of extremity were not resolved. It was unknown if the reporter considered the numbness of upper extremities and tingling of extremity to be related to Boostrix. It was unknown if the company considered the numbness of upper extremities and tingling of extremity to be related to Boostrix. Additional Information: GSK Receipt Date : 21-FEB-2025 Patient received boostrix vaccine, complained of numbness and tingling radiating from their shoulder to their fingers on the arm the vaccine was administered on. Still felt it months after receiving the vaccine. Started day after they received the vaccine (Numbness). Symptoms were not treated. More
2828309 M 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
the other was only injected with the diluent.; the other was only injected with the diluent.; This n... the other was only injected with the diluent.; the other was only injected with the diluent.; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: the other was only injected with the diluent.) and inappropriate dose of vaccine administered (Verbatim: the other was only injected with the diluent.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date 20-FEB-2025 Other Healthcare Professionals reported that two customers came in to get vaccinated for RSV. Once customer received the properly mixed vaccine, the other was only injected with the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2828310 M 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
dose 1 about a year ago ( did not have date) and states his insurance did not cover dose 2 so he nev... dose 1 about a year ago ( did not have date) and states his insurance did not cover dose 2 so he never received it.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in November 2023). 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: dose 1 about a year ago ( did not have date) and states his insurance did not cover dose 2 so he never received it.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter was the patient that states he received Shingrix dose 1 about a year ago ( did not have date) and states his insurance did not cover dose 2 so he never received it. The reporter asked if he has to restart series. Information provided per content. The patient stated that he would get dose 2 soon. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2828311 76 F KS 02/26/2025 RVX
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Pain in extremity, Pruritus, Rash, Urticaria; Pain in extremity, Pruritus, Rash,... Pain in extremity, Pruritus, Rash, Urticaria; Pain in extremity, Pruritus, Rash, Urticaria More
Hives; arm was sore; breaking out under my cheek bone and right arm; it itches like crazy; This non-... Hives; arm was sore; breaking out under my cheek bone and right arm; it itches like crazy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Previously administered products included Zostavax (received on an unknown date). On 09-JAN-2025, the patient received the 1st dose of Shingles vaccine (intramuscular, left arm) .5 ml and RSV vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine and RSV vaccine, the patient experienced pruritus (Verbatim: it itches like crazy). On an unknown date, the patient experienced hives (Verbatim: Hives), pain in arm (Verbatim: arm was sore) and skin breakout (Verbatim: breaking out under my cheek bone and right arm). The outcome of the hives, pruritus and skin breakout were not resolved and the outcome of the pain in arm was resolved. It was unknown if the reporter considered the hives, pruritus, pain in arm and skin breakout to be related to Shingles vaccine and RSV vaccine. It was unknown if the company considered the hives, pruritus, pain in arm and skin breakout to be related to Shingles vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter reported that a patient received Shingles and RSV vaccine and experienced hives, sore arm and itching. She received many years ago a shingles vaccine (Zostavax). The reporter states that her health care professional recommended Shingrix and she received her 1st dose on January 9th, 2025, at her health care professional office. The patient reports she received the vaccine in her left arm. The lot number and expiry date was unknown. The patient reports that she received an RSV vaccine on the same date. The reporter did not know the brand name of the RSV formulation. The patient reports her arm was sore at the beginning but has resolved. The patient reports 2 weeks ago had a breaking of a strange hive on one hand and right wrist and it itches like crazy. The reporter states she was given a steroid shot (unknown name). Now breaking out under cheek bone and right arm and it itches like fire. The patient reports it was not resolved. When asked about sharing other medical history or medications she states not at this time. No additional event was reported. More
2828312 02/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Post herpetic neuralgia, Vaccination failure; Herpes zoster, Post... Herpes zoster, Post herpetic neuralgia, Vaccination failure; Herpes zoster, Post herpetic neuralgia, Vaccination failure More
Suspected vaccination failure; got it a year after the Shingrex shots/ It was the worst outbreak eve... Suspected vaccination failure; got it a year after the Shingrex shots/ It was the worst outbreak ever; Post herpetic neurologic pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (He/ she got in his/her early 20's, twice in his/her 50's). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got it a year after the Shingrex shots/ It was the worst outbreak ever) and post herpetic neuralgia (Verbatim: Post herpetic neurologic pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was resolved (duration 3 months). It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 11-FEB-2025 The patient self-reported this case for himself/herself. This case was reported by a patient via (Facebook) interactive digital media. Patient had gotten it in his/her early 20s, twice in my 50s, and finally received the 2-shot Shingrix in his/her 60s. Then he/she got it a year after the Shingrix shots. It was the worst outbreak ever. The post-herpetic neurologic pain had been unbearable for 3 months. He/she had been told the vaccine was not 100 percent. This case was considered as suspected vaccination failure as details regarding 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 about the laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose) More
2828313 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; developed shingles after taking Shingrix; This serious case was repor... suspected vaccination failure; developed shingles after taking Shingrix; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 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: developed shingles after taking Shingrix). The outcome of the vaccination failure was not reported and the outcome of the shingles was 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: 21-FEB-2025 The patient developed shingles after taking Shingrix. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2828314 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain, Swelling Pain, Swelling
Pain; swelling; This non-serious case was reported by a consumer via interactive digital media and d... Pain; swelling; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included mucinous carcinoma. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Pain) and swelling (Verbatim: swelling). The outcome of the pain and swelling were not reported. It was unknown if the reporter considered the pain and swelling to be related to Shingrix. It was unknown if the company considered the pain and swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 20-FEB-2025 Patient asked if they can take Shingrix while being treated for mucinous carcinoma. Patient had the first shot the day before diagnosis and had pain, swelling , etc More
2828315 02/26/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
shingles really are bad, I got the 1st part of the shingles vaccine and got a really bad case of the... shingles really are bad, I got the 1st part of the shingles vaccine and got a really bad case of them; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles really are bad, I got the 1st part of the shingles vaccine and got a really bad case of them). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 18-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that shingles really were bad, he/she got the 1st part of the shingles vaccine and got really bad case of them. The reporter mentioned that he/she not getting the second part of the vaccine. More
2828316 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I received a shingrix shot in 2019. When am due for another shot; This non-serious case was reported... I received a shingrix shot in 2019. When am due for another shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I received a shingrix shot in 2019. When am due for another shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 21-FEB-2025 The reporter reported that the patient received a Shingrix shot in 2019. The patient asked when he/she due for another shot. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2828317 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Heart rate decreased Heart rate decreased
Low heart rate afterwards; This non-serious case was reported by a consumer via interactive digital ... Low heart rate afterwards; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of heart rate low in a 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 heart rate low (Verbatim: Low heart rate afterwards). The outcome of the heart rate low was not reported. It was unknown if the reporter considered the heart rate low to be related to Shingrix. It was unknown if the company considered the heart rate low to be related to Shingrix. Additional Information: GSK Receipt Date: 21-FEB-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine and had low hear rate afterwards. More
2828318 69 M ID 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster, Injection site discharge, Injection site erosion, Injection site ... Herpes zoster, Injection site discharge, Injection site erosion, Injection site pruritus, Injection site reaction More
still in the open sore stage/oozing lesions developed at injection site; injection site started to i... still in the open sore stage/oozing lesions developed at injection site; injection site started to itch (Pruritus); received first shingrix shot and had a shingles breakout at the injection site/oozing lesions developed at front and back right shoulder and righ arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erosion in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included ankylosing spondylitis. Concomitant products included certolizumab pegol (Cimzia). On 11-OCT-2024, the patient received the 1st dose of Shingrix (injection, right deltoid) .5 ml. In OCT-2024, 5 days after receiving Shingrix, the patient experienced injection site erosion (Verbatim: still in the open sore stage/oozing lesions developed at injection site), injection site itching (Verbatim: injection site started to itch (Pruritus)) and shingles (Verbatim: received first shingrix shot and had a shingles breakout at the injection site/oozing lesions developed at front and back right shoulder and righ arm). The outcome of the injection site erosion, injection site itching and shingles were not resolved. It was unknown if the reporter considered the injection site erosion, injection site itching and shingles to be related to Shingrix. It was unknown if the company considered the injection site erosion, injection site itching and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JAN-2025 The patient received Shingrix. The patient did not know the lot number of the vaccine that was administered. The patient reported that 2 days after getting the vaccine, injection site started to itch (Pruritus) (Symptomatic) The patient also reported he had a shingles breakout at the injection site that was still in the open sore stage The patient reported 5 days after getting the vaccine oozing lesions developed at injection site, front and back right shoulder, and right arm (Symptomatic). The patient reported that his symptoms had not resolved completely, stating that his skin still itches (Pruritus) and 2 lesions remain oozing at the time of reporting. The patient wanted to know if he should get the 2nd shot or continue to wait for the sores to go away. More
2828319 F PA 02/26/2025 HEP
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
no record of her getting a dose 3; This non-serious case was reported by a pharmacist via call cente... no record of her getting a dose 3; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Hepatitis B vaccine for prophylaxis. Previously administered products included Hepatitis B vaccine (1st dose received in 2023) and Hepatitis B vaccine (2nd dose received one a month later of 1st dose). On an unknown date, the patient did not receive the 3rd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: no record of her getting a dose 3). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-FEB-2025 The patient states she got the hepatitis b vaccine years ago. The patient was not sure how long ago, not sure if she completed series, and was not sure of manufacturer. Fast forward, pharmacist states she found in records that in 2023 patient got an initial dose of Hepatitis B then got one a month later but there was no record of her getting a dose 3, which led incomplete course of vaccination. The reported consented to follow up. Pharmacist did not know if the Hepatitis B the patient received was Engerix B or not. More
2828320 F CA 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Guillain-Barre syndrome Guillain-Barre syndrome
Guillain-Barre Syndrome; This serious case was reported by a nurse via call center representative an... Guillain-Barre Syndrome; This serious case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy. The company considered the guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 12-FEB-2025 The reporter was a GlaxoSmithKline representative who was reporting on behalf of an healthcare professional (nurse practitioner). The reporter had asked the representative if Arexvy could caused Guillain-Barre Syndrome. The reporter had a 60 year old female patient who developed Guillain-Barre Syndrome after receiving unknown vaccines. It was uncertain if the vaccine had been Arexvy.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK vaccine Arexvy. More
2828321 66 F CO 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93kk4
Extra dose administered Extra dose administered
administration of a 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via cal... administration of a 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 93kk4, expiry date 31-JAN-2027) for prophylaxis. Previously administered products included Shingrix (1st dose received on 10th Oct 2024) and Shingrix (2nd dose received on 11th Dec 2024). On 17-FEB-2025, the patient received the 3rd dose of Shingrix. On 17-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: administration of a 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 17-FEB-2025 The reporter called to request safety information as the immunocompetent patient received 3rd dose of Shingrix, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. More
2828322 70 F IN 02/26/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 04774
Inappropriate schedule of product administration Inappropriate schedule of product administration
she was due for a Second dose a few months later and a third dose 6 months after that initial. She j... she was due for a Second dose a few months later and a third dose 6 months after that initial. She just came in for her Second dose,; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received HAB (Twinrix) (batch number 04774) for prophylaxis. Previously administered products included Twinrix (1st dose received in Sep 2024). On 17-FEB-2025, the patient received the 2nd dose of Twinrix. On 17-FEB-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: she was due for a Second dose a few months later and a third dose 6 months after that initial. She just came in for her Second dose,). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-FEB-2025 The reporter called to inquire about a patient who they administered a Twinrix vaccine back in September, she was due for a second dose a few months later and a third dose 6 months after that initial. However she came in for her second dose late, so, they were not sure that she should come in for her third dose in a month and keep the 6 months after the 1st one or they should wait a while after the second dose. The patient received 2nd dose longer than the recommended interval, which led to lengthening of vaccination schedule. More
2828323 F CA 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93KK4
Product storage error Product storage error
An 84 years old female patient received a dose of Shingrix after the vaccine had a temperature excur... An 84 years old female patient received a dose of Shingrix after the vaccine had a temperature excursion at an unknown temperature for 72 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 93KK4, expiry date 31-JAN-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: An 84 years old female patient received a dose of Shingrix after the vaccine had a temperature excursion at an unknown temperature for 72 hours.). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK Receipt Date: 19-FEB-2025 A Pharmacy Manager called to report that they administered Shingrix to a patient after a temperature excursion which led to product storage error. The Shingrix vaccine was exposed to an unknown temperature for 72 hours. More
2828324 M CA 02/26/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
a two year old patient was administered a Kinrix dose; patient was intended to be administered a dip... a two year old patient was administered a Kinrix dose; patient was intended to be administered a diphtheria, tetanus, pertussis, and polio vaccines separately, but by mistake it was administered a kinrixdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included Diphtheria vaccine toxoid (Diphtheria) for prophylaxis, Tetanus vaccine toxoid (Tetanus vaccine) for prophylaxis, Pertussis vaccine for prophylaxis and Polio vaccine for prophylaxis. On 04-FEB-2025, the patient received Kinrix. On an unknown date, the patient received Diphtheria, Tetanus vaccine, Pertussis vaccine and Polio vaccine. On 04-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a two year old patient was administered a Kinrix dose) and wrong vaccine administered (Verbatim: patient was intended to be administered a diphtheria, tetanus, pertussis, and polio vaccines separately, but by mistake it was administered a kinrixdose). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-FEB-2025 The reporter reported that a two year old patient was intended to be administered a diphtheria, tetanus, pertussis, and polio vaccines separately, but by mistake it was administered a Kinrix dose which led to inappropriate age at vaccine administration and wrong vaccine administered. Reporter needs advise on this situation. Vaccination date and patient demographics were obtained, no vaccine detail was provided from the reporter end. More
2828325 62 M AZ 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Headache, Pyrexia Headache, Pyrexia
Onset of headache and fever like symptoms overnight after shot Onset of headache and fever like symptoms overnight after shot
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