🏥 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 💀 🏥 🚑 ♿ ⚠️
2831748 89 M 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X72D2
Extra dose administered Extra dose administered
Patient received an additional dose of the shigrix vaccine. Patient received an additional dose of the shigrix vaccine.
2831749 56 F IA 03/17/2025 COVID19
PNC20
 PFIZER\BIONTECH
PFIZER\WYETH
 LM7786
LJ5284
Injection site erythema, Injection site pruritus, Injection site swelling, Lip s... Injection site erythema, Injection site pruritus, Injection site swelling, Lip swelling, Nasal congestion; Injection site erythema, Injection site pruritus, Injection site swelling, Lip swelling, Nasal congestion More
Pt. states she had swelling and redness at injection site on left arm. Pt. states patchy area with i... Pt. states she had swelling and redness at injection site on left arm. Pt. states patchy area with itching in left arm that started approximately 1 inch below injection site that measured approximately 5x3 inches around, irregular shaped. Pt. states she also had some nasal stuffiness and lower lip swelling following injection. Pt. states no concerns for breathing issues at time of reaction and so forth. More
2831750 62 F WA 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 x5742
Pruritus, Rash, Swelling Pruritus, Rash, Swelling
significant localized rash, swelling, itching significant localized rash, swelling, itching
2831751 0.33 F GA 03/17/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U7767AA
LX2497
Y009339
Death; Death; Death Death; Death; Death
Death 1 week after getting shots, unknown if related Death 1 week after getting shots, unknown if related
✓
2831752 66 F CT 03/17/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 3043333
3043333
3043333
Abdominal pain, Abnormal faeces, Biopsy colon abnormal, Blood test normal, Clost... Abdominal pain, Abnormal faeces, Biopsy colon abnormal, Blood test normal, Clostridium test negative; Colitis microscopic, Colonoscopy abnormal, Computerised tomogram abdomen normal, Culture stool negative, Diarrhoea; Faecal calprotectin increased More
Three days after the vaccine, I developed unusual stools. This progressed and worsened over the next... Three days after the vaccine, I developed unusual stools. This progressed and worsened over the next weeks turning from loose stool to diarrhea. Upon a seven times per day diarrhea on 12/26/24 I was sent to an urgent care center (no regular Dr appointments during Christmas week). I had blood tests, stool tests, was given a precautionary antibiotic due to abdominal pain and diverticulitis was suspected. A CAT scan disproved this. I was pretty much home bound for 12 weeks due to urgent 'bathroom calls', usually 1 hour after eating. I finally had a colonoscopy on 2/28/25 and biopsies were taken. Pathology returned result of microscopic lymphocytic colitis. The past week, the 13th week has been a mixed bag of semi-normal bowel movements. More
2831753 45 M OR 03/17/2025 PNC15
 MERCK & CO. INC.
 Y005465
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient presented for 3rd dose of HPV vaccine and was given PCV 15 in error. No symptoms noted at th... Patient presented for 3rd dose of HPV vaccine and was given PCV 15 in error. No symptoms noted at the time if administration of vaccine. Patient has been contacted, and clinic will conduct further follow-up. More
2831754 57 F CO 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 a5t73
Exposure via unknown route Exposure via unknown route
The patient received the shot and the when the pharmacist activated the safety mechanism, the small ... The patient received the shot and the when the pharmacist activated the safety mechanism, the small amount that was left in the needle squirted in the patient's eye. More
2831755 0.92 F NC 03/17/2025 PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 LX4482
LX4482
LX4482
Full blood count, Influenza virus test negative, Lymphocyte percentage increased... Full blood count, Influenza virus test negative, Lymphocyte percentage increased, Metabolic function test normal, Neutrophil percentage decreased; Platelet count increased, Rash, Rash macular, Rash maculo-papular, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urine analysis normal, White blood cell count increased More
Starting ~11 hours following, she had a diffuse macular papular rash across thighs, back of knees th... Starting ~11 hours following, she had a diffuse macular papular rash across thighs, back of knees that then spread down to her ankles. 20 min following, here soles of her feet swelled and turned bright red. no rash across chest or back. More
2831756 17 M NY 03/17/2025 MMRV
 MERCK & CO. INC.
 Y002374
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
MMRV given to a 17 year old. no adverse reactions MMRV given to a 17 year old. no adverse reactions
2831757 70 F MA 03/17/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 ln0591
u8519ea
Product storage error; Product storage error Product storage error; Product storage error
Patient was administered Covid 19 vaccine that was beyond use. Prefilled syringe, syringe tip was at... Patient was administered Covid 19 vaccine that was beyond use. Prefilled syringe, syringe tip was attached for more than 4 hours. More
2831758 65 F TN 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Headache, Pain, Pyrexia Headache, Pain, Pyrexia
Patient requested prevnar-20, but patient received Shingrix in error by pharmacist. She experienced... Patient requested prevnar-20, but patient received Shingrix in error by pharmacist. She experienced severe symptoms with fever, body aches and headache. More
2831759 0.33 M AK 03/17/2025 DTAPHEPBIP
IPV
PNC15
RV5
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 5j7ef
w18511m
y010035
2051974
Circumstance or information capable of leading to medication error, Wrong produc... Circumstance or information capable of leading to medication error, Wrong product administered; Circumstance or information capable of leading to medication error, Wrong product administered; Circumstance or information capable of leading to medication error, Wrong product administered; Circumstance or information capable of leading to medication error, Wrong product administered More
Pt was given pediarix, and IPOL polio. Both the hib bottle and the polio bottle were stored side b... Pt was given pediarix, and IPOL polio. Both the hib bottle and the polio bottle were stored side by side. Both vials were similar in size and color. The polio was drawn up and injected instead of the hib bottle. More
2831760 67 F TX 03/17/2025 PNC21
 MERCK & CO. INC.
 Y011819
Erythema, Pain, Swelling, Tenderness Erythema, Pain, Swelling, Tenderness
Swelling, tenderness, pain, red Swelling, tenderness, pain, red
2831762 10 M CO 03/17/2025 MMR
 MERCK & CO. INC.
 X004346
Expired product administered, No adverse event Expired product administered, No adverse event
The child di not have adverse event. The vaccine was expired The child di not have adverse event. The vaccine was expired
2831763 0.33 M NC 03/17/2025 DTAPHEPBIP
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 B532G
Y013470
LG5574
2052020
Pyrexia, Urticaria; Pyrexia, Urticaria; Pyrexia, Urticaria; Pyrexia, Urticaria Pyrexia, Urticaria; Pyrexia, Urticaria; Pyrexia, Urticaria; Pyrexia, Urticaria
Patient developed urticaria and subjective fever 14 hours after receiving immunization. He was evalu... Patient developed urticaria and subjective fever 14 hours after receiving immunization. He was evaluated in the ED 2 days in a row. He was seen in our office 72 hours after receiving all 4 vaccines, and still experiencing urticaria on arms, legs, back, chest, and inguinal folds More
2831764 66 F TX 03/17/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LJ5284
LJ5284
Cough, Ear swelling, Erythema, Joint swelling, Pyrexia; Skin warm Cough, Ear swelling, Erythema, Joint swelling, Pyrexia; Skin warm
Patient experienced symptoms approximately 8 hours after vaccine administration, reporting swollen j... Patient experienced symptoms approximately 8 hours after vaccine administration, reporting swollen joints, high fever (100.9 F), swollen ears (swollen, red, hot to touch) and coughing. More
2831765 5 F OH 03/17/2025 DTAPIPV
 SANOFI PASTEUR
 4L454 (DO SOLON
Chills, Cyanosis, Livedo reticularis Chills, Cyanosis, Livedo reticularis
Mottled skin on neck and face on injected side, blue lips, rigors lasting approximately 30 minutes Mottled skin on neck and face on injected side, blue lips, rigors lasting approximately 30 minutes
2831766 0.67 F MI 03/17/2025 DTAPHEPBIP
HEP
PNC15
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4N2PM
47D3S
Y010035
Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
Patient was given a separate Hepatitis B vaccine in addition to a combination vaccine that included ... Patient was given a separate Hepatitis B vaccine in addition to a combination vaccine that included DTap, Hep B and IPV. Patients mother informed and declines any symptoms or adverse side effects. Local health department also notified. More
2831767 70 F VA 03/17/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4LJ4T
4LJ4T
Contusion, Erythema, Headache, Loss of consciousness, Nausea; Nodule, Pain, Swel... Contusion, Erythema, Headache, Loss of consciousness, Nausea; Nodule, Pain, Swelling, Vomiting More
Redness, swelling, painful-(stabbing pain),swollen with a knot, bruised, headache, nausea, vomited n... Redness, swelling, painful-(stabbing pain),swollen with a knot, bruised, headache, nausea, vomited next day and passed out next day--she has been using Ice, Tylenol or Ibuprofen More
2831768 13 F ND 03/17/2025 HEP
HEPA
HPV9
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 2ME34
4T93R
Y007991
Y015100
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Hepatitis A Adult dose given to pediatric client. Hepatitis A Adult dose given to pediatric client.
2831769 56 M FL 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 425OR
Burning sensation, Rash, Rash vesicular Burning sensation, Rash, Rash vesicular
Patient noticed a vesicular rash on her neck that eventually extended along the dermatome. It sprea... Patient noticed a vesicular rash on her neck that eventually extended along the dermatome. It spreaded to her neck, chest, and arm and feels like sunburn More
2831770 0.75 F TX 03/17/2025 MMR
 MERCK & CO. INC.
Rash, Rash maculo-papular Rash, Rash maculo-papular
Maculopapular rash to trunk Maculopapular rash to trunk
2831771 68 F AL 03/17/2025 PNC21
PNC21
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 y013009
y013009
cx4hl
cx4hl
Burning sensation, Erythema, Injected limb mobility decreased, Pain in extremity... Burning sensation, Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling; Pruritus; Burning sensation, Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling; Pruritus More
Patient reports having swollen and painful arm after receiving 2 vaccines Capvaxive and Boostrix. ... Patient reports having swollen and painful arm after receiving 2 vaccines Capvaxive and Boostrix. The patient received both vaccines in the left arm on Thursday 27th. The next day the patient reported her arm became red, swollen, painful, burning, and itching. On Tuesday 4th her arm continued to become more swollen and red. She reported the incident to her physician was treated with a steroid shot. The patient visits us today to report the incident to the pharmacy. She said although the redness and burning stopped after 2 weeks she still has lingering arm pain, range of motion issues, pain in her fingers and hand. More
2831772 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Decreased appetite, Insomnia, Weight decreased Decreased appetite, Insomnia, Weight decreased
Iost a lot of weight; lack of appetite; lack of sleep; This non-serious case was reported by a consu... Iost a lot of weight; lack of appetite; lack of sleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weight loss in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (recived 1st dose on an unknown date). On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weight loss (Verbatim: Iost a lot of weight), appetite absent (Verbatim: lack of appetite) and sleep loss (Verbatim: lack of sleep). The outcome of the weight loss, appetite absent and sleep loss were not reported. It was unknown if the reporter considered the weight loss, appetite absent and sleep loss to be related to Shingrix. It was unknown if the company considered the weight loss, appetite absent and sleep loss to be related to Shingrix. Additional Information: GSK receipt date: 01-FEB-2024 This case was reported by a patient via interactive digital media. The patient said he/she suffered severe side effects after the second dose of the vaccine that sent them to the emergency room. The patient experienced weight loss, lack of appetite and sleep. The patient reported that he/she had been at least 6times in the emergency department of different hospitals. More
2831773 M NY 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient never received second dose of Shingrix; This non-serious case was reported by a consumer via... patient never received second dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received over 2 years ago). 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: patient never received second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter was the patient who received his first dose of Shingrix over 2 years ago. He never received his second dose which led to incomplete course of vaccination. More
2831774 F MD 03/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Chills, Fatigue, Headache, Injection site erythema, Injection site induration; I... Chills, Fatigue, Headache, Injection site erythema, Injection site induration; Injection site swelling, Injection site warmth, Pyrexia More
raised bump that is red, 4 inches from injection site, size of a thumb; raised bump that is red and ... raised bump that is red, 4 inches from injection site, size of a thumb; raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb; Swelling of injection site; hardening injection site; Fever; Headache; Fatigue; Chills; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21-FEB-2025, the patient received Shingrix (left deltoid) .5 ml. In FEB-2025, less than a week after receiving Shingrix, the patient experienced chills (Verbatim: Chills). On 22-FEB-2025, the patient experienced injection site swelling (Verbatim: Swelling of injection site), injection site induration (Verbatim: hardening injection site), fever (Verbatim: Fever), headache (Verbatim: Headache) and fatigue (Verbatim: Fatigue). On 28-FEB-2025, the patient experienced raised rash (Verbatim: raised bump that is red, 4 inches from injection site, size of a thumb) and feeling hot (Verbatim: raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb). The patient was treated with cetirizine hydrochloride (Zyrtec) and ibuprofen. On 25-FEB-2025, the outcome of the injection site swelling, fever, headache, fatigue and chills were resolved and the outcome of the injection site induration was resolved (duration 3 days). The outcome of the raised rash and feeling hot were not resolved. The reporter considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix. The company considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 Reporter was a pharmacist reporting for herself. More
2831775 56 F CO 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 557PZ
Headache, Malaise, Pain, Pyrexia Headache, Malaise, Pain, Pyrexia
body ache; fever; general malaise; headache; This non-serious case was reported by a nurse via call ... body ache; fever; general malaise; headache; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 557PZ, expiry date 30-SEP-2025) for prophylaxis. On 26-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 26-FEB-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache). On 27-FEB-2025, the patient experienced general body pain (Verbatim: body ache), fever (Verbatim: fever) and general malaise (Verbatim: general malaise). On 04-MAR-2025, the outcome of the fever was resolved (duration 5 days). The outcome of the headache, general body pain and general malaise were unknown. The reporter considered the headache, general body pain, fever and general malaise to be related to Shingrix. The company considered the headache, general body pain, fever and general malaise to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter reported that a female patient received her second dose of Shingrix on 26-FEB- 2025 and started having a headache that same evening. The patient started also having body aches, on and off fever, and general malaise the next day, 27-FEB-2025 and the fever persisted until 4-MAR-2025. The headache, body aches and general malaise were continuing at least through Friday 7-MAR-2025, and the reporter was unsure if they persist on, 10-MAR-2025. They reported all that was provided about these adverse events. More
2831776 85 M NY 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
internal between 1st dose and 2nd dose was too long; This non-serious case was reported by a pharmac... internal between 1st dose and 2nd dose was too long; 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 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (recived 1st dose on 04-DEC-2021). On 30-DEC-2024, the patient received the 2nd dose of Shingrix. On 30-DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: internal between 1st dose and 2nd dose was too long). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 10-MAR-2025 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2831777 F NY 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
late dose; This non-serious case was reported by a pharmacist and described the occurrence of drug d... late dose; This non-serious case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 22-NOV-2022). On 13-JAN-2025, the patient received the 2nd dose of Shingrix. On 13-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 10-MAR-2025 The pharmacist reported that a patient received her first dose on 22-NOV-2022 and her second dose on 13-JAN-2025, which led to drug dose administration interval too long. More
2831778 M MO 03/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles flares after receiving both vaccine doses; This serious case... Suspected vaccination failure; shingles flares after receiving both vaccine doses; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus. On 17-JUL-2020, the patient received the 2nd dose of Shingrix. On 02-FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles flares after receiving both vaccine doses). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles 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 to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 11-MAR-2025 The patient self-reported this case for himself. The patient had reported shingles flares after receiving both vaccine doses. The provider did not have documented an official shingles diagnoses. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2831779 M 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash Rash
Rash everywhere; This non-serious case was reported by a consumer and described the occurrence of ge... Rash everywhere; This non-serious case was reported by a consumer and described the occurrence of generalized rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included transcatheter aortic valve replacement. Concomitant products included apixaban (Eliquis). On 17-FEB-2025, the patient received Shingrix. On 24-FEB-2025, 7 days after receiving Shingrix, the patient experienced generalized rash (Verbatim: Rash everywhere). The outcome of the generalized rash was not resolved. It was unknown if the reporter considered the generalized rash to be related to Shingrix. It was unknown if the company considered the generalized rash to be related to Shingrix. Additional Information: GSK Receipt Date: 11-MAR-2025 The case was self reported by patient. The patient received Shingrix vaccine and experienced rash everywhere. More
2831780 F NJ 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
already received 2 doses; This non-serious case was reported by a pharmacist via other manufacturer ... already received 2 doses; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: already received 2 doses). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 07-MAR-2025 The reporter reported that the patient came into their pharmacy for a 2nd dose of shingles and after vaccination realized they already received 2 doses, which led to extra dose administered. More
2831781 F 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
My sister was very ill for 3 days after her first dose,it scared me; This non-serious case was repor... My sister was very ill for 3 days after her first dose,it scared me; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. 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 illness (Verbatim: My sister was very ill for 3 days after her first dose,it scared me). The outcome of the illness was resolved (duration 3 days). The reporter considered the illness to be related to Shingrix. The company considered the illness to be related to Shingrix. Additional Information: GSK Receipt Date: 09-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that he read about all the negative side effects that did not go away. A lot of people were now living with bad things caused by the vaccine that would never go away. The reporter sister was very ill for 3 days after her first dose, it scared the reporter. More
2831782 03/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I've had it 3 more times; This serious case was reported by a co... Suspected vaccination failure; I've had it 3 more times; 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 (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've had it 3 more times). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAR-2025 The case was received from the patient via interactive digital media. The patient had shingles, then got both shots. The patient have had it 3 more times after the vaccine. This case was considered as suspected vaccination failure as details regarding 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles(1st dose)and Shingles(2nd dose) More
2831783 M 03/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Fall, Herpes zoster, Vaccination failure Fall, Herpes zoster, Vaccination failure
suspected vaccination failure; shingles on the face; This serious case was reported by a consumer vi... suspected vaccination failure; shingles on the face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: shingles on the face). The outcome of the vaccination failure and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. Patient had shingles on the face from a fall. He reported that he also had the Shingles vaccine 3 years earlier. The patient further stated that medical stuff was dumb. 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine More
2831784 F 03/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Injection site reaction, Rash, Vaccination failure; Herpes zoster... Herpes zoster, Injection site reaction, Rash, Vaccination failure; Herpes zoster, Injection site reaction, Rash, Vaccination failure More
Suspected vaccination failure; shingles under her breast the first time in 2023; Shingles under her ... Suspected vaccination failure; shingles under her breast the first time in 2023; Shingles under her left breast; sore rash at the injection site; sore rash at the injection site; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included lumpectomy (had a Lumpectomy in her right breast). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, left arm). On 08-MAR-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced shingles (Verbatim: Shingles under her left breast). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles under her breast the first time in 2023), injection site pain (Verbatim: sore rash at the injection site) and injection site rash (Verbatim: sore rash at the injection site). The patient was treated with valaciclovir (Valacyclovir) and gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the shingles was resolved and the outcome of the injection site pain and injection site rash were resolved (duration 2 weeks). It was unknown if the reporter considered the vaccination failure, shingles, shingles, injection site pain and injection site rash to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, shingles, injection site pain and injection site rash to be related to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had both shots and still had shingles. She had both doses of Shingrix in 2023 and had shingles twice since receiving both doses. The patient had shingles under her breast the first time in 2023, after receiving both doses of Shingrix, but could not provide any further details of this event. The patient had shingles again now, 11-MAR-2025, that started on Saturday, 8-MAR-2025, again as breaking out under her left breast. The patient was taking Valacyclovir 1gm, 1 Tablet every 8 hours, prescribed by her physician on 9-MAR-2025, and Gabapentin 300mg, 1 Capsule at bedtime for the pain. The patient also reported that after the second dose of Shingrix, her left arm broke out in a big, sore rash at the injection site, that started the day after receiving the second dose. The patient reported that the soreness and the rash both lasted for a couple of weeks. The patient received both doses in her left arm. The patient reported both doses of Shingrix were given by her pharmacist at Pharmacy in 2023. The patient reported she had a Lumpectomy in her right breast pre-existing dose of Shingrix. 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 provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2831785 F 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
pain in left knee to ankle; This non-serious case was reported by a consumer via interactive digital... pain in left knee to ankle; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in joint involving lower leg in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. In SEP-2024, the patient received the 1st dose of Shingrix. In SEP-2024, 4 hrs after receiving Shingrix, the patient experienced pain in joint involving lower leg (Verbatim: pain in left knee to ankle). The outcome of the pain in joint involving lower leg was not resolved. The reporter considered the pain in joint involving lower leg to be related to Shingrix. The company considered the pain in joint involving lower leg to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that the same happened to them and 4 hours after she had the first shot and had pain in left knee to ankle. That was last September and still had problems with it. Consumer didn't want to get the shot in the first place and deeply regret on that and Doctors, of course, she don't believe that was possible. The follow-up could not be possible as no contact details were available. More
2831786 03/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Nausea Chills, Nausea
Chills; nausea; This non-serious case was reported by a consumer via interactive digital media and d... Chills; nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills 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 chills (Verbatim: Chills) and nausea (Verbatim: nausea). The outcome of the chills and nausea were not reported. It was unknown if the reporter considered the chills and nausea to be related to Shingrix. It was unknown if the company considered the chills and nausea to be related to Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via (Shingrix GSK chat BOT) interactive digital media. The patient received Shingrix vaccine and experienced chills and nausea. More
2831788 F 03/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Ophthalmic herpes zoster, Vaccination failure; Ophthalmic herpes zoster, Vaccina... Ophthalmic herpes zoster, Vaccination failure; Ophthalmic herpes zoster, Vaccination failure More
Suspected vaccination failure; I got both shots and less than a year later I came down with the shin... Suspected vaccination failure; I got both shots and less than a year later I came down with the shingles in my right eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: I got both shots and less than a year later I came down with the shingles in my right eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date : 10-MAR-2025 This case was reported by a patient via interactive digital media. The patient got both shots and less than a year later she came down with the shingles in her right eye. It was horrible. 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 provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2831789 13 M WI 03/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9PG49
Expired product administered Expired product administered
a patient got an expired dose of Engerix-B on March 7th 2025; This non-serious case was reported by ... a patient got an expired dose of Engerix-B on March 7th 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received HBV (Engerix B) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis. Previously administered products included Hepatitis B vaccines (Patient got prior Hepatitis B vaccines 1 st dose on February 8th 2012) and Hepatitis B vaccines (Patient got prior Hepatitis B vaccines 2nd on 30-APR-2012). On 07-MAR-2025, the patient received Engerix B. On 07-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a patient got an expired dose of Engerix-B on March 7th 2025). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-MAR-2025 Certified Medical Assistant explained that a patient got an expired dose of Engerix-B on March 7th 2025, which led to Expired vaccine used. The dose was expired on December 28th, 2024. Patient got 2 prior Hepatitis B vaccines on February 8th, 2012, and April 30th, 2012. Lot number and expiration date for the prior 2 doses were unknown by the caller, and brand name was not mentioned. The reporter consented to follow up. More
2831790 F NJ 03/17/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 AE2J7
Extra dose administered Extra dose administered
second dose recently on March Twenty-twenty five; This non-serious case was reported by a other heal... second dose recently on March Twenty-twenty five; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AE2J7, expiry date 16-AUG-2025) for prophylaxis. On 07-MAR-2025, the patient received the 2nd dose of FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: second dose recently on March Twenty-twenty five). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter reported that a patient that was administered a first dose of Flulaval in September 2024 and a second dose recently in March 2025, which led to extra dose administered. More
2831791 74 F NY 03/17/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 BL473
Product preparation issue Product preparation issue
was given the vaccine of the solute, but not of the mixture; was given the vaccine of the solute, bu... was given the vaccine of the solute, but not of the mixture; was given the vaccine of the solute, but not of the mixture; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis. On 07-MAR-2025, the patient received Arexvy. On 07-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: was given the vaccine of the solute, but not of the mixture) and inappropriate dose of vaccine administered (Verbatim: was given the vaccine of the solute, but not of the mixture). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 10-MAR-2025 Reporter stated that they have a resident who gave the vaccine (Arexvy), was given the vaccine of the solute, but not of the mixture, the powder mix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. So was not reconstituted it and they were wondering what they do now. More
2831792 0.17 M WA 03/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
patient under 4 years of age received Kinrix; patient under 4 years of age received Kinrix as their ... patient under 4 years of age received Kinrix; patient under 4 years of age received Kinrix as their their 1st DTAP and IPV dose; 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-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. On 05-MAR-2025, the patient received the 1st dose of Kinrix. On 05-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient under 4 years of age received Kinrix) and inappropriate schedule of product administration (Verbatim: patient under 4 years of age received Kinrix as their their 1st DTAP and IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of product administration 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: 10-MAR-2025 Office manager reported patient under 4 years of age received Kinrix as their 1st DTAP and IPV dose, which led to an inappropriate age at vaccine administration and inappropriate schedule of product administration. More
2831793 42 F TX 03/17/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 4J452
Product preparation issue Product preparation issue
42 years old patient received only the sterile saline diluent part of Hiberix; 42 years old patient ... 42 years old patient received only the sterile saline diluent part of Hiberix; 42 years old patient received only the sterile saline diluent part of Hiberix; 42 years old patient received only the sterile saline diluent part of Hiberix; 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 42-year-old female patient who received Hib (Hiberix) (batch number 4J452, expiry date 15-MAR-2026) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate age at vaccine administration (Verbatim: 42 years old patient received only the sterile saline diluent part of Hiberix), inappropriate preparation of medication (Verbatim: 42 years old patient received only the sterile saline diluent part of Hiberix) and inappropriate dose of vaccine administered (Verbatim: 42 years old patient received only the sterile saline diluent part of Hiberix). The outcome of the inappropriate age at vaccine administration, inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 10-MAR-2025 Reporter stated that they administered only the sterile saline diluent part of Hiberix to a 42 years old female patient which led to inappropriate age at vaccination , inappropriate preparation of medication and inappropriate dose of vaccine administered. Also asked when can they revaccinate the patient. More
2831794 FL 03/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received the second dose 2 months after the first dose; This non-serious case was reported by a phar... received the second dose 2 months after the first 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 patient who received HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long (Verbatim: received the second dose 2 months after the first 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: 11-MAR-2025 The pharmacist called to enquire on behalf of a patient what would happen if patient receive the 3rd dose of Twinrix in less than 6 months, was there any problem. Further the pharmacist asked, If they get the second dose 2 months from the 1st one, what could happen and at the beginning of the call the pharmacist said that it was a hypothetical situation. However, later in the call the pharmacist mentioned that a patient had already received the second dose 2 months after the first dose. The patient received 2nd dose of Twinrix, which led to lengthening of vaccination schedule. More
2831795 63 F IN 03/17/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call... intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 63-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 11-MAR-2025, the patient received Priorix. On 11-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-MAR-2025 The reporter reported that the intramuscular administration of Priorix to 3 patients, which led to Subcutaneous injection formulation administered by other route.; Sender's Comments: US-GSK-US2025029884:Same reporter/Different patient US-GSK-US2025029891:Same reporter/Different patient More
2831796 F NJ 03/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A dose of Kinrix was administered to a 20 weeks old female patient.; This non-serious case was repor... A dose of Kinrix was administered to a 20 weeks old female patient.; 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 20-week-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. Previously administered products included Pediarix (received doses on an unknown date). On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A dose of Kinrix was administered to a 20 weeks old female patient.). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-MAR-2025 The health care professional reported that they administered a dose of Kinrix to a 20 weeks old female patient for their 2nd dose of DTaP and IPV, which led to inappropriate age at vaccine administration. The patient had previous doses of Pediarix. The reporter was ask was this a mistake or would it be a problem for the baby. More
2831797 F MO 03/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center repres... Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received HAB (Twinrix) (expiry date 03-JAN-2025) for prophylaxis. Previously administered products included Twinrix (received 1st dose of Twinrix in February 2023). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-MAR-2025 The pharmacist wanted to know if they should restart the series or give directly the second dose of Twinrix after receiving the first dose in February 2023. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2831798 43 M 03/17/2025 COVID19
 MODERNA
 020f21a
Atrial fibrillation Atrial fibrillation
The developed atrial fibrillation (afib); This spontaneous case was reported by a patient and descri... The developed atrial fibrillation (afib); This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (The developed atrial fibrillation (afib)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020f21a) for COVID-19 prophylaxis. No Medical History information was reported. On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (The developed atrial fibrillation (afib)) (seriousness criteria hospitalization and medically significant). At the time of the report, ATRIAL FIBRILLATION (The developed atrial fibrillation (afib)) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. Patient never had any heart problems in his life. About a month after started getting weird feeling in his chest. Patient then had heart palpitations. That got worse and worse ended up in the overnight with Afib and it comes and goes. Patient had every test possible. It was unknown if the patient experienced any additional symptoms and events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-783005 (E2B Linked Report).; Reporter's Comments: Company Comments: The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783005:Invalid case for lot of people More
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2831801 03/17/2025 COVID19
 PFIZER\BIONTECH
Atrial fibrillation, Cerebrovascular accident Atrial fibrillation, Cerebrovascular accident
AFib; Stroke; This is a spontaneous report received from a Consumer or other non HCP. A patient (ag... AFib; Stroke; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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