🏥 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 💀 🏥 🚑 ♿ ⚠️
2825787 27 M NC 02/11/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 AU1078A
AU1078A
Dermatitis, Erythema, Pruritus, Pustule, Scab; Scar, Secretion discharge, Skin l... Dermatitis, Erythema, Pruritus, Pustule, Scab; Scar, Secretion discharge, Skin lesion More
Service member reports AEFI of dermatitis limited to the injection arm noted upon awakening day 1 af... Service member reports AEFI of dermatitis limited to the injection arm noted upon awakening day 1 after receipt of IIV 11/15/2023 (lot #AU1078A SEQ). He states the lesions were pruritic, painful, fixed, discrete, continued to enlarge over time, but new lesions didn?t develop, had some thin drainage when the ?popped?, ultimately scabbed and have left scarring; scattered erythematous pustules limited to the injection arm. Duration of lesions was about three weeks. Treatment was OTC topical antibiotic. More
2825788 17 M GA 02/11/2025 HPV9
HPV9
HPV9
MNQ
MNQ
MNQ
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y013712
Y013712
Y013712
U8256AB
U8256AB
U8256AB
Abdominal pain, Amylase, C-reactive protein, Differential white blood cell count... Abdominal pain, Amylase, C-reactive protein, Differential white blood cell count, Faecal calprotectin; Full blood count, Lipase, Metabolic function test, Occult blood, Rash; Red blood cell sedimentation rate, Vomiting; Abdominal pain, Amylase, C-reactive protein, Differential white blood cell count, Faecal calprotectin; Full blood count, Lipase, Metabolic function test, Occult blood, Rash; Red blood cell sedimentation rate, Vomiting More
Within a few days of receiving vaccines patient developed abd pain, vomiting, and a rash. Within a few days of receiving vaccines patient developed abd pain, vomiting, and a rash.
2825789 25 M KS 02/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 MD9SL
Extra dose administered, No adverse event Extra dose administered, No adverse event
No noted ADR, but pt received extra HBV does that was not indicated. Pt has had no adverse reactions... No noted ADR, but pt received extra HBV does that was not indicated. Pt has had no adverse reactions at this time to any vaccines. More
2825790 9 F TN 02/11/2025 IPV
 SANOFI PASTEUR
 x1c891m
Inappropriate schedule of product administration Inappropriate schedule of product administration
pt had 2 polio vaccines (age 4 and 9) 3rd dose given on 1/17/2025, vaccine was given 5 days too so... pt had 2 polio vaccines (age 4 and 9) 3rd dose given on 1/17/2025, vaccine was given 5 days too soon. No treatment was needed, pt will have to return for 3rd vaccine More
2825791 49 F KS 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 94se2
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pt did not experience adverse event, however should not have received series at all. Pt received 2 d... Pt did not experience adverse event, however should not have received series at all. Pt received 2 doses (complete series) prior to age 50 with no immunocompromising condition. Pt does have hx of shingles. No ADR, pt doing well even now. More
2825792 38 F AK 02/11/2025 FLU3
MMR
 SEQIRUS, INC.
MERCK & CO. INC.
 946620
x028353
Impaired driving ability, Loss of personal independence in daily activities, Mig... Impaired driving ability, Loss of personal independence in daily activities, Migraine, Mobility decreased, Vision blurred; Impaired driving ability, Loss of personal independence in daily activities, Migraine, Mobility decreased, Vision blurred More
Onset of 70 hour long migraine with complete blurred vision in left eye. Proscribed Migraine medica... Onset of 70 hour long migraine with complete blurred vision in left eye. Proscribed Migraine medication management unsuccessful in reducing migraine symptoms. Bedridden for the duration of the migraine, unable to attend work duties, unsafe to drive for treatment. Phone consultation with healthcare professional, recommended Urgent care or ER for migraine IV therapy, unable to comply with recommendation due to transportation issue and sole caregiver of young children. More
2825797 69 M TX 02/11/2025 PNC20
 PFIZER\WYETH
 LK6651
Asthenia, Chills, Diarrhoea, Nausea, Vomiting Asthenia, Chills, Diarrhoea, Nausea, Vomiting
Patient wife reported her spouse symptoms about 2:33 pm today when I phoned her about her test resul... Patient wife reported her spouse symptoms about 2:33 pm today when I phoned her about her test results. Patient states after he got vaccine and was leaving the office on elevator he started feeling nausea. After he got home, he started having vomiting, watery diarrhea, chills, and weakness. Per MD He should rest and try to maintain good hydration. I have prescribed Zofran to help minimize the nausea. He can try over the counter Pepto-Bismol or Imodium to help the diarrhea. If he develops any pains, then Tylenol would be advised. If more serious symptoms develop then ER evaluation would be advised. Patient verbalized understanding. More
2825798 51 F OH 02/11/2025 COVID19
COVID19
 JANSSEN
JANSSEN

Acute myocardial infarction, Asthenia, Back pain, Coronary arterial stent insert... Acute myocardial infarction, Asthenia, Back pain, Coronary arterial stent insertion, Depressed mood; Feeling abnormal, Nausea, Pain in extremity More
I got the shot and i felt really weird and not right and something wasnt right and i didnt have any ... I got the shot and i felt really weird and not right and something wasnt right and i didnt have any energy and feeling down and nauseous and I thought that i had the flu. That feeling never went away, i started have pain in my arm and in my back and went in for the widow maker. The address for the doctor. More
2825799 58 F MI 02/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 K4JH7
No adverse event No adverse event
no adverse event no adverse event
2825800 59 F GA 02/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 92NK2
Headache, Heart rate increased, Palpitations Headache, Heart rate increased, Palpitations
Patient received Hep B vaccine (Engerix) around 12:05pm. at 12:16 pm patient presented to front desk... Patient received Hep B vaccine (Engerix) around 12:05pm. at 12:16 pm patient presented to front desk staff complaining of headache and feeling like her heart was racing. Patient was brought back into clinic. BP checked at 12:18pm. BP-150/73 P-73; Advised patient that her BP was elevated but heart rate is normal. Patient complain of headache in right frontal lobe. Patient is here by herself and walked to clinic for appt. Offered to contact EMS. Patient declined for me to call EMS. Stated that "she didnt want me to call EMS.". Asked patient how was she going to get home and patient stated that she may "call a taxi". Patient does not live far from the health dept. Patient has only eaten a oatmeal pie today. Advised patient to eat when she gets home and take meds as ordered ny her physician. Advised patient if headache continues to call her doctor or EMS for evaluation. BP checked again at 12:23pm BP-146/72 P-71. Advised patient to wait an additional 15 mins in lobby before she leaves . Patient voices understanding. More
2825801 63 F 02/11/2025 COVID19
 MODERNA
Injection site vesicles Injection site vesicles
Blister at injection site. Still present 1 month later. Blister at injection site. Still present 1 month later.
2825802 68 M MN 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4723S
Unevaluable event Unevaluable event
NONE NONE
2825803 9 M CA 02/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 95BJ9
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient had completed Hepatitis B series (3 shots) previously, a not needed fourth extra dose was ad... Patient had completed Hepatitis B series (3 shots) previously, a not needed fourth extra dose was administered. No symptoms after 24 hours from vaccination. More
2825804 32 F MO 02/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 T5D73
No adverse event, Wrong product administered No adverse event, Wrong product administered
patient got Hep B vaccine when she wanted a meningococcal vaccine, she had no reaction to the Hep b ... patient got Hep B vaccine when she wanted a meningococcal vaccine, she had no reaction to the Hep b vaccine. More
2825807 M UT 02/11/2025 FLUX
VARZOS
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Bell's palsy; Bell's palsy Bell's palsy; Bell's palsy
Bell's palsy; This serious case was reported by a physician via sales rep and described the occ... Bell's palsy; This serious case was reported by a physician via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown deltoid) and Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown. The reporter considered the bell's palsy to be related to Shingrix. The company considered the bell's palsy to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The patient received Shingrix and Influenza vaccine at the same time and experienced bell's palsy. It was unknown if reporter considered the bell's palsy to be related to Influenza vaccine.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK drug Shingrix. More
2825808 F PA 02/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 ET475
Exposure during pregnancy Exposure during pregnancy
Vaccine exposure during pregnancy; This non-serious prospective pregnancy case was reported by a nur... Vaccine exposure during pregnancy; This non-serious prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number ET475) for prophylaxis. On 23-MAY-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the vaccine exposure during pregnancy was unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 30 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Estimated Delivery/Due date: 07-AUG-2024 Pregnancy Details (Neonate 1): Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 23-MAY-2024 The Nurse reported that a patient received Boostrix vaccine during pregnancy, which led to vaccine exposure during pregnancy. The reporter consented to follow up. Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated. More
2825809 U 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Diarrhoea, Headache, Lymph node pain, Mobility decreased, Nausea Diarrhoea, Headache, Lymph node pain, Mobility decreased, Nausea
lymph node in that arm hurts; can't raise my arm; diarrhea; nausea; mild headache; This non-ser... lymph node in that arm hurts; can't raise my arm; diarrhea; nausea; mild headache; This non-serious case was reported by a consumer and described the occurrence of lymph node pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 14-JAN-2025, the patient received Shingrix. On 15-JAN-2025, 1 days after receiving Shingrix, the patient experienced lymph node pain (Verbatim: lymph node in that arm hurts) and mobility decreased (Verbatim: can't raise my arm). In JAN-2025, the patient experienced diarrhea (Verbatim: diarrhea), nausea (Verbatim: nausea) and headache (Verbatim: mild headache). The outcome of the lymph node pain and mobility decreased were resolved and the outcome of the diarrhea, nausea and headache were not reported. It was unknown if the reporter considered the lymph node pain, diarrhea, nausea, headache and mobility decreased to be related to Shingrix. It was unknown if the company considered the lymph node pain, diarrhea, nausea, headache and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 15-JAN-2025 The reporter reported that patient got the vaccine a day before the reporting. The day following armpit lymph node in that arm hurts, cannot raise his/her arm, diarrhea, nausea. Mild headache but nothing compared to lymph pain. More
2825810 46 M 02/11/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Bexsero to a a high-risk patient who is 46 years old; This non-serious case was reported by a physic... Bexsero to a a high-risk patient who is 46 years old; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 46-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo). On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero to a a high-risk patient who is 46 years old). The outcome of the inappropriate age at vaccine administration was 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: 14-JAN-2025 The physician reported that healthcare professional gave Bexsero to a a high-risk patient who was 46 years old which led to inappropriate age at vaccine administration. More
2825811 U 02/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Back pain Arthralgia, Back pain
Patient agonizing back pain and extremely painful; shoulder pains without the rash; This non-serious... Patient agonizing back pain and extremely painful; shoulder pains without the rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of back pain in a 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 back pain (Verbatim: Patient agonizing back pain and extremely painful) and shoulder pain (Verbatim: shoulder pains without the rash). The outcome of the back pain and shoulder pain were not reported. It was unknown if the reporter considered the back pain and shoulder pain to be related to Shingles vaccine. It was unknown if the company considered the back pain and shoulder pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that shingles was the form of same virus as chickenpox. The vaccine introduces a virus into your system in a small dose for the purpose of minimizing the effects if contract the illness but if had chickenpox, the virus was already introduced into body and no need for a vaccine. The patient had bad complications as extreme back pain and shoulder pains without rash from this vaccine since getting it five years ago from date of reporting. The reporter reported that virus lies dormant in body and rarely comes back in most cases but this was not the case with patient just info gave was told by physician. The follow-up could not be possible as no contact details were available. More
2825812 U 02/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; still got shingles; 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. 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 shingles (Verbatim: still got shingles). 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. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 28-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she had the shots and still got shingles. Patient believed it would have been worse if he/she did not had the shots. Patient indicated that it was horrible. Also, asked to pray to never get them again. The follow-up could not be possible as no contact details were available. 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
2825813 U 02/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Influenza like illness Influenza like illness
flu like symptoms; This non-serious case was reported by a consumer via interactive digital media an... flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose of vaccine on an unknown date,was fine). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the influenza-like symptoms was resolved (duration 24 hrs). It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine. It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-JAN-2025 This case was reported by a patient via interactive digital media. The patient had flu like symptoms for only 24 hours. More
2825814 U 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Peripheral swelling Erythema, Peripheral swelling
my arm is still very red and swollen; my arm is still very red and swollen; This non-serious case ... my arm is still very red and swollen; my arm is still very red and swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis. In FEB-2025, the patient received Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: my arm is still very red and swollen) and swelling arm (Verbatim: my arm is still very red and swollen). The outcome of the erythema of extremities and swelling arm were not resolved. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix. It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix. Additional Information: GSK Receipt Date: 05-FEB-2025 This case was reported by a patient via (Shingrix GSK) interactive digital media. The reporter reported that a patient received Shingrix 3 days ago and patient arm was still very red and swollen. More
2825815 U 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash erythematous, Swelling Rash erythematous, Swelling
redness rash; swelling; This non-serious case was reported by a consumer via call center representat... redness rash; swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash 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 red rash (Verbatim: redness rash) and swelling (Verbatim: swelling). The outcome of the red rash and swelling were not resolved. It was unknown if the reporter considered the red rash and swelling to be related to Shingrix. It was unknown if the company considered the red rash and swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 05-FEB-2025 The patient self-reported this case. The patient experienced the redness rash and swelling after receiving Shingrix vaccine and asked when will redness rash and swelling go away More
2825816 U 02/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-FEB-2025 This case was reported by a patient via interactive digital media. Patient had the shots and still got the shingles 6 weeks in and still hurting. The patient was asking for something which would helps him/her with the pain. 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
2825817 U 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
it hurt like hell; This non-serious case was reported by a consumer via interactive digital media an... it hurt like hell; 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. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: it hurt like hell). The outcome of the pain was resolved. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK receipt date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got the shot of Shingrix vaccine and experienced it hurt like hell. The reporter reported that it would not wish that on anyone. More
2825818 28 F MI 02/11/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
DH382
Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, E... Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, Extra dose administered More
pregnant accidentally received 1st dose; pregnant accidentally received a second dose; Live birth; r... pregnant accidentally received 1st dose; pregnant accidentally received a second dose; Live birth; received a second dose of Boostrix; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of live birth in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number DH382) for prophylaxis. On 03-AUG-2023, the patient received the 2nd dose of Boostrix. In JUL-2023, the patient received the 1st dose of Boostrix. On 03-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: received a second dose of Boostrix). The patient experienced live birth (Verbatim: Live birth). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant accidentally received 1st dose) and vaccine exposure during pregnancy (Verbatim: pregnant accidentally received a second dose). The outcome of the live birth, vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 30 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Details (Neonate 1): Actual Delivery Date: Delivery Type: vaginal Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 3270 grams (7lbs 3oz) Delivery Notes: The healthy baby was born at 38 weeks, 6 days gestation, baby's length was 48.3 centimeter (19 inches) and head circumference was 31.5 centimeter 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-AUG-2023 The pharmacist reported that patient was 30 weeks pregnant when she accidentally received the second dose of Boostrix. The patient administered first dose of Boostrix (batch numer DH382) two weeks prior of second dose (July2023). The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. Follow-up information received on 07-MAY-2024. A previous report was received because a pregnant women received a second Boostrix dose in error. The patient and her baby was discharged on postpartum day 1. Summary of changes: The patient's pregnancy details, event details and narrative were updated. Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated. More
2825819 27 F IN 02/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M4E4A
Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered
pregnant patient received 2 doses of Boostrix approximately 14 days apart; pregnant patient received... pregnant patient received 2 doses of Boostrix approximately 14 days apart; pregnant patient received 2 doses of Boostrix approximately 14 days apart; pregnant patient received 2 doses of Boostrix approximately 14 days apart; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 23-AUG-2023, the patient received Boostrix. On 09-AUG-2023, the patient received Boostrix. On 23-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart) and vaccine exposure during pregnancy (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 29 Weeks Pregnancy Exposure (Boostrix): Trimester unknown Gestation time at first exposure (Boostrix): 27 Weeks Pregnancy Exposure (Boostrix): Trimester unknown Last Menstrual Period Date: 01-FEB-2023 Estimated Delivery/Due date: 08-NOV-2023 Pregnancy Details (Neonate 1): Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date 25 August 2023: A registered nurse called in to report that a pregnant patient received 2 doses of Boostrix approximately 14 days apart and wished to know how to proceed. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. The patient received 2 doses of Boostrix approximately 14 days apart which led to extra dose administered and vaccine exposure during pregnancy. Follow up information received on 22-Sep-2023. Summary of changes: The patient tab and narrative updated Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type and narrative were updated. More
2825820 F PA 02/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M4E4A
Exposure during pregnancy Exposure during pregnancy
third trimester of pregnancy (28 weeks gestation), received Boostrix; This non-serious prospective p... third trimester of pregnancy (28 weeks gestation), received Boostrix; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis. On 11-DEC-2023, the patient received Boostrix. On 11-DEC-2023, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: third trimester of pregnancy (28 weeks gestation), received Boostrix). The outcome of the vaccine exposure during pregnancy was unknown. Pregnancy exposure: Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Lost to follow up 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: 13-DEC-2023 A nurse reported that, the patient in her third trimester of pregnancy (28 weeks gestation), received Boostrix, which led to vaccine exposure during pregnancy. The date of last menstrual period and estimated delivery date were unknown. Nothing else was reported. The reporter consented to follow up. Follow-up information received on 20-SEP-2024 and 17-OCT-2024 VAERS details were updated. This pregnancy case was now considered lost to follow-up. Summary of Changes: FU Tracking memo in general tab updated, pregnancy outcome updated as lost to follow-up and narrative updated. Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated. More
2825821 F TX 02/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 CX4HL
Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered
Drug Exposure During Pregnancy; Drug Exposure During Pregnancy; Extra dose; This non-serious prospec... Drug Exposure During Pregnancy; Drug Exposure During Pregnancy; Extra dose; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis. On 20-SEP-2024, the patient received the 2nd dose of Boostrix. On 03-SEP-2024, the patient received the 1st dose of Boostrix. On 20-SEP-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy) and vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in second trimester Pregnancy Exposure (Boostrix): To mother in second trimester Estimated Delivery/Due date: 02-DEC-2024 Pregnancy Outcome: Pregnancy was ongoing 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: 24-SEP-2024 The reporter had a patient, who was pregnant, and who received the Tdap on 03-SEP-2024, and then another one on 20-SEP-2024, and reporter need to know if GSK had any research or data that know like any effects or anything like that. The reporter mentioned that both vaccines where administer during the 2nd pregnancy trimester of the patient. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Boostrix during pregnancy, which led to extra dose administered. Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated. More
2825822 30 F IL 02/11/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, E... Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, Extra dose administered More
pregnant woman in her 36.1 week of pregnancy, receive the Boostrix; already had the Boostrix during ... pregnant woman in her 36.1 week of pregnancy, receive the Boostrix; already had the Boostrix during this pregnancy; However, looking back the woman already had the Boostrix during this pregnancy,; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 24-SEP-2024, the patient received the 2nd dose of Boostrix (intramuscular). On an unknown date, the patient received the 1st dose of Boostrix. On 24-SEP-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: However, looking back the woman already had the Boostrix during this pregnancy,). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant woman in her 36.1 week of pregnancy, receive the Boostrix) and vaccine exposure during pregnancy (Verbatim: already had the Boostrix during this pregnancy). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing 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: 24-SEP-2024 The health care professional reported that a pregnant patient in her 36.1 week of pregnancy, received the Boostrix on the day of reporting, which led to vaccine exposure during pregnancy. However, looking back the women already had Boostrix during this pregnancy, which led vaccine exposure during pregnancy and extra dose administered. The reporter was unsure of the date due to computer being down, no symptoms. Upon internal review the case was updated on 11-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated. More
2825823 F CA 02/11/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 395JH
Product preparation issue Product preparation issue
Hiberix + only diluent given; Hiberix + only diluent given; This non-serious case was reported by a ... Hiberix + only diluent given; Hiberix + only diluent given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Hib (Hiberix) (batch number 395JH) for prophylaxis. On 15-JAN-2025, the patient received Hiberix. On 15-JAN-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Hiberix + only diluent given) and inappropriate dose of vaccine administered (Verbatim: Hiberix + only diluent given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 22-JAN-2025 The nurse reported that the diluent portion of Hiberix vaccines was administered to a patient without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. More
2825824 65 M NJ 02/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Inappropriate schedule of product administration, Product prescribing error; Ina... Inappropriate schedule of product administration, Product prescribing error; Inappropriate schedule of product administration, Product prescribing error More
Drug prescribing error; The patient received the first dose of Shingrix in 2022 and 2nd in May 2024;... Drug prescribing error; The patient received the first dose of Shingrix in 2022 and 2nd in May 2024; 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 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in 2022). In MAY-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient did not receive the 3rd dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received the first dose of Shingrix in 2022 and 2nd in May 2024). On an unknown date, the patient experienced drug prescribing error (Verbatim: Drug prescribing error). The outcome of the drug dose administration interval too long and drug prescribing error were unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 The pharmacist reported that she had a prescription for a patient for Shingrix, but it will be the patient's 3rd dose which led to drug prescribing error. The patient received the first dose of Shingrix in 2022 and 2nd in May 2024. The pharmacist thinks the physician may have forgotten the patient received the 1st dose in 2022 and that's why the 3rd dose was prescribed. The patient received 2nd dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule. More
2825825 F AR 02/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age More
A 4 months old female patient received a dose of Kinrix; Kinrix was administered for the 2nd dose of... A 4 months old female patient received a dose of Kinrix; Kinrix was administered for the 2nd dose of DTaP and IPV; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. On an unknown date, the patient received the 2nd dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 4 months old female patient received a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was administered for the 2nd dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration 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: 04-FEB-2025 The reporter reported that a 4 months old patient received Kinrix and Kinrix was administered for the 2nd dose of DTaP and IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. And wanted to know if there was anything if they should do. More
2825826 M IN 02/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X4T99
Incorrect route of product administration Incorrect route of product administration
A 55 years old male patient received a dose of manevo; This non-serious case was reported by a pharm... A 55 years old male patient received a dose of manevo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 55-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis. On an unknown date, the patient received Menveo (subcutaneous). On an unknown date, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: A 55 years old male patient received a dose of manevo). The outcome of the intramuscular formulation administered by other route was unknown. Additional Information: GSK Receipt Date: 05-FEB-2025 The pharmacist reported that they administered a dose of Menveo (1 vial) subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter was ask what was the recommendations to follow. More
2825827 66 M NM 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Myalgia, Pyrexia, Rash Myalgia, Pyrexia, Rash
sore muscles; fever; rash; This non-serious case was reported by a consumer via call center represen... sore muscles; fever; rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 05-FEB-2025, the patient received Shingrix (intramuscular). On 06-FEB-2025, 1 days after receiving Shingrix, the patient experienced muscle soreness (Verbatim: sore muscles), fever (Verbatim: fever) and rash (Verbatim: rash). The outcome of the muscle soreness, fever and rash were unknown. It was unknown if the reporter considered the muscle soreness, fever and rash to be related to Shingrix. It was unknown if the company considered the muscle soreness, fever and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 06-FEB-2025 The reporter reported that a patient received his Shingrix vaccination and reporting day morning he awoke with fever, muscle aches and rash on his stomach and arms. More
2825828 M CA 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 HA5HA
Inappropriate schedule of product administration, Product preparation issue Inappropriate schedule of product administration, Product preparation issue
Only adjuvant portion; Only adjuvant portion; late 2nd dose; This non-serious case was reported by a... Only adjuvant portion; Only adjuvant portion; late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number HA5HA, expiry date 13-NOV-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 17-MAY-2024). On 04-FEB-2025, the patient received the 2nd dose of Shingrix. On 04-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant portion), inappropriate dose of vaccine administered (Verbatim: Only adjuvant portion) and drug dose administration interval too long (Verbatim: late 2nd dose ). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were unknown. Additional Information: GSK Receipt Date: 06-FEB-2025 The health care professional reported that he/she asked regards the Shingles vaccine (Shingrix), if a patient was given just the diluent only and not the vaccine it self, when was safe to get the dose of vaccine, which led to inappropriate preparation of medication and inappropriate doseof vaccine administered. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2825829 1 M OK 02/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Kinrix was administered to a 13-month-old patient instead of Pediarix; Kinrix was administered to a ... Kinrix was administered to a 13-month-old patient instead of Pediarix; Kinrix was administered to a 13-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 28-JAN-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 28-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was administered to a 13-month-old patient instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 13-month-old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 06-FEB-2025 The reporter reported that the Kinrix was administered to a 13-month-old patient instead of Pediarix which led to, wrong vaccine administered and inappropriate age at vaccine administration. The reporter stated that they had always re-vaccinated after 30 days an in because it was considered an invalid dose but their stated, they did not had to re-vaccinate because it was the same dose. The vaccine administration facility was the same as primary reporter. More
2825830 59 F FL 02/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received the first dose of Shingrix almost 2 years ago and did not return for the 2nd dose; This non... received the first dose of Shingrix almost 2 years ago and did not return for the 2nd 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 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 20-APR-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: received the first dose of Shingrix almost 2 years ago and did not return for the 2nd dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 07-FEB-2025 The pharmacist stated a patient received the first dose of Shingrix almost 2 years ago and did not return for the 2nd dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2018187736:same reporter More
2825831 72 F IA 02/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2553X
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient received a first dose of Twinrix in Aug 7th 2024 and second dose was given today Feb 7th 202... patient received a first dose of Twinrix in Aug 7th 2024 and second dose was given today Feb 7th 2025; 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 72-year-old female patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 07-AUG-2024, batch number 2553X, expiry date 25-SEP-2026). On 07-FEB-2025, the patient received the 2nd dose of Twinrix. On 07-FEB-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received a first dose of Twinrix in Aug 7th 2024 and second dose was given today Feb 7th 2025). The outcome of the drug dose administration interval too long was 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: 07-FEB-2025 A pharmacist reported that a patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule The pharmacist asked if series should be re started More
2825832 M CA 02/11/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient started the Havrix series in 2019 but never received the second dose.; This non-serious case... patient started the Havrix series in 2019 but never received the 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 29-year-old male patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: patient started the Havrix series in 2019 but never received the second dose.). The outcome of the incomplete course of vaccination was 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: 07-FEB-2025 The pharmacist reported that a patient started the Havrix series in 2019 but never received the second dose. Till the time of reporting, the patient did not receive the 2nd dose of Havrix, which led to an incomplete course of vaccination. More
2825833 60 F 02/11/2025 RSV
 MODERNA
Blood glucose increased, Pain in extremity Blood glucose increased, Pain in extremity
sore arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN E... sore arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY ("sore arms") in a 60-year-old female patient who received mRNA-1345 (mRESVIA) for Lower respiratory tract infection. Concurrent medical conditions included Diabetes. On 04-Feb-2025, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) 1 dosage form. On 05-Feb-2025, after starting mRNA-1345 (mRESVIA), the patient experienced PAIN IN EXTREMITY ("sore arms"). At the time of the report, PAIN IN EXTREMITY ("sore arms") outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2025, Blood glucose: high blood sugar of 185.. The action taken with mRNA-1345 (mRESVIA) (Intramuscular use) was unknown. No concomitant medication was reported. No treatment information was reported. This case was linked to MOD-2025-782121 (Patient Link). More
2825834 60 F 02/11/2025 COVID19
 MODERNA
Blood glucose increased, Pain in extremity Blood glucose increased, Pain in extremity
"sore arms"; This spontaneous case was reported by a patient and describes the occurrence ... "sore arms"; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY ("sore arms") in a 60-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes. On 04-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 05-Feb-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY ("sore arms"). At the time of the report, PAIN IN EXTREMITY ("sore arms") outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2025, Blood glucose increased: high blood sugar of 185. No concomitant medication was reported. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-782124 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-782124:mRESVIA RSV Vaccine More
2825835 59 F TX 02/11/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure, Weight COVID-19, Vaccination failure, Weight
COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A 60-year-ol... COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A 60-year-old female patient received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for COVID-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2022 (unspecified if ongoing). There were no concomitant medications. Past drug history included: Paxlovid, start date: Jul2022, for COVID-19 treatment. Vaccination history included: COVID-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization; Moderna (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2025, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Weight: About 155. The patient had nirmatrelvir/ritonavir (PAXLOVID) before and then she started with a couple of years ago and that she got all her boosters. The patient guesses that she can get COVID-19 again. So, she had PAXLOVID before and she has COVID-19 and PAXLOVID again. Therapeutic measures included nirmatrelvir/ritonavir (300/100 mg), oral, at 3 tablets, twice daily, for 5 days from 06Feb2025 (ongoing). More
2825836 61 F IL 02/11/2025 PNC20
 PFIZER\WYETH
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
the most painful shot I have ever gotten; near it's swollen and red where at the site of the in... the most painful shot I have ever gotten; near it's swollen and red where at the site of the injection; near it's swollen and red where at the site of the injection; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Feb2025 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) at the age of 61 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the most painful shot I have ever gotten"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "near it's swollen and red where at the site of the injection". Additional information: Consumer stated that patient actually got a Prevnar 20, 0.5 milliliter shot 05Feb2025 (yesterday) in the morning and it was the most painful shot patient had ever gotten and patient was just been living like because patient just do and may be patient should not have but right but patient have, near it's swollen and red where at the site of the injection so, patient was concerned about that. Patient did not know if there was something patient should do about it. Consumer was requested to visit nearest Health Care Professional or Pharmacist in case of emergency. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2825837 F NY 02/11/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Back pain, Blood test, COVID-19, Drug ineffective, Malaise; SARS-CoV-2 test Back pain, Blood test, COVID-19, Drug ineffective, Malaise; SARS-CoV-2 test
I got COVID; I got COVID; I haven't been feeling well and the different symptoms I am having; p... I got COVID; I got COVID; I haven't been feeling well and the different symptoms I am having; pain in the right side of my back; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 58-year-old female patient 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 included: "covid" (unspecified if ongoing), notes: this is the second time I have covid, but the first time I did not have any symptoms I didn't know I had it but when I got tested it shows that I had covid. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID"; MALAISE (non-serious), outcome "not recovered", described as "I haven't been feeling well and the different symptoms I am having"; BACK PAIN (non-serious), outcome "not recovered", described as "pain in the right side of my back". The events "i got covid" and "i haven't been feeling well and the different symptoms i am having" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: I have the antibodies; SARS-CoV-2 test: I got COVID; I had covid. Clinical course: The reporter stated that, "The doctor told me last night, you know, because he hasn't been feeling well and the different symptoms this is the second time he has covid, but the first time did not have any symptoms he didn't know he had it but when I got tested it shows that he had covid had to be quarantined but this time had vaccinations,. Reporter stated" I've had two vaccinations and I have the bloodwork showing that I have the antibodies but then I got the covid test I got Covid from a family member had a baby, I was kind of helping the baby, and somehow I get the COVID, and I started the symptoms, and like the Covid and yesterday I went to the ER (emergency room) you know I have to get an (inaudible) because I've been having a pain in the right side of my back and the lung doctor was saying I need to get the medication because it's going to help (inaudible) down so it doesn't make the symptoms worse so I can get better. " The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2825838 M 02/11/2025 RSV
 PFIZER\WYETH
Dyspnoea, Gait disturbance, Malaise, Vomiting Dyspnoea, Gait disturbance, Malaise, Vomiting
he was very sick; vomiting; difficulty breathing; couldn't walk 10 feet to the bathroom; This i... he was very sick; vomiting; difficulty breathing; couldn't walk 10 feet to the bathroom; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he was very sick"; VOMITING (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "couldn't walk 10 feet to the bathroom". Additional information: he was very sick and was vomiting, had difficulty breathing, and couldn't walk 10 feet to the bathroom after receiving rsv vaccine. Batch/lot number is not provided, and it cannot be obtained. More
2825839 70 F ME 02/11/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8437DA
UT8437DA
Basophil count increased, Contusion, Decreased appetite, Eosinophil count increa... Basophil count increased, Contusion, Decreased appetite, Eosinophil count increased, Musculoskeletal stiffness; Pain in extremity, Peripheral swelling, Sleep disorder, Swelling, Weight decreased More
Condition aggravated; lack appetite; gained 4 to 5 pounds that came on overnight; stiff; elevated ba... Condition aggravated; lack appetite; gained 4 to 5 pounds that came on overnight; stiff; elevated basophil count; severe inflammatory responses of very high eosinophils; feet hurt'; trouble with sleep; arm was sore; bruised; experiencing swelling in her arms, feet, and hands since receiving fluzone hd/ swelling went up my arm, over shoulder, to side of my neck; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves, a 70 years old female patient who had condition aggravated, arm was sore, bruised, feet hurt', trouble with sleep, lack appetite, severe inflammatory responses of very high eosinophils, gained 4 to 5 pounds that came on overnight, elevated basophil count, stiff and experiencing swelling in her arms, feet, and hands since receiving fluzone hd/ swelling went up her arm, over shoulder, to side of her neck after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history included Erythema. The patient's past vaccination(s) included Fluzone High Dose Quadrivalent on 21-Oct-2021. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Pain, Headache and Peripheral swelling. Concomitant medications included Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]) for Insomnia and Decreased appetite; and Paracetamol (Tylenol) for Pain and Fatigue. On 15-Jan-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8437DA) (unknown strength, expiry date) via intramuscular route in the left deltoid for Immunization. On 15-Jan-2025, the patient developed experiencing swelling in her arms, feet, and hands/ swelling went up her arm, over shoulder, to side of her neck (swelling), arm was sore (pain in extremity), bruised (contusion) (latency-same day); on 16-Jan-2025, the patient developed feet hurt' (pain in extremity), trouble with sleep (initial insomnia) (latency-1 day); on 28-Jan-2025, the patient developed severe inflammatory responses of very high eosinophils (eosinophil count increased), elevated basophil count (basophil count increased) (latency-13 days); on an unknown date, the patient developed lack appetite (decreased appetite), condition aggravated, stiff (musculoskeletal stiffness), gained 4 to 5 pounds that came on overnight (weight increased) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. Reportedly, The caller was a nurse and the patient. She stated, '' she was looking to let people know of the reaction and ask for help with how to treat it.'' She said, she had local reactions from other vaccines and that was why she did not wanted the high-dose. With Pneumovax she reacted and was told not to take any PCV in the future. With Shingrix, the same thing. As a child ''she would miss school with arm swelling, pain and redness with DTaP shots''. Her physician's office was busy doing assessments and no one asked her which flu vaccine she wanted. They administered the injection, saying they gave it to her because she is of age. She realized after the dose that it was the high dose vaccine. In the past it was written down that she had a common reaction to a flu shot but could still receive flu shots in the future. She purposely do not get my tetanus boosters because of her history. She would only get a tetanus booster if she was actually injured.'' She was able to obtain an appointment with another physician at the office. She was told Guillain-Barre was ruled out. She was told that she had a severe inflammatory reaction. Relevant laboratory test results included: Blood test - On 28-Jan-2025: [showed severe inflammatory responses of very high eosinophils and elevated basophil count.] Weight - On 28-Jan-2025: [gained 4 to 5 pounds that came on overnight] Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. More
2825840 F 02/11/2025 UNK
 UNKNOWN MANUFACTURER
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
stated her daughter's friend got flublok and she wasn't 18 yet with no reported adverse ev... stated her daughter's friend got flublok and she wasn't 18 yet with no reported adverse event; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age female patient who had received Influenza Trivalent Recombinant Vaccine [Flublok TIV] and she wasn't 18 yet with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the less than 18 years old patient received a unknown dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly: "Caller refused to provide event information without her friend's approval." Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2825862 12 M OR 02/11/2025 DTAP
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 9KB9G
U8375AA
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No known adverse effects post vaccination. Pt was given Dtap instead of Tdap. No known adverse effects post vaccination. Pt was given Dtap instead of Tdap.
2825863 59 F 02/11/2025 PNC21
 MERCK & CO. INC.
Pruritus, Urticaria Pruritus, Urticaria
PATIENT STARTED EXPERIENCING ITCHING AND HIVES A DAY AFTER THE VACCINE AND STILL HAD THEM 5 DAYS AFT... PATIENT STARTED EXPERIENCING ITCHING AND HIVES A DAY AFTER THE VACCINE AND STILL HAD THEM 5 DAYS AFTER THE VACCINE. More
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