๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

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

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2844813 2 F 06/12/2025 MMRV
 MERCK & CO. INC.
 Y020299
Anaphylactic reaction, Cough, Urticaria, Wheezing Anaphylactic reaction, Cough, Urticaria, Wheezing
Patient received ProQuad dose, about 5-10minutes after administration started to develop hives to fa... Patient received ProQuad dose, about 5-10minutes after administration started to develop hives to face and abdomen, also developed cough and wheezing. Epinephrine, Benadryl and albuterol administered for anaphylactic reaction. Patient then transferred to emergency room for further evaluation. More
2844814 8 M TN 06/12/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 9D25P
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
N/A N/A
2844815 6 M FL 06/12/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 H3N97
Urticaria Urticaria
Patient received first dose of the Hepatitis A vaccine on 6/9/2025. The patient's father stated... Patient received first dose of the Hepatitis A vaccine on 6/9/2025. The patient's father stated that the patient had hives appear on both upper extremities. He stated the hives appeared when he woke up the next morning after receiving the vaccines. The patient's father denies that patient had a reaction in the past to vaccines. More
2844816 56 F 06/12/2025 PNC21
 MERCK & CO. INC.
 Z004302
Injection site erythema, Injection site warmth, Pyrexia Injection site erythema, Injection site warmth, Pyrexia
Patient developed cellulitis appearing reaction to injection site of CAPVAXIVE. Extensive erythema, ... Patient developed cellulitis appearing reaction to injection site of CAPVAXIVE. Extensive erythema, subjective fevers, warm to touch. More
โœ“
2844817 4 M NV 06/12/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
No adverse event, Wrong product administered No adverse event, Wrong product administered
No adverse reaction, Patient was to be given MMRV vs Menvo. No adverse reaction, Patient was to be given MMRV vs Menvo.
2844818 55 F 06/12/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
Hypoaesthesia Hypoaesthesia
when pt arrived for her 4th dose of rabies vaccine, 06/12/2025, Pt states she noticed persistent num... when pt arrived for her 4th dose of rabies vaccine, 06/12/2025, Pt states she noticed persistent numbness in fingertips of right arm within a few days after receiving her 3rd rabies vaccine.dose. pt states she has history of fingertip numbness previously but it has not resolved in this case. pt states she was evaluated by her dr and that "the dr said she will be fine and to ask for the next dose be given in left arm." No other symptoms were reported and pt denies any pain at the time 3rd dose was given. counseled pt on risks again and for her to follow up with her dr again if no improvement. 4th dose was given in left arm per the request of pt per dr. More
2844819 53 F 06/12/2025 PNC21
 MERCK & CO. INC.
 Z004301
Injection site erythema, Injection site swelling, Pyrexia Injection site erythema, Injection site swelling, Pyrexia
Patient developed cellulitis type reaction 1 day after administration of vaccine. Subjective fevers,... Patient developed cellulitis type reaction 1 day after administration of vaccine. Subjective fevers, increasing erythema and swelling to injection site. More
2844820 13 F TX 06/12/2025 HIBV
 MERCK & CO. INC.
Breast cyst, Cyst removal, Impaired healing, Keloid scar Breast cyst, Cyst removal, Impaired healing, Keloid scar
When she was vaccinated she had to have 3 series, she started growing cyst in her breast and they we... When she was vaccinated she had to have 3 series, she started growing cyst in her breast and they were the size of a golf ball and they had to be removed. Once she was cut she grew keloids and it affected her body from healing and she kept growing cyst that had to be removed and creating more keloids that scared her. She was seen by plastic surgery but they could not remove any more because they would come back worse and now we are going to see another doctor to see if there is any other treatment. More
2844821 0.58 F CA 06/12/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH
 U8313AA
LG5578
Pruritus, Urticaria; Pruritus, Urticaria Pruritus, Urticaria; Pruritus, Urticaria
7 month old with itchy hives all over the body post vaccination within less than 2 hours. Patient wa... 7 month old with itchy hives all over the body post vaccination within less than 2 hours. Patient was referred to ER for further evaluation. More
2844822 16 M TX 06/12/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 49M9N
U8375AB
Vomiting; Vomiting Vomiting; Vomiting
Patient vomited after vaccines Patient vomited after vaccines
2844823 7 M KS 06/12/2025 DTAPIPV
MMR
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 u8009ab
y008289
y013348
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 More
patient is 7 years old and was given quadracel which is indicated for ages 4-6 years old patient is 7 years old and was given quadracel which is indicated for ages 4-6 years old
2844824 38 F AZ 06/12/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945656
Abdominal pain upper, Diarrhoea, Nausea, Skin warm Abdominal pain upper, Diarrhoea, Nausea, Skin warm
Experienced nausea, stomach cramps, warmness, and diarrhea about 12 hours after receiving shot (06/... Experienced nausea, stomach cramps, warmness, and diarrhea about 12 hours after receiving shot (06/06/2025 at 4pm), which went away on 06/08/2025 at 10pm. She states that she did not receive treatment but waited it out. More
2844825 19 F PA 06/12/2025 COVID19
 MODERNA
 8080799
Expired product administered, No adverse event Expired product administered, No adverse event
Patient received vaccine on 6/12/25 that was expired. Vaccine lot number was 8080799 and expiration ... Patient received vaccine on 6/12/25 that was expired. Vaccine lot number was 8080799 and expiration was 6/7/25. No signs/symptoms. Pt waited around 30 min after vaccination and was fine. More
2844826 1.58 M 06/12/2025 DTAPIPVHIB
HEPA
MMR
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 UK329AA
Y008483
Y014096
Febrile convulsion; Febrile convulsion; Febrile convulsion Febrile convulsion; Febrile convulsion; Febrile convulsion
febrile seizure, treated at local ED, simple (<15mins), back to baseline prior to discharge febrile seizure, treated at local ED, simple (<15mins), back to baseline prior to discharge
2844827 13 F MI 06/12/2025 MMRV
 MERCK & CO. INC.
 Y020300
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse event- patient above eligible age to receive this vaccination No adverse event- patient above eligible age to receive this vaccination
2844831 17 F MI 06/12/2025 MMRV
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 Y020300
DL4YY
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 Adverse Event- patient above eligible age to receive MMRV No Adverse Event- patient above eligible age to receive MMRV
2844832 74 F TX 06/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Injection site erythema, Injection site swelling, Peripheral swelling, Rash Injection site erythema, Injection site swelling, Peripheral swelling, Rash
Swelling and redness at injection site, small bumps on back and 1 small bump on forearm. Swelling and redness at injection site, small bumps on back and 1 small bump on forearm.
2844833 18 M CO 06/12/2025 HEPA
YF
 MERCK & CO. INC.
SANOFI PASTEUR
 Y017625
UK136AB
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Administrator accidentally gave an adult dose of Hepatitis A vaccine to an 18 year old instead of a ... Administrator accidentally gave an adult dose of Hepatitis A vaccine to an 18 year old instead of a pediatric dose. Parent was called and notified. More
2844835 11 M AL 06/12/2025 HPV9
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 Y005835
LN75D
Injection site erythema, Injection site pruritus, Injection site swelling; Injec... Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling More
The mother stated the child woke up the following morning with reddness & swelling & itchine... The mother stated the child woke up the following morning with reddness & swelling & itchiness at injection site. Mom spoke to on call doctor that night & was told to draw a circle around it. Mom stated it was a little larger this morning. Told to give Ipuprophen, Benedryl & warm compresses More
2844849 0.67 M CA 06/12/2025 DTAP
 SANOFI PASTEUR
 UK303AB
Erythema, Peripheral swelling Erythema, Peripheral swelling
red bump on the right thigh red bump on the right thigh
2844850 16 F WA 06/12/2025 MMRV
 MERCK & CO. INC.
 Y008786
No adverse event, Pregnancy test negative, Product administered to patient of in... No adverse event, Pregnancy test negative, Product administered to patient of inappropriate age More
Staff member administered vaccine above to patient. vaccine was not ordered. vaccine was ordered by ... Staff member administered vaccine above to patient. vaccine was not ordered. vaccine was ordered by provider as meningococcal, but MMRV was given. notified patient's mother of vaccine that was given incorrectly. mother was given VIS and possible side effects to be aware of, patient and mother verbalized understanding. patient and mother agreed to come into clinic today 6/12/25 for pregnancy test and to give correct vaccine as instructed by Dr. patient came in with grandmother at 3:00PM. pregnant test was given, Dr. confirmed test was negative. patient was given correct vaccine and VIS information sheet was given as well to patient and grandmother. patient advised to wait in lobby for at least 15 minutes and report any adverse effects or reactions. patient waited and tolerated vaccine without any adverse effects or reactions. More
2844851 12 F OR 06/12/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Z005469
Z005469
Blood pressure decreased, Dizziness, Fatigue, Nausea, Syncope; Tonic clonic move... Blood pressure decreased, Dizziness, Fatigue, Nausea, Syncope; Tonic clonic movements More
Within 5 minutes of receiving her HPV vaccine while seated, patient expressed that she felt lighthea... Within 5 minutes of receiving her HPV vaccine while seated, patient expressed that she felt lightheaded. RN advised her to put her head between her knees but before she could comply she had a syncopal event with tonic-clonic movements lasting about 45 seconds. She resumed consciousness and reported feeling very tired. She was moved by her father into a lying position on the exam table. Vital signs were taken noting a decrease in her blood pressure, patient reported feeling nauseated and continuing to feel lightheaded. Cool cloths were placed on her forehead and the back of her neck and an emesis bag was provided. At 15 minutes vital signs were rechecked and had returned to baseline, patient remained nauseated, tired, weak, and lightheaded. A juice box and a handful of crackers were placed at bedside, patient declined to eat/drink due to nausea. RN continued to monitor patient in 10-minute intervals with no change in symptoms, gave a dose of Zofran at 45 minutes per verbal order from Dr. Patient vomited at 60 minutes and immediately reported feeling better, nausea and lightheadedness resolved, patient ate some crackers and drank some water, tolerated both. Patient reported complete resolution of symptoms at 75 minutes. Discharged home with all symptoms resolved. More
2844852 39 F CA 06/12/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6199
EN6199
Anxiety, Dizziness, Neurological symptom, Palpitations, Rash; Tinnitus, Vertigo Anxiety, Dizziness, Neurological symptom, Palpitations, Rash; Tinnitus, Vertigo
Lightheadedness and vertigo. Tinnitus, skin rashes and other neurological symptoms. Palpitations and... Lightheadedness and vertigo. Tinnitus, skin rashes and other neurological symptoms. Palpitations and anxiety. More
2844853 56 F CA 06/12/2025 PNC20
 PFIZER\WYETH
 LN4929
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Patient displayed redness of left deltoid and warm to touch. Patient displayed redness of left deltoid and warm to touch.
2844854 55 M FL 06/12/2025 PNC21
TDAP
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y013009
EB499
PJ353
Heart rate abnormal, Injection site pain, Pyrexia; Heart rate abnormal, Injectio... Heart rate abnormal, Injection site pain, Pyrexia; Heart rate abnormal, Injection site pain, Pyrexia; Heart rate abnormal, Injection site pain, Pyrexia More
Patient was given 3 vaccines on 6/11/25. Patient mentioned he experienced pain at the injection sit... Patient was given 3 vaccines on 6/11/25. Patient mentioned he experienced pain at the injection site and fever. Patient also mentioned that he has an abnormal heart beat now after getting the vaccines administered. More
2844856 59 M CA 06/12/2025 PNC20
TDAP
VARZOS
 PFIZER\WYETH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 MF0425
U8389AA
75D3A
Discomfort, Eye swelling, Lacrimation increased, Ocular hyperaemia, Uveitis; Dis... Discomfort, Eye swelling, Lacrimation increased, Ocular hyperaemia, Uveitis; Discomfort, Eye swelling, Lacrimation increased, Ocular hyperaemia, Uveitis; Discomfort, Eye swelling, Lacrimation increased, Ocular hyperaemia, Uveitis More
Severe uveitis of the right (swelling/redness/watery eyes with discomfort on cheek and nose. Severe uveitis of the right (swelling/redness/watery eyes with discomfort on cheek and nose.
2844857 1.08 M OH 06/12/2025 UNK
 UNKNOWN MANUFACTURER
Febrile convulsion Febrile convulsion
My baby had a seizure a febrile seizure which are listed rare side effects of this vaccine. Went to ... My baby had a seizure a febrile seizure which are listed rare side effects of this vaccine. Went to hospital by ambulance today. More
โœ“
2844865 2 F LA 06/12/2025 DTAPIPVHIB
HEP
PNC15
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 uk2169ba
y014090
y010035
No adverse event, Wrong patient; No adverse event, Wrong patient; No adverse eve... No adverse event, Wrong patient; No adverse event, Wrong patient; No adverse event, Wrong patient More
when the vaccines were drawn up and the vaccine stickers were placed on the forms, the patient name ... when the vaccines were drawn up and the vaccine stickers were placed on the forms, the patient name and DOB were switched and the vaccines were switched and administered to the wrong patient. no adverse signs or symptoms occured. More
2844866 0.75 F LA 06/12/2025 DTAP
HEPA
IPV
 SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
 3CA55C1
Y014585
W1C831M
No adverse event, Wrong patient; No adverse event, Wrong patient; No adverse eve... No adverse event, Wrong patient; No adverse event, Wrong patient; No adverse event, Wrong patient More
When the vaccines were drawn up and the vaccine stickers were pulled on the links forms, the patient... When the vaccines were drawn up and the vaccine stickers were pulled on the links forms, the patients name and DOB were switched and the vaccines were switched and administered to the wrong patient. No adverse signs or symptoms occured More
2844542 0.17 M AL 06/11/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK194AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
patient was administered with the Hib part that was diluted with sterile water with no reported adve... patient was administered with the Hib part that was diluted with sterile water with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 month old male patient was administered with Diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] whose HIB part that was diluted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation; and Hepatitis B vaccine (ENGERIX-B [Hepatitis B vaccine]) for Immunisation. On 04-Jun-2025, the patient received a dose 0.5ml of suspect Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UK194AA and expiry date-31-Mar-2026) (strength-unknown) via intramuscular route in lateral side of the thigh for Immunization the whose HIB part that was diluted with sterile water with no reported adverse event (single component of a two-component product administered) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844543 IL 06/11/2025 IPV
 SANOFI PASTEUR
 W1C831M
No adverse event, Product storage error No adverse event, Product storage error
Opened ipol exposed to 8.07 ๏ฟฝC to 9.76 ๏ฟฝC upto 14 minutes also it has been exposed to several te... Opened ipol exposed to 8.07 ๏ฟฝC to 9.76 ๏ฟฝC upto 14 minutes also it has been exposed to several temperature excursions. After excursions this was administered to three patients with no reported adverse event; Initial information received on 06-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 3 patient and is reported opened IPV (VERO) [IPOL] exposed to 8.07 ๏ฟฝc to 9.76 ๏ฟฝc upto 14 minutes also it has been exposed to several temperature excursions after excursions this was administered to three patients 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, IPOL exposed to 8.07 ๏ฟฝc to 9.76 ๏ฟฝc upto 14 minutes also it has been exposed to several temperature excursions, after excursions this was administered to three patients Suspension for injection of lot W1C831M and expiry date: 21-Nov-2025 (strength and dose: not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (poor quality product administered) (latency: on same day). Reportedly, Previous Excursion Dec-2024 - 3.2 C to 8.67 C for 15 minutes, with IPOL (opened) Aug-2024 - 4.97 C to 8.27 C for 15 minutes, with IPOL (opened) May-2024 - 4.97 C to 8.27 C for 15 minutes, without IPOL (opened) Jan-2024 - 4.16 C to 9.02 C for 15 minutes, without IPOL (opened)Human error: No. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844544 0.33 F UT 06/11/2025 HIBV
 SANOFI PASTEUR
 UK111AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
inappropriate use due to administration of ACTHIB prepared with sterile water with no reported adver... inappropriate use due to administration of ACTHIB prepared with sterile water with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who was administered with inappropriate use due to administration of HIB (PRP/T) vaccine [ACT-HIB] prepared with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation. On 04-Jun-2025, the patient received a 0.5ml dose 2 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength, frequency-once (lot UK111AA and expiry date-31-Aug-2025) via intramuscular route in the left thigh for Immunization which was prepared with sterile water with no reported adverse event (product preparation error) (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844551 64 F MD 06/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Chills, Headache, Injection site erythema, Injection site induration, Injection ... Chills, Headache, Injection site erythema, Injection site induration, Injection site pain; Injection site pruritus, Injection site warmth, Pyrexia More
Day2 Low grade fever, chills, headache, injection site sore; Day 4+ injection site red, hard, hot, i... Day2 Low grade fever, chills, headache, injection site sore; Day 4+ injection site red, hard, hot, itchy More
2844553 WA 06/11/2025 TDAP
 SANOFI PASTEUR
 U5213BA
Expired product administered, No adverse event Expired product administered, No adverse event
possible administration of an expired product with no reported Adverse events; Initial information r... possible administration of an expired product with no reported Adverse events; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves possible administration of expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] to a unknown age and unknown gender patient 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 in 2017, the patient received an dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (once), Suspension for injection, (unknown strength and expiry date) lot U5213BA via unknown route in unknown administration site for immunization which might have been expired with no reported adverse event (expired product administered) (latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844554 4 F MD 06/11/2025 DTAPIPV
DTAPIPV
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 N7GC9
N7GC9
Z005150
Z005150
Immunisation reaction, Injection site cellulitis, Injection site erythema, Injec... Immunisation reaction, Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain; Injection site pruritus, Injection site swelling, Injection site warmth; Immunisation reaction, Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain; Injection site pruritus, Injection site swelling, Injection site warmth More
06-03-2025 per mother - golf ball size lump @ injection site (L) upper thigh = painful, itchy, red, ... 06-03-2025 per mother - golf ball size lump @ injection site (L) upper thigh = painful, itchy, red, swollen, warm to touch Dx cellulitis L03.119 Vaccine reaction T50.Z95A More
2844594 F MI 06/11/2025 PNC21
 MERCK & CO. INC.
Influenza like illness Influenza like illness
FBE reported AE on behalf of HCP who reported on behalf of themselves that they experienced flu-like... FBE reported AE on behalf of HCP who reported on behalf of themselves that they experienced flu-like symptoms within 48 hours of being administered CAPVAXIVE. Additional patient demographics unknown. No additional AE details reported. FBE was made aw; This spontaneous report was received from an Other health professional and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced flu-like symptoms within 48 hours of being administered CAPVAXIVE. At the reporting time, the outcome of the event was unknown. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. More
2844595 F AL 06/11/2025 HPV4
 MERCK & CO. INC.
 X014950
No adverse event, Suspected counterfeit product No adverse event, Suspected counterfeit product
Email received on 29MAY2025 at 12:22 PM ET from Merck Employee titled: "Gardasil๏ฟฝ [Human Papi... Email received on 29MAY2025 at 12:22 PM ET from Merck Employee titled: "Gardasil๏ฟฝ [Human Papillomavirus Quadrivalent Vaccine, Types 6, 11, 16, and 18, Recombinant] - HCP Request" containing a forwarded email from; No symptoms reported; This spontaneous report was received from a nurse practitioner and refers to a(n) female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), lot #X014950, expiration date: 19-Dec-2025 (exact dose, route of administration and anatomical location were not provided) for an unknown indication. On an unknown date, the patient contacting to verify the authenticity of a Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine dose she received in another country. The vaccine was administered in a local clinic, but she did not see the outer packaging. She would like to confirm whether this batch (X014950) was officially distributed to country and whether it is part of a recognized public health or supported program. She would appreciate our confirmation and any additional information you could provide (suspected counterfeit product). No symptoms reported (no adverse event). More
2844596 F NC 06/11/2025 PNC21
 MERCK & CO. INC.
Hypersensitivity, Immediate post-injection reaction, Oral herpes, Vaccination si... Hypersensitivity, Immediate post-injection reaction, Oral herpes, Vaccination site swelling More
Fever blister; a suspected allergic reaction; vaccination site redness; vaccination site swelling; f... Fever blister; a suspected allergic reaction; vaccination site redness; vaccination site swelling; fever; This spontaneous report was received from a nurse referring to a 64-year-old female patient. The patient's concurrent conditions included type 2 diabetes mellitus (T2DM), and Asthma. Concomitant medications included Valtrex (Valaciclovir hydrochloride), Aspirin (Acetylsalicylic acid; Ascorbic acid), Advair (Fluticasone propionate; Salmeterol xinafoate), and Albuterol (Salbutamol sulfate). Drug Reactions/Allergies included Opioids (Opioids), Dilantin (Phenytoin), and Meperidine (Pethidine). On 30-May-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered by Intramuscular route in Left Deltoid for prevention of pneumococcal infection (lot # and expiration date were not reported) On 30-May-2025, the patient experienced vaccination site redness and vaccination site swelling. Vaccine was given in the left deltoid and redness and swelling was noted immediately after administration but wasn't warm or painful. The patient reported a subjective fever but never took her temperature (pyrexia). On 03-Jun-2025, the patient experienced a suspected allergic reaction (Hypersensitivity). On that day, the patient presented to the clinic with a suspected allergic reaction. The patient's temperature was taken at the appointment, and it was reported that the patient to be afebrile. It was also reported that the patient had fever blisters around her mouth and was given Valtrex as treatment (Oral herpes). At the reporting time, the patient was recovering the reported events. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown. Lot # is being requested and will be submitted if received. More
2844597 MD 06/11/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
MMR
MMR
MMR
MMR
MMR
MMR
MMR
MMR
RV5
RV5
RV5
RV5
RV5
RV5
RV5
RV5
DTPPVHBHPB
DTPPVHBHPB
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MSP VACCINE COMPANY
MSP VACCINE COMPANY
 U7970BA
U7970BA
U7970BA
U7970BA
U7970BA
U7970BA
U7970BA
U7970BA
Y010656
Y010656
Y010656
Y010656
Y010656
Y010656
Y010656
Y010656
Y007615
Y007615
Y007615
Y007615
Y007615
Y007615
Y007615
Y007615
2088619
2088619
2088619
2088619
2088619
2088619
2088619
2088619
U7970BA
U7970BA
Product storage error; No adverse event, Product administered to patient of inap... Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error; Product storage error; No adverse event, Product administered to patient of inappropriate age, Product storage error More
HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unkn... HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unknown). Unknown how many patients received products after improperly stored. No Additional information provided. No Additional AE/ No PQC. VAXELIS: U; No adverse event; This spontaneous report was received from an other health care professional and refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported. It was reported that the following vaccines experienced multiple temperature excursions: Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot# Y010656, expiration date: 29-Nov-2026) 0.5 mL; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y007615, expiration date: 11-Apr-2026) 0.5 mL; sterile diluent (MERCK STERILE DILUENT), (lot #1973278, expiration date: 06-May-2026) 0.5 mL; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), (lot #U7970BA, expiration date: 30-Nov-2026) 0.5 mL; Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2088619, expiration date: 09-Mar-2026) 2 mL. The temperature excursions occurred as follows: on 16-DEC-2024, the lowest temperature of 34 F for 23 Hours and the highest of 41 F for 23 Hours; on 20-DEC-2024, the lowest temperature of 35 F for 16 Hours and the highest of 36 F for 16 Hours; on 23-DEC-2024, the lowest temperature of 34 F for 4 Hours and the highest of 37 F also for 4 Hours; on 30-DEC-2024, the lowest temperature of 37 F for 1 Hour and the highest of 64 F for 1 Hour. The vaccines were administered on 16, 20, 23, and 30-DEC-2024. It was unknown how many patients received products after being improperly stored (Product storage error). No additional information was provided. There was no additional AE (No adverse event). This is an invalid report due to multiple patients involved and lack of patients' identifiers. Follow-up information was received on 09-JUN-2025. The patient was currently 59 years old (product administered to patient of inappropriate age). Details regarding the vaccinations were not provided. It was reported that there were no adverse reactions to any of the administered vaccines. The case was no longer considered to be invalid.; Reporter's Comments: Keywords : ; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-06-09 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2292822 , Central date : 2025-06-09 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : US-009507513-2292822 More
2844598 1.33 IL 06/11/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE; 16 month old was administered PROQUAD inadvertently with VARIVAX; This spontaneous... No additional AE; 16 month old was administered PROQUAD inadvertently with VARIVAX; This spontaneous report was received from a nurse and refers to a 16-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Jun-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 mL and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, 0.5 mL (dose number, route of administration, anatomical location, lot # and expiration date were not reported for both), for prophylaxis (Accidental overdose). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection, 0.5 ml (lot# and expiry date were not reported). The reporter stated that was the only information she received in the email and did not have any additional information to provide. No additional adverse event was reported. Additional information is not expected. More
2844599 NY 06/11/2025 HEPA
 MERCK & CO. INC.
 X026485
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; Caller reported AE on behalf of a patient who was inadvertently administered an ex... No additional AE; Caller reported AE on behalf of a patient who was inadvertently administered an expired dose of adult VAQTA on 06/10/2025 (w/ no TEs)-- SUPPORTED via post-expiry memo. No symptoms reported. No additional AE details reported. Obtained consent to conta; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-JUN-2025, the patient was inadvertently vaccinated with expired Hepatitis A Vaccine, Inactivated Suspension for injection (VAQTA) (adult), 1 ml (1ml/dose), lot #X026485, expiration date: 11-MAY-2025, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (Expired product administered). No additional adverse events. The outcome of the events was not known. The action taken with the suspect vaccine was not reported, but established as not applicable. More
2844600 WA 06/11/2025 HPV9
 MERCK & CO. INC.
 Z002903
Syringe issue, Underdose Syringe issue, Underdose
second dose of GADASIL 9 received was "insufficient" due to "a lot of leakage during ... second dose of GADASIL 9 received was "insufficient" due to "a lot of leakage during vaccination".; second dose of GADASIL 9 received was "insufficient" due to "a lot of leakage during vaccination".; second dose of GADASIL 9 received was "insufficient" due to "a lot of leakage during vaccination".; This spontaneous report was received from a Nurse and refers to a patient of not reported age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-JUN-2025, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z002903, expiration date reported as 03-DEC-2026 but upon internal validation was stated as 15-DEC-2026) (strength, dose description, route of administration not reported) for prophylaxis. It was reported that during vaccination the patient dose received was "insufficient" due to "a lot of leakage during vaccination. Nurse stated that the second dose was administered by a separate HCP and it was not reported that any leakage occurred at the time of vaccination and was unable to confirm if leakage occurred or if patient received less than recommended dose (vaccine underdose, device leakage, poor quality device used). More
2844601 F SC 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate schedule of vaccine administered; This non-serious case was reported by a pharmacist v... Inappropriate schedule of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2018). 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: Inappropriate schedule of vaccine administered). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-JUN-2025 This report was submitted via the online direct entry reporting system. The reporter was a pharmacist. The pharmacist reported a that according to the a patient received a dose of the Zoster Vaccine in 2018. The patient did not recall ever having the vaccine and did not think she ever had Shingrix and had not yet had the second dose. The pharmacist stated that the vaccine administered according to the online records reads Zoster. The pharmacist believed the patient received Shingrix in 2018, but the online record indicated Zoster vaccine. Shingrix or Zostavax could not be confirmed by the reporter at the time of the call. More
2844602 60 M NY 06/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Bone pain, Dizziness, Heart rate increased, Hypertension, Pain; Pain in extremit... Bone pain, Dizziness, Heart rate increased, Hypertension, Pain; Pain in extremity, Pollakiuria, Procedural pain, Sleep disorder More
injected arm hurts; high blood pressure (bottom number); pulse high; Dizziness; body hurts / bones h... injected arm hurts; high blood pressure (bottom number); pulse high; Dizziness; body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area; body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area; body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area; making it hard to sleep; he keeps getting up every 30 to 40 minutes to pee; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included hernia repair (Hernia surgery about 3 years ago). Previously administered products included Shingrix with an associated reaction of no adverse event (no problems with other vaccines, no side effects from Shingrix shot 1). Concomitant products included tamsulosin hydrochloride (Tamsulosin), enalapril maleate (Enalapril), pantoprazole sodium sesquihydrate (Pantoprazole) and Centrum. On 02-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular use, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: injected arm hurts), diastolic blood pressure increased (Verbatim: high blood pressure (bottom number)), pulse increased (Verbatim: pulse high), dizziness (Verbatim: Dizziness), hernia pain (Verbatim: body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area), general body pain (Verbatim: body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area), bone pain (Verbatim: body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area), sleeplessness (Verbatim: making it hard to sleep) and nocturnal urinary frequency (Verbatim: he keeps getting up every 30 to 40 minutes to pee). The outcome of the pain in arm, diastolic blood pressure increased, hernia pain, general body pain, bone pain, sleeplessness and nocturnal urinary frequency were not resolved and the outcome of the pulse increased was resolved and the outcome of the dizziness was resolving. It was unknown if the reporter considered the pain in arm, diastolic blood pressure increased, pulse increased, dizziness, hernia pain, general body pain, bone pain, sleeplessness and nocturnal urinary frequency to be related to Shingrix. It was unknown if the company considered the pain in arm, diastolic blood pressure increased, pulse increased, dizziness, hernia pain, general body pain, bone pain, sleeplessness and nocturnal urinary frequency to be related to Shingrix. Additional Information: GSK receipt date: 03-JUN-2025 The reporter is the patient. Yesterday, patient made my second vaccine, and patient did not know I feel like my blood pressure 118/(unintelligible), pulse 110, and feel like dizzy and my body hurt. The voicemail did NOT include the name of the GSK vaccine. Outbound call made by GRC (GSK Response Center) on June 4th, 2025. Vaccine was confirmed as being Shingrix. Patient received Shingrix, on Monday June 2nd, 2025, dose 2, intramuscularly in the left upper arm deltoid. Patient states that the injected arm still hurts. High blood pressure: The patient reports that the bottom number (diastolic) of his blood pressure is higher than normal. Examples of recent readings: 118/93 and 120/94. Normally the bottom number is about 72. [Normally the top number is about 120]. Event not resolved "bottom number is still high." Pulse is high: the patient's pulse was 110 but normally his pulse is 75. (Event resolved) Dizziness. The patient is still a little dizzy but not as dizzy as yesterday. Body hurts: He states that his body is hurting, and he feels like his bones hurt and this is making it hard for him to sleep last night as also he keeps getting up every 30 to 40 minutes to pee. Also, he has noted that he has been experiencing pain in the hernia area. He does not know if this pain is connected to the Shingrix shot or not. More
2844603 70 F UT 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Urticaria Erythema, Urticaria
2 quarter sized, red, welts on the left side of lower neck where it meets shoulder/ felt the second ... 2 quarter sized, red, welts on the left side of lower neck where it meets shoulder/ felt the second one; This non-serious case was reported by a consumer via call center representative and described the occurrence of welts in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 02-JUN-2025, the patient received the 2nd dose of Shingrix (left arm). On 03-JUN-2025, 1 days after receiving Shingrix, the patient experienced welts (Verbatim: 2 quarter sized, red, welts on the left side of lower neck where it meets shoulder/ felt the second one). The outcome of the welts was not resolved. It was unknown if the reporter considered the welts to be related to Shingrix. It was unknown if the company considered the welts to be related to Shingrix. Additional Information: GSK Receipt Date: 04-JUN-2025 A female patient reported she received second dose of Shingrix vaccine in the left arm and 24 hours later she noticed the first welt and this morning (48 hours after vaccine) felt the second one. The reporter is experiencing 2 quarter sized, red, welts on the left side of lower neck where it meets shoulder. She consulted with her pharmacist as her HCP is on vacation. The medical advice disclaimer was provided and spoke per PI, offered PI and Shingrix website and the reporter was referred to Health Care Professional. More
2844604 69 F MD 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash, Rash pruritic, Skin discolouration Rash, Rash pruritic, Skin discolouration
reddish-gray areas of skin discoloration remain; rash started on her torso; she developed a dry, itc... reddish-gray areas of skin discoloration remain; rash started on her torso; she developed a dry, itchy rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Shingles), stroke (Has had two strokes. The first one was about two years ago and the second in Mar 2025.), heart attack (Heart attack about two years ago) and rash (frequent rashes). Concurrent medical conditions included drug allergy (Allergic to neomycin and other unspecified antibiotics). On 15-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 22-APR-2025, 7 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: she developed a dry, itchy rash). On an unknown date, the patient experienced skin discolouration (Verbatim: reddish-gray areas of skin discoloration remain) and rash (Verbatim: rash started on her torso). The patient was treated with prednisone acetate (Prednisone) and clobetasol propionate (Clobetasol). The outcome of the itchy rash and rash were resolving and the outcome of the skin discolouration was not resolved. It was unknown if the reporter considered the itchy rash, skin discolouration and rash to be related to Shingrix. It was unknown if the company considered the itchy rash, skin discolouration and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 04-JUN-2025 The case was self reported by patient, she was also a retired health care professional(nurse). On 15 Apr 2025 she received her first Shingrix dose and on 22 Apr 2025 she developed a dry, itchy rash. The rash started on her torso. Over the next two weeks, the rash spread to both arms (not near the injection site), and her back. She saw an health care professional for the rash and was given oral prednisone for ten days. About two weeks after seeing an health care professional, she saw her dermatologist and was treated with clobetasol cream 0.025 percent twice daily. A biopsy of the rash showed hypersensitivity to an arthropod or a medication. The rash was resolving, but reddish gray areas of skin discoloration remain where the rash has healed. She was on numerous medications but declined to provide the list during this call. Nothing else was reported. More
2844605 F PA 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Oral herpes Oral herpes
she began breaking out with cold sores on her mouth/lips; This non-serious case was reported by a co... she began breaking out with cold sores on her mouth/lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included arthritis and hypertension. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 months after receiving Shingrix, the patient experienced cold sores (Verbatim: she began breaking out with cold sores on her mouth/lips). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the cold sores was not resolved. It was unknown if the reporter considered the cold sores to be related to Shingrix. It was unknown if the company considered the cold sores to be related to Shingrix. Additional Information: GSK Receipt Date: 04-JUN-2025 The reporter reported that a patient received both doses of Shingrix vaccine and approximately 3 months later she began breaking out with cold sores on her mouth/lips. The consumer states she has had approximately 2 or 3 outbreaks per year for the last few years. Consumer states she is being treated for the outbreaks and was prescribed Valtrex to be taken at onset of cold sore. No further information was obtained/provided. More
2844606 F SC 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Blood pressure abnormal Blood pressure abnormal
Patient stated having blood pressure.; This non-serious case was reported by a other health professi... Patient stated having blood pressure.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of blood pressure abnormal in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blood pressure abnormal (Verbatim: Patient stated having blood pressure.). The outcome of the blood pressure abnormal was not reported. It was unknown if the reporter considered the blood pressure abnormal to be related to Shingrix. It was unknown if the company considered the blood pressure abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 03-JUN-2025 The healthcare professional (HCP) stated that he/she knew that patient (over 50 years) had blood pressure, but the reporter was unaware what she was circling for (referring to Pharmacy Patients questionnaire). The patient did not have the data about high or low blood pressure. The reporter reported that the patient marked Yes on Pharmacy's questionnaire field long term diseases without specifications. Patient stated having blood pressure. More
2844607 F 06/11/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
My daughter six months ago vaccinated with bexsero (first dose)/She is 5 years old.; This non-seriou... My daughter six months ago vaccinated with bexsero (first dose)/She is 5 years old.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: My daughter six months ago vaccinated with bexsero (first dose)/She is 5 years old.). 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: 04-JUN-2025 This case was reported by interactive digital media The reporter reported that daughter six months ago vaccinated with his/her Bexsero (first dose) and now they were going for the second dose. The reporter reported did she need a third dose. 5 year old patient received Bexsero which led to, Inappropriate age at vaccine administration. More
2844608 06/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain Herpes zoster, Pain
diagnosed with shingles/shockingly painful; This non-serious case was reported by a consumer via int... diagnosed with shingles/shockingly painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: diagnosed with shingles/shockingly painful). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-JUN-2025 Reporter stated that in extremely rare cases, if a person has lowered immunity and gets the vaccine, they can get shingles. Patient got the vaccine a week and a half ago and was diagnosed with shingles three days later and it was shockingly painful. More
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