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
2839194 43 F OH 05/01/2025 HEP
HEP
HEP
TDAP
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR





Back pain, Cough, Fatigue, Guillain-Barre syndrome, Hypoaesthesia; Immunoglobuli... Back pain, Cough, Fatigue, Guillain-Barre syndrome, Hypoaesthesia; Immunoglobulin therapy, Influenza, Neck pain, Pain, Paraesthesia; Pyrexia; Back pain, Cough, Fatigue, Guillain-Barre syndrome, Hypoaesthesia; Immunoglobulin therapy, Influenza, Neck pain, Pain, Paraesthesia; Pyrexia More
Patient received a dose of TDaP and hepatitis B (vaccine specifics not available at this time) appro... Patient received a dose of TDaP and hepatitis B (vaccine specifics not available at this time) approximately 3 weeks prior to symptom onset. About 2 weeks prior to symptom onset patient was ill with influenza A for approximately 3 days. Her symptoms included fevers, cough, body aches and fatigue. She recovered from influenza. Her GBS symptoms started 4/15/25 with neck and back pain. She then developed hand and feet numbness, tingling and pain. She was hospitalized from 4/17-4/19 and diagnosed with Guillain-Barre Syndrome, treated with IVIG and as of 4/28 is making a slow recovery. More
โœ“ โœ“ โœ“
2839195 65 F TN 05/01/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Injection site reaction, Skin reaction Injection site reaction, Skin reaction
skin reaction near injection site and on back of neck under hairline skin reaction near injection site and on back of neck under hairline
2839196 17 F TX 05/01/2025 MNQ
 SANOFI PASTEUR
Loss of consciousness Loss of consciousness
As per patient, she had a covid vaccine previously and she passed out. Per patient, she had other va... As per patient, she had a covid vaccine previously and she passed out. Per patient, she had other vaccines after and did not experience any adverse effects or side effects. Patient was consulted before immunization. Patient was accompanied by her mother. Patient received meningitis vaccine and passed out after 10 seconds approx. Patient took about a 30 minutes rest at pharmacy and a sugar drink was given to her. She felt better after and left the pharmacy with her mother. More
2839197 74 F TX 05/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 F95YS
Injection site erythema, Injection site pain, Injection site rash Injection site erythema, Injection site pain, Injection site rash
Patient says that her arm experienced, redness, rash, and tenderness at injection site, roughly two ... Patient says that her arm experienced, redness, rash, and tenderness at injection site, roughly two inches in diameter More
2839198 58 F CA 05/01/2025 PNC21
 MERCK & CO. INC.
 Z002626
Erythema, Peripheral swelling Erythema, Peripheral swelling
PATIENT COMPLAINED AFTER 3 DAYS, HER ARM SWELLED UP AND VERY RED PATIENT COMPLAINED AFTER 3 DAYS, HER ARM SWELLED UP AND VERY RED
2839199 11 F HI 05/01/2025 FLU3
HPV9
MNQ
TDAP
 SEQIRUS, INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 AW1611A
Y014059
AMAB056A
3BH5K
Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope
Patient had a vasovagal syncope episode after receiving HPV9 #1, Afluria (flu), Menveo #1, and Boost... Patient had a vasovagal syncope episode after receiving HPV9 #1, Afluria (flu), Menveo #1, and Boostrix #1 vaccinations. Patient sat on the exam table for a minute after administration then stepped down from the table and took 4-5 steps towards the door to exit the room. Patient stopped at the door and appeared to be dizzy. Patient was helped to the ground without any injury. Patient's legs were elevated, and a cool, wet towel was applied to forehead. Patient was also offered sugar (lollipop). Patient's blood pressure was taken twice on left arm (1030: BP 110/73, P 91; 1040: BP 107/72, P 80). Patient was asked how was feeling and stated felt better. Patient was also able to answer questions appropriately (correct name as well as mother's name). Patient sat upright then was helped up and helped to a chair. Patient and mother waited while nursing staff reported the incident to the provider patient seen earlier this morning. Provider instructed that patient be monitored for another 20 minutes and if doing well could then leave the clinic. After 20 minutes, patient verbalized doing well. Nursing staff instructed mother that if patient has another lightheaded spell while walking to the car to have patient sit down, then have anyone near by notify our clinic or anyone with a badge to get help. Mother verbalized understanding. More
2839200 66 M HI 05/01/2025 COVID19
 NOVAVAX
Chest pain Chest pain
Chest pain. Advised to go to ER. Cause undetermined Chest pain. Advised to go to ER. Cause undetermined
2839201 0.75 F KY 05/01/2025 DTAPIPVHIB
PNC15
 SANOFI PASTEUR
MERCK & CO. INC.
 UK196AA
Y010032
Death, Decreased appetite, Infant irritability, Pyrexia, Unresponsive to stimuli... Death, Decreased appetite, Infant irritability, Pyrexia, Unresponsive to stimuli; Death, Decreased appetite, Infant irritability, Pyrexia, Unresponsive to stimuli More
Mother of child reports child had fever and fussiness on the evening of 4/9/25. Fever resolved 4/10/... Mother of child reports child had fever and fussiness on the evening of 4/9/25. Fever resolved 4/10/25. However, her fussiness persisted, and child's appetite was poor. Given child's fussiness the evening of 4/10/25, her mother reported to me, child slept in her parent's bed. Her parents awakened to find her non-responsive on the morning of 4/11/25 and they activated EMS. Child was transported to Hospital (redacted). She did not survive and was pronounced dead in the hospital. More
โœ“ โœ“
2839202 27 M TX 05/01/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Biopsy kidney abnormal, IgA nephropathy, Protein urine present, Urine analysis a... Biopsy kidney abnormal, IgA nephropathy, Protein urine present, Urine analysis abnormal; Biopsy kidney abnormal, IgA nephropathy, Protein urine present, Urine analysis abnormal More
Contracted IGA Nephrapothy discovered through protein in urine and confirmed through kidney biopsy i... Contracted IGA Nephrapothy discovered through protein in urine and confirmed through kidney biopsy in August 2023 More
2839203 45 F OH 05/01/2025 PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH





Arthralgia, Blood creatine phosphokinase normal, Blood culture, Blood lactic aci... Arthralgia, Blood creatine phosphokinase normal, Blood culture, Blood lactic acid, Blood magnesium normal; Brain natriuretic peptide normal, C-reactive protein increased, Chest pain, Dyspnoea, Electrocardiogram ST segment elevation; Electrocardiogram ST-T segment elevation, Electrocardiogram T wave abnormal, Hyperhidrosis, Inflammatory marker increased, Injection site erythema; Injection site pain, International normalised ratio normal, Lacrimation increased, Metabolic function test normal, Myalgia; Myocardial necrosis marker increased, Nausea, Procalcitonin increased, Prothrombin time normal, Red blood cell sedimentation rate increased; Sinus tachycardia, Troponin increased, Vomiting, White blood cell count increased More
Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received... Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received 4/28/25. States that since then she has been having nausea, vomiting, chest pain on and off. States that chest pain occasionally radiates to her left arm. She also endorses entire body muscle and joint aches, new onset diaphoresis and lacrimation. States the last time she had chest pain was last night. States the last time she vomited was this morning. Also states she had some shortness of breath. EKG was obtained which showed ST elevation in V1 and V2 and T wave elevation in V4. When compared to EKG from 4/16/2025 there was T wave inversion on V4. Given different EKG findings on today's EKG when compared to 2 weeks ago with ST elevation and T wave elevation recommended patient go immediately to emergency room for further cardiac workup. There was some tenderness and mild erythema on the left deltoid and injection site. In the ER, EKG showed normal sinus tachycardia. There was concern for myositis vs myocarditis given abnormal EKG and heart enzymes with elevated inflammatory markers. There was also concern for potential lupus flare as a result of the vaccine or at least coinciding with the timing of the vaccine. More
โœ“
2839204 74 M MA 05/01/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Headache, Hypertension Headache, Hypertension
Hight Blood Pressure, Head Ache Hight Blood Pressure, Head Ache
2839206 4 F FL 05/01/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Y017516
Injection site swelling; Injection site swelling Injection site swelling; Injection site swelling
Swelling to left upper thigh (administration site) vertical - 10.5 cm width -8.5 cm. Swelling to left upper thigh (administration site) vertical - 10.5 cm width -8.5 cm.
2839207 6 M VA 05/01/2025 MMRV
 MERCK & CO. INC.
 Y010306
Pain in extremity Pain in extremity
Pt will moderate / severe leg pain > 30 days post vaccine. Pt will moderate / severe leg pain > 30 days post vaccine.
โœ“
2839211 59 M DE 05/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 94ZE4
Herpes zoster, Pain, Rash Herpes zoster, Pain, Rash
Rash (4/17/25), pain. Went to Dr (4/29/25) they diagnosed as shingles. Rash (4/17/25), pain. Went to Dr (4/29/25) they diagnosed as shingles.
2839212 1.5 F OK 05/01/2025 DTAPIPV
HEPA
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 3RT93
J4K4X
Y004114
Injection site pain, Pyrexia, Wrong product administered; Injection site pain, P... Injection site pain, Pyrexia, Wrong product administered; Injection site pain, Pyrexia, Wrong product administered; Injection site pain, Pyrexia, Wrong product administered More
Patient was given the DTAP-IPV combo instead of DTAP and IPV given separately. Mom states patient ha... Patient was given the DTAP-IPV combo instead of DTAP and IPV given separately. Mom states patient has had no issues other than sore legs and low grade fever. Mom contacted 5/1/2025. More
2838874 18 F GA 04/30/2025 HPV9
 MERCK & CO. INC.
 1957404
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; HCP calling to report TE's for GARDASIL 9 advised the vaccine was administere... No adverse event; HCP calling to report TE's for GARDASIL 9 advised the vaccine was administered to a patient on 03/11/2025. The GARDASIL 9 experienced two separate TE's before being administered.; This spontaneous report was received from a Consumer or other non health professional and refers to an 18-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #1957404, which was confirmed to be valid, expiration date: 05-Oct-2025 (dose, units, and route of administration were not reported) for prophylaxis. It was reported that the vaccine experienced two separate temperature excursions (TE's) before being administered (Product storage error). Temperature on 29-JAN-2025 was 35.8 F, and on 30-JAN-2025, it was 35.6 F for the time frame of 15 minutes and 10 minutes. No additional details were provided. There was no additional AE/PQC reported (No adverse event). More
2838875 NM 04/30/2025 MMRV
 MERCK & CO. INC.
 Y019464
No adverse event, Underdose No adverse event, Underdose
No additional AE.; HCP calling to report that 1 year old patient received less than the desired dose... No additional AE.; HCP calling to report that 1 year old patient received less than the desired dose of PROQUAD on 4/7/2025. Caller states patient received approximately about 0.1 ml due to human error. No adverse effects reported. No other information provided. Confir; This spontaneous report was received from an other health professional and refers to a(n) 1-year-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 07-APR-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection, lot #Y019464, expiration date: 24-MAY-2026 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). The patient received less than the desired dose of PROQUAD. Caller states patient received approximately about 0.1 ml due to human error (accidental underdose). No adverse effects reported (no adverse event). More
2838876 NV 04/30/2025 HEPA
 MERCK & CO. INC.
 X024966
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AEs/PQC reported; Caller reported VAQTA administered after expiration date.; This spon... No additional AEs/PQC reported; Caller reported VAQTA administered after expiration date.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-MAR-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated Injection (lot #X024966 which was determined to be a valid lot number, expiration date: 23-Mar-2025) 1 mL (Dose: 1 mL), administered by Intramuscular route as prophylaxis (expired product administered). No additional adverse event provided. More
2838877 F IA 04/30/2025 PNC21
PNC21
UNK
UNK
 MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
Y019158
Malaise; Malaise; Malaise; Malaise Malaise; Malaise; Malaise; Malaise
Patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencin... Patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise.; Patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise.; Pharmacist reported patient received a second dose of CAPVAXIVE on Apr 15, 2025. Pharmacist explained that patient received first dose of CAPVAXIVE in Colorado, so his electronic medical system did not notify him because it only picks up medications; Information has been received from Business Partner/CRO on 16-Apr-2025. This spontaneous report was received from an Consumer or other non 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 15-Apr-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Y019158, expiration date: 20-May-2026), dose number 2,. On Feb-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine, dose number 1, (lot # and expiration date were not reported). On 15-Apr-2025, the patient was vaccinated with two doses of non-product or non-Merck product (indication, expiration date, and lot # were not reported) (Extra dose administered). On unknown date, the patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise. At the reporting time, the outcome of all of the events was unknown. The action taken with all of the vaccines was reported as not applicable. The causal relationship between all of the events and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between all of the events and non-product or non-Merck product was unknown/not reported/not provided. More
2838878 F NV 04/30/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HEPA
HEPA
HEPA
HIBV
HIBV
HIBV
MMR
MMR
MMR
PNC15
PNC15
PNC15
VARCEL
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
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.
 9P329
9P329
9P329
C24B9
C24B9
C24B9
UK042AA
UK042AA
UK042AA
X026330
X026330
X026330
HR3649
HR3649
HR3649
Y013348
Y013348
Y013348
Cough, Influenza A virus test negative, Influenza B virus test negative, Measles... Cough, Influenza A virus test negative, Influenza B virus test negative, Measles antibody negative, Pyrexia; Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, SARS-CoV-2 test negative; Upper-airway cough syndrome, Urticaria, Vomiting; Cough, Influenza A virus test negative, Influenza B virus test negative, Measles antibody negative, Pyrexia; Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, SARS-CoV-2 test negative; Upper-airway cough syndrome, Urticaria, Vomiting; Cough, Influenza A virus test negative, Influenza B virus test negative, Measles antibody negative, Pyrexia; Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, SARS-CoV-2 test negative; Upper-airway cough syndrome, Urticaria, Vomiting; Cough, Influenza A virus test negative, Influenza B virus test negative, Measles antibody negative, Pyrexia; Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, SARS-CoV-2 test negative; Upper-airway cough syndrome, Urticaria, Vomiting; Cough, Influenza A virus test negative, Influenza B virus test negative, Measles antibody negative, Pyrexia; Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, SARS-CoV-2 test negative; Upper-airway cough syndrome, Urticaria, Vomiting; Cough, Influenza A virus test negative, Influenza B virus test negative, Measles antibody negative, Pyrexia; Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract congestion, SARS-CoV-2 test negative; Upper-airway cough syndrome, Urticaria, Vomiting More
Measles PCR positive; presented with rash on 2/13/2025 described as hives subjectively; RESPIRATORY ... Measles PCR positive; presented with rash on 2/13/2025 described as hives subjectively; RESPIRATORY SYMPTOM; Flu A was negative; Flu B was negative; SARS-COV-2 TEST NEGATIVE; Diagnosed with RSV same day; RSV Rapid multiplex postivie; COUGH; VOMITING; UPPER-AIRWAY COUGH SYNDROME; congestion; PYREXIA; This spontaneous report was received from the Food and Drug Administration (FDA) regulatory authority (2828620-1) regarding a 1-year-old female patient. The patient had no documented medical history and no known allergies. The patient๏ฟฝs concomitant therapies were unknown and concurrent conditions were not reported. On 23-JAN-2025, the patient was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered by Intramuscular route in the right leg (RL) (lot number reported as HR3649 was invalid for Pneumococcal 15-valent Conjugate Vaccine [VAXNEUVANCE], expiration date was not reported); with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered by Subcutaneous route in the left leg (LL) (lot number X026330 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date not provided but upon internal validation established as 07-NOV-2025), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number was not provided); with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), administered by Subcutaneous route in the RL (lot number Y013348 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date not provided but upon internal validation established as 02-AUG-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number was not provided); all of them were administered as prophylaxis. On that same date, she was also vaccinated with the fist dose of HIB vaccine conj (tet tox) (ACTHIB) administered by Intramuscular route in the RL (lot number reported as UK042AA, expiration date and indication were not reported); with the first dose of Hepatitis a vaccine inact (HAVRIX) administered by Intramuscular route in the LL (lot number reported as C24B9, indication and expiration date were not reported); and with Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX), administered by Intramuscular route in the LL (lot number reported as 9P329, indication and expiration date were not reported) (dose, formulation and vaccination scheme frequency were not reported for any of mentioned vaccines). On 07-FEB-2025, the patient experienced congestion (Respiratory tract congestion), cough, vomiting, respiratory symptom, upper-airway cough syndrome, pyrexia, Respiratory syncytial virus (RSV) multiplex was positive (respiratory syncytial virus test positive) and was diagnosed with RSV virus infection (respiratory syncytial virus infection). That day, COVID test was negative (SARS-COV-2 test negative), flu A was negative (influenza A virus test negative) and flu B was negative (influenza B virus test negative). Symptoms resolved on an unspecified date. On 13-FEB-2025, the patient experienced rash described as hives subjectively (urticaria) per urgent case visit on 14-FEB-2025. She was treated with amoxicillin. On 15-FEB-2025, measles PCR test was positive (Morbillivirus test positive). On an unknown day, the patient recovered from all the events. The reporter considered the event of Morbillivirus test positive to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (reported as attributed to vaccine-strain) and sterile diluent (BAXTER STERILE DILUENT), while the causal relationship with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX), HIB vaccine conj (tet tox) (ACTHIB), Hepatitis a vaccine inact (HAVRIX) and sterile diluente (BAXTER STERILE DILUENT) was not reported. The causal relationship between the suspect vaccines and sterile diluent regarding the events of Respiratory tract congestion, cough, vomiting, respiratory symptom, upper-airway cough syndrome, pyrexia, respiratory syncytial virus test positive, respiratory syncytial virus infection, SARS-COV-2 test negative, influenza A virus test negative, influenza B virus test negative and urticaria was not provided. More
2838879 F 04/30/2025 VARZOS
VARZOS
 MERCK & CO. INC.
MERCK & CO. INC.

Computerised tomogram head, Headache, Ophthalmic herpes zoster, Pain, Rash; Scar Computerised tomogram head, Headache, Ophthalmic herpes zoster, Pain, Rash; Scar
shingles with ocular involvement; diagnosed with shingles; This spontaneous report was received from... shingles with ocular involvement; diagnosed with shingles; This spontaneous report was received from a consumer and refers to herself, a female patient of unknown age. The patient's medical history , concurrent conditions and concomitant therapies were not reported. On 2015 (reported as approximately 10 years ago), the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) for prophylaxis (strength, dose number, vaccination schedule, expiration date, and lot # were not reported). On early March of 2025 (also reported as approximately 10 years later), the patient developed shingles with ocular involvement (ophthalmic herpes zoster). Her symptoms began with unilateral, L-sided headache, for which her PCP obtained a head CT (results not provided). Her pain significantly worsened to the point where she presented to the emergency room and was diagnosed with shingles (Herpes zoster). Patient had a small rash on her left forehead, and involvement of her L eye (but not the retina, conflicting information) and was started on steroids, antivirals and pain medication (gabapentin). On an unspecified date in 2025, she was followed closely by XXX Hospital and her symptoms have now resolved aside from occasional mild headache (conflicting information). She denied any vision loss or chronic pain. Rash has resolved with slight scarring (recovered). The causal relationship between the events and suspect vaccine were unknown/not reported/not provided. As per internal review, the event ophthalmic herpes zoster was determined to be medically significant. More
2838880 F 04/30/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 M040412
N001533
N021732
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More
first dose on 5/10/17, second dose on 6/21/17 and third dose on 9/24/18; This spontaneous report has... first dose on 5/10/17, second dose on 6/21/17 and third dose on 9/24/18; This spontaneous report has been received from a consumer, regarding herself, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications were not reported. On 10-May-2017, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #M040412, expiration date: 30-Jun-2019), dose number 1, on 21-Jun-2017, the dose number 2, and on 24-Sep-2018, dose number 3 (inappropriate schedule of product administration); all at a dose of 0.5 mL for prophylaxis. More
2838881 IN 04/30/2025 HEPA
 MERCK & CO. INC.
 X025908
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE details reported.; was inadvertently administered expired VAQTA on 04/25/2025; This... No additional AE details reported.; was inadvertently administered expired VAQTA on 04/25/2025; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-APR-2025, the patient was inadvertently administered dose of expired hepatitis A vaccine, inactivated (VAQTA) (0.5 ml/dose; lot # X025908, expiration date: 24-APR-2025; strength, formulation, dose #, route and anatomical site were unknown) for prophylaxis (expired product administered). No additional adverse event details reported (no adverse event). The outcome of the event was unknown. More
2838882 4 M HI 04/30/2025 MMR
UNK
UNK
UNK
VARCEL
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
 Y000225
3CA20C1
NIC74IM
U8442BA
Y011019
Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
No other information provided. No additional AEs/PQC reported.; vaccines administered after temperat... No other information provided. No additional AEs/PQC reported.; vaccines administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a(n) 4-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On 17-APR-2025, the patient was vaccinated with vaccines that suffered temperature excursion with a temperature - 9.8 C, for a time frame of 2 hours 3 minutes, with digital data logger: dose number 2Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection (lot #Y000225, expiration date: 03-JAN-2026), administered by Subcutaneous route in Left Thigh; dose # 2 of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection (lot #Y011019, expiration date: 18-JUN-2026), administered by subcutaneous route in Left Thigh, both as prophylaxis (exact doses not reported), reconstituted with sterile diluent. Also received on the same date, Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (Dtap) (lot #3CA20C1, expiration date: 28-FEB-2026) (Previous doses: 4, administered right thigh), administered by Intramuscular route; Ipv (Polio vaccine inact) (lot #NIC74IM, expiration date: 17-NOV-2025) (Number of previous doses: 3, administered right thigh), administered by Intramuscular route; and Influenza vaccine (Influenza vaccine) (lot #U8442BA, expiration date: 30-JUN-2025) (Number of previous doses: 4, administered Right thigh), administered by Intramuscular route (doses, indications were not reported). No previous temperature excursions were reported. No other information provided. No additional adverse events (AEs)/product quality complaints (PQC) reported. More
2838883 IL 04/30/2025 MMR
MMR
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Ill-defined disorder; Ill-defined disorder; Ill-defined disorder; Ill-defined di... Ill-defined disorder; Ill-defined disorder; Ill-defined disorder; Ill-defined disorder More
Inbound call from HCP requesting MIR. HCP did mention that her patient received the second dose of M... Inbound call from HCP requesting MIR. HCP did mention that her patient received the second dose of MMR-II today and patient has a bilateral simple mastectomy and bilateral axillary lymph node biopsy scheduled for 20MAY2025.; This spontaneous report has been received from a consumer regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On 28-APR-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). Both doses were reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported). On an unknown date, the patient experienced ill-defined disorder. The reporter mentioned that her patient had a bilateral simple mastectomy and bilateral axillary lymph node biopsy scheduled for 20-MAY-2025. The outcome of the event was unknown. The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported. More
2838884 F HI 04/30/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y017511
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AEs; Caller reported vaccines administered after temperature excursions; This spontane... No additional AEs; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a physician and refers to a 13-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis A Vaccine, Inactivated (VAQTA), Diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+)Pertussis vaccine acellular 5-component (+)Polio vaccine inact 3v (MRC 5) (+) Tetanus vaccine toxoid (PENTACEL), Hepatitis b vaccine and Pneumococcal vaccine conj 20v (CRM197) (PREVENAR 20) . On 31-Mar-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA [recombinant Human albumin]) administered subcutaneous on the right thigh as prophylaxis (Lot No. Y017511 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and but upon internal validation established as 15-Apr-2026; that was reconstituted with sterile diluent, administered subcutaneous (indication, Lot No., and expiration date was not provided) (product storage error). No additional adverse event was reported (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-04-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2838885 M 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Bell's palsy Bell's palsy
Bell's palsy; This serious case was reported by a consumer via call center representative and d... Bell's palsy; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In FEB-2025, the patient received the 1st dose of Shingrix. 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. It was unknown if 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: 25-APR-2025 The patient is the reporter. The patient received the first dose of Shingrix about 2.5 months ago in February 2025, and developed Bell's Palsy. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025050413:Different patient More
2838886 F 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Bell's palsy Bell's palsy
Bell's palsy; This serious case was reported by a consumer via call center representative and d... Bell's palsy; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, several weeks 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. It was unknown if 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: 25-APR-2025 The patient was an acquaintance of the reporter. A couple weeks after receiving Shingrix, the patient developed Bell's Palsy. The date of vaccination was not provided and which dose of Shingrix was not provided.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025050407:Different patient More
2838887 56 F NC 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal, Mobility decreased, Myalgia, Pain, Pain in extremity Feeling abnormal, Mobility decreased, Myalgia, Pain, Pain in extremity
Pain in arm; general soreness / between my toes and web of hands hurt and thumbs; miserable; In bed ... Pain in arm; general soreness / between my toes and web of hands hurt and thumbs; miserable; In bed all day; Muscle pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling miserable in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain (received first dose on an unknown date (refer case US2025AMR048591)). Concurrent medical conditions included migraine headache (since child). On 19-APR-2025, the patient received the 2nd dose of Shingrix. On 20-APR-2025, 1 days after receiving Shingrix, the patient experienced feeling miserable (Verbatim: miserable), bedridden (Verbatim: In bed all day) and muscle pain (Verbatim: Muscle pain). On 21-APR-2025, the patient experienced pain in arm (Verbatim: Pain in arm) and general body pain (Verbatim: general soreness / between my toes and web of hands hurt and thumbs). The outcome of the feeling miserable, bedridden and muscle pain were resolving and the outcome of the pain in arm and general body pain were not resolved. The reporter considered the feeling miserable and bedridden to be related to Shingrix. It was unknown if the reporter considered the muscle pain, pain in arm and general body pain to be related to Shingrix. The company considered the feeling miserable and bedridden to be related to Shingrix. It was unknown if the company considered the muscle pain, pain in arm and general body pain to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR048591 Additional Information: GSK Receipt Date: 21-APR-2025 The reporter received a text message this morning from a friend (patient) who had received the Shingrix vaccine. The patient mentioned that she was miserable and in bed all day suffering from the effects of vaccination. The patient also mentioned that she got vaccine on Saturday and on Sunday morning she did not had a single muscle that did not hurt. The patient stated it was the worst reaction to any vaccine she ever had. She slept all day in between moaning in pain and only thing she did was feed cats and that was Herculean effort. The patient was hurt on the first one too but yesterday was just awful and still sore but can handle today so far. She meant in between the toes and web of hands hurt and thumbs and you name it, there was nothing which did not hurt. The patient stated that today her arm does which is to be expected and general soreness like survived a battle. She has had migraine headaches since she was a child.; Sender's Comments: US-GSK-US2025AMR048591:Same patient/Diffrent dose More
2838888 76 F NC 04/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Arthralgia, Injected limb mobility decreased, Injection site pain, Injection sit... Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site warmth, Loss of personal independence in daily activities; Pain More
Joint pain/Elbow pain; pain in her entire upper right arm, radiating all the way from the top of her... Joint pain/Elbow pain; pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.; had soreness at injection site/Injection site pain; Injection site warmth; unable to bring her arm up; unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypothyroidism, diabetes, blood cholesterol increased (Cholesterol high), gastroesophageal reflux (gastric reflux), energy decreased, anxiety and depression. Concomitant products included levothyroxine sodium (Euthyrox), tirzepatide (Mounjaro), rosuvastatin, omeprazole, magnesium oxide, clonazepam, duloxetine hydrochloride (Cymbalta), citric acid, inositol, magnesium citrate, musa x paradisiaca, pyridoxine hydrochloride (Kidney Cop) and aspirin. On 15-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 15-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: had soreness at injection site/Injection site pain) and injection site warmth (Verbatim: Injection site warmth). In APR-2025, the patient experienced mobility decreased (Verbatim: unable to bring her arm up) and activities of daily living impaired (Verbatim: unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain). On 20-APR-2025, the patient experienced arthralgia (Verbatim: Joint pain/Elbow pain) and pain in arm (Verbatim: pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.). The outcome of the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired were resolving. It was unknown if the reporter considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix. Additional Information: GSK Receipt Date: 21-APR-2025 The patient self-reported this case for herself. The reporter received her first Shingrix in her right deltoid. She reported that the same day, she had soreness and warmth at the injection site, which still persists but was improving. At beginning 20th April 2025 she noted pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow. She stated that she was unable to bring her arm up far enough to done a pair of earrings or come hair due to the pain. She stated that it may be a little better on the day of reporting. More
2838889 66 F NY 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
administered two doses of SHINGRIX in the consumers right arm; This non-serious case was reported by... administered two doses of SHINGRIX in the consumers right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of overdose in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included breast cancer, lung nodule and lung neoplasm surgery. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 28-DEC-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On 28-DEC-2024, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: administered two doses of SHINGRIX in the consumers right arm). On 28-DEC-2024, the outcome of the overdose was not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 On 28 December 2024 the patient presented to the pharmacy for her first dose of Shingrix. The vaccinating healthcare professional administered two doses of Shingrix in the patient's right arm which led to overdose. The consumer reported that she was diagnosed with breast cancer in 2016 and also reported she had a nodule was removed from her lung in 2012. Other Products were reported as no More
2838890 70 F MS 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 F95YS
Eye swelling Eye swelling
Left eye Swollen; This non-serious case was reported by a pharmacist via call center representative ... Left eye Swollen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of eye swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number F95YS, expiry date 31-MAR-2027) for prophylaxis. On 23-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 23-APR-2025, less than a day after receiving Shingrix, the patient experienced eye swelling (Verbatim: Left eye Swollen). The outcome of the eye swelling was not resolved. It was unknown if the reporter considered the eye swelling to be related to Shingrix. It was unknown if the company considered the eye swelling to be related to Shingrix. Additional Information: GSK receipt date: 23-APR-2025 The pharmacist called on behalf of the patient who had received her first Shingrix vaccine today in her left arm and came back 2 hours later same day with her swollen left eye. More
2838891 F IL 04/30/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect route of product administration Incorrect route of product administration
inadvertently gave Priorix intramuscularly instead of Subcutaneous; This non-serious case was report... inadvertently gave Priorix intramuscularly instead of Subcutaneous; This non-serious case was reported by a consumer via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) for prophylaxis. On 23-APR-2025, the patient received Priorix. On 23-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: inadvertently gave Priorix intramuscularly instead of Subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-APR-2025 Nurse inadvertently gave Priorix intramuscularly instead of subcutaneous, which led to subcutaneous injection formulation administered by other route. More
2838892 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain, Pain in extremity Injection site pain, Pain in extremity
injection site pain; Arm pain; This non-serious case was reported by a other health professional via... injection site pain; Arm pain; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain) and pain in arm (Verbatim: Arm pain). The outcome of the injection site pain and pain in arm were resolved. The reporter considered the injection site pain and pain in arm to be related to Shingrix. The company considered the injection site pain and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 23-APR-2025 The reporter was Respriatory Therapists. During group presentation, multiple audience members (HCPs) shared experience with receiving Shingrix including injection site pain and arm pain. Pain described as very painful and hesitation to receive second dose as a result. More
2838893 64 F 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
swollen 6 in. by 2 in swelling starting just below the injection site; Very painful; Hot; Red; This ... swollen 6 in. by 2 in swelling starting just below the injection site; Very painful; Hot; Red; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concomitant products included paracetamol (Tylenol) and levocabastine hydrochloride (Zyrtec). On 24-APR-2025, the patient received the 1st dose of Shingles vaccine. On 24-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced injection site swelling (Verbatim: swollen 6 in. by 2 in swelling starting just below the injection site), pain (Verbatim: Very painful), feeling hot (Verbatim: Hot) and erythema (Verbatim: Red). The outcome of the injection site swelling, pain, feeling hot and erythema were not resolved. It was unknown if the reporter considered the injection site swelling, pain, feeling hot and erythema to be related to Shingles vaccine. It was unknown if the company considered the injection site swelling, pain, feeling hot and erythema to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-APR-2025 This report was submitted via the online direct entry reporting system. The patient had very painful, hot red swollen 6 inch by 2 inch swelling starting just below the injection site. The patient had never before had a reaction like this to a vaccine. More
2838894 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal, Pain Feeling abnormal, Pain
About 5 days later I noticed a weird sensation on my right thigh that has been persistent for 8 days... About 5 days later I noticed a weird sensation on my right thigh that has been persistent for 8 days now; It feels like any time my hair follicles move, there is a stinging kind of pain; It knocked me on my butt for 2 days but i got better; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weird feeling in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced weird feeling (Verbatim: About 5 days later I noticed a weird sensation on my right thigh that has been persistent for 8 days now), pain (Verbatim: It feels like any time my hair follicles move, there is a stinging kind of pain) and unwell (Verbatim: It knocked me on my butt for 2 days but i got better). The outcome of the weird feeling was not resolved and the outcome of the pain was not reported and the outcome of the unwell was resolved. It was unknown if the reporter considered the weird feeling, pain and unwell to be related to Shingrix. It was unknown if the company considered the weird feeling, pain and unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 21-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that recently got second Shingrix shot, (about two weeks ago, in right arm it knocked on my butt for 2 days, but the reporter got better. About 5 days later reporter noticed a weird sensation on right thigh that has been persistent for 8 days now. It felt like any time reporter hair follicles move, there was a stinging kind of pain. It had been very distracting.; Sender's Comments: US-GSK-US2025AMR049026:same reporter different patient US-GSK-US2025AMR049051:same reporter different patient US-GSK-US2025AMR049045:same reporter different patient More
2838895 F 04/30/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Blister, Chemotherapy, Herpes zoster, Herpes zoster oticus, Pain; Post herpetic ... Blister, Chemotherapy, Herpes zoster, Herpes zoster oticus, Pain; Post herpetic neuralgia, Vaccination failure More
Suspected vaccination failure; dealing with Ramsay Hunt Syndrome; Mine is on the left side of my fac... Suspected vaccination failure; dealing with Ramsay Hunt Syndrome; Mine is on the left side of my face and head with ear involvement and blisters all around my eye; PHN right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included c-section, knee replacement and neck surgery (with titanium plates and screws). 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), ramsay-hunt syndrome (Verbatim: dealing with Ramsay Hunt Syndrome) (serious criteria GSK medically significant), shingles (Verbatim: Mine is on the left side of my face and head with ear involvement and blisters all around my eye) and post herpetic neuralgia (Verbatim: PHN right now). The outcome of the vaccination failure and shingles were not reported and the outcome of the ramsay-hunt syndrome and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, shingles and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 22-APR-2025 This case was reported by a patient via interactive digital media. The patient was dealing with Ramsay Hunt Syndrome and post herpetic neuralgia right now and she never experienced pain like this in her life. She had three children, one was a C-section, two total knee replacements, neck surgery with titanium plates and screws and more but none of it compared to the pain she had been experienced for two months. Her was on the left side of her face and head with ear involvement and blisters all around her eye. She got the vaccine but chemo treatments wiped out the vaccine. The reporter stated that to get vaccinated. 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2838896 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; and nowhave the Shingles; This serious case was reported by a consume... Suspected vaccination failure; and nowhave the 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. In DEC-2024, 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: and nowhave the 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: 21-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the shot in December and now have the Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; 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
2838897 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I never got my second shingles shot; This non-serious case was reported by a consumer via interactiv... I never got my second shingles shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (1st dose received on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I never got my second shingles shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date : 23-APR-2025 The patient never got her/his second shingles shot. It's been over a year since he/she had first one. The patient asked what should he/she did. Till the time of reporting the patient had not received the second dose of Shingles vaccine, which led to incomplete course of vaccination. More
2838898 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I got shingles two months after getting the vaccine.; This serious ca... Suspected vaccination failure; I got shingles two months after getting the vaccine.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles two months after getting the vaccine.). 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 Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 25-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient got shingles two months after getting the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix More
2838899 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Hypersomnia Hypersomnia
slept a lot; This non-serious case was reported by a consumer via interactive digital media and desc... slept a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleep excessive in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). 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 sleep excessive (Verbatim: slept a lot). The outcome of the sleep excessive was resolved. It was unknown if the reporter considered the sleep excessive to be related to Shingles vaccine. It was unknown if the company considered the sleep excessive to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-APR-2025 This case was reported by a patient via interactive digital media. The patient had both shots and first had no problem and after the second slept a lot and patient was good. More
2838900 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; I got the shingle shot to an still got them; This serious case was re... Suspected vaccination failure; I got the shingle shot to an still got them; 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: I got the shingle shot to an still got them). 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: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient got the shingle shot and still got them even the mild case hurts. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2838901 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, 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, an unknown time 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 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: 24-APR-2025 This case was reported by a patient via interactive digital media. The patient had vaccine and still got shingles. The patient was so done with the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2838902 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Immediate post-injection reaction Herpes zoster, Immediate post-injection reaction
after the second shot I immediately contracted shingles; This non-serious case was reported by a con... after the second shot I immediately contracted shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 61-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: after the second shot I immediately contracted shingles). 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 : 22-APR-2025 The patient had both shingles shots and after the second shot immediately contracted shingles internally. The patient would not get another shot and hope did not get them again. More
2838903 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
arm a little sore; This non-serious case was reported by a consumer via interactive digital media an... arm a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 23-APR-2025, the patient received the 2nd dose of Shingles vaccine. On 23-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm a little sore). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. Patient got the second shot and arm was little sore, there was no other problem. More
2838904 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; received the shingle shot and still got shingles; This serious case w... suspected vaccination failure; received the shingle shot and 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: received the shingle shot and 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: 22-APR-2025 This case was reported via interactive digital media. The people who received the shingle shot, still got the shingles. The people were playing with their immune system. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2838905 04/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site pain Injection site pain
The shot does hurt; This non-serious case was reported by a consumer via interactive digital media a... The shot does hurt; 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 (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 pain (Verbatim: The shot does hurt). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 23-APR-2025 This case was reported by a patient via interactive digital media. Reporter reported that the shot did hurt. More
2838906 19 F CA 04/30/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 T5D73
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Engerix-B administration in a pregnant woman; This non-serious prospective pregnancy case was report... Engerix-B administration in a pregnant woman; 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 female patient who received HBV (Engerix B adult) (batch number T5D73, expiry date 10-APR-2027) for prophylaxis. On 19-FEB-2025, the patient received the 1st dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced vaccine exposure during pregnancy (Verbatim: Engerix-B administration in a pregnant woman). The outcome of the vaccine exposure during pregnancy was not applicable. Pregnancy exposure: Pregnancy Exposure (Engerix B adult): To mother in second trimester 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: 22-APR-2025, 23-APR-2025 Nurse wanted to know if it was okay to administer a second dose of Engerix-B to a 20-years-old pregnant patient and what would be the administration schedule for someone with that age. Also, mentioned that she received the first dose being already pregnant with 14 weeks and 5 days on 19-FEB-2025, which led to vaccine exposure during pregnancy. More
2838907 F CA 04/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 J32PB
Product preparation issue Product preparation issue
received only the adjuvant portion of Shingrix; received only the adjuvant portion of Shingrix; This... received only the adjuvant portion of Shingrix; received only the adjuvant portion of Shingrix; 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 52-year-old female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 On 22 April 2025, a medical supervisor called to report that they accidentally administered only the adjuvant portion of Shingrix to a female patient. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter enquired if we had any safety recommendations. More
2838908 F MD 04/30/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 553J7
Expired product administered Expired product administered
A 13 years old female patient received an expired dose of Engerix-B; This non-serious case was repor... A 13 years old female patient received an expired dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HBV (Engerix B) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis. On 22-APR-2025, the patient received Engerix B. On 22-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: A 13 years old female patient received an expired dose of Engerix-B). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 23-APR-2025 The medical assistant report that a patient received an expired dose of Engerix-B which led to, expired vaccine used. The reporter had a questioned did they need to revaccinate the patient. More
๐Ÿ“‹ Privacy Policy & Data Disclaimer