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
2845279 55 M KS 06/17/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LK6655
EB499
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Provider gave verbal order for vaccine. RN administered pneumococcal vaccine. Provider intended for ... Provider gave verbal order for vaccine. RN administered pneumococcal vaccine. Provider intended for patient to receive T-Dap. More
2845280 4 M VI 06/17/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Z007581
Injection site rash; Injection site rash Injection site rash; Injection site rash
Tiny bumps on both arms at the injection site; not itchy, painful, or bothersome to patient. Parent ... Tiny bumps on both arms at the injection site; not itchy, painful, or bothersome to patient. Parent reports the right arm is worse than the left arm. Symptoms are improving. Parent denies any fever, or any anaphylactic symptoms. Please note this is the first time patient has received the combination (DTaP-IPV) vaccine; however, patient has received four doses of the DTaP in combination vaccines and DTaP as an individual vaccine, and three doses of IPV in combination vaccines. Patient has received the Proquad vaccine previously with no adverse reactions. More
2845281 12 M MI 06/17/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
No adverse event No adverse event
PATIENT HAS HAD NO ADVERSE REACTION TO THE VACCINE PATIENT HAS HAD NO ADVERSE REACTION TO THE VACCINE
2845282 0.17 M SC 06/17/2025 DTPPVHBHPB
DTPPVHBHPB
PNC15
PNC15
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 U7767AA
U7767AA
Z003633
Z003633
Y015019
Y015019
Chest X-ray normal, Crying, Influenza A virus test negative, Influenza B virus t... Chest X-ray normal, Crying, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative; SARS-CoV-2 test negative; Chest X-ray normal, Crying, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative; SARS-CoV-2 test negative; Chest X-ray normal, Crying, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative; SARS-CoV-2 test negative More
Patient became inconsolable 4+ hours after vaccinations. Patient was seen at ER for this. Patient became inconsolable 4+ hours after vaccinations. Patient was seen at ER for this.
2845283 57 F FL 06/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 PE9G5
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was accidentally administered an expired dose of Engerix-B (29 days after listed expiration)... Patient was accidentally administered an expired dose of Engerix-B (29 days after listed expiration). Patient was notified immediately of event and advised to let us know of any issues. Pharmacy contacted CDC and GSK Pharmaceuticals for guidance. Per CDC, as a non-live vaccine it is recommended to repeat the dose as soon as possible as it is considered invalid and patient may then resume series as scheduled. GSK pharmaceuticals stated they have not evaluated the immunogenicity or safety following an administration of an expired vaccine and does not make any recommendations regarding revaccination. However, results from in-house analytical potency testing have shown that the vaccine remains within the approved specifications for up to 30 days following the expiration date. Patient was informed of these findings and stated that she would like to repeat the dose per CDC recommendations. No reports of any adverse reactions following administration of expired dose. More
2845284 11 F MI 06/17/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
Unevaluable event Unevaluable event
NONE NONE
2845285 0.33 M VA 06/17/2025 DTAPIPVHIB
DTAPIPVHIB
PNC15
PNC15
RV5
RV5
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UK174AB
UK174AB
Y010035
Y010035
2052020
2052020
Diarrhoea, Diet refusal, Faeces discoloured, Irritability, Retching; Vomiting; D... Diarrhoea, Diet refusal, Faeces discoloured, Irritability, Retching; Vomiting; Diarrhoea, Diet refusal, Faeces discoloured, Irritability, Retching; Vomiting; Diarrhoea, Diet refusal, Faeces discoloured, Irritability, Retching; Vomiting More
Patient being seen at clinic today for diarrhea and vomiting. Mom states patient is refusing to eat ... Patient being seen at clinic today for diarrhea and vomiting. Mom states patient is refusing to eat as he normally does, gagging frequently during bottles, and has only had a total of 9 ounces today. (Was able to drink another 2 oz in clinic) Patient started the Gerber stage 2 juices either Sunday or Monday and seemed to be doing well getting 1 ounce per day. No juice given today. Vomiting occurred yesterday before eating, no emesis after; no cough preceding emesis. No vomiting today. One episode of diarrhea today- green and watery. No juice today. Had 4m vaccines on Monday. No rxn after first set at 2m other than some increased fussiness. Did not swallow entire rotavirus dose at 2m, but did this time, so Mom is wondering if it could be related to the full dose of the Rotavirus vaccine. Has had 3 or 4 good wet diapers today, which less than normal. Mom denies fevers, cough, congestion, runny nose, and fatigue. Patient has had no known sick exposures. More
2845286 27 F FL 06/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9K34M
Extra dose administered, No adverse event Extra dose administered, No adverse event
Associate was given a Hep B vaccine on 6/10/25 and another on 6/12/25, notified patient and pharmaci... Associate was given a Hep B vaccine on 6/10/25 and another on 6/12/25, notified patient and pharmacist, associate reports no adverse reaction or symptoms More
2845287 76 M ME 06/17/2025 COVID19
 MODERNA
 3043335
Expired product administered, No adverse event Expired product administered, No adverse event
Expired SARS-CoV-2 (COVID-19) 50 mcg/0.5 mL preservative-free vaccine administered to patient who qu... Expired SARS-CoV-2 (COVID-19) 50 mcg/0.5 mL preservative-free vaccine administered to patient who qualified for booster dose. Vaccine expired on JUN 9, 2025, subsequently administered on JUN 11, 2025. Patient notified on JUN 11, 2025. Patient has been educated to report any adverse drug reactions following vaccine administration. No adverse drug reactions have been reported by patient. No further visits or hospitalization needed post administration of expired vaccine. More
2845288 13 M FL 06/17/2025 HPV9
 MERCK & CO. INC.
 Y013407
Blood glucose normal, Chest pain, Dizziness, Syncope Blood glucose normal, Chest pain, Dizziness, Syncope
Patient felt dizzy with s chest pain and collapsed on the floor, 911 was called and transfered to ER Patient felt dizzy with s chest pain and collapsed on the floor, 911 was called and transfered to ER
2845289 25 F TX 06/17/2025 HPV9
 MERCK & CO. INC.
 Z002903
Fall, Syncope Fall, Syncope
syncopal episode with fall syncopal episode with fall
2845290 36 F SC 06/17/2025 COVID19
 JANSSEN
Abortion induced, Exposure during pregnancy, Foetal hypokinesia, Magnetic resona... Abortion induced, Exposure during pregnancy, Foetal hypokinesia, Magnetic resonance imaging abnormal More
On March 19, 2021, I receive the Janssen vaccine. On March 21, I felt fetal movement declining. A fe... On March 19, 2021, I receive the Janssen vaccine. On March 21, I felt fetal movement declining. A fetal MR scan using multiple single slice fast spin-echo T2-weighted images of the brain, along with coronal T1 and axial diffusion techniques was performed on March 23, 2021, and read on March 24, 2021. The reading indicated sequela of germinal matrix hemorrhaging; one prior and one present. It all happened so fast, but the doctors at hospital informed us that the baby would not have a strong chance of surviving, and if she survived, would have a very difficult and short life. The pregnancy was terminated at hospital on March 27, 2021. More
โœ“
2845291 59 F PA 06/17/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019158
Y019158
Cellulitis, Erythema, Pain in extremity, Skin infection, Skin warm; Swelling Cellulitis, Erythema, Pain in extremity, Skin infection, Skin warm; Swelling
Per Provider's documentation regarding office visit on 6/13/25: ("Cellulitis of upper ext... Per Provider's documentation regarding office visit on 6/13/25: ("Cellulitis of upper extremity, unspecified laterality/ Adverse effect of vaccine, initial encounter Patient reported pain, warmth, and redness in her right upper extremity that started the night prior. She states that she received two vaccinations for hepatitis and pneumonia during her annual physical on the 6/6/25, and she noticed the symptoms approximately one week later. The patient describes the affected area as feeling hot and painful, and she denies any associated fevers, chills, nausea, or vomiting. Likely to be skin infection. Prescribed Keflex 500 mg, Take 1 capsule (500 mg total) by mouth 4 (four) times a day for 7 days. Rationale explained. Risk and benefits explained. Recommended ice application to the affected area to help with swelling. Discussed the importance of monitoring for fever or spreading redness; advised to contact if these symptoms occur. Continue to monitor for improvement in symptoms.") Follow-up with patient 6/16/25: Patient reported she doing much better since being prescribed antibiotic. No complaints at this time. No new symptoms. More
2845292 41 F FL 06/17/2025 HPV9
 MERCK & CO. INC.
 y015179
Joint effusion, Mobility decreased, Pain in extremity, X-ray limb abnormal Joint effusion, Mobility decreased, Pain in extremity, X-ray limb abnormal
started to lose movement in arm, went to doctor who prescribed medication and had corticosteroid in... started to lose movement in arm, went to doctor who prescribed medication and had corticosteroid injection for pain . has been taking injections for 15 days no. doing physical therapy and starting pain medication. meloxicam. More
2845293 59 F MI 06/17/2025 HIBV
 MERCK & CO. INC.
 W034365
Expired product administered Expired product administered
Expired vaccine given to patient. Patient notified. Expired vaccine given to patient. Patient notified.
2845294 43 F OH 06/17/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 49M2F
Anger, Irritability, Suicidal ideation Anger, Irritability, Suicidal ideation
Irritability, angry, suicidal Irritability, angry, suicidal
2845295 10 M PA 06/17/2025 MMR
 MERCK & CO. INC.
 Y013131
Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pallor Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Pt became diaphoretic, light headed, pale, nauseated ,passed out 15 minutes after receiving vaccine.... Pt became diaphoretic, light headed, pale, nauseated ,passed out 15 minutes after receiving vaccine. Basic observation, pt return to normal, no treament needed. Pt discahrged to home at 14.10 More
2845296 0.17 F IL 06/17/2025 RV5
 MERCK & CO. INC.
 2117044 (DOWNER
Faecal occult blood positive, Haematochezia Faecal occult blood positive, Haematochezia
Bloody stools, lasting ~10 days Bloody stools, lasting ~10 days
2845297 19 F 06/17/2025 MNQ
 SANOFI PASTEUR
 U8256AB
Wrong product administered Wrong product administered
Patient received Menquadfi vaccine instead of Trumenba vaccine. Patient received Menquadfi vaccine instead of Trumenba vaccine.
2845298 6 M MS 06/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 H3N97
Extra dose administered Extra dose administered
Patient given 3rd dose of Hepatitis A vaccine in error. Patient received 1st Hep A on 3/22/2022. Pa... Patient given 3rd dose of Hepatitis A vaccine in error. Patient received 1st Hep A on 3/22/2022. Patient received 2nd Hep A on 10/01/2024. More
2845300 0.17 M TX 06/17/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH
 U8335AA
MF0415
Urticaria; Urticaria Urticaria; Urticaria
Acute urtucaria, given Benadryl and improved within 30min-1hour Acute urtucaria, given Benadryl and improved within 30min-1hour
2845301 45 F MD 06/17/2025 HEP
PNC20
 DYNAVAX TECHNOLOGIES CORPORATION
PFIZER\WYETH
 946062
MF0425
Rash; Rash Rash; Rash
Patient developed localized rash to left arm Patient developed localized rash to left arm
2845302 59 F IN 06/17/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.

Decreased appetite, Headache, Injection site erythema, Injection site pain, Inje... Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site swelling; Pain, Pyrexia More
I had a fever from Tuesday 6/3- Thursday 6/5, of over 103.00. At one point my temperature was 103.6.... I had a fever from Tuesday 6/3- Thursday 6/5, of over 103.00. At one point my temperature was 103.6. At the injection site my arm was red and swollen almost from shoulder to elbow, and was very sore. I had a constant headache and body aches. I was unable to eat during this time. More
2845303 84 M GA 06/17/2025 PNC20
 PFIZER\WYETH
 LN4927
Extra dose administered Extra dose administered
Patient had already received Prevnar 20 on11/05/2022. Patient came in with a prescription from the p... Patient had already received Prevnar 20 on11/05/2022. Patient came in with a prescription from the provider, hence the vaccine was given again. More
2845304 81 M TX 06/17/2025 COVID19
 NOVAVAX
 6024MF013
Pain, Product administered at inappropriate site, Surgery, Tendon injury Pain, Product administered at inappropriate site, Surgery, Tendon injury
The patient claims that he experienced pain after receiving the Novavax vaccine at our pharmacy that... The patient claims that he experienced pain after receiving the Novavax vaccine at our pharmacy that did not go away after a few days as expected. He went to the doctor to get evaluated and the doctor told him that his tendon has been injected through during vaccination resulting in a hole. The doctor advised that this would not heal without surgery. The patient has been in physical pain since the vaccine and decided to get the surgery. He then had to have his arm in a sling for 6 weeks post operation and is still in physical pain. He will be starting physical therapy soon to help with mobility and the pain. The patient and his wife (redacted name 06/07/19xx) received the same vaccine on the same day. Spouse (redacted name) did not experience the same pain but notes that her vaccine was also given very high on her shoulder. More
โœ“
2845305 74 M IA 06/17/2025 DTAP
IPV
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 Jf7DM
Y1A201M
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
Pharmacy received orders from clinic to administer Ipol and Infanrix on 6/4/2025. Clinic send duplic... Pharmacy received orders from clinic to administer Ipol and Infanrix on 6/4/2025. Clinic send duplicate orders in error on 6/10/25 and pharmacy administered Ipol and Infanrix to patient on 6/10/2025 as well. No adverse events yet reported from patient on 6/17/25. Clinic aware. More
2845307 84 M IA 06/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
Extra dose administered Extra dose administered
Patient received a 3rd dose of Shingrix inappropriately Patient received a 3rd dose of Shingrix inappropriately
2845308 61 M FL 06/17/2025 UNK
 UNKNOWN MANUFACTURER
 945660
Asthenia, Hyperhidrosis, Myalgia, Palpitations Asthenia, Hyperhidrosis, Myalgia, Palpitations
extreme weakness, muscle pain, palpitations, sweats resulting in hospitalization extreme weakness, muscle pain, palpitations, sweats resulting in hospitalization
2845309 18 F WA 06/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
No adverse event No adverse event
No adverse events No adverse events
2845311 10 M 06/17/2025 HPV9
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012776
X027348
Dizziness, Lipids, Loss of consciousness, Syncope, Vomiting; Dizziness, Lipids, ... Dizziness, Lipids, Loss of consciousness, Syncope, Vomiting; Dizziness, Lipids, Loss of consciousness, Syncope, Vomiting More
Patient received HPV and PPV23. Felt fine initially. Then had a finger prick for a lipid panel t... Patient received HPV and PPV23. Felt fine initially. Then had a finger prick for a lipid panel test. After the lipid panel was completed, pt became light headed. Had a syncopal episode. I was able to catch him and lower him to the ground. Regained consciousness after a few seconds and then vomited. Pt remained on the ground until he was feeling less light headed. Was brought to an exam room, applied cool compresses to head/neck and given juice. Remained in an exam room until he was feeling better. More
2845312 23 F TX 06/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Immediate post-injection reaction, Peripheral swelling, Skin warm Immediate post-injection reaction, Peripheral swelling, Skin warm
Immediately after administration in the deltoid muscle, the patient's arm got hot and was likel... Immediately after administration in the deltoid muscle, the patient's arm got hot and was likely swelling after wards (2 minutes after administration of twinrix) . Discussed the possibility of the arthus reaction and referred to provider and monitoring, ice pack, anti-inflammatory medications and to follow up if needed. More
2845313 1.5 F CA 06/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient received a dose of the Heplisav-B vaccine, when the vaccine is indicated for ages 18 years a... Patient received a dose of the Heplisav-B vaccine, when the vaccine is indicated for ages 18 years and older. The patient was 18 months at the time of the incident. More
2845314 68 F 06/17/2025 COVID19
 MODERNA
 80803
Cough, Dyspnoea, Headache, Myalgia Cough, Dyspnoea, Headache, Myalgia
On 6/9/25 during a scheduled call, participant reported the following symptoms after receiving the v... On 6/9/25 during a scheduled call, participant reported the following symptoms after receiving the vaccine on 6/6/25: starting on 6/6/25 pt had headache, muscle pain, "fever" (99.6F), headache, cough and shortness of breath. Pt reported symptoms being mild and they were able to continue daily activities. Pt stated that they weren't certain if SOB and coughing was related to vaccine or not. Symptoms subsided on 6/7/25. Pt states they did not seek any medical attention or take any medication for symptoms. RN advised pt to seek medical attention if needed, and pt acknowledged that they will seek treatment if needed. More
2845338 F CT 06/17/2025 HEPA
MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 DN273
Y008591
Y015101
Aphthous ulcer, Decreased appetite, Pyrexia; Aphthous ulcer, Decreased appetite,... Aphthous ulcer, Decreased appetite, Pyrexia; Aphthous ulcer, Decreased appetite, Pyrexia; Aphthous ulcer, Decreased appetite, Pyrexia More
This spontaneous report was received from a consumer or other non-health professional and refers to ... This spontaneous report was received from a consumer or other non-health professional and refers to a(n) 1-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies were not reported. On 28-MAR-2025, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y008591, expiration date: 30-APR-2026) administered by intramuscular (IM) route, additionally, she received Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015101, expiration date: 06-SEP-2026) administered by IM route and the Hepatitis A Vaccine, inactivated (VAQTA), (lot #DN273) administered by IM route (expiration date were not reported, lot verification was not found, invalid lot number).All reported vaccines were reconstituted with sterile diluent solution for injection (MERCK STERILE DILUENT) (lot number and expiration date not provided). All reported vaccines were for treatment of recommended vaccinations/prophylaxis. On 29-MAR-2025, the patient experienced oral sores (canker), fever, and losing appetite. As treatment the heath care professional (HCP), recommended over the counter medications, such as ibuprofen and acetaminophen (TYLENOL). At the reporting time, the patient had not recovered from the events. The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), and Hepatitis A Vaccine, inactivated (VAQTA) was not provided. Executive Summary: On 02-APR-2025, Pharmacovigilance requested a Medium Priority Adverse Event Quality Investigation Report (AEQIR) for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Package Lot # Y008591 (Fill Batch # 0001722121) following receipt of an adverse event report. Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) Batch # 0001722121 was confirmed to be processed at the Merck site with a date of Manufacture of 27-OCT-2023. The entire batch quantity was shipped to the Merck Site, where it was partially packaged into Package Lot # Y008591 with an expiry of 30-APR-2026. The remainder Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) Fill Batch # 0001722121 was packaged into Package Lot # Y008583. This Full Investigation has assessed the following elements: Scope and Background, Complaint Sample Evaluation, AEQIR Lot History, Event History, Use of Product and Reported Patient Outcome, Vendor/Supplier Investigation Retention Sample Evaluation and Testing, Batch Record Review, Logs, Deviations Review, Vendor/Supplier Investigation, Release Testing, Component and Raw Material Release Testing, Change Control Review, Stability Results, Merck Supporting Investigation, Distribution Center Supporting Investigation, Potential Quality Issues Identified, and Review of Previous CAPAs. There is no complaint sample associated with this AEQIR as the report was initiated for a dose that was administered. On 30-APR-2025, queries in the systems were performed and indicate that this is the first and only Adverse Event Quality Investigation Report (AEQIR) assigned to the Merck Complaint Investigation Unit (CIU) associated with M-M-R๏ฟฝII Fill Batch # 0001722121 / associated Package Lot #s Y008591 and Y008583. Downstream investigation into packaging, warehousing and distribution of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Fill Batch # 0001722121 / Package Lot # Y008591 by the Merck CIU and Distribution Center were completed, and no quality issues were identified. A review of the manufacturing documents and quality system records determined that the manufacturing processes at Merck were in a state of control during the processing of this batch and confirmed that all results for this batch met requirements and specifications. All Quality Notifications were investigated in accordance with procedure and were determined to have no product impact. Overall, there were no safety, purity, or potency concerns identified with the Merck processing of M-M-R๏ฟฝII, Fill Batch # 0001722121 / Package Lot # Y008591. On 02-APR-2025, Pharmacovigilance requested a Medium Priority Adverse Event Quality Investigation Report (AEQIR) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Package Lot # Y015101 (Fill Batch # 0001784932) following receipt of an adverse event report. Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Fill Batch # 0001784932 was confirmed to be processed at the Merck site with a Date of Manufacture of 06-MAY-2025. The entire batch quantity was shipped to the Merck Site, where it was fully packaged into Package Lot # Y015101 with an expiry of 06-SEP-2026. This Full Investigation has assessed the following elements: Scope and Background, Complaint Sample Evaluation, AEQIR Lot History, Event History, Use of Product and Reported Patient Outcome, Vendor/Supplier Investigation Retention Sample Evaluation and Testing, Batch Record Review, Logs, Deviations Review, Vendor/Supplier Investigation, Release Testing, Component and Raw Material Release Testing, Change Control Review, Stability Results, Merck Supporting Investigation, Distribution Center Supporting Investigation, Potential Quality Issues Identified, and Review of Previous CAPAs. There is no complaint sample associated with this AEQIR as the report was initiated for a dose that was administered. On 30-APR-2025, queries in the systems were performed and indicate that this is the first and only Adverse Event Quality Investigation Report (AEQIR) assigned to the Merck Complaint Investigation Unit (CIU) associated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Fill Batch # 0001784932 / associated Package Lot # Y015101. Downstream investigation into packaging, warehousing and distribution of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Fill Batch # 0001784932 / Package Lot # Y015101 by the Merck CIU and Distribution Center were completed, and no quality issues were identified. A review of the manufacturing documents and quality system records determined that the manufacturing processes at Merck were in a state of control during the processing of this batch and confirmed that all results for this batch met requirements and specifications. All Quality Notifications were investigated in accordance with procedure and were determined to have no product impact. Overall, there were no safety, purity, or potency concerns identified with the Merck processing of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Fill Batch # 0001784932, Package Lot # Y015101. More
2845339 F NM 06/17/2025 MMR
MMR
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Measles antibody, Mumps antibody test negative, Rubella antibody negative; Measl... Measles antibody, Mumps antibody test negative, Rubella antibody negative; Measles antibody, Mumps antibody test negative, Rubella antibody negative More
she was was not sufficiently vaccinated against mumps and rubella.; she was was not sufficiently vac... she was was not sufficiently vaccinated against mumps and rubella.; she was was not sufficiently vaccinated against mumps and rubella.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant medications included leflunomide. On an unknown date, "in the 80's or 90's", the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported). On an unspecified date in 2025 (reported as "recently"), the patient had measles, mumps and rubella titers drawn and it showed that she was not sufficiently vaccinated against mumps and rubella (the result of measles titer was not reported). The outcome of the events was not reported. Causality assessment was not provided. Lot# is being requested and will be submitted if received. More
2845340 F TX 06/17/2025 MMRV
 MERCK & CO. INC.
 Y010306
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No Additional AE; HCP called to report a 47 year old female received a dose of PROQUAD, caller state... No Additional AE; HCP called to report a 47 year old female received a dose of PROQUAD, caller stated this was a first dose. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.; This spontaneous report was received from a nurse and refers to a 47-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-Jun-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL (lot #Y010306 and expiration date reported as 01-Dec-2025) (route of administration and vaccination site was not provided) administered for prophylaxis (product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent, solution for injection. No side effects or symptoms were reported. No additional information was provided. No Additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). More
2845341 KY 06/17/2025 HIBV
 MERCK & CO. INC.
 X007544
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; PEDVAX HIB was administered to 1 consumer following a temperature excursi... No additional AE reported; PEDVAX HIB was administered to 1 consumer following a temperature excursion. No additional AE reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported. On 27-May-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (1 dosage form, lot # X007544, expiration date: 20-Nov-2025; strength, route of administration, dose number in series and anatomical site not provided) for prophylaxis. The vaccine was administered following a temperature excursion: 18.8C for 9 hours and 20 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event reported. More
2845342 62 F IL 06/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Joint swelling, Peripheral swelling Joint swelling, Peripheral swelling
swelling in feet and ankles; feet swelling; This non-serious case was reported by a consumer via cal... swelling in feet and ankles; feet swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of ankle swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included minimal change disease (diagnosed 10 years ago). Concomitant products included prednisone and lisinopril. On 28-MAY-2025, the patient received the 1st dose of Shingrix. On 29-MAY-2025, 1 days after receiving Shingrix, the patient experienced ankle swelling (Verbatim: swelling in feet and ankles) and swelling of feet (Verbatim: feet swelling). The outcome of the ankle swelling and swelling of feet were not resolved. It was unknown if the reporter considered the ankle swelling to be related to Shingrix. The reporter considered the swelling of feet to be related to Shingrix. It was unknown if the company considered the ankle swelling to be related to Shingrix. The company considered the swelling of feet to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JUN-2025 The reporter was the patient. The patient received Shingrix vaccine and had major swelling in feet and ankles. The patient was diagnosed with Minimal Change Disease (MCD) 10 years ago. The patient believes she had the disease for 30 years before she was diagnosed. The patient's Minimal Change Disease presents with swollen feet and ankles, which has been under control with current medication. When she becomes ill with a cold, or infection, she experiences swelling in feet and ankles and bottom torso. When this happens, she would took an increased dose of prednisone which will resolve the swelling. The patient takes Prednisone 15 microgram daily and Lisinopril 5 microgram daily to treat MCD. The patient sees a nephrologist who treats and monitors her MCD. On 28 May 2025, the patient received the first dose of Shingrix. Within 24 hours, the patient began to experience major swelling in her feet and ankles. Subsequently, the patient increased the Prednisone dose to 30 microgram daily to treat the swelling at the time of the call she was taking 25 microgram daily of Prednisone. The swelling of her feet and ankles has not resolved. The patient was confident that the swollen feet was related to the Shingrix vaccine. The patient did not plan to get the second dose of Shingrix vaccine. The patient has lab work done every 3 months to monitor MCD. Her next lab work is due in July 2025. More
2845343 NJ 06/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Inappropriate schedule of product administration Inappropriate schedule of product administration
received the 1st dose on 2019. On may 3rd, 2025 the 2nd dose of Twinrix was administered.; This non-... received the 1st dose on 2019. On may 3rd, 2025 the 2nd dose of Twinrix was administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose in 2019). On 03-MAY-2025, the patient received the 2nd dose of Twinrix. On 03-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received the 1st dose on 2019. On may 3rd, 2025 the 2nd dose of Twinrix was administered.). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-JUN-2025 The pharmacist reported that the patient had Twinrix received the 1st dose in 2019 and on 3rd May 2025 the 2nd dose of Twinrix was administered. The reporter asked how they treat that situation and did it count as the first or does the third dose would be in October 2025 and asked should they restart the series. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule; Sender's Comments: US2025072143:Case created for 2nd patient More
2845344 06/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still get shingles 3 or 4 times a year; This serious case was reporte... Suspected vaccination failure; still get shingles 3 or 4 times a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get shingles 3 or 4 times a year). 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: 10-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the shots a few years ago and still got shingles 3 or 4 times a year, sucks. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine. More
2845345 06/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and 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 was not reported and the outcome of the shingles was resolved (duration 3 weeks). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 10-JUN-2025 This case was reported by a patient via interactive digital media. A year after getting a two-part vaccine the patient still got shingles, although it was relatively mild and lasted less than three weeks. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2845346 06/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Pruritus, Vaccination failure; Herpes zoster, Pruritus, Vaccinati... Herpes zoster, Pruritus, Vaccination failure; Herpes zoster, Pruritus, Vaccination failure More
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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). 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 and Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 10-JUN-2025 This case was reported by a patient via interactive digital media. Patient got the Shingrix vaccine (2shots) and still got it. However immediately went on med and was confined to small area with some itching. Dermatologist gave lotion which helped the patient, and stated that yes do get the vaccine as it may keep from getting a bad case. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2845347 06/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
did not feel good for 2 days; This non-serious case was reported by a consumer via interactive digit... did not feel good for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: did not feel good for 2 days). The outcome of the feeling unwell was resolved (duration 2 days). It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. It was unknown if the company considered the feeling unwell to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-JUN-2025 This case was reported by a patient via interactive digital media The patient reported that he/she got shot number one of Shingles vaccine will get the next one in August. The patient stated he/she did not feel good for 2 days, but it was worth it. More
2845348 M OK 06/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 H97H2
Inappropriate schedule of product administration Inappropriate schedule of product administration
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center repres... Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number H97H2, expiry date 29-MAR-2027) for prophylaxis. Previously administered products included Shingrix (patient received a first dose of Shingrix back in September 21, 2018). On 08-APR-2025, the patient received the 2nd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 10-JUN-2025 Other HCP reported that a patient received a first dose of Shingrix back in September 21, 2018 and then a second dose was given April 8, 2025, which led to drug dose administration interval too long. This case linked with US2025072149 reported by same reporter.; Sender's Comments: US-GSK-US2025072149:case created for husband and wife More
2845349 55 F NJ 06/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Inappropriate schedule of product administration Inappropriate schedule of product administration
A female patient had Twinrix and received the 1st dose on 2019 and On may 3rd, 2025 the 2nd dose of ... A female patient had Twinrix and received the 1st dose on 2019 and On may 3rd, 2025 the 2nd dose of Twinrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received first dose of Twinrix in 2019). On 03-MAY-2025, the patient received the 2nd dose of Twinrix. On 03-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: A female patient had Twinrix and received the 1st dose on 2019 and On may 3rd, 2025 the 2nd dose of Twinrix was administered). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-JUN-2025 The pharmacist reported that the second patient had Twinrix and received the 1st dose in 2019. On 03 May 2025 the 2nd dose of Twinrix was administered. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments: US-GSK-US2025AMR074623:case created for 2nd patient More
2845350 0.17 F NC 06/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5895B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administration in a 2 month old; This non-serious case was reported by a other health professional v... administration in a 2 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5895B, expiry date 16-FEB-2026) for prophylaxis. On 10-JUN-2025, the patient received Kinrix. On 10-JUN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration in a 2-month-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: 10-JUN-2025 The reporter reported that 2-month-old patient received Kinrix vaccine which led to, inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. More
2845351 M FL 06/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Never received second dose; This non-serious case was reported by a pharmacist via call center repre... Never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient. Previously administered products included Shingrix (received a Shingrix vaccine 3 and 1/2 years ago in 12/2021). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Never received second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-JUN-2025 Pharmacist reported that a male patient received a Shingrix vaccine 3 and 1/2 years ago in 12/2021. Never received second dose and patient wanted to finish series if possible. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2845352 MA 06/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 XS27B
Expired product administered Expired product administered
Expired dose administered; This non-serious case was reported by a other health professional via cal... Expired dose administered; 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 patient who received HBV (Engerix B) (batch number XS27B, expiry date 17-MAR-2025) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). 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: 12-JUN-2025 The healthcare provider mentioned that a patient was given an expired Engerix-B vaccine which led to, expired vaccine used. The reporter did not mention date of administration during the call. More
2845353 73 M MD 06/17/2025 COVID19
 MODERNA
 3046734
Device issue, No adverse event Device issue, No adverse event
No adverse effect; Complained about the plunger of a vaccine from lot #3046734/having to push the pl... No adverse effect; Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.) and NO ADVERSE EVENT (No adverse effect) in a 73-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3046734) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 12-Jun-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that HCP had to push the plunger very hard while giving the vaccine to the patient. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported. The Device Problem Information include FDA code: 1670, IMDRF Code: A23, Device problem: Use of Device Problem. Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2025: Live follow-up received contains non-significant information: reference number added. More
2845354 06/17/2025 PNC20
 PFIZER\WYETH
Cellulitis Cellulitis
Localized cellulitis; This is a spontaneous report received from an Other HCP from medical informati... Localized cellulitis; This is a spontaneous report received from an Other HCP from medical information team. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Localized cellulitis". Additional information: Localized cellulitis as an adverse effect of the PCV20 vaccine. There was one confirmed patient who has had that in the last week. They have been doing some research, and it looked like it was a rare occurrence in PCV23, but did not see anything related to PCV20. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122230 same reporter/product/AE, different patient; More
๐Ÿ“‹ Privacy Policy & Data Disclaimer