🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2839303 60 F 05/02/2025 YF
 SANOFI PASTEUR
 UK133AB
Paraesthesia, Urticaria Paraesthesia, Urticaria
Patient experienced hives on inner elbows and a prickly feeling. Was prescribed steroidal cream whic... Patient experienced hives on inner elbows and a prickly feeling. Was prescribed steroidal cream which helped a little bit More
2839304 0.5 F SD 05/02/2025 DTAPIPV
PNC15
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Y010032
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Pt was given Kinrix vaccine and should have been given Vaxelis vaccine. No adverse event reported by... Pt was given Kinrix vaccine and should have been given Vaxelis vaccine. No adverse event reported by patient family. More
2839305 33 F SD 05/02/2025 HPV9
 MERCK & CO. INC.
 Y012508
Arthralgia, Condition aggravated, Neck pain Arthralgia, Condition aggravated, Neck pain
Patient received HPV vaccine on 3/25/25. At that visit, she was also seen for chronic right neck and... Patient received HPV vaccine on 3/25/25. At that visit, she was also seen for chronic right neck and shoulder pain and a PT referral was sent for the patient. On 4/2/25, the patient was seen by PT and also sent in a message to the provider asking if the HPV vaccine could have anything to do with the increased pain that she was having. The provider said that it was unlikely and sent in a steroid for the patient and told her to continue with PT. Today, the physical therapist called me to ask if it could be related to the vaccine as the patient continues to have pain and decreased ROM. The nurse involved does not remember giving the vaccine but states she is always careful about site location. More
2839306 1 M WI 05/02/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 DN273
7HG2A
y013348
Blister, Pyrexia, Rash, Respiratory tract congestion, Skin discolouration; Blist... Blister, Pyrexia, Rash, Respiratory tract congestion, Skin discolouration; Blister, Pyrexia, Rash, Respiratory tract congestion, Skin discolouration; Blister, Pyrexia, Rash, Respiratory tract congestion, Skin discolouration More
Pt presents to clinic on 04/16/2025with rash on his back, the bumps on his back are purple open blis... Pt presents to clinic on 04/16/2025with rash on his back, the bumps on his back are purple open blisters, he has had a fever along with congestion. Mom wanted treatment, acyclovir 200 mg/5 mL suspension for 5 days. He returned to clinic on 05/02/2025 mom states his rash had gone away until 3 days ago it returned and is worse than before he also is running a fever again with congestion. cephalexin 250 mg/5 mL suspension 7days and acyclovir 200 mg/5 mL suspension for 5 days were prescribed at todays visit. More
2839307 1 M TX 05/02/2025 UNK
 UNKNOWN MANUFACTURER
Febrile convulsion Febrile convulsion
12moM here for evaluation after febrile seizure. History is consistent with simple febrile seizure. ... 12moM here for evaluation after febrile seizure. History is consistent with simple febrile seizure. Reviewed the natural history of febrile seizure, including risk of recurrence of febrile seizure and risk of development of lifetime seizure disorder. Reviewed what to do if this happens again. Source of the fever is possibly the vaccines given yesterday, specifically MMR is known to be associated with febrile seizure. Reviewed with mom that it is still recommended that he receive this risk as the benefit of immunity against measles outweighs the risks of a self-contained febrile seizure with no adverse long term effects. Will report this occurrence to VAERS. More
2839308 2 M NM 05/02/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 X008385
Expired product administered, No adverse event Expired product administered, No adverse event
mmr vaccine was given to the correct pt., the correct vaccine/medication, the correct route, no alle... mmr vaccine was given to the correct pt., the correct vaccine/medication, the correct route, no allergies or side effects to pt. The error was the mmr vaccine was expired (lot # X008385, expired on 03/21/25) & given on date of service given which was, 03/21/25. More
2839309 0.75 M CA 05/02/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014391
Y014391
Erythema, Injection site erythema, Injection site induration, Injection site urt... Erythema, Injection site erythema, Injection site induration, Injection site urticaria, Rash macular; Urticaria More
MMR vaccine administered IM in Right Thigh at 1018. Approximately 15 minutes later Mother of patient... MMR vaccine administered IM in Right Thigh at 1018. Approximately 15 minutes later Mother of patient started noticing some redness and hives in face and at injection site. When I assessed the patient, redness/blotchiness noted in face and redness and large induration noted in Right thigh where injection was given, approximately 5x6cm in size. Patient acting fine, no SOB, wheezing, vomiting, or hives in any other areas noted. Oxygen saturation at 100% on room air, HR 126. At approximately 1045 Diphenhydramine 2.5mL was administered orally per Dr.'s verbal order. Patient tolerated well. After 15 minutes of Diphenhydramine administration, facial redness and blotchiness resolved and redness and induration in thigh still present but decreasing in size. No other signs or symptoms noted. Dr. assessed patient and discharged them with a referral to an Allergy. More
2839310 79 M AL 05/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3j2s2
Gait disturbance, Malaise, Mobility decreased, Pain Gait disturbance, Malaise, Mobility decreased, Pain
Pt states has severe pain around waist area. Pt states struggled to walk. He felt "too sick t... Pt states has severe pain around waist area. Pt states struggled to walk. He felt "too sick to go to the doctor." Pt stated he felt "almost paralyzed from waist down for 2 days." More
2839311 67 M FL 05/02/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Abdominal pain, Blood test, Cardiac function test normal, Chest pain, Computeris... Abdominal pain, Blood test, Cardiac function test normal, Chest pain, Computerised tomogram abdomen abnormal; Dyspnoea, Intensive care, Laboratory test, Mechanical ventilation, Multiple organ dysfunction syndrome; Pancreatitis acute, Pancreatitis necrotising, Sleep disorder, Vomiting More
Awoke at midnight April 13th with acute chest pain and trouble breathing, taken to Medical Center ED... Awoke at midnight April 13th with acute chest pain and trouble breathing, taken to Medical Center ED- cardiac workup completed with no significant findings, discharged home. Went back to sleep for several hours, awoke around 9am with severe abdominal paina and vomiting. Went back to ER at Medical Center where CT scan was done for suspected cholecystitis - found severe acute pancreatitis with 90% necrosis of the pancreas. By Monday at midnight was in multi organ failure and on a ventilator. Doctors repeatedly stressing they could not determine what caused - no history of alcohol abuse or evidence gallstone More
✓ ✓
2839312 66 F MI 05/02/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 8080797
388494
Deep vein thrombosis, Dyspnoea, Pulmonary embolism, Thromboembolectomy; Deep vei... Deep vein thrombosis, Dyspnoea, Pulmonary embolism, Thromboembolectomy; Deep vein thrombosis, Dyspnoea, Pulmonary embolism, Thromboembolectomy More
Patient informed after her last dose of Spikevax (10/21/2024) she experienced shortness of breath th... Patient informed after her last dose of Spikevax (10/21/2024) she experienced shortness of breath that began on 10/31/24 and resulted in her hospitalization on 11/01/24, during which she underwent a procedure to remove a saddle pulmonary embolism and received further treatment for DVT in one leg. She stated that the doctors at the hospital felt that the clot had originated in her leg. More
✓ ✓
2839313 43 F NY 05/02/2025 VARCEL
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No side effects but patient had written in chart receiving Remicade IV every 8 weeks so should not h... No side effects but patient had written in chart receiving Remicade IV every 8 weeks so should not have been administered. Luckily, she missed her last infusion and stated that it's been 3 months since last Remicade dose. Ideally, she would not have received until full 6 months after last dose. She was instructed to monitor for any adverse reaction or signs and symptoms of varicella infection. She wa also instructed to let her treating doctor that she received a live vaccine today. More
2839314 41 F CA 05/02/2025 TDAP
 SANOFI PASTEUR
 U8122AA
Headache, Hyperhidrosis, Injection site cellulitis, Malaise, Respiratory tract c... Headache, Hyperhidrosis, Injection site cellulitis, Malaise, Respiratory tract congestion More
Pt states that she started not feeling well the next morning. Pt reports waking up sweating along wi... Pt states that she started not feeling well the next morning. Pt reports waking up sweating along with having a headache and congestion. Pt went to ER after dealing with symptoms for 3 days. Pt dx with cellulitis at the site of the injection. Pt given abx (cephalexin). Pt aware to complete full dose of abx. More
2839315 0.58 M MO 05/02/2025 RV5
 MERCK & CO. INC.
 2142099
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No AE to report. Patient was inadvertently given a dose of Rotateq at the age of 7 months when he ha... No AE to report. Patient was inadvertently given a dose of Rotateq at the age of 7 months when he had not received it previously due to not starting it before 15 weeks of age. More
2839316 30 F 05/02/2025 MMRV
 MERCK & CO. INC.
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Proquad was given instead of MMR Proquad was given instead of MMR
2839317 17 F TX 05/02/2025 MENB
MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 B4J4B
B4J4B
B4J4B
Asthenia, Blood glucose normal, Blood pressure decreased, Chills, Dizziness; Ele... Asthenia, Blood glucose normal, Blood pressure decreased, Chills, Dizziness; Electrocardiogram normal, Headache, Human chorionic gonadotropin negative, Injection site pain, Injection site swelling; Neck pain, Pallor, Syncope More
Fainted for a few seconds, went pale, blood pressure dropped, dizzy, chills. As the says passed, she... Fainted for a few seconds, went pale, blood pressure dropped, dizzy, chills. As the says passed, she developed arm pain, redness and tender at couch on right arm and swollen around the shot area, neck pain ,headaches, low energy. Parent took patient to ER for further evaluation. More
2839318 1 F CO 05/02/2025 MMRV
 MERCK & CO. INC.
 x021640
Extra dose administered Extra dose administered
Patient was given MMRV instead of MMR. PT also received dose of Varicella on date of service. Patient was given MMRV instead of MMR. PT also received dose of Varicella on date of service.
2839321 82 KS 05/02/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y009108
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No additional AE/no PQC reported; Nurse called and reported that a dose of PROQUAD was inadvertently... No additional AE/no PQC reported; Nurse called and reported that a dose of PROQUAD was inadvertently administered to an adult patient no 4/16/2025. Caller stated no patient symptoms have been reported. No additional AE/no PQC reported.; This spontaneous report was received from a nurse and refers to an 82-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (valid lot number Y009108, expiration date: 06-NOV-2025) one dose with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported) prophylaxis (product administered to patient of inappropriate age). No adverse event (AE) reported. More
2839322 M 05/02/2025 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and 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: 27-APR-2025 This case was reported by patient's child via interactive digital media. Reporter's parent had gotten it after they had received the shot. 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. This case is linked with US2025AMR051995, reported by same reporter.; 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. US-GSK-US2025AMR051995:female case More
2839323 75 F IL 05/02/2025 RSV
RSV
RSV
RSV
RSV
RSV
RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 LN5496
LN5496
LN5496
LN5496
LN5496
LN5496
LN5496
LN5496
Autoimmune disorder, Blood pressure increased, Dysarthria, Dysstasia, Immunoglob... Autoimmune disorder, Blood pressure increased, Dysarthria, Dysstasia, Immunoglobulin therapy; Myasthenia gravis, Thyroid disorder; Asthenia, Back disorder, Balance disorder, Condition aggravated, Dyspnoea; Fatigue, Mechanical ventilation, Muscular weakness, Weight decreased; Autoimmune disorder, Blood pressure increased, Dysarthria, Dysstasia, Immunoglobulin therapy; Myasthenia gravis, Thyroid disorder; Asthenia, Back disorder, Balance disorder, Condition aggravated, Dyspnoea; Fatigue, Mechanical ventilation, Muscular weakness, Weight decreased More
Patient's representative called to notify me of ongoing issues post RSV vaccination. Issues in... Patient's representative called to notify me of ongoing issues post RSV vaccination. Issues include thyroid dysfunction caused by an autoimmune response, trouble standing, increased blood pressures and slurred speech. Patient diagnosised with myasthenia gravis and given immunoglobulin therapy which helped relieve symptoms. More
✓
2839329 61 F 05/02/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
technician administered vaccine IM instead of SC. per manufacturer ref number 02289659 marco, no inc... technician administered vaccine IM instead of SC. per manufacturer ref number 02289659 marco, no increased risk of adverse events and no need to repeat vaccine. More
2839330 23 M WA 05/02/2025 IPV
IPV
 SANOFI PASTEUR
SANOFI PASTEUR
 W1B511M
W1B511M
Fatigue, Injection site erythema, Injection site pain, Injection site swelling, ... Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise; Mucosal discolouration, Nasopharyngitis, Pyrexia More
I was supposed to be receiving a Tuberculin PPD test intradermally in the left arm and instead recei... I was supposed to be receiving a Tuberculin PPD test intradermally in the left arm and instead received IPOL (inactivated poliovirus). The first day the spot location began to swell and the next day I noticed a head cold- fever, fatigue/malaise along with substantial amount of green mucous coming out of my nose and throat. The area where I was injected also started lightly throbbing over the next couple of days along with a red dot near the site of infection that became more faint over the next few days. More
2839331 50 F CO 05/02/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 47d3s
Underdose Underdose
Administered peds hep B dose to adult patient Administered peds hep B dose to adult patient
2839332 36 M TX 05/02/2025 IPV
 SANOFI PASTEUR
 y1a212m
Cold sweat, Dizziness Cold sweat, Dizziness
Patient became very dizzy and light headed after receiving vaccine. Broke out in a cold sweat. Pati... Patient became very dizzy and light headed after receiving vaccine. Broke out in a cold sweat. Patient blood pressure was normal with first reading. Second reading would not register. Patient's spouse, a nurse, stated patient had come straight from giving plasma and had not eaten. Patient refused to speak with store management and refused offer for emt's. Patient was given some candy to help with possible low blood sugar from giving plasma and water also due to giving plasma. After about 15 to 20 minutes patient stated dizziness had subsided and blood pressure readings were back to normal again. Patient stated felt better and wanted to leave without any other intervention. Spouse took patient home. patient returned to store later in evening around 6:20 pm to advise he was feeling better after eating More
2839333 66 F FL 05/02/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No actual sign of adverse event reported, however pt administered vaccine 5 months apart (not per gu... No actual sign of adverse event reported, however pt administered vaccine 5 months apart (not per guidelines). Pharmacy requires adverse reporting to VAERS since administered outside of guidelines. More
2839334 69 F NV 05/02/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 mf0416
mg5s9
Injection site erythema, Injection site induration, Pain in extremity; Injection... Injection site erythema, Injection site induration, Pain in extremity; Injection site erythema, Injection site induration, Pain in extremity More
Patient complains of knott in arm / swelling at injection site and red dotting. Patient also complai... Patient complains of knott in arm / swelling at injection site and red dotting. Patient also complains of pain in the arm More
2839335 54 F IN 05/02/2025 COVID19
 PFIZER\BIONTECH
Psoriasis Psoriasis
Within six weeks of the vaccination I developed scalp psoriasis. I never had it before. Within six weeks of the vaccination I developed scalp psoriasis. I never had it before.
2839992 11 F ME 05/02/2025 HPV9
MENB
MNQ
TDAP
 MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y008986
HP9988
U8351CA
25A2F
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Patient received a men B vaccine without any indicated risk factors to support administration before... Patient received a men B vaccine without any indicated risk factors to support administration before 16 years of age More
2839072 F GA 05/01/2025 PNC21
 MERCK & CO. INC.
Fatigue, Malaise Fatigue, Malaise
Patient also felt tired and general malaise for approximately 24 hours after the injection.; she had... Patient also felt tired and general malaise for approximately 24 hours after the injection.; she had received CAPVAXIVE vaccine and experienced swelling and redness in her arm where the injection occurred. Patient also had some head and warmth in the arm at the injection site.; she had received CAPVAXIVE vaccine and experienced swelling and redness in her arm where the injection occurred. Patient also had some head and warmth in the arm at the injection site.; she had received CAPVAXIVE vaccine and experienced swelling and redness in her arm where the injection occurred. Patient also had some head and warmth in the arm at the injection site.; Patient also felt tired and general malaise for approximately 24 hours after the injection.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age (also reported as older than 50). The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine Injection (CAPVAXIVE) injection, administered as prophylaxis, strength reported as: 168 mcg/ ml (Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency). On an unknown date, the patient experienced swelling and redness in her arm where the injection occurred (vaccination site swelling) (vaccination site erythema); had some head and warmth in the arm at the injection site (vaccination site warmth) and felt tired and general malaise for approximately 24 hours after the injection (fatigue) (malaise). On an unknown date, the patient recovered from all the events. The causal relationship between all the events with the suspect vaccine was not provided. More
2839073 MO 05/01/2025 MMR
MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y007623
Y012077
Y010045
Incorrect dose administered, No adverse event; Incorrect dose administered, No a... Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event More
No additional AE; NSC Specialist transferred customer who reports a 13-month-old was inadvertently a... No additional AE; NSC Specialist transferred customer who reports a 13-month-old was inadvertently administered MMRII, PROQUAD and VARIVAX at the same time on 28APR2025. No symptoms reported. HCP agreed to correspondence. No additional AE/No PQC reported.; This spontaneous report was received from a Nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported. On 28-Apr-2025, the patient was inadvertently vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 mL, administered as prophylaxis (Lot No. Y007623 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported and upon internal validation established as 11-Apr-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); also with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA [recombinant Human albumin]) (PROQUAD), 0.5 mL, administered as prophylaxis (Lot No. Y012077 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 05-Jan-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided), and with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 mL, administered as prophylaxis (Lot No. Y010045 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 29-May-2026) strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); all doses were reconstituted with sterile diluent (indication, Lot No., expiration date and route were not provided (accidental overdose). No additional adverse event was reported (No adverse event). More
2839083 1 M KY 05/01/2025 HEP
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.

Abnormal behaviour, Aphasia, Decreased eye contact, Depressed mood, Stereotypy; ... Abnormal behaviour, Aphasia, Decreased eye contact, Depressed mood, Stereotypy; Abnormal behaviour, Aphasia, Decreased eye contact, Depressed mood, Stereotypy More
After vaccination, there were signs of injury including speech regression, loss of joy and happiness... After vaccination, there were signs of injury including speech regression, loss of joy and happiness, and the development of odd behavior like arm flapping, eye contact avoidance etc. More
✓
2839084 3 M OR 05/01/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.

Chest X-ray normal, Febrile convulsion, Influenza virus test negative, Pyrexia, ... Chest X-ray normal, Febrile convulsion, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urine analysis normal More
High fever (103.4) resulting in febrile seizure. Taken by ambulance to hospital where he was monitor... High fever (103.4) resulting in febrile seizure. Taken by ambulance to hospital where he was monitored for about four hours. Tests were run to determine the cause of the fever (chest x-ray, nasal swab, urinalysis), but nothing was abnormal in tests. More
2839085 05/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I did get this vaccine, but I'm worried that I got it; This seri... Suspected vaccination failure; I did get this vaccine, but I'm worried that I got it; 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 did get this vaccine, but I'm worried that I got it). 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. Patient did got this vaccine, but was worried that I got it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2839088 31 F NC 05/01/2025 COVID19
COVID19
TDAP
TDAP
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 304333
304333
KR75K
KR75K
Arthralgia, Flushing, Headache, Injection site erythema, Injection site pain; Pa... Arthralgia, Flushing, Headache, Injection site erythema, Injection site pain; Pain, Pyrexia; Arthralgia, Flushing, Headache, Injection site erythema, Injection site pain; Pain, Pyrexia More
Returned to clinic for re-eval on 4/29/25. Tactile fever, headache, bodyaches 24 hours after injecti... Returned to clinic for re-eval on 4/29/25. Tactile fever, headache, bodyaches 24 hours after injection. Progressed to (L) arm tenderness at injection site alongside erythema that started at 48 hours and progressed to time of visit. Unilateral left shoulder pain and bilateral cheek flushing. No angioedema, wheezing on exam concerning for anaphylaxis. Suspect delayed localized reaction. Treated with PRN hydroxizine and hydrocortisone 2.59. 6 cm of circular erythema with no induration to left deltoid. FNP-C More
2839116 NJ 05/01/2025 MMRV
 MERCK & CO. INC.
 Y014436
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; The medical assistant is reporting that a patient received improperly stored vacci... No additional AE; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, past drug reactions and allergies were not reported. On 21-APR-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), 1 dosage form, administered as prophylaxis (lot number Y014436 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date 22-FEB-2026; vaccination scheme frequency, anatomical site of injection, and route of administration were not provided), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not provided), after a temperature excursion (TE) at 5.5 degree Fahrenheit (F) up to 14.4 degree F for 40 minutes, and 14.5 degree F up to 46.4 degree F (15.8 degree F) for 10 minutes, with no previous TE (Product storage error). No additional adverse event was reported for the patient. More
2839117 4 F HI 05/01/2025 MMRV
 MERCK & CO. INC.
 Y017511
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs; Vaccine administered after temperature excursion; This spontaneous report was rec... No additional AEs; Vaccine administered after temperature excursion; This spontaneous report was received from a Physician and refers to a 4-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (DTAP), and Polio vaccine inact (IPV). On 11-MAR-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose number 2, administered by Subcutaneous route in Left Thigh as prophylaxis (lot number Y017511 has been verified to be valid for Measles, Mumps, Rubella and Varicella [Oka-Merck] Virus Vaccine Live [PROQUAD], expiration date 15-APR-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date was not provided). The dose was administered after a temperature excursion (TE) that occurred at -9.8 degree Celsius (C) for 2 hours and 3 minutes, with no previous temperature excursion. No additional adverse event was reported for the patient. More
2839118 F 05/01/2025 COVID19
 PFIZER\BIONTECH
Cerebrovascular accident Cerebrovascular accident
she had a stroke / hard for her to write now; This is a solicited report received from a Consumer or... she had a stroke / hard for her to write now; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-AMGEN INC-25-0118644-SR-01 (AMGEN INC), US-AMGEN-USASL2025083176 (AMGEN). This serious solicited report (USASL2025083176) was reported to Amgen on 24/APR/2025 by a consumer from a commercial program and involves a 74-year-old (Elderly) female patient who had a stroke / hard for her to write now [PT: cerebrovascular accident] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, around three years ago, the patient had a stroke after taking a Covid vaccine injection. It was hard for her to write now due to stroke. No treatment information was received. The outcome of the events cerebrovascular accident was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event cerebrovascular accident. The causal relationship between the event cerebrovascular accident and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested. This individual case report does not change the safety profile of the product. The reporter's assessment of the causal relationship of "she had a stroke / hard for her to write now" with the suspect product(s) COVID-19 Vaccine - Manufacturer Unknown and etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen's Causality Assessment: The event Stroke was considered as unrelated to etanercept. Enbrel is under agreement with Amgen.; Sender's Comments: There is not a reasonable possibility that the event stroke was related to the suspect drugs considering the products safety profile and pharmacokinetic characteristics. The event could most likely be due to patient underlying contributory factors. Detailed clinical course and complete medical history with any other concomitant medication would aid in comprehensive medical assessment. This case will be reassessed upon receipt of additional information. More
2839119 65 F CA 05/01/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Asthenia, Condition aggravated, Electric shock sensation, Hypoaesthesia, Malaise... Asthenia, Condition aggravated, Electric shock sensation, Hypoaesthesia, Malaise; Peripheral swelling, Rheumatoid arthritis, Tremor More
Flare up of Rheumatoid Arthritis; Electrical shocks running down her arms and legs; Numbness/ Hands ... Flare up of Rheumatoid Arthritis; Electrical shocks running down her arms and legs; Numbness/ Hands felt numb; Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them; Swollen hands and feet; Sick all over; Had no energy; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on unknown date). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira). In FEB-2021, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (Verbatim: Flare up of Rheumatoid Arthritis) (serious criteria GSK medically significant), electric shock sensation (Verbatim: Electrical shocks running down her arms and legs), numbness in hand (Verbatim: Numbness/ Hands felt numb), tremor (Verbatim: Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them), peripheral swelling (Verbatim: Swollen hands and feet), sickness (Verbatim: Sick all over) and loss of energy (Verbatim: Had no energy). The outcome of the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy were resolved. It was unknown if the reporter considered the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix. The company considered the rheumatoid arthritis aggravated to be unrelated to Shingrix. It was unknown if the company considered the electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix. Linked case(s) involving the same patient: US2021253751 Additional Information: GSK Receipt Date: 17-APR-2025 The reporter reported that within 12 hours of receiving the second dose of Shingrix, she began to experience a bad immune response. The second dose of Shingrix was in February, 2021. Shingrix had triggered a flare up of her Rheumatoid Arthritis (RA). The patient experienced electrical shocks running down her arms and legs, her hands felt numb and she had no control over them. Her legs would also shake uncontrollably. Her hands and feet became swollen. The patient also reported she was sick all over, and had no energy. The patient stated it took almost 1 year for her joints to be back to where they were before receiving Shingrix.; Sender's Comments: Rheumatoid arthritis aggravated is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GLAXOSMITHKLINE-US2021253751:same patient saperet case is created due to time gap More
2839120 53 M NC 05/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Burning sensation, Pain in extremity Burning sensation, Pain in extremity
knocked her on butts out /noticed a weird sensation on my right thigh; sort of a vague areal pain. n... knocked her on butts out /noticed a weird sensation on my right thigh; sort of a vague areal pain. not an itch, more like a burning sensation; This non-serious case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on an unknown date). In APR-2025, the patient received the 2nd dose of Shingrix (right arm). In APR-2025, less than a week after receiving Shingrix, the patient experienced weird feeling (Verbatim: knocked her on butts out /noticed a weird sensation on my right thigh) and pain burning (Verbatim: sort of a vague areal pain. not an itch, more like a burning sensation). The outcome of the weird feeling was not resolved and the outcome of the pain burning was not reported. It was unknown if the reporter considered the weird feeling and pain burning to be related to Shingrix. It was unknown if the company considered the weird feeling and pain burning to be related to Shingrix. Additional Information: GSK Receipt Date: 21-APR-2025 The patient received the second dose of the Shingrix vaccine about two weeks ago in their right arm. It knocked him on the butt for 2 days, but got better. About 5 days later the patient noticed a weird sensation on right thigh that has been persistent for 8 days now. The patient had a sensation felt like a stinging pain whenever the hair follicles moved, which was very distracting. The patient had been trying to figure out if he was bitten by a spider, (no visible bite), or if this is a side effect associated with the vaccine. The pharmacist stated it feels like what his whole body felt like when he had just gotten the shot. The pharmacist enquired about the stinging kind of pain, the patient described sort of a vague areal pain and not an itch, more like a burning sensation. The pharmacist stated that any discussions should not be taken as medical advice, and individuals were referred to their healthcare provider as the primary resource for patient care. More
2839121 05/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I don't know when I got my first dose of the shingles shot; This non-serious case was reported ... I don't know when I got my first dose of the shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient had received 1st dose on unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I don't know when I got my first dose of the shingles shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 27-APR-2025 Patient reported via chatbot and stated that he/she don't know when they got first dose of the shingles shot. Also asked what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose? Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. More
2839122 05/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
If it's been over 6 months since my first shingles shot, do I have to start over with 2 shots; ... If it's been over 6 months since my first shingles shot, do I have to start over with 2 shots; 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 (received 1st dose over 6 months ago). 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: If it's been over 6 months since my first shingles shot, do I have to start over with 2 shots). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-APR-2025 The patient reported that it had been over 6 months since the patient's first shingles shot and asked do he/she had to start over with 2 shots. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. More
2839123 M 05/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash, Rash pruritic Rash, Rash pruritic
had an itchy rash on his chest; This non-serious case was reported by a consumer via interactive dig... had an itchy rash on his chest; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced itchy rash (Verbatim: had an itchy rash on his chest). The outcome of the itchy rash was not reported. It was unknown if the reporter considered the itchy rash to be related to Shingrix. It was unknown if the company considered the itchy rash to be related to Shingrix. Additional Information: GSK Receipt Date: 25-APR-2025 The patient's wife reported this case. The patent (husband) and reporter were scheduled for second Shingrix shot in the next week and he had an itchy rash on his chest for more than a year. More
2839124 CO 05/01/2025 HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 CT3Z7
5JX2E
4H297
Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
Higher than Approved Dose (Overdose); Extra dose administered; 2nd dose administered at longer inter... Higher than Approved Dose (Overdose); Extra dose administered; 2nd dose administered at longer interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adult patient who received HBV (Engerix B) (batch number CT3Z7, expiry date 13-FEB-2027) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis and HBV (Engerix B) (batch number 4H297, expiry date 06-APR-2026) for prophylaxis. Previously administered products included Engerix B (1st dose received on 12-OCT-2023 with lot number-XS278, expiry date-17-Mar-2025) and Engerix B (3rd dose received on 05-SEP-2024 with lot number 92NK2, expiry date- 29-SEP-2026). On 11-APR-2025, the patient received the 5th dose of Engerix B. On 05-MAR-2025, the patient received the 4th dose of Engerix B. On 12-MAR-2024, the patient received the 2nd dose of Engerix B. On 12-MAR-2024, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose administered at longer interval). On 05-MAR-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered). On 11-APR-2025, the patient experienced extra dose administered (Verbatim: Higher than Approved Dose (Overdose)). The outcome of the extra dose administered, extra dose administered and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 21-APR-2025 Physician Assistant reported he/she had a patient who was given five vaccines for Hepatitis B, Engerix B and just wanted to go over any potential actions that should be take in place for any potential side effects from this. The patient received 2nd dose at longer interval than recommended which led to lengthening of vaccination schedule. The patient received 4th and 5th dose not as per schedule which led extra dose administered. The reporter did not consent to follow-up. More
2839125 IL 05/01/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration, Underdose Incorrect route of product administration, Underdose
received second dose of Priorix intramuscularly instead of subcutaneous; Adult patient received Prio... received second dose of Priorix intramuscularly instead of subcutaneous; Adult patient received Priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a adult patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 28-APR-2025, the patient received the 2nd dose of Priorix (intramuscular). On 28-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received second dose of Priorix intramuscularly instead of subcutaneous) and inappropriate age at vaccine administration (Verbatim: Adult patient received Priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-APR-2025 The pharmacist reported that an adult patient received second dose of Priorix intramuscularly instead of subcutaneous, which led to subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration More
2839126 78 M NY 05/01/2025 MMR
 MERCK & CO. INC.
Abdominal pain upper, Diarrhoea, Fatigue, Night sweats, Rash Abdominal pain upper, Diarrhoea, Fatigue, Night sweats, Rash
Woke up in morning with severe fatigue, next day develop fever of 100, then rash appeared all over m... Woke up in morning with severe fatigue, next day develop fever of 100, then rash appeared all over my body and I developed diarrhea. I still am ver fatigued, rash is still present and stomach still painful. Also have had night sweats More
2839127 55 F VA 05/01/2025 PNC20
PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH



Arthralgia, Axillary pain, Back pain, Chills, Condition aggravated; Dizziness, E... Arthralgia, Axillary pain, Back pain, Chills, Condition aggravated; Dizziness, Erythema, Fatigue, Insomnia, Myalgia; Pain, Pain in extremity, Peripheral swelling, Pyrexia, Tremor; Vomiting More
arm swollen, red and pain spread to elbow and armpit. Fever, chills, bodyaches, shaky, back, pain, ... arm swollen, red and pain spread to elbow and armpit. Fever, chills, bodyaches, shaky, back, pain, shoulder pain, vomit, dizzy, extreme fatigue, insomnia, muscle and joint pain more pronounced than usual. Symptoms started 4 hours after injection on April 1st and still having pain and fatigue. More
✓
2839128 10 F KY 05/01/2025 HEP
HEPA
IPV
MMRV
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y007989
J4K4X
YIA201M
Y014435
X449Y
Circumstance or information capable of leading to medication error; Circumstance... Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error More
Unnecessary vaccines given due to receiving vaccines 4/22/2025. Paperwork (work-up) done before 4/22... Unnecessary vaccines given due to receiving vaccines 4/22/2025. Paperwork (work-up) done before 4/22/2025, student needing all vaccines. Database not checked again, gave all "needed" vaccines. Educated CNA that paperwork cannot be done more than a week in advance due to students receiving vaccines at other places. All vaccines entered into database. This all took place at a school vaccine clinic via the immunization team. More
2839129 5 F KY 05/01/2025 DTAPHEPBIP
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 TC47K
N3429
Circumstance or information capable of leading to medication error, Extra dose a... Circumstance or information capable of leading to medication error, Extra dose administered; Circumstance or information capable of leading to medication error, Extra dose administered More
Student was administered unnecessary doses of Pediarix (Dtap, Hep B, Polio). Nurse completed the rec... Student was administered unnecessary doses of Pediarix (Dtap, Hep B, Polio). Nurse completed the record review of student and missed a vaccine record in student education profile. the vaccine record was not entered into database or EHR. Nurse then entered vaccine records from profile into database and EHR. the Dtap vaccine was flagged "age too young," Hep B, Polio, and MMR was not flagged, however they were extra doses. More
2839130 13 F MA 05/01/2025 HPV9
 MERCK & CO. INC.
 W011455
Expired product administered Expired product administered
Vaccine expired on 12/11/2024 Vaccine expired on 12/11/2024
2839131 4 F NY 05/01/2025 DTAP
HEP
HIBV
IPV
MMR
PNC20
VARCEL
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 3CA25C1
7NX57
UK175AA
X1D141M
X027902
HN5980
Y020586
Product preparation error; Product preparation error; Product preparation error;... Product preparation error; Product preparation error; Product preparation error; Product preparation error; Product preparation error; Product preparation error; Product preparation error More
A Hib vaccine was administered to a patient using sterile water as a diluent instead of the manufact... A Hib vaccine was administered to a patient using sterile water as a diluent instead of the manufacturer -supplied - Hib specific diluent. The parent of the child will be contacted and advised to return to the clinic for proper revaccination. No adverse events were observed or reported at the time of submission. More
2839132 51 F TX 05/01/2025 PNC21
 MERCK & CO. INC.
 Z002626
Cellulitis, Erythema, Peripheral swelling, Skin warm, Ultrasound abdomen Cellulitis, Erythema, Peripheral swelling, Skin warm, Ultrasound abdomen
After receiving the vaccination patient developed swelling, redness and warmth to her left upper ext... After receiving the vaccination patient developed swelling, redness and warmth to her left upper extremity. This continued to worsen over 1 to 2 days. It did not seem to improve and then worsened again and is spreading towards the inner arm. She presented to my clinic and it appeared she had a vaccine reaction and then developed a superimposed cellulitis. Point-of-care ultrasound demonstrated cobble stoning consistent with cellulitis. She was treated with BActim. More
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