🏥 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 💀 🏥 🚑 ♿ ⚠️
2845150 53 F KY 06/16/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 LM2222
LM2222
LM2222
LM2222
LM2222
LM2222
LM2222
LM2222
Anti-cyclic citrullinated peptide antibody negative, Antibody test negative, Ant... Anti-cyclic citrullinated peptide antibody negative, Antibody test negative, Antinuclear antibody negative, Arthralgia, Aspartate aminotransferase increased; Autoantibody positive, Barium swallow normal, Biopsy muscle abnormal, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased; Blood magnesium normal, Blood phosphorus normal, Blood uric acid decreased, Borrelia test negative, C-reactive protein normal; Dysphagia, Electromyogram abnormal, Fatigue, Full blood count, HIV test negative; Hepatitis viral test negative, Magnetic resonance imaging abnormal, Metabolic function test, Monocyte percentage increased, Muscle atrophy; Muscular weakness, Myalgia, Myopathy, Myositis, Red blood cell sedimentation rate normal; Regurgitation, Rheumatoid factor negative, Serum ferritin increased, Thyroid function test normal, Vitamin D decreased; White blood cell count decreased More
Development of fatigue, joint pain, muscle pain, and muscle weakness as well as dysphagia. Rated he... Development of fatigue, joint pain, muscle pain, and muscle weakness as well as dysphagia. Rated her pain a 3-4 out of 10 on average. This was very atypical for her. Developed dysphagia and regurgitation More
✓ ✓
2845151 12 F TX 06/16/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y015599
Y015599
U8494AA
U8494AA
793PT
793PT
Blood glucose decreased, Hyperhidrosis, Loss of consciousness, Pallor, Seizure; ... Blood glucose decreased, Hyperhidrosis, Loss of consciousness, Pallor, Seizure; Syncope; Blood glucose decreased, Hyperhidrosis, Loss of consciousness, Pallor, Seizure; Syncope; Blood glucose decreased, Hyperhidrosis, Loss of consciousness, Pallor, Seizure; Syncope More
A few minutes after vaccination, child had an episode of pallor, passing out/syncope, and per mom: s... A few minutes after vaccination, child had an episode of pallor, passing out/syncope, and per mom: seizing episode. Provider immediately responded, had child lay flat on exam table. HR low (55) - see notes below and diaphoretic and pallor. Monitored for about 15 min, noted BP and HR increased to appropriate levels during that monitoring. Child was less diaphoretic and color returned. Noted had not eaten breakfast. Child was given sucker/lollipop and snack to assist in correcting any drop in blood glucose. Believed to be a vasovagal response and possible low blood glucose event d/t fasting and stressor of receiving vaccines. Noted child was fearful at the time of vaccination. VS after event: 1050: 93/55, hr 55 (laying) 1052: 95/61 hr 88 (laying) 1055: 98/59 hr 90 (sitting) 1100: 91/62 hr 96 (standing) no breakfast, nervous More
2845152 4 M LA 06/16/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8209CB
Y019171
Injection site erythema, Injection site reaction, Injection site vesicles, Urtic... Injection site erythema, Injection site reaction, Injection site vesicles, Urticaria; Injection site erythema, Injection site reaction, Injection site vesicles, Urticaria More
On 6/11/25 @ 8:34pm I received a message from RN regarding patient's shots, she attached a phot... On 6/11/25 @ 8:34pm I received a message from RN regarding patient's shots, she attached a photo of his arm. It appears to be a reaction to the one of the vaccines. She instructed the Mother to give the child Benadryl and to take child to the clinic in the AM or the ER tonight if child began having worse symptoms. I explained I was out of town but would report it to VAERs on 6/16/25 when I returned. I asked for Mother to call me. The child's right upper arm was erythematous, whelps and what appeared to be blisters were noted . No fever reported. Child was "acting fine". More
2845153 66 M WA 06/16/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
This subcutaneous vaccine formulation was administered as IM. No abnormal S/S to report. This was... This subcutaneous vaccine formulation was administered as IM. No abnormal S/S to report. This was administration error only. Reported to PCP immediately. Follow up Titers put in place to check if patient received immunity from it. More
2845154 74 M TX 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Injection site erythema Injection site erythema
Patient said his reaction was delayed by about 4 days. He had redness around the injection site with... Patient said his reaction was delayed by about 4 days. He had redness around the injection site with red dots inside the redness (circle of about 3 inches long). Patient has eczema and other dermatitis. More
2845155 77 F MA 06/16/2025 TDAP
 SANOFI PASTEUR
 3CA22C1
Arthralgia, Injected limb mobility decreased, Neck pain, Pain, Pain in extremity Arthralgia, Injected limb mobility decreased, Neck pain, Pain, Pain in extremity
she's been having pain in her arm that radiates to the back of the shoulder to her neck. States... she's been having pain in her arm that radiates to the back of the shoulder to her neck. States she is unable to lift her right arm, if she needs to she is using the left to assist. Symptoms started night she got vaccine More
2845157 2 M AL 06/16/2025 DTAPIPVHIB
HEPA
PNC20
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 UK114AA
C24B9
GY1932
Expired product administered; Expired product administered; Expired product admi... Expired product administered; Expired product administered; Expired product administered More
After vaccinations were administered to the child it was discovered that the Prevnar 20 dose expired... After vaccinations were administered to the child it was discovered that the Prevnar 20 dose expired in 12/2024. Dose was manually added to Department of Public Health during the visit because the nurse was not able to scan the barcode. After discovery that the Prevnar was expired, the dose was deleted from Department of Public Health. The dose will be repeated at the next clinic visit. More
2845158 13 F MN 06/16/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 3e99m
eb499
Urticaria; Urticaria Urticaria; Urticaria
Hives started 6/5 and come and go, Treated with benadryl and zyrtec 10mg once daily. No other sympt... Hives started 6/5 and come and go, Treated with benadryl and zyrtec 10mg once daily. No other symptoms More
2845160 77 F NV 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Erythema, Pruritus, Urticaria Erythema, Pruritus, Urticaria
patient experienced hives/itching/red bumps on skin at least 6 hours post vaccination administration patient experienced hives/itching/red bumps on skin at least 6 hours post vaccination administration
2845161 25 M WA 06/16/2025 COVID19
 MODERNA
 Adu- BOO11
Dizziness, Loss of consciousness, Syncope Dizziness, Loss of consciousness, Syncope
Prior to vaccination, pt was asked if he has ever felt faint or dizzy/fainted after receiving a vacc... Prior to vaccination, pt was asked if he has ever felt faint or dizzy/fainted after receiving a vaccine, which he denied. Vaccine was given around 10:50 am while pt was sitting. Shortly after vaccination (around 30 seconds) pt appeared to look faint. RN administering vaccine stood next to pt and verbally checked how pt was feeling. Pt was closing eyes and appearing dizzy. Pt was given juice and a snack which at this time pt did not have. Once pt was appearing to come more around, pt stated that he had not eaten much in the last 2 days. Staff was able to get pt to sit in chair and have snack for about 10 minute s and reporting feeling ok. Pt then got up from chair stating he was going to get his bag but would come back and finish snack. RN was then alerted by community health navigators in hallway that pt had passed out. RN went to pts side to check on him and assisted pt to sofa nearby. BP check 140/78, pulse 73, O2 100%. Pt stated that he did not hit head. Sports Drink and snacks were again given to pt as he had not eaten much recently. After pt had Sports drink and snack, staff assisted pt to a different room to lie on sofa. Pt stated he felt okay at this time but agreed to lay down for some time. After another 10 minutes, pt decided to leave facility, declining any other care. Pt appeared well to staff at this time. More
2845162 20 M NY 06/16/2025 MMR
 MERCK & CO. INC.
 X024177
Expired product administered, No adverse event Expired product administered, No adverse event
Patient given MMR dose #2 on 6/16/2025. MMR vaccine expired on 6/11/2025. Vaccine given in the 1000... Patient given MMR dose #2 on 6/16/2025. MMR vaccine expired on 6/11/2025. Vaccine given in the 1000 hour and he returned to class. Patient returned to clinic in the 1400 hour and informed of administration of expired vaccine. He was asymptomatic. More
2845163 54 F NC 06/16/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6203
EN6203
Blood test, Borrelia test positive, Electromyogram, Genetic testing, Laboratory ... Blood test, Borrelia test positive, Electromyogram, Genetic testing, Laboratory test abnormal; Motor neurone disease, Muscular weakness, Peroneal nerve palsy More
Weakness in left leg, partial foot drop after 2nd dose on 3/18/21. Weakness in left leg, partial foot drop after 2nd dose on 3/18/21.
✓
2845164 47 F MA 06/16/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH
 026L20A
026L20A
024M20A
024M20A
FF2587
FF2587
Granulomatous lymphadenitis, Immunohistochemistry, Sarcoidosis, Thymectomy, Thym... Granulomatous lymphadenitis, Immunohistochemistry, Sarcoidosis, Thymectomy, Thymoma malignant; Thymus enlargement; Granulomatous lymphadenitis, Immunohistochemistry, Sarcoidosis, Thymectomy, Thymoma malignant; Thymus enlargement; Granulomatous lymphadenitis, Immunohistochemistry, Sarcoidosis, Thymectomy, Thymoma malignant; Thymus enlargement More
Dose 1: 1/19/2021 Lot#026L20A expires 6/28/21; Dose 2 2/16/2021 Lot#024M20A expires 8/3/2021 both d... Dose 1: 1/19/2021 Lot#026L20A expires 6/28/21; Dose 2 2/16/2021 Lot#024M20A expires 8/3/2021 both doses in left arm. Pfizer vaccination 12/20/2021 Lot#FF2587 expired 12/2021 left arm booster. More
✓ ✓
2845165 16 M OH 06/16/2025 HPV9
 MERCK & CO. INC.
 x019196
Unevaluable event Unevaluable event
none at this time none at this time
2845166 65 F ME 06/16/2025 MMR
 MERCK & CO. INC.
Fatigue, Migraine Fatigue, Migraine
cluster migraine, fatigue cluster migraine, fatigue
2845167 63 F NC 06/16/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


UNK
UNK
UNK
Dizziness, Headache, Pain, Pain in extremity; Arthralgia, Back pain, Chest pain,... Dizziness, Headache, Pain, Pain in extremity; Arthralgia, Back pain, Chest pain, Dizziness, Headache; Mobility decreased, Pain, Pain in extremity; Dizziness, Headache, Pain, Pain in extremity; Arthralgia, Back pain, Chest pain, Dizziness, Headache; Mobility decreased, Pain, Pain in extremity More
pt states that later that night after getting vaccinated her arm was hurting. By the next day everyt... pt states that later that night after getting vaccinated her arm was hurting. By the next day everything on her body was hurting and aching. Especially her legs as they felt like they locked up. Her hands, elbow, and area around her back and chest were aching. She took a couple of ibuprofen and then a BC powder. She contacted her clinic to let them know how bad she was hurting and they told her that these symptoms were part of the vaccine side effects that may last a week or two but it has been longer than that. She states if she isn't taking something for the pain, that the pain is terrible and she doesn't know what else to do. During the first week she experienced dizziness and headaches that is better now but she continues having body aches and pains and has to have pain meds. More
2845168 7 F DE 06/16/2025 HEPA
HEPA
 MERCK & CO. INC.
MERCK & CO. INC.
 X2233
X2233
Crying, Decreased appetite, Eye pain, Fatigue, Headache; Pyrexia Crying, Decreased appetite, Eye pain, Fatigue, Headache; Pyrexia
Friday 6/13 woke up c/o bilateral eye pain, headaches, fevers up to 102 headaches fatigue and decrea... Friday 6/13 woke up c/o bilateral eye pain, headaches, fevers up to 102 headaches fatigue and decreased appetite. Motrin helps the fevers but pain severe in eyes will cry in pain per Mom. More
2845169 1.25 M VA 06/16/2025 DTAPIPV
 SANOFI PASTEUR
 u8009AB
Product dose omission issue, Wrong product administered Product dose omission issue, Wrong product administered
Client was given Quadracel instead of Vaxelis which was the vaccine intended. Client missed third H... Client was given Quadracel instead of Vaxelis which was the vaccine intended. Client missed third Hep B vaccine More
2845170 17 F MD 06/16/2025 ADEN_4_7
HEP
 TEVA PHARMACEUTICALS
GLAXOSMITHKLINE BIOLOGICALS
 100038907
32M5G
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 More
Adenovirus pills given with instructions not to touch, bite, crush or chew pill and chase with water... Adenovirus pills given with instructions not to touch, bite, crush or chew pill and chase with water. I notice patient chewing and she spat the pills in a cup. She did not swallow pills. More
2845172 60 F MA 06/16/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 58160-0823-11
58160-0823-11
58160-0823-11
Aphasia, Computerised tomogram head normal, Computerised tomogram neck normal, D... Aphasia, Computerised tomogram head normal, Computerised tomogram neck normal, Dysarthria, Electrocardiogram normal; Electroencephalogram normal, Magnetic resonance imaging head normal, Magnetic resonance imaging neck normal, Muscle contractions involuntary, Paraesthesia; Vertigo More
Within 14 days of administration I experienced vertigo while seated, and word finding difficulities.... Within 14 days of administration I experienced vertigo while seated, and word finding difficulities. Subsequently I experienced intermittent aphasia, dysarthria, tingling on the left side of my head and face, muscle contrations in my neck. More
✓
2845173 60 M MO 06/16/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8733
EW1062
Contusion, Pain in extremity, Peripheral swelling, Supraventricular tachycardia,... Contusion, Pain in extremity, Peripheral swelling, Supraventricular tachycardia, Thrombosis; Contusion, Pain in extremity, Peripheral swelling, Supraventricular tachycardia, Thrombosis More
Blood clots in legs and arms. SVTs. Very painful, swollen and one had bruising. Some lasting week... Blood clots in legs and arms. SVTs. Very painful, swollen and one had bruising. Some lasting weeks most last a few days. I take ibuprofen for the pain. More
2845174 0.67 M TX 06/16/2025 DTAPIPVHIB
 SANOFI PASTEUR
Autism spectrum disorder, Crying, Non-24-hour sleep-wake disorder, Pyrexia Autism spectrum disorder, Crying, Non-24-hour sleep-wake disorder, Pyrexia
Fever, increased crying & deminished sleep cycles for months Fever, increased crying & deminished sleep cycles for months
✓
2845175 5 M VA 06/16/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.

Blister, Blister rupture, Pruritus, Rash erythematous, Scab; Varicella post vacc... Blister, Blister rupture, Pruritus, Rash erythematous, Scab; Varicella post vaccine More
Around two weeks after the proquad vaccine, patient presented with itchy small, fluid-filled blister... Around two weeks after the proquad vaccine, patient presented with itchy small, fluid-filled blisters all over his arms and legs. Quickly over the next 48 they spread all over his legs, arms, some of his back and belly. They were not present on his feet, hands, or in his mouth. There was no fever. They appeared to leak a clear fluid initially, and then over the next few days, the red bumps developed scabs. New bumps showed up for several days, with a mix of bumps, blisters, and scabs. We brought him to the doctor a couple days in to rule out any other virus, but chicken pox caused by the vaccine appeared to be the mostly likely scenario. More
2845176 54 F NY 06/16/2025 PNC21
 MERCK & CO. INC.
 z005765
Arthralgia, Swelling, Ultrasound scan, X-ray Arthralgia, Swelling, Ultrasound scan, X-ray
left shoulder pain, swelling x 11 days. left shoulder pain, swelling x 11 days.
2845177 57 M NY 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93n4j
No adverse event No adverse event
no AE observed no AE observed
2845178 13 M TX 06/16/2025 HPV9
 MERCK & CO. INC.
 Y012508
Fall, Generalised tonic-clonic seizure, Head injury Fall, Generalised tonic-clonic seizure, Head injury
Approximately 1-2 minutes after administration into left deltoid, patient experienced tonic-clonic ... Approximately 1-2 minutes after administration into left deltoid, patient experienced tonic-clonic seizure activity. He was sitting on the table during administration, fell forward, off the table and hit his head. Patient was examined by physician post seizure and advised to proceed to ER. Mother declined ambulance transportation. Patient was wheelchaired to his family vehicle, placed in the passenger side, and dad and mom proceeded to take him to the ER for further evaluation and imaging studies. More
2845179 16 M WA 06/16/2025 MNQ
 SANOFI PASTEUR
 U8494AA
Product preparation issue Product preparation issue
Sterile diluent was added to the vaccine vial, and the vaccine was administered to the patient. The ... Sterile diluent was added to the vaccine vial, and the vaccine was administered to the patient. The patient reported a full sensation and no other symptoms. Per the manufacturer, this dose is considered invalid and will need to be re-administered. More
2845180 64 M NY 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ek225
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pt received an extra dose of shingrix. Dose 1- 8/22/2020, Dose 2- 7/5/2021, Dose 3- 4/1/2025. Pt did... Pt received an extra dose of shingrix. Dose 1- 8/22/2020, Dose 2- 7/5/2021, Dose 3- 4/1/2025. Pt did not experience any adverse effects from this. More
2845181 5 M NC 06/16/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.

Attention deficit hyperactivity disorder, Behaviour disorder, Insomnia, Oppositi... Attention deficit hyperactivity disorder, Behaviour disorder, Insomnia, Oppositional defiant disorder, Tic; Tourette's disorder More
Developed facial tic, followed by vocal tic, developed behavioral issues. Had to be seen by speciali... Developed facial tic, followed by vocal tic, developed behavioral issues. Had to be seen by specialist to address ask if the issues. He is now in multiple medications when he was on nothing prior and was a normal healthy kid. More
✓
2845187 3 M 06/16/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

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 More
Consumer reports no symptoms or effects since getting the MMR II vaccine; No additional AE; he is 41... Consumer reports no symptoms or effects since getting the MMR II vaccine; No additional AE; he is 41 years old and that was his first dose of the MMR II, reporting he believes he had a dose of one of the MMRs as a child/ I think I had one dose of one of the MMRs as a child, but that was like 38 years ago" so he had not further information.; This spontaneous report was received from a Consumer or other non health professional and refers to a 41-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. In approximately 1987 (reported as around 38 years ago), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (reported as MMR vaccine) (manufacturer unknown), Injection, dose number 1, (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 21-May-2025 around 6:00 PM, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, dose number 2, (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). It was reported, that the patient was 41 years old and on 21-MAY-2025 at 6:00 PM that was his first dose of the suspect vaccine (discrepancy), reporting he believed he had a dose of one of the MMR vaccine as a child. He thank he had one dose of one of the MMRs as a child, but that was like 38 years ago, so he had not further information (Inappropriate schedule of product administration). Consumer reported no symptoms or effects since getting the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine; no additional AE (no adverse event). Additional information is not expected. More
2845188 14 M OK 06/16/2025 HPV9
 MERCK & CO. INC.
 W017539
Expired product administered Expired product administered
No additional AE.; Inbound call from HCP calling to report administration of GARDASIL-9 that was exp... No additional AE.; Inbound call from HCP calling to report administration of GARDASIL-9 that was expired. Caller states that the first dose of the series was administered to a 14 year old male on 3-JUN-2025. Caller reports that the dose administered on 4-JAN-2025. C; Information has been received from a Medical Assistant and refers to a 14-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-Jun-2025, the first dose of the series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (0.5 mL once, lot #W017539, expiration date: 04-Jan-2025; strength and route were not provided) was administered to the patient for prophylaxis (expired vaccine used). It was also reported that the dose administered on 04-Jan-2025. No symptomatic adverse events reported. No additional AE. No additional information at that time. More
2845189 F UT 06/16/2025 RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
a 2 month old female patient was inadvertently given a second dose of ROTATEQ very early; No other A... a 2 month old female patient was inadvertently given a second dose of ROTATEQ very early; No other AE/No PQC.; This spontaneous report was received from a Nurse and refers to a 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 05-JUN-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), dose number 1, at a dose of 2 mL (route of administration, lot # and expiration date were not reported). then, on an unknown date, conflicting information also reported as 13-JUN-2026, inadvertently given a second dose very early, at a dose of 2 mL (route of administration, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No other AE/No PQC. More
2845190 06/16/2025 RVX
RVX
RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Extra dose administered, Respiratory syncytial virus infection, Vaccination fail... Extra dose administered, Respiratory syncytial virus infection, Vaccination failure; Extra dose administered, Respiratory syncytial virus infection, Vaccination failure; Extra dose administered, Respiratory syncytial virus infection, Vaccination failure; Extra dose administered, Respiratory syncytial virus infection, Vaccination failure More
suspected vaccination failure; RSV; received 4 vaccines; This serious case was reported by a consume... suspected vaccination failure; RSV; received 4 vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis, RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included respiratory syncytial virus infection. On an unknown date, the patient received the 4th dose of RSV vaccine, the 3rd dose of RSV vaccine, the 2nd dose of RSV vaccine and the 1st dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and extra dose administered (Verbatim: received 4 vaccines). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 09-JUN-2025 This case was reported by a patient via interactive digital media. Patient received 4 vaccines and became infected again and felt again like they did before had received any vaccinations, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding RSV infection 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 vaccine RSV vaccine (Dose 1, 2, 3 and 4). More
2845191 76 F TN 06/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain, Somnolence Pain, Somnolence
she felt sleepy; she felt achy; This non-serious case was reported by a consumer via call center rep... she felt sleepy; she felt achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included osteoporosis, hypothyroidism and asthma. Previously administered products included influenza vaccine with an associated reaction of pain in extremity (received in left arm in October 2017 and experienced increase in urination) and Prevnar 13 with an associated reaction of pain in extremity (received in left arm in October 2017 and experienced increase in urination). On 29-MAY-2025, the patient received the 1st dose of Shingles vaccine (left arm). On 29-MAY-2025, less than a day after receiving Shingles vaccine, the patient experienced sleepiness (Verbatim: she felt sleepy) and pain (Verbatim: she felt achy). The outcome of the sleepiness and pain were resolved (duration 2 days). It was unknown if the reporter considered the sleepiness and pain to be related to Shingles vaccine. It was unknown if the company considered the sleepiness and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-JUN-2025 The reporter then reports that in October of 2017 She received the flu vaccine with the pneumonia vaccine called Prevnar 13 in the left arm at the same time. She states the night of the vaccines in 2017 her left arm had pain, and she had a hard time getting out of bed. The reporter states that getting bed was especially difficult due to have to urinate frequently. The reporter believes that the increase in urination was due to the Flu and Pneumonia vaccine. She states that she received her first Shingles vaccine. The reporter states that the day of her vaccine she felt sleepy and achy. This lasted 2 days and then resolved. More
2845192 F 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Ageusia, Taste disorder Ageusia, Taste disorder
Loss of taste; This non-serious case was reported by a consumer and described the occurrence of tast... Loss of taste; This non-serious case was reported by a consumer and described the occurrence of taste loss in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease, atrial fibrillation and spinal stenosis. Concomitant products included oxycodone hydrochloride (Oxycodone) and metoprolol succinate (Metoprolol). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced taste loss (Verbatim: Loss of taste). The outcome of the taste loss was unknown. It was unknown if the reporter considered the taste loss to be related to Shingrix. It was unknown if the company considered the taste loss to be related to Shingrix. Additional Information: GSK receipt date: 07-JUN-2025 Consumer stated that before loss of taste, both salt & sweet were intensified, way too strong for patient and patient would always been an addict of both most through life. Patient had antibiotics. More
2845193 50 M NY 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pruritus, Urticaria Pruritus, Urticaria
Hives on waist and chest; Itch; This non-serious case was reported by a consumer via call center rep... Hives on waist and chest; Itch; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypertension (has hypertension). Concomitant products included amlodipine maleate (Amlodipine). On 02-JUN-2025, the patient received the 1st dose of Shingrix. On 09-JUN-2025, 7 days after receiving Shingrix, the patient experienced hives (Verbatim: Hives on waist and chest) and pruritus (Verbatim: Itch). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the hives and pruritus were resolved. It was unknown if the reporter considered the hives and pruritus to be related to Shingrix. It was unknown if the company considered the hives and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JUN-2025 The reporter was the patient. The patient received the first dose of Shingrix on Monday, 2 June 2025 from a local pharmacy. On 9 June 2025, the patient experienced hives and itch on his waist and chest. The patient took Benadryl and the hives resolved. More
2845194 06/16/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; couple months later came down with it; This serious case was reported... Suspected vaccination failure; couple months later came down with 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, several months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: couple months later came down with it). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 06-JUN-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and a couple months later came down with it (respiratory syncytial virus infection). It was horrible. The patient thought the symptoms would have lessened since he/she had been vaccinated. The patient said nope. It took a month to turn the corner to feeling somewhat better. The patient further said that he/she would rather have covid than that, any day. This case was considered as suspected vaccination failure as details regarding laboratory test confirming respiratory syncytial virus infection 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine More
2845195 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
I took Shingrix first shot on date 11/22/2019 and the second shot on date 05/16/2022; This non-serio... I took Shingrix first shot on date 11/22/2019 and the second shot on date 05/16/2022; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 22-NOV-2019). On 16-MAY-2022, the patient received the 2nd dose of Shingrix. On 16-MAY-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I took Shingrix first shot on date 11/22/2019 and the second shot on date 05/16/2022). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 06-JUN-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The patient took Shingrix first shot, and the second shot received later than the recommended interval, which led to lengthening of vaccination scheduled. More
2845196 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
Still feeling achy today; This non-serious case was reported by a consumer via interactive digital m... Still feeling achy today; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-JUN-2025, the patient received the 1st dose of Shingrix. In JUN-2025, less than a week after receiving Shingrix, the patient experienced pain (Verbatim: Still feeling achy today). The outcome of the pain was not resolved. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported that he/she received a first dose of Shingrix vaccine last Wednesday and was still feeling achy today. The patient enquired was this normal. More
2845197 06/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Neuralgia, Vaccination failure Herpes zoster, Neuralgia, Vaccination failure
Suspected vaccination failure; Shingles; nerve pain; This serious case was reported by a consumer vi... Suspected vaccination failure; Shingles; nerve pain; 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. Concurrent medical conditions included immunocompromised (because I was compromised is why I got them). On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and nerve pain (Verbatim: nerve pain). The patient was treated with amitriptyline. The outcome of the vaccination failure was not reported and the outcome of the shingles and nerve pain were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and nerve pain 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 and nerve pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. Consumer reported that had the shingles, same places as you. He /she was still deal with the nerve pain from the shingles. It's had been 3 years on Mother's Day. The reporter mentioned his /her doctor said there's no cure for shingle pain and did provide a script. The reporter mentioned doctor prescribed Amitriptyline 10 mg tab and was mentioned to take 2 Tab in the morning and 2 tabs at night. The reporter mentioned It's not a cure but sure helps. The reporter was also mentioned had gotten the shingle shot 2 months before the shingles appeared and said that because was compromised why got them. The reporter was waiting on getting a liver. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 the clinical description, details regarding completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2845198 06/16/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Back pain, Blister, Feeling abnormal, Herpes zoster, Hypoaesthesia; Musculoskele... Back pain, Blister, Feeling abnormal, Herpes zoster, Hypoaesthesia; Musculoskeletal chest pain, Paraesthesia, Vaccination failure More
Suspected vaccination failure; still got a mild case; This serious case was reported by a consumer v... Suspected vaccination failure; still got a mild case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got a mild case). 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: 08-JUN-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she took the vaccine and still got a mild case. It was awful. The patient had pain in his/her right rib around to stabbing pain in his/her back, numbness and tingling on his/her stomach. He/she only had about 7-8 blisters. Miserable. 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2845199 06/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
made me very sick; This non-serious case was reported by a consumer via interactive digital media an... made me very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: made me very sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that the vaccine made him/her very sick. More
2845200 06/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Erythema, Pain in extremity Erythema, Pain in extremity
arm hurts; red arm; This non-serious case was reported by a consumer via interactive digital media a... arm hurts; red arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurts) and erythema of extremities (Verbatim: red arm). The outcome of the pain in arm and erythema of extremities were not reported. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and erythema of extremities to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-JUN-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine, but arm hurts and was red the second day. More
2845201 06/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Eye haematoma, Fall, Herpes zoster, Ophthalmic herpes zoster, Vaccination failur... Eye haematoma, Fall, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure More
Suspected vaccination failure; Shingles a year later in my left eye; shingles a year later on the le... Suspected vaccination failure; Shingles a year later in my left eye; shingles a year later on the left part of my head; had a bad fall; hematoma in left eye; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles a year later in my left eye) (serious criteria GSK medically significant), shingles (Verbatim: shingles a year later on the left part of my head), fall (Verbatim: had a bad fall) and eye hematoma (Verbatim: hematoma in left eye). The outcome of the vaccination failure, ophthalmic herpes zoster, shingles, fall and eye hematoma were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, fall and eye hematoma to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, fall and eye hematoma to be related to Shingles vaccine. Additional Information: GSK receipt date: 09-JUN-2025 This case was reported by a patient via interactive digital media. Patient had shingles shots and got shingles a year later on the left part of head and in left eye. Physician said patient would have been screaming with pain, if it weren't for the fact that patient had shots. The virus attacks areas where immunity is the lowest, especially on the head. Patient had a bad fall 7 months earlier that resulted in a hematoma over left eye. 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine More
2845202 06/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Dizziness, Fatigue, Injection site pain Dizziness, Fatigue, Injection site pain
pain at the injection site; light headedness; exhaustion; This non-serious case was reported by a co... pain at the injection site; light headedness; exhaustion; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 06-JUN-2025, the patient received the 1st dose of Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: pain at the injection site), light headedness (Verbatim: light headedness) and exhaustion (Verbatim: exhaustion). The outcome of the injection site pain, light headedness and exhaustion were not reported. It was unknown if the reporter considered the injection site pain, light headedness and exhaustion to be related to Shingles vaccine. It was unknown if the company considered the injection site pain, light headedness and exhaustion to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the first shot one day prior to the reporting and experienced light headedness, pain at the injection site, exhaustion. The patient would took it over shingles. More
2845203 2 F VA 06/16/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 9532H
Incorrect route of product administration Incorrect route of product administration
administered a dose of Hiberix subcutaneously instead of intramuscularly; This non-serious case was ... administered a dose of Hiberix subcutaneously instead of intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 2-year-old female patient who received Hib (Hiberix) (batch number 9532H, expiry date 16-JUL-2026) for prophylaxis. On 06-JUN-2025, the patient received Hiberix. On 06-JUN-2025, an unknown time after receiving Hiberix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered a dose of Hiberix subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 06-JUN-2025 Nurse called to request information about the possible routes of administration if another nurse administered a dose of Hiberix subcutaneously instead of intramuscularly, which led intramuscular formulation administered by other route. More
2845204 IL 06/16/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
Havrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024); This non-serious case was... Havrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024)). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 06-JUN-2025 Medical assistant reported that Havrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was 9.76 Celsius and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions reported. The majority of all vaccines reported were administered to patients, which led to incorrect storage of drug. Caller transferred from vaccine reimbursement center, the reporter did not have patient, product, other adverse event details available during call. This is 1 of 8 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect More
2845205 IL 06/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
Boostrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature rea... Boostrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes).; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes).). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 06-JUN-2025 The medical assistant reported that Boostrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was 9.76 Celsius and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions reported. The majority of all vaccines reported were administered to patients, which led to incorrect storage of drug. Caller transferred from vaccine reimbursement center, the reporter did not have patient, product, other adverse event details available during call. This is 1 of 8 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect More
2845206 IL 06/16/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
INFANRIX was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024); This non-serious case w... INFANRIX was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Infanrix) for prophylaxis. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: INFANRIX was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024)). The outcome of the incorrect storage of drug 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: 06-JUN-2025 Medical assistant reported that Infanrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024) which led to incorrect storage of drug. Highest temperature reached was 9.76C and they were above range for 1 hour and 15 minutes in total 75 minutes. No other excursions had occurred. The majority of all vaccines reported were administered to patients. healthcare professional did not have patient, product, other adverse event details available during call. This was 1 of 6 linked cases reported by same reporter, different suspect.; Sender's Comments: US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect More
2845207 IL 06/16/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
ENGERIX-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature r... ENGERIX-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) 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 incorrect storage of drug (Verbatim: ENGERIX-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 06-JUN-2025 MA reports that Engerix-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was 9.76C and they were above range for 1 hour and 15 minutes in total (5 into15 minutes). No other excursions. The majority of all vaccines reported were administered to patients, which led to incorrect storage of vaccine.; Sender's Comments: US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect More
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