🏥 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 💀 🏥 🚑 ♿ ⚠️
2835842 52 F OH 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ts525
Erythema, Injection site swelling, Pain in extremity, Pyrexia Erythema, Injection site swelling, Pain in extremity, Pyrexia
Patient complained of fever as well as a red, sore arm. Patient states arm is swollen at injection ... Patient complained of fever as well as a red, sore arm. Patient states arm is swollen at injection site around the size of a lemon More
2835843 62 F VT 04/11/2025 COVID19
TDAP
 MODERNA
SANOFI PASTEUR
 B0005
3CA30C1
Aphasia, Brain fog, Electrocardiogram normal, Fatigue; Aphasia, Brain fog, Elect... Aphasia, Brain fog, Electrocardiogram normal, Fatigue; Aphasia, Brain fog, Electrocardiogram normal, Fatigue More
Brain fog, fatigue, speech difficulty. Assessed in the ER for stroke (stroke work-up negative) Brain fog, fatigue, speech difficulty. Assessed in the ER for stroke (stroke work-up negative)
2835844 11 F OH 04/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X4T99
Erythema, Skin warm Erythema, Skin warm
Redness to arm. Warm at touch. Redness to arm. Warm at touch.
2835845 90 M 04/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 3E99M
Mobility decreased, Muscular weakness Mobility decreased, Muscular weakness
IBC from daughter that they no longer require the vaccines. Patient was taken off Ultomiris as he ha... IBC from daughter that they no longer require the vaccines. Patient was taken off Ultomiris as he had a reaction to the medication. Patient experienced muscle weakness and had trouble getting out of bed for 6 hours after first dose. With the second dose of the medication, patient was not able to get up for 3 days. Patient is currently in rehab. Doctor has cancelled any further Ultomiris doses and said due to his age they will try something less invasive. At his age of 91, his body just cannot tolerate the medication. More
2835846 68 M NE 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 33fd3
Psoriasis Psoriasis
Patient had an outbreak of psoriasis within days after 2nd Shingrix vaccine which required medical a... Patient had an outbreak of psoriasis within days after 2nd Shingrix vaccine which required medical attention More
2835847 63 F NM 04/11/2025 FLU3
 SANOFI PASTEUR
 UT8514JA
Injection site swelling, Syringe issue, Underdose Injection site swelling, Syringe issue, Underdose
Needle entered arm but syringe would not push. No vaccine went in arm. Injection site developed so... Needle entered arm but syringe would not push. No vaccine went in arm. Injection site developed some slight swelling. More
2835848 0.75 M MA 04/11/2025 DTAPIPV
FLU3
HIBV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 U8209CB
275NJ
UK208AA
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; No adverse event, Product administered to patient of inappropriate age More
No adverse reactions. Patient tolerated vaccine well. Nurse and supervisor met and reviewed proper a... No adverse reactions. Patient tolerated vaccine well. Nurse and supervisor met and reviewed proper ages and dosage for vaccines and supervisor provided written educational materials to the nurse to review. More
2835849 61 M CO 04/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Priorix given intramuscularly instead of subcutaneously, no reported adverse effects from patient re... Priorix given intramuscularly instead of subcutaneously, no reported adverse effects from patient reported More
2835850 1 M MI 04/11/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012074
Y011017
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient recieved MMRV and Varicella so 2 doses of varicella Patient recieved MMRV and Varicella so 2 doses of varicella
2835851 27 M FL 04/11/2025 TDAP
 SANOFI PASTEUR
 3BH5K
Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Patient received tetanus shot in his left arm on 1/30/25 and reported the following day on 1/31 of a... Patient received tetanus shot in his left arm on 1/30/25 and reported the following day on 1/31 of arm pain. Patient was advised to apply warm compress, take ibuprofen, and to move arm around. Patient reported stiffness and difficulty to move arm on 2/10/25, requested physical therapy ordered by primary care provider and reported on latest PT visit on 4/8/25 that therapy has helped with left arm pain. More
2835852 54 M FL 04/11/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Brain fog, Chills, Choking sensation, Depression, Dyspnoea; Dysstasia, Fall, Lab... Brain fog, Chills, Choking sensation, Depression, Dyspnoea; Dysstasia, Fall, Laboratory test, Muscle atrophy, Muscle injury; Muscle spasms, Tinnitus, Vascular injury More
I had a minor laminectomy surgery on Feb 3rd, 2021. My doctor said it was ok to take Pfiser Covid va... I had a minor laminectomy surgery on Feb 3rd, 2021. My doctor said it was ok to take Pfiser Covid vaccine in March when it came out. After my part 2 second shot, I woke up to a massive whole body muscle spasm and fell to the floor. I could not breathe properly and was shivering. I had brain fog. Form that point forward, i got worse to where i developed tinnitus in April, and could not stand up straight for more that 5 seconds, All doctors and physical therapists were puzzled as to why I was not recovering from the surgery like others. NO ONE questioned the vaccine until three years later! My muscles atrophied and I could not breathe properly for months. It felt like I was choking and my muscles were also not receiving oxygen. I felt I was dying. What made it worse is NO ONE questioned the vaccine! I had to find out from Facebook groups of people with similar symptoms. I tried natural therapies to repair the muscular and vascular damage,. I am still not fully recovered and very depressed and now I am an Anti Vaxxer! My symptoms are document at various doctors and physical therapists that NEVER suspected the vaccine. Now I hear from same doctors that many of the patients are complaining of similar injuries after the vaccine. More
✓ ✓
2835853 0.5 M WI 04/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 ek7dg
Wrong product administered Wrong product administered
DO asked MA to not let patient leave as pt has sickle cell anemia and needs an Menveo vaccine. MA gr... DO asked MA to not let patient leave as pt has sickle cell anemia and needs an Menveo vaccine. MA grab already mixed Menveo vaccine and administer vaccine in left thigh. Dr and MA didnt realize that there was another type of Menveo. More
2835854 63 F CA 04/11/2025 COVID19
COVID19
 MODERNA
MODERNA
 044B21A
044B21A
Chest X-ray normal, Computerised tomogram thorax normal, Cough, Fatigue, Orophar... Chest X-ray normal, Computerised tomogram thorax normal, Cough, Fatigue, Oropharyngeal pain; Post-acute COVID-19 syndrome, Productive cough More
Chronic lung phlegm, coughing, very frequent, also bad fatigue and some other symptoms which are not... Chronic lung phlegm, coughing, very frequent, also bad fatigue and some other symptoms which are not as bad like sore throat, but I am in a hurry to complete this form before you close me out. More
✓
2835855 5 M TX 04/11/2025 MMR
MMR
MMR
MMR
MMR
MMR
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y013130
Y013130
Unevaluable event; Extra dose administered, No adverse event; Unevaluable event;... Unevaluable event; Extra dose administered, No adverse event; Unevaluable event; Extra dose administered, No adverse event; Unevaluable event; Extra dose administered, No adverse event; Unevaluable event; Extra dose administered, No adverse event More
None None
2835856 74 F CO 04/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Patient given Priorix intramuscularly instead of the required subcutaneous route. Patient has not re... Patient given Priorix intramuscularly instead of the required subcutaneous route. Patient has not reported any adverse reaction to the incorrect route. More
2835857 71 M KY 04/11/2025 COVID19
 PFIZER\BIONTECH
 LN0591
Arthralgia, Injected limb mobility decreased, Injection site pain Arthralgia, Injected limb mobility decreased, Injection site pain
Patient presents to clinic for right sided shoulder pain following Pfizer covid-19 vaccine at the cl... Patient presents to clinic for right sided shoulder pain following Pfizer covid-19 vaccine at the clinic yesterday 4/10 at approx 2:30 pm. Patient has had Moderna and Pfizer covid vaccines in past w/o incident Patient reports that at the time of injection there was no pain. However within 1 hour a sharp aching discomfort developed at injection site. Overnight the pain worsened and patient cannot move his arm all the way. Pain at rest 0/10 Pain with movement 8/10 OTC denies no previous injuries to the right shoulder, no surgeries to right shoulder. Patient expresses concern over "seeing the nurse drop the vaccine on the floor before giving it to me" More
2835858 4 M OK 04/11/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Y019175
Erythema, Induration, Peripheral swelling; Erythema, Induration, Peripheral swel... Erythema, Induration, Peripheral swelling; Erythema, Induration, Peripheral swelling More
Pt returned to clinic after 48 hours with guarantor reporting swelling and redness around arm that ... Pt returned to clinic after 48 hours with guarantor reporting swelling and redness around arm that started the next day after administration of vaccines. Pt came home from school the day after vaccines at 13:00 reporting swelling of arm with no pain present. Firmness in swelling felt around deltoid muscle . Pt returned to clinic after 48 hrs for f/u with visible swelling and redness noted in length 6 inchs x width 6 inchs . Upper arm swelling measurements taken around entire arm were 9 inches compared to non vaccinated arm of 7 inches around. Prescribed antibiotic and Benadryl by PCP. Mother instructed to continue to monitor and mark new changes if increased swelling or report any changes as needed and return to clinic asap with any new concerns. Educated on worsening S/S and to return to clinic or go to nearest ER if necessary. More
2835859 5 F UT 04/11/2025 TYP
 SANOFI PASTEUR
 W1A991M
Incorrect dose administered Incorrect dose administered
Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. ... Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. Counseling and training done with MA. More
2835860 7 M WA 04/11/2025 DTAP
 SANOFI PASTEUR
 3CA25C1
Urticaria Urticaria
Widespread hives all over patient's body. Widespread hives all over patient's body.
2835861 4 M UT 04/11/2025 TYP
 SANOFI PASTEUR
 W1A991M
Incorrect dose administered Incorrect dose administered
Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. ... Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. Counseling and training done with MA. More
2835862 9 F IL 04/11/2025 HEP
IPV
MMR
MMR
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 32M5G
X1C891M
x027447
x027447
LX494
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event More
Patient pulled arm away during subcutaneous administration of MMR vaccine to left arm. Less than hal... Patient pulled arm away during subcutaneous administration of MMR vaccine to left arm. Less than half of the dose appeared to have been administered. Parent was informed and consented to re-administration of the vaccine. A repeat dose of the same MMR lot number was administered subcutaneously to the right arm. No adverse symptoms were observed. More
2835863 2 F UT 04/11/2025 TYP
 SANOFI PASTEUR
 W1A991M
Wrong product administered Wrong product administered
Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. ... Multidose vial purchased erroneously and placed in the Polio location. MA did not verified vaccine. Counseling and training done with MA. More
2835864 19 M MA 04/11/2025 HPV9
MENB
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 1957407
77KA5
Injection site erythema, Injection site rash, Injection site swelling; Injection... Injection site erythema, Injection site rash, Injection site swelling; Injection site erythema, Injection site rash, Injection site swelling More
Patient complains of swelling, redness at site as well as rash at site of injection Patient complains of swelling, redness at site as well as rash at site of injection
2835865 71 F TX 04/11/2025 PNC21
PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 y019158
y019158
Y019158
Y019158
Hypoaesthesia, Influenza like illness, Injection site pain, Nausea; Chills, Head... Hypoaesthesia, Influenza like illness, Injection site pain, Nausea; Chills, Headache, Injection site erythema, Injection site swelling, Nausea; Hypoaesthesia, Influenza like illness, Injection site pain, Nausea; Chills, Headache, Injection site erythema, Injection site swelling, Nausea More
She experienced flu-like symptoms the night of the vaccine. She states extremely painful arm at inje... She experienced flu-like symptoms the night of the vaccine. She states extremely painful arm at injection site. Arm is still sore and mild numbness over a week later. States she slept for 24 hours after vaccine and was extremely nauseous. More
2835866 47 M PA 04/11/2025 COVID19
COVID19
 JANSSEN
MODERNA
 206172117
041J21A
Herpes zoster oticus; Herpes zoster oticus Herpes zoster oticus; Herpes zoster oticus
Ramsey Hunt Syndrome. See Medical history Ramsey Hunt Syndrome. See Medical history
✓ ✓
2835867 4 F AL 04/11/2025 DTAPIPV
MMR
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U79088A
Y009782
Y017061
Injection site reaction; Injection site reaction; Injection site reaction Injection site reaction; Injection site reaction; Injection site reaction
Moderate to severe injection site reaction over anterior R thigh, 10 - 12 cm in greatest dimension. ... Moderate to severe injection site reaction over anterior R thigh, 10 - 12 cm in greatest dimension. Developed in first 24 hours. No systemic sx noted. Advised cool compresses, Tylenol / Motrin PRN, and OTC topical 1% HC for itching PRN. Discussed signs of anaphylaxis, reasons to seek emergency care. More
2835872 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hepatic enzyme increased Hepatic enzyme increased
post-hepatic transplant so elevated liver labs/transient elevation in liver labs; liver transplant; ... post-hepatic transplant so elevated liver labs/transient elevation in liver labs; liver transplant; This serious case was reported by a physician via sales rep and described the occurrence of elevated liver enzymes in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced elevated liver enzymes (Verbatim: post-hepatic transplant so elevated liver labs/transient elevation in liver labs) (serious criteria life threatening) and liver transplant (Verbatim: liver transplant) (serious criteria clinically significant/intervention required). The outcome of the elevated liver enzymes was resolved and the outcome of the liver transplant was not reported. The reporter considered the elevated liver enzymes to be related to Shingrix. It was unknown if the reporter considered the liver transplant to be related to Shingrix. The company considered the elevated liver enzymes and liver transplant to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 08-APR-2025 The reporter stated that the patient was post-hepatic transplant so elevated liver labs were serious, even if the elevated labs were transient.; Sender's Comments: Hepatic enzyme increased and Liver transplant are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
✓
2835873 46 F NJ 04/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 327EB
Dizziness, Dyspnoea, Nausea, Nervousness, Paraesthesia Dizziness, Dyspnoea, Nausea, Nervousness, Paraesthesia
After receiving TwinRix vaccine, patient felt nervous, dizzy, light headed and nauseous, tingling i... After receiving TwinRix vaccine, patient felt nervous, dizzy, light headed and nauseous, tingling in her hands and had shortness of breath. I called 911. Pt had some gatorade to drink. She started feeling better later on. Emt took her to hospital for further evaluation. More
2835874 54 M CA 04/11/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945661
Rash Rash
Patient reports rash all over body. Patient states rash subsided over a few days. Patient reports rash all over body. Patient states rash subsided over a few days.
2835875 64 F OR 04/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 445TK
445TK
Chills, Erythema, Pain, Pain in extremity, Peripheral swelling; Skin warm Chills, Erythema, Pain, Pain in extremity, Peripheral swelling; Skin warm
Pt presented with swollen, red, warm arm. Pt also had chills overnight. Pt c/o pain in the arm, pt r... Pt presented with swollen, red, warm arm. Pt also had chills overnight. Pt c/o pain in the arm, pt reports pain when laying over affected arm or even when she lifts up her arm. Clinic provider will assess pt further and treat symptoms. More
2835876 21 F CO 04/11/2025 VARCEL
 MERCK & CO. INC.
 Y014182
Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
4/11/25 Pt reports being pregnant after administration of Varivax subcutaneously in the L upper arm ... 4/11/25 Pt reports being pregnant after administration of Varivax subcutaneously in the L upper arm for employment. No immediate side effects LMP 3/6/25, estimated due date per LMP 12/16/25. First OB appointment scheduled for 5/16/25. More
2835877 15 F CA 04/11/2025 HEP
IPV
MMR
TD
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
 95BJ9
Y1A201M
Y003499
U8492BA
Y015100
Dyskinesia, Loss of consciousness, Syncope; Dyskinesia, Loss of consciousness, S... Dyskinesia, Loss of consciousness, Syncope; Dyskinesia, Loss of consciousness, Syncope; Dyskinesia, Loss of consciousness, Syncope; Dyskinesia, Loss of consciousness, Syncope; Dyskinesia, Loss of consciousness, Syncope More
Hep B, Varicella and Td administered in left deltoid. Following the 3rd vaccine the patient fainted... Hep B, Varicella and Td administered in left deltoid. Following the 3rd vaccine the patient fainted and moved arms and legs involuntarily for less than 5 seconds. She regained consciousness in 1-2 minutes. She reports the same thing happened after the HPV vaccine when she got immunizations in 10/2024 More
2835887 25 M SC 04/11/2025 HEPAB
HPV9
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 P2443
Y012508
U8115AA
Seizure; Seizure; Seizure Seizure; Seizure; Seizure
Patient received 3 vaccinations. About 5 minutes after administration he proceeded to have a seizur... Patient received 3 vaccinations. About 5 minutes after administration he proceeded to have a seizure for approx 1 min before losing consciousnous for approx 2 min. Upon awakening he threw up. EMS was called to the scene. Pt began feeling much better afterwards. EMS took vitals and Blood Sugar reading. Pt was allowed to go home. No history of seizures or prior adverse reactions were reported or claimed. More
2835888 69 M PA 04/11/2025 COVID19
 MODERNA
 8081564
Injection site pain, Mobility decreased, Rash, Secretion discharge Injection site pain, Mobility decreased, Rash, Secretion discharge
Spikevax administered on 3/22/25 @ 11:27 am. PT reported that about an hour after vaccination, he s... Spikevax administered on 3/22/25 @ 11:27 am. PT reported that about an hour after vaccination, he started to get pain at the injection site. The next morning pt felt that he could not move his arm and thought he was having a stroke. Pt then noticed he was getting small raised bumps and eventually excesive mucus. Pt took atarax on his own(has on hand for another condition) and called his PCP and infectious disease dr. Pt was seen by both, who as per patient, agreed to monitor pt's condition. At this time, while pt feels he has not fully recovered, he is improving and feels he will be recovered soon. More
2835889 22 F MO 04/11/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 33025BD
33025BD
Chest pain, Dyspnoea, Laboratory test normal, Muscle spasms, Pollakiuria; Throat... Chest pain, Dyspnoea, Laboratory test normal, Muscle spasms, Pollakiuria; Throat tightness More
Have had chest pains, trouble breathing pain in arms muscle spasm feel like throat is constantly clo... Have had chest pains, trouble breathing pain in arms muscle spasm feel like throat is constantly closing can't eat or drink without it feeling like my throat is closing now can't stop using bathroom (peeing) and constipated More
2835890 1 M IL 04/11/2025 DTAPIPVHIB
DTAPIPVHIB
HEPA
HEPA
PNC15
PNC15
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 UK194AA
UK194AA
DN273
DN273
Y010032
Y010032
Febrile convulsion, Influenza A virus test negative, Influenza B virus test nega... Febrile convulsion, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Tremor; Febrile convulsion, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Tremor; Febrile convulsion, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Tremor More
Pt taken to ER with possible febrile seizure. Parent reported he was shaking and had foam near his m... Pt taken to ER with possible febrile seizure. Parent reported he was shaking and had foam near his mouth, lasted approx 10 mins per mom. Mom gave 3.75mL Tylenol given at 2200. Parents state fever was 101.4 at home. More
2835891 0.33 M WA 04/11/2025 DTAPIPVHIB
DTAPIPVHIB
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
 3CA11C1
3CA11C1
HR3650
HR3650
Crying, Dyspnoea, Hypotonic-hyporesponsive episode, Infant irritability, Pallor;... Crying, Dyspnoea, Hypotonic-hyporesponsive episode, Infant irritability, Pallor; Peripheral coldness, Somnolence; Crying, Dyspnoea, Hypotonic-hyporesponsive episode, Infant irritability, Pallor; Peripheral coldness, Somnolence More
Medical Assistant administered vaccines. Per her and father's report, patient's face start... Medical Assistant administered vaccines. Per her and father's report, patient's face started to turn white about 5 minutes after though was responsive, active, and smiling. Medical assistant informed provider and was advised to watch and wait in the room. About 5 minutes later medical assistant informed provider color was not returning. Provider went into the room. Patient had significant pallor, face was cold to touch, however was responsive, active, smiling. Continued to stay in the room to monitor. About 5 more minutes passed, patient started to get more color return to his face. Shortly after started to become irritable and started to cry intermittently, breaths appeared shallow, counted to be 42 breaths per minute, then became tired and seemed to have difficulty keeping his eyes open. Was responsive to stimuli however very drowsy. Would slightly respond when father tried to wake him. Concern for Hypotonic-hyporesponsive episode. EMS called. EMS arrived to exam room. Patient care summary printed with vaccines administered while EMS was present for them to take to the ER. Note completed after they were on their way to ER. More
2835892 4 F GA 04/11/2025 DTAPIPV
DTAPIPV
HEPA
HEPA
MMRV
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.





Computerised tomogram normal, Electroencephalogram abnormal, Magnetic resonance ... Computerised tomogram normal, Electroencephalogram abnormal, Magnetic resonance imaging normal, Scan with contrast normal, Seizure; Sensory disturbance; Computerised tomogram normal, Electroencephalogram abnormal, Magnetic resonance imaging normal, Scan with contrast normal, Seizure; Sensory disturbance; Computerised tomogram normal, Electroencephalogram abnormal, Magnetic resonance imaging normal, Scan with contrast normal, Seizure; Sensory disturbance More
Beginning in April 2024, my daughter began reporting a recurring sensation described as a "leg ... Beginning in April 2024, my daughter began reporting a recurring sensation described as a "leg fizzle" in her left leg. Over the following weeks, these sensations progressed into observable physical seizure activity, which began in May 2024. An EEG was performed in May, confirming seizure activity. Both MRI and CT scans were conducted and returned normal findings. Despite these normal imaging results, the seizure activity has continued to progress. She was officially diagnosed with a seizure disorder in mid-2024 and began treatment shortly thereafter. She is currently taking Aptiom (eslicarbazepine acetate) and lacosamide as prescribed anticonvulsant medications. However, she continues to experience nightly seizures, indicating that the condition is not fully controlled by current treatment. More
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2835893 14 F VA 04/11/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Asthenia, Fall, Lethargy, Loss of consciousness, Musculoskeletal stiffness; Pall... Asthenia, Fall, Lethargy, Loss of consciousness, Musculoskeletal stiffness; Pallor More
Within fifteen minutes of receiving the MMR vaccine, my daughter stiffened and and drained of color.... Within fifteen minutes of receiving the MMR vaccine, my daughter stiffened and and drained of color. She then closed her eyes and fell over with her body stiffened. I was able to catch her as she fell. She remained unconscious while we yelled for the nurse to come back out to the reception. Within a couple minutes she began to relax and come to. She was given some fruit juice and crackers and they took her blood pressure. She felt strong enough to return to the car within about twenty minutes. For the remainder of the day she felt very weak and was lethargic. More
2835937 20 F MA 04/11/2025 FLU3
UNK
 SEQIRUS, INC.
UNKNOWN MANUFACTURER
 946609
3CA59C
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
This Tuberculin Derivation Expires 11/2027. It as opened on 3/4/2025 with BUD date 4/2/2025. It had ... This Tuberculin Derivation Expires 11/2027. It as opened on 3/4/2025 with BUD date 4/2/2025. It had not been disposed of on 4/2/2025 and was used on 4/4/2025 for TB skin testing. The patient was seen on 4/7/2025 for TB Read (before this was realized) without any averse reactions. More
2835483 OK 04/10/2025 HPV9
 MERCK & CO. INC.
 Y010656
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
no adverse event; infant patient was inadvertently administered an adolescent dose of GARDASIL 9; T... no adverse event; infant patient was inadvertently administered an adolescent dose of GARDASIL 9; This spontaneous report has been received from a consumer regarding an infant patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 03-MAR-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, 0.5 milliliter, lot number Y010656 which has been verified to be valid, expiration date reported and validated as 29-NOV-2026 (strength, scheme, route of administration, anatomical site not reported). Medical assistant stated that an infant patient was inadvertently administered an adolescent dose that was meant for their older sibling who was of age to receive their first dose. Medical Assistant confirmed the patient involved has not experienced any medical concerns or symptoms after the dose of the vaccine was inadvertently administered to the infant patient. No additional information provided. (Product administered to patient of inappropriate age) (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02763078-02763070 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V7QvFYAV|04042025230052|4876 , Central date : 2025-04-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2260612 , MNSC case number : 02763078 , MNSC interaction number : 02763070 , Integration log UniqueID : 500UW00000V7QvFYAV|04042025230052|4876 , Service cloud CaseID : 500UW00000V7QvFYAV More
2835484 F 04/10/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Carditis, Heavy menstrual bleeding Arthralgia, Carditis, Heavy menstrual bleeding
hearts inflamed; bleeds more; joint pain; she got sick; This is a spontaneous report received from a... hearts inflamed; bleeds more; joint pain; she got sick; This is a spontaneous report received from a Physician from medical information team. A 44-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "hearts inflamed"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "bleeds more"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; ILLNESS (non-serious), outcome "unknown", described as "she got sick ". Clinical course: The patient asked if the data reports of the menstrual irregularities were released or known in Mar2022 to the public, physicians, or patients. She was upset about how everything played out, not having enough data, and being forced into taking the vaccine. She stated that Pfizer should be held liable for the damages her body was going through. She learned a big lesson and realized that she would never take a vaccine that wasn't FDA approved, as it came out too quickly and no one knew the safety or post marketing results. As a physician, she was not recommending the Pfizer covid vaccine to anyone until all of the safety data was out and then they will talk about it. She spoke to Pfizer MI previously and received an email from Medical Information with an attachment regarding the side effects of the Pfizer Covid vaccine. She had read the information and sent it to the doctor that was in charge of her medical exemption, in which the doctor provided that they didn't know about the information that was sent. The patient asked if Pfizer had released a meta-analysis in 2021 to providers, public or anyone, or if it most likely post marketing collection data. The information that HCP was previously sent included reports of menstrual irregularities and CONS. She was specifically speaking upon reports of menstrual irregularities. She saw the data collected in Sep2021 and Sep2022 and onwards, in which she was trying to get the vaccine around Mar2022. She was compliant with the 1st and 2nd shot and there were case reports of vaccines causing things such as bleeding, heart problems, joint pain, and other things. The patient stated that she took the vaccine, she bled more, had joint pain, her heart was inflamed, and her body was getting damaged because of the vaccine but it's not a severe reaction. She stated that she got sick from the Pfizer Covid-19. It was very frightening and everyone continued to say, "take it, take it, take it". The patient asked who was compensating patients for their body getting damaged by the vaccine and if the CICP was a program from Pfizer or if it's a federal program. She was also querying if it was considered fully vaccinated if you take the 1st and 2nd dose, then why does the booster need to be administered.; Sender's Comments: There is not a reasonable possibility that the reported events heart inflammation, menstrual bleeding, arthralgia, and illness were related to the suspect product events most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate. More
2835485 78 F NY 04/10/2025 PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH


Abdominal pain, Abdominal pain upper, Alopecia, Amnesia, Arthralgia; Dizziness, ... Abdominal pain, Abdominal pain upper, Alopecia, Amnesia, Arthralgia; Dizziness, Erythema, Eye disorder, Hepatic pain, Inflammation; Injection site pain, Muscle atrophy, Pruritus, Rash, Vomiting More
memory loss; rash; itchy skin; stomach pain; liver pain; abdominal pain; dizziness; eye problem; inf... memory loss; rash; itchy skin; stomach pain; liver pain; abdominal pain; dizziness; eye problem; inflammation of the ankle; vomiting; red face; hair loss; shoulder and arm pain of the injection; shoulder and arm pain of the injection; reduction of muscular tissue; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Dec2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years for immunisation. The patient's relevant medical history included: "Cardiac ablation", start date: 2024 (unspecified if ongoing); "Lung cancer", start date: 2019 (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 09Dec2024, outcome "not recovered"; DIZZINESS (non-serious) with onset 09Dec2024, outcome "not recovered"; EYE DISORDER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "eye problem"; ALOPECIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "hair loss"; ARTHRITIS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "inflammation of the ankle"; PRURITUS (non-serious) with onset 09Dec2024, outcome "not recovered", described as "itchy skin"; HEPATIC PAIN (non-serious) with onset 09Dec2024, outcome "not recovered", described as "liver pain"; AMNESIA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "memory loss"; RASH (non-serious) with onset 09Dec2024, outcome "not recovered"; ERYTHEMA (non-serious) with onset 09Dec2024, outcome "not recovered", described as "red face"; MUSCLE ATROPHY (non-serious) with onset 09Dec2024, outcome "not recovered", described as "reduction of muscular tissue"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2024, outcome "not recovered" and all described as "shoulder and arm pain of the injection"; ABDOMINAL PAIN UPPER (non-serious) with onset 09Dec2024, outcome "not recovered", described as "stomach pain"; VOMITING (non-serious) with onset 09Dec2024, outcome "not recovered". Therapeutic measures were not taken as a result of amnesia, rash, pruritus, abdominal pain upper, hepatic pain, abdominal pain, dizziness, eye disorder, arthritis, vomiting, erythema, alopecia, vaccination site pain, arthralgia, muscle atrophy. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2835486 M 04/10/2025 COVID19
 PFIZER\BIONTECH
Malaise, Vomiting Malaise, Vomiting
vomiting; being in bed all night; ROUTE: subcutaneously; This is a spontaneous report received from ... vomiting; being in bed all night; ROUTE: subcutaneously; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "recovered"; MALAISE (non-serious), outcome "recovered", described as "being in bed all night"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "recovered", described as "ROUTE: subcutaneously". Additional information: Patient described vomiting and being in bed all night after receiving the Pfizer COVID-19 vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2835487 68 F GA 04/10/2025 IPV
 SANOFI PASTEUR
 W1A191M
Expired product administered, No adverse event Expired product administered, No adverse event
patient received an expired dose of ipol with no reported adverse events; Initial information receiv... patient received an expired dose of ipol with no reported adverse events; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 68 years old female patient received an expired dose of IPV (Vero) [Ipol] with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Immunisation. On 07-Apr-2025, the patient received an expired, 0.5ml dose (once) of suspect IPV (Vero), Suspension for injection, Strength standard, lot W1A191M Expiry date 16-Feb-2025 via subcutaneous route in the left arm for prophylactic vaccination (immunisation) with no reported adverse events (expired product administered) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2835488 CO 04/10/2025 IPV
 SANOFI PASTEUR
 W1PS11M
No adverse event, Product storage error No adverse event, Product storage error
patient received IPOL After excursion with no reported adverse events; Initial information received ... patient received IPOL After excursion with no reported adverse events; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA100789 (same reporter) This case involves an unknown age and unknown gender patient who received IPV (Vero) [IPol] (opened) after temperature excursion with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date the patient received an unknown dose of suspect IPV (Vero) (opened), Suspension for injection, lot W1PS11M, (Unknown Strength) and expiry date 08-Sep-2025 via unknown route in unknown administration site for immunisation, after being exposed to temperature excursion with no reported adverse events (poor quality product administered) (Latency Same day). Reportedly, Duration and temperature of excursion: 22-Jan-25: negative 13 F for 4 Hours; Previous Excursion: 31-Dec-24: 48 F for 30 minutes; Reason: Fridge malfunction; Was product administered: Yes, for opened IPol (opened); Was it related to a human error: No. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA100789:FLUZONE More
2835496 1.25 M 04/10/2025 HIBV
HIBV
MMR
MMR
PNC20
PNC20
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.







Crying, Feeling abnormal, Irritability, Lacrimation increased, Ocular hyperaemia... Crying, Feeling abnormal, Irritability, Lacrimation increased, Ocular hyperaemia; Pyrexia, Rash, Rash erythematous, Sleep disorder, Stridor; Crying, Feeling abnormal, Irritability, Lacrimation increased, Ocular hyperaemia; Pyrexia, Rash, Rash erythematous, Sleep disorder, Stridor; Crying, Feeling abnormal, Irritability, Lacrimation increased, Ocular hyperaemia; Pyrexia, Rash, Rash erythematous, Sleep disorder, Stridor; Crying, Feeling abnormal, Irritability, Lacrimation increased, Ocular hyperaemia; Pyrexia, Rash, Rash erythematous, Sleep disorder, Stridor More
Within 48 hrs of shot, my son was crying everytime he tried to walk and his sleep was disrupted but ... Within 48 hrs of shot, my son was crying everytime he tried to walk and his sleep was disrupted but he began feeling a little better. 7-8 days after the vaccines, he developed a fever of 101, was lethargic, so fussy, miserable. He fevered off and on for three days, then developed raspy breathing and a clear runny nose. The next day he developed a red bumpy rash on his cheeks, along with very watery, bloodshot eyes. It seems like he has a full on measles infection. More
2835498 NY 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Guillain-Barre syndrome Guillain-Barre syndrome
had been diagnosed with Guillain-Barre syndrome after vaccination with SHINGRIX; This serious case w... had been diagnosed with Guillain-Barre syndrome after vaccination with SHINGRIX; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: had been diagnosed with Guillain-Barre syndrome after vaccination with SHINGRIX) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 The reporter reported that he found a on line group of consumers posting they had been diagnosed with Guillain-Barre syndrome after vaccination with Shingrix. This case is linked with US2025041538, reported by same reporter.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025041538:Same reporter 1 of 2 More
2835501 F PA 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
she has not received the 2nd dose yet; This non-serious case was reported by a consumer via call cen... she has not received the 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine 0.5 ml on 23-APR-2022). On an unknown date, the patient did not receive the 2nd dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she has not received the 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 The reporter was a 76-year-old female patient. The patient reported on April 4th, 2025, that she received her 1st dose of Shingrix vaccine on April 23, 2022, at a local pharmacy. The patient did not know in which arm she received the vaccine. The patient reported she had not received the 2nd dose yet. She reported she was not aware that she had not taken the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835502 M OR 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
The patient took frist dose of Shingrix several years ago but not yet received the second dose; This... The patient took frist dose of Shingrix several years ago but not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose several years ago). 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: The patient took frist dose of Shingrix several years ago but not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-APR-2025 The patient received the first dose of Shingrix several years ago and unable to provide a date of vaccination, lot number with expiry date. The patient had not yet received the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
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