🏥 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 💀 🏥 🚑 ♿ ⚠️
2838034 56 F CO 04/25/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4D333
No adverse event, Underdose No adverse event, Underdose
No side effects, patient was just administered a pediatric dose rather than an adult dose. No side effects, patient was just administered a pediatric dose rather than an adult dose.
2838035 0.17 F GA 04/25/2025 DTAP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 M52GG
2G273
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
patient was given pediarix and infarix at same date and time patient was given pediarix and infarix at same date and time
2838036 2 F ME 04/25/2025 UNK
 UNKNOWN MANUFACTURER
Ear pain, Rash Ear pain, Rash
since being vaccinated the pt has been complaining about her ears hurting. Her right ear seems to be... since being vaccinated the pt has been complaining about her ears hurting. Her right ear seems to be hurting more than the left. She keeps putting her hand deep into her mouth like it is hurting her also. On 4/24/25 when the mother was changing the pts diaper she noticed a rash that resembled ant bites was from the waist line up to the neck line. It didn't seem to be itching or hurting her. She was taken to her Pediatrician on 4/25/25 for to check the rash. It has since spread to the back. She was given a strep test but not given the results yet. The mother mentioned to the staff that she thought it maybe related to the vaccine that she recently was given but that was quickly dismissed by them. She was told it looked viral and not vaccine related. More
2838037 52 M FL 04/25/2025 COVID19
 PFIZER\BIONTECH
 LN0589
Expired product administered Expired product administered
vaccine was expired when given vaccine was expired when given
2838038 1.17 F KS 04/25/2025 HEPA
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012227
Y014440
Injection site erythema, Injection site swelling; Injection site erythema, Injec... Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling More
Redness and swelling at the injection site noticed on 04/24/25 Redness and swelling at the injection site noticed on 04/24/25
2838039 51 F TX 04/25/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Blood calcium increased, Blood glucose normal, Blood magnesium increased, Brain ... Blood calcium increased, Blood glucose normal, Blood magnesium increased, Brain fog, Cardiac monitoring; Dysphonia, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Joint swelling; Paraesthesia, Paraesthesia oral, Peripheral swelling, Pharyngeal swelling, Protein total increased; Rash, Rash macular, Urticaria More
Saturday, 4/12/25 @ approx 10am I noticed a welping rash on my abdomen & in between my breasts w... Saturday, 4/12/25 @ approx 10am I noticed a welping rash on my abdomen & in between my breasts when I was getting dressed. My throat felt a little swollen & my voice was raspy sounding. I called (redacted) & spoke to the on call operator who said I should probobly go to the nearest Urgent Care. At approx 11am I arrived @ Urgent Care in (redacted). The doctor observed the rash had spread to my arms, back, neck. My face/throat was swollen. Lips/tongue numb & tingly. Heart rate was @ 96bpm. The doctor injested steroids & had me wait in the room for approx 15mins. During this time the nurse/doctor came to check my vitals/swelling. Because I drove myself to the Urgent Care, the doctor opted to not give me the Benadryl shot but instead prescribed 3 prescriptions that she instructed that I take 2 (Famotidine 20mg & Benadryl) right away after picking up at pharmacy. The 3rd prescription (Prednisone 20mg) I was to start taking immediately the following day & continue taking all medications as directed. If symptons worsen, to contact them. On Monday, 4/14/25 I had a routine visit scheduled with my Endocrinoligist, I saw Dr. at Endocrinology & Assoc. My rash was gone, but obvious swelling was still present. My Endoc. noted my rapid heart rate (still in 90's) & decided to make a few adjustments to my routine Blood Pressure medication (Losartan/HCTZ) & to cut the morning dose to half. She also ordered blood work, The blood results indicated several things: My Calcium was very High @ 10.7 0n a range of 8.4-10.2mg/dl. My Glucose was High @ 140 on a range of 70-110mg/dl. My T. Protein was High @ 8.3 on a scale of 6.0-7.8g/dl. Dr. requested that I repeat labs in one week. In addition, she is having me monitor & upload my BP & heart rate to her throughout the week. On Wednesday, 4/16/25 when I was getting dressed I noticed my skin appeared "blotchy". No itching or rash, just blotchy. I felt a little tired feeling but never thought much more bout it. My husband travels with his career & was out of town this week. The end of this day I came home never set our home alarm, never fed the dog, fully dressed shoes & all went to sleep on the living room sofa. I am sharing this because it was about this time that I began a strange "brain fog" I cannot explain. Friday, 4/18/25 I started experiencing my calves, ankles & feet swelling if I stood on my feet for too long. Tuesday, 4/22/25 I went for 2nd set of blood work. New results indicated Calcium had went down @10.2, still high end of range but down. My Glucose was still High @ 102 but down from the 140 week prior. However, new week results indicated a new issue. My Magnesium is now High @ 2.4 0n a scale of 1.6-2.3mg/dl. I am currently having tingling & numbness in both forearms hands/fingers. The raspy voice still there but not as bad as before. I am still experencing the swelling in calves, ankles & feet. Thankfully the brain fog is no longer there. More
2838040 70 M FL 04/25/2025 COVID19
 PFIZER\BIONTECH
 LN0589
Expired product administered Expired product administered
vaccine expired when given vaccine expired when given
2838041 8 F MI 04/25/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
In error patient was suppose to receive Tdap In error patient was suppose to receive Tdap
2838042 10 M CO 04/25/2025 TYP
YF
 SANOFI PASTEUR
SANOFI PASTEUR
 Y2A021M
UK134AA
Crying, Loss of consciousness, Musculoskeletal stiffness; Crying, Loss of consci... Crying, Loss of consciousness, Musculoskeletal stiffness; Crying, Loss of consciousness, Musculoskeletal stiffness More
Patient was fine with first vaccine administered (Typhim VI) but after yellow fever vaccine, patient... Patient was fine with first vaccine administered (Typhim VI) but after yellow fever vaccine, patient began to cry and then went stiff. Loss of consciousness occurred. Patient began to slide off the chair but was caught before hitting the ground. Patient recovered shortly thereafter and was kept at the pharmacy for observation for several minutes. No further loss of consciousness or adverse symptoms occurred. Patient was offered a drink of cold water and then taken home by their parents. Follow up occurred 20 minutes after patient left facility and no further adverse events or symptoms were reported by patient's mother. More
2838043 0.67 M CO 04/25/2025 PPV
 MERCK & CO. INC.
 Y009239
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
Patient was due for Prevnar 20, he was given Pneumovax 23 instead. Mother reports no adverse event o... Patient was due for Prevnar 20, he was given Pneumovax 23 instead. Mother reports no adverse event or side effects after vaccination. More
2838044 75 F TX 04/25/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Chills, Decreased appetite, Dizziness, Headache, Pain in extremity; Sleep disord... Chills, Decreased appetite, Dizziness, Headache, Pain in extremity; Sleep disorder More
pt says she after getting the vaccine she had soreness in left arm and had developed a bad headache,... pt says she after getting the vaccine she had soreness in left arm and had developed a bad headache, became dizzy, chills with no fever, loss of appetite, and did not sleep well. By morning she felt some better but not well. Her arm is still tender and she is still tired. More
2838045 53 F 04/25/2025 HEPA
 MERCK & CO. INC.
 y017625
Burning sensation, Erythema, Influenza like illness Burning sensation, Erythema, Influenza like illness
flu like symptoms and redness and burning flu like symptoms and redness and burning
2838046 18 M IL 04/25/2025 MENB
 PFIZER\WYETH
 LF5302
Pain Pain
Persistent Stinging in muscle. Pain increasing when raising arm. Persistent Stinging in muscle. Pain increasing when raising arm.
2838047 4 M AR 04/25/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U7908AB
Y016874
Injection site erythema, Injection site induration, Injection site swelling; Inj... Injection site erythema, Injection site induration, Injection site swelling; Injection site erythema, Injection site induration, Injection site swelling More
4 y/o child was given routine vaccines on 4/22/2025 around 4:15pm. Mother called facility on 4/24/25... 4 y/o child was given routine vaccines on 4/22/2025 around 4:15pm. Mother called facility on 4/24/25 wanting to speak to a nurse. I talked with her. Mother states on 4/23/2025 around 8:30pm-child was taking a bath and removed the bandaid from the arm and had a big puffy ring under the bandaid. Mother states arm was swollen, red and had a hard knot under bandaid. She took him to the ER that night. She states they gave him Benadryl, a steriod, and antibiotics and said they was treating him for an allergic reaction to the vaccine and cellulitis. Mother states the area was 12cm x 11cm in size on his arm. She denies that the child was having any pain, states it was very itchy to him. I explained to her again about possible swelling, redness and knot with any vaccine. I questioned her about a possible reaction to the bandaid. It was left on the arm for over 24 hours. She denies him ever having a problem with bandaids in the past. When I spoke with mother on 4/24/2025 she was at Dr.'s office with child for a follow up. She states that the area had gotten worse since 4/23/25 night @ the ER with more swelling and the skin was even starting to crack open. I called mother today 4/25/2025 to follow up and to see how MD appt. was yesterday evening. Mother states symptoms have improved a lot since yesterday. She states the swelling has started to go down and it's not as red. She states nurse practitioner did feel like it was an allergic reaction to the vaccine but wasn't 100% sure. NP advised mother to continue giving child the medication prescribed in the ER and no new meds were prescribed. Mother asked about child getting Tdap in the future when child is 11 years of age. I advised her that she would want to discuss that with PCP at that time. She is states she wants him to get it if he can since it will be the last Tdap he has to get for school. Advised mother that would be up to his PCP. Mother thanked me for calling and checking on the child today. More
2838048 13 F WI 04/25/2025 HPV9
 MERCK & CO. INC.
 Y012864
Loss of consciousness Loss of consciousness
Patient passed out when checking out from her visit. Patient was observed for 10 minutes in the exam... Patient passed out when checking out from her visit. Patient was observed for 10 minutes in the exam room post vaccine. Patient regained consciousness quickly and was assisted to a wheelchair. Patient was laid on exam table in supine position with head of bed at approximately 30 degrees and given juice to drink after sitting up further. More
2838049 66 F NM 04/25/2025 COVID19
MMR
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
A2B72
Fine motor skill dysfunction, Hypoaesthesia, Pain, Paraesthesia; Fine motor skil... Fine motor skill dysfunction, Hypoaesthesia, Pain, Paraesthesia; Fine motor skill dysfunction, Hypoaesthesia, Pain, Paraesthesia More
Continual paresthesia in right arm for past month since vaccination. Numbness, tingling, shooting pa... Continual paresthesia in right arm for past month since vaccination. Numbness, tingling, shooting pains, more pronounced at night. Slight difficulty with fine motor activities of right fingers. More
2838050 36 F CA 04/25/2025 PPV
 MERCK & CO. INC.
Unevaluable event Unevaluable event
Wasn't given this vaccine it was allegedly administered to me by pharmacy on 10/04/2023 malicio... Wasn't given this vaccine it was allegedly administered to me by pharmacy on 10/04/2023 malicious intent to harm me and my mother More
2838051 0.33 M MA 04/25/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK112AA
Crying, Infant irritability Crying, Infant irritability
Inconsolable crying >12 hrs. Started in the evening of the vaccine date. Continued through the n... Inconsolable crying >12 hrs. Started in the evening of the vaccine date. Continued through the night and irritability persisted then next day. More
2838052 53 F VT 04/25/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 02TJ20-2A
02TJ20-2A
02TJ20-2A
050L20A
050L20A
050L20A
Acute kidney injury, Blood creatinine increased, Blood urea increased, Chronic k... Acute kidney injury, Blood creatinine increased, Blood urea increased, Chronic kidney disease, Dehydration; Dialysis, Glomerular filtration rate decreased, Immunisation reaction, International normalised ratio increased, Mitral valve incompetence; Renal failure; Acute kidney injury, Blood creatinine increased, Blood urea increased, Chronic kidney disease, Dehydration; Dialysis, Glomerular filtration rate decreased, Immunisation reaction, International normalised ratio increased, Mitral valve incompetence; Renal failure More
AFTER THE FIRST DOSE , MY CREATNIN WAS RISED UP TO 3.4 AND MY INR 18.0 THEY FOUND OUT I ALSO HAD 3 T... AFTER THE FIRST DOSE , MY CREATNIN WAS RISED UP TO 3.4 AND MY INR 18.0 THEY FOUND OUT I ALSO HAD 3 TEAR /HOLES ARUND MY MITRAL VALVE AFTER 2ND SHOT, I WAS GETTNG DEHUDRATED DESPITE OF DRINKINGSO MUCH WATER .AFTER SOME DOAGNOSTIC TESTING , MY CREATNI 8.5, I WAS TOLD I HAVE AKI OR KIDNET FAILURE.AND ENDED UP IN HOSPITAL 12 DAYS AND GETTING DIALYSISi NEVER HAD ADVERSE REATION TO ANY VACCINE TIL COVID VACCIN. SINCE THEN I HVE ADVERSE REACYTION TO FLUE VACCIN, MY KIDNEY FUNTION FALL AN CRATNING INSCREASES ABOUT 3.4 AND M NOW I HAVE A CHRONIC KIDNEY DSEASE . MY GFR IS LOW, MY CREATNING AND BUN ARE HIGH. More
✓ ✓ ✓
2838053 60 M MI 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 a725y
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received 3 extra dose ( 5 total). reports no issues patient received 3 extra dose ( 5 total). reports no issues
2838054 57 F VA 04/25/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Hypoaesthesia, Magnetic resonance imaging joint, Muscle spasms, Pain, Paraesthes... Hypoaesthesia, Magnetic resonance imaging joint, Muscle spasms, Pain, Paraesthesia; Sleep disorder, Tenderness, X-ray limb More
On the day of the injection (December 26, 2024), I experience soreness, deep pain, spasm and throbbi... On the day of the injection (December 26, 2024), I experience soreness, deep pain, spasm and throbbing . The arm and shoulder became tingly, numb and tender to the touch. The pain wakes me from sleep. The has not resolved over 4 months. I received the following therapies but the pain and discomfort have not resolved the issue: Ice therapy, massage, red light therapy, infrared therapy, sauna therapy, acupuncture, physical therapy, lidocaine spray, bio freeze patches and cream. I began using a prescription muscle relaxer and pain relief rub on Feb 18, 2025. I am currently receiving physical therapy. More
2838055 11 M GA 04/25/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Y010466
U8256AB
U8122AA
Dyskinesia, Loss of consciousness, Musculoskeletal stiffness, Unresponsive to st... Dyskinesia, Loss of consciousness, Musculoskeletal stiffness, Unresponsive to stimuli; Dyskinesia, Loss of consciousness, Musculoskeletal stiffness, Unresponsive to stimuli; Dyskinesia, Loss of consciousness, Musculoskeletal stiffness, Unresponsive to stimuli More
HPV, Tdap, and Meningitis given at 11:45am, 11:48am mom came in office after pulling out of parking ... HPV, Tdap, and Meningitis given at 11:45am, 11:48am mom came in office after pulling out of parking space stating child having a seizure. Mom explained he started to pass out, body went stiff, had a couple of jerking motions, and could not respond to her-patient evaluated by doctor, MA's, and PA at 1148am. Child was coherent, drinking juice, no other symptoms. More
2838056 10 F MI 04/25/2025 MNQ
 SANOFI PASTEUR
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
On 9/23/2024. Patient received menquadfi and she was under the age of 11. On 9/23/2024. Patient received menquadfi and she was under the age of 11.
2838057 82 F 04/25/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945663
Chest discomfort, Pruritus, Throat tightness Chest discomfort, Pruritus, Throat tightness
Patient was given Venofer 50mg IVP at 9:20am, not her first dose tolerated well previously. Patient&... Patient was given Venofer 50mg IVP at 9:20am, not her first dose tolerated well previously. Patient's second dose of Heplisav-B (Lot#:945663 EXP 1/31/27) series was given at 10:19 am with no reaction within the next 2 hours, previously her first dose was tolerated well. At 12:24 patient started complaining of itching all over her body, Benadryl 50mg PO given at 12:32 pm since there was no access available, she was done with her treatment. Within the next 2 minutes she started complaining of her throat closing up, 911 was called, her son was notified. She wanted to be taken to hospital, all her belongings went with her via ambulance. BP was stable throughout treatment, with a low reading that was due to loose cuff, BP was stable upon second reading. She complained that she had pills stuck in her chest area from this morning before she came in, PCT offered water at 12pm when the patient notified her. More
2838058 0.5 M CA 04/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Erythema of eyelid, Injection site discharge, Injection site inflammation, Rash Erythema of eyelid, Injection site discharge, Injection site inflammation, Rash
Redness of lower eyelids, inflammation of injection site along with bruising and discomfort. Rash lo... Redness of lower eyelids, inflammation of injection site along with bruising and discomfort. Rash located on the chest and abdomen. More
2838059 82 F WA 04/25/2025 PNC20
 PFIZER\WYETH
 LK6655
Injection site pruritus, Injection site rash, Skin mass Injection site pruritus, Injection site rash, Skin mass
Nodule under skin and rash near vaccine site and partially down arm that lasted for a few days. Slig... Nodule under skin and rash near vaccine site and partially down arm that lasted for a few days. Slightly itchy, but not extreme. Resolved on its own eventually. More
2838060 51 F VA 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Injection site erythema, Injection site rash, Injection site swelling, Injection... Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth More
Patient developed redness and swelling around injection site with raised edges, hot to touch, and ra... Patient developed redness and swelling around injection site with raised edges, hot to touch, and rash that extended down arm. patient is taking tylenol, using hydrocortisone cream, and going to take benadryl. Patient said hydrocortisone seemed to help some. More
2838061 4 M TN 04/25/2025 VARCEL
 MERCK & CO. INC.
 Y017062
Inappropriate schedule of product administration Inappropriate schedule of product administration
PT GIVEN LIVE VACCINE TOO CLOSE TO ANOTHER LIVE VACCINE. 25 DAYS OUT INSTEAD OF 28. INFORMED MOTHER... PT GIVEN LIVE VACCINE TOO CLOSE TO ANOTHER LIVE VACCINE. 25 DAYS OUT INSTEAD OF 28. INFORMED MOTHER OF ERROR AND TOLD WHEN TO RETURN FOR THE NEXT DOSE. More
2838062 1.67 F MI 04/25/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2345B
Incorrect dose administered Incorrect dose administered
An adult dose was given to to pediatric An adult dose was given to to pediatric
2838063 66 F AZ 04/25/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Blood glucose fluctuation, Fatigue, Headache, Influenza, Mobility decreased; Ras... Blood glucose fluctuation, Fatigue, Headache, Influenza, Mobility decreased; Rash, Skin warm More
at first she felt fine, and then it got sore in the evening. the next day she woke up she felt fatig... at first she felt fine, and then it got sore in the evening. the next day she woke up she felt fatigued and extreme headache. she tried to get rid of headache with allegra, an another decongestant. at 7:00 PM she took the low dose aspirin. she described the symptoms to having the worst flu, she went to bed most of the day. blood glucose spiked and decreased a bunch throughout the day. up to 250 at around 12:00PM. she said she took protein to try and combat the spikes. patient also has a large warm rash More
2838064 0.58 F SC 04/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Faeces discoloured Faeces discoloured
Within 45 minutes of receiving the shot, patient had a grey colored stool that had a chemical smell.... Within 45 minutes of receiving the shot, patient had a grey colored stool that had a chemical smell. 7 hours after receiving the shot, patient had another grey and white colored stool. Patient only had one stool a day for the past month in the morning and she has that prior to shot. No foods were changed and her normal schedule was followed. No fevers or any other symptoms. Just suddenly grey/white stool More
2838065 12 M 04/25/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8375AB
U8252AA
No adverse event, Wrong patient; No adverse event, Wrong patient No adverse event, Wrong patient; No adverse event, Wrong patient
MCV4 U8375AB Right Deltoid IM, and Tdap U8252AA Left Deltoid IM, was inadvertently administered to ... MCV4 U8375AB Right Deltoid IM, and Tdap U8252AA Left Deltoid IM, was inadvertently administered to patient. Instead of intended recipient. The patient was verbally asked to state his name, which he did. I then stated the the date of birth and the patient said yes. I proceeded with the vaccine. The error was identified shortly after administration. Patient was observed for 30 Minutes, there was no adverse reaction. Patient's mother was notified immediately and provided with a full explanation of the error. Provider was informed at 11:18AM School Nurse was also notified. More
2838066 1.08 M TX 04/25/2025 HEPA
MMRV
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 DN273
Y014437
Y015101
Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
Patient received Varivax, ProQuad, and Hep A on 3/14/2025. Mother was notified regarding extra Varic... Patient received Varivax, ProQuad, and Hep A on 3/14/2025. Mother was notified regarding extra Varicella dose via Proquad product approx. an hour after administration. A follow up call 3/17/2025 to patient was made and mother reported patient did well over the week. He was afebrile, and immunization sites with no changes. More
2838067 1.25 F TX 04/25/2025 DTAP
HIBV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 M52GG
27G3F
Injection site urticaria, Rash, Urticaria; Injection site urticaria, Rash, Urtic... Injection site urticaria, Rash, Urticaria; Injection site urticaria, Rash, Urticaria More
She developed hives after injections at each vaccination site, bilateral wrists, and both side of fa... She developed hives after injections at each vaccination site, bilateral wrists, and both side of face, spread up arms and down legs. She was given oral Benadryl and monitored at the clinic office for 2 hours after injections. Hives resolved and rash had improved prior to leaving. Instructed to go to ER if hives recurred, swelling of face, trouble breathing, wheezing, or rash worsened. More
2838068 4 M AZ 04/25/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 34MF9
Y018157
Injection site rash; Injection site rash Injection site rash; Injection site rash
Rash on thigh at injection site Rash on thigh at injection site
2838069 78 M NY 04/25/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 E75E5
LL942
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
PATIENT RECEIVED ONE DOSE OF AREXVY ON 11/14/2023 AND THEN A SECOND DOSE OF AREXVY ON 12/21/2024 PATIENT RECEIVED ONE DOSE OF AREXVY ON 11/14/2023 AND THEN A SECOND DOSE OF AREXVY ON 12/21/2024
2838070 66 F 04/25/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX4484
594G2
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Gave Prevnar 20 instead of the ordered Shingrix, called pt to inform them of what had happened. Subm... Gave Prevnar 20 instead of the ordered Shingrix, called pt to inform them of what had happened. Submitted an RL. Pt came back to receive correct vaccine. Informed provider and supervisor of the incident. More
2838071 4 F TX 04/25/2025 TD
 SANOFI PASTEUR
 U8492BA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient came in clinic with a form from school saying she needed the vaccine. This vaccine was not s... Patient came in clinic with a form from school saying she needed the vaccine. This vaccine was not supposed to be given to a four year old. No adverse event. More
2838089 0.25 M OR 04/25/2025 RV5
 MERCK & CO. INC.
 209662
Bradycardia, Infantile apnoea, Oxygen saturation decreased, Underdose Bradycardia, Infantile apnoea, Oxygen saturation decreased, Underdose
decreased oxygen saturation/additional oxygen support; experienced apnea; experienced bradycardia to... decreased oxygen saturation/additional oxygen support; experienced apnea; experienced bradycardia to a rate of 53; received a 2 mL dose but the chart noted a partial dose.; This spontaneous report was received from a pharmacist and refers to a 3-month male patient. The patient's concurrent conditions included Premature Baby, NICU, and oxygen support. Concomitant medications included Hepatitis B Vaccine (manufacturer unknown), Diphtheria vaccine toxoid;HIB vaccine conj (tet tox);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid) (PENTACEL), Pneumococcal vaccine (manufacturer un known) . On 06-APR-2025, the patient was vaccinated with a first dose of dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (lot #209662, expiration date: 27-MAR-2026), dose: 2 mL, but it was reported that the baby received a 2 mL dose but the chart noted a partial dose(Underdose) , administered by Oral route for prophylaxis reported as Primary immunization. After being administered the vaccine, on the same day, the patient experienced apnea, bradycardia to a rate of 53 (units not provided), decreased oxygen saturation. The baby did not respond to suctioning or repositioning. The baby needed additional oxygen support. The hospitalization prolonged, on an unknown day in 2025. The baby was still admitted in hospital. The patient recovered from the events on the same day (on 06-APR-2025). It was mentioned that the reporter stated that he/she was undecided if patient would get second dose The causal relationship between the events and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown. The reporter considered, the events of experienced apnea bradycardia to a rate of 53 and decreased oxygen saturation/additional oxygen support to be medically significant. More
2838090 M 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Facial nerve neuritis Facial nerve neuritis
Facial nerve inflammation; This serious case was reported by a consumer via call center representati... Facial nerve inflammation; This serious case was reported by a consumer via call center representative and described the occurrence of neuritis cranial in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced neuritis cranial (Verbatim: Facial nerve inflammation) (serious criteria GSK medically significant). The outcome of the neuritis cranial was unknown. It was unknown if the reporter considered the neuritis cranial to be related to Shingrix. The company considered the neuritis cranial to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 22-APR-2025 Consumer reported that a few months after receiving Shingrix, he experienced facial nerve inflammation.; Sender's Comments: Neuritis cranial is an unlisted event which is considered unrelated to GSK vaccine Shingrix More
2838091 M NH 04/25/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Aphonia, Cough, Fatigue Aphonia, Cough, Fatigue
lost his voice; he developed fatigue; cough; loss of appetite; This non-serious case was reported by... lost his voice; he developed fatigue; cough; loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of voice in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Influenza vaccine (Influenza vaccin) for prophylaxis and COVID-19 vaccine for prophylaxis. In OCT-2024, the patient received Arexvy, Influenza vaccin and COVID-19 vaccine. In OCT-2024, an unknown time after receiving Arexvy and Influenza vaccin, the patient experienced loss of voice (Verbatim: lost his voice), fatigue (Verbatim: he developed fatigue), cough (Verbatim: cough) and appetite lost (Verbatim: loss of appetite). The outcome of the loss of voice was not resolved and the outcome of the fatigue, cough and appetite lost were resolving. It was unknown if the reporter considered the loss of voice, fatigue, cough and appetite lost to be related to Arexvy. It was unknown if the company considered the loss of voice, fatigue, cough and appetite lost to be related to Arexvy. Additional Information: GSK Receipt Date : 17-APR-2025 Patient reported he received Arexvy vaccine on October of 2024. After received the vaccine, he developed fatigue, loss of appetite, cough, and losted his voice. Patient reported his voice had not recovered since he started experiencing the side effect. Patient reporeds that he received the Covid vaccine and a Flu vaccine the same day he received arexvy. It was unknown if the reporter considered the loss of voice, fatigue, cough and appetite lost to be related to Covid 19 vaccine and Flu vaccine. More
2838092 53 F CO 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site pruritus, Injection site rash Injection site erythema, Injection site pruritus, Injection site rash
developed redness at the injection site; developed rash at the injection site; developed itchy at th... developed redness at the injection site; developed rash at the injection site; developed itchy at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-FEB-2025, the patient received the 1st dose of Shingrix (left deltoid). On 11-FEB-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: developed redness at the injection site). On an unknown date, the patient experienced injection site rash (Verbatim: developed rash at the injection site) and injection site itching (Verbatim: developed itchy at the injection site). The outcome of the injection site erythema, injection site rash and injection site itching were resolved (duration 4 weeks). It was unknown if the reporter considered the injection site erythema, injection site rash and injection site itching to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site rash and injection site itching to be related to Shingrix. Additional Information: GSK receipt date: 18-APR-2025 The patient reported that she experienced redness at the injection site the day she received her 1st dose of Shingrix, on 11th February 2025. The patient reported that this red area started getting bigger and bigger, and stayed itchy and red off and on for about a month (no specific date provided). The patient mentioned that she received the first dose of the Shingrix vaccine and developed a very large red, itchy rash at the injection site which lasted about 4 weeks. The patient had a doubt was it safe for her to receive the second dose. The patient received her vaccine at her local pharmacy from the pharmacist. The patient did not have the lot number and expiry information or route of administration. More
2838093 M 04/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient who received his first dose of SHINGRIX in 2018. His records does not indicate that he recei... patient who received his first dose of SHINGRIX in 2018. His records does not indicate that he received a second dose even though he thinks he did. Unknown if he received 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 elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in 2018). 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: patient who received his first dose of SHINGRIX in 2018. His records does not indicate that he received a second dose even though he thinks he did. Unknown if he received second dose.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 23-APR-2025 The patient self-reported this case. The patient received his first dose of Shingrix in 2018 and his records did not indicate that he received a second dose even though he thought he did and was unknown if he received second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025049324:Same reporter,Different patient More
2838094 60 M GA 04/25/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4ZC23
Product storage error Product storage error
patient given Priorix that was frozen prior to reconstitution; This non-serious case was reported by... patient given Priorix that was frozen prior to reconstitution; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 60-year-old male patient who received MMR (Priorix) (batch number 4ZC23, expiry date 01-SEP-2025) for prophylaxis. On 12-FEB-2025, the patient received Priorix (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: patient given Priorix that was frozen prior to reconstitution). 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: 15-APR-2025 The patient given Priorix (MMR) that was frozen prior to reconstitution, which led incorrect storage of drug. More
2838095 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Dizziness, Headache, Myalgia Dizziness, Headache, Myalgia
I am having headaches; muscle ache; light headed after the shingles vaccine; This non-serious case w... I am having headaches; muscle ache; light headed after the shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache (Verbatim: I am having headaches), muscle pain (Verbatim: muscle ache) and light headedness (Verbatim: light headed after the shingles vaccine). The outcome of the headache, muscle pain and light headedness were not reported. It was unknown if the reporter considered the headache, muscle pain and light headedness to be related to Shingles vaccine. It was unknown if the company considered the headache, muscle pain and light headedness to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 15-APR-2025 This case was reported by a patient via interactive digital media. Reporter had headaches, muscle ache and light headed after the shingles vaccine. More
2838096 F 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
I had a sore arm for 3 days; This non-serious case was reported by a consumer via interactive digita... I had a sore arm for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (Received 1st dose of Shingles vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: I had a sore arm for 3 days). The outcome of the pain in arm was resolved (duration 3 days). It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The patient just had 2nd shot. The patient had a sore arm for 3 days. The follow-up could not be possible as no contact details were available. This case was linked with case US2025AMR048363 for husband. More
2838097 M 04/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Decreased appetite, Fatigue, Headache, Malaise, Pyrexia Decreased appetite, Fatigue, Headache, Malaise, Pyrexia
fatigue; loss of appetite; fever; Headache; sick; This non-serious case was reported by a consumer v... fatigue; loss of appetite; fever; Headache; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fatigue (Verbatim: fatigue), appetite lost (Verbatim: loss of appetite), fever (Verbatim: fever), headache (Verbatim: Headache) and sickness (Verbatim: sick). The outcome of the fatigue, appetite lost, fever and headache were not reported and the outcome of the sickness was resolved (duration 2 days). It was unknown if the reporter considered the fatigue, appetite lost, fever, headache and sickness to be related to Shingles vaccine. It was unknown if the company considered the fatigue, appetite lost, fever, headache and sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The husband had 2nd shot. He was sick for 2 days. Had stomach loss of appetite, fever, headache and fatigue all day. More
2838098 04/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Headache, Malaise, Skin warm Headache, Malaise, Skin warm
my arm is still warm; headache every day; unwell; This non-serious case was reported by a consumer v... my arm is still warm; headache every day; unwell; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin warm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included shingles. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced skin warm (Verbatim: my arm is still warm), headache (Verbatim: headache every day) and unwell (Verbatim: unwell). The outcome of the skin warm was not resolved and the outcome of the headache was unknown and the outcome of the unwell was not reported. It was unknown if the reporter considered the skin warm, headache and unwell to be related to RSV vaccine. It was unknown if the company considered the skin warm, headache and unwell to be related to RSV vaccine. Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that that he/she put it on shingles eight days ago. The reporter arm still had it warm. The patient got a headache every day and he/she was not in headaches. The reporter better said that the patient was unwell on body without needing. More
2838099 04/25/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Rash pruritic, Vaccination failure; Herpes zoster, Rash pruritic,... Herpes zoster, Rash pruritic, Vaccination failure; Herpes zoster, Rash pruritic, Vaccination failure More
Suspecyted vaccination failurre; 5 months later I got shingles/Started down my right arm, now my an... Suspecyted vaccination failurre; 5 months later I got shingles/Started down my right arm, now my ankles and feet; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 5 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspecyted vaccination failurre) (serious criteria GSK medically significant) and shingles (Verbatim: 5 months later I got shingles/Started down my right arm, now my ankles and feet). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 18-APR-2025 This case was reported by a patient via interactive digital media. The patient got the shingles shot (both of them), five months later got shingles. It has been 7 months and still have them. No pain, just constant itching from the rashes. They disappear from one spot, and resurface in another, started down to right arm, now on ankles and feet. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). More
2838100 04/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
suspected vaccination failure; got again later; This serious case was reported by a consumer via int... suspected vaccination failure; got again later; 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. The patient's past medical history included respiratory syncytial virus infection. On an unknown date, the patient received RSV vaccine. On an unknown date, less than a year after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: got again later). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved. 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: 17-APR-2025 This case was reported by a patient via interactive digital media. The patient got Respiratory Syncytial Virus vaccine. The patient got one respiratory syncytial virus infection but had it right before the shot, could take effect and turned serious. The patient got respiratory syncytial virus infection again later in year very mild quick recovery. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding 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 (h/o respiratory syncytial virus infection, insufficient information regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
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