🏥 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 💀 🏥 🚑 ♿ ⚠️
2833058 80 M AR 03/25/2025 COVID19
 MODERNA
 053B22A
COVID-19 COVID-19
covid infection with hospitalization after vaccination covid infection with hospitalization after vaccination
2833059 17 F TN 03/25/2025 MNQ
MNQ
 SANOFI PASTEUR
SANOFI PASTEUR
 U8370AA
U8370AA
Balance disorder, Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis; Mu... Balance disorder, Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis; Musculoskeletal stiffness, Nausea, Paraesthesia More
Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and... Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and clammy, sweating, and unsteady. She remained alert and oriented x person, place, time. Once lying down she began to improve slowly, but still did not feel well. BP was 99/62 lying, HR 68, O2 sat 99%. Patient had not eaten prior to vaccination. Patient began complaining of her hands "tingling" and becoming rigid. This subsided minutes later. Another BP taken lying down, 113/72. Sitting up shortly after BP was 86/62. Patient was given gatorade, water and peanut butter crackers AFTER glucose was checked (87). Patient remained in clinic for 15 more minutes, BP before leaving was 106/70, patient stated she felt "about 80%" better. More
2833061 80 F AR 03/25/2025 COVID19
 MODERNA
 204G23A
COVID-19 COVID-19
covid infection with hospitalization after vaccination covid infection with hospitalization after vaccination
2833062 65 F CA 03/25/2025 RSV
RSV
RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

UNK
UNK
Injection site pain; Injection site pain; Injection site pain; Injection site pa... Injection site pain; Injection site pain; Injection site pain; Injection site pain More
Continued soreness in arm at injection site. Continued soreness in arm at injection site.
2833063 17 F TN 03/25/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U7961AA
U7961AA
Balance disorder, Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis; Ma... Balance disorder, Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis; Malaise, Musculoskeletal stiffness, Nausea, Paraesthesia More
Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and... Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and clammy, sweating, and unsteady. She remained alert and oriented x person, place, time. Once lying down she began to improve slowly, but still did not feel well. BP was 99/62 lying, HR 68, O2 sat 99%. Patient had not eaten prior to vaccination. Patient began complaining of her hands "tingling" and becoming rigid. This subsided minutes later. Another BP taken lying down, 113/72. Sitting up shortly after BP was 86/62. Patient was given gatorade, water and peanut butter crackers AFTER glucose was checked (87). Patient remained in clinic for 15 more minutes, BP before leaving was 106/70, patient stated she felt "about 80%" better. More
2833064 79 F AR 03/25/2025 COVID19
 MODERNA
 056A22A
COVID-19 COVID-19
covid infection with hospitalization after vaccination covid infection with hospitalization after vaccination
2833065 62 F PA 03/25/2025 UNK
 UNKNOWN MANUFACTURER
 Y019157
Injection site erythema, Pruritus, Rash macular, Skin warm Injection site erythema, Pruritus, Rash macular, Skin warm
Patient stated the following via phone: Stated received pneumonia vaccine on 3/20/2025 at this off... Patient stated the following via phone: Stated received pneumonia vaccine on 3/20/2025 at this office. Noted that did well with vaccine but last evening began with redness on LEFT arm at injection site. This AM, woke up noting "itching, blotching and redness extending down the inner LEFT arm below the elbow. Shared that arm is warm to touch. Denies difficulty breathing. Advised to go to Urgent Care now. Verbalized understanding of same. On 3/25/2025 during Urgent Care visit, was ordered the following Cleocin, Prednisone and OTC Benadryl. More
2833066 55 M MI 03/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Blister Blister
The patient stated that he had no reaction to the 1st vaccine but had blisters on his chest, back, a... The patient stated that he had no reaction to the 1st vaccine but had blisters on his chest, back, and arms following his 2nd vaccine 6 days later. More
2833067 11 F NC 03/25/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y012865
Y012865
U8271AB
U8271AB
U8252AA
U8252AA
Disorientation, Dizziness, Hypotension, Pallor, Presyncope; Tachycardia; Disorie... Disorientation, Dizziness, Hypotension, Pallor, Presyncope; Tachycardia; Disorientation, Dizziness, Hypotension, Pallor, Presyncope; Tachycardia; Disorientation, Dizziness, Hypotension, Pallor, Presyncope; Tachycardia More
patient became hypotensive, pale, dizzy, disoriented, lightheaded. tachycardia. patient monitored in... patient became hypotensive, pale, dizzy, disoriented, lightheaded. tachycardia. patient monitored in office x 1.5 hours, sent to e.d.. pt discharged at 1640 from e.d. after vitals stabilized. patient diagnosed with vasovagal reaction after vaccination injections. More
2833068 25 F GA 03/25/2025 VARCEL
 MERCK & CO. INC.
 Y011712
No adverse event, Product storage error No adverse event, Product storage error
Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any si... Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction. More
2833069 1.25 M PA 03/25/2025 DTAPIPVHIB
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UK196AA
LK6653
Erythema of eyelid, Peripheral swelling, Pyrexia, Swelling of eyelid; Erythema o... Erythema of eyelid, Peripheral swelling, Pyrexia, Swelling of eyelid; Erythema of eyelid, Peripheral swelling, Pyrexia, Swelling of eyelid More
The patient is a 15-month-old male who presents for evaluation of fever and swollen eyelids. He is a... The patient is a 15-month-old male who presents for evaluation of fever and swollen eyelids. He is accompanied by his mother and father who presented today due to facial swelling of his eyes and thigh after a vaccine was given. Patient has moderate bilateral eye swelling and additional swelling around the injection site. He had a fever which occurred this morning at 9 AM. Temperature was 103 this morning and the mom did give Tylenol. Patient did receive the DTaP, haemophilus influenza B, pneumonia and polio vaccine. Patient also appears fussy and irritable. No prior reactions from immunizations in the past The patient's mother reports that he experienced a significant fever this morning, with temperatures ranging between 103 and 104 degrees Fahrenheit. Upon awakening at 9 AM, he was found to have notably swollen eyelids, which were more erythematous than usual. The mother administered Tylenol in response to the fever. It is noteworthy that the patient received his vaccinations during their last visit yesterday. More
2833070 70 M SC 03/25/2025 RSV
RSV
 MODERNA
MODERNA

Hypoaesthesia, Limb discomfort, Muscular weakness, Paraesthesia, Rash; Tinea inf... Hypoaesthesia, Limb discomfort, Muscular weakness, Paraesthesia, Rash; Tinea infection More
Presented to ED with bilateral lower extremity weakness, and bilateral upper extremity numbness/ting... Presented to ED with bilateral lower extremity weakness, and bilateral upper extremity numbness/tingling and heaviness sensation. Admitted to hospital and neurology consulted. Neurology noted "possible post vaccine transverse myelitis." Patient completed 3-days of IV steroids and minimal to no symptoms at time of discharge. ID was consulted due to rash on his left upper extremity, likely tinea. ID recommended submission to VAERS. More
✓
2833071 6 F CO 03/25/2025 HEP
HEPA
IPV
MMRV
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 47D3S
DN273
Y1A201M
Y013579
NZ552
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
Patient was in clinic with her older sister (age 8), and both needed tetanus shots. When vaccinating... Patient was in clinic with her older sister (age 8), and both needed tetanus shots. When vaccinating this patient, RN administered the wrong tetanus shot. Patient should have received DTaP, but received Tdap. Patient will need to repeat the dose with DTaP. All other vaccines in this visit were administered correctly. More
2833072 8 F CO 03/25/2025 DTAP
HEP
HEPA
IPV
MMRV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
 2CA20C1
47D3S
DN273
Y1A201M
Y013579
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
Patient came to clinic with younger sister (age 6) and both needed tetanus vaccines. When vaccinatin... Patient came to clinic with younger sister (age 6) and both needed tetanus vaccines. When vaccinating, RN accidentally administered DTaP to this patient instead of Tdap. All other vaccines in this visit were administered appropriately. Patient's DTaP is considered a valid dose in the series and will not need to be repeated. More
2833073 27 F FL 03/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 pg3rp
Dyspnoea, Swelling face Dyspnoea, Swelling face
2 hours after vaccination, we got a call from the patient who said she was having swelling in the fa... 2 hours after vaccination, we got a call from the patient who said she was having swelling in the face and touble breathing. I informed the patient to call 911 and go the nearest hospital and to take benadryl if she has it available. More
2833074 2 M NC 03/25/2025 COVID19
FLU3
HEPA
 PFIZER\BIONTECH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 LN0591
UT8462MA
22GP3
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
Wrong age dose/ No know adverse reaction Wrong age dose/ No know adverse reaction
2833075 22 M MI 03/25/2025 MMRV
 MERCK & CO. INC.
 Y004543
Wrong product administered Wrong product administered
Pt received MMRV vaccine and should have received the same vaccines but separately. MMR and Varicel... Pt received MMRV vaccine and should have received the same vaccines but separately. MMR and Varicella More
2833076 2 F OK 03/25/2025 MMRV
 MERCK & CO. INC.
Wrong product administered Wrong product administered
MMRV erroneously given by nurse to patient when MMR should have been given. Was also given a varice... MMRV erroneously given by nurse to patient when MMR should have been given. Was also given a varicella vaccine separately this day as well. More
2833077 70 M WV 03/25/2025 PNC20
 PFIZER\WYETH
 Y013009
Erythema, Fatigue, Injection site rash, Pain, Pyrexia Erythema, Fatigue, Injection site rash, Pain, Pyrexia
High fever of 104 F, Fatigue, severe body aches, rash on the site of injection with perfused redness... High fever of 104 F, Fatigue, severe body aches, rash on the site of injection with perfused redness to the left arm More
2833078 65 F NY 03/25/2025 PNC20
 PFIZER\WYETH
Injection site cellulitis, Injection site erythema, Injection site pruritus Injection site cellulitis, Injection site erythema, Injection site pruritus
Progressive erythema, itching at site of injection - treated as secondary cellulitis Progressive erythema, itching at site of injection - treated as secondary cellulitis
2833079 77 M PA 03/25/2025 FLU3
 SANOFI PASTEUR
 U8521DA
Unevaluable event Unevaluable event
N/A N/A
2833080 20 M NC 03/25/2025 YF
 SANOFI PASTEUR
 UK133AB
Chest discomfort, Dyspnoea, Nasal congestion, Swelling face, Urticaria Chest discomfort, Dyspnoea, Nasal congestion, Swelling face, Urticaria
Mother reports trouble breathing, chest tightness, hives, nasal congestion, face swelling Mother reports trouble breathing, chest tightness, hives, nasal congestion, face swelling
2833081 33 M GA 03/25/2025 FLU3
HEP
IPV
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 5RE93
945659
X1D141M
LX494
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, L... Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness More
Patient became dizzy and lightheaded after last dose of vaccine given. Patient was moved to bench an... Patient became dizzy and lightheaded after last dose of vaccine given. Patient was moved to bench and cool air and towel placed on neck. Patient was also given a soda to sip. Patient passed out while sitting on bench being assisted by two nurses. Used ammonia swab to wake patient up. Patient was able to talk to nurses then he went out again. Ammonia swab used again. Patient came around and was lowered to the floor and placed on left side. Patient was able to tell us his name and date of birth. Patient was kept in recovery position until he felt better. Patient was then escorted to his car where his wife was. BP checked several times: 9:44am- BP-108/62 P-79; 9:46am BP-78/48 P-559; 9:48am- BP- 97/71 P-68; 9:50am- BP-94/68 P-72. Patient also had a TB skin test placed prior to vaccines being given. After event, patient stated that this happened when he had blood drawn yesterday. Explained to patient that he did not report this when he was asked about previous reactions he said no. Advised patient to report this in the future when receiving vaccines or having blood drawn. Patient voiced understanding. More
2833082 1 F KY 03/25/2025 HEPA
 MERCK & CO. INC.
 X021931
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Adult dose given in series instead of peds dose given, by accident. Adult dose given in series instead of peds dose given, by accident.
2833084 52 F OH 03/25/2025 MMR
MMR
PNC21
PNC21
VARZOS
VARZOS
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y013172
Y013172
Y013009
Y013009
N77J2
N77J2
Body temperature increased, Imaging procedure, Incisional drainage, Laboratory t... Body temperature increased, Imaging procedure, Incisional drainage, Laboratory test normal, Localised infection; Pain, Peripheral swelling; Body temperature increased, Imaging procedure, Incisional drainage, Laboratory test normal, Localised infection; Pain, Peripheral swelling; Body temperature increased, Imaging procedure, Incisional drainage, Laboratory test normal, Localised infection; Pain, Peripheral swelling More
Patient received 3 vaccines stated she was hospitalized for infection of left arm, swelling, tempera... Patient received 3 vaccines stated she was hospitalized for infection of left arm, swelling, temperature, and had to have arm lanced 3 days after vaccines. Stated she was in the hospital for 3 days with temperature and pain, stated pain with 12 hours of vaccine. Verbally upset she stated she does not want any of the vaccines again and wanted me to document issue. Pharmacist told patient of all risk at time of vaccine, increased temperature, swelling of arm, arm hot to the touch, red swollen area, and other flu like symptoms/ body pain, along with any treatment suggestions for side effects. Patient had arm lanced and drained, given IV antibiotics, and given oral and antibiotics and pain medication. More
✓
2833085 74 F AL 03/25/2025 PNC21
 MERCK & CO. INC.
 Y011819
Injection site erythema, Injection site rash, Skin exfoliation Injection site erythema, Injection site rash, Skin exfoliation
A patient came to the consultation counter and told the pharmacist that a couple of days after her c... A patient came to the consultation counter and told the pharmacist that a couple of days after her capvaxive vaccine (03/05/2025) she noticed a rash that was red well below the site of her injection. It later healed and the top layer of skin peeled off. More
2833086 68 F 03/25/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 y013009
7zm55
Dysstasia, Feeling abnormal, Pain; Dysstasia, Feeling abnormal, Pain Dysstasia, Feeling abnormal, Pain; Dysstasia, Feeling abnormal, Pain
Patient states that she felt achy, tired and had difficulty getting up and about like being "hi... Patient states that she felt achy, tired and had difficulty getting up and about like being "hit with a baseball bat" . Reaction did not improve and she saw her MD 2 days following administration. MD told her "definitely due to Shingrix vaccine". MD gave her two "shots" , but she is not sure what they were. Patient starting feeling two days following being seen by her MD. More
2833087 74 F NC 03/25/2025 COVID19
COVID19
 MODERNA
MODERNA

Chills, Decreased appetite, Fatigue, Pain, Pyrexia; Somnolence Chills, Decreased appetite, Fatigue, Pain, Pyrexia; Somnolence
fever (topped out at 102.2), chills, some aches, fatigue, lack of appetite, sleepiness; began in eve... fever (topped out at 102.2), chills, some aches, fatigue, lack of appetite, sleepiness; began in evening of 3/21 and lasted until 3/24 in late afternoon More
2833088 0.33 M CA 03/25/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
no adverse effects noted. no adverse effects noted.
2833089 80 F MO 03/25/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LJ5283
A5T73
Muscular weakness, Pyrexia; Muscular weakness, Pyrexia Muscular weakness, Pyrexia; Muscular weakness, Pyrexia
patient's daughter called stating since she received the shot, that same night patient has been... patient's daughter called stating since she received the shot, that same night patient has been feeling feverish and treating that with Tylenol. Daughter also reported patient's legs don't have any strength and have to help support her to use the restroom. More
2833101 5 F NJ 03/25/2025 UNK
 UNKNOWN MANUFACTURER
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE/PQC reported.; Product origin unknown; HCP stated that a female patient inadverntly... No additional AE/PQC reported.; Product origin unknown; HCP stated that a female patient inadverntly received a unknown HPV quadrivalent vaccine when she was 5 years old.; This spontaneous report was received from a registered nurse and refers to a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2013 when she was 5 years old, the patient inadvertently received quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (manufacturer unknown) (reported as an unknown HPV quadrivalent vaccine) (strength, dose, formulation, route of administration, lot # and expiration date were not reported) as prophylaxis (Product administered to patient of inappropriate age, Product origin unknown). The patient was currently 17 years old. No additional adverse event (AE) reported (No adverse event). More
2833102 M PA 03/25/2025 RV5
RV5
UNK
UNK
 MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
Y005880
Infant irritability; Infant irritability; Infant irritability; Infant irritabili... Infant irritability; Infant irritability; Infant irritability; Infant irritability More
The patient received their first dose of ROTATEQ on 10/9/2024, then traveled where they received an ... The patient received their first dose of ROTATEQ on 10/9/2024, then traveled where they received an UNKNOWN ROTAVIRUS on 11/11/2024 and 12/12/2024. The patient received a dose of ROTATEQ on 2/25/2025; The parents brought the patient to a pediatric urgent care because they were being fussy. The patient has since completely recovered from being fussy and has not had any medical concerns since.; The patient received their first dose of ROTATEQ on 10/9/2024, then traveled where they received an UNKNOWN ROTAVIRUS on 11/11/2024 and 12/12/2024. The patient received a dose of ROTATEQ on 2/25/2025; This spontaneous report was received from a medical assistant and refers to a 5-month-old (also reported as 6-month-old, conflicting information) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-Oct-2024, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), 2 mL / three dose series, administered by oral route as rotavirus vaccination (lot # and expiration date were not reported). Then the patient traveled where he (reported as they, conflicting information) received unknown rotavirus vaccine on 11-Nov-2024 (second dose, strength, dose, formulation, indication, expiration date, and lot # were not reported) and 12-Dec-2024, (third dose, strength, dose, formulation, indication, expiration date, and lot # were not reported). On 25-Feb-2025, the patient was vaccinated with the forth dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) (lot #Y005880, expiration date: 19-Nov-2025), 2 mL / three dose series, administered by oral route as rotavirus vaccination (Interchange of vaccine products, Extra dose administered). Operator of device was health professional. On 25-Feb-2025, after the patient received Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), the parents brought the patient to a pediatric urgent care because they were being fussy. The Physician of the urgent care told the parents that the patient was ok and no medical treatments were necessary and to continue to monitor the patient. The patient had since completely recovered from being fussy and has not had any medical concerns since." Medical Assistant confirmed the patient had made a recovery from "being fussy", and was not provided any additional information. The action taken was not applicable. The causal relationship between the event of fussy and Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), unknown rotavirus vaccine was not reported. Lot # is being requested and will be submitted if received. More
2833103 0.75 FL 03/25/2025 MMRV
 MERCK & CO. INC.
 Y016872
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE; HCP called to report a dose of PROQUAD was given to a 9-month-old patient.; This s... No additional AE; HCP called to report a dose of PROQUAD was given to a 9-month-old patient.; This spontaneous report was received from a physician and refers to a 9-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 05-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y016872, expiration date: 07-Apr-2026) 0.5 mL, diluted in sterile diluent (MERCK STERILE DILUENT), 0.5 mL (expiration date, and lot # were not reported) for prophylaxis (Inappropriate age at vaccine administration). Healthcare provider (HCP) stated he intended to administer the child the vaccine dose for upcoming international travel as the parents were concerned about MMR outbreaks. No symptoms reported. More
2833104 M IL 03/25/2025 VARCEL
 MERCK & CO. INC.
 Y015558
No adverse event, Underdose No adverse event, Underdose
No other AE/PQC reported.; patient was administered less than a full dose of VARIVAX.; This spontane... No other AE/PQC reported.; patient was administered less than a full dose of VARIVAX.; This spontaneous report was received from a Nurse and refers to a(n) 12-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Mar-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015558, expiration date: 16-Sep-2026) administered by unknown route as prophylaxis. The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), for the treatment of prophylaxis together with sterile diluent (MERCK STERILE DILUENT) (lot#, expiration date, route of administration were all not provided). On the same date, the patient experienced administered less than a full dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (vaccine underdose). There were no other adverse events reported (no adverse event). Reporter stated he did not know how much of the dose the patient received. More
2833105 F NC 03/25/2025 PNC21
 MERCK & CO. INC.
Arthralgia, Injection site pain, Musculoskeletal pain, Pain in extremity, Paraes... Arthralgia, Injection site pain, Musculoskeletal pain, Pain in extremity, Paraesthesia More
pins and needles sensation in her right palm; tip of her right thumb pain; fatigue; right wrist pain... pins and needles sensation in her right palm; tip of her right thumb pain; fatigue; right wrist pain; right scapula pain; Skin was tender at the injection site/pain from her right upper arm; This spontaneous report was received from a/an nurse and refers to a(n) female patient (herself) of unknown age. The patient's medical history included pneumonia. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), 0.5 mL, administered by intramuscular route in right upper arm for vaccination (strength, lot # and expiration date were not reported). It was reported that she received Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) on 07-Mar-2025 in her right upper arm and a "few hours later" she developed fatigue and pain from her right upper arm into the right scapula and from the right wrist to the tip of her right thumb as well as a pins and needles sensation in her right palm. Skin was tender at the injection site but no swelling or redness She stated the pain increased overnight and lasted for about 24 hours. No other information provided. The patient recovered/resolved from all events on 08-Mar-2025. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided. Lot# is being requested and will be submitted if received. More
2833106 M IN 03/25/2025 MMR
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
received both doses of MMR II prior to the recommended age of 4 years old; No additional AE reported... received both doses of MMR II prior to the recommended age of 4 years old; No additional AE reported; This spontaneous report was received from a Pharmacist and refers to her son, a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. The pharmacist reported her son received both doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) prior to the recommended age of 4 years old (Product administered to patient of inappropriate age). She reported the doses were administered approximately 3 months apart. No adverse event reported. More
2833107 UT 03/25/2025 HIBV
 MERCK & CO. INC.
 Y005248
No adverse event, Product preparation issue No adverse event, Product preparation issue
No additional AE; Medical Assistant reports another HCP at their office gave PEDVAXHIB to a patient ... No additional AE; Medical Assistant reports another HCP at their office gave PEDVAXHIB to a patient with STERILE DILUENT however PEDVAXHIB does not require reconstitution. The incident occurred as they; This spontaneous report was received from an Other health professional (medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 18-Mar-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Suspension for injection (valid lot #Y005248, expiration date: 17-Sep-2026), 0.5 mL administered once for prophylaxis (dose number, anatomical location, and route of administration were not provided) that was incorrectly reconstituted with sterile diluent (BAXTER STERILE DILUENT, reported as DILUENT MRK) Solution for injection, formulation pre-filled syringe (valid lot #1960083, expiration date: 04-Feb-2026) at clinic. Medical Assistant reported that another health care professional (HCP) at their office gave Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) to a patient with sterile diluent (BAXTER STERILE DILUENT), however suspect vaccine did not require reconstitution (product preparation error). The incident occurred as they were vaccinating siblings, one sibling needed measles mumps and rubella vaccine (MMRII) and one needed Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), so sterile diluent (BAXTER STERILE DILUENT) was mixed into Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) and given to one patient. No side effects or symptoms were reported. The whole vial of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) was given with the sterile diluent (BAXTER STERILE DILUENT) pre-filled syringe mixed in. Only one patient was involved as other sibling received their MMRII properly. No additional adverse event (AE) was reported (no adverse event). More
2833108 NY 03/25/2025 MMRV
 MERCK & CO. INC.
 Y004547
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No symptoms reported; Nurse calling to report a 28 year old patient was inadvertently administered a... No symptoms reported; Nurse calling to report a 28 year old patient was inadvertently administered a PROQUAD dose.; This spontaneous report was received from a Nurse and refers to a 28-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 21-FEB-2025, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), administered as prophylaxis (lot number Y004547 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), expiration date 19-AUG-2025; dose, formulation, vaccination scheme frequency, route of administration and anatomical site of injection were not provided) (Product administered to patient of inappropriate age), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (formulation, dose, indication, expiration date, lot number and route of administration were not reported). No symptoms reported and no additional adverse events of details were provided (No adverse event). More
2833109 4 KS 03/25/2025 MMR
 MERCK & CO. INC.
 X011441
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous r... No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 09-Jul-2024 at 11:46 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 9.2 degrees Celsius for 13 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter.; Reporter's Comments: More
2833110 1 KS 03/25/2025 MMR
 MERCK & CO. INC.
 X011441
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous r... No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 1-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Jan-2025 at 02:48 PM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter.; Reporter's Comments: More
2833112 4 KS 03/25/2025 MMR
 MERCK & CO. INC.
 X011441
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous r... No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-NOV-2024 at 11:42 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter.; Reporter's Comments: More
2833113 1 KS 03/25/2025 MMR
 MERCK & CO. INC.
 X011441
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous r... No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Sep-2024 at 10:07 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter.; Reporter's Comments: More
2833114 62 M NY 03/25/2025 FLU4
VARZOS
VARZOS
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
Incomplete course of vaccination, Injection site pain; Incomplete course of vacc... Incomplete course of vaccination, Injection site pain; Incomplete course of vaccination, Injection site pain; Incomplete course of vaccination, Injection site pain More
Soreness at injection site; The patient has not yet received the second dose; This non-serious case ... Soreness at injection site; The patient has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Influenza vaccine inact split 4v (Fluzone quadrivalent) for prophylaxis. On 25-NOV-2019, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 25-NOV-2019, the patient received Fluzone quadrivalent (unknown arm). On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at injection site) and incomplete course of vaccination (Verbatim: The patient has not yet received the second dose). The outcome of the injection site pain was unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 13-MAR-2025 The patient self-reported this case for himself. The patient received the first dose of Shingrix and had not yet received the second dose till the time of reporting, which led to an incomplete course of vaccination. The patient also received Fluzone Quad vaccine at the same time. The patient believed the vaccines were given in different arms. The patient had soreness at the injection site after receiving Shingrix. No other conditions were provided. It was unknown if the reporter considered the injection site pain to be related to Fluzone Quad vaccine. More
2833115 66 M VA 03/25/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 xx9n4
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Inappropriate age at vaccine administration; This non-serious case was reported by a consumer via ca... Inappropriate age at vaccine administration; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 66-year-old male patient who received MMR (Priorix) (batch number xx9n4) for prophylaxis. Concurrent medical conditions included diabetes (Diabetes). On 07-MAR-2025, the patient received the 1st dose of Priorix. On 07-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-MAR-2025 The consumer was the reporter. The reporter stated that he received his first dose of Priorix on 07th March 2025 and the patient was 66 years old which led to inappropriate age at vaccine administration. The patient was born in and did not think he was vaccinated in his country. Due to increased cases of , in the where was resides, he was contacted by his pharmacy and advised he should be vaccinated. The patient was unable to provide the street address, zip code, phone number for the pharmacy. The patient stated that he has a diagnosis of Type 2 diabetes. No further information was obtained/provided. More
2833116 M TN 03/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Illness, Pyrexia Illness, Pyrexia
had fever; illness; This non-serious case was reported by a other health professional via sales rep ... had fever; illness; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: had fever) and illness (Verbatim: illness). The outcome of the fever and illness were resolved (duration 1 week). It was unknown if the reporter considered the fever and illness to be related to Shingrix. It was unknown if the company considered the fever and illness to be related to Shingrix. Additional Information: GSK Receipt Date: 17-MAR-2025 The other health professional reported that the patient had side effects after dose 1 of Shingrix. The patient had fever and illness for a week. More
2833117 03/25/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Dermatitis contact, Rash erythematous; Dermatitis contact, Rash erythematous Dermatitis contact, Rash erythematous; Dermatitis contact, Rash erythematous
early red rash was poison ivy; This non-serious case was reported by a consumer via interactive digi... early red rash was poison ivy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of red rash 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced red rash (Verbatim: early red rash was poison ivy). The outcome of the red rash was not reported. It was unknown if the reporter considered the red rash to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the red rash to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she actually think did both shots. At first the reporter thought the early red rash was poison ivy, until he/she thought why does not it itch. So the reporter looked it up online (on a Saturday) and when he/she saw it might be shingles and having it near your eye could cause blindness. The reporter got to an emergency room as soon as possible. They checked the reporter's eye with some kind of ultra violet thing and said he/she was fine but called the other docs in to see it. The reporter was so thankful. he/she feel the vaccine kept it from being painful or hurting my eye (Though, since it was around Halloween, it was a great zombie look). More
2833118 F 03/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain Herpes zoster, Pain
still get the stabbing pains every now and then; This non-serious case was reported by a consumer vi... still get the stabbing pains every now and then; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: still get the stabbing pains every now and then). The outcome of the pain was not resolved. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 18-MAR-2025 This case was reported by a patient via interactive digital media. The patient was about 55 only had a few patches on right side. It cleared up but every blue moon right side where the patches of shingles were feels like been stabbed with a knife and it can last anywhere from 1 to 3 days each episode. The patient believe the shingles were living on the nerves inside body. The patient did get the Shingrix shot and, still get the stabbing pains every now and then. More
2833119 03/25/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 UNK
UNK
Ophthalmic herpes zoster, Pain, Pruritus, Vaccination failure; Ophthalmic herpes... Ophthalmic herpes zoster, Pain, Pruritus, Vaccination failure; Ophthalmic herpes zoster, Pain, Pruritus, Vaccination failure More
Suspected vaccination failure; which went into my eye; got the shingles anyway, which went into my e... Suspected vaccination failure; which went into my eye; got the shingles anyway, which went into my eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: which went into my eye) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles anyway, which went into my eye). The patient was treated with gabapentin and paracetamol (Tylenol). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and shingles were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingrix and Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and the Shingrix vaccine and got the shingles anyway, which went into eye, and still suffering with after effects of itching and stabbing pains in the area. The patient on 300 microgram gabapentin three times a day, which helps a little, use ice packs and anti-itch cream and Tylenol. 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 Shingrix and Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix and Shingles vaccine. More
2833120 F 03/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain Herpes zoster, Pain
getting them every couple of months; hurt; This non-serious case was reported by a consumer via inte... getting them every couple of months; hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: getting them every couple of months) and pain (Verbatim: hurt). The outcome of the shingles and pain were resolved. The reporter considered the shingles and pain to be related to Shingrix. The company considered the shingles and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported would be them mildly, but they still hurt. The patient did get one shot of Shingrix but could not continue them because of the bad reaction. The patient was getting shingles every couple of months and tried every trick in the book. The reporter reported well she did the fast and never got a breakout until broke fast. So now the patient pretty much only eat fruit and veggies, it's been so nice. More
2833121 03/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; And I still got them; This serious case was reported by a consumer vi... Suspected vaccination failure; And I still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: And I still got them). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 6 weeks). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 The case was received from the patient via interactive digital media. The reporter self-reported this case foe himself/herself. The reporter had the vaccine and still got them. The reporter reported that but, he/she was sure that they were not as bad for taking the vaccine. They lasted 6 weeks. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
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