๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

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

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2823495 94 F OH 01/29/2025 PNC20
 PFIZER\WYETH
 LJ5283
Death, Seizure like phenomena Death, Seizure like phenomena
Vaccine received on 1/21- had 30 sec seizure like activity that evening. Remained alert and oriented... Vaccine received on 1/21- had 30 sec seizure like activity that evening. Remained alert and oriented per baseline. Sitting in recliner after evening meal when staff found already deceased. Had extensive health history and comorbidities. More
โœ“
2823496 46 F FL 01/29/2025 COVID19
 PFIZER\BIONTECH
 Fh8030
Aphasia, Cerebrovascular accident, Intracranial aneurysm Aphasia, Cerebrovascular accident, Intracranial aneurysm
Began to suffer from aphasia, eventually hospitalized for stroke and then brain aneurysm Began to suffer from aphasia, eventually hospitalized for stroke and then brain aneurysm
โœ“
2823497 64 F WV 01/29/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4b47k
74nc9
Arthralgia, Breast pain; Arthralgia, Breast pain Arthralgia, Breast pain; Arthralgia, Breast pain
patient has been experiencing pain in arm from shoulder to elbow down around breast, started with v... patient has been experiencing pain in arm from shoulder to elbow down around breast, started with vaccine and has continued, she has take tylenol More
2823498 59 M MN 01/29/2025 COVID19
 PFIZER\BIONTECH
 LN0558
Pain Pain
Soreness. No treatment Soreness. No treatment
2823499 1.25 M PA 01/29/2025 MMR
 MERCK & CO. INC.
 Y010046
Syringe issue Syringe issue
Unknown dose of MMR administered due to defective sterile diluent prefilled syringe Unknown dose of MMR administered due to defective sterile diluent prefilled syringe
2823500 1.5 F VA 01/29/2025 COVID19
HEPA
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 3044211
DN273
Idiopathic urticaria, Injection site erythema; Idiopathic urticaria, Injection s... Idiopathic urticaria, Injection site erythema; Idiopathic urticaria, Injection site erythema More
Idiopathic urticaria that lasted for 2 weeks after administration with erythema that started at the ... Idiopathic urticaria that lasted for 2 weeks after administration with erythema that started at the right thigh (site of the HepA vaccine). I am a pediatric allergist and reaction was immunologic related to the innate response to these rather than IgE More
2823501 45 F 01/29/2025 TD
 MASS. PUB HLTH BIOL LAB
 A146A
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient had vaccines on 2/22/22 not sure for one Patient had vaccines on 2/22/22 not sure for one
2823502 1.33 M 01/29/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 M23G5
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients a... Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 1 when he received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10. More
2823503 4 M AZ 01/29/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 3RT93
Y015989
Injection site cellulitis; Injection site cellulitis Injection site cellulitis; Injection site cellulitis
Cellulitis on L upper arm. Rx Keflex Cellulitis on L upper arm. Rx Keflex
2823504 30 F MT 01/29/2025 COVID19
FLU3
HPV9
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 3043335
N737Y
X020725
Syncope; Syncope; Syncope Syncope; Syncope; Syncope
After completing IM Vx administration of Flu, Moderna, and HPV (1) Pt experienced textbook syncopal ... After completing IM Vx administration of Flu, Moderna, and HPV (1) Pt experienced textbook syncopal episode. Pt regained full level of consciousness within seconds. This nurse had Pt in laying position for 5 mins prior to coming to sitting position for additional 10 mins. At that time the Pt was escorted to front desk area to check out. Pt had continued monitoring for another 15 mins. Pt stated they felt safe to leave after checkout was complete. Education was given on S/S to watch for over the next few days. More
2823505 1.25 M PA 01/29/2025 HIBV
HIBV
HIBV
SMALL
SMALL
SMALL
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS





Autism spectrum disorder, Brain lobectomy, Developmental regression, Ear infecti... Autism spectrum disorder, Brain lobectomy, Developmental regression, Ear infection, Electroencephalogram; Epilepsy, Laboratory test, Magnetic resonance imaging, Magnetoencephalography, Scan; Seizure, Speech disorder developmental, Surgery, Whole-genome sequencing; Autism spectrum disorder, Brain lobectomy, Developmental regression, Ear infection, Electroencephalogram; Epilepsy, Laboratory test, Magnetic resonance imaging, Magnetoencephalography, Scan; Seizure, Speech disorder developmental, Surgery, Whole-genome sequencing More
Patient began regressing in cognition. His speech did not develop and he began having repeated ear ... Patient began regressing in cognition. His speech did not develop and he began having repeated ear infections. He had his first seizure 4 months later and was diagnosed with epilepsy. He has had his whole genome sequenced with no findings that would suggest congenital abnormalities. More
โœ“ โœ“ โœ“
2823506 77 M OK 01/29/2025 PNC20
RSV
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 HE6171
HF5022
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient had already received the same RSV vaccine on 1/9/2024. Patient had already received the same RSV vaccine on 1/9/2024.
2823507 37 M ID 01/29/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EL3240
eh9899
Demyelination, Nerve degeneration, Neuropathy peripheral; Demyelination, Nerve d... Demyelination, Nerve degeneration, Neuropathy peripheral; Demyelination, Nerve degeneration, Neuropathy peripheral More
Late onset of Peripheral neuropathy bilaterally in both feet that was gradual over the next year(202... Late onset of Peripheral neuropathy bilaterally in both feet that was gradual over the next year(2022) to the point currently. I have confirmed demyelination and degeneration of the nerves in my feet bilaterally, requiring me to start gabapentin (which I did not tolerate) More
โœ“
2823508 37 M VA 01/29/2025 COVID19
 JANSSEN
Alopecia areata, Dermatitis atopic, Dermatosis, Hidradenitis, Psoriasis Alopecia areata, Dermatitis atopic, Dermatosis, Hidradenitis, Psoriasis
Developed psoriasis, atopic dermatitis, hidradenitis suppurativa, alopecia areata and dermatoses on ... Developed psoriasis, atopic dermatitis, hidradenitis suppurativa, alopecia areata and dermatoses on the chest, trunk, back, arms and inner thighs. More
โœ“
2823509 46 F CA 01/29/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ER2613
ER2613
Biopsy lymph gland abnormal, Lymphoedema, Malignant melanoma in situ, Melanocyti... Biopsy lymph gland abnormal, Lymphoedema, Malignant melanoma in situ, Melanocytic naevus, Pathology test; Skin neoplasm excision More
Within a few weeks of the COVID shots I had noticed a congenital mole on my left calf starting to ch... Within a few weeks of the COVID shots I had noticed a congenital mole on my left calf starting to change. This was a mole I was told would never cause me problems and that it was just ugly. I continued to watch it for a few weeks until I reached out to my doctor in May 2021 and I was diagnosed with melanoma in June. I had SLNB and then WLE surgery with clear margins. As a result of the lymph node testing I was left with severe lymphedema in the left leg which is still problematic. I have since had more melanoma - forehead in-situ and then the original calf melanoma spread as in-transit melanoma to my shin in 2023. Now stage 3b. I now have a 4th melanoma on my back that I have WLE for next week. More
โœ“
2823510 3 F CA 01/29/2025 MNQ
PPV
 NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 NR394
X022827
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Menveo for age 10-55 was given to a 3-year old. There was no adverse reaction and no harm reached t... Menveo for age 10-55 was given to a 3-year old. There was no adverse reaction and no harm reached the patient. More
2823511 25 F SC 01/29/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 AZ453
Peripheral swelling, Pruritus, Rash Peripheral swelling, Pruritus, Rash
On January 16, 2025, donor received first Anti-HBS immunization. Within 15 minutes of the immunizati... On January 16, 2025, donor received first Anti-HBS immunization. Within 15 minutes of the immunization, the donor started to experience itchy and swelling on the left hand. A rash developed on the donor's hand and finger. Donor was monitored and ice pack placed on hand. Donors breathing and heart rate remained normal and denied any other symptoms. Donor's vital signs remained within normal limits. Donor was monitored for approximately 20 minutes in which the hand color returned to normal. The itching and swelling subsided almost immediately after ice pack was placed. More
2823512 31 M MN 01/29/2025 VARCEL
 MERCK & CO. INC.
 Y010374
Erythema, Skin warm, Swelling Erythema, Skin warm, Swelling
Raised reddened area warm to touch and 2 small Raised reddened area warm to touch and 2 small
2823513 61 M CA 01/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9tlj7
Herpes zoster Herpes zoster
Patient reported that 1 week after receiving their first dose of Shingrix they developed shingles an... Patient reported that 1 week after receiving their first dose of Shingrix they developed shingles and required treatment. More
โœ“
2823514 82 F TX 01/29/2025 RSV
 PFIZER\WYETH
Cerebrovascular accident, Injection site erythema, Injection site swelling Cerebrovascular accident, Injection site erythema, Injection site swelling
injection site redness and swelling, stroke 24-48 hours after vaccine, no history of stroke injection site redness and swelling, stroke 24-48 hours after vaccine, no history of stroke
โœ“ โœ“ โœ“
2823515 73 M WA 01/29/2025 RAB
 SANOFI PASTEUR
 W1D211M
Arthralgia, Injection site bruising, Injection site pain, Pain Arthralgia, Injection site bruising, Injection site pain, Pain
Pt received 4 doses of rabies post-exposure treatment, 3 in the R deltoid and the final dose in the ... Pt received 4 doses of rabies post-exposure treatment, 3 in the R deltoid and the final dose in the L deltoid. Pt reports soreness at the injection site since the vaccines were administered, but last weekend (1/25) began experiencing intense pain with movement and bruising on the right bicep. The bruising is new, but the soreness has been ongoing on his right shoulder since the vaccines were administered. Hook test performed, negative for tear. Will see sports medicine for medical management/therapy. Ice/heat for relief. Topical lidocaine and diclofenac. More
2823516 90 F CA 01/29/2025 COVID19
 MODERNA
 8080750
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Swelling and redness to site where COVID vaccine was previously administered, new order to apply war... Swelling and redness to site where COVID vaccine was previously administered, new order to apply warm compress and administer Tylenol as needed for pain. More
2823517 24 F WA 01/29/2025 RSV
 PFIZER\WYETH
 kc7884
Exposure during pregnancy, Extra dose administered, No adverse event Exposure during pregnancy, Extra dose administered, No adverse event
Patient was given 2 RSV vaccines 1/8 and 1/22, provider noted no harm to patient was caused. patient... Patient was given 2 RSV vaccines 1/8 and 1/22, provider noted no harm to patient was caused. patient did not seek emergency care as none was needed per provider More
2823518 1.08 F OH 01/29/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 tf27t
X022986
Y006522
Muscle twitching; Muscle twitching; Muscle twitching Muscle twitching; Muscle twitching; Muscle twitching
twitching for a day after getting the vaccines twitching for a day after getting the vaccines
2823519 25 M VA 01/29/2025 ANTH
 EMERGENT BIOSOLUTIONS
 300214A
Laboratory test normal, Lymph nodes scan abnormal, Lymphadenopathy, Pain in jaw,... Laboratory test normal, Lymph nodes scan abnormal, Lymphadenopathy, Pain in jaw, Swelling face More
In subsequent evening going into the AM, patient developed submandibular swelling with pain, and no ... In subsequent evening going into the AM, patient developed submandibular swelling with pain, and no systemic symptoms. Worsening, and showing obvious swelling to that area of his face, without erythema. More
โœ“
2823520 52 M MN 01/29/2025 PNC21
 MERCK & CO. INC.
 Y011819
Dizziness, Head injury, Seizure Dizziness, Head injury, Seizure
The patient had a seizure four minutes after received a vaccine. The seizure lasted around 10 minut... The patient had a seizure four minutes after received a vaccine. The seizure lasted around 10 minutes. At first patient felt light headed and was sitting down then stood up right before he slowly went to the floor but head slowly hit the floor. Paramedics were called and patient came out of seizure while they were there present. Patient went with paramedics to run some tests. Patient discussed prior fainting with vaccinations but only happened a few times and has received vaccinations at pharmacy in past. Also discussed epilepsy but controlled on medications More
2823521 68 F FL 01/29/2025 PNC21
 MERCK & CO. INC.
 y013009
Erythema, Hyperhidrosis, Swelling Erythema, Hyperhidrosis, Swelling
On 01/29/2025 Patient came back to pharmacy complaining about local adverse reaction (redness,sorene... On 01/29/2025 Patient came back to pharmacy complaining about local adverse reaction (redness,soreness, swelling ) from capvaxive vaccine from 01/24/2025. I advised her to take over the counter benadryl and do ice compression. If it does not get better then it needs to have provider's attention. More
2823522 12 F TX 01/29/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y008843
Y008843
U8271AB
U8271AB
CX4HL
CX4HL
Cold sweat, Confusional state, Dyskinesia, Musculoskeletal stiffness, Nausea; Pa... Cold sweat, Confusional state, Dyskinesia, Musculoskeletal stiffness, Nausea; Pallor; Cold sweat, Confusional state, Dyskinesia, Musculoskeletal stiffness, Nausea; Pallor; Cold sweat, Confusional state, Dyskinesia, Musculoskeletal stiffness, Nausea; Pallor More
Adolscent female became pale and confused after walking to the waiting area at the completion of vac... Adolscent female became pale and confused after walking to the waiting area at the completion of vaccinations. Her mother reports She leaned back in her chair and became stiff, then her arms began to jerk for approximately 15 seconds. Nurse had her sit bent over with her head down over her knees, cold compress was applied to her neck and under her chin. She complained of a sharp headache across her forehead at a 10 on a 1-10 scale. Student remained pale and clammy for the next 10-15 minutes. Headache went to a 5 on 1-10 scale after five minutes. Observed a full 30 minutes more. Student began to feel better with some nausea and dull headache. Mother decline a ride to the emergency department. Hard candy was offered. Student left alert, oriented and ambulated out of the lobby with her parent. Follow up to the mother the following day and she reports that the student is doin fine now. More
2823523 4 F MI 01/29/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Extra dose administered Extra dose administered
client received a dtap and a IPV on 10/18/2024 a fourth dose in each series. I misread the record a... client received a dtap and a IPV on 10/18/2024 a fourth dose in each series. I misread the record and gave an additional dose of DI today to client that wasn't necessary. dose was not due until 04/18/2025. Explained the error to patients mother and she verbalized understanding . Mom stated she will return on 07/29/2025 for appropriate dose. More
2823524 2 M WA 01/29/2025 HEPA
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011643
Y010184
Fatigue, Inappropriate schedule of product administration, Lethargy; Fatigue, In... Fatigue, Inappropriate schedule of product administration, Lethargy; Fatigue, Inappropriate schedule of product administration, Lethargy More
Vaccine Administration Error- Patient was given Hep A and Varicella before recommended administratio... Vaccine Administration Error- Patient was given Hep A and Varicella before recommended administration dates. Patient reported no abnormal reaction or response. Parents stated he had his "typical reaction" of feeling run down and lethargic. More
2823525 58 F TX 01/29/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8506MA
UT8506MA
Asthenia, Dizziness, Eye swelling, Facial pain, Feeling hot; Head discomfort, He... Asthenia, Dizziness, Eye swelling, Facial pain, Feeling hot; Head discomfort, Headache, Nausea, Somnolence More
Patient developed the following symptoms after the vaccine: dizziness, feeling warmth throughout her... Patient developed the following symptoms after the vaccine: dizziness, feeling warmth throughout her body, sensation of left eyeball swelling, nausea, drowsiness, left face pain, head feeling weird, headache, weakness. More
2823526 65 F CA 01/29/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Abdominal pain upper, Asthenia, Dizziness, Gait disturbance, Gastritis; Headache... Abdominal pain upper, Asthenia, Dizziness, Gait disturbance, Gastritis; Headache, Loss of consciousness, Loss of personal independence in daily activities, Malaise, Mobility decreased; Pain, Pain in extremity, Thirst More
pt says her arm was little sore the day of the vaccine but the next day she was running errands she ... pt says her arm was little sore the day of the vaccine but the next day she was running errands she bacame weak and her walking became slower. Her gait was getting worse. She became thirsty and felt like she was going to pass out. She was at a store and needed to drive home but was worried about getting home. Once she got home she had to climb stairs to get into her room. She wanted to email her son to let him know she was not feeling well but was so weak she could not type. Her entire body was hurting. She passed out and slept for hours but stayed in the bed for 5 days total. She only got out of the bed to urinate. She could hear the phone ringing but couldn't answer it. Her stomach was so inflammed she had to stay laying down. She had headach with the stomach ache. After the 5th day she was able to start functioning more normally. By the 6th day she felt normal. She contacted the pharmacy to let them know. She saw her PCP on Dec 24th and notated her reactions. More
2823528 73 F ME 01/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4m472
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Pt called ~4pm in Wednesday 1/29/25 asking about what to do with swelling, redness and heat of upper... Pt called ~4pm in Wednesday 1/29/25 asking about what to do with swelling, redness and heat of upper right arm. Recommended going to Walk-in care, trying cold compress for swelling (about 4 inches in diameter) as well as taking some ibuprofen (not to exceed 32oomg/day). She mentioned a similar reaction when receiving the first Shingrix but not as expansive in area. More
2823529 4 M GA 01/29/2025 DTAPIPV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 3RT93
KH2BD
Y005921
Injection site pruritus, Injection site rash; Injection site pruritus, Injection... Injection site pruritus, Injection site rash; Injection site pruritus, Injection site rash; Injection site pruritus, Injection site rash More
Patient had a rash develop the day after vaccines on the right thigh. No leg pain, but parents repor... Patient had a rash develop the day after vaccines on the right thigh. No leg pain, but parents reported patient had been scratching at leg. Parents gave a singular dose of Benadryl but no apparent improvement. Patient was brought in to the office to be seen by his pediatrician. on 1/29/2025 More
2823530 63 F MA 01/29/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LM2219
UT8468JA
Blood iron decreased, Fluid retention, Protein total decreased, Swelling, Vitami... Blood iron decreased, Fluid retention, Protein total decreased, Swelling, Vitamin D decreased; Blood iron decreased, Fluid retention, Protein total decreased, Swelling, Vitamin D decreased More
COVID19 vaccine and flu vaccine given concurrently. Patient has received these vaccines in the past ... COVID19 vaccine and flu vaccine given concurrently. Patient has received these vaccines in the past but not given concurrently. Developed fluid retention/swelling after vaccinations, and was hospitalized in 1/2025 for fluid retention, swelling, low protein, low iron, low vitamin D. More
โœ“
2823531 64 F GA 01/29/2025 COVID19
 MODERNA
 3030340
Breast cancer female, Radiotherapy, Surgery Breast cancer female, Radiotherapy, Surgery
Patient states that she received covid19 vaccine on November 18, 2023 and in December 2023 she was d... Patient states that she received covid19 vaccine on November 18, 2023 and in December 2023 she was diagnosed with breast cancer. She had surgery in 1/2024 and radiation. She states she is currently fine More
โœ“
2823532 65 F NM 01/29/2025 COVID19
 NOVAVAX
 6024MF021
Incorrect route of product administration Incorrect route of product administration
PATIENT CALLED THE PHARMACY WANTING TO TELL THE PHARMACY THAT SHE THINKS THE NOVAVAX VACCINE WAS ADM... PATIENT CALLED THE PHARMACY WANTING TO TELL THE PHARMACY THAT SHE THINKS THE NOVAVAX VACCINE WAS ADMINISTERED INCORRECTLY. SHE STATES THAT THE VACCINATOR PINCHED HER SKIN WHILE INJECTING, AND THAT SHE DID NOT FEEL THE NEEDLE. SHE ALSO STATES THAT SHE DID NOT HAVE TYPICAL VACCINE SIDE EFFECTS FOR 2 DAYS, INSTEAD OF 1 DAY THAT SHE IS USED TO. PHARMACIST TRIED TO RATIONALIZE WITH PATIENT THAT WE USE THE APPROPRIATE NEEDLES FOR IM INJECTION (1 INCH ) AND THE SIDE EFFECTS DOES NOT SOUND ATYPICAL. THE PATIENT WAS ADAMENT THAT SHE THOUGHT IT WAS ADMINISTERED SUBCUTANEOUSLY AND THAT THIS IS REPORTED TO MAKE SURE EVERYONE IS AWARE. More
2823533 73 F TX 01/29/2025 COVID19
PNC21
 MODERNA
MERCK & CO. INC.
 8080799
Y011819
Injection site erythema, Injection site pruritus; Injection site erythema, Injec... Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus More
PATIENT HAD 2 VACCINES ON 01/15/25, SPIKEVAX AND CAPVAXIVE, SINCE THEN PT HAS REPORTED OF RED AND IC... PATIENT HAD 2 VACCINES ON 01/15/25, SPIKEVAX AND CAPVAXIVE, SINCE THEN PT HAS REPORTED OF RED AND ICTCHING ON THE INJECTION SITE, PT CALLED TODAY AND REPORTED OF THE SYMPTOMS THAT STARTED ON 1/15/25 EVENING AND LAST UNTIL NOW. More
2823561 U GA 01/29/2025 MMRV
 MERCK & CO. INC.
 y014306
No adverse event, Product storage error No adverse event, Product storage error
HCP called to report a T/E and reports improperly stored PROQUAD was given to 2 patients on 1/17/202... HCP called to report a T/E and reports improperly stored PROQUAD was given to 2 patients on 1/17/2025. No symptoms or side effects reported. Related AE case filed in 02738574. No additional AE/no PQC. ? Names of vaccines involved (including lot; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, or concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number wheter Y014306 or Y015990 has been verified to be a valid lot number, with expiration date 18-FEB-2026 and 23-MAR-2026, respectively) administered as prophylaxis (dosage, route of administration and anatomical location were not reported) for prophylaxis, which underwent a temperature excursion, at -13.4 ๏ฟฝC (-14 ๏ฟฝC up to 10 ๏ฟฝC ) for 4 hours 30 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-2501USA006018: More
2823562 U IL 01/29/2025 VARCEL
 MERCK & CO. INC.
 Y006522
No adverse event, Product storage error No adverse event, Product storage error
No symptomatic adverse events were reported. No additional AE; The HCP reports that VARIVAX was inad... No symptomatic adverse events were reported. No additional AE; The HCP reports that VARIVAX was inadvertently administered after suffering from a Temperature Excursion.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 17-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter, lot # Y006522; which has been verified to be valid lot # for varicella virus vaccine live (Oka/Merck), expiration date: 25-MAR-2026, administered as prophylaxis (strength, dose number, route, anatomical location of administration and vaccination scheme frequency were not provided) (product storage error) after a temperature excursion (TE) occurred at a temperature of -11.6 C degrees Celsius during a time frame of 3 hours 5 minutes and 0 seconds. Previous temperature excursions could not be confirmed. No additional adverse event (AE) was reported (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2501USA008877: US-009507513-2501USA009045: US-009507513-2501USA008880: US-009507513-2501USA008882:02740767 US-009507513-2501USA007446: US-009507513-2501USA008935: US-009507513-2501USA007047: US-009507513-2501USA008861: More
2823563 16 M KY 01/29/2025 HPV9
 MERCK & CO. INC.
 W029724
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; FBE called on behalf of nurse to report an expired dose of GARDASIL 9 was administ... No additional AE; FBE called on behalf of nurse to report an expired dose of GARDASIL 9 was administered to 1 patient. Per FBE, nurse stated dose expired on 1/8/2025 and was administered on 1/22/2025. FBE stated the nurse did not report any patient symptoms or provide; This spontaneous report was received from a registered nurse referring to a 16-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 22-JAN-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number W029724, expiration date 08-JAN-20225 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported. More
2823564 4 U SC 01/29/2025 MMRV
 MERCK & CO. INC.
 X018814
Expired product administered, No adverse event Expired product administered, No adverse event
The HCP stated the patient did no experience any adverse issues or side effects from the administere... The HCP stated the patient did no experience any adverse issues or side effects from the administered dose of PROQUAD; A HCP called to inquire about the viability of an expired dose of PROQUAD (X018814 01/07/2025) that was administered to a patient on 01/24/2025.; The HCP was unsure if the PROQUAD had ever undergone a temperature excursion (TE).; This spontaneous report was received from a nurse and refers to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 24-JAN-2025, the patient was vaccinated with an expired and potentially improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live ([rHA recombinant human albumin]) (PROQUAD) injection, lot #X018814; which has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 07-JAN-2025, administered for prophylaxis (strength, vaccination schedule, exact quantity volume, route and anatomical site of administration were not provided) (Expired product administered; Product storage error). The reporter inquired about the viability of this expired dose. In addition, she stated she was not sure if it had ever undergone a temperature excursion (TE) and could not provide more information related to it. The patient did not experience any adverse issues or side effects (no adverse event). More
2823565 U NC 01/29/2025 HPV9
 MERCK & CO. INC.
Influenza virus test positive Influenza virus test positive
tested positive for flu; received their second dose of GARDASIL 9 dose 3 weeks after their first dos... tested positive for flu; received their second dose of GARDASIL 9 dose 3 weeks after their first dose, instead of the four weeks minimal interval; This spontaneous report has been received from a nurse practitioner regarding a 23-year-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On an unspecified date, the patient received their second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, scheme, route of administration, anatomical site, lot number and expiration date not reported) 3 weeks after their first dose, instead of the four weeks minimal interval (Inappropriate schedule of vaccine administered). On an unknown date (also reported as today), the caller stated that the patient tested positive for flu (Influenza virus test positive). The outcome of the events was unknown. The causal relationship between the suspect vaccine and the events was unknown. More
2823566 35 F CA 01/29/2025 HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.




Abdominal pain, Arthralgia, Dysphagia, Endometriosis, Fatigue; Gastrointestinal ... Abdominal pain, Arthralgia, Dysphagia, Endometriosis, Fatigue; Gastrointestinal tube insertion, Histoplasmosis, Hypersensitivity, Hysterectomy, Inappropriate schedule of product administration; Loss of personal independence in daily activities, Mass excision, Mobility decreased, Pain, Pain in extremity; Peripheral swelling, Pharyngeal mass, Swollen tongue, Systemic lupus erythematosus, Thrombectomy; Thrombosis, Weight decreased More
patient continued to experience swelling as the weeks went by. Her entire body was hurting due to sw... patient continued to experience swelling as the weeks went by. Her entire body was hurting due to swelling, especially in her hands, fingers, and ankles. Physician prescribed steroids, but she continued to experience pain for months; histoplasmosis; feeding tube placed; full hysterectomy; endometriosis/Abdominal pain; clots removed from her legs; lumps removed from her throat; had lost significant weight; difficulty swallowing; patient's palms began to swell. Within 12 hours, patient's tongue was enlarged and she could no longer swallow. Her husband took her to the emergency room for an allergic reaction to the vaccine; Patient was 35 years old when she received her first dosage of Gardasil; This initial spontaneous report was received from a lawyer on 24-JAN-2025 regarding a case in litigation and refers to a female patient (pt) of 35 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 15-DEC-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular Injection route of administration, lot number and expiration date were not reported) for preventing cervical cancer (Product administered to patient of inappropriate age). The second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular Injection route of administration, lot number and expiration date were not reported) for preventing cervical cancer was administered on 28-JAN-2021. It was reported that on 28-JAN-2021 within two hours of receiving the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine, pt.'s palms began to swell. Within 12 hours, pt.'s tongue was enlarged and she could no longer swallow. Her husband took her to the emergency room for an allergic reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine (Allergy to vaccine). Pt. was given intravenous medication to reduce the swelling and was eventually discharged with an emergency EpiPen. Pt. continued to experience swelling as the weeks went by. Her entire body was hurting due to swelling, especially in her hands, fingers, and ankles. Physician prescribed steroids, but she continued to experience pain for months. Pt. was eventually diagnosed with autoimmune Lupus (Systemic lupus erythematosus). She had also been diagnosed with histoplasmosis, endometriosis, and had had a full hysterectomy. She continued to experience severe daily pain and fatigue. She has had clots removed from her legs several times (Thrombectomy), as well as lumps removed from her throat (Mass excision). She experienced abdominal pain and difficulty swallowing (Dysphagia) and had lost significant weight (Weight decreased). She had had a feeding tube placed (Gastrointestinal tube insertion) and must use it to take her daily medications. Before Vaccination, pt. was very active outdoors. She jogged every morning and was always at their children's school functions. She would go swimming and work out at her local GYM. She enjoyed having fun with her family. They would take trips to theme parks. Since the Gardasil vaccine, Pt's life had changed from a normal, healthy, active person to barely being able to get out of bed to go to the bathroom. She had a long-term goal of starting her own restaurant, but that has changed due to her health. She could no longer participate in her children's school functions, go on trips, or do fun things with her family. As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced injuries, patient had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of the events was reported as not recovered. Causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was related. Upon internal review the events of Systemic lupus erythematosus, Histoplasmosis, Gastrointestinal tube insertion, hysterectomy, allergy to vaccine treated with given intravenous medication to reduce the swelling and was eventually discharged with an emergency EpiPen were considered medically significant. The events were considered disabling by the reporter. More
โœ“
2823567 30 F MO 01/29/2025 MMR
 MERCK & CO. INC.
 X026222
Foreign body in skin or subcutaneous tissue, Occupational exposure to product, S... Foreign body in skin or subcutaneous tissue, Occupational exposure to product, Syringe issue More
No additional adverse event was reported; the needle and it instead came off the syringe and caused ... No additional adverse event was reported; the needle and it instead came off the syringe and caused a needle stick in the staff members left hand.; CALLER CONFIRMED JUST THE NEEDLE CAME OFF, NO PART OF THE SYRINGE CAME OFF/ needle pooped off; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; device connection issue; Poor quality device used; This spontaneous report was received from registered nurse and refers to a 30-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-JAN-2025, the patient was vaccinated with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, unk, lot #1973259, expiration date: 03-MAR-2026 (strength, route of administration, and indication were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #X026222, expiration date: 06-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that the needle popped off a diluent syringe after it was used to administered a vaccine. The problem occurred when the staff member tried to engage the safety on the needle and it instead came off the syringe and caused a needle stick in the staff member left hand (Injury associated with device, needle issue, device connection issue and poor quality device used). The product was administered to the patients body fluids (Occupational exposure to product and accidental exposure to product). No additional adverse event was reported. More
2823568 U CA 01/29/2025 MMRV
 MERCK & CO. INC.
 Y013583
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; HCP calling to report T/E. HCP stated PROQUAD (s) are not back in range. PROQUAD w... No adverse event; HCP calling to report T/E. HCP stated PROQUAD (s) are not back in range. PROQUAD was administered during a temperature excursion on 1/23/2025. No additional AE reported. NO PQC reported. Was the product administered? YES, PROQUAD Y013583 2/03/2; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 23-JAN-2025, the patient was vaccinated with the first, improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y013583 has been verified to be a valid lot number, expiration date was not provided, but upon internal validation was established as 03-FEB-2026 (exact dose, route of administration and anatomical location were nor provided) for prophylaxis. On 23-JAN-2025, administered dose of vaccine was exposed to the temperature excursion (product storage error). No more information available. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event). More
2823569 U CA 01/29/2025 MMRV
 MERCK & CO. INC.
 Y013583
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; PROQUAD was administered during a temperature excursion on 1/23/2025.; This sponta... No additional AE; PROQUAD was administered during a temperature excursion on 1/23/2025.; This spontaneous report was received from a medical assistant, concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection experienced a temperature excursion (TE), for unknown time at unknown temperature. No previous TE reported. On 23-JAN-2025, the patient was vaccinated with the first dose of the vaccine involved in the TE measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, and route of administration were not provided; lot #Y013583 has been verified to be valid for this vaccine, expiration date reported and confirmed as 03-FEB-2026). (Product use issue). No additional adverse event was reported (No adverse event). More
2823570 F NY 01/29/2025 VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
Extra dose administered, Fatigue, Herpes zoster, Vaccination failure; Extra dose... Extra dose administered, Fatigue, Herpes zoster, Vaccination failure; Extra dose administered, Fatigue, Herpes zoster, Vaccination failure; Extra dose administered, Fatigue, Herpes zoster, Vaccination failure More
after 3 vaccines I still get outbreaks on my lower back / suspected vaccination failure; outbreaks o... after 3 vaccines I still get outbreaks on my lower back / suspected vaccination failure; outbreaks on my lower back; extra dose administered; This serious case was reported by a other health professional and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included hip replacement (The patient underwent hip replacement surgery 5 years ago.). Concomitant products included valaciclovir (Valacyclovir). On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: after 3 vaccines I still get outbreaks on my lower back / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: outbreaks on my lower back) and extra dose administered (Verbatim: extra dose administered). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-JAN-2025 The drug dosage for Shingles was reported as 30mg. It was reported that after the patient had a hip replacement 5 years ago and after 3 vaccines, the patient still got outbreaks on her lower back (exhaustion), which led to extra dose administered. The outcome for exhaustion was reported as resolved with sequelae. The symptoms were treated. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding herpes zoster 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, completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1, 2 & 3). More
2823571 F 01/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
General malaise; This non-serious case was reported by a consumer via sales rep and described the oc... General malaise; This non-serious case was reported by a consumer via sales rep and described the occurrence of general malaise in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-JAN-2025, the patient received the 1st dose of Shingrix (left arm). On 12-JAN-2025, 1 days after receiving Shingrix, the patient experienced general malaise (Verbatim: General malaise). On 13-JAN-2025, the outcome of the general malaise was resolved (duration 1 day). The reporter considered the general malaise to be related to Shingrix. The company considered the general malaise to be related to Shingrix. Additional Information: GSK Receipt Date: 15-JAN-2025 The reporter reported that the patient received receive first dose of Shingrix. The patient had general malaise. More
2823572 F 01/29/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; DID NOT ELIMINATE SHINGLES, IN FACT MOVED TO OTHER SIDE OF MY BODY; T... Suspected vaccination failure; DID NOT ELIMINATE SHINGLES, IN FACT MOVED TO OTHER SIDE OF MY BODY; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: DID NOT ELIMINATE SHINGLES, IN FACT MOVED TO OTHER SIDE OF MY BODY). 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 Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 The reporter reported that the patient received the 2 shots of Shingrix vaccine and experienced the Shingles. Shingles did not eliminate in fact they moved to other side of body. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2. More
๐Ÿ“‹ Privacy Policy & Data Disclaimer