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
2848886 0.42 M WA 07/08/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Pyrexia, Urticaria Pyrexia, Urticaria
Provider visit notes on 07/03/25 "On exam diffuse urticarial rash, then mother states fever ea... Provider visit notes on 07/03/25 "On exam diffuse urticarial rash, then mother states fever earlier in the night although afebrile at this time Overall no concerning findings requiring ER admission or significant treatments. Recommend monitoring for resolution if it is related to the vaccine to discuss with PCP vaccine regimen. Can trial OTC antihistamine such as Zyrtec. Follow Up: Return to urgent care or go to the nearest Emergency Room immediately if symptoms significantly worsen. Otherwise follow up with your PCP in 3-5 days, by calling for an appointment." More
2848887 76 F FL 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 SKB 7ZM55
Extra dose administered Extra dose administered
INCORRECTLY ADMINISTERED A THIRD DOSE OF SHINGRIX TO THIS PATIENT - RECIEVED FIRST DOSE 2/16/2022 AN... INCORRECTLY ADMINISTERED A THIRD DOSE OF SHINGRIX TO THIS PATIENT - RECIEVED FIRST DOSE 2/16/2022 AND SECOND DOSE 3/27/2023 More
2848888 53 F AZ 07/08/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Arthralgia, Dizziness, Fatigue, Headache, Injection site induration; Injection s... Arthralgia, Dizziness, Fatigue, Headache, Injection site induration; Injection site pain, Myalgia, Pyrexia, Skin warm More
First evening: headache, dizziness, tired, muscle and joint pain, hives. Painful site of injection, ... First evening: headache, dizziness, tired, muscle and joint pain, hives. Painful site of injection, hardened, fever, took 2 Tylenol. Following day: same symptoms, just bigger hives/rash hot to the touch feeling of skin being stretched out to the max. Took two Tylenol. Called pharmacy and they suggested ice packs and benadryl rub and take ibuprofen. Third day: no more fever, bigger hives/rash, continued ice packs and NSAIDs. Fourth day, Monday, bigger hives, messaged PCP of the situation. Fourth day, Tuesday, bigger hives, appointment with PCP More
2848889 1.42 M WA 07/08/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Fatigue, Pyrexia, Respiratory symptom Fatigue, Pyrexia, Respiratory symptom
Provider VISIT ON 7/5/25 :URI symptoms including high fever now 4 days past vaccinations and fatigue... Provider VISIT ON 7/5/25 :URI symptoms including high fever now 4 days past vaccinations and fatigue. No other symptoms Cough and congestion. Recommend ongoing supportive care including ibuprofen and/or Tylenol, as needed, frequent nasal saline rinses, and oral fluids. I recommend PCP follow-up as needed. I instructed the family to go to emergency department if worsening symptoms including trouble breathing high fevers, vomiting or other concerning symptoms. Follow Up: Return to urgent care or go to the nearest Emergency Room immediately if symptoms significantly worsen. Otherwise follow up with your PCP in 3-5 days, by calling for an appointment. More
2848890 50 F VT 07/08/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 A5T73
A5T73
Abdominal pain upper, Chills, Diarrhoea, Mobility decreased, Pain in extremity; ... Abdominal pain upper, Chills, Diarrhoea, Mobility decreased, Pain in extremity; Peripheral swelling, Vomiting More
Patient reported that her R arm got really swollen and was very painful, stated she could not lift h... Patient reported that her R arm got really swollen and was very painful, stated she could not lift her arm. This started Friday night. Friday night she also woke up with stomach cramping and ended up vomiting through out the day. Also had cold chills & diarrhea. This subsided on Sunday 7/6, about 3 days s/p vaccine was given. More
2848891 18 M OR 07/08/2025 COVID19
COVID19
 MODERNA
MODERNA
 054C21A
050E21A
Myocarditis; Myocarditis Myocarditis; Myocarditis
Both vaccines were given at pharmacy in (withheld). Pt has had two events of Hospitilization for M... Both vaccines were given at pharmacy in (withheld). Pt has had two events of Hospitilization for Myocarditis with no prior medical conditions. Once on 2/08/2024 and 01/28/2025. Provider feels that they are related to COVID Vaccines. More
โœ“
2848892 13 F MI 07/08/2025 DTAP
HPV9
MNQ
 SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
 3CA11C1
Y012865
U8375AA
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient was given a Dtap vaccine when she should have been given a Tdap vaccine. No abnormal reactio... Patient was given a Dtap vaccine when she should have been given a Tdap vaccine. No abnormal reaction. More
2848893 1.25 M WA 07/08/2025 DTAP
DTAP
HIBV
HIBV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 5KR3R
5KR3R
Y014938
Y014938
Crying, Generalised tonic-clonic seizure, Lethargy, Postictal state, Pyrexia; Tr... Crying, Generalised tonic-clonic seizure, Lethargy, Postictal state, Pyrexia; Tremor; Crying, Generalised tonic-clonic seizure, Lethargy, Postictal state, Pyrexia; Tremor More
Call 07/03 "Mom reports pt had vaccines yesterday (7/2/25): Dtap HIB Sites of injection look go... Call 07/03 "Mom reports pt had vaccines yesterday (7/2/25): Dtap HIB Sites of injection look good. Pt developed a fever this evening T100.4 axillary (Taken "ten minutes ago" from call). Pt is currently sleeping and is wearing an Owlet sock: Earlier today: 110 Highest during sleep: 147 (last taken mom reports when this writer called her back). 98-100 O2 Sat when mom read last." ED visit 07/04/25: patient presented with generalized tonic-clonic seizure lasting approximately 5 minutes. Onset occurred at home while being put down for rest. Fever began yesterday following vaccination, treated with Ibuprofen. Today fever exceeded 100๏ฟฝF. Seizure characterized by generalized shaking with some head bobbing, non-focal event. Seizure activity continued upon EMS arrival and was ongoing until Versed administration, less than 10 min. Post-ictal period notable for lethargy initially, arrives crying and not wanting to be bothered. No evidence of trauma. Definite fever preceding illness. Parents sought care due to seizure activity and fever. Discussed fever control with parents, recommending Ibuprofen and Tylenol at first sign of fever. No evidence bacterial infection, did not obtain CXR without resp sx, with normal O2 sat and reassuring exam, antibiotics not indicated. Tolerated PO well without vomiting. Soft abdomen, no surgical process suspected. Fever likely due to teething combined with recent vaccination, possible concomitant viral illness. 07/05 : History of Present Illness: Patient is a 15 m.o. male febrile seizures yesterday and visited ED, now with mild fevers today but responding to meds OV 07/07 1. Febrile Seizure. The febrile seizure is likely due to a viral infection rather than post-vaccination effects. The absence of a family history of seizure disorders suggests a low risk of developing a seizure disorder in the future. The fever has subsided, and the rash is consistent with hand, foot, and mouth disease caused by the coxsackievirus. The rash is not contagious. The likelihood of another febrile seizure is low, but if it occurs, Tylenol or ibuprofen can be used to manage the fever and pain. The parents were advised to keep him cool during future illnesses to prevent rapid temperature changes. More
2848894 5 M NH 07/08/2025 VARCEL
 MERCK & CO. INC.
 Y019319
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was administered duplicative vaccines to ones received last year. Patient is not exhibiting ... Patient was administered duplicative vaccines to ones received last year. Patient is not exhibiting any signs that they are in distress at all. More
2848895 0.08 F MI 07/08/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946062
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
We are not aware of any side effects from giving the wrong vaccine to the child. She was given an ad... We are not aware of any side effects from giving the wrong vaccine to the child. She was given an adult version of Hepatitis B vaccine instead of the pediatric version. More
2848896 1.25 M WA 07/08/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Body temperature increased, Fatigue, Rhinorrhoea Body temperature increased, Fatigue, Rhinorrhoea
CALL 6/26 : Sent home from daycare for temp 103.9. 15-20" ago temp 104.6. gave Tylenol again. T... CALL 6/26 : Sent home from daycare for temp 103.9. 15-20" ago temp 104.6. gave Tylenol again. Tired. May have slight runny nose No one else sice in home today but dad had small cold a couple days ago. When sleeping, nose very congested. Plenty of wet diapers. CALL 6/26 AROUNG 9 PM" Mom calls back to report concern that fever is not lowering despite alternating Tylenol and Motrin. 8:45p 103.6 rectal -1.5 hours after pt received Motrin. Mom reports that pt has a "slight runny nose" but only when he is upset. Currently does not have a runny nose. Currently mom reports pt is eating "Ritz Crackers." Pt is able to swallow liquids and mom reports pt has been nursing "a lot today." Last wet diaper: 2045 Pt is able to move his neck and all extremities normally." UC VISIT 06/26/25 "This is an 15 m.o. year old male who presents with fever, mild cough, congestion and 2+ bilateral tonsillomegaly that began today. He is well appearing, breathing comfortably without hypoxia on room air. Systemic involvement is noted by the presence of fever. Symptoms are most likely due to viral etiology. Given the history, exam, and workup I have a low suspicion for bacterial AOM, bacterial pharyngeal pathology, bacterial pneumonia or sepsis. Plan: Ongoing supportive care including APAP/NSAIDs for fever/pain Continued electrolyte rich fluid intake Follow Up: PCP or Urgent Care in a few days for recheck if not improving Specific reasons to go to the emergency department were discussed if worsening More
2848898 16 M GA 07/08/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 55N34
57H54
Asthenia, Cold sweat, Dizziness, Pallor, Vision blurred; Asthenia, Cold sweat, D... Asthenia, Cold sweat, Dizziness, Pallor, Vision blurred; Asthenia, Cold sweat, Dizziness, Pallor, Vision blurred More
At 10:28 am after recieving MENV and BEX pt skin appeared pale and was visibly weak/lightheaded. Ski... At 10:28 am after recieving MENV and BEX pt skin appeared pale and was visibly weak/lightheaded. Skin was clammy to touch. parent reported pt had not had anything to eat this morning. pt stated vision had become blurry. Assisted by the RN. Vitals taken at 10:28 BP-106/66 02-96% P-78, 10:31 BP-110/76 02-96% P-68, 10:36 BP-101/64 02-96% P-70. pt was able to stand and ambulate as normal. pt no longer presented with pale or clammy skin and stated that he feels much better and no longer c/o blurry vision, lightheadedness, weakness. family was accompanied to facility parking lot. pt left with parent More
2848899 17 F KY 07/08/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 3275B
No adverse event, Wrong product administered No adverse event, Wrong product administered
Youth was administered Menveo vaccine in error. Records indicate youth received MCV4 on 01/14/2019, ... Youth was administered Menveo vaccine in error. Records indicate youth received MCV4 on 01/14/2019, MenACWY-TT on 12/22/2023. Youth was scheduled to receive Menb vaccination but nurse administered Menvo in error. No adverse reactions noted. More
2848900 72 F TX 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Urticaria Urticaria
2nd day past vaccine I had hives on my face. I've had hives in 2012 so I knew what it was. I di... 2nd day past vaccine I had hives on my face. I've had hives in 2012 so I knew what it was. I did take a photo if it needs to be seen. They were gone the next day. More
2848901 65 M TX 07/08/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Arthritis, Blood test normal, Chills, Dizziness, Eye disorder; Influenza like il... Arthritis, Blood test normal, Chills, Dizziness, Eye disorder; Influenza like illness, Myalgia, Pain, Rash, Rash pruritic; Tinnitus, Visual impairment, Vitreous floaters More
I had serious flu-like symptoms for two weeks. Chills, body and muscle aches, inflammation in my kne... I had serious flu-like symptoms for two weeks. Chills, body and muscle aches, inflammation in my knee joints, a high ringing in my ears, and extreme dizziness. My doctor started me on Prednisone 40 mg and slowly tapered. As the taper began, I developed an itchy rash along my right arm and on the right side of my trunk, and my ears began ringing again, with dizziness accompanying it, only alleviated by lying down. Since the rash developed, I?ve begun taking 40 mg of Benadryl daily, plus I have applied hydrocortisone cream 1% to the rash site, as well as triamcinilone cream. None of it has affected the itching. In the middle,of all this, on June 18th around 4:00 pm, I was driving home and had a sudden impairment of my eyesight. As far as the retinal specialist can tell, I had a sizeable amount of tissue break off inside my right eye, creating a number of floaters in my eye. They have not gone away since then. More
2848902 12 M 07/08/2025 TDAP
 SANOFI PASTEUR
 4CA28C1
Expired product administered Expired product administered
Tdap was ordered for patient, The vaccine was given to patient and then realized it was expired. I n... Tdap was ordered for patient, The vaccine was given to patient and then realized it was expired. I notified my manager and PA. The provider explained to patient and mother no harm will come from vaccine expiration. Updated Vaccine given to patient. More
2848903 28 F MI 07/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 eb499
Injection site swelling, Pain in extremity Injection site swelling, Pain in extremity
Patient reported swelling at site of injection and intense arm pain. Consulted to use tylenol/Motrin... Patient reported swelling at site of injection and intense arm pain. Consulted to use tylenol/Motrin to help with arm pain and contact us in 24-48 hours if pain persists or gets worse. More
2848904 MO 07/08/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
no additional AE; a temperature excursion; This spontaneous report was received from a nurse on 02-J... no additional AE; a temperature excursion; This spontaneous report was received from a nurse on 02-Jul-2025 and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 16-Jun-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y015108, expiration date: 06-Sep-2026) 0.5 ml as prophylaxis. There is a temperature excursion of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) at 6.3F for 16 minutes (Product storage error). There was no previous temperature excursion. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date not provided). No additional AE (no adverse event). At the reporting time, the outcome of the events was unknown. More
2848905 55 F NJ 07/08/2025 TDAP
 SANOFI PASTEUR
 u8352aa
Pain in jaw Pain in jaw
Donor started with severe jaw pain 2 days after vaccine Donor started with severe jaw pain 2 days after vaccine
2848906 36 M AR 07/08/2025 DTAP
DTAP
DTAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Unknown
Unknown
Unknown
Arthralgia, Back pain, Computerised tomogram neck, Computerised tomogram normal,... Arthralgia, Back pain, Computerised tomogram neck, Computerised tomogram normal, Injected limb mobility decreased; Loss of personal independence in daily activities, Mobility decreased, Neck pain, Osteoarthritis, Pain; Sleep disorder, X-ray limb abnormal More
I received a Tdap vaccine in my left shoulder on April 16th, 2024. Within hours I began experiencing... I received a Tdap vaccine in my left shoulder on April 16th, 2024. Within hours I began experiencing persistent shoulder and neck pain that did not improve with time. The pain limited my ability to lift my arm, turn my head, sleep comfortably, and perform daily activities. I returned to the same provider multiple times over the next three months. A CT scan was performed within the first two months, but no clear diagnosis was made and I was not offered further treatment or imaging like MRI or ultrasound. The pain continued for over 15 months, radiating into my neck , upper back and shoulders. I later sought care from a sports medicine physician, received a cortisone injection and was prescribed oral steroids. An X-ray showed arthritis, but my symptoms began immediately after the injection and had never occurred prior. At the time of this report, symptoms have recently improved slightly, but I continue to seek evaluation for a possible vaccine related shoulder injury. No soft tissue imaging has been performed yet. More
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2848907 18 F AL 07/08/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
Erythema, Pain in extremity, Rash, Skin warm, Urticaria Erythema, Pain in extremity, Rash, Skin warm, Urticaria
R Arm: Hives, redness, soreness, warm to the touch. Face: rash R Arm: Hives, redness, soreness, warm to the touch. Face: rash
2848908 11 M 07/08/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR


Injection site induration, Injection site pruritus, Injection site swelling, Inj... Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth More
R arm progressively became more swollen, hard, warm over the 24 hours after injection. Itchy at the... R arm progressively became more swollen, hard, warm over the 24 hours after injection. Itchy at the sire of injection. Improved on it's own after several days. More
2848909 87 M CA 07/08/2025 COVID19
COVID19
 MODERNA
MODERNA

Body temperature increased, Brain fog, COVID-19, Disorientation, Fatigue; SARS-C... Body temperature increased, Brain fog, COVID-19, Disorientation, Fatigue; SARS-CoV-2 test positive More
Pt states he had fatigue the next day after vaccine. The following Monday he was disoriented that co... Pt states he had fatigue the next day after vaccine. The following Monday he was disoriented that continued Tuesday so he took a home covid test that was positive. His PCP started him on Paxlovid. He took another covid test about a week later and it was negative. He thinks he misread the covid test that it wasn't positive because he was so disoriented. He has brain fog and get confused like he lost his perception to detail to what he is trying to see and read. It was scary since he has never experienced anything like this before. These symptoms seem to be a little better today. Temperature was slightly elevated first couple of days but is back to normal. More
2848910 1.92 M OH 07/08/2025 DTPPVHBHPB
MMR
 MSP VACCINE COMPANY
MERCK & CO. INC.
Y019108
Gait disturbance, Injection site pain, Pyrexia; Gait disturbance, Injection site... Gait disturbance, Injection site pain, Pyrexia; Gait disturbance, Injection site pain, Pyrexia More
Leg pain causing toddler to not want to bear his own weight on right leg. Fever (to be expected) aft... Leg pain causing toddler to not want to bear his own weight on right leg. Fever (to be expected) after 24 hours leg pain still present, Tylenol helped pain but limping still occurring. This is not a normal reaction. More
2848911 16 F VA 07/08/2025 HEP
HEPA
MMRV
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 7NX57
42DM9
Y020299
U8361AA
X449Y
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Inadvertently gave MMRV to client instead of administering separately an MMR vaccine and a Varicella... Inadvertently gave MMRV to client instead of administering separately an MMR vaccine and a Varicella vaccine. Client was verbally informed of the error and instructed to return to the health clinic in one month to receive the two requested vaccines (MMR & VAR). Client was observed and showed no adverse effects. Client was provided a current vaccine record which listed the administration of the combination vaccine (MMRV). More
2848912 75 F IL 07/08/2025 COVID19
COVID19
COVID19
IPV
IPV
IPV
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR





Agitation, Balance disorder, Blood test, Chest discomfort, Dizziness; Ear pain, ... Agitation, Balance disorder, Blood test, Chest discomfort, Dizziness; Ear pain, Electrocardiogram, Erythema, Fatigue, Headache; Magnetic resonance imaging, Nausea, Pruritus, Respiratory rate decreased, Scan with contrast; Agitation, Balance disorder, Blood test, Chest discomfort, Dizziness; Ear pain, Electrocardiogram, Erythema, Fatigue, Headache; Magnetic resonance imaging, Nausea, Pruritus, Respiratory rate decreased, Scan with contrast More
Weird weighty feeling in chest, mild deminished breathing, bad headache, R inner ear hurting, severe... Weird weighty feeling in chest, mild deminished breathing, bad headache, R inner ear hurting, severe dizziness and difficulty with balance more than usual, nausea and mental agitation. Went to (withheld name) Hospital ER to see if vertigo or stroke...given morphine for headache, given MRI with and w/o contrast. Dr. felt not vertigo and not stroke. R arm had begun itching and turning red so put Cortisone on it and relieved itch. Sent home and took 3-4 days to begin recovery....fatigue still and take Rx for nausea which is better. More
2848913 24 M MN 07/08/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 017B21A
039B21A
058H21A
Anxiety, Chronic fatigue syndrome, Depression; Anxiety, Chronic fatigue syndrome... Anxiety, Chronic fatigue syndrome, Depression; Anxiety, Chronic fatigue syndrome, Depression; Anxiety, Chronic fatigue syndrome, Depression More
Anxiety, depression, and chronic fatigue syndrome- years of medication, therapy, TMS therapy Anxiety, depression, and chronic fatigue syndrome- years of medication, therapy, TMS therapy
2848914 51 M MO 07/08/2025 COVID19
 PFIZER\BIONTECH
 me6072
Injected limb mobility decreased Injected limb mobility decreased
Patient called stating hours after he received the vaccine, he was unable to move his left arm. Patient called stating hours after he received the vaccine, he was unable to move his left arm.
2848915 0.75 M IL 07/08/2025 RAB
RAB
RAB
RAB
RAB
RAB
RAB
RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 fdp00543
fdp00543
fdp00543
fdp00543
FDP00527
FDP00527
FDP00527
FDP00527
Adenovirus test, Bordetella test negative, Chlamydia test negative, Coronavirus ... Adenovirus test, Bordetella test negative, Chlamydia test negative, Coronavirus test negative, Ear irrigation; Enterovirus test negative, Erythema multiforme, Feeling hot, Human metapneumovirus test, Human rhinovirus test; Influenza A virus test negative, Influenza B virus test negative, Lethargy, Mycoplasma test negative, Pyrexia; Rash, Respiratory syncytial virus test negative, Respirovirus test negative, Rubulavirus test negative; Adenovirus test, Bordetella test negative, Chlamydia test negative, Coronavirus test negative, Ear irrigation; Enterovirus test negative, Erythema multiforme, Feeling hot, Human metapneumovirus test, Human rhinovirus test; Influenza A virus test negative, Influenza B virus test negative, Lethargy, Mycoplasma test negative, Pyrexia; Rash, Respiratory syncytial virus test negative, Respirovirus test negative, Rubulavirus test negative More
Pts mother states that patient received the first dose of Rabies Vaccine and Immunoglobulin 7/3/25 a... Pts mother states that patient received the first dose of Rabies Vaccine and Immunoglobulin 7/3/25 at 12:00am in ER, denies any initial reaction. Mother states that he was mildly lethargic and felt warm to touch around 11-12hrs after initial vaccination. Mother states that patient was under his aunts care and was administered Tylenol for warmth/comfort and then was given a second dose of Tylenol in the evening. Mother states that the next day 7/4/25, patient was acting better. Then the following day 7/5/25, Mother states patient was burning up and took a rectal temperature which showed 102.3F. Mother states that she gave patient Tylenol, and then went to ER. Mother states temp was 101.1F during triage and had gotten up to 102.6F during ER visit. Patient was administered Tylenol and Motrin in ER. (mother states that patient had never had Motrin prior to this previously) that they did viral testing which was negative, checked pts ears and did an ear irrigation, states pts ears were clear. Mother states that the ER physician thought the fever was related to the Rabies vaccine and discharged patient to monitor at home and rotate Tylenol/Motrin for fever. Advised mother to continue with Second dose of Rabies Vaccine scheduled for 7/6/2025. Mother states that patient did receive the second dose in the morning of 7/6/25. Mother states she continued rotating Tylenol and Ibuprofen, fever was breaking but patient still felt warm to touch. Mother states that the next morning 7/7/25, she continued rotating Tylenol/Ibuprofen and was doing good for the remainder of the day. Mother states that his temp was doing good at 97.8F. Mother states in the evening she noticed a rash starting around 8pm. Mother states that the rash continued to progress/worsen. Rash present to full body, not localized. Mother states she called ER and was advised to not bring patient into ER unless he is having difficulty breathing. Mother states that when patient woke up this AM 7/8/25 the rash has continued to worsen and mother brought patient to ER this morning. Mother states that patient was diagnosed with erythema multiforme minor. States that ER physician states patient can continue with Rabies series since the patient is already producing an immune response/immune response has already occurred. More
2848916 59 F TX 07/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 H4279
Blister Blister
I woke this morning from after getting it and i broke out with blisters all over my hands and some o... I woke this morning from after getting it and i broke out with blisters all over my hands and some on my legs also on my feet. I am homeless so i live in my vehicle. I have a doctors appoint July 16th to get it checked out. More
2848917 69 F NE 07/08/2025 PNC20
 PFIZER\WYETH
 Ln4927
Injection site erythema Injection site erythema
Pt reported redness around the injection site this morning. Or was contacting md Pt reported redness around the injection site this morning. Or was contacting md
2848918 63 F FL 07/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 JB27A
Extra dose administered, No adverse event Extra dose administered, No adverse event
PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE ONCE SHE REQUESTED ON IMMUNIZATION CONSENT FORM. RPH ... PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE ONCE SHE REQUESTED ON IMMUNIZATION CONSENT FORM. RPH FAILED TO VERIFY IN WEBSITE IF SHE HAD ALREADY RECEIVED IT. ONCE THIS ERROR WAS REPORTED FROM PHARMACY CUSTOMER EXPERIENCE TO THE PHARMACY 2 DAYS AFTER, WE HAD CONTACTED PATIENT. SHE WAS ASKED ABOUT A POSSIBLE SIDE EFFECTS SUCH AS FEVER, FATIGUE, OR INJECTION SITE PAIN. PATIENT DID NOT EXPERIENCED ANY OF THEM AND CONFIRMED THAT SHE HAD REQUESTED AND SIGNED ADMINISTRATION OF RSV More
2848919 31 F CO 07/08/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 793PT
793PT
Dizziness, Feeling abnormal, Impaired work ability, Lip swelling, Nausea; Pain i... Dizziness, Feeling abnormal, Impaired work ability, Lip swelling, Nausea; Pain in jaw, Urticaria More
7/8/2025 03:39:10 PM MDT > pt states she has hives on one side of her face, and now it's on ... 7/8/2025 03:39:10 PM MDT > pt states she has hives on one side of her face, and now it's on the other side of her face, unable to go to work. She states she is dizzy and nauseous. She states she didn't take her meds, but then took them but is now feeling bad. Pt is unsure when hives started. She states she looked at her face 30 min ago. Pt denies new lotion or face soap, denies new foods. Pt denies difficulty breathing, difficulty swallowing, states jaw hurts and lips feel swollen too. More
2848920 54 M ID 07/08/2025 PNC20
 PFIZER\WYETH
 lx4482
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Redness and minor swelling around the injection site. No pain or heat. Redness and minor swelling around the injection site. No pain or heat.
2848921 M CA 07/08/2025 FLUX
SMALLMNK
 UNKNOWN MANUFACTURER
BAVARIAN NORDIC
 Unknown
Unknown
Gait disturbance, Impaired driving ability, Malaise, Memory impairment; Gait dis... Gait disturbance, Impaired driving ability, Malaise, Memory impairment; Gait disturbance, Impaired driving ability, Malaise, Memory impairment More
had to think about how to drive or could not remember how to drive; trouble walking; Patient was fee... had to think about how to drive or could not remember how to drive; trouble walking; Patient was feeling a little under the weather/ Really felt out of it; Patient was sick on top of that; Case reference number US-BN-2025-001117 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV25-1523) on 24-Jun-2025 and concerns a 43-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received the first dose of Jynneos (batch number: unknown), at an unknown dose, via unknown route at unknown site of administration for smallpox / monkeypox, along with some other inactivated vaccines, among which was the influenza vaccine. On an unspecified date, unknown amount of time after the first dose of Jynneos, the patient was feeling a little under the weather. The patient felt really out of it and felt like having trouble with walking. The patient also reported wanting to drive but had to think about how to do so, or could not remember how to drive, the patient was sick on top of that. Because of these experiences, there is hesitation about receiving the second dose of Jynneos. The patient was due for their second dose of Jynneos on 27-Jun-2025. At the time of the initial report, the outcome of the events of malaise, gait disturbance, illness and mental impairment was unknown. The reporter assessed the events of malaise, gait disturbance, illness and mental impairment as non-serious and not related to Jynneos, since the patient received multiple shots, influenza shot etcetera. However the event of mental impairment was assessed as serious due to medically significance. Additional information received from pharmacist via Bavarian Nordic on 25-Jun-2025 included: MedComm reference number: USBAV25-1536, reporter details, causality assessment. Additional information received from pharmacist via Bavarian Nordic on 26-Jun-2025 included: MedComm reference number: USBAV25-1555, co-suspect medication, causality assessment updated, additional event.; Reporter's Comments: A 43-year-old male patient experienced a serious event of mental impairment (medical significance) and non-serious events of gait disturbance, malaise and illness on an unspecified date, unknown amount of time after the patient received the first dose of Jynneos for smallpox / monkey pox, along with some other inactivated vaccines, among which was the influenza vaccine. Mental impairment and gait disturbance are unlisted and unexpected for Jynneos per RA1 v7 and RA, whilst malaise is listed and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. Due to missing critical clinical details (including onset, dose, route, duration, patient comorbidities, outcome, and timing), and presence of confounding factors (co-administered vaccines), the causality of the reported adverse events in relation to Jynneos in the context of the available information appears unlikely related. This case is considered as serious due to medical significance.; Sender's Comments: A 43-year-old male patient experienced a serious event of mental impairment (medical significance) and non-serious events of gait disturbance, malaise and illness on an unspecified date, unknown amount of time after the patient received the first dose of Jynneos for smallpox / monkey pox, along with some other inactivated vaccines, among which was the influenza vaccine. Mental impairment and gait disturbance are unlisted and unexpected for Jynneos per RA1 v7 and RA, whilst malaise is listed and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. Due to missing critical clinical details (including onset, dose, route, duration, patient comorbidities, outcome, and timing), and presence of confounding factors (co-administered vaccines), the causality of the reported adverse events in relation to Jynneos in the context of the available information appears unlikely related. This case is considered as serious due to medical significance. More
2848922 76 F OH 07/08/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
Arthralgia, Blood glucose increased, Condition aggravated, Gait disturbance, Inj... Arthralgia, Blood glucose increased, Condition aggravated, Gait disturbance, Injection site mass; Injection site pain, Joint stiffness, Limb mass, Lip swelling, Pain in extremity; Pyrexia More
still in constant pain on mainly her legs; getting stiff at the joints; lower lip is now swollen; ha... still in constant pain on mainly her legs; getting stiff at the joints; lower lip is now swollen; hard time walking/Difficulty in walking; she had a large painful lump on her arm at the site of the injection; shot her blood sugar to over 400; many large lumps on both legs from her butt to her toes; high fever; she hurt everywhere including every joint/Joint pain; Pain injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus (Existed prior to receiving the Shingrix vaccine) and osteoporosis (Existed prior to receiving the Shingrix vaccine). On 12-APR-2025, the patient received the 1st dose of Shingrix (right arm). On 12-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site), fever (Verbatim: high fever) and joint pain (Verbatim: she hurt everywhere including every joint/Joint pain). On 19-APR-2025, the patient experienced injection site lump (Verbatim: she had a large painful lump on her arm at the site of the injection), blood sugar increased (Verbatim: shot her blood sugar to over 400), walking difficulty (Verbatim: hard time walking/Difficulty in walking) and lower extremity mass (Verbatim: many large lumps on both legs from her butt to her toes). On 15-JUN-2025, the patient experienced stiff joint (Verbatim: getting stiff at the joints) and lip swelling (Verbatim: lower lip is now swollen). On an unknown date, the patient experienced leg pain (Verbatim: still in constant pain on mainly her legs). The outcome of the injection site pain, injection site lump, joint pain, stiff joint, walking difficulty, lip swelling, leg pain and lower extremity mass were not resolved and the outcome of the blood sugar increased was not reported and the outcome of the fever was resolved. It was unknown if the reporter considered the injection site pain, injection site lump, blood sugar increased, fever, joint pain, stiff joint, walking difficulty, lip swelling, leg pain and lower extremity mass to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site lump, blood sugar increased, fever, joint pain, stiff joint, walking difficulty, lip swelling, leg pain and lower extremity mass to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JUN-2025 The patient reporting she received her first Shingrix vaccine. That evening vaccine, the patient said she hurt everywhere including every joint. She had a high fever the night of the injection. One week later the patient states she had a large painful lump on her arm at the site of the injection. The patient states she was having a hard time walking because of many large lumps on both legs from her butt to her toes. On 19-April-2025 the health care professional gave her a steroid that shot her blood sugar to over 400. The patient had to wait to see the health care professional for an appointment until 13-June-2025. The health care professional ordered a Magnetic Resonance Imaging that she took on 15-June-2025. The patient reports her hands were getting stiff at the joints, she was still in constant pain on mainly her legs that was making it hard for her to walk and the lumps were still present on both legs. The patient also mentioned her lower lip was now swollen.; Sender's Comments: US-GSK-US2025075741:SAME reporter More
2848923 F NC 07/08/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
3rd dose received after 6 months (longer than recommended); 2nd dose received on 21st days; This non... 3rd dose received after 6 months (longer than recommended); 2nd dose received on 21st days; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On an unknown date, the patient received the 3rd dose of Twinrix and the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 3rd dose received after 6 months (longer than recommended)) and drug dose administration interval too short (Verbatim: 2nd dose received on 21st days). The outcome of the drug dose administration interval too long and drug dose administration interval too short were 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: 27-JUN-2025 The reporter was a female adult patient. The patient was also a HCP (Pharmacist). The patient received Twinrix in 2013 or 2014. The patient received Twinrix at 0 month, 21 days, and 6-month schedule. The patient received 3rd dose of Twinrix,?later than the recommended interval, which led to lengthening of vaccinations schedule. The patient received 2nd dose of Twinrix,?earlier than the recommended interval, which led to shortening of vaccinations schedule. This case is linked with US2025081319 reported by same reporter.; Sender's Comments: US-GSK-US2025081319:Same reporter,Different patient More
2848924 67 M SC 07/08/2025 FLUX
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Inappropriate schedule of product administration, Skin warm; Inappropriate sched... Inappropriate schedule of product administration, Skin warm; Inappropriate schedule of product administration, Skin warm More
arm was warmer; received the second dose 1 month ago; This non-serious case was reported by a consum... arm was warmer; received the second dose 1 month ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin warm in a 67-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. Previously administered products included Shingrix (received the first dose of shingrix in 2019). Concurrent medical conditions included diabetes (Diabetes). In MAY-2025, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received Influenza vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine and Influenza vaccine, the patient experienced drug dose administration interval too long (Verbatim: received the second dose 1 month ago). On an unknown date, the patient experienced skin warm (Verbatim: arm was warmer). The outcome of the skin warm was unknown and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the skin warm to be related to Shingles vaccine and Influenza vaccine. It was unknown if the company considered the skin warm to be related to Shingles vaccine and Influenza vaccine. Additional Information: GSK Receipt Date: 30-JUN-2025 The patient's arm was warmer for the second shot of Shingrix than when he got the flu vaccine. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2025AMR083726, reported by same reporter for different patient.; Sender's Comments: US-GSK-US2025AMR083726:husband case More
2848925 M TX 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
He has not yet had the second dose which was due between 24 Dec 2024 and 24 Apr 2025, but will recei... He has not yet had the second dose which was due between 24 Dec 2024 and 24 Apr 2025, but will receive it today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (On 24-OCT-2024, the patient received 1st dose). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: He has not yet had the second dose which was due between 24 Dec 2024 and 24 Apr 2025, but will receive it today). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-JUL-2025 This report was submitted via the online direct entry reporting system. The Pharmacy technician reported that the patient received his first dose on 24 Oct 2024. The patient not yet had the second dose which was due between 24-Dec-2024 and 24-Apr-2025 but would receive it on the day of reporting. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. More
2848926 F PA 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received her first dose of Shingrix a year ago. She never received her second dose; This non-serious... received her first dose of Shingrix a year ago. She never received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose a year ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received her first dose of Shingrix a year ago. She never received her second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-JUL-2025 The patient self-reported this case. The patient received her first dose of Shingrix a year ago and never received her second dose Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2848927 F 07/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
sick; This non-serious case was reported by a consumer via interactive digital media and described t... sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved (duration 3 weeks). It was unknown if the reporter considered the sickness to be related to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK receipt date: 18-JUN-2025 The case was received from the consumer via interactive digital media. The reporter stated that RSV vaccines make you sick. The reporter knows someone who got one and she's been such for 3 weeks. More
2848928 07/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Migraine Migraine
migraine; This non-serious case was reported by a consumer via interactive digital media and describ... migraine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of migraine in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced migraine (Verbatim: migraine). The outcome of the migraine was not reported. It was unknown if the reporter considered the migraine to be related to Arexvy. It was unknown if the company considered the migraine to be related to Arexvy. Additional Information: GSK Receipt Date: 28-JUN-2025 This case was reported by a patient via interactive digital media. Patient stated that after receiving Arexvy vaccine they get migraines often. More
2848929 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
had a dose of Shingrix 5 years ago, had another dose yesterday; This non-serious case was reported b... had a dose of Shingrix 5 years ago, had another dose yesterday; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 5 years ago). On 28-JUN-2025, the patient received the 2nd dose of Shingrix. On 28-JUN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: had a dose of Shingrix 5 years ago, had another dose yesterday). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 29-JUN-2025 The patient received 2nd dose at longer interval than recommended which led lengthening of vaccination schedule. The reporter asked did he/she need a third dose in 2 to 4 months. More
2848930 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered at inappropriate site Product administered at inappropriate site
i have taken first dose of Shingrix at buttock; This non-serious case was reported by a consumer via... i have taken first dose of Shingrix at buttock; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of vaccine administered at inappropriate site in a 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 vaccine administered at inappropriate site (Verbatim: i have taken first dose of Shingrix at buttock). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK Receipt Date: 28-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that have taken first dose of Shingrix at buttock which led to vaccine administered at inappropriate site. The reporter asked was it ok. More
2848931 07/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; 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, 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she got the shot of Shingles vaccine and then got the shingles four months after the vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2848932 07/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
Arm is killing me but no side effects so far; This non-serious case was reported by a consumer via i... Arm is killing me but no side effects so far; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 02-JUL-2025, the patient received the 1st dose of Shingles vaccine (unknown arm). On 02-JUL-2025, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm is killing me but no side effects so far). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK receipt date: 02-JUL-2025 This case was reported by a patient via interactive digital media. Patient stated that they just got first shot on the day of reporting and arm was killing him/her but no side effects were there till the time of reporting. More
2848933 F PA 07/08/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 92DJ3
Expired product administered Expired product administered
vaccine was expired since 5/3/2025 and the patient received it today on 6/18/2025; This non-serious ... vaccine was expired since 5/3/2025 and the patient received it today on 6/18/2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-day-old female patient who received HBV (Engerix B) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis. On 18-JUN-2025, the patient received Engerix B. On 18-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: vaccine was expired since 5/3/2025 and the patient received it today on 6/18/2025). The outcome of the expired vaccine used 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-JUN-2025 License practice nurse called to report that a 5 days old female patient received an expired dose of Engerix-B. The vaccine was expired since 5/3/2025 and the patient received it today on 6/18/2025. The reporter asked do we have to revaccinate the patient. More
2848934 F NY 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Does the series have to be restarted; This non-serious case was reported by a pharmacist via call ce... Does the series have to be restarted; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 14-MAR-2023 with batch number YA493 and lot expiry 13-APR-2026). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Does the series have to be restarted). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 20-JUN-2025 The pharmacist reported that the patient received Shingrix first dose back on 14-MAR-2024. The reporter was ask did the series have to be restarted if patient receives first dose more than 6 months. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. More
2848935 F 07/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema Injection site erythema
Shingrix - Redness close to injection site; This non-serious case was reported by a pharmacist via c... Shingrix - Redness close to injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly 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 injection site erythema (Verbatim: Shingrix - Redness close to injection site). The outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JUN-2025 A pharmacist mentioned that a patient reported redness close to the injection site. The pharmacist said that redness was few inches down to the injection site. This patient received the first dose of Shingrix between 21-28 days ago (did not provide specific date of administration). The pharmacist mentioned that patient was in her early 70s (not specific age provided). No further details provided. The reporter consented to follow up. More
2848936 MS 07/08/2025 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; Shingles; This serious case was reported by a pharmacist via sales re... Suspected Vaccination failure; Shingles; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a 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, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. 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: 01-JUL-2025 The pharmacist reported that the patient was fully vaccinated with Shingrix and a year later patient had a breakthrough shingles case. The reporter asked should the patient get another series of Shingrix. This case was considered as suspected vaccination failure since the details regarding the 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, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
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