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
2841322 48 F MI 05/16/2025 MMR
 MERCK & CO. INC.
 X026329
Cellulitis, Limb mass Cellulitis, Limb mass
Patient was seen on 4/8/25 for Immigration physical and was given Tdap and Flu (Flu was given in Rig... Patient was seen on 4/8/25 for Immigration physical and was given Tdap and Flu (Flu was given in Right Deltoid), labs were drawn and found that patient had no immunity to MMR. Patient returned on 4/15/25 and was given the MMR vaccine subQ in R Arm. Patient returned on 5/12/25 and informed provider that she noticed a bump under her arm and started noticing it 5/10/25 in the morning. Provider determined that it was acute cellulitis and patient was given Cephalexin Capsule 500mg to take every 6 hours for 10 days. Patient was asked to follow up in 2 days if not getting better. Patient has not followed up or contacted us with any other issues. More
2841323 52 F NC 05/16/2025 COVID19
 JANSSEN
 202A21A
Diplopia, Magnetic resonance imaging normal, Muscle disorder, Pain, Paraesthesia Diplopia, Magnetic resonance imaging normal, Muscle disorder, Pain, Paraesthesia
Right side muscle failure, pain, tingling, double vision Right side muscle failure, pain, tingling, double vision
โœ“
2841324 0.08 M VA 05/16/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 u7788aa
u7788aa
lx4482
lx4482
2003177
2003177
CSF test, Differential white blood cell count, Full blood count, Metabolic funct... CSF test, Differential white blood cell count, Full blood count, Metabolic function test, Seizure; Urine analysis; CSF test, Differential white blood cell count, Full blood count, Metabolic function test, Seizure; Urine analysis; CSF test, Differential white blood cell count, Full blood count, Metabolic function test, Seizure; Urine analysis More
family reports seizure activity family reports seizure activity
2841325 11 M LA 05/16/2025 TDAP
 SANOFI PASTEUR
 U8252AA
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
redness and swelling at the injection site redness and swelling at the injection site
2841326 64 F IN 05/16/2025 PNC20
 PFIZER\WYETH
 lx4484
Injection site rash, Rash, Rash erythematous Injection site rash, Rash, Rash erythematous
Red rash developed in a circle below the vaccine site and then areas in the armpit crease on the sam... Red rash developed in a circle below the vaccine site and then areas in the armpit crease on the same arm of vaccine. Pt also received 2 other vaccines on the same day but on the opposite arm. More
2841327 34 F WA 05/16/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



Arthralgia, Autonomic nervous system imbalance, Coagulopathy, Decreased appetite... Arthralgia, Autonomic nervous system imbalance, Coagulopathy, Decreased appetite, Diarrhoea; Drug hypersensitivity, Fibromyalgia, Haematoma, Headache, Hot flush; Hyperacusis, Impaired healing, Insomnia, Irritability, Musculoskeletal stiffness; Photophobia, Temperature intolerance, Tendon disorder More
I received pfizer vaccine two doses following a month from apart. Side adverse begin same day after ... I received pfizer vaccine two doses following a month from apart. Side adverse begin same day after second dose with photophobia, headache, muscle stiffness in the neck and back area. dysautonomia, join pain, allergies to medicines in general only able to tolerate herbal medicine. diarrhea, no appetite, hot flashes, noisy intolerance, cold intolerance, tendinopathies, symptoms like fibromyalgia, insomnia, irritability, coagulations issues, hematomas, wound delay repair. Everything is almost resolved with herbal medicine, time, and many physicians I have to consult in order to help me resolve this. Currently taking supplements and herbal medicine and symptoms are stable. More
โœ“
2841328 62 F TX 05/16/2025 PNC21
 MERCK & CO. INC.
 Y019158
Decreased appetite, Headache, Peripheral swelling, Pruritus, Rash Decreased appetite, Headache, Peripheral swelling, Pruritus, Rash
Rush and swollen on the left arm with 2 times one hand size which started 2nd day of the Shot, now i... Rush and swollen on the left arm with 2 times one hand size which started 2nd day of the Shot, now in 7 days, rush and swollen area still larger than a palm size; itchy; 2-days fever; 4-days headache; 7-days no appetites More
2841329 62 F FL 05/16/2025 PNC20
 PFIZER\WYETH
 LX4482
Disorientation, Injection site pain, Injection site swelling, Oligomenorrhoea Disorientation, Injection site pain, Injection site swelling, Oligomenorrhoea
1. start "menstral cycle" x1wk 2. spacial disoriented x 3 days 3. local injection site swe... 1. start "menstral cycle" x1wk 2. spacial disoriented x 3 days 3. local injection site swelling and painful x 4 days. More
2841330 29 M CA 05/16/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH














Acne, Alopecia, Angina pectoris, Anxiety, Arthralgia; Asthenia, Dairy intoleranc... Acne, Alopecia, Angina pectoris, Anxiety, Arthralgia; Asthenia, Dairy intolerance, Fatigue, Food intolerance, Gastrointestinal pain; Gluten sensitivity, Hepatic pain, Hypoaesthesia, Loose tooth, Panic attack; Poor quality sleep, Pruritus, Sciatica, Spinal pain, Tooth loss; Varicose vein, Vision blurred; Acne, Alopecia, Angina pectoris, Anxiety, Arthralgia; Asthenia, Dairy intolerance, Fatigue, Food intolerance, Gastrointestinal pain; Gluten sensitivity, Hepatic pain, Hypoaesthesia, Loose tooth, Panic attack; Poor quality sleep, Pruritus, Sciatica, Spinal pain, Tooth loss; Varicose vein, Vision blurred; Acne, Alopecia, Angina pectoris, Anxiety, Arthralgia; Asthenia, Dairy intolerance, Fatigue, Food intolerance, Gastrointestinal pain; Gluten sensitivity, Hepatic pain, Hypoaesthesia, Loose tooth, Panic attack; Poor quality sleep, Pruritus, Sciatica, Spinal pain, Tooth loss; Varicose vein, Vision blurred More
I started to feel a lot of itching and I scratched my arm, they told me it was normal, I waited 10 m... I started to feel a lot of itching and I scratched my arm, they told me it was normal, I waited 10 minutes there, then I felt my teeth were loose and my joints hurt, especially in my spine, I saw blurry, at the time I did not have medical insurance and I endured the symptoms, with the next dose my hair fell out, I lost a tooth and my body began to fill with small pimples like acne and I could not sit for more than 10 minutes, they told me it was sciatic nerve, I saw blurry, I had panic and anxiety attacks, my limbs fell asleep, my heart hurt, I got varicose veins and my liver and intestines started to hurt, I became intolerant to dairy, gluten and many more foods, I began to feel very weak and exhausted nobody believed me, I do not sleep well, for the third dose I began to suspect the vaccine but I had to have it in order to continue with a process and once I had the last dose all the symptoms They got worse, then I tried to explain it to the doctors and I feel judged, misunderstood, and they don't believe me. They tell me it could be fibromyalgia, spondyloarthritis, etc. More
โœ“
2841331 73 F MN 05/16/2025 RSV
 PFIZER\WYETH
 LN5463
Cardiac disorder, Resuscitation Cardiac disorder, Resuscitation
Pt reported cardiac emergency when home later that day. CPR was performed until EMT arrived. Pt reported cardiac emergency when home later that day. CPR was performed until EMT arrived.
โœ“
2841332 19 M KY 05/16/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 C24B9
Underdose Underdose
Pt was given a ped. dose of Hep A instead of an adult dose. Pt recently turned 19 ten days ago. Pt... Pt was given a ped. dose of Hep A instead of an adult dose. Pt recently turned 19 ten days ago. Pt to be given 2 ped doses today to make dosage correct per recommendation of PEDIATRIC IMMUNIZATION NURSE COORDINATOR Department for Public Health Division of Epidemiology and Health Planning (DEHP) Immunization Branch More
2841333 12 F MN 05/16/2025 PNC21
 MERCK & CO. INC.
 Z002626
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient was given wrong pneumococcal vaccine based on the patient's age. Not treatment or adve... Patient was given wrong pneumococcal vaccine based on the patient's age. Not treatment or adverse outcomes More
2841334 53 F FL 05/16/2025 PNC20
 PFIZER\WYETH
 LK6651
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
mild redness, swelling and warmth at site of injection. vaccine was not given by the reporter, it wa... mild redness, swelling and warmth at site of injection. vaccine was not given by the reporter, it was documented as IM, but site of reaction appears subcutaneous as it is not over the deltoid More
2841335 69 F 05/16/2025 COVID19
 MODERNA
 8081260
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
shoulder/arm pain after vaccine administration shoulder/arm pain after vaccine administration
2841336 31 F GA 05/16/2025 VARCEL
 MERCK & CO. INC.
 Y010184
Injection site erythema, Injection site induration, Injection site warmth Injection site erythema, Injection site induration, Injection site warmth
CLIENT REPORTED VIA PHONE 5-14-25, REDNESS AND WARM TO TOUCH AT INJECTION SITE FROM 5-13-25. CLIENT... CLIENT REPORTED VIA PHONE 5-14-25, REDNESS AND WARM TO TOUCH AT INJECTION SITE FROM 5-13-25. CLIENT RETURNED TO CLINIC 5-15-25 AND REDNESS, WARM TO TOUCH , AND HARDNESS NOTED AT CENTER. CLIENT WAS REFERRED TO PCP. CLIENT PHONED BACK 5-15-25 PM AND STATED SHE WAS TREATED WITH PREDNISONE INJECTION AND ORAL ANTIBIOTIC PER FNP. STATED SHE HAD NO FOLLOW UP APPOINTMENT AT THIS TIME. More
2841337 74 F VT 05/16/2025 PNC20
 PFIZER\WYETH
 LN4927
Injection site pain, Injection site pruritus, Injection site swelling, Injection... Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth More
Pt noted reaction started about an hour after initial injection. Experiencing swelling of injection ... Pt noted reaction started about an hour after initial injection. Experiencing swelling of injection site, painful, itching, and injection site hot to touch. Sxs started 5/9 and completely resolved on 5/13. Pt used cortizone cream for the itching. More
2841338 1 M CA 05/16/2025 MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y011637
Y011637
Y013348
Y013348
Contusion, Epistaxis, Haemoglobin normal, Immune thrombocytopenia, Petechiae; Pl... Contusion, Epistaxis, Haemoglobin normal, Immune thrombocytopenia, Petechiae; Platelet count decreased, Rash, Rash erythematous, White blood cell count normal; Contusion, Epistaxis, Haemoglobin normal, Immune thrombocytopenia, Petechiae; Platelet count decreased, Rash, Rash erythematous, White blood cell count normal More
Small red rash over body, scattered pettechiae all over body with many bruises on forehead and lower... Small red rash over body, scattered pettechiae all over body with many bruises on forehead and lower extremities. ITP diagnosis received on 4/9/25. Spontaneous nosebleed on 4/9/2025. Started on oral prednisone, received in 2 weeks; now off treatment. Platelets on 5/6: 154. More
2841339 53 F IL 05/16/2025 PNC21
 MERCK & CO. INC.
 y019157
Cellulitis, Injection site erythema, Injection site warmth, Pyrexia, Rash Cellulitis, Injection site erythema, Injection site warmth, Pyrexia, Rash
Patient started developing a rash and fever shortly after getting capvaxive vaccine, along with redn... Patient started developing a rash and fever shortly after getting capvaxive vaccine, along with redness at the site of administration and area became warm to the touch. Patient followed up with her provider who diagnosed the reaction as cellulitis and prescribed keflex to the patient. More
2841341 50 M MO 05/16/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Asthenia, Ataxia, Chills, Cough, Diarrhoea; Fall, Haematuria, Myalgia, Pyrexia Asthenia, Ataxia, Chills, Cough, Diarrhoea; Fall, Haematuria, Myalgia, Pyrexia
Extreme fever, uncontrollable shivering, full body myalgia, weakness, ataxia with actual falls, diar... Extreme fever, uncontrollable shivering, full body myalgia, weakness, ataxia with actual falls, diarrhea, rough cough, hematuria More
2841342 1.25 M WA 05/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 CX4HL
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Tdap given instead of Dtap. Patient had not reaction or symptoms from vaccine Tdap given instead of Dtap. Patient had not reaction or symptoms from vaccine
2841343 10 F TN 05/16/2025 YF
YF
 SANOFI PASTEUR
SANOFI PASTEUR
 UK133AB
UK133AB
Fatigue, Headache, Neck pain, Pain, Pyrexia; Rash, White blood cell count decrea... Fatigue, Headache, Neck pain, Pain, Pyrexia; Rash, White blood cell count decreased More
5/9/25 - HA, tiredness, fever, soreness. Rash presented on 5/14/25. Hurt pt to move her neck to lo... 5/9/25 - HA, tiredness, fever, soreness. Rash presented on 5/14/25. Hurt pt to move her neck to look down but that has gotten better throughout the day today. More
2841344 60 F 05/16/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
no know adverse reactions however injection was given IM instead of SQ no know adverse reactions however injection was given IM instead of SQ
2841345 14 F VA 05/16/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 77KA5
Immediate post-injection reaction, Injection site erythema, Rash, Rash pruritic Immediate post-injection reaction, Injection site erythema, Rash, Rash pruritic
Right after administering the vaccine in the right deltiod , I noticed some bright redness form at t... Right after administering the vaccine in the right deltiod , I noticed some bright redness form at the site of the injection. I asked that patient wait around in office for 15mins to make sure no other reactions form. Pt waiting in the room for 20mins and when I went back to examine the arm, the redness had resolved. I discharged the patient at the time. After returning home, patient developed a pruritic rash on biceps bilaterally. After benadryl, that rash subsided. More
2841346 76 F CA 05/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75D3A
Burning sensation, Injection site pruritus, Injection site rash, Injection site ... Burning sensation, Injection site pruritus, Injection site rash, Injection site warmth More
Patient came to the pharmacy on 05/16/25, states they recieved a Shingrix vaccine on 05/13/25. Patie... Patient came to the pharmacy on 05/16/25, states they recieved a Shingrix vaccine on 05/13/25. Patient states, the next day they had a burning sensation on their left arm, skin hot to the touch, patient states it is itchy, and site of injection has a rash is increasing. Informed patient to seek medical attention and to inform primary provider. More
2841347 57 M WA 05/16/2025 DTAPIPVHIB
 SANOFI PASTEUR
Dizziness, Hypotension, Pain, Pyrexia Dizziness, Hypotension, Pain, Pyrexia
3 days after DTap injection I felt faint as I walk into my work office. When I got home I measured ... 3 days after DTap injection I felt faint as I walk into my work office. When I got home I measured my blood pressure and it was between SYS: 91-99 DIA: 45-59 BPM: 43-50. On 5/12 I went back to my doctor to report my low blood pressure issue and he referred me to contact my cardiologist ( appointment on May 20). On May 14 I had a fever with body ache and again low bp. More
2841348 6 F MT 05/16/2025 DTAP
IPV
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 3CA55C1
X1C891M
Y009589
Fall, Loss of consciousness, Musculoskeletal stiffness; Fall, Loss of consciousn... Fall, Loss of consciousness, Musculoskeletal stiffness; Fall, Loss of consciousness, Musculoskeletal stiffness; Fall, Loss of consciousness, Musculoskeletal stiffness More
Vaccine given at 11:35. Pt tolerated well. Moved on to siblings, Pt fell out of chair she was sittin... Vaccine given at 11:35. Pt tolerated well. Moved on to siblings, Pt fell out of chair she was sitting in while giving sibling vaccine. Pt was posturing in a stiff position with head back and bilateral legs and arms stiff. Appeared momentarily unconscious but regained consciousness within seconds. VS: 126/78 HR: 81 RR:38 O2 sats: 99%. Completely oriented within seconds and denied any pain. No further follow up required. More
2841350 69 M LA 05/16/2025 PNC20
 PFIZER\WYETH
 LK6651
Pain in extremity, Peripheral swelling, Urticaria Pain in extremity, Peripheral swelling, Urticaria
Right arm swelling, welts, and pain - Advised to apply ice for 15 minutes three times a day. Medrol ... Right arm swelling, welts, and pain - Advised to apply ice for 15 minutes three times a day. Medrol Dose pack and Benadryl OTC as directed or Cetirizine OTC as directed. At time of visit no welts, mild swelling and redness. More
2841351 0.5 M AZ 05/16/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Crying, Diarrhoea, Injection site erythema, Injection site nodule, Insomnia Crying, Diarrhoea, Injection site erythema, Injection site nodule, Insomnia
10 pm patient woke up with inconsolable crying for 3 hours, injection sites noted to be dollar coin ... 10 pm patient woke up with inconsolable crying for 3 hours, injection sites noted to be dollar coin size red and large knots underneath the skin. Patient started having diarrhea around 2 am. Around 8 stools a day for 13 days, unsure if related to vaccine (rotavirus vaccine was NOT given). However the inconsolable crying lasted 2 nights, within the 48hrs of administration. Resolved with time and lack of sleep. More
2841375 F DC 05/16/2025 HPV9
 MERCK & CO. INC.
 Y015179
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Nurse practitioner calling to report that a dose of GARDASIL 9 was inadvertently administered to a p... Nurse practitioner calling to report that a dose of GARDASIL 9 was inadvertently administered to a pregnant woman who is "30 or 31 weeks gestation." She states that the woman was in the office for her second dose of an unspecified hepatitis b vaccine; Nurse practitioner calling to report that a dose of GARDASIL 9 was inadvertently administered to a pregnant woman who is "30 or 31 weeks gestation.; She states that the woman was in the office for her second dose of an unspecified hepatitis b vaccine when the medication error occurred; She states that the patient has been alerted and has has not experienced any clinical side effects; This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's medical history, historical drugs, obstetric history, concurrent conditions, and concomitant therapies were not reported. There were no known allergies. On an unspecified date (reported as about 30-31 weeks ago), the patient became pregnant. All the information regarding this pregnancy such as last menstrual period date and date of conception were not reported. On 11-Apr-2025, when she presented to the office for her second dose of an unspecified hepatitis B vaccine, she was inadvertently vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Y015179, expiration date: 28-Jan-2027), administered by intramuscular route in a medication error while she was at 30 or 31 weeks of gestation (Maternal exposure during pregnancy) (Product use in unapproved population) (Wrong vaccine administered). She stated that the patient had been alerted and had not experienced any clinical side effects. The patient had been advised to follow up with her OBGYN but the caller was unsure if the patient had called at that point. Nurse practitioner stated that the patient did sign a form that stated the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was going to be administered even though it was a medication error. She also stated she had alerted compliance and her medical director about the incident as well. At the time of this report, both fetal and pregnancy outcome were unknown. More
2841376 AK 05/16/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 X011431
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
No adverse event; Caller reported AE on behalf of a patient who was administered expired MMR-II on 0... No adverse event; Caller reported AE on behalf of a patient who was administered expired MMR-II on 04/24/2025 w/ no TEs-- SUPPORTED via post-expiry memo. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. Additional AEs Filed (Ca; This spontaneous report was received from a nurse 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 24-Apr-2025, the patient was vaccinated with expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X011431, expiration date: 19-Apr-2025, 0.5 mL (formulation, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expired vaccine used). No additional adverse event reported (no adverse event). More
2841377 NM 05/16/2025 HPV9
 MERCK & CO. INC.
 Y012508
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; HBP reported patient was administered GARDASIL9 during a temperature excursion. Da... no adverse event; HBP reported patient was administered GARDASIL9 during a temperature excursion. Date of administration was 04/22/2025. No additional details reported. No additional AE reported. No PQC reported. ? Names of vaccines involved (including lot/exp); This spontaneous report was received from a non health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-Apr-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #Y012508, expiration date: 01-Jan-2027), dose number 1, (anatomical location and administration route were not reported) as prophylaxis. It was reported that this first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was administered during a temperature excursion of 0๏ฟฝC, in a time frame of 1 hour 0 minutes; and was confirmed that no previous temperature excursions occurred. No additional details and no additional AEs were reported. More
2841378 M NJ 05/16/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 X013193
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
No additional AE; HCP reports an expired dose of MMR II was inadvertently administered; Information ... No additional AE; HCP reports an expired dose of MMR II was inadvertently administered; Information has been received from Business Partner/CRO on 15-May-2025. This spontaneous report was received from a/an Nurse and refers to a(n) 64-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-May-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X013193, expiration date: 08-May-2025). On an unknown date, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), for the treatment of Prophylaxis. On 13-May-2025, the patient experienced HCP reports an expired dose of MMR II was inadvertently administered. On an unknown date, the patient experienced No additional AE. At the reporting time, the outcome of HCP reports an expired dose of MMR II was inadvertently administered and No additional AE was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. More
2841379 F PA 05/16/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945658
Expired product administered, No adverse event Expired product administered, No adverse event
Received ENGERIX-B as second dose; 17 Year Old Patient Received Heplisav-B; Initial report received ... Received ENGERIX-B as second dose; 17 Year Old Patient Received Heplisav-B; Initial report received on 29-Apr-2025. A physician in the US (PA) reported that a 17-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 21-Mar-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 945658, expiration date 31-Jan-2027, and NDC number 43528-003-01) intramuscularly in the left deltoid. After the vaccine was administered, the staff discovered the product was not approved in patients of her age. In Apr-2025, approximately one month after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number, expiration date, route, and site not provided)] that had expired. On an unknown date, the patient had unspecified bloodwork performed which showed no immunity from her childhood vaccines. The patient's college noted that her childhood vaccine was "given too early." No adverse effects were reported. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2841380 35 F 05/16/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Exposure during pregnancy, Headache, Nausea, Product use issue Exposure during pregnancy, Headache, Nausea, Product use issue
Arexvy received to pregnant 35 years old female; Nausea; Headache; Arexvy received to pregnant 35 ye... Arexvy received to pregnant 35 years old female; Nausea; Headache; Arexvy received to pregnant 35 years old female; This non-serious prospective pregnancy case was reported by a other health professional and described the occurrence of nausea in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 05-MAY-2025, the patient received Arexvy. On 05-MAY-2025, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Arexvy received to pregnant 35 years old female). On 06-MAY-2025, the patient experienced nausea (Verbatim: Nausea) and headache (Verbatim: Headache). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy received to pregnant 35 years old female). The outcome of the nausea and headache were resolving and the outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. It was unknown if the reporter considered the nausea and headache to be related to Arexvy. It was unknown if the company considered the nausea and headache to be related to Arexvy. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 07-MAY-2025 The pregnant patient received Arexvy vaccine with primary care provider clinic and reported concerns with having received the wrong vaccine to her prenatal care providers, including himself/herself, which led to vaccine exposure during pregnancy and product use for unapproved population. Patient was encouraged to report incident. The patient received nausea and headache. More
2841381 M NC 05/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Headache Headache
has had a headache on and off for over 3 days; This non-serious case was reported by a nurse via sal... has had a headache on and off for over 3 days; This non-serious case was reported by a nurse via sales rep and described the occurrence of headache in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: has had a headache on and off for over 3 days). The outcome of the headache was resolving. The reporter considered the headache to be related to Shingrix. The company considered the headache to be related to Shingrix. Additional Information: GSK Receipt Date: 08-MAY-2025 The reporter mentioned that patient had a headache on and off for over 3 days since vaccine administration. More
2841382 39 F IL 05/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Malaise, Pain, Pyrexia Fatigue, Malaise, Pain, Pyrexia
aches; Fatigue; Fever; feeling unwell; This non-serious case was reported by a physician and describ... aches; Fatigue; Fever; feeling unwell; This non-serious case was reported by a physician and described the occurrence of fever in a 39-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included tingling, pain, shingles, vesicles (posterior right arm, right leg, genital area), fatigue, colitis (suspected), polyp, colonoscopy (done on 13-JUN-2024, colonoscopy recall 2-3 years no colitis), renal stone (kidney stone analysis done on DEC-2019), cardiac ablation (for cardiac arrhythmia on 15-MAY-2005), cardiac arrhythmia, alcohol use (current, 1-2 times per year, 15-MAY-2020) and computerized tomogram abnormal. Previously administered products included Valtrex and Valganciclovir (received in JUL-2020). Concurrent medical conditions included systemic lupus erythematosus, asthma, cytomegalovirus infection (chronic), immunocompromised, mouth ulcer, genital ulceration, nausea, fever, hypotension, vomiting, sepsis, therapeutic drug monitoring, transaminitis, urinary tract infection, allergic to cats and dust allergy. Concomitant products included hydroxychloroquine, valaciclovir (Valacyclovir), salbutamol (Albuterol Hfa), azathioprine, biotin, loratadine, tizanidine, colecalciferol (Vitamin D3) and cyanocobalamin. Family history included heart disease, unspecified (patient's father), fibromyalgia (patient's mother) and hypertension (patient's mother). On 05-SEP-2024, the patient received the 1st dose of Shingrix. In SEP-2024, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: Fever), feeling unwell (Verbatim: feeling unwell), pain (Verbatim: aches) and fatigue (Verbatim: Fatigue). The patient was treated with paracetamol (Tylenol). In SEP-2024, the outcome of the pain and fatigue were resolved. The outcome of the fever and feeling unwell were resolving. It was unknown if the reporter considered the fever, feeling unwell, pain and fatigue to be related to Shingrix. It was unknown if the company considered the fever, feeling unwell, pain and fatigue to be related to Shingrix. Linked case(s) involving the same patient: US2025024878 Additional Information: GSK Receipt Date:16-APR-2025 The patient used B-12 1000 mcg oral tablet, 1000 mcg is equal to 1 Tab, PO, Daily (Once Daily) as concomitant. The place of vaccination in VAERS details was reported as mercy one trees medical cende. The patient experienced reaction from Shingrix injection. Fevers 99.9 today on 26-SEP-2024 it was (99-100.6) The pain present but no actual or suspected pain. The patient was 39-year-old who presents for an acute visit for fevers after Shingles vaccine. Reported after getting the Shingrix vaccine on 05-SEP-2024 she developed a fever and generally feeling unwell. She stated for the first 2 days she ran a fever as high as 101.8 then after that had further low grade fevers. She had aches and fatigue. Only tries to use Tylenol sparingly. No further mediation changes. She was feeling a bit better. No sores or outbreaks at this time. On 06-FEB-2025, the patient who presented for her second Shingles vaccine. Last visit she was evaluated with an acute visit for fevers after Shingles vaccine and stated she did feel bad a few days after her vaccine she did not feel well and had fevers on and off for some time but does need her second vaccine prior to starting Benlysta per. She presented here for her second Shingles vaccine. She went to last week. She does have a dry hacky cough but no chest pain or SOB (shortness of breath). TB test in December 2024 negative. She was immunocompromised with SLE and intermittent outbreaks of oral and genital ulcers but was currently stable on evaluation today. She would also like to continue towards using less valacyclovir and even some day discontinuing her suppressive therapy, however she had been doing well at this time therefore they would continue current regimen, no recent outbreak. Patient would also like to discuss shingles vaccine and they did discuss at last visit, she checked with her insurance and was covered as she was immunocompromised. Previously in history, before receiving vaccine, when she had her outbreaks, she had get vesicles to her posterior right arm, right leg and genital area at times. Typically when she was more stressed. Reported that she has had to take the abortive therapy a couple times over the year but again tries not to unless only necessary. She continues her daily suppressive Valtrex and not missing doses. She does not have side effects. Today she denies any current outbreaks to her arm, leg or genital area. Continues regular labs per Rheumatology and reported as stable. Now also following GI (gastrointestinal) Dr. for evaluation for suspected colitis. Last 2-3 small polyps. Colonoscopy recall 2-3 years no colitis. Several days after received Shingrix, the patient experienced feeling unwell. Less than 3 weeks after received Shingrix, the patient experienced pain and fatigue. For tolerance of the 2nd dose refer linked case US2025024878, reported by the same reporter.; Sender's Comments: US-GSK-US2025024878:case for 2nd dose More
2841383 05/16/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours... Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination More
I have the shingles now; I did not know you needed a second vaccination after about 7 years; This no... I have the shingles now; I did not know you needed a second vaccination after about 7 years; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I have the shingles now) and incomplete course of vaccination (Verbatim: I did not know you needed a second vaccination after about 7 years). The outcome of the shingles was not resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date :06-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she did not knowyou needed a second vaccination after about 7 years. Consumer reported that no one told , and he/she had the shingles now. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. More
2841384 05/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
got the shot and both were sick for 3 days; This non-serious case was reported by a consumer via int... got the shot and both were sick for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in specified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got the shot and both were sick for 3 days). The outcome of the sickness was resolved (duration 3 days). It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK receipt date: 05-MAY-2025 This case was reported by a patient via interactive digital media. Reporter stated that a couple at their church got the shot and both were sick for 3 days. More
2841385 05/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I develop shingles after I got the vaccination; This serious case was... Suspected vaccination failure; I develop shingles after I got the vaccination; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I develop shingles after I got the vaccination). 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 : 08-MAY-2025 This case was reported by a patient via interactive digital media. The patient developed shingles after he/she got the vaccination for it internally. 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 Shingles vaccine. More
2841386 OH 05/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation error Product preparation error
Can shingrix be mixed with a plain diluen; Inappropriate dose of vaccine administered; This non-seri... Can shingrix be mixed with a plain diluen; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Can shingrix be mixed with a plain diluen) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-MAY-2025 The patient administered Shingrix which was mixed with a plain diluent, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked could Shingrix be mixed with a plain diluent. More
2841387 05/16/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Pruritus, Vaccination failure; Herpes zoster, Pain, Pruritu... Herpes zoster, Pain, Pruritus, Vaccination failure; Herpes zoster, Pain, Pruritus, Vaccination failure More
Suspected vaccination failure; Just came down with shingles; This serious case was reported by a con... Suspected vaccination failure; Just came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox at young age). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Just came down with 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 and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated he/she got both (Shingles) vaccination shots 4 years ago (from the date of reporting). The patient stated he/she just came down with shingles. The patient's physician said it was very early and mild case, but they sting and itch bad. The patient enquired why did he/she got them. This case was considered as suspected vaccination failure as details regarding 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine." More
2841388 05/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity, Pruritus Pain in extremity, Pruritus
My arm hurts so much; and was so itchy; This non-serious case was reported by a consumer via interac... My arm hurts so much; and was so itchy; 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 an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: My arm hurts so much) and pruritus (Verbatim: and was so itchy). The outcome of the pain in arm and pruritus were not reported. It was unknown if the reporter considered the pain in arm and pruritus to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and pruritus to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she was just vaccinated. And his/her arm hurts so much, and it was so itchy. Reporter mentioned that was going to delay getting the second shot. The follow-up could not be possible as no contact details were available. More
2841389 05/16/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles weeks later; This serious case was reported by a c... Suspected vaccination failure; still got shingles weeks later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles weeks later). 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 and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media. The patient took both series of Shingle shots and still got shingles weeks later. This case was considered as suspected vaccination failure as details regarding 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. " More
2841390 05/16/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Death Death
infant died within 10 days of Infanrix vaccination; This serious case was reported by a other health... infant died within 10 days of Infanrix vaccination; This serious case was reported by a other health professional via interactive digital media and described the occurrence of unknown cause of death in a infant patient who received DTPa (Infanrix) for prophylaxis. On an unknown date, the patient received Infanrix. On an unknown date, 10 days after receiving Infanrix, the patient experienced unknown cause of death (Verbatim: infant died within 10 days of Infanrix vaccination) (serious criteria death and GSK medically significant). The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Infanrix and Infanrix Pre-Filled Syringe Device. The company considered the unknown cause of death to be unrelated to Infanrix and Infanrix Pre-Filled Syringe Device. 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: 30-APR-2025 This case was reported by the reporter via interactive digital media. It was reported that sixty-nine infants (patients) died after received Infanrix vaccine out of those sixty-seven died within 10 days of vaccination. This was 1 of 69 linked cases reported by same reporter.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Infanrix and Infanrix PRE-FILLED SYRINGE DEVICE.; Reported Cause(s) of Death: Unknown cause of death More
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2841392 M TN 05/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal, Injection site pain, Pyrexia Feeling abnormal, Injection site pain, Pyrexia
patient experienced injection site pain; fever; felt like crap; This non-serious case was reported b... patient experienced injection site pain; fever; felt like crap; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: patient experienced injection site pain), fever (Verbatim: fever) and feeling abnormal (Verbatim: felt like crap). The outcome of the injection site pain, fever and feeling abnormal were resolved (duration 36 hrs). It was unknown if the reporter considered the injection site pain, fever and feeling abnormal to be related to Shingrix. It was unknown if the company considered the injection site pain, fever and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 08-MAY-2025 Patient was approximately 60 years old. Patient had been vaccinated with Shingrix and a few hours after the injections the patient experienced injection site pain, within a few hours experienced fever and "felt like crap". The symptoms lasted about 36 hours and patient is fully recovered. More
2841393 F TN 05/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Injection site swelling, Pyrexia Fatigue, Injection site swelling, Pyrexia
swelling around the injection site /made a motion of about a 6 inch circle on her arm; Fever; Fatigu... swelling around the injection site /made a motion of about a 6 inch circle on her arm; Fever; Fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 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 swelling (Verbatim: swelling around the injection site /made a motion of about a 6 inch circle on her arm), fever (Verbatim: Fever) and fatigue (Verbatim: Fatigue). The outcome of the injection site swelling was not reported and the outcome of the fever and fatigue were resolved (duration 1 day). It was unknown if the reporter considered the injection site swelling, fever and fatigue to be related to Shingrix. It was unknown if the company considered the injection site swelling, fever and fatigue to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR061338 Additional Information: GSK Receipt Date: 09-MAY-2025 A female patient, approximately 55 years old, received both doses of the Shingrix vaccine. After each dose the patient experienced swelling around the injections site and made a motion of about a 6 inch circle on her arm. She also experienced fever, fatigue that lasted about a day each time. For tolerance to second dose, refer case US2025AMR061338. More
2841394 05/16/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I have it again for the second time; This serious case was reported b... Suspected vaccination failure; I have it again for the second time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and upadacitinib (Rinvoq) for product used for unknown indication. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Rinvoq. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have it again for the second time). The action taken with Rinvoq was unknown. 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 12-MAY-2025 The case was received from the patient via interactive digital media. The reporter reported that had it again for the second time. It was so bad after the first time that he/she had the two vaccines so he/she would not get it again. Find out it was from Rinvoq that caused it this time. No more vaccines for him/her. It was unknown if the reporter considered the vaccination failure and shingles to be related to Rinvoq.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2) More
2841395 05/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspeceted vaccination failure; 2nd time I had shingles/3rd time I got them it was a very light case... Suspeceted vaccination failure; 2nd time I had shingles/3rd time I got them it was a very light case/4th time having them and the pictures speak for themselves; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 2nd time I had shingles/3rd time I got them it was a very light case/4th time having them and the pictures speak for themselves). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. 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: 12-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that they had received the vaccine after the second time they had shingles. The third time they had shingles, it was a very light case. They were now experiencing their fourth episode, which was described as awful, with accompanying pictures. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2841396 F 05/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Back pain, Breast pain, Herpes zoster, Vaccination failure Back pain, Breast pain, Herpes zoster, Vaccination failure
Suspeceted vaccination failure; am currently suffering from shingles; This serious case was reported... Suspeceted vaccination failure; am currently suffering from shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: am currently suffering from shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. 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: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that she was vaccinated a year ago. The patient was currently suffering from shingles. The patient guesses the jab did not work. The pain in my back and right breast was unbearable at times. Praying it goes away soon. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2841397 05/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
it was very painful for 5 days; This non-serious case was reported by a consumer via interactive dig... it was very painful for 5 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: it was very painful for 5 days). The outcome of the pain was resolved (duration 5 days). It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 13-MAY-2025 This case was reported by a patient via interactive digital media. The reporter stated that it was very painful for 5 days. He/she did not know if he/she would get the 2nd dose or now. More
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