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
2814903 67 F TX 12/09/2024 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 745JK
Fatigue, Muscular weakness, Sensory loss; Asthenia, Biopsy muscle, Blood test, C... Fatigue, Muscular weakness, Sensory loss; Asthenia, Biopsy muscle, Blood test, Computerised tomogram, Dysphagia; Fall, Inflammation, Limb discomfort, Loss of consciousness, Magnetic resonance imaging; Mobility decreased, Musculoskeletal stiffness, Pyrexia, Quality of life decreased More
PATIENT STATED FATIGUE, MUSCLE WEAKNESS THROUGHOUT BODY. LEGS GIVE OUT. MOTOR SENSORY LOSS. PATIENT STATED FATIGUE, MUSCLE WEAKNESS THROUGHOUT BODY. LEGS GIVE OUT. MOTOR SENSORY LOSS.
2849962 64 F VA 07/16/2025 COVID19
PNC20
RSV
 PFIZER\BIONTECH
PFIZER\WYETH
PFIZER\WYETH
 ME6072
LN4930
Fatigue, Headache, Injection site erythema, Injection site swelling, Injection s... Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth; Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth; Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth More
Patient reported reaction to either COVID or Prevnar vaccine administered in the left arm. Patient r... Patient reported reaction to either COVID or Prevnar vaccine administered in the left arm. Patient reports onset of headaches (reports worse than typical HA that she has due to allergies/congestion) and fatigue starting the following day. Two days after injection, patient reports delayed onset of swelling/redness/warmth of left arm close to injection site. Patient reports improvement and near resolution of symptoms nearly 2 weeks later but arm still appears slightly swollen and red, with no discomfort. More
2849963 55 F OR 07/16/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4MG3E
Bell's palsy, Facial paralysis, Fatigue, Malaise, Myalgia Bell's palsy, Facial paralysis, Fatigue, Malaise, Myalgia
Received MMR vaccine Saturday, July 12 at 5:30 PM Sunday morning July 13 woke up with left sided fac... Received MMR vaccine Saturday, July 12 at 5:30 PM Sunday morning July 13 woke up with left sided facial paralysis/Bell?sPalsy, extreme fatigue, muscle soreness, and malaise. More
2849964 0.17 M SC 07/16/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
HIBV
HIBV
HIBV
PNC20
PNC20
PNC20
PNC20
PNC20
RV5
RV5
RV5
RV5
RV5
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 2G273
2G273
2G273
2G273
2G273
7006393
7006393
7006393
7006393
7006393
LK6653
LK6653
LK6653
LK6653
LK6653
2073367
2073367
2073367
2073367
2073367
Blood chloride normal, Blood folate normal, Blood thyroid stimulating hormone no... Blood chloride normal, Blood folate normal, Blood thyroid stimulating hormone normal, Carbon dioxide decreased, Electrocardiogram normal; Electroencephalogram normal, Haematocrit decreased, Haemoglobin decreased, Hypotonia, Lymphocyte percentage; Magnetic resonance imaging normal, Monocyte percentage increased, Neutrophil percentage, Platelet count normal, Respiratory rate decreased; Seizure like phenomena, Somnolence, Staring, Transferrin saturation decreased, Vitamin B12 increased; White blood cell count normal; Blood chloride normal, Blood folate normal, Blood thyroid stimulating hormone normal, Carbon dioxide decreased, Electrocardiogram normal; Electroencephalogram normal, Haematocrit decreased, Haemoglobin decreased, Hypotonia, Lymphocyte percentage; Magnetic resonance imaging normal, Monocyte percentage increased, Neutrophil percentage, Platelet count normal, Respiratory rate decreased; Seizure like phenomena, Somnolence, Staring, Transferrin saturation decreased, Vitamin B12 increased; White blood cell count normal; Blood chloride normal, Blood folate normal, Blood thyroid stimulating hormone normal, Carbon dioxide decreased, Electrocardiogram normal; Electroencephalogram normal, Haematocrit decreased, Haemoglobin decreased, Hypotonia, Lymphocyte percentage; Magnetic resonance imaging normal, Monocyte percentage increased, Neutrophil percentage, Platelet count normal, Respiratory rate decreased; Seizure like phenomena, Somnolence, Staring, Transferrin saturation decreased, Vitamin B12 increased; White blood cell count normal; Blood chloride normal, Blood folate normal, Blood thyroid stimulating hormone normal, Carbon dioxide decreased, Electrocardiogram normal; Electroencephalogram normal, Haematocrit decreased, Haemoglobin decreased, Hypotonia, Lymphocyte percentage; Magnetic resonance imaging normal, Monocyte percentage increased, Neutrophil percentage, Platelet count normal, Respiratory rate decreased; Seizure like phenomena, Somnolence, Staring, Transferrin saturation decreased, Vitamin B12 increased; White blood cell count normal More
Patient became sleepy, ultimately developing poor muscle tone, slow breathing, and seizure like move... Patient became sleepy, ultimately developing poor muscle tone, slow breathing, and seizure like movements. He was seen at a local ED and transferred to another ED for further care. He had labs, EKG, MRI, and admitted to hospital. While in the hospital he had seizure-like events - staring spells. EEG was done. He improved and was discharged home. More
โœ“
2849965 27 M MN 07/16/2025 VARCEL
 MERCK & CO. INC.
 Y020586
Peripheral swelling, Pruritus, Rash Peripheral swelling, Pruritus, Rash
Employee noticed itchiness and bumps on his hands on 7/12. As the day went on he noticed the rash ac... Employee noticed itchiness and bumps on his hands on 7/12. As the day went on he noticed the rash across his entire body. Employee went to Hospital for medical treatment where he was given Dexamethasone . More
2849966 66 F GA 07/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Feeling hot, Pyrexia Feeling hot, Pyrexia
On June 13, 2025 I had a fever the entire day. After that going forward for the entire month of Jun... On June 13, 2025 I had a fever the entire day. After that going forward for the entire month of June my body temperature was warm to hot only during the night. From the time I laid down going into the next morning. I did not have a fever just body was warm/hot to the touch. I am in menopause, and I used to have night sweat with hot flash for a short period of time. But this was different and continued every night without any sweating. So, what I attributed it to was side effect from the vaccination. More
2849967 19 M TX 07/16/2025 HEP
MENB
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 A5DP7
52N4S
37R35
Asthenia, Fatigue, Pain; Asthenia, Fatigue, Pain; Asthenia, Fatigue, Pain Asthenia, Fatigue, Pain; Asthenia, Fatigue, Pain; Asthenia, Fatigue, Pain
1 dose(1 ml ) Engerix B given. Patient is 19 y/o . Engerix B vaccine given is for 20 y/o and older. ... 1 dose(1 ml ) Engerix B given. Patient is 19 y/o . Engerix B vaccine given is for 20 y/o and older. Patient reported feeling tired the day of vaccination. Patient reported the following symptoms the day after vaccination : body aches, headache, weakness, tiredness. Patient informed the symptoms he described are most likely common after receiving vaccinations. More
2849985 12 M OR 07/16/2025 MNQ
 SANOFI PASTEUR
 U8494AA
Incorrect route of product administration Incorrect route of product administration
On 07/15/2025 Patient, DOB 04/XX/20XX (MRN withheld) was seen in clinic by provider for a new patien... On 07/15/2025 Patient, DOB 04/XX/20XX (MRN withheld) was seen in clinic by provider for a new patient visit including Vaccines. Patient was due for his MCV 4 , Hep A, and HPV. Mother of the patient was given VIS prior to administration and the VAR was completed. Patients Hep A and Hpv vaccines were administered Intramuscular without issue. While his MCV 4 was administered Subcutaneous without issue. His MCV4 was discovered to be incorrectly administered Subcutaneously shortly after administering the dose. I quickly alerted Provider of the error, and we referred to the CDC website for direction on next steps. Per the CDC the vaccine does not need to be administered. I referred to the standing order for guidance as well. And precautionarily consulted with (withheld name). I was told by both providers that administering in the cite I did would cause slow absorption. Per protocol I also reached out to the patient/ parent of the patient to inform of this incident however the patient was unable to be reached. I also notified my immediate supervisor (name withheld) of the incident. In addition I also reported on VAERS. My goal in the future is to be more mindful of what medication I am administering and where. More
2849986 52 F CA 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 A5T73
Erythema, Pain, Pruritus, Skin warm Erythema, Pain, Pruritus, Skin warm
Redness measuring 10 x 6 cm. Warm to touch. Per patient it is very itchy and hurts when laying down ... Redness measuring 10 x 6 cm. Warm to touch. Per patient it is very itchy and hurts when laying down on her left side. More
2849987 18 F TX 07/16/2025 MENB
 PFIZER\WYETH
 LW8911
Vision blurred Vision blurred
patient developed blurred vision the following day in the morning, lasted a few hours, came and went... patient developed blurred vision the following day in the morning, lasted a few hours, came and went, now resolved without intervention More
2849988 80 M VA 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
PATIENT HAD A LARGE SWOLLEN RED CIRCLE SURROUNDING THE AREA THAT RECEIVED THE VACCINE PATIENT HAD A LARGE SWOLLEN RED CIRCLE SURROUNDING THE AREA THAT RECEIVED THE VACCINE
2849989 16 M MS 07/16/2025 HPV9
HPV9
HPV9
MNQ
MNQ
MNQ
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y009051
Y009051
Y009051
U8256AB
U8256AB
U8256AB
Diarrhoea, Dizziness, Dizziness postural, Dysarthria, Dyskinesia; Electrocardiog... Diarrhoea, Dizziness, Dizziness postural, Dysarthria, Dyskinesia; Electrocardiogram normal, Feeling hot, Muscle spasms, Nausea, Pallor; Palpitations; Diarrhoea, Dizziness, Dizziness postural, Dysarthria, Dyskinesia; Electrocardiogram normal, Feeling hot, Muscle spasms, Nausea, Pallor; Palpitations More
Symptoms started 7/12. Started having odd muscle spasms, head jerking, hands/arms fidget, dizziness,... Symptoms started 7/12. Started having odd muscle spasms, head jerking, hands/arms fidget, dizziness, heart racing, nauseous, and slurred speech. He slept in a cold room and that helped. He slept almost all day 7/13. On 7/13 he got very hot and started feeling dizzy and got pale. Symptoms are starting to improve some today. He got dizzy upon sitting up too quickly today and got dizzy when he got over heated today. He has also had diarrhea 7/13. More
2849990 46 M WA 07/16/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9K34M
Injection site induration, Injection site pain, Injection site swelling, Injecti... Injection site induration, Injection site pain, Injection site swelling, Injection site warmth More
S- 46 year old, Male calls clinic (7/16/25) and states they "received Hepatitis B booster on 7/... S- 46 year old, Male calls clinic (7/16/25) and states they "received Hepatitis B booster on 7/8/25 and has swelling and pain on injection site". B- Pt OV 7/8/25 with Dr. where the second dose of Hepatitis B vaccine was administered to pt in their left deltoid. Pt has had pain "soreness" and swelling on left deltoid every since getting the vaccine. A- Pt states they were given Hepatitis B vaccine on their left deltoid. Golf ball size swollen hard area on left deltoid. Pt denies redness but it's hot to the touch. Painful and pt describes pain as "soreness". Feels "soreness" especially at night. Denies SOB, itchiness, and hives. Pt states they get hives every once in a while at their waist. Pt states they have never had a reaction to a vaccine before. Pt states they have tried ice packs and Ibuprofen but they are not helping. R- Concern for a possible Hepatitis B reaction based on pt reported symptoms. Pt is scheduled for a f/u appt. More
2849997 14 F NY 07/16/2025 HPV9
 MERCK & CO. INC.
 Y012776
Dizziness, Loss of consciousness, Pallor, Presyncope, Syncope Dizziness, Loss of consciousness, Pallor, Presyncope, Syncope
Patient was in sitting position and within 2 minutes of getting the vaccine for pale and dizzy and f... Patient was in sitting position and within 2 minutes of getting the vaccine for pale and dizzy and fainted back into the patient bed. She lost consciousness for a few seconds then came immediately back and was talking and knew her name. We got her an ice pack and water. After about 5 minutes we sat her up but she proceeded to have nearvsuncope again donated her down, legs above their heart for about 20 minutes. Gave her apple juice as she had not eaten at all before coming to the office. We observed her here for another 30 minutes. She ate some cookies, felt well and left. On follow up phone call hours later mom felt she was still a little groggy. She was resting and hydrating. More
2849998 0.33 M CA 07/16/2025 PNC20
 PFIZER\WYETH
 MF0416
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Mother notice, babies left thigh was red and swollen this morning at 10:00 AM, baby received vaccine... Mother notice, babies left thigh was red and swollen this morning at 10:00 AM, baby received vaccines yesterday. Mother then brought baby in to be checked by Dr. Rx hydrocortisone 2.5% topical cream was prescribed twice daily x 5day. More
2849999 58 M AZ 07/16/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8735
ER8735
ER8735
ER8735
Ankle brachial index, Blood gases, Blood test, Brain fog, Cardiac stress test; C... Ankle brachial index, Blood gases, Blood test, Brain fog, Cardiac stress test; Cardiovascular disorder, Computerised tomogram, Dyspnoea, Echocardiogram, Exercise tolerance decreased; Heart rate increased, Magnetic resonance imaging, Nerve conduction studies, Neuralgia, Pain in extremity; Respiratory alkalosis, Thrombosis, Ultrasound scan, Vascular test, X-ray More
Was in great health prior to vaccines, was a labeled Ironman All World Athlete finishing in top 10% ... Was in great health prior to vaccines, was a labeled Ironman All World Athlete finishing in top 10% of my age group and a shell of that since the devastating effects of the COVID Vaccines. Chronic Respiratory Alkalosis, high heart rate, blood clot right leg, severe reduced exercise capacity, nerve pain, brain fog, blood flow affected, excruciating pain in lower legs, labored breathing during exercise, higher than normal heart rate when exercising, More
โœ“
2850013 73 F CO 07/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 35A77
Erythema, Periorbital oedema Erythema, Periorbital oedema
SHINGRIX VAC 7/14. Bilateral Erythema. Edema below both eye. (L) > (R). No other clear precipitat... SHINGRIX VAC 7/14. Bilateral Erythema. Edema below both eye. (L) > (R). No other clear precipitation, factor. Will treat with Benadryl. More
2850014 0.4 F MI 07/16/2025 DTAPIPVHIB
PNC20
RV5
 SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.
 UK332AA
LP4947
Y015021
Product preparation issue; Product preparation issue; Product preparation issue Product preparation issue; Product preparation issue; Product preparation issue
None - Pentacel vaccine was not given, just diluent was given None - Pentacel vaccine was not given, just diluent was given
2849676 NY 07/15/2025 HEPA
 MERCK & CO. INC.
 X026666
Expired product administered, No adverse event Expired product administered, No adverse event
no adverse event; Nurse reported that an expired VAQTA was administered to a patient today. No addi... no adverse event; Nurse reported that an expired VAQTA was administered to a patient today. No additional AEs were reported, no further information provided. No PQC.; This spontaneous report was received from a Nurse Practitioner 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 30-Jun-2025 (also reported as: today), the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot #X026666, expiration date: 29-May-2025 (expired product administered), 1 dosage form (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse event. More
2849686 31 F CO 07/15/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Asthenia, Computerised tomogram head, Dizziness, Fatigue, Head discomfort; Heada... Asthenia, Computerised tomogram head, Dizziness, Fatigue, Head discomfort; Headache, Impaired work ability, Migraine, Nausea More
I had a bedriden migraine for weeks after my 2nd pfizer dose of COVID-19. My head was so heavy that ... I had a bedriden migraine for weeks after my 2nd pfizer dose of COVID-19. My head was so heavy that i could barely lift it, and I was very dizzy, weak, and nauseous. Here I am 3 years later still dealing with horrific migraines with dizziness, chronic fatigue, and nausea from this vaccine and NOT ONE of my doctors ever offered to report it for me, even when I kept asking!!! I have never had a migraine in my life before this vaccine and lived very healthy. It has RUINED MY LIFE and I am in the process of filing disability because I am a nurse and have not been able to work with the constant chronic migraine! I was in the ER because they thought I had a brain bleed. More
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2849690 66 F KY 07/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Dizziness, Headache, Injection site erythema, Injection site pain, Injection sit... Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling; Pyrexia, Vomiting More
large swelling, redness, pain at site 18 hours later, fever, headache, vomiting, lightheadedness large swelling, redness, pain at site 18 hours later, fever, headache, vomiting, lightheadedness
2849696 07/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
My arm just hurt like heck; This non-serious case was reported by a consumer via interactive digita... My arm just hurt like heck; 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 just hurt like heck). The outcome of the pain in arm was resolved (duration 36 hrs). 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: 08-JUL-2025 Patient's first dose had been worse than his/her second dose. His/her arm had just hurt like heck for about 36 hours. More
2849697 07/15/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
Boostrix Administration after temperature excursion; This non-serious case was reported by a nurse v... Boostrix Administration after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JUL-2025 A nurse had mentioned that a Boostrix vaccine had been exposed to minus 5.66 Fahrenheit. When the vaccine reached 27 (the health care professional could not confirm whether this temperature was in Celsius or Fahrenheit), it had been administered to a patient, which led to Incorrect storage of drug. The health care professional had asked for efficacy data. More
2849698 70 F 07/15/2025 COVID19
 MODERNA
Influenza like illness Influenza like illness
After the second one she said she felt a little sick and it seemed like she had a little bit of the ... After the second one she said she felt a little sick and it seemed like she had a little bit of the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After the second one she said she felt a little sick and it seemed like she had a little bit of the flu) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (After the second one she said she felt a little sick and it seemed like she had a little bit of the flu). At the time of the report, INFLUENZA LIKE ILLNESS (After the second one she said she felt a little sick and it seemed like she had a little bit of the flu) had resolved. No concomitant medications provided by the reporter. It was reported that patient had 7 Moderna vaccines for Covid. After the second Moderna vaccine patient felt a little sick and it seemed like she had a little bit of the flu. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-788038 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788038:Tracking only case for Women More
2849731 37 F CA 07/15/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y018398
Y015760
X022737
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
no symptoms reported; repeat dose 6/10/25; GARDASIL 9 was administered to a patient after product ex... no symptoms reported; repeat dose 6/10/25; GARDASIL 9 was administered to a patient after product experienced a temperature excursion; This spontaneous report was received from a medical assistant 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 06-MAY-2025 (discrepancy, reported as 06-MAY-2026), the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a dose of 0.5 mL, lot #Y018398, expiration date: 04-NOV-2026, for prophylaxis (route of administration and anatomical location were not reported). The administered vaccine underwent temperature excursion prior to administration (30.0 F for 15 hours; no previous temperature excursions) (Product storage error). No symptoms reported (No adverse event). The report is invalid due to lack of the patient's identifiers. Follow-up information was received on 20-Jun-2025. The patient was a 37-year-old female. On 06-May-2025, the patient was vaccinated with the second dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) administered in the right deltoid. On an unspecified date, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) lot #Y015760, expiration date: 10-Feb-2027, administered in the left deltoid. On an unspecified date, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) lot #X022737, expiration date: 12-Apr-2026, administered in the left deltoid (all details regarding vaccination could not be captured due to illegible source document). The following narrative was reported: The refrigerator where the immunizations were stored was out of range the morning of [missing information due to illegible source document]; vaccine given temperature was in range however unsure of how many [missing information due to illegible source document]; there was a temperature excursion. Called manufacturer recommended for [missing information due to illegible source document] to repeat dose. The provider was informed and the patient was contacted. On 10-Jun-2025, the patient was vaccinated with the repeat dose (inappropriate schedule of product administration). The case was no longer considered to be invalid.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02801226-02801218 , CLIC number : , ESTAR number : , IRMS number : 500UW00000aF2stYAC|20062025230039|5889 , Central date : 2025-06-21 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2283569 , MNSC case number : 02801226 , MNSC interaction number : 02801218 , Integration log UniqueID : 500UW00000aF2stYAC|20062025230039|5889 , Service cloud CaseID : 500UW00000aF2stYAC More
2849732 14 M TX 07/15/2025 MMRV
 MERCK & CO. INC.
 Y019173
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No symptoms reported; HCP reported 14 year old patient receiving PROQUAD inadvertently; This spontan... No symptoms reported; HCP reported 14 year old patient receiving PROQUAD inadvertently; This spontaneous report was received from a physician assistant and refers to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Jun-2025, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), solution for injection (lot #Y019173, expiration date: 18-May-2026), the vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot# 1973239, expiration date: 14-Feb-2026), dose at 0.5 mL, administered as prophylaxis (route of administration, anatomical site and dose number in series were not provided) (Product administered to patient of inappropriate age). No symptoms reported (No adverse event). In addition, it was stated that they planned to complete a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) series for this patient. More
2849733 F NY 07/15/2025 PNC21
 MERCK & CO. INC.
 Z004301
Unevaluable event Unevaluable event
been admitted to the hospital; This spontaneous report was received from a pharmacist and refers to ... been admitted to the hospital; This spontaneous report was received from a pharmacist and refers to a(n) 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 unknown date in June 2025 (reported as 22-Jun-2025 or 24-Jun-2025 but unable to confirm), the patient was vaccinated with pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), 0.5 mL, lot number Z004301, expiration date was not reported but was established as 07-Sep-2026 upon internal validation, administered by intramuscular route for immunization and prevention of pneumonia (strength and anatomical location were not reported). Unknown if product was available for retrieval. On unknown date in June 2025, the patient was admitted to the hospital (hospitalization). Hospital name and address unknown. At the reporting time, the outcome of event hospitalization was unknown. The reporter considered the event of hospitalization to be related to pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reporter felt the AE was related to the specific lot # as he also reported a second patient adverse event related to this lot). This is one of two reports received from the same reporter. This is a non-valid case due to lack of patient identifiers. Follow-up information has been received from pharmacist, on 10-JUL-2025. The patient's information and contact information has been updated, it refers to a 96-years-old female patient.; Sender's Comments: Priority : 2 , Is case serious : Yes , MNSC number : 02829466-02829461 , CLIC number : , ESTAR number : , IRMS number : 500UW00000eSGu1YAG|10072025230029|6503 , Central date : 2025-07-11 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2301181 , MNSC case number : 02829466 , MNSC interaction number : 02829461 , Integration log UniqueID : 500UW00000eSGu1YAG|10072025230029|6503 , Service cloud CaseID : 500UW00000eSGu1YAG More
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2849734 16 F VA 07/15/2025 HPV9
 MERCK & CO. INC.
 Y012865
Injection site rash, Rash Injection site rash, Rash
presented with a rash located at injection site, under belly, arms, and legs.; presented with a rash... presented with a rash located at injection site, under belly, arms, and legs.; presented with a rash located at injection site, under belly, arms, and legs.; This spontaneous report was received from a medical assistant and referred to a 16-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) (lot #Y012865, expiration date: 10-Oct-2026, 0.5ml/ series, intramuscular injection left arm) for prophylaxis. On unknown date in April 2025 (sometime during the first week of April 2025), the patient presented with a rash located at injection site, under belly, arms, and legs. The patient sought medical attention. On unknown date in 2025 (a few days later), the patient recovered fully from the events with no intervention. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as not applicable. The causal relationship between all events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. More
2849735 45 F TX 07/15/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration Inappropriate schedule of product administration
HCP called and reported that a patient received a first dose of GARDASIL 9 on 09MAY2025 at age 45 ye... HCP called and reported that a patient received a first dose of GARDASIL 9 on 09MAY2025 at age 45 years old, and the patient is now due for her second dose of GARDASIL 9 and is currently 46 years old. Second dose has not yet been administered, but pr; No additional AE; This spontaneous report was received from a nurse and refers to a currently 46-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 09-May-2025 (at age 45 years old), the patient received a first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), administered for prophylaxis (strength, dose, route, anatomical site, lot # and expiration date were not reported). The patient was now due for her second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) and was currently 46 years old. Second dose has not yet been administered (Inappropriate schedule of product administration). Limited patient demographics provided. No additional information was known by reporter. No additional AE/PQC (No adverse event). Lot# is being requested and will be submitted if received. More
2849736 F CA 07/15/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient age of 18 months, received Heplisav-B today in the office; Initial report received on 12-Jun... Patient age of 18 months, received Heplisav-B today in the office; Initial report received on 12-Jun-2025. A nurse reported that an 18-month-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 12-Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). The patient was 18 months at the time she received the vaccine. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2849737 TX 07/15/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
Patient Took First Dose On 12/6/2024, Is It Too Late For The Second Dose?; Initial report received o... Patient Took First Dose On 12/6/2024, Is It Too Late For The Second Dose?; Initial report received on 16-Jun-2025. A pharmacist reported that a patient (age, gender, race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet. No medical history or concomitant medication were reported. On 06-Dec-2024, the patient received dose 1 of a hepatitis B HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available). At the time of this report, the patient has not received the second dose yet. No additional information was provided. Reporter did not give consent to contact them for additional data. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2849738 M MN 07/15/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Inappropriate schedule of product administration Inappropriate schedule of product administration
Heplisav-B Dose On 6 March 2025, Engerix-B Given As Second Dose By Accident On 15 May 2025.; Inappro... Heplisav-B Dose On 6 March 2025, Engerix-B Given As Second Dose By Accident On 15 May 2025.; Inappropriate Schedule of Vaccine Administered; Initial report received on 23-Jun-2025. A nurse reported that a 54-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given ENGERIX-B as the second dose by accident. No medical history or concomitant medications were reported. On 06-Mar-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 15-May-2025, 71 days after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number not provided)]. The reporter was inquiring about the time interval between HEPLISAV-B doses in the event ENGERIX-B was given as the second dose by accident. No additional information was reported. The reporter declined to provide further information. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2849739 F VA 07/15/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 16 Year Old Received Heplisav-B on 24Jun25, Is There Anything We Should Monitor ?; Initial report ... A 16 Year Old Received Heplisav-B on 24Jun25, Is There Anything We Should Monitor ?; Initial report received on 24-Jun-2025. A nurse reported that a 16-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 24-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported). The patient was 16 years old at the time of vaccination. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2849740 M VT 07/15/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Extra dose administered Extra dose administered
Patient had Heplisav-B Doses Two Years Apart; Initial report received on 25-Jun-2025. A nurse repor... Patient had Heplisav-B Doses Two Years Apart; Initial report received on 25-Jun-2025. A nurse reported that a 46-year-old male received doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two years apart. No medical history or concomitant medications were reported. On 03-Jul-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). On 11-Jun-2025, 710 days after receiving dose 1 of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2849741 07/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Paralysis Paralysis
partially paralyzed; This serious case was reported by a consumer via interactive digital media and ... partially paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (Verbatim: partially paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported. It was unknown if the reporter considered the paralysis to be related to Shingles vaccine. The company considered the paralysis to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 07-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter stated that his/her coworker was partially paralyzed from the Shingle shot and in pain.; Sender's Comments: A case of Paralysis, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2849742 07/15/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Unevaluable event Unevaluable event
After getting the shot I ended in the hospital; This serious case was reported by a consumer via int... After getting the shot I ended in the hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a 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 hospitalization (Verbatim: After getting the shot I ended in the hospital) (serious criteria hospitalization). The outcome of the hospitalization was not reported. It was unknown if the reporter considered the hospitalization to be related to RSV vaccine. The company considered the hospitalization to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned that after getting the RSV shot, he/she ended up in the hospital.; Sender's Comments: A case of Hospitalisation, unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
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2849743 0.17 M NC 07/15/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 25G23D
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
KINRIX was administered to a 2 month old child; This non-serious case was reported by a other health... KINRIX was administered to a 2 month old child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-week-old male patient who received DTPa-IPV (Kinrix) (batch number 25G23D, expiry date 21-AUG-2026) for prophylaxis. On 07-JUL-2025, the patient received Kinrix. On 07-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: KINRIX was administered to a 2 month old child). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-JUL-2025 The heath care professional reported that a dose of Kinrix was administered to a 2 month old child (inappropriate age), which led to inappropriate age at vaccine administration. More
2849744 F SC 07/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
missed dose/never received the second dose; This non-serious case was reported by a consumer via cal... missed dose/never received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received the first dose of Shingrix in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed dose/never received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 30-JUN-2025 and 02-JUL-2025 The reporter was the patient. The patient received the first dose of Shingrix in 2019, and never received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025082464:husband case More
2849745 07/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; everyone i know who got vax got shingles; This serious case was repor... suspected vaccination failure; everyone i know who got vax got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified 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 vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: everyone i know who got vax got 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: 08-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter reported that everyone he/she knows who got vaccine and got shingles. 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 Shingles vaccine. More
2849746 07/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Fatigue, Headache, Herpes zoster, Pyrexia Fatigue, Headache, Herpes zoster, Pyrexia
Little tired; little low grade fever; bit of a headache.Getting shingles is a lot worse.; This non-s... Little tired; little low grade fever; bit of a headache.Getting shingles is a lot worse.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness 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 tiredness (Verbatim: Little tired), low grade fever (Verbatim: little low grade fever) and headache (Verbatim: bit of a headache.Getting shingles is a lot worse.). The outcome of the tiredness, low grade fever and headache were not reported. It was unknown if the reporter considered the tiredness, low grade fever and headache to be related to Shingles vaccine. It was unknown if the company considered the tiredness, low grade fever and headache to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The reporter reported that just got the vaccine. Little tired, little low-grade fever, bit of a headache. Getting shingles was a lot worse. The reporter aunt had it. Think of the worst possible place to have covered in sores, and you were correct. More
2849747 07/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
shingles; This non-serious case was reported by a consumer and described the occurrence of shingles ... shingles; This non-serious case was reported by a consumer and described the occurrence of shingles 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 shingles (Verbatim: shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt Date: 11-JUL-2025 This case was reported by a patient via interactive digital media. The patient got one shot and then a week later had shingles and not received the second dose. More
2849748 39 M OH 07/15/2025 ANTH
TYP
 EMERGENT BIOSOLUTIONS
SANOFI PASTEUR
 300215A
X1A261M
Injection site pain, Pain; Injection site pain, Pain Injection site pain, Pain; Injection site pain, Pain
Significant pain at the injection site developed several hours after the injection. No reported ede... Significant pain at the injection site developed several hours after the injection. No reported edema or erythema. Pain persists deep around the injection site (left lateral upper arm) 4-months after the injection. Member reports pain when he flexes his arm in a curling motion. And he reports that he has difficulty (pain) when he tries to lift heavy objects. Patient evaluated today as he is returning from deployment. More
2849749 48 F PA 07/15/2025 FLU3
 SANOFI PASTEUR
 TFAA2429
Immediate post-injection reaction, Injection site pain, Pain Immediate post-injection reaction, Injection site pain, Pain
Immediate pain at the injection site radiating down the left arm following brachial plexus. Pain has... Immediate pain at the injection site radiating down the left arm following brachial plexus. Pain has been persistent since the injection. No other known injuries. Checking lateral neck xray to r/o C7 compression. Will start gabapentin for symptomatic pain relief. Start PT. Referred to ortho. Consider EMG studies. More
2849750 46 M GA 07/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5Y49C
Product preparation issue Product preparation issue
she administered the first vial, just the suspension liquid; she administered the first vial, just t... she administered the first vial, just the suspension liquid; she administered the first vial, just the suspension liquid; 46 year old received Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 46-year-old male patient who received Herpes zoster (Shingrix) (batch number 5Y49C) for prophylaxis. On 30-JUN-2025, the patient received Shingrix. On 30-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: she administered the first vial, just the suspension liquid), inappropriate dose of vaccine administered (Verbatim: she administered the first vial, just the suspension liquid) and inappropriate age at vaccine administration (Verbatim: 46 year old received Shingrix). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were not applicable. Additional Information: GSK receipt date: 30-JUN-2025 Other HCP reported that a patient was due to the Shingrix vaccine and the medical assistant who administered the vaccine did not reconstitute with the second vial, she administered the first vial, just the suspension liquid. Reporter asked if they go ahead and make another vaccine reconstituted and administer to the patient on the day of reporting and will they be any adverse effects if they do that. The patient received only 1 vial of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2849751 59 F CT 07/15/2025 PNC20
 PFIZER\WYETH
 LP4946
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Patient states site of pneumonia vaccine is swollen, hot, & has approx 4inch red band on left ar... Patient states site of pneumonia vaccine is swollen, hot, & has approx 4inch red band on left arm Denies Fever, SOB, CP, Trouble swallowing Allergies: is allergic to prednisone and extract of poison oak. Symptoms started Friday 7/11/25 More
2849752 56 F MI 07/15/2025 PNC20
 PFIZER\WYETH
Injection site rash, Injection site warmth Injection site rash, Injection site warmth
Hand size hot rash at injection site 4 days+. Starting day after injection Hand size hot rash at injection site 4 days+. Starting day after injection
2849753 0.08 F TX 07/15/2025 DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
IPV
IPV
IPV
IPV
IPV
IPV
IPV
IPV
PNC15
PNC15
PNC15
PNC15
PNC15
PNC15
PNC15
PNC15
RV5
RV5
RV5
RV5
RV5
RV5
RV5
RV5
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.







































Acidosis, Alpha-1 anti-trypsin increased, Biopsy intestine abnormal, Blood album... Acidosis, Alpha-1 anti-trypsin increased, Biopsy intestine abnormal, Blood albumin decreased, Blood culture negative; Blood sodium decreased, Blood urea increased, C-reactive protein increased, CSF culture negative, Carbon dioxide decreased; Chemokine increased, Cholelithiasis, Culture urine negative, Diarrhoea, Endoscopy gastrointestinal abnormal; Faecal calprotectin increased, Faeces discoloured, Full blood count, Gastritis, Gastroenteritis eosinophilic; Gastrointestinal mucosal exfoliation, Gastrointestinal tube insertion, Genetic testing, Haematocrit decreased, Haemoglobin decreased; Hypoalbuminaemia, Immunology test normal, Inflammatory bowel disease, Milk allergy, Mucous stools; Parenteral nutrition, Platelet count increased, Procalcitonin increased, Stool analysis, Stool sodium increased; Ultrasound abdomen abnormal, Weight gain poor, White blood cell count increased; Acidosis, Alpha-1 anti-trypsin increased, Biopsy intestine abnormal, Blood albumin decreased, Blood culture negative; Blood sodium decreased, Blood urea increased, C-reactive protein increased, CSF culture negative, Carbon dioxide decreased; Chemokine increased, Cholelithiasis, Culture urine negative, Diarrhoea, Endoscopy gastrointestinal abnormal; Faecal calprotectin increased, Faeces discoloured, Full blood count, Gastritis, Gastroenteritis eosinophilic; Gastrointestinal mucosal exfoliation, Gastrointestinal tube insertion, Genetic testing, Haematocrit decreased, Haemoglobin decreased; Hypoalbuminaemia, Immunology test normal, Inflammatory bowel disease, Milk allergy, Mucous stools; Parenteral nutrition, Platelet count increased, Procalcitonin increased, Stool analysis, Stool sodium increased; Ultrasound abdomen abnormal, Weight gain poor, White blood cell count increased; Acidosis, Alpha-1 anti-trypsin increased, Biopsy intestine abnormal, Blood albumin decreased, Blood culture negative; Blood sodium decreased, Blood urea increased, C-reactive protein increased, CSF culture negative, Carbon dioxide decreased; Chemokine increased, Cholelithiasis, Culture urine negative, Diarrhoea, Endoscopy gastrointestinal abnormal; Faecal calprotectin increased, Faeces discoloured, Full blood count, Gastritis, Gastroenteritis eosinophilic; Gastrointestinal mucosal exfoliation, Gastrointestinal tube insertion, Genetic testing, Haematocrit decreased, Haemoglobin decreased; Hypoalbuminaemia, Immunology test normal, Inflammatory bowel disease, Milk allergy, Mucous stools; Parenteral nutrition, Platelet count increased, Procalcitonin increased, Stool analysis, Stool sodium increased; Ultrasound abdomen abnormal, Weight gain poor, White blood cell count increased; Acidosis, Alpha-1 anti-trypsin increased, Biopsy intestine abnormal, Blood albumin decreased, Blood culture negative; Blood sodium decreased, Blood urea increased, C-reactive protein increased, CSF culture negative, Carbon dioxide decreased; Chemokine increased, Cholelithiasis, Culture urine negative, Diarrhoea, Endoscopy gastrointestinal abnormal; Faecal calprotectin increased, Faeces discoloured, Full blood count, Gastritis, Gastroenteritis eosinophilic; Gastrointestinal mucosal exfoliation, Gastrointestinal tube insertion, Genetic testing, Haematocrit decreased, Haemoglobin decreased; Hypoalbuminaemia, Immunology test normal, Inflammatory bowel disease, Milk allergy, Mucous stools; Parenteral nutrition, Platelet count increased, Procalcitonin increased, Stool analysis, Stool sodium increased; Ultrasound abdomen abnormal, Weight gain poor, White blood cell count increased; Acidosis, Alpha-1 anti-trypsin increased, Biopsy intestine abnormal, Blood albumin decreased, Blood culture negative; Blood sodium decreased, Blood urea increased, C-reactive protein increased, CSF culture negative, Carbon dioxide decreased; Chemokine increased, Cholelithiasis, Culture urine negative, Diarrhoea, Endoscopy gastrointestinal abnormal; Faecal calprotectin increased, Faeces discoloured, Full blood count, Gastritis, Gastroenteritis eosinophilic; Gastrointestinal mucosal exfoliation, Gastrointestinal tube insertion, Genetic testing, Haematocrit decreased, Haemoglobin decreased; Hypoalbuminaemia, Immunology test normal, Inflammatory bowel disease, Milk allergy, Mucous stools; Parenteral nutrition, Platelet count increased, Procalcitonin increased, Stool analysis, Stool sodium increased; Ultrasound abdomen abnormal, Weight gain poor, White blood cell count increased More
Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the ... Adverse Event: Following administration of routine 2-month vaccines on April 15, 2025 including the oral rotavirus vaccine my daughter developed persistent diarrhea, poor weight gain, hypoalbuminemia, and elevated inflammatory markers within days. Stools became green, watery, and mucousy with visible intestinal sloughing. She was ultimately diagnosed with severe intestinal inflammation with crypt dropout and eosinophilic infiltration on biopsy, consistent with an early inflammatory bowel disease process or severe immune dysregulation. She required bowel rest, TPN (total parenteral nutrition), and hospitalization for over 6 weeks. Treatment: She was made NPO and placed on TPN. She was started on steroids (methylprednisolone then transitioned to prednisolone) and famotidine. Elemental formula (Neocate) was introduced slowly via NG and PO feeds as symptoms improved. Outcome: We were discharged on in early June and she has continued to do very well. She is now gaining weight, having normal stools, and is tolerating feeds by mouth. She is currently titrating off of both steroids and famotidine. No further signs of active inflammation or diarrhea since discharge. More
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2849754 11 F MI 07/15/2025 HPV9
 MERCK & CO. INC.
 Y015179
Unevaluable event Unevaluable event
no adverse reactions noted. no adverse reactions noted.
2849755 49 F OH 07/15/2025 TDAP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8115AA
U8115AA
U8115AA
Antineutrophil cytoplasmic antibody, Antinuclear antibody, Biopsy skin, Chills, ... Antineutrophil cytoplasmic antibody, Antinuclear antibody, Biopsy skin, Chills, Culture wound; Cutaneous vasculitis, Erythema, Gram stain negative, Hepatitis B virus test, Hepatitis C virus test; Metabolic function test, Pain, Prothrombin time, Pyrexia, Urine analysis More
Fever, chills, and body aches that began approx 17 hrs after injection and lasted about 12 hours; 48... Fever, chills, and body aches that began approx 17 hrs after injection and lasted about 12 hours; 48 hrs after injection I developed itchless, flat, red spots on my legs that increased in number and density over the next several weeks. Visit and testing by dermatologist Dr. on 6/17, confirmed Leukocytoclastic vasculitis without any underlying immune/disease condition. Suspected the reaction was a response to the vaccine. 7/15/25-just completed 15 day course of steroids which calmed the reaction. The spots have mostly subsided with just a few small new ones. More
2849756 53 F VA 07/15/2025 PNC13
 PFIZER\WYETH
Injected limb mobility decreased, Injection site pain Injected limb mobility decreased, Injection site pain
I know it was the pneumonia vaccine but not positive of that was the name of it. Soreness and pain ... I know it was the pneumonia vaccine but not positive of that was the name of it. Soreness and pain beginning a few hours after the vaccine. Kept getting worse and then range of motion became, and is limited. Took Tylenol as I can?t take nsaids. Called a virtual doctor about 4 days later for painkillers but he couldn?t prescribe them. Saw an md within my same practice within a week and she diagnosed as virsa and prescribed oral steroids and muscle relaxers - did no imaging. Today, which is two weeks out i saw someone at facility who had knowledge of sirva and gave me a cortisone injection in the arm- have been having some excruciating pain before that when moving adm high or wirh any abrupt movements. More
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