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
2843450 41 F CA 06/01/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Adnexa uteri pain, Asthenia, Dizziness, Fatigue, Haematocrit decreased; Haemoglo... Adnexa uteri pain, Asthenia, Dizziness, Fatigue, Haematocrit decreased; Haemoglobin decreased, Haemorrhagic ovarian cyst, Heavy menstrual bleeding, Lethargy, Loss of personal independence in daily activities; Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Menstrual disorder, Renal pain More
The patient's menstrual cycle began two days after the vaccine and has not stopped. So from Apr... The patient's menstrual cycle began two days after the vaccine and has not stopped. So from April 15 to at least June 1st she has been menstrating and has had severe symptoms such as pain in the ovaries and kidneys. She was given birth control progesterone for one month which did not stop the bleeding entirely. The patient reported mostly heavy days with a few days of light bleeding. In May, the patient had an ultrasound done which showed several hemorrhagic cysts had formed on both ovaries. The patient asked to be removed from the birth control as she felt it was making her even sicker, with more kidney pain, nausea, and moodiness. The patient had significant difficulty doing her normal work, and quit her full time job because she could not function mentally because of the pain of her menstration. She claims her mind is constantly in anguish from the bleeding and her ovaries feel as if they are experiencing twisting and burning. She has tried to get out of the house and walk but complains she feels very tired, lightheaded, lethargic, with very limited energy. The patient kept track of her periods for years which were always regular 4-5 days every 23-28 days. This is the first/only instance of trouble with her menstraul cycle being abnormal. She is in pain and wants medical advice on how to stop the bleeding. More
2843451 51 M MI 06/01/2025 COVID19
 PFIZER\BIONTECH
 EWD0176
Attention deficit hyperactivity disorder, Condition aggravated, Depression, Diab... Attention deficit hyperactivity disorder, Condition aggravated, Depression, Diabetic neuropathy, Type 2 diabetes mellitus More
Diabetes about 1 year later and increase in depression. Diabetes about 1 year later and increase in depression.
โœ“
2843452 77 M NC 06/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ35
Inappropriate schedule of product administration, Respiratory rate decreased Inappropriate schedule of product administration, Respiratory rate decreased
Patient received his 2nd shingles vaccine yesterday. It was not within the 2-6 month range. The pre... Patient received his 2nd shingles vaccine yesterday. It was not within the 2-6 month range. The previous was March of 2024. The patient does have COPD and when he got home , he felt as if his breathing was slowed down. He did go to the ER and was given a antibiotic and naproxen. More
2843453 42 M PA 06/01/2025 HPV9
 MERCK & CO. INC.
Brain fog, Dizziness, Fatigue Brain fog, Dizziness, Fatigue
- Day 0?3 post-vaccination: Onset of symptoms including dizziness, lightheadedness, brain fog, and ... - Day 0?3 post-vaccination: Onset of symptoms including dizziness, lightheadedness, brain fog, and extreme fatigue. These symptoms were new and sudden, distinct from prior autoimmune flares. - Day 4?14: Symptoms gradually improved, returning close to baseline. - Day 15?30: Symptoms returned abruptly, now including neck stiffness, increased cognitive dysfunction, and worsened lightheadedness, especially after meals or prolonged standing. - Present status: Symptoms are persistent and interfere with daily functioning. Strong suspicion of autonomic nervous system involvement (e.g., POTS, dysautonomia) and/or small fiber neuropathy flare, likely autoimmune in nature. More
2843454 76 M NY 06/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
Injection site rash, Rash, Rash erythematous, Rash pruritic Injection site rash, Rash, Rash erythematous, Rash pruritic
Patient had rash down left arm from injection site to wrist, also had rash on right side of neck and... Patient had rash down left arm from injection site to wrist, also had rash on right side of neck and chest. Red itchy rash that looked like hives. More
2843455 78 M GA 06/01/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 M4B34
Extra dose administered Extra dose administered
Patient came to the pharmacy asked if he could get the Twinrix, we gave him the vaccine on 11/7/24 a... Patient came to the pharmacy asked if he could get the Twinrix, we gave him the vaccine on 11/7/24 and he came back on 12/14/25 after receiving the text notification that he is due for the 2nd dose, he came back again after 5 months after getting the notification for the 3rd dose but after checking the database, it shows that he already received 2 incomplete doses from pharmacy in 2023. He wanted to get the 3rd dose from another pharmacy but we informed him that he already received total of 4 doses since 2023. More
2843456 4 M MI 06/01/2025 MMR
 MERCK & CO. INC.
 X026328
Anaphylactic reaction, Cough, Rhinorrhoea, Throat clearing Anaphylactic reaction, Cough, Rhinorrhoea, Throat clearing
Anaphylaxis - coughing, throat clearing, runny nose Anaphylaxis - coughing, throat clearing, runny nose
2843457 75 F SC 06/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 E754F
Injection site pruritus, Injection site swelling, Injection site warmth Injection site pruritus, Injection site swelling, Injection site warmth
Localized reaction aprox. 4" around injection site. Swollen, itchy, warm. Localized reaction aprox. 4" around injection site. Swollen, itchy, warm.
2843458 53 F CO 06/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75GZ7
Colonoscopy, Diarrhoea Colonoscopy, Diarrhoea
Patient experiencing Diarrhea for 8 weeks and currently ongoing. Patient is treated with medication ... Patient experiencing Diarrhea for 8 weeks and currently ongoing. Patient is treated with medication to manage adverse event. More
2843459 4 F NE 06/01/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Injection site cellulitis, Injection site hypersensitivity Injection site cellulitis, Injection site hypersensitivity
cellulitis/hypersensitive site reaction cellulitis/hypersensitive site reaction
2843460 37 F MO 06/01/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 ey57a
Loss of consciousness, Vomiting Loss of consciousness, Vomiting
Patient passed out and also vomited Patient passed out and also vomited
2843461 78 M NJ 06/01/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LK494
EK225
Joint swelling, Rash; Joint swelling, Rash Joint swelling, Rash; Joint swelling, Rash
PATIENT EXPERIANCING RASH, ANKLE SWELLING PATIENT EXPERIANCING RASH, ANKLE SWELLING
2843462 65 M CO 06/01/2025 COVID19
FLU3
MMR
PNC21
 PFIZER\BIONTECH
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 LM7786
U8527BA
X018902
Y013009
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mo... Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity More
Patient reported a sore arm off and on since receiving vaccines which is typically worse at night an... Patient reported a sore arm off and on since receiving vaccines which is typically worse at night and sometimes makes it hard to pick up objects. Patient states he heard/read that MRNA vaccines just stay in the muscle. No treatment mentioned and has be occurring since 3/18/2025 when vaccines were administered. No follow up has occurred with PCP per patient. More
2843463 0.25 F 06/01/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 TC47K
97F4B
HM8949
Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hem... Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness More
Unconsolable crying started within twenty-four hours and continued for days without ceasing; fussine... Unconsolable crying started within twenty-four hours and continued for days without ceasing; fussiness continued for weeks. Unilateral weakness turning to stiffness down one side of body as if paralysis (arm and leg on same side), change in crying voice. Corresponded with pediatrician office. More
2843501 61 F CA 06/01/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011819
Y011819
Asthenia, Chills, Hand-foot-and-mouth disease, Malaise, Migraine; Pyrexia, Tachy... Asthenia, Chills, Hand-foot-and-mouth disease, Malaise, Migraine; Pyrexia, Tachycardia, Vomiting, White blood cell count increased More
patient stated that she felt sick after the vaccine with chills, fever, vomit, migraine, weakness, t... patient stated that she felt sick after the vaccine with chills, fever, vomit, migraine, weakness, tachycardia, and elevated WBC treated with Vancomycin. was also given Benadryl in the hospital. She picked up Norco 5mg at pharmacy on 5/1/2025 prescriptions stated for migraine. Then was seen by her primary care doctor on 5/1/2025 for prescriptions for Ibuprofen, valtrex , triamcinolone, for hand foot mouth disease that she says that she got at the hospital on 4/29/25. More
2843502 48 M TX 06/01/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 944942
Extra dose administered Extra dose administered
NONE NONE
2843503 1.25 F GA 06/01/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
PNC20
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH





Amylase normal, Blood calcium, Blood culture, Blood gases normal, C-reactive pro... Amylase normal, Blood calcium, Blood culture, Blood gases normal, C-reactive protein; Differential white blood cell count, Febrile convulsion, Full blood count, Irritability, Metabolic function test; Musculoskeletal stiffness, Procalcitonin; Amylase normal, Blood calcium, Blood culture, Blood gases normal, C-reactive protein; Differential white blood cell count, Febrile convulsion, Full blood count, Irritability, Metabolic function test; Musculoskeletal stiffness, Procalcitonin More
Febrile seizures Evaluated at ER for febrile seizure, ruled by attending physician to be vaccine-in... Febrile seizures Evaluated at ER for febrile seizure, ruled by attending physician to be vaccine-induced. All tests including blood gases and urine were normal; nasal swab not performed. Highest recorded temperature was 101๏ฟฝF, rectal temperature prior to visit was 97.3๏ฟฝF. Mother reports full-body seizure 05/21/2025 at 1900 hours, lasting 1-2 seconds, occurring every minute for 10 minutes for a total of 13 seizures. Patient had bowel movement and urination with each seizure, full diaper after 10 minutes. Transported via ambulance to hospital, where another seizure occurred in the emergency room. Condition improved the following day: more consolable, less irritable, eating and drinking well, normal bowel movements and urination, walking independently today but needed walker assistance day after ER visit, playful, taking two naps instead of one. Mother reports possible minor seizure 5/22/2025, woke up at 0230 hours with heart rate 89 and oxygen saturation 98-99. Patient woke up fine, fell back asleep, back stiffened and arched for a minute, then relaxed. Total 15 seizures between 05/21/2025 and 05/22/2025. More
2843504 0.33 F 06/01/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 5YB7L
TC3N5
LA6406
5N2AN
Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hem... Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness; Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness More
Extreme, unconsolable crying for days; fussiness lasted weeks. One sided weakness that progressed i... Extreme, unconsolable crying for days; fussiness lasted weeks. One sided weakness that progressed into stiff, board-like paralysis on one full side of body. This happened after the two month appointment and was discussed with provider. Provider wished to proceed citing it would confuse office staff to split up the vaccines-the effects were reproduced with the recurrent exposure and lasted longer than the previous encounter, specifically the unilateral, board-like stiffness. Corresponded effects to provider office. More
2843417 1 M OH 05/31/2025 MMR
 MERCK & CO. INC.
 S007814
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse effects reported.; Product was expired 3/14/2021, was administered on 4/1/2021.; This sp... No adverse effects reported.; Product was expired 3/14/2021, was administered on 4/1/2021.; This spontaneous report was received from a Nurse and refers to an 1-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 01-APR-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, lot #S007814, expiration date reported as 14-MAR-2021 (dose, strength, route of administration, anatomical location of vaccine were not reported) and diluted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) for prophylaxis. The patient did not experience adverse effects. More
2843418 M CT 05/31/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMABO56A
Product preparation error Product preparation error
reconstituted with sterile water instead of the MenCYW-135; Menveo - Reconstitution with sterile wat... reconstituted with sterile water instead of the MenCYW-135; Menveo - Reconstitution with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMABO56A, expiry date 31-AUG-2025) for prophylaxis. On 28-MAY-2025, the patient received Menveo. On 28-MAY-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water instead of the MenCYW-135) and inappropriate dose of vaccine administered (Verbatim: Menveo - Reconstitution with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-MAY-2025 A nurse reported that a patient was given a dose of Menveo (2 vial) that was reconstituted with sterile water instead of the MenCYW-135 liquid component which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The nurse asked for the recommended interval to repeat the dose. Consented to follow up. More
2843431 58 F 05/31/2025 PNC20
 PFIZER\WYETH
 lj5280
Chills, Influenza like illness, Malaise, Pyrexia Chills, Influenza like illness, Malaise, Pyrexia
Patient called and states she is having a reaction to the vaccine she received on Saturday. She stat... Patient called and states she is having a reaction to the vaccine she received on Saturday. She states she started having flu-like symptoms (fever, chills, general malaise) on Sunday, followed by an injection site reaction starting Monday. She called concerning her arm. She is experiencing swelling, pain, redness, warmth, itching and it?s ?hard?. The affected area starts at the shoulder and extends about 4 inches. I advised her to ice on and off for 20minutes, take Tylenol, and Benadryl before bed, if no relief in 24hrs or symptoms worsen to have it examined by provider. 48 hours late, patient reports arm is still symptomatic, but is improving. More
2843432 77 M CA 05/31/2025 COVID19
 MODERNA
 3046732
Arthralgia Arthralgia
joint pain left wrist knee and ankle joint pain left wrist knee and ankle
2843433 79 F FL 05/31/2025 RSV
 PFIZER\WYETH
 HY1812
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Swelling and erythema at injection site 2 days after vaccination. Swelling and erythema at injection site 2 days after vaccination.
2843434 50 F PA 05/31/2025 PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Arthralgia, Asthenia, Back pain, Burning sensation, Dizziness; Ear pain, Headach... Arthralgia, Asthenia, Back pain, Burning sensation, Dizziness; Ear pain, Headache, Hyperhidrosis, Myalgia, Nausea; Neck pain, Oropharyngeal pain, Pain in extremity, Tunnel vision More
Deep muscle or pain and burning in left arm down tips of fingers. Throat and ears hurt. Dizziness, n... Deep muscle or pain and burning in left arm down tips of fingers. Throat and ears hurt. Dizziness, nausea, feeling faint, eye sight change to tunnel vision and darkness, sweating, and weakness. Neck and shoulder pain. Weakness and lower back pain with left leg pain, and headache. More
2843435 43 M WI 05/31/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 018B521A
018B521A
030A21A
030A21A
Acne, Arthropod bite, Laboratory test, Magnetic resonance imaging head, Staphylo... Acne, Arthropod bite, Laboratory test, Magnetic resonance imaging head, Staphylococcal infection; Swelling of eyelid; Acne, Arthropod bite, Laboratory test, Magnetic resonance imaging head, Staphylococcal infection; Swelling of eyelid More
Developed MRSA four different times in a row in 2021, first infection developed from a minor bug bit... Developed MRSA four different times in a row in 2021, first infection developed from a minor bug bite and took over a month to treat, daily visits to the walk-in clinic. This repeated itself with another MRSA infection from a pimple 3 other times. Had to get an MRI to see if the infection had spread to my eyes and they had been swollen shut for 4 days I couldn't see. More
โœ“
2843436 64 F FL 05/31/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 Ew0196
Ew0196
Fc3l84
Fc3l84
Balance disorder, Deafness, Dizziness, Hearing aid user, Laboratory test; Magnet... Balance disorder, Deafness, Dizziness, Hearing aid user, Laboratory test; Magnetic resonance imaging, Vertigo; Balance disorder, Deafness, Dizziness, Hearing aid user, Laboratory test; Magnetic resonance imaging, Vertigo More
SEVERE VERTIGO, both times of the required 2 shot required, first 08/24/2021, second required was 9/... SEVERE VERTIGO, both times of the required 2 shot required, first 08/24/2021, second required was 9/14/2021 More
โœ“
2843437 58 F VA 05/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 Y7XG3
Rash, Rash erythematous, Rash pruritic Rash, Rash erythematous, Rash pruritic
PATIENT COMPLAINED OF A RED VERY ITCHY RASHES ON TORSO - UPPER BACK / THORAX / ARMPITS / BREASTS AN... PATIENT COMPLAINED OF A RED VERY ITCHY RASHES ON TORSO - UPPER BACK / THORAX / ARMPITS / BREASTS AND MOVING TO NECK A SHORT WHILE AFTER THE VACCINE WAS ADMINISTERED . More
2843438 57 F OK 05/31/2025 PNC21
 MERCK & CO. INC.
 y019157
Rash Rash
rash and hospitalized rash and hospitalized
2843439 51 F IN 05/31/2025 COVID19
COVID19
PNC21
PNC21
 MODERNA
MODERNA
MERCK & CO. INC.
MERCK & CO. INC.



Arthralgia, Chills, Dysgeusia, Fatigue, Headache; Injection site erythema, Injec... Arthralgia, Chills, Dysgeusia, Fatigue, Headache; Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia; Arthralgia, Chills, Dysgeusia, Fatigue, Headache; Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia More
Moderate redness/pain/swelling at injection site (4?x4?), headache, joint pain, muscle aches, fever... Moderate redness/pain/swelling at injection site (4?x4?), headache, joint pain, muscle aches, feverish, chills, fatigue, food tastes strange, More
2843441 71 F PA 05/31/2025 PNC21
PNC21
PNC21
PNC21
RSV
RSV
RSV
RSV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Z004301
Z004301
Z004301
Z004301
4B22T
4B22T
4B22T
4B22T
Blood culture, Blood lactic acid, Blood test, Cardiac monitoring, Chest X-ray; C... Blood culture, Blood lactic acid, Blood test, Cardiac monitoring, Chest X-ray; Computerised tomogram abdomen, Culture urine, Electrocardiogram, Full blood count, Gait disturbance; Influenza virus test, Metabolic function test, Pollakiuria, Pyrexia, Respiratory syncytial virus test; SARS-CoV-2 test, Scan with contrast, Troponin, Urine analysis; Blood culture, Blood lactic acid, Blood test, Cardiac monitoring, Chest X-ray; Computerised tomogram abdomen, Culture urine, Electrocardiogram, Full blood count, Gait disturbance; Influenza virus test, Metabolic function test, Pollakiuria, Pyrexia, Respiratory syncytial virus test; SARS-CoV-2 test, Scan with contrast, Troponin, Urine analysis More
Developed high fever of 103 and could barely walk. Also urinating more than normal. Had to call 911... Developed high fever of 103 and could barely walk. Also urinating more than normal. Had to call 911 times take me to ER More
2843442 73 F PA 05/31/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Dysarthria, Fatigue, Gait disturbance Dysarthria, Fatigue, Gait disturbance
patient had fatigue, unsteady gait, slurred speech patient had fatigue, unsteady gait, slurred speech
2843443 1.25 F OR 05/31/2025 HEPA
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 LDN273
LN4928
Y005922
Pyrexia, Rash erythematous; Pyrexia, Rash erythematous; Pyrexia, Rash erythemato... Pyrexia, Rash erythematous; Pyrexia, Rash erythematous; Pyrexia, Rash erythematous More
patient attend 15month WCC at Primary Care Office on 5/29/25. Parents reported seeing the beginnings... patient attend 15month WCC at Primary Care Office on 5/29/25. Parents reported seeing the beginnings of a red pinpointed slightly raised rash on stomach that day while in the exam room PRIOR to receiving 3 of the scheduled vaccines she was due for, but it was minor. what was clear and what prompted a call to the same PCP office on 5/31/25 by both parents, is that the rash started spreading by late 5/29 and clearly morning of 5/30. rash also associated with low grade fever, no higher than 100.4 , but mostly 99. Patient is in no apparent distress, change in behaviors or routines, appetite, rash has spread in 24-48 hrs of the visit , if not that night to full stomach, back , bilateral arms and legs, tops of feet's and hands , some on fingers. some scattered around chin area and jaw. slightly raised, not fluid filled yet. does not appear to itch or be painful . fever controlled by Motrin. rash is not deep purple - red pink. not blotchy . various stages of size. has 1 spot on bottom of foot. More
2843444 34 F NJ 05/31/2025 HPV9
 MERCK & CO. INC.
 z005055
Dizziness, Lethargy, Pallor, Posture abnormal Dizziness, Lethargy, Pallor, Posture abnormal
patient reported feeling faint after exiting vaccine room-she was advised to take a seat to be obser... patient reported feeling faint after exiting vaccine room-she was advised to take a seat to be observed-patient looked pale and lethargic- head tilted back but was responsive when called and sat up-patient reported she had not eaten-was observed till she looked stronger and was offered a drink-by 15 minutes, patient husband had arrived and she was talking and feeling better and went home. More
2843445 27 M AZ 05/31/2025 YF
YF
 SANOFI PASTEUR
SANOFI PASTEUR
 uk125aa
uk125aa
Dizziness, Eye movement disorder, Muscle contractions involuntary, Pallor, Synco... Dizziness, Eye movement disorder, Muscle contractions involuntary, Pallor, Syncope; Thirst More
After I administered the yellow fever vaccine, patient expressed concerns about feeling sick since h... After I administered the yellow fever vaccine, patient expressed concerns about feeling sick since he had work that night and the next day. We were discussing about immune support supplements and what to expect if feeling unwell. After a couple minutes of talking, they were about to leave and I was going to direct them to sit outside for a while before heading out, but when patient got up to leave, he felt dizzy and his skin turned pale. Patient's girlfriend and I helped him to sit back down into the chair. Once in the chair, patient took deep slow breaths. I asked his girlfriend if this had ever happen before, but then patient fainted in the chair and his girlfriend held him upright. His body was contracting and eyes rolling to the back of his head. I left the room for help from other pharmacist. Someone helped to call 911, and I tried to call a manager through the phone, but no one picked up, so I went to the front of the warehouse to notify a supervisor to let a manager know 911 was called and to help direct them to the pharmacy. Another person went to the patient to check and make sure they were okay. He mentioned when the patient regained consciousness, he said he was "really thirsty". EMT arrived and they were directed to the vaccine room. We closed the door to give privacy and space. A supervisor came around a couple minutes later to let us know an ambulance was coming through the tire center to gurney the patient out. Once the ambulance arrived, they smoothly came through and helped the patient out. More
2843446 35 M NY 05/31/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FP 7136
FP 7136
FP 7136
Asthma, Back pain, Condition aggravated, Dyspnoea exertional, Essential hyperten... Asthma, Back pain, Condition aggravated, Dyspnoea exertional, Essential hypertension; Insomnia, Persistent depressive disorder, Pollakiuria, Post-traumatic stress disorder, Sciatica; Vitamin D deficiency More
Primary hypertensionPTSD (post-traumatic stress disorderUrinary frequency Short of breath on exertio... Primary hypertensionPTSD (post-traumatic stress disorderUrinary frequency Short of breath on exertionPersistent depressive disorderBMI 22.0-22.9, adultPrimary insomniaVitamin D deficiencyModerate persistent asthma without complicationChronic bilateral low back pain with left-sided sciaticaPrimary hypertension More
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2843447 58 F CO 05/31/2025 HEPAB
PNC21
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 P2443
Y019157
Injection site erythema, Injection site mass, Pyrexia; Injection site erythema, ... Injection site erythema, Injection site mass, Pyrexia; Injection site erythema, Injection site mass, Pyrexia More
Patient called stating she has had a fever (unknown what temperature as she did not have a thermomet... Patient called stating she has had a fever (unknown what temperature as she did not have a thermometer), knot at the injection site, and red splotches on her left arm. She stated the redness was not itchy and was in more that one spot on her arm. The redness had not gotten worse over the past 48 hours. Patient has been treating with acetaminophen. More
2843448 51 F MD 05/31/2025 COVID19
 PFIZER\BIONTECH
 Ew0198
Angina pectoris, Rash macular, Skin discolouration Angina pectoris, Rash macular, Skin discolouration
Heart pain necessitating emergency room visit; rashes and red blotches on and off over the next year... Heart pain necessitating emergency room visit; rashes and red blotches on and off over the next years. Small Black and blue marks all over arms and legs after vaccination. More
2843254 F CA 05/30/2025 HPV9
 MERCK & CO. INC.
Accident at work, Accidental exposure to product, Injury associated with device,... Accident at work, Accidental exposure to product, Injury associated with device, Syringe issue More
Accidental exposure; FBE calling on behalf a nurse who reported GARDASIL 9 syringe had broken and in... Accidental exposure; FBE calling on behalf a nurse who reported GARDASIL 9 syringe had broken and injured another nurse in the practice while administering product on 22APR2025. Filing AE for the nurse injury and filing potential patient AE as it was not confirmed durin; FBE calling on behalf a nurse who reported GARDASIL 9 syringe had broken and injured another nurse in the practice while administering product on 22APR2025. Filing AE for the nurse injury and filing potential patient AE as it was not confirmed durin; This spontaneous report was received from a Nurse and refers to a(n) female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-Apr-2025, an unknown patient would be vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot # and expiration date were not reported), as prophylaxis (Case # 2282009); however, during the vaccination procedure, the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) syringe had broken and injured a nurse in the practice while administering product (syringe broken, injury associated with device, accidental exposure to product). The outcome of the event was not reported. More
2843255 5 MO 05/30/2025 MMRV
 MERCK & CO. INC.
Circumstance or information capable of leading to medication error, Underdose Circumstance or information capable of leading to medication error, Underdose
no adverse event; HCP called and reported a patient who did not receive a full dose of PROQUAD on 13... no adverse event; HCP called and reported a patient who did not receive a full dose of PROQUAD on 13MAY2025 due to moving their arm during administration. Limited demographics provided. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, frequency, route of administration, lot # and expiration date were not reported) as a prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). On 13-May-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). However, the patient did not receive a full dose of due to moving their arm during administration (accidental underdose). No additional information was known by reporter. More
2843256 M FL 05/30/2025 MMRV
MMRV
MMRV
MMRV
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Y015355
Y015355
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No adverse event; Patient received PROQUAD dose on 3/14/2024, 1/31/2025 and on 3/14/2025; This sp... No adverse event; Patient received PROQUAD dose on 3/14/2024, 1/31/2025 and on 3/14/2025; This spontaneous report was received from a medical assistant on 13-MAY-2025 and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical vaccines include Measles, mumps, and rubella virus vaccine live (MMRII) and Varicella virus vaccine live (Oka/Merck) (VARIVAX) ad mistered on 01-FEB-2024. On 14-MAR-2024 at another clinic, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot#, expiration date, dose number, anatomical location, route of administration were not reported) and with sterile diluent (MERCK STERILE DILUENT) (lot#, expiration date, dose number, anatomical location, route of administration were not reported) for Prophylaxis. The Medical assistant reported that on 31-JAN-2025 and 14-MAR-2025 , the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y015355, expiration date: 10-MAR-2026), dose 0.5 mL (conflicting information reported as first and second dose respectively by the same reporter) (dose number, anatomical location, route of administration were not reported) and with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (Extra dose administered). No additional adverse event or quality complaint was reported. No additional Adverse events reported. More
2843257 31 KY 05/30/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y000225
Y017208
Extra dose administered, No adverse event, Product administered to patient of in... Extra dose administered, No adverse event, Product administered to patient of inappropriate age; Extra dose administered, No adverse event, Product administered to patient of inappropriate age More
no additional AE; a 31 year old patient was administered both PROQUAD and VARIVAX on 4/16/2025.; PRO... no additional AE; a 31 year old patient was administered both PROQUAD and VARIVAX on 4/16/2025.; PROQUAD was given to a 31-year-old patient; A dose of VARIVAX was given previously on 3/17/2025 and a dose of PROQUAD was given on 3/21/2025 to the same patient.; This spontaneous report was received from a nurse on 27-May-2025 and refers to a 31-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y014939, expiration date: 04-Sep-2026) 0.5 ml, administered by Intramuscular route. On 21-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y000225, expiration date: 03-Jan-2026) 0.5 mL, administered by Intramuscular route (Product administered to patient of inappropriate age, Inappropriate schedule of product administration). On 16-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y014939, expiration date: 04-Sep-2026) 0.5 ml, administered by Intramuscular route and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date: 13-Apr-2026) 0.5 mL, administered by Intramuscular route (overdose). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date unknown). The vaccines were administered as prophylaxis. No additional AE (no adverse event). More
2843258 F 05/30/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Seizure; Seizure Seizure; Seizure
Grandmother of patient reporting that patient began having seizures after having GARDASIL administer... Grandmother of patient reporting that patient began having seizures after having GARDASIL administered. She is not sure if it was GARDASIL or GARASIL 9. She says it was administered a year or two ago. She does not have any additional information and; This spontaneous report was received from the patient's grandmother and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In approximately 2023, reported as "a year or two ago", the patient was vaccinated with the company unidentified Human Papillomavirus (HPV) vaccine (name and lot number not provided), administered by Unknown route (reported as "Injection") for the indication "vaccine". On an unknown date, after having the vaccine, the patient began having seizures. The reporter did not have any additional. At the reporting time, the outcome of seizures was unknown. The causal relationship between the event the company unidentified Human Papillomavirus (HPV) vaccine was not reported. Upon internal review, the event of seizure was determined to be medically significant. Additional information is not expected. More
2843259 05/30/2025 HBHEPB
 MERCK & CO. INC.
 W032685
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; HCP calling to report a patient was administered PEDVAXHIB today 5/28/2025 after t... No additional AE; HCP calling to report a patient was administered PEDVAXHIB today 5/28/2025 after the expiration date of 5/8/2025.; This spontaneous report was received from a health care professional referring to a patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On 28-MAY-2025, the patient was vaccinated with an expired dose of Haemophilus B conjugate vaccine (Meningococcal protein conjugate) suspension for injection (PEDVAXHIB), for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W032685, with expiration date on 08-MAY-2025) (Expired product administered). There was not adverse event reported. More
2843260 F 05/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Myalgia Myalgia
muscle pain in the arm; This non-serious case was reported by a consumer via interactive digital med... muscle pain in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In APR-2025, the patient received Shingles vaccine. In APR-2025, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: muscle pain in the arm). The outcome of the muscle pain was not reported. It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine. It was unknown if the company considered the muscle pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The reporter's mother had muscle pain in the arm for a month and a half since the vaccine was given. The muscle pain since vaccine administration one month ago. More
2843261 PA 05/30/2025 TDAP
 SANOFI PASTEUR
 U8339BA
No adverse event, Product storage error No adverse event, Product storage error
Temperature excursion occurred with max/low temp. reached 63.0 F for 96 hours with no reported adver... Temperature excursion occurred with max/low temp. reached 63.0 F for 96 hours with no reported adverse event; Initial information received on 27-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves temperature excursion of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] occurred with max/low temp. reached 63.0 f for 96 hours with no reported adverse event. On an unknown date, the caller reported that an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis vaccine Suspension for injection (lot U8339BA and expiry date-30-Nov-2026) (strength-unknown) via unknown route in unknown administration site for Immunization with max/low temp. reached 63.0 f for 96 hours with no reported adverse event (product storage error). Reportedly- extended stability data does not cover the excursion, human error was involved (door was left open), The product was not administered Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2843262 KY 05/30/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK225AB
No adverse event, Product preparation issue No adverse event, Product preparation issue
only the liquid portion of pentacel was given to a patient with no reported adverse event; Initial i... only the liquid portion of pentacel was given to a patient with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered with only the liquid portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (lot UK225AB, expiry date 31-Jul-2026; strength standard and frequency once) via unknown route in unknown administration site for Immunization and only the liquid portion of pentacel was given to a patient with no reported adverse event (single component of a two-component product administered) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2843269 6 F CO 05/30/2025 MMR
 MERCK & CO. INC.
Confusional state, Crying, Hypotonia, Staring, Unresponsive to stimuli Confusional state, Crying, Hypotonia, Staring, Unresponsive to stimuli
Possible seizure, and started blankly into space for about 15 to 20 seconds, was completely limp and... Possible seizure, and started blankly into space for about 15 to 20 seconds, was completely limp and unresponsive. Then was sobbing and confused after. More
2843276 DC 05/30/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AEs; patient supposed to only receive VARIVAX but also received PROQUAD along with VAR... No additional AEs; patient supposed to only receive VARIVAX but also received PROQUAD along with VARIAVX; 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 27-MAY-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (strength, dose, route, lot #, and expiration date of both vaccines were not reported). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The patient was supposed to only receive Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) but also received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) along with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (Overdose). No additional adverse events were reported. Lot# is being requested and will be submitted if received. More
2843277 PA 05/30/2025 VARCEL
 MERCK & CO. INC.
 Y020586
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; that improperly stored VARIVAX was administered; This spontaneous report was recei... No additional AE; that improperly stored VARIVAX was administered; This spontaneous report was received from a Physician and referred 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 28-May-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #Y020586, expiration date: 17-Dec-2026) 0.5 mL (0.5 mL) for prophylaxis (Improper storage of product in use). Temperature was 40F, Time frame was 2 hours 0 minutes 0 seconds. No previous temperature excursion. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date not reported). No additional AE. More
2843278 05/30/2025 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; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 23-MAY-2025, 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: 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 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: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient got two vaccines and was diagnosed with shingles on the day of reporting. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 ) and Shingles vaccine (dose 2). More
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