🏥 VAERS Vaccine Data Browser

🔒 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.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 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 "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 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:

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

Limitations:

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

⚠️ 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
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2848770 72 M TX 07/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Arthralgia, Limb discomfort, Pain in extremity, Pruritus, Rash; Rash pruritic, U... Arthralgia, Limb discomfort, Pain in extremity, Pruritus, Rash; Rash pruritic, Urticaria More
At the advice of my PCP, I decided to get an updated Shingles Vaccine injection. (previous injectio... At the advice of my PCP, I decided to get an updated Shingles Vaccine injection. (previous injection was greater than 15 years ago). June 19, 2025 received Shingrix injection @ ~1:00pm in the left arm June 20-23, left arm felt heavy, sore but nothing bad June 24-25, the top of the right ear lobe became itchy but no rash June 25-29, a rash started on the inside of the left arm, near the elbow. Very itchy. Nothing seemed to work in relieving the itchiness. Some internal achiness in the shoulder area. Arm strength seems to be impacted. June 30th called Dermatologist to get an appointment. Rash was spreading to front waistline area. July 3rd, went to Dermatologist, diagnosed as hives, likely as a result of an allergic reaction to the Shingrix injection. Dermatologist prescribed medicine to alleviate the hives. July 3-7, rash spread to the right butt area, around the back side of the waist. Other areas where itchiness has started including the upper chest, shoulders and back of the neck, as well as down the leg toward the knee area. No issues below the knee. July 7, uncertain if getting better, still uncomfortable as hell. The initial areas on the inside of the left arm appear to be waning away, rash still visible but smaller, not itching. More
2848771 71 F SC 07/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 x4535
Hemiparesis, Immediate post-injection reaction, Pain Hemiparesis, Immediate post-injection reaction, Pain
Customer was administered first dose of Shingrix vaccine in left arm on 6/11/25. Reported immediate ... Customer was administered first dose of Shingrix vaccine in left arm on 6/11/25. Reported immediate soreness. Customer stated she felt some weakness begin in left arm about two days after vaccination. She states this has progressed to include her right arm at times as well as her legs. These symptoms were not reported to pharmacy until 7/7/25. She denies seeking medical treatment for complaints. Pharmacist notified PCP via phone regarding symptoms with customer's permission and advised the customer to seek medical treatment same day. Customer was observed walking around store / pharmacy on 7/7/25 in person. At that time customer still had not sought medical treatment from doctor. More
2848772 57 F WA 07/07/2025 COVID19
 MODERNA
 052C21A
Urticaria Urticaria
Broke out in hives all over my body, I now break out in hives 2 to 3 x a year. Broke out in hives all over my body, I now break out in hives 2 to 3 x a year.
✓
2848537 12 F GA 07/06/2025 MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR



Chills, Laboratory test normal, Mouth ulceration, Pain, Pyrexia; Respiratory syn... Chills, Laboratory test normal, Mouth ulceration, Pain, Pyrexia; Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal, Vulval ulceration; Chills, Laboratory test normal, Mouth ulceration, Pain, Pyrexia; Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal, Vulval ulceration More
Spiked a 103 fever, chills, body aches, and Apthous Ulcer in Vulva and mouth. Fever broke on July 2... Spiked a 103 fever, chills, body aches, and Apthous Ulcer in Vulva and mouth. Fever broke on July 2, she is still suffering with the ulcers. More
2848538 39 F WA 07/06/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946060
Arthralgia, Myalgia Arthralgia, Myalgia
Patient reports that exactly one week after vaccination, she experienced joint pain and muscle pain ... Patient reports that exactly one week after vaccination, she experienced joint pain and muscle pain all over her body. Now, 3 weeks later, she only has pain in one elbow - she says it feels bruised. More
2848539 50 F MO 07/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2hj99
Pain, Paraesthesia, Product administered at inappropriate site Pain, Paraesthesia, Product administered at inappropriate site
vaccine determinded to have been administered too high and ito the joint. pt had shooting/tingling p... vaccine determinded to have been administered too high and ito the joint. pt had shooting/tingling pain. pt took ibuprofen with no relief. pt went to urgent care the next morning and received prednisone, zofran, lidocaine patch, cyclobenzaprine, and norco. More
2848540 51 F PR 07/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GJ952
Injection site erythema, Injection site mass, Injection site pain, Injection sit... Injection site erythema, Injection site mass, Injection site pain, Injection site warmth More
Patient reported pain during the administration of the vaccine, and later during the day she develop... Patient reported pain during the administration of the vaccine, and later during the day she developed redness in the administration area, as well as a "bump" and the area feeling warm to the touch. She used cold compresses for the symptoms, but it didn't help. The symptoms lasted for more than 5 days. More
2848541 79 M FL 07/06/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Heart rate decreased, Nausea, Vomiting Heart rate decreased, Nausea, Vomiting
Patient reported he started with nausea and vomiting at home and went to the ER . he said he was ad... Patient reported he started with nausea and vomiting at home and went to the ER . he said he was admitted for 24 hours due to a low heart rate . More
2848542 62 F NC 07/06/2025 PNC15
PNC15
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019158
Y019158
Arthralgia, Erythema, Headache, Induration, Myalgia; Pyrexia, Swelling Arthralgia, Erythema, Headache, Induration, Myalgia; Pyrexia, Swelling
Generalized myalgias, arthralgias, headache, low grade fever x 48 hours with redness and swelling of... Generalized myalgias, arthralgias, headache, low grade fever x 48 hours with redness and swelling of 10 x 7 cm induration for 72 hours. More
2848564 56 F TX 07/06/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 PJ353
PJ353
PJ353
Abdominal pain upper, Asthenia, Dizziness, Fatigue, Injection site erythema; Inj... Abdominal pain upper, Asthenia, Dizziness, Fatigue, Injection site erythema; Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth, Pruritus; Pyrexia, Rash More
Patient received both Shingrix (1st dose) and Capvaxive (NDC: 00006-4347-02, lot: Z002626, Exp: 09/0... Patient received both Shingrix (1st dose) and Capvaxive (NDC: 00006-4347-02, lot: Z002626, Exp: 09/04/2026) on left deltoid muscle on 7/2/25, On 7/3/25, patient reported the following symptoms: 1. Fever/tired/slight stomach pain/weak/dizziness that last for 3 days. 2. Rashes/bumpiness/itching on both legs around the knees area, lower 1/3 part of her thighs, and upper 1/3 part of her calves area--- according to patient there is no change in food or medications and she strongly believed those bumps/itchiness are caused by the vaccine(s). 3. Primary concern are the Pain, Redness, firm, inflame, and warm to touch of the injection site and the surrounding area (about the size of a golf ball). Patient was recommend to apply ice pack to the area 20 min every hours and taking tylenol 500mg (2 tab Q6-8HPRN PAIN), loratadine, hydrocortisone 1% cream. Patient will try to get in contact with her primary provider to assess/resolve the reaction and potentially get some steroid. More
2848565 48 F AZ 07/06/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
 945660
945660
Blood test, Computerised tomogram, Ear pain, Headache, Hemiparesis; Magnetic res... Blood test, Computerised tomogram, Ear pain, Headache, Hemiparesis; Magnetic resonance imaging, Neurological symptom, Pain in extremity, Swelling face, Vomiting More
Pain from right arm to the back of the right side of head to the ear. Massive headache, face swellin... Pain from right arm to the back of the right side of head to the ear. Massive headache, face swelling, vomiting and right side weakness with neurological symptoms More
✓ ✓
2848519 F NY 07/05/2025 MMR
 MERCK & CO. INC.
 Y008290
No adverse event, Occupational exposure to product No adverse event, Occupational exposure to product
No adverse event; HCP reports MMR II vaccine splashed into HCP right eye when she was drawing up the... No adverse event; HCP reports MMR II vaccine splashed into HCP right eye when she was drawing up the medication. Caller states the HCP rinsed her eye with tap water and is not currently experiencing any symptoms. Caller states MD from office also examined eye and di; Accidental exposure; Exposure via mucosa; This spontaneous report was received from a registered nurse and refers to a(n) female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-Jun-2025, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y008290, expiration date: 24-Apr-2026) diluted in sterile diluent (MERCK STERILE DILUENT), splashed into the HCP right eye when she was drawing up the medication (Exposure via mucosa, Accidental exposure to product, Occupational exposure to product). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), was supposed to be administered for Prophylaxis. She rinsed her eye with tap water and was not experiencing any symptom. A physician from the office examined the eye and did not see any irritation No adverse event was reported. More
2848520 MS 07/05/2025 PNC20
 PFIZER\WYETH
 LP4947
Death, Injection site discomfort, Injection site erythema, Injection site swelli... Death, Injection site discomfort, Injection site erythema, Injection site swelling More
Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection si... Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Inappropriate dose of vaccine administered; This is a spontaneous report received from a Nurse from a sales representative. An elderly patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, single (Lot number: GW7964) and as dose number unknown, single (Lot number: LP4947) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset Oct2024, outcome "unknown", described as "Inappropriate dose of vaccine administered"; VACCINATION SITE ERYTHEMA (death, hospitalization), VACCINATION SITE SWELLING (death, hospitalization), VACCINATION SITE DISCOMFORT (death, hospitalization), outcome "fatal" and all described as "Redness, swollen, discomfort at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site discomfort. The patient date of death was unknown. Reported cause of death: "Redness, swollen, discomfort at the injection site". It was not reported if an autopsy was performed. Clinical course: Redness, swollen, discomfort at the injection site. At least two occurrences of this of late, one of which required hospitalization.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination site erythema, vaccination site swelling, and vaccination site discomfort; and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site; Redness, swollen, discomfort at the injection site More
✓ ✓
2848521 62 F NC 07/05/2025 COVID19
 PFIZER\BIONTECH
 ER2613
Illness, Knee arthroplasty, Pain, Pyrexia Illness, Knee arthroplasty, Pain, Pyrexia
fever; sick; aches, pains; knee replacement surgery in January; This is a spontaneous report receive... fever; sick; aches, pains; knee replacement surgery in January; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 62-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: ER2613) at the age of 62 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Weight loss" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ZEPBOUND taken for weight decreased (ongoing); NEVIBOLOL DCI taken for hypertension (ongoing); METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 21Jan2025, outcome "unknown", described as "knee replacement surgery in January"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown" and all described as "aches, pains". Clinical course: the patient reported that when she got a covid vaccine, she experienced a fever within few hours and got pretty sick. She had aches, pains and a fever. She also had knee replacement surgery in Jan, so she thought perhaps that had something to do with her experience.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132274 Same patient and drug, different dose and event; More
2848523 5 M HI 07/05/2025 UNK
 UNKNOWN MANUFACTURER
Dyspnoea, Injection site swelling Dyspnoea, Injection site swelling
DIFFICULTY BREATHING, SWELLING AT INJECTION SITE DIFFICULTY BREATHING, SWELLING AT INJECTION SITE
2848524 53 M CO 07/05/2025 MMR
 MERCK & CO. INC.
 Y014095
Rash, Rash erythematous, Rash pruritic Rash, Rash erythematous, Rash pruritic
RASH DEVELOPED BEHIND EARS, THEN SPREAD TO NECK AND SHOULDERS. RED AND ITCHY RASH DEVELOPED BEHIND EARS, THEN SPREAD TO NECK AND SHOULDERS. RED AND ITCHY
2848525 54 M FL 07/05/2025 COVID19
 MODERNA
Pain in extremity, Superficial vein thrombosis, Ultrasound Doppler abnormal Pain in extremity, Superficial vein thrombosis, Ultrasound Doppler abnormal
Blood clots formed in superficial veins in right leg. They dissipated after 5 weeks with no treatme... Blood clots formed in superficial veins in right leg. They dissipated after 5 weeks with no treatment. Blood clots returned on 7/4/2025 in right leg. Moderate pain is being observed by the patient. More
2848526 56 F VA 07/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Headache, Nausea, Pyrexia, Vomiting Chills, Headache, Nausea, Pyrexia, Vomiting
Fever, chills, headache, vomiting, nausea Fever, chills, headache, vomiting, nausea
2848527 56 F TX 07/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Blister, Chest pain, Fatigue, Herpes zoster, Hypoaesthesia Blister, Chest pain, Fatigue, Herpes zoster, Hypoaesthesia
Got shingles 2 weeks after. Chest pain arm numbness, extreme fatigue and of course the blisters Got shingles 2 weeks after. Chest pain arm numbness, extreme fatigue and of course the blisters
2848528 19 F OH 07/05/2025 MENB
 PFIZER\WYETH
 HG6057
Back pain, Headache, Nausea Back pain, Headache, Nausea
Patient called clinic to report that after she got home, approximately 1 hours after immunization, s... Patient called clinic to report that after she got home, approximately 1 hours after immunization, she began to have headache, backache and nausea. She took two ibuprofen (200mg each) and currently (about 2 hours after administration) feels like symptoms are subsiding. Advised her to continue to monitor symptoms, rest, and drink plenty of fluids, and if symptoms worsen in any way, she should go to ER for evaluation. Plan is to follow up with patient tomorrow by phone to check on her condition. More
2848529 55 F CA 07/05/2025 HEPA
TDAP
TYP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Z003701
U8366AA
X2A411M
Rash, Skin lesion; Rash, Skin lesion; Rash, Skin lesion Rash, Skin lesion; Rash, Skin lesion; Rash, Skin lesion
Reports rash on both arms that started 3 days after shots which spread to chest, back and face. No ... Reports rash on both arms that started 3 days after shots which spread to chest, back and face. No edema/shortness of breath. States residual skin lesions on face More
2848530 79 F CA 07/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 793pt
Neuropathy peripheral Neuropathy peripheral
Patient started getting neuropathy in both feet on or around 06/26/25. The sensation is progressing ... Patient started getting neuropathy in both feet on or around 06/26/25. The sensation is progressing upward to her legs. As of 07/05/25 she is still experiencing the neuropathy. More
2848531 79 F CA 07/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946062
Neuropathy peripheral Neuropathy peripheral
Patient started getting neuropathy in both feet on or around 06/26/25. The sensation is progressing ... Patient started getting neuropathy in both feet on or around 06/26/25. The sensation is progressing upward to her legs. As of 07/05/25 she is still experiencing the neuropathy. She received 2 vaccines on 6/23 and 6/25 so unable to determine which vaccine may have caused the reaction More
2848532 60 F CO 07/05/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 ln4929
5A4XG
Cellulitis; Cellulitis Cellulitis; Cellulitis
PATIENT CAME IN TO THE PHARMACY AND REPORTED THAT THEY HAD STARTED EXPERIENCING MILD CELLULITIS SYMP... PATIENT CAME IN TO THE PHARMACY AND REPORTED THAT THEY HAD STARTED EXPERIENCING MILD CELLULITIS SYMPTOMS AND WANTED US TO REPORT. THE PATIENT IS AN MD. NOT CURRENTLY NEEDING TO RECEIVE ANY TREATMENT FOR HTE CONDITION. More
2848533 22 M MI 07/05/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0167
EW0167
EW0167
EW0167
EW0167
EW0167
EW0167
EW0167
EW0167
EW0185
EW0185
EW0185
EW0185
EW0185
EW0185
EW0185
EW0185
EW0185
Aphasia, Asthenia, Biopsy heart abnormal, Blood pressure decreased, Blood test; ... Aphasia, Asthenia, Biopsy heart abnormal, Blood pressure decreased, Blood test; Brain injury, Cardiac ablation, Cardiac arrest, Cardiac ventricular scarring, Cardioversion; Cognitive disorder, Computerised tomogram head, Computerised tomogram heart, Dysstasia, Echocardiogram; Echocardiogram abnormal, Electrocardiogram, Electrocardiogram ambulatory, Executive dysfunction, Exercise electrocardiogram; Gait inability, Genetic testing, Hypoxia, Impaired work ability, Implantable defibrillator insertion; Intensive care, Loss of personal independence in daily activities, Lung assist device therapy, Magnetic resonance imaging head, Magnetic resonance imaging heart abnormal; Memory impairment, Multiple organ dysfunction syndrome, Muscle atrophy, Positron emission tomogram, Posture abnormal; Pulmonary embolism, Pulmonary haemorrhage, Resuscitation, Scan with contrast, Therapeutic embolisation; Thromboembolectomy, Urine analysis, Ventricular tachycardia, Weight decreased; Aphasia, Asthenia, Biopsy heart abnormal, Blood pressure decreased, Blood test; Brain injury, Cardiac ablation, Cardiac arrest, Cardiac ventricular scarring, Cardioversion; Cognitive disorder, Computerised tomogram head, Computerised tomogram heart, Dysstasia, Echocardiogram; Echocardiogram abnormal, Electrocardiogram, Electrocardiogram ambulatory, Executive dysfunction, Exercise electrocardiogram; Gait inability, Genetic testing, Hypoxia, Impaired work ability, Implantable defibrillator insertion; Intensive care, Loss of personal independence in daily activities, Lung assist device therapy, Magnetic resonance imaging head, Magnetic resonance imaging heart abnormal; Memory impairment, Multiple organ dysfunction syndrome, Muscle atrophy, Positron emission tomogram, Posture abnormal; Pulmonary embolism, Pulmonary haemorrhage, Resuscitation, Scan with contrast, Therapeutic embolisation; Thromboembolectomy, Urine analysis, Ventricular tachycardia, Weight decreased More
Item 18 On Saturday, August 21, 2021, while on evening run, patient suffered a catastrophic sudden c... Item 18 On Saturday, August 21, 2021, while on evening run, patient suffered a catastrophic sudden cardiac arrest. At the time he was a 22 year-old recent college graduate, just beginning an extremely promising professional career in management consulting. He was a former college athlete, strong, healthy, in excellent physical condition, and worked out every day. (Note: patient received two doses of the Pfizer Covid-19 vaccine on April 28 and May 19, 2021) When stricken with cardiac arrest, patient would have died on the spot, if not for random passersby who jumped in to provide CPR. By chance, one of these persons was a physician also out for a run. Another five people provided extensive aid. These people also happened to be experienced cardiac ICU and cardiac step-down nurses. These strangers gave the patient a chance for survival. Patient?s condition was dire and ER medical staff had great difficulty stabilizing his ventricular tachycardia. Even with max doses of five (5) different vasopressors, he still required numerous and repeated cardioversion therapy to restart or stabilize his heart rhythm. As a result, patient had prolonged low oxygen flow, contributing to internal organ damage and an anoxic brain injury. Prior to this cardiac event, patient had no congenital defects, no genetic predisposition or family history of heart disease. While in hospital, MRI imaging and a heart biopsy revealed no abnormalities, aside from significant ventricular scarring associated with the cardiac arrest. Patient was in cardiac ICU at Hospital for four (4) weeks. The multi-system organ failures worsened, before slowly rebounding. One week after cardiac arrest, on 08/28/2021, patient developed left lung bleed and nearly died during a procedure to remove clotting, when he again went into v-tach and blood pressure dropped dangerously low. He was then placed on ECMO (VV) life support for eight days, so specialists could safely perform repeated procedures to repair and restore the damaged lung. Patient received an implanted cardioverter defibrillator (ICD), and after six weeks was discharged from the hospital (10/02/2021). He had survived an out-of-hospital cardiac arrest (less than 10% survival rate) but also lost 50 lbs. and his considerable muscle mass. He was severely weakened, unable to stand, walk or hold his head up, and now with brain damage. Patient was admitted to a facility for five (5) weeks of intensive multi-discipline inpatient therapy, including re-learning to walk, speak and begin to regain strength. Then, patient began outpatient Day Rehab. For the next six months, patient endured exhausting physical (PT), occupational (OT) and speech/cognitive therapy (SLP), six hours per day, five days per week. He required extensive therapy to address his brain injury and the new deficits and challenges it caused. Patient was discharged from facility on 05/03/2022, no longer requiring PT and OT. Patient continued to present with substantial cognitive communication deficits from the anoxic brain injury. These deficits included significant impairment in short term and verbal working memory, as well as impaired executive function, reasoning, cognitive flexibility and decreased cognitive endurance. Cognitive and language deficits included decreased high-level word finding, verbal organization, response elaboration and decreased verbal/non-verbal pragmatic skills. Patient was recommended for ongoing SLP therapy, 2-3 times/week, targeting his numerous deficits. This treatment began 05/09/2022 and continues to this day. Patient has made great improvements since that time, but has not been able to live independently, nor work. Although patient has recently (March 2025) tested exceptionally high for math, logic, reasoning, analytic abilities, language and verbal skills, his short-term and working memory is severely compromised due to the brain injury. Finally, as of May 2025, patient is able to begin working, initially on a limited, part-time basis only, and in far more simplified and less demanding work. Patient?s cardiac health is currently stable and good, but has not been without problems. After extensive testing and elimination of other potential causes, it is believed the cardiac arrest was brought on by myocarditis, likely the negative reaction to the Covid vaccine. The damage to patient?s heart was significant, but he is able to work out daily. He continues to be followed by local cardiologist at home, as well as specialists. He has had two (2) difficult ventricular ablations, most recently in January 2025, a very complicated 12-hour procedure. One additional such procedure perhaps less difficult is anticipated in 4Q2025. There is no disputing the significant life-changing impact of patient?s August 2021 cardiac arrest. It nearly ended a healthy young man?s life, and certainly interrupted a promising professional career, and left an extremely intelligent and capable individual with an extensive brain injury. It is uncertain if patient?s prior career, at the level he started, will be able to be resumed. More
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2848534 55 M CA 07/05/2025 HEP
PNC20
 DYNAVAX TECHNOLOGIES CORPORATION
PFIZER\WYETH

Injection site swelling, Pain; Injection site swelling, Pain Injection site swelling, Pain; Injection site swelling, Pain
after 3 days, pain slowly improving , no redness, slightly swollen around injection site after 3 days, pain slowly improving , no redness, slightly swollen around injection site
2848535 68 F CA 07/05/2025 TD
 SANOFI PASTEUR
 Y019157
Rash Rash
Patient received vaccine on 6/29/25 but got a rash on 7/4/25. She said she is doing better with ice ... Patient received vaccine on 6/29/25 but got a rash on 7/4/25. She said she is doing better with ice packs and Tylenol. Pt was advised to take Benadryl and Ibuprofen if symptoms worsen and to call MD. More
2848536 65 F CA 07/05/2025 MMR
 MERCK & CO. INC.
 Y015022
Urticaria Urticaria
A few small hives appeared on stomach area after a hot bath. Resolved in a few hours. No treatment t... A few small hives appeared on stomach area after a hot bath. Resolved in a few hours. No treatment taken. More
2848423 F NY 07/04/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019157
Y019157
Cough, Erythema, Headache, Injection site pain, Nausea; Oropharyngeal pain, Pain... Cough, Erythema, Headache, Injection site pain, Nausea; Oropharyngeal pain, Pain, Pain in extremity, Swelling More
COUGH; HEADACHE; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; NAUSEA; OROPHARYNGEAL PAIN; PAIN; PAI... COUGH; HEADACHE; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; NAUSEA; OROPHARYNGEAL PAIN; PAIN; PAIN IN EXTREMITY; SWELLING; Information has been received from the Food Drug Administration (FDA) (agency # 2834478-1) on 16-JUN-2025 This spontaneous report refers to a 65-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included head cold, Covid +, hypothyroidism, IBS,, asthma, reflux, and Allergy to Erythromycin. Concomitant medications included Wixela inhub (Fluticasone propionate;Salmeterol xinafoate), Levothyroxine (Levothyroxine sodium), Dicyclomine (Dicycloverine hydrochloride), Vitamin D3 Ol (Colecalciferol), Multivitamin (Ascorbic acid;Nicotinamide;Retinol;Riboflavin;Thiamine;Vitamin d nos), Calcium d (Ascorbic acid;Calcium gluconate;Calcium lactate;Calcium phosphate dibasic;Ergocalciferol), Vilazodone hcl (Vilazodone hydrochloride), Famotidine d (Famotidine), Alprazolams (Alprazolam), Clomipramine (Clomipramine hydrochloride). On 31-Mar-2025, at private, the patient was vaccinated in her left arm with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) intramuscular, lot #: Y019157, expiration date not provided but upon internal validation stablished as: 23-MAY-2026; dose and anatomical location were not provided) administered for prophylaxis. On 31-Mar-2025, the patient experienced cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at injection site. (Baseball size) Self treated with Tylenol and OTC cold medicine. arm redness, swelling went down within 24 hours. Declined office visit to assess. On unspecified date in 2025, the patient recovered from all adverse events. The causal relationship between the adverse events and suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2834478-1 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2848424 AL 07/04/2025 MMRV
 MERCK & CO. INC.
 Z007214
No adverse event, Product storage error No adverse event, Product storage error
HCP reported that the patient did not experience any adverse side effects from administered dose; HC... HCP reported that the patient did not experience any adverse side effects from administered dose; HCP called to report TE for PROQUAD with a prior excursion on 6/18/2025 and a current excursion on 07/02/2025 that was administered post excursion to a patient on 06/24/2025.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JUN-2025, the patient was vaccinated with a improper storage Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) Injection (lot #Z007214, expiration date: 05-Oct-2026) at a dose of 0.5 mL reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis following a temperature excursion of 8.6F for 1 hour, 17 minutes, 0 seconds, and 6.8F for 0 hours, 47 minutes, 0 seconds. HCP reported that the patient did not experience any adverse side effects from administered dose was unknown. More
2848425 MO 07/04/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No symptoms reported. No additional AE; This case pertains to one patient who received improperly st... No symptoms reported. No additional AE; This case pertains to one patient who received improperly stored VARIVAX on 06/30/2025.; This spontaneous report has been received from a nurse, regarding to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 30-JUN-2025, the patient was vaccinated with improperly storage of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at a dose of 0.5 milliliter (ml) (lot #Y015108, expiration date: 06-SEP-2026) plus sterile diluent as prophylaxis (dose, route of administration, and anatomical site of injection were not reported). The administered doses were stored at a temperature of 6.3 degrees Fahrenheit (F) during a time frame of 16 minutes (product storage error). There was no previous temperature excursion. No additional side effects were reported in the patients. More
2848426 MO 07/04/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP reported that VARIVAX and PROQUAD were administered to multiple patients on mu... No additional AE; HCP reported that VARIVAX and PROQUAD were administered to multiple patients on multiple dates after being improperly stored. This case pertains to one patient who received improperly stored VARIVAX on 06/25/2025; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On 25-JUN-2025, the patient was vaccinated with an improperly Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #Y015108, expiration date: 06-SEP-2026) at a dose of 0.5 mL (route of administration not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis following a temperature excursion of 6.3F for 0 hours 16 minutes 0 seconds. No additional adverse event reported. More
2848427 54 M IL 07/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 97D52
Product preparation issue Product preparation issue
Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being ... Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis. On 13-FEB-2025, the patient received Shingrix (intramuscular use). On 13-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter considered the medication error without harm.; Sender's Comments: US-GSK-US2025061270:same reporter differnt patient More
2848428 61 M IL 07/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 97D52
Product preparation issue Product preparation issue
Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being ... Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis. Previously administered products included Venlafaxine (received a dose on an unknown date). On 21-APR-2025, the patient received Shingrix. On 21-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments: US-GSK-US2025061270: More
2848429 12 M CA 07/04/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FH443
Wrong product administered Wrong product administered
Bexsero was unintentionally administered; This non-serious case was reported by a other health profe... Bexsero was unintentionally administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis. On 24-JUN-2025, the patient received the 1st dose of Bexsero. On 24-JUN-2025, immediately after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero was unintentionally administered). The outcome of the wrong vaccine administered 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: 01-JUL-2025 A vaccine coordinator reported the administration of a Bexsero vaccine to a patient by a member of the staff. She wanted to know how to proceed after this incident. The reporter wanted to report that Bexsero was unintentionally administered, and no other data was provided, which led to wrong vaccine administered. It was explained that it was administered within the recommended range of age. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. More
2848430 12 NV 07/04/2025 DTAP
DTAP
 SANOFI PASTEUR
UNKNOWN MANUFACTURER

No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
patient had their 5 previous doses, they are good to go. The 5th dose given to the patient was a Tda... patient had their 5 previous doses, they are good to go. The 5th dose given to the patient was a Tdap, not a DTaP with no reported adverse event; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old and unknown gender patient in which 5th dose was given was of Diphtheria, Tetanus And Acellular Pertussis Vaccine [Tdap] instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] 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 dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Tdap] produced by unknown manufacturer, unknown formulation, (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization as 5th dose, instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly,Nurse mentioned that the medical practice previously administered DTaP to a now 12 year-old patient. They are aware that as long as patient had their 5 previous doses, they are good to go. The 5th dose given to the patient was a Tdap, not a DTaP as patient is already 1. 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
2848431 1 M TX 07/04/2025 HIBV
 SANOFI PASTEUR
 UK148AA
No adverse event, Product preparation error No adverse event, Product preparation error
given the ACTHIB vaccine but didn't dilute it with the HIB diluent/diluted it with another dilu... given the ACTHIB vaccine but didn't dilute it with the HIB diluent/diluted it with another diluent that was for PROQUAD & VARICELLA, with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered with HIB (PRP/T) Vaccine [ACT-HIB] but didn't dilute it with the hib diluent/diluted it with another diluent that was for proquad & varicella, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for and HIB vaccine (HIB vaccine) for Immunisation. On 12-Jun-2025, the patient received 0.5 ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, lot UK148AA, expiry date:30-Sep-2025,strength:standard, frequency:once, via intramuscular route in the left thigh for immunisation but didn't dilute it with the hib diluent/diluted it with another diluent that was for proquad & varicella, with no reported adverse event (product preparation error) (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
2848432 0.25 M MI 07/04/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK038AA
Expired product administered, No adverse event Expired product administered, No adverse event
administration of an expired product with no reported adverse event; Initial information received on... administration of an expired product with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old male patient who was administered with an expired dose 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 01-Jul-2025, the patient received 0.5 ml of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date- 30-Jun-2025 and lot UK038AA) once via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency- same day). Reportedly, reporter would like to know the possible adverse reactions and if there was a need to revaccinate. 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
2848443 79 F NY 07/04/2025 COVID19
COVID19
 MODERNA
MODERNA
 013H21B
013H21B
Biopsy bone marrow, Breast cancer female, Chemotherapy, Mastectomy, Myelodysplas... Biopsy bone marrow, Breast cancer female, Chemotherapy, Mastectomy, Myelodysplastic syndrome; Platelet count decreased, Transfusion, White blood cell count increased More
Breast Cancer diagnosed in November 2022. Never had any issues prior to the Moderna vaccine. Mastect... Breast Cancer diagnosed in November 2022. Never had any issues prior to the Moderna vaccine. Mastectomy one breast January 2023. Diagnosed with MDS May 2024. Blood work showed very low platelets and high white blood count. Has tried chemotherapy pill that gave my mother extreme neuropathy. My mother has had 3 different very painful bone marrow biopsys. My mother has had many transfusions and etc. prior to the Moderna Booster my mother was in very good health. My mother has now been given a very poor prognosis. More
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2848450 MO 07/04/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No symptoms reported. No additional AE/no PQC.; one patient who received improperly stored VARIVAX o... No symptoms reported. No additional AE/no PQC.; one patient who received improperly stored VARIVAX on 06/27/2025; This spontaneous report was received from a Nurse on 02-Jul-2025 and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-Jun-2025, the patient was vaccinated with improperly stored varicella virus vaccine live (oka-merck) (VARIVAX), Injection (lot #Y015108, expiration date: 06-Sep-2026, 0.5 mL; route and anatomical site were not provided) for Prophylaxis (Product storage error). The vaccine was exposed to a temperature excursion of 6.3 Fahrenheit for 16 minutes. No previous temperature excursion was involved. No symptoms or additional adverse event (AE) reported. More
2848451 M WI 07/04/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 N733B
Exposure via skin contact, Product leakage, Underdose Exposure via skin contact, Product leakage, Underdose
the product leaked onto the patient's arm; ENGERIX-B leaked while administering to the patient;... the product leaked onto the patient's arm; ENGERIX-B leaked while administering to the patient; full dose was not administered; product leaked; Product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of exposure via skin contact in a male patient who received HBV (Engerix B adult) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced exposure via skin contact (Verbatim: the product leaked onto the patient's arm), accidental exposure while administering drug (Verbatim: ENGERIX-B leaked while administering to the patient), accidental underdose (Verbatim: full dose was not administered), product leakage (Verbatim: product leaked) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the exposure via skin contact, accidental exposure while administering drug, accidental underdose, product leakage and pharmaceutical product complaint were not applicable. Additional Information: GSK Receipt Date: 23-JUN-2025 The nurse reported that one prefilled syringe of Engerix b leaked while administering to the patient. Because of this, the product leaked onto the patient's arm and the full dose was not administered which led to accidental underdose. It was confirmed that luer lock needle was used. More
2848452 40 F IL 07/04/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 J942L
Product preparation error Product preparation error
reconstituted with sterile water from Merck Sharp and amp;; This non-serious case was reported by a... reconstituted with sterile water from Merck Sharp and amp;; 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 adult female patient who received MMR (Priorix) (batch number J942L, expiry date 08-NOV-2026) for prophylaxis. On 23-JUN-2025, the patient received Priorix. On 23-JUN-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water from Merck Sharp and amp;). The outcome of the wrong solution used in drug reconstitution 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: 24-JUN-2025 Nurse practitioner explained that on June 23rd 2025, 2 patients were vaccinated with Priorix doses that were accidentally reconstituted with sterile water from Merck Sharp. Dohme vaccines instead of the Priorix corresponding diluent provided by Glaxo Smith Kline which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2025079396, reported by same reporter different patient; Sender's Comments: US-GSK-US2025079396:same reporter /different patient More
2848468 MD 07/04/2025 MMRV
 MERCK & CO. INC.
 Y008280
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
no adverse event; wrong product administered; Interchange of vaccine products; Medical Assistant cal... no adverse event; wrong product administered; Interchange of vaccine products; Medical Assistant calling with a report of an adverse event regarding PROQUAD. Medical Assistant stated that a patient older than the recommended age for administration of PROQUAD was administered a dose today, 6/10/2025, during a routine vaccinatio; This spontaneous report was received from other health professional (medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 10-JUN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (valid lot #Y008280, expiration date 21-OCT-2025 upon internal validation) 0.5 mL (two dose series) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (indication, expiration date, and lot # were not reported). It was informed that that the suspect vaccine was administered to a patient older than the recommended age (product administered to patient of inappropriate age). However, the patient should be vaccinated with a booster dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R-II) (wrong product administered/interchange of vaccine products). The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered due to an oversight while preparing the patient for vaccination and confirmed the patient had not reported any medical concerns or symptoms at this time after being vaccinated (no adverse event). No additional information provided. More
2848469 F AR 07/04/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Needle issue, Occupational exposure to product; Needle issue, Occupational expos... Needle issue, Occupational exposure to product; Needle issue, Occupational exposure to product More
No additional AE; a medical assistant was preparing VARIVAX to administer to a patient when somehow ... No additional AE; a medical assistant was preparing VARIVAX to administer to a patient when somehow the needle bent and it squirted into the medical assistants eye.; medical assistant was preparing VARIVAX to administer to a patient when somehow the needle bent and it squirted into the medical assistants eye; the needle bent and it squirted into the medical assistants eye. Nurse confirmed no PQC reporting it was a in house needle that bent, saying it was a non Merck product.; This spontaneous report was received from an Office Manager (Healthcare Business Professional [HBP]) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 24-Jun-2025 about 1:00 PM, the patient (medical assistant) was preparing Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date and lot # were not reported) to administer to a patient, when somehow the needle bent and it squirted into the medical assistants eye (Accidental exposure to product, Occupational exposure to product). It was a in house needle that bent, it was a non-Merck product (Needle issue). It was reported the suspect vaccine squirted into medical assistant eye and the medical assistant rinsed it out. It might have been the medical assistants left eye but she was not sure, there had been no pain or any other complaints since the incident occurred. The reporter did not know any further details regarding the event reporting the medical assistant and health care professional (HCP) were busy with another patient. When asked about patient, HBP reports no adverse event (AE) for patient. No additional AE (no adverse event). Lot # is being requested and will be submitted if received. More
2848470 85 F MA 07/04/2025 PNC21
 MERCK & CO. INC.
 Y019157
Injection site erythema, Injection site swelling, Pain in extremity Injection site erythema, Injection site swelling, Pain in extremity
The patient complained that first 4 days after the vaccination, her arm was "sore" and on ... The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful.; The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful.; The patient complained that first 4 days after the vaccination, her arm was "sore" and on the 5th day the injection site got "red and swollen" and her arm was painful./However, pain and redness spread up to her elbow; However, pain and redness spread up to her elbow; This spontaneous report was received from a pharmacist and refers to a 85-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported. On 12-JUN-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) solution for injection, 1 dose, lot #Y019157, expiration date: 23-MAY-2026, administered by intramuscular route as routine vaccination (anatomical site was not reported). For first 4 days after the vaccination the patient complained that her arm was "sore" and on the 5th day the injection site got red and swollen and her arm was painful. She went to an urgent care and received a prescription for Doxycycline 100mg twice a day for 7 days. However, pain and redness spread up to her elbow, so she went to an unspecified hospital and received unspecified IV antibiotic. Confirmed with pharmacist that the patient was not hospitalized. At the reporting time, the patient had not recovered from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported but established as not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. More
2848471 PA 07/04/2025 RVX
RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Y018376
Y018376
Y018376
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
ROTATEQ administered to a patient to greater that 32 weeks old. HCP stated that the patient was admi... ROTATEQ administered to a patient to greater that 32 weeks old. HCP stated that the patient was administered their third dose of ROTATEQ today, 6/25/2025, due to the patient being behind with their vaccination appointments; No additional AE; HCP calling to report adverse event regarding ROTATEQ administered to a patient to greater that 32 weeks old.; This spontaneous report was received from a medical assistant and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (2 mL / three dose series) (lot #Y018376, expiration date reported as and upon internal validation confirmed to be: 07-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. On an unspecified date, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (2 mL / three dose series) (lot #Y018376, expiration date reported as and upon internal validation confirmed to be: 07-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. On 25-Jun-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (2 mL / three dose series) (lot #Y018376, expiration date reported as and upon internal validation confirmed to be: 07-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. On that day (today), Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was administered to the patient who was greater than 32 weeks old (Product administered to patient of inappropriate age). Health care professional (HCP) stated that the patient was administered their third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) today, due to the patient being behind with their vaccination appointments (inappropriate schedule of product administration). HCP confirmed the patient has not experienced any medical concerns at this time after being administered Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) beyond the recommended 32 weeks age. No additional information was provided. No additional adverse event or product quality compliant (AE/PQC) was noted (no adverse event). More
2848472 PA 07/04/2025 HPV9
 MERCK & CO. INC.
 W031448
Expired product administered, No adverse event Expired product administered, No adverse event
No symptoms reported; expired dose of GARDASIL 9 was administered to a patient.; This spontaneous re... No symptoms reported; expired dose of GARDASIL 9 was administered to a patient.; This spontaneous report was received from a Registered Nurse 30-Jun-2025.and refers to a patient of unknown age and gender. The patient's medical history concurrent conditions and concomitant therapies were not reported. On 25-Feb-2025, the patient was vaccinated with an expired vaccine of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) (dose number, lot #W031448, expiration date: 12-Feb-2025), dose:0.5 mL for Prophylaxis (Expired product administered). No symptoms reported More
2848473 MO 07/04/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP called to report a temperature excursion for VARIVAX and PROQUAD. HCP reported... No additional AE; HCP called to report a temperature excursion for VARIVAX and PROQUAD. HCP reported that VARIVAX and PROQUAD were administered to multiple patients on multiple dates after being improperly stored. This case pertains to one patient who received imprope; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Jun-2025, the was vaccinated with improper storage dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), formulation: injection, lot #Y015108, expiration date: 06-Sep-2026, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). On an unknown date, administered dose of vaccine was exposed to the temperature excursion of 6.3 degrees Fahrenheit (F) for 16 minutes (product storage error). No additional adverse event reported (no adverse event). This is one of several reports received from the same reporter. More
2848474 MO 07/04/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP reported that VARIVAX and PROQUAD were administered to multiple patients on mu... No additional AE; HCP reported that VARIVAX and PROQUAD were administered to multiple patients on multiple dates after being improperly stored. This case pertains to one patient who received improperly stored VARIVAX on 06/10/2025; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-JUN-2025, the patient was vaccinated with an improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #Y015108, expiration date: 06-SEP-2026) at a dose of 0.5 mL (route of administration not reported ) which was reconstituted with sterile diluent (MERCK STERILE DILUENT), at a dose of 0.5 mL (lot # and expiration date, route of administration were not reported) for prophylaxis following a temperature excursion of 6.3F for 0 hours 16 minutes 0 seconds. No additional adverse event was reported. More
2848475 TX 07/04/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 z014790
z014790
2014790
2014790
No adverse event, Product administered to patient of inappropriate age; Product ... No adverse event, Product administered to patient of inappropriate age; Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age; Product administered to patient of inappropriate age, Wrong product administered More
No additional AEs were reported; Healthcare worker reported that a 2 month old patient received a do... No additional AEs were reported; Healthcare worker reported that a 2 month old patient received a dose of GARDASIL 9. No additional AEs were reported, no further information provided. No PQC.; This spontaneous report was received from a healthcare worker and refers to 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-Jul-2025, the 2-month-old patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (invalid lot #z014790, expiration date: 22-Apr-2026) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events (AEs) were reported. no further information provided. More
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