🏥 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 💀 🏥 🚑 ♿ ⚠️
2823920 16 M NE 01/31/2025 HEP
HPV9
MENB
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
X024727
Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope; Dyskinesi... Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope; Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope; Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope More
Immediately after administration of HPV vaccine in patient s Right arm, patient was syncopal with mu... Immediately after administration of HPV vaccine in patient s Right arm, patient was syncopal with muscle spasms/jerking for <1 minute. Patient was helped to supine position on exam table during episode. Patient s father in room with patient. Patient regained consciousness within 1 minute. Took sequential blood pressures. Blood pressures within normal limits shortly after syncopal episode. Nurses completed orthostatic pressures, within normal for laying, sitting and standing. Also offered cool air, cool compresses to neck/axilla, juice and pretzels. Patient took 1 sip of juice and declined pretzels. Patient stated felt normal. Walked around exam room without dizziness. Patient denies dizziness, AOx4 . At 10:35am discharge instructions given. Dad states will stay home with patient. Patient stable More
2823921 1.08 M SC 01/31/2025 VARCEL
 MERCK & CO. INC.
 y011020
Rash, Wheezing Rash, Wheezing
After receiving vaccine, patient experienced a rash and wheezing. Benadryl given 10 minutes after a... After receiving vaccine, patient experienced a rash and wheezing. Benadryl given 10 minutes after administration of vaccine. EMS notified. More
2823922 76 M MI 01/31/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 014H22A
014H22A
014H22A
014H22A
Abscess, Atelectasis, Blood culture negative, COVID-19, Chest X-ray abnormal; Cu... Abscess, Atelectasis, Blood culture negative, COVID-19, Chest X-ray abnormal; Culture wound positive, Dyspnoea, Electrolyte imbalance, Eschar, Legionella test; Limb injury, Lung infiltration, Patient isolation, Respiratory failure, SARS-CoV-2 test positive; Staphylococcal infection, Streptococcus test negative, Wound, Wound cellulitis More
Discharge Summary DO (Resident) ? General Medicine Cosigned by: DO at 1/27/2025 5:05 PM Attestatio... Discharge Summary DO (Resident) ? General Medicine Cosigned by: DO at 1/27/2025 5:05 PM Attestation signed by DO at 1/27/2025 5:05 PM I have personally interviewed and examined the patient on the date of service of the attached note. Management was discussed with DO. I agree with the documented findings and plan of care in their note. Brief exam: Patient was alert and oriented times three, wearing his home mask. Lungs CTAB. Cardio RRR. Abdomen soft, bowel sounds present. Brief history and medical decision making: : Patient was admitted and treated for a sternal wound with cellulitis and a RLE wound. He had been maintained on cefazolin 2 grams IV every 8 hours during his hospital stay. Wound cluture from 1/22 demonstrated MSSA.Blood cultures from 1/21/25 2/2 remain negative. CXR demonstrated Right lung infiltrate versus atelectasis. Strep pneumo and legionella antigens were negative. COVID 19 ws positive and he has been maintained in enhanced respiratory isolation. Paxlovid course was initated. He has Mulitiple myeloma with leukopenia noted during this admission. He follows with Dr and was undergoing chemotherapy prior to his hospitalization. He has also been treated for acute kidney injury on CKD. He was evaluated by wound care on the day of discharge. . Keflex was ordered upon discharge to complete a total 14 day course of antibiotics. Lasix was transitioned to torsemide 40 mg po daily upon discharge. Endocrine referral for diabetic management was placed upon discharge. Physician Discharge Summary Name: Medical Record #: Age: 78 y.o. DOB: Admit date: 1/21/2025 Discharge date: 1/27/2025 Admitting Physician: No admitting provider for patient encounter. Attending Physician at the Time of Discharge: DO Primary Care Physician: DO, Reason for Admission: Respiratory insuffiencey, RLE/Sternal wounds Brief Summary of Hospital Stay: Patient was hospitalized for treatment of COVID and skin wounds. His clinical status improved with Paxlovid, pulmonary hygiene, and antibiotics with wound care. Hospital Course: Patient is a 78 y.o. male with relevant PMH of multiple myeloma in remission, pain from bone metastases, peripheral neuropathy 2/2 T2DM, BPH, coronary artery disease, chronic HFpEF, gout, IDA, HLD, OSA, and CKD 3B presenting for dyspnea. He was found to be COVID positive, with a wound with eschar on his right lower extremity and a sternal wound/abscess. He started and completed a course of Paxlovid for his COVID along with pulmonary hygiene. He was started on vancomycin for his wounds, eventually downgraded to Cefazolin. He received 5 total days of antibiotics while inpatient. He was seen by wound care for wound dressings and changes. His wounds dramatically improved with antibiotics and wound care. His respiratory status improved as well never requiring oxygen. He will be sent home to complete a 14 day antibiotics course with Keflex for 9 days. Additionally his Lasix was transitioned to torsemide 40 mg daily due to better bioavailability, less electrolyte derangements and less risk for AKI/dehydration. A referral to Endocrine was placed for management of his diabetes. Discharged to Home Health Care Svcs. More
✓
2823923 1 F OK 01/31/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
No adverse event, Wrong product administered No adverse event, Wrong product administered
Kinrix was mistakenly given by the medical assistant in the clinic with MMR, Varicella and Flu. Hep ... Kinrix was mistakenly given by the medical assistant in the clinic with MMR, Varicella and Flu. Hep A was accidently replaced with Kinrix instead of given as ordered. This is the pt. 4th dose of Dtap/IPV since birth. There was no adverse reaction as of now, just wrong vaccine given at the wrong age. More
2823924 67 F GA 01/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 354M3
Mobility decreased, Myalgia Mobility decreased, Myalgia
Patient experienced severe muscle pain in her arms and legs. Patient couldn't get out bed for ... Patient experienced severe muscle pain in her arms and legs. Patient couldn't get out bed for 2 days. More
2823925 13 M TN 01/31/2025 FLU3
HPV9
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 495MK
X024251
Refusal of vaccination; Refusal of vaccination Refusal of vaccination; Refusal of vaccination
PATIENT KEPT JERKING AWAY AND REFUSED TO TAKE THE VACCINE AFTER MOTHER ACCEPTED THE IMMUNIZATION. IN... PATIENT KEPT JERKING AWAY AND REFUSED TO TAKE THE VACCINE AFTER MOTHER ACCEPTED THE IMMUNIZATION. INTAKE HAD BEEN PERFORMED AND VACCINE HAD BEEN SCANNED OUT AND PRPEPARED FOR ADMINISTRATION AND ONCE THE NURSE ENTERED THE ROOM TO ADMINISTER THE CHILD BECAME INSISTANT HE WAS NOT GOING TO TAKE THE SHOTS. More
2823926 45 F VA 01/31/2025 FLU3
HEPA
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 72RF2
T9TL9
LM99N
Underdose; Underdose; Underdose Underdose; Underdose; Underdose
Patient was given a Hep A pediatric dose in error. Was noticed immediately and was given a Hep A adu... Patient was given a Hep A pediatric dose in error. Was noticed immediately and was given a Hep A adult dose. Client was informed of the situation. Client had no complications after or any concerns. Client had no after vaccination complications. More
2823927 3 M MI 01/31/2025 DTAP
UNK
 SANOFI PASTEUR
UNKNOWN MANUFACTURER

Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
Patient showed signs of cellulitis on 01-29-2025 in his left thigh. The affected area was swollen, r... Patient showed signs of cellulitis on 01-29-2025 in his left thigh. The affected area was swollen, red, and warm. The pediatrician prescribed him Prednisolone and Cephalexin. After 1 day of taking the medications his leg did not appear as swollen, although it was still just as red. Today is day 3 of taking the medication and his leg appears much less swollen and red, although it is still slightly swollen and red. More
2823928 7 M MI 01/31/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 BH57H
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse affects noted. Patient should have received TDaP, received DTaP instead. No adverse affects noted. Patient should have received TDaP, received DTaP instead.
2823929 30 M OR 01/31/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3ZH27
Arthralgia, Pain, Product administered at inappropriate site Arthralgia, Pain, Product administered at inappropriate site
Patient reports that the Tdap was given very close the shoulder joint and has had joint pain in that... Patient reports that the Tdap was given very close the shoulder joint and has had joint pain in that shoulder since the vaccine was administered. States that the vaccine was given right below the shoulder joint and he developed a lot of aching into the shoulder but no aching or pain into the deltoid muscle. He has not take anything for the pain does have pain with some shoulder movements. Denies any swelling or discoloration. States that symptoms will wax and wane and that 3 days ago his symptoms were more severe than they are currently. Suspect patient had the Tdap vaccine administered into the subacromial bursa given location of where the vaccine was administered. Discussed that this should continue to resolve with supportive care and encouraged use of anti-inflammatories with ibuprofen or Aleve as well as warm compresses and topical Voltaren gel. More
2823930 2 M KY 01/31/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Medication error- Vaccine was to be given to sister Medication error- Vaccine was to be given to sister
2823931 30 F IN 01/31/2025 TDAP
 SANOFI PASTEUR
 U8274AAF8211312
Injected limb mobility decreased, Pain, Sleep disorder, X-ray limb normal Injected limb mobility decreased, Pain, Sleep disorder, X-ray limb normal
12/25/2024 it was reported that the patient was having a lot of trouble moving her right arm at the ... 12/25/2024 it was reported that the patient was having a lot of trouble moving her right arm at the shoulder. She could not lift arm over her head without a lot of pain. Having a hard time sleeping due to the pain. Recommended to take ibuprofen and alternating ice and heat to the area. 1/2/2025 still experiencing same symptoms. Patient was requested to come back in for an evaluation. Patient was seen on 1/8/2025. Celecoxib 200 mg was prescribed. Seen again in the office on 1/20/2025. Amoxicillin 500 mg, benzonatate 200mg, diclofenac sodium 75mg and lidocaine 5% patch prescribed. Shoulder X-ray ordered and referral to PT was placed. X-ray was unremarkable. More
2823932 4 F KY 01/31/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 T5727
Wrong product administered Wrong product administered
Medication Error- Vaccine was to be given to brother Medication Error- Vaccine was to be given to brother
2823933 78 F AL 01/31/2025 PNC20
 PFIZER\WYETH
 lj5281
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
Vaccination was duplication. Originally given 3/25/22 but did not pull up in pharmacy system or in s... Vaccination was duplication. Originally given 3/25/22 but did not pull up in pharmacy system or in state database so repeated on 1/30/25. Patient denied any adverse effects other than sore arm. More
2823934 93 F WI 01/31/2025 FLU3
 SANOFI PASTEUR
 U8524CA
No adverse event, Wrong product administered No adverse event, Wrong product administered
Gave influenza vaccine by mistake. Was suppose to give pneumonia vaccine. Patient has not experienc... Gave influenza vaccine by mistake. Was suppose to give pneumonia vaccine. Patient has not experienced any adverse symptoms from additional flu vaccine. More
2823935 14 M MI 01/31/2025 MMRV
 MERCK & CO. INC.
 Y013573
Unevaluable event Unevaluable event
None None
2823936 11 M MI 01/31/2025 HPV9
MENB
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Y005835
55N34
NR5DX
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Patient is 11 years old and accidently received MenB vaccine instead of MenACWY vaccine. He does not... Patient is 11 years old and accidently received MenB vaccine instead of MenACWY vaccine. He does not have any medical indication to have it early. More
2823937 71 F OK 01/31/2025 FLU3
PPV
 SANOFI PASTEUR
MERCK & CO. INC.

Fatigue, Feeling cold, Productive cough; Fatigue, Feeling cold, Productive cough Fatigue, Feeling cold, Productive cough; Fatigue, Feeling cold, Productive cough
pt developed a cough and alot of phlegm with drainage coming down causing her to cough. She has been... pt developed a cough and alot of phlegm with drainage coming down causing her to cough. She has been taking OTC meds to dry it up along with a breathing treatment and her inhaler. She is feeling cold and tired today like she needs to go back to bed, but is feeling some better. More
2823938 3 M ME 01/31/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9PT2F
Injection site bruising, Injection site erythema, Injection site pruritus Injection site bruising, Injection site erythema, Injection site pruritus
Patient has red itchy area around the injection site with light bruising. Patient has red itchy area around the injection site with light bruising.
2823939 33 F OH 01/31/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Injected limb mobility decreased, Injection site pain, Magnetic resonance imagin... Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal, Nerve stimulation test normal, Pain; X-ray normal; Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal, Nerve stimulation test normal, Pain; X-ray normal More
Felt immediate pain from the injection point. Noted to the clinician that injection was higher than ... Felt immediate pain from the injection point. Noted to the clinician that injection was higher than normal. Was assured it was normal. Arm was in severe pain for 48 hours, I could not move it more than a few inches. Once initial pain receded there was local pain with most movement. This went on for 2.5 months with requests to my GP for physical therapy referral in November and in December for an ortho appointment for the ongoing pain. I went to physical therapy for a month before going to the Ortho clinic where I was sent for x-rays and MRIs and nerve testing. I am scheduled for a cortisone injection end of January. More
2823940 48 M MD 01/31/2025 PNC20
 PFIZER\WYETH
 IJ5284
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was given Prevnar 20 outside of recommended age with no clinical indication to give it earli... Patient was given Prevnar 20 outside of recommended age with no clinical indication to give it earlier than 50 years old More
2823941 1 F 01/31/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 000000
x026329
x011425
Injection site reaction, Irritability, Rash erythematous, Rash vesicular, Skin l... Injection site reaction, Irritability, Rash erythematous, Rash vesicular, Skin lesion; Injection site reaction, Irritability, Rash erythematous, Rash vesicular, Skin lesion; Injection site reaction, Irritability, Rash erythematous, Rash vesicular, Skin lesion More
fussy with rash mostly localized to right lateral leg, dermatomal in nature, vesicular in different ... fussy with rash mostly localized to right lateral leg, dermatomal in nature, vesicular in different stages with erythematous base. initially thought to be related to HFM outbreak at school, however no lesions on soles or palms. 5-10 mild lesions on trunk, face, right foot. >100 lesions on right lateral leg. Supportive care initially with acetaminophen and ibuprofen and fluids. Now adding acyclovir due to progressive worsening. More
2823942 47 F GA 01/31/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
 945656
945656
Arthralgia, Food poisoning, Injected limb mobility decreased, Injection site pai... Arthralgia, Food poisoning, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities; Sleep disorder More
The vaccine was administered in my right arm (not left as the record states). I felt usual soreness... The vaccine was administered in my right arm (not left as the record states). I felt usual soreness at the injection site that evening and the following day. When I woke up on the morning of 1/18 my arm was hurting and not at the injection site but higher up on my arm. I took ibuprofen, applied ice and BioFreeze. My range of motion was decreased and it was difficult to move my arm, put on clothing, and carry anything. I experienced difficulty sleeping due to the pain. This continued for several days and the pain would transfer to different areas of my upper arm and shoulder. I made a doctor's appointment on 1/23 but I had to cancel due to food poisoning. I continued to do the same treatment, gently massaging and the range of motion improved. The pain lessened as well. The severity of the pain lessened but I am still experiencing pain 17 days later and this is not a reaction I have ever had to receiving a vaccine. I contacted the pharmacy and they advised me to report this and to follow up with my primary care physician. I have an appointment scheduled for 2/7. More
2823943 49 F CA 01/31/2025 COVID19
 JANSSEN
Gait inability, Hemiplegia, Mobility decreased Gait inability, Hemiplegia, Mobility decreased
I got the vaccine at 3:00 p.m. and was partially paralyzed on the left side of my body by 10:00 p.m.... I got the vaccine at 3:00 p.m. and was partially paralyzed on the left side of my body by 10:00 p.m. I could not move and had to call paramedics More
✓ ✓
2823944 25 F CA 01/31/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 3043823
DJ2ZN
Arthralgia, Pain, Pain in extremity; Arthralgia, Pain, Pain in extremity Arthralgia, Pain, Pain in extremity; Arthralgia, Pain, Pain in extremity
Patient had bilateral arm pain initially. Pain improved in left arm but persisted on right arm. Wa... Patient had bilateral arm pain initially. Pain improved in left arm but persisted on right arm. Was seen in clinic and though to have normal post-vaccine pain but seen again on 1/30/25 and still having pain in arm/shoulder with movement. More
2823945 14 M TX 01/31/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FC3183
FC3183
Audiogram, Deafness neurosensory, Deafness unilateral, Dizziness, Ear pain; Head... Audiogram, Deafness neurosensory, Deafness unilateral, Dizziness, Ear pain; Headache, Magnetic resonance imaging head, Nausea, Tympanometry, Vestibular function test abnormal More
Right Ear pain, headache, dizzyness, Nausea, and loss of hearing. Right Ear pain, headache, dizzyness, Nausea, and loss of hearing.
✓
2823946 43 M KS 01/31/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 Y5XYT
Inappropriate schedule of product administration Inappropriate schedule of product administration
3rd dose of the Hep B series was given too early. It is recommended to be given 8 weeks after the 2n... 3rd dose of the Hep B series was given too early. It is recommended to be given 8 weeks after the 2nd dose and it was given 5 weeks after the 2nd dose. This requires the patient to be re-vaccinated in 8 weeks after the last given vaccine. More
2823947 78 F NY 01/31/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00613
Death Death
Patient was seen at our clinic on 1/28/25 for a rabies booster shot due to a raccoon bite. She was s... Patient was seen at our clinic on 1/28/25 for a rabies booster shot due to a raccoon bite. She was scheduled to return 1/31/25 for day 3. She only needed rabies boosters due to having had the pre-exposure series. She works at a center. On Jan 30th, 2025 patient was found deceased in her home. She was alone. Cause of death is being investigated. More
✓
2823948 1.25 F SC 01/31/2025 DTAP
FLU3
HEPA
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 9KB9G
UT8434MA
DN273
X017448
LG5578
Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
Redness, swelling and warmth noted to all injection sites- worse being the injection sites on the ri... Redness, swelling and warmth noted to all injection sites- worse being the injection sites on the right thigh- FLU, PCV 20 and HIB. Parents giving ibuprofen- encouraged to continue with NSAIDS and warm compresses/baths. Can consider antihistamine (Zyrtec 2.5 ml once daily). TO go to the ER with worsening redness, swelling or onset of fever. More
2823949 83 F SC 01/31/2025 RSV
 PFIZER\WYETH
 ln5487
Extra dose administered, No adverse event Extra dose administered, No adverse event
There was no adverse event. Patient was given Arexvy on 1/26/24 and Abrysvo on 10/10/24 so received ... There was no adverse event. Patient was given Arexvy on 1/26/24 and Abrysvo on 10/10/24 so received an additional RSV vaccination when not needed/recommended. More
2823950 3 M WA 01/31/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FT9142
FT9142
FT9142
FT9142
FT9142
FT9142
FT9142
Abnormal weight gain, Apnoea, Arthralgia, Balance disorder, COVID-19; Central ne... Abnormal weight gain, Apnoea, Arthralgia, Balance disorder, COVID-19; Central nervous system neuroblastoma, Dysarthria, Dyskinesia, Eye movement disorder, Facial paralysis; Fatigue, Fine motor skill dysfunction, Gait disturbance, Hypercapnia, Hypothermia; Hypovolaemic shock, Intensive care, Magnetic resonance imaging abnormal, Magnetic resonance imaging head normal, Mechanical ventilation; Mental status changes, Mood altered, Neoplasm, Neurological symptom, Pneumonia aspiration; Posture abnormal, ROHHAD syndrome, Rash, Respiratory failure, SARS-CoV-2 antibody test positive; SARS-CoV-2 test positive, Serum sickness, Slow speech, Somnolence More
On 7/5/22, this then 3-year 3-month-old previously healthy male received his first Pfizer CoVID-19 v... On 7/5/22, this then 3-year 3-month-old previously healthy male received his first Pfizer CoVID-19 vaccine; he was also prescribed oral amoxicillin x 14 days for sinusitis. After some 9 days of antibiotic, he developed rash, joint pain and fatigue. On 7/14/22, he was diagnosed with serum sickness. After six weeks of intermittent courses of prednisone, his condition improved. Family met with an allergist, who discussed patient with allergy colleagues. Per parents, the allergists assessed amoxicillin as the culprit with 95% likelihood, and CoVID vaccine as 5% likelihood, and suggested that only rechallenge with one or the other could confirm which. They declined rechallenge at this time. On 4/6/23 (at age 4), he received DtaP, IPV, MMR and live varicella vaccines. After this, parents report, he experienced return of joint pain, which was more frequent, more severe and more long-lasting. Also starting in April 2023, he began to gain weight, 8 lbs in 8 weeks, up to 98th percentile for age. Lab workup revealed beta-thalassemia. In June 2023, his joint pains returned (unable to walk to the mailbox) and he developed fatigue. In July 2023, his symptoms stabilized. In August 2023, patient and his older brother attended daytime summer camp where they were exposed to CoVID-19. Then 8/21/23, during a family trip, family developed symptoms of CoVID-19 infection. Patient however also developed neurologic signs/symptoms, including eyes rolling back and involuntary head bobbing. After developing droopy eyes and fatigue, he was admitted to Hospital on 8/25/23, where MRI brain was unrevealing, but CoVID-19 testing of upper respiratory tract specimen was positive by PCR. He was discharged after 2 days. In September 2023, he experienced progressive neurologic decline consisting of abnormal eye movements and head movements, progressively slow/garbled speech, balance issues, a change in affect, and regression of fine and gross motor skills. Mother reached out to hospital Immunology to inquire about possible long CoVID as a sequela of his initial CoVID-19 vaccine, and triggered subsequently by his 4-year-old vaccines and then by his CoVID-19 infection, requesting that his CoVID-19 spike protein antibody levels be tested (see January 2024 events below). On 9/19/23, parents noted worsening sleepiness and hypothermia, and he was admitted to Hospital. During the subsequent 3-month hospitalization, he had 3 stints in the intensive care unit, for workup of autonomic dysregulation; management of hypernatremia, altered mental status and respiratory failure during MRI; and management of hypovolemic shock with altered mental status, respectively. He underwent extensive diagnostic testing of the central nervous system and endocrine system, particularly the hypothalamic-pituitary-adrenal axis. He received immunomodulatory treatments for presumed inflammatory process, including methylprednisolone, intravenous immune globulins, and Anakinra. He was discharged from the hospital 12/14/23 with a nasogastric tube and positive airway pressure ventilatory support at night, with a clinical impression of ROHHAD (rapid-onset obesity, hypothalamic dysfunction, hypoventilation, and autonomic dysregulation) syndrome, a condition with known association with paraneoplastic autoimmune encephalitis secondary to neuro-endocrine tumors. On 1/11/24, he was admitted again to Hospital with acute-on-chronic hypoxemic and hypercarbic respiratory failure requiring mechanical ventilation due to disordered breathing and severe apnea. Because of a strong published association of ROHHAD with neuro-endocrine tumors, his previous central nervous system imaging was reviewed, MRI repeated, and a suspicious para-spinous tumor identified. On 2/2/24, he underwent resection of the mass, which was identified as neuroblastoma, and susbsequently received high-dose cyclophosphamide. During January 2024, he received ampicillin-sulbactam and amoxicillin-clavulanate as treatment for suspected aspiration pneumonia, without any adverse effects; parents consider that amoxicillin was thus eliminated as cause of initial serum sickness, leaving CoVID-19 vaccine as culprit. On 1/22/24, he underwent CoVID-19 antibody testing: spike IgG Ab positive, nucleocapsid IgG Ab negative, consistent with vaccine exposure but not infection. He remained hospitalized for 11 months, was discharged in December 2024, and readmitted in January 2025. More
2823951 77 F AZ 01/31/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 388485
388485
Chest pain, Death, Polyarteritis nodosa, Pyrexia, Refusal of treatment by patien... Chest pain, Death, Polyarteritis nodosa, Pyrexia, Refusal of treatment by patient; Renal disorder, Skin lesion More
Patient's husband reported that patient received a dose of Fluad on 11/1/2024 and was hospitali... Patient's husband reported that patient received a dose of Fluad on 11/1/2024 and was hospitalized on 11/17/2024 at Clinic until she passed away on 12/10/2024. Patient's symptoms at time of hospitalization included fevers, skin lesions on arms/legs, and chest pain. During the course of her hospitalization, she was diagnosed with poylarteritis nodosa, a rare form of vasculitis, with renal involvement. At some point during the hospitalization, she refused intubation. According to the patient's husband, the doctor suspected that the influenza vaccination she received may have affected her immune system and eventually led to the previously described series of events. More
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2823952 62 F FL 01/31/2025 PNC20
 PFIZER\WYETH
 LC5482
Rash Rash
rash rash
2823954 16 F FL 01/31/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Y010656
ZH7SN
EK7D6
Blood glucose normal, Pallor; Blood glucose normal, Pallor; Blood glucose normal... Blood glucose normal, Pallor; Blood glucose normal, Pallor; Blood glucose normal, Pallor More
Pt here today for 16 year old well child. She received menveo, bexsero, and gardasil. After vaccines... Pt here today for 16 year old well child. She received menveo, bexsero, and gardasil. After vaccines were administered pt began to turn pale and closed her eyes and this medical assistant helped position pt to lie down so pt wouldn?t hurt herself. As soon as pt was lied down pt immediate asked ?what happened?? After providing verbal reassurance pt was instructed to remain lying down and her vitals were as followed: Bp100/60, 76 HR, 18 RR, 98% O2, 83 fasting blood sugar. Pt was also evaluated by aprn after vitals were obtained.After 30 minutes pt was A&Ox4 and reported feel better and wanting to go home. Pt was then discharged. More
2823955 F RI 01/31/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U7947AA
LC5483
HP495
Dyskinesia, Electroencephalogram normal, Muscle spasms, Respiratory viral panel,... Dyskinesia, Electroencephalogram normal, Muscle spasms, Respiratory viral panel, Rotavirus test positive; Dyskinesia, Electroencephalogram normal, Muscle spasms, Respiratory viral panel, Rotavirus test positive; Dyskinesia, Electroencephalogram normal, Muscle spasms, Respiratory viral panel, Rotavirus test positive More
On 1/18 patient was noted to have several episodes of abnormal movements that appeared like spasms i... On 1/18 patient was noted to have several episodes of abnormal movements that appeared like spasms including brief flexion of her head and upper extremities which lasted few seconds and repeated for few minutes, after which she returned to baseline. Patient was evaluated at Hospital ED and admitted for EEG and neurological evaluation. Patient has not had any additional episodes of abnormal movement. EEG was normal and neurological evaluation was normal. After discussion with neurology team, it was concluded that the abnormal movement episode was and isolated event and likely not related to immunizations received the day prior. Patient has been well since the hospitalization. More
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2823956 66 F CO 01/31/2025 PNC20
 PFIZER\WYETH
 LG5576
Arthralgia, Injection site pain, Musculoskeletal pain Arthralgia, Injection site pain, Musculoskeletal pain
Patient reports pain in her left shoulder where her injection site of the pneumonia vaccine was give... Patient reports pain in her left shoulder where her injection site of the pneumonia vaccine was given on 1/24/25. She stated that the pain had gotten worse and then was in her left shoulder blade area 1-2 days later. She reports that her shoulder blade pain has subsided but her injection site, deltoid area that extends to her "shoulder joint" area is still hurting. She states that there is no bruising but "it feels like it is bruised. More
2823957 U PA 01/31/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 LN4P2
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received Arexvy vaccine on 1/28/25. Unbeknownst to staff, the patient had already received ... Patient received Arexvy vaccine on 1/28/25. Unbeknownst to staff, the patient had already received Abrysvo vaccine on 1/4/24. We asked patient if she had received an RSV vaccine in the past and she said no. Our system did not catch the duplicate immunizations at verification and record. No adverse events reported, we are just filing report since the 2 rsv shots in 2 consecutive years is currently outside guidelines. More
2823958 75 M PA 01/31/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 LN4P2
Extra dose administered Extra dose administered
Patient received Arexvy vaccine on 1/28/25. Unbeknownst to staff, the patient had already received ... Patient received Arexvy vaccine on 1/28/25. Unbeknownst to staff, the patient had already received Abrysvo vaccine on 1/4/24. We asked patient if she had received an RSV vaccine in the past and she said no. Our system did not catch the duplicate immunizations at verification and record. No adverse events reported, we are just filing report since the 2 rsv shots in 2 consecutive years is currently outside guidelines. More
2823965 1.58 M TX 01/31/2025 DTAPIPVHIB
HEPA
 SANOFI PASTEUR
MERCK & CO. INC.
Y007585
Urticaria; Urticaria Urticaria; Urticaria
a patient experienced hives 2 days after being administered VAQTA (first dose in series) concomitant... a patient experienced hives 2 days after being administered VAQTA (first dose in series) concomitantly with PENTACEL.; This spontaneous report was received from Physician and refers to a 19-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included prophylaxis. Concomitant therapies were not reported. On 07-JAN-2025, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #Y007585, expiration date reported as 12-MAR-2025, but upon internal validations was established as 31-OCT-2025 (strength, and route of administration were not provided) in his right leg; and diphtheria vaccine toxoid, hib vaccine conj (tet tox) and with the third dose of pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), (strength, formulation, lot #, expiry date, and route of administration were not provided). On 09-JAN-2025 after 2 days of vaccination, the patient experienced a boke out in hive all over his body and scalp. At the time of reporting, the patient was recovering from the event. The reporter considered event to be related to hepatitis a vaccine, inactivated (VAQTA). More
2823966 U IL 01/31/2025 MMRV
 MERCK & CO. INC.
 Y013574
No adverse event, Product storage error No adverse event, Product storage error
The HCP reports that PROQUAD was inadvertently administered after suffering from a Temperature Excur... The HCP reports that PROQUAD was inadvertently administered after suffering from a Temperature Excursion. No symptomatic adverse events were reported.; The HCP reports that PROQUAD was inadvertently administered after suffering from a Temperature Excursion. No symptomatic adverse events were reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) (used to reconstitute the vaccine lot# and expiration date unknown). On 13-DEC-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml/ series, lot #Y013574 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as: 03-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided). Operator of device was health professional. The diluent used to reconstitute the vaccine lot# and expiration date unknown. The HCP reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was inadvertently administered after suffering from a temperature excursion (Product storage error). The current information available was that the product reached 11.6c and was out of range for 3 hours 5 minutes 0 seconds, but previous excursions could not be confirmed. Previous excursions could not be confirmed. No symptomatic adverse events were reported (No adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2501USA008885: US-009507513-2501USA008877: More
2823967 18 U MD 01/31/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013582
y013347
Incorrect dose administered, No adverse event, Product administered to patient o... Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age; Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age More
No additional AEs were reported.; Healthcare worker reported that a 18 years old patient received VA... No additional AEs were reported.; Healthcare worker reported that a 18 years old patient received VARIVAX and PROQUAD together on the same day on 1/22/2025.; Healthcare worker reported that a 18 years old patient received PROQUAD; This spontaneous report was received from other health professional and refers to 18-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 22-JAN-2025, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose description reported as 1 dose), administered as prophylaxis (Lot No. y013347 has been verified to be a valid lot number for [varicella virus vaccine live (oka/merck)], expiration date reported and upon internal validation established as 02-AUG-2026) (strength, dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided); together with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA[recombinant human albumin]) (PROQUAD) injection dose description reported as 1 dose, administered as prophylaxis (Lot No. Y013582 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 03-FEB-2026) (strength, dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) (overdose)(product administered to patient of inappropriate age) No additional adverse event was reported (no adverse event) More
2823968 U LA 01/31/2025 HPV9
 MERCK & CO. INC.
 X004375
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Customer calling to report that an expired dose of GARDASIL 9 was administered. Do... No additional AE; Customer calling to report that an expired dose of GARDASIL 9 was administered. Dose administered 1/28/2025, dose expired 1/2/2025. Vaccine did not experience temperature excursion. No additional AE, no PQC. No additional information.; This spontaneous report was received from and administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JAN-2025, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X004375, expiration date: 02-JAN-2025 (Expired product administered), administered for prophylaxis (dose, route of administration and anatomical location were not provided).Vaccine did not experience temperature excursion. No additional AE, noPQC. No additional information. More
2823969 5 U NY 01/31/2025 MMRV
 MERCK & CO. INC.
 X019302
Expired product administered, No adverse event Expired product administered, No adverse event
no additional adverse event was reported; expired vaccine administered to a patient; This spontaneou... no additional adverse event was reported; expired vaccine administered to a patient; This spontaneous report was received from physician and refers to a 5-year-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown). On 29-JAN-2025, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #X019302, expiration date: 14-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported. More
2823970 U WA 01/31/2025 HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.
 W008704
W022795
Injection site erythema, Injection site induration, Nausea, Pyrexia; Injection s... Injection site erythema, Injection site induration, Nausea, Pyrexia; Injection site erythema, Injection site induration, Nausea, Pyrexia More
Patient had fever; nausea; localized erythmea at injection site that was very red and hard; localize... Patient had fever; nausea; localized erythmea at injection site that was very red and hard; localized erythmea at injection site that was very red and hard; Child was administered RECOMBIVAX HB on 1/31/2023 and 8/08/2023; This spontaneous report has been received from a nurse regarding a child of unknown age and gender. Historical vaccines included hepatitis b vaccine rhbsag (yeast) (ENGERIX). Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 31-JAN-2023, the patient was vaccinated with second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), intramuscular injection, 5 per 0.5 micrograms per milliliter for prophylaxis, lot number W008704 which has been verified to be valid, expiration date not reported but upon internal review established as 18-NOV-2024 (dose, route of administration and anatomical site not provided). Subsequently, on 08-AUG-2023 the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), intramuscular injection, 5 per 0.5 micrograms per milliliter for prophylaxis, lot number W022795 which has been verified to be valid, expiration date not reported but upon internal review established as 19-MAY-2025 (dose, route of administration and anatomical site not provided). (Inappropriate schedule of vaccine administered) On an unspecified date, the patient experienced fever, nausea, localized erythema at injection site that was very red and hard (vaccination site erythema) (vaccination site induration). The reporter stated that it took 3 weeks to go away. However, the reporter did not confirm if the adverse event occurred at both of administered dates and refused to provide any additional information. The outcome of the events was unknown. The causal relationship between the suspect vaccines and the events was unknown. More
2823971 F 01/31/2025 HPV9
 MERCK & CO. INC.
Incomplete course of vaccination Incomplete course of vaccination
Consumer called to report they received their first dose of GARDASIL 9 on 03/22/2024 and did not ret... Consumer called to report they received their first dose of GARDASIL 9 on 03/22/2024 and did not return for their second dose until today, 01/29/2025.; No additional AE; This spontaneous report was received from a female patient of unknown age. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided. On 22-MAR-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided) and came out on 29-JAN-2025, for their second dose, however the health care professional was unsure if the vaccine schedule needed to be repeated entirely or to continue and administer the second dose. No side effects or symptoms reported. More
2823972 1.25 U IA 01/31/2025 DTAPIPVHIB
MMR
UNK
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
UNKNOWN MANUFACTURER
MERCK & CO. INC.
Y007615

Y011020
Extra dose administered, No adverse event, Product preparation error; Extra dose... Extra dose administered, No adverse event, Product preparation error; Extra dose administered, No adverse event, Product preparation error; Extra dose administered, No adverse event, Product preparation error; Extra dose administered, No adverse event, Product preparation error More
No other AE; Medical assistant calling to report an adverse event. Caller reporting the facility in... No other AE; Medical assistant calling to report an adverse event. Caller reporting the facility inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the; Medical assistant calling to report an adverse event. Caller reporting the facility inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the; VAXELIS Vaccine/also administered the PENTACEL Vaccine; This spontaneous report was received from a medical assistant referred to a 15 month old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 27-JAN-2025, the facility inadvertently reconstituted both the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin(rHA) (M-M-R II) (lot # Y007615, expiration date 11-APR-2026; strength, dose, route were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # Y011020, expiration date 18-JUN-2026; strength, dose, route were not reported) vaccines with the diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS) (lot # U7921AA, expiration date 31-OCT-2026; strength, dose, route were not reported) instead of the STERILE DILUENT (strength, dose, route, lot #, expiration date were not reported) (product preparation error). The patient received both vaccines on the same day (wrong product administered). This patient was also administered the diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(PENTACEL) (lot # UK167AA, expiration date 31-OCT-2025; strength, dose, route were not reported)on the same day (accidental overdose). No adverse event was reported. Additional information is not expected. More
2823973 59 F MO 01/31/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 3L620Z
Eye pruritus, Hypersensitivity, Lacrimation increased, Swelling, Upper-airway co... Eye pruritus, Hypersensitivity, Lacrimation increased, Swelling, Upper-airway cough syndrome More
Hospitalisation; Hypersensitivity; Eye pruritus; Lacri mation increased; Upper-airway cough syndrome... Hospitalisation; Hypersensitivity; Eye pruritus; Lacri mation increased; Upper-airway cough syndrome; Swelling; This serious case was reported by a consumer via other manufacturer and described the occurrence of hospitalization in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3L620Z, expiry date 31-OCT-2026) for prophylaxis. Co-suspect products included dupilumab for prophylaxis. Concurrent medical conditions included asthma, allergy (At the time of event, the patient had ongoing allergy) and drug allergy (penicillin vk 500 mg tablet). Concomitant products included semaglutide. On an unknown date, the patient received Arexvy and dupilumab (subcutaneous) 300 mg. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hospitalization (Verbatim: Hospitalisation) (serious criteria hospitalization), allergy (Verbatim: Hypersensitivity), eye pruritus (Verbatim: Eye pruritus), watering eyes (Verbatim: Lacri mation increased), upper-airway cough syndrome (Verbatim: Upper-airway cough syndrome) and swelling (Verbatim: Swelling). The patient was treated with ibuprofen. Dupilumab was discontinued. The outcome of the hospitalization, allergy and swelling were unknown and the outcome of the eye pruritus, watering eyes and upper-airway cough syndrome were not reported. It was unknown if the reporter considered the hospitalization, allergy, eye pruritus, watering eyes, upper-airway cough syndrome and swelling to be related to Arexvy. The company considered the hospitalization to be unrelated to Arexvy. It was unknown if the company considered the allergy, eye pruritus, watering eyes, upper-airway cough syndrome and swelling to be related to Arexvy. Additional Information: GSK Receipt Date: 16-JAN-2025 Initial information received on 01-May-2023 regarding an unsolicited valid serious case received from Patient. This case involved a 61 years old female patient who was hospitalized and had allergy symptoms and swelling while being treated with Dupilumab [Dupixent] delivered via pre-filled syringe and Respiratory Syncytial Virus (RSV) vaccine prot. subunit PreF3 [Arexvy]. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing allergy: penicillin vk 500 mg tablet (Drug hypersensitivity). It was unknown if the patient had any additional medical history, concomitant disease or risk factor. Concomitant medications included semaglutide ( wegovy). On an unknown date, the patient started taking Dupilumab Solution for injection at dose of 300 mg QO W subcutaneous (strength: 300mg/2ml for severe persistent asthma uncomplicated via pre-filled syringe. On an unknown date on 15-December, the patient start taking Arexvy (RSV vaccine prot. subunit PreF3) (Unknown dosage, unknown: formulation, strength, frequency, route and indication). Patient reported she was experienced allergy (hypersensitivity) (onset date and latency unknown) symptoms-itchy watery eyes (eye pruritus) (lacrim ation increased) and drainage in her throat (Upper-airway cough syndrome) (onset date and latency unknown). no head congestion. Also mentioned she was hospitalized last year (hospitalization) (onset date: 2022) (unknown latency) (Batch number: 3L620Z and expiry date: 31-Oct-2026). Patient missed a dose due to being at (in) hospital. Patient reported swelling (onset: unknown, latency: unknown) (Batch number: 3L620Z and expiry date: 31-Oct-2026) after receiving the respiratory syncytial virus vaccine, arexvy, on 15-December. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was unknown if the reporter considered the hospitalization, allergy, eye pruritus, watering eyes, upper-airway cough syndrome and swelling to be related to Dupilumab.; Sender's Comments: Hospitalisation is an unlisted event which is considered unrelated to GSK drug Arexvy. More
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2823975 F 01/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Influenza like illness, Rash Herpes zoster, Influenza like illness, Rash
Sick like flu; Developed shingle like rash on my torso; This non-serious case was reported by a cons... Sick like flu; Developed shingle like rash on my torso; This non-serious case was reported by a consumer and described the occurrence of influenza like illness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza like illness (Verbatim: Sick like flu) and vesicular rash (Verbatim: Developed shingle like rash on my torso). The outcome of the influenza like illness was unknown and the outcome of the vesicular rash was not resolved. It was unknown if the reporter considered the influenza like illness and vesicular rash to be related to Shingrix. It was unknown if the company considered the influenza like illness and vesicular rash to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JAN-2025 The symptoms were not treated. The reporter did not consented to follow up. More
2823976 59 F FL 01/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Condition aggravated, Dermatitis atopic Condition aggravated, Dermatitis atopic
flare up of symptoms since taking shingrix vaccine; fl are up of sy mptoms over the past month; This... flare up of symptoms since taking shingrix vaccine; fl are up of sy mptoms over the past month; This non-serious case was reported by a physician via other manufacturer and described the occurrence of atopic dermatitis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included dupilumab (Dupixent) solution for injection for atopic dermatitis. On an unknown date, the patient received Shingrix. On 27-APR-2020, the patient started Dupixent (subcutaneous). On 02-OCT-2024, an unknown time after receiving Shingrix, the patient experienced atopic dermatitis (Verbatim: flare up of symptoms over the past month). On an unknown date, the patient experienced atopic dermatitis (Verbatim: flare up of symptoms since taking shingrix vaccine). The action taken with Dupixent was unknown. The outcome of the atopic dermatitis and atopic dermatitis were unknown. It was unknown if the reporter considered the atopic dermatitis and atopic dermatitis to be related to Shingrix. It was unknown if the company considered the atopic dermatitis and atopic dermatitis to be related to Shingrix. Additional Information: GSK receipt date: 03-JAN-2025 Patient had flare up of symptoms since taking Shingrix vaccine and flare up of symptoms over the past month while she was treated with Dupilumab. The patient's past medical history, concomitant, Vaccination and fam ily history were not provided. On 27-Apr-2020, the patient started taking Dupilumab solution for injection (strength: 300mg/2mL). at a dose of 300 mg QO W subcutaneously for other atopic dermatitis. It was reported that a flare up of symptoms over the past month. Patient reported they usually get a flare up when she travels nights because of sheets or she catches something. Patient stated Dupilumab is working well for them. Corrective treatment were not reported for both events. Reported outcome were unknown for both events. More
2823977 6 F 01/31/2025 TDAP
 UNKNOWN MANUFACTURER
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Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 7 year old girl had taken DT vaccine at age 6; This non-serious case was reported by a consumer vi... A 7 year old girl had taken DT vaccine at age 6; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, an unknown time after receiving dTpa vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: A 7 year old girl had taken DT vaccine at age 6). The outcome of the inappropriate age at vaccine administration was unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that the 7 year old patient had taken DT vaccine at age 6 which led to inappropriate age at vaccine administration. The reporter asked was it allowed for this patient to take a boost Dtap Boostrix 6 months after her last dose. More
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