🏥 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 💀 🏥 🚑 ♿ ⚠️
2849282 5 F NC 07/10/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB
Injection site discomfort, Injection site erythema, Injection site pruritus Injection site discomfort, Injection site erythema, Injection site pruritus
One day after shot was given (patient also received proquad on the right thigh and had no issues), p... One day after shot was given (patient also received proquad on the right thigh and had no issues), patient developed itching and redness on her anterior left thigh. There was discomfort and the redness increased in size to extend from her leg crease to just above her knee. More
2849283 58 F 07/10/2025 PNC21
PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y019158
Y019158
Y019158
Y019158
Injection site erythema, Injection site reaction, Urticaria; Fatigue, Injection ... Injection site erythema, Injection site reaction, Urticaria; Fatigue, Injection site pain, Injection site reaction, Injection site swelling, Urticaria; Injection site erythema, Injection site reaction, Urticaria; Fatigue, Injection site pain, Injection site reaction, Injection site swelling, Urticaria More
Large raised red welt approx 2x4 inches centered on injection site, additional 1 inch diameter welt ... Large raised red welt approx 2x4 inches centered on injection site, additional 1 inch diameter welt above armpit on same side as injection More
2849284 55 M 07/10/2025 PNC21
 MERCK & CO. INC.
 Y019158
Fatigue, Lymphadenopathy, Rash, Rash papular, Tenderness Fatigue, Lymphadenopathy, Rash, Rash papular, Tenderness
fatigue, swollen lymph node, raised tender rash under axilla on injection side fatigue, swollen lymph node, raised tender rash under axilla on injection side
2849285 1.42 M CA 07/10/2025 DTAPHEPBIP
DTAPHEPBIP
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.



Hot flush, Irritability, Mental status changes, Seizure, Streptococcus test nega... Hot flush, Irritability, Mental status changes, Seizure, Streptococcus test negative; Urine analysis normal; Hot flush, Irritability, Mental status changes, Seizure, Streptococcus test negative; Urine analysis normal More
At 10:30 on Saturday June 21st, patient went into a full seizure and did not come back to himself un... At 10:30 on Saturday June 21st, patient went into a full seizure and did not come back to himself until 4 hours later. Patient ate breakfast and played fine that morning, he was fussy and a little flush before the seizure but did not have a fever from the thermometer I used. More
2849286 13 M NY 07/10/2025 MNQ
 SANOFI PASTEUR
Fatigue, Headache, Lethargy Fatigue, Headache, Lethargy
Extreme lethargy, severe headaches for several days, intense fatigue. Extreme lethargy, severe headaches for several days, intense fatigue.
2849287 52 F VT 07/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74NC9
Headache, Lymphadenopathy, Pyrexia Headache, Lymphadenopathy, Pyrexia
Patient reported on 7/7/25 stating she had a swollen gland under her left armpit, fever x2days, an... Patient reported on 7/7/25 stating she had a swollen gland under her left armpit, fever x2days, and a headache x3days. Not aware of a treatment. PCP was made aware and we marked her chart being allergic to the vaccine. We called her back 7/8/25 and the pt stated she was better. More
2849288 6 F 07/10/2025 DTAPIPVHIB
HEPA
MMR
VARCEL
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 UK109AA
L4EA4
Y004114
X021280
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; No adverse event, Product administered to patient of inappropriate age More
No adverse event occurred No adverse event occurred
2849289 61 F CT 07/10/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 MF0425
MF0425
Injection site erythema, Injection site pain, Injection site reaction, Injection... Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Sleep disorder; Vaccination site cellulitis More
Injection site reaction - Persistent pain and swelling at the site of recent pneumococcal vaccinatio... Injection site reaction - Persistent pain and swelling at the site of recent pneumococcal vaccination - Onset of new redness and increased swelling yesterday - Pain is constant and severe, disrupting sleep - Tylenol provides no relief of symptoms - No similar reactions to previous vaccinations Cellulitis Cellulitis at vaccination site, likely bacterial. Bactrim chosen due to penicillin allergy and stomach upset history. - Prescribe Bactrim DS (sulfamethoxazole and trimethoprim) for 14 days, minimum 7 days. - Advise Bactrim twice daily with food. - Prescribe Zofran (ondansetron) 4 mg as needed for nausea. - Recommend dietary prebiotics and probiotics. - Prescribe naproxen for pain and inflammation, advise with food. - Outline redness with skin pen for monitoring. - Schedule follow-up in 7 days. - Instruct to return if no improvement by Wednesday. More
2849290 46 M AZ 07/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 X449Y
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Patient presents for follow-up on labs and to discuss pain and swelling at the injection site from a... Patient presents for follow-up on labs and to discuss pain and swelling at the injection site from a tetanus vaccine administered 2 days ago. The patient has a history of type 2 diabetes with hyperglycemia. Patient reports developing pain and localized swelling at the injection site with redness following the tetanus vaccination. He suspects he might have a low-grade fever but denies any rashes or hives. The patient describes the symptoms as mild at this time. He has not experienced any signs of cellulitis. There is localized edema near the injection site and pain to palpation. More
2849291 2 M UT 07/10/2025 MMR
 MERCK & CO. INC.
 Y020516
Abnormal behaviour, Bruxism, Gait disturbance, Self-destructive behaviour Abnormal behaviour, Bruxism, Gait disturbance, Self-destructive behaviour
About two weeks after receiving his MMR. Parents observed an overnight change where he started self-... About two weeks after receiving his MMR. Parents observed an overnight change where he started self-stimming pretty heavily. Palms to ears while vocalizing and beating hands against ears, fidgeting with his ears, repetitive phrases, jaw clenching with lateral shifting, fingers flicking, escalating quickly within the first week. He was distracted by the stimming that they couldn't get his attention, he became very aware of sounds in general. He became preoccupied with lining up dominos, not anything he did before. He is reactive to fatigue, excitement and upset, started toe walking, he got more physical by ramming head into moms body and responding to deep pressure. More
2849292 4 M TX 07/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 H3N97
Product prescribing error Product prescribing error
Provider erroneously ordered Havrix instead of Kinrix Provider erroneously ordered Havrix instead of Kinrix
2849293 11 F 07/10/2025 MNQ
 SANOFI PASTEUR
 u8573aa
Urticaria Urticaria
Hives all over the body on the same day of vaccine administered. Hives all over the body on the same day of vaccine administered.
2849294 23 F OH 07/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 XS27B
Expired product administered Expired product administered
Vaccine was expired by 2 months Vaccine was expired by 2 months
2849295 4 F TX 07/10/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 414154
Y019176
Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness
patient left fine from clinic with no symptoms or reaction on 7/7/2025. Mom states 24 hours after va... patient left fine from clinic with no symptoms or reaction on 7/7/2025. Mom states 24 hours after vaccine was given patient had redness, tenderness to area and also said it was warm to touch. More
2849296 12 F MI 07/10/2025 MENB
 PFIZER\WYETH
 GH4067
Wrong product administered Wrong product administered
Patients mother called, stated patient was given the incorrect vaccine. When the mother turned in t... Patients mother called, stated patient was given the incorrect vaccine. When the mother turned in the MCIR to the school they noticed MenB was given to the patient but Men Conjug should have been given. I told the mother i would look into this and call her back. I verified doctor entered the order in the chart as Men Conjug however, MenB lot# GH4067 was charted as given 7/1/2025. MenB was also on the MCIR as given 7/1/2025. I verified the counts for MenB and Men Conjug were correct (in fridge and MCIR). I notified doctor. Doctor asked me to call the health department for clarification on adverse reactions and to call. I spoke to someone at the Health Dept. She stated no harm will come from giving the MenB vaccine early. This will not count toward her future MenB dose when she is old enough to get it. She also stated patient could receive the Men Conjug anytime. No waiting period. I did report all information back to doctor and other. Mother was contacted and appt was made for 7/15/25 to give Men Conjug to the patient. More
2849297 9 M MN 07/10/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 77J49
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
PT EXCEED AGE LIMIT FOR PEDIARIX, PT TOLERATED VACCINE WELL WITH NO REACTION TO VACCINE. PT'S P... PT EXCEED AGE LIMIT FOR PEDIARIX, PT TOLERATED VACCINE WELL WITH NO REACTION TO VACCINE. PT'S PARENT CALLED AND INFORMED WILL NEED TO RETURN TO CLINIC TO RECEIVED CORRECT VACCINE. More
2849298 17 F IA 07/10/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4n222
Product preparation issue Product preparation issue
Vaccine was not reconstituted and patient only received the diluent. Adverse advent=no virus protect... Vaccine was not reconstituted and patient only received the diluent. Adverse advent=no virus protection More
2849299 10 F MI 07/10/2025 MMRV
 MERCK & CO. INC.
 Y017204
Unevaluable event Unevaluable event
NO SIGNS OR SYMPTOME POST THE VACCINE, WE CALL THE MOTHER TO CHECK AT HER TODAY. NO SIGNS OR SYMPTOME POST THE VACCINE, WE CALL THE MOTHER TO CHECK AT HER TODAY.
2849300 0.33 M MT 07/10/2025 RV5
 MERCK & CO. INC.
 2117044
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pt received 1st dose of Rotavirus at age 4 months, but was aged out of the first dose already when h... Pt received 1st dose of Rotavirus at age 4 months, but was aged out of the first dose already when he received it. More
2849301 1 F GA 07/10/2025 HIBV
 SANOFI PASTEUR
 UK148AA
Body temperature increased, Decreased appetite, Dyspnoea, Pallor Body temperature increased, Decreased appetite, Dyspnoea, Pallor
Elevated temperature under 100.4, lethargy, labored breathing, pallor, and decreased appetite. Elevated temperature under 100.4, lethargy, labored breathing, pallor, and decreased appetite.
2849302 69 F CA 07/10/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LN4928
793PT
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Swelling R arm x yesterday 7/9/25. Had got PCV 20 & Tdap 7/3/25 stated was fine then some swelli... Swelling R arm x yesterday 7/9/25. Had got PCV 20 & Tdap 7/3/25 stated was fine then some swelling yesterday and more today. Mild red, mild itching no f/c/s no sob no pain no malaise no previous reaction More
2849303 56 M IL 07/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 42DM9
Underdose Underdose
I made a mistake and administered the pediatric/adolescent Havrix instead of the adult Havrix. When ... I made a mistake and administered the pediatric/adolescent Havrix instead of the adult Havrix. When I realized that I had made the mistake, I immediately notified my supervisor, (name withheld) R.N., and our Physician Assistant, (name withheld). They looked at Ask the Experts from the immunize.org for the remedy to the error and it was decided that we needed to call the patients (name withheld and his wife, name withheld DOB 10/XX/19XX, were both receiving travel vaccinations for a trip to (withheld). I will also be submitting a VAERS report for her because the same mistake was made with her Hep A vaccination) to have them return on the same day for a second dose of the pediatric/adolescent Havrix to complete the first dose of the Hep A series. They returned around 3:30pm and both patients were given a second dose of the pediatirc/adolescent Havrix. The intramuscular injections were given in the same arm. The same lot number was used. I gave them a reminder to make an appointment on or after 1/9/26 for the second Hep A in the series. More
2849304 55 F IL 07/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 42DM9
Underdose Underdose
I made a mistake and administered the pediatric/adolescent Havrix instead of the adult Havrix. When ... I made a mistake and administered the pediatric/adolescent Havrix instead of the adult Havrix. When I realized that I had made the mistake, I immediately notified my supervisor, and our Physician Assistant, They looked at immunize.org for the remedy to the error and it was decided that we needed to call the patients (Patient and her husband, , were both receiving travel vaccinations for a trip. I already submitted a VAERS report for Patients husband, VAERS 1060129, because the same mistake was made with his Hep A vaccination) to have them return on the same day for a second dose of the pediatric/adolescent Havrix to complete the first dose of the Hep A series. They returned around 3:30pm and both patients were given a second dose of the pediatirc/adolescent Havrix. The intramuscular injections were given in the same arm. The same lot number was used. I gave them a reminder to make an appointment on or after 1/9/26 for the second Hep A in the series. More
2849305 07/10/2025 COVID19
 PFIZER\BIONTECH
Epistaxis Epistaxis
She met someone 3 days ago, who also experiences the same symptoms as her/nose bleeding; This is a s... She met someone 3 days ago, who also experiences the same symptoms as her/nose bleeding; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "She met someone 3 days ago, who also experiences the same symptoms as her/nose bleeding". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849306 66 M SC 07/10/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
 HG5967
379AT
Contusion, Hypoaesthesia, Pain in extremity, Vaccination site pain; Contusion, H... Contusion, Hypoaesthesia, Pain in extremity, Vaccination site pain; Contusion, Hypoaesthesia, Pain in extremity, Vaccination site pain More
Soreness in the arm; sore injection site; Soreness in the arm; Like he could not feel anything; brui... Soreness in the arm; sore injection site; Soreness in the arm; Like he could not feel anything; bruised; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Lot number: HG5967) at the age of 66 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), as dose number unknown, single (Lot number: 379AT), in left deltoid for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO taken for diabetes mellitus; TELMISARTAN taken for hypertension. Vaccination history included: Covid-19 vaccine (primary immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Soreness in the arm"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "sore injection site"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Soreness in the arm; Like he could not feel anything"; CONTUSION (non-serious), outcome "unknown", described as "bruised". The events "soreness in the arm", "sore injection site" and "soreness in the arm; like he could not feel anything" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, hypoaesthesia, contusion. Clinical course: The patient received all the doses of the COVID vaccine, like he received all different COVID vaccine and the last vaccine that he received (clarified as Pfizer COVID-19 Vaccine) had the side effect on him. He consulted his family doctor, and they cannot figure out why. The side effect that he is experiencing is soreness in the arm for over a year and half. The side effect is soreness in the arm, like he could not feel anything, and this was from the last vaccine that he received. LOT#: HG5967. Took Tylenol every now and then, but it (soreness in arm) still keeps coming back. It goes away, it may help for a while, but Tylenol wears off and he do not want to keep talking too much Tylenol. He has been experiencing this for over a year and a half, and the side effect would not go away. So, again, they tried to consult the doctor. They did not find anything and his arm could not feel anything. That is how he described it. Got all the different covid vaccine and the last vaccine has residual side effects, and his family doctor can't figure out why. He is wondering why he is having that soreness still in the arm that bruised. The (inaudible) checked the arm and they couldn't feel any knots or anything in the arm. The internal family doctor on his annual checkup did not find anything and can't explain. The patient is just curious on what's going on because it is not a pleasant feeling. Residual side effects (sore injection site) from 31Oct2023 Covid vaccine. More
2849307 M 07/10/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH







Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated, Biop... Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated, Biopsy bone marrow, Biopsy liver; Biopsy lymph gland, Blood alkaline phosphatase, Blood bilirubin, Blood culture, Blood immunoglobulin G; Blood lactate dehydrogenase, C-reactive protein, CD30 expression, CD4/CD8 ratio, Cell marker; Cold type haemolytic anaemia, Complement factor C3, Computerised tomogram abdomen, Computerised tomogram pelvis, Coombs direct test; Culture, Culture urine, Flow cytometry, Fluorescent in situ hybridisation, Haemoglobin; Haptoglobin, Histology, Immunophenotyping, Investigation, Laboratory test; Physical examination, Platelet count, Reticulocyte count, Serum ferritin, Urine analysis; Weight, White blood cell count More
cold agglutinin hemolytic anemia (CAHA); The initial case was missing the following minimum criteria... cold agglutinin hemolytic anemia (CAHA); The initial case was missing the following minimum criteria: Literature report: No adverse effect. Upon receipt of follow-up information on 27Jun2025, this case now contains all required information to be considered valid. This is a literature report. A 56-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vitiligo" (ongoing); "Graves' disease" (ongoing); "diabetes mellitus" (ongoing); "hospital" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 VACCINE (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COLD TYPE HAEMOLYTIC ANAEMIA (medically significant), outcome "unknown", described as "cold agglutinin hemolytic anemia (CAHA)". Clinical course: A 56-year-old male with a past medical history of vitiligo, Graves' disease, and diabetes mellitus presented to the hospital with symptoms of lethargy, loss of appetite, night sweats, and 10-lb weight loss for 1 month. The patient reported that the onset of the above-mentioned symptoms started within a week of the mRNA booster vaccine for COVID-19. The physical exam was remarkable for pallor and jaundice. Laboratory workup revealed leukocytosis (White blood cell count 24 K/uL), anemia (Hemoglobin 8.0 g/dL), thrombocytosis (platelets 554 K/uL), mild transaminitis (alanine aminotransferase 88, aspartate aminotransferase 164, alkaline phosphatase 273), and hyperbilirubinemia (total bilirubin 11.2 mg/dL, direct bilirubin 8.3 mg/dL). Haptoglobin was <7.75 mg/dL, reticulocyte count was elevated (30.59%), and lactate dehydrogenase was 1423 U/L, all suggestive of hemolysis (Table 1). Acute phase reactants were elevated (C- reactive protein 14 mg/dL, ferritin 944 ng/mL). The direct antiglobulin test was positive for complement component 3 (C3) but negative for immunoglobulin G (IgG), a serologic pattern consistent with CAHA. Flow cytometry showed a high CD4/ CD8 positive T-Cell ratio of 17.23. Computed tomography (CT) of the abdomen and pelvis revealed hepatosplenomegaly with isolated lymphadenopathy in the porta hepatis (Figure 1). Further evaluation, including lymph node biopsy, demonstrated a mixed lymphoid population with occasional large atypical lymphoid cells. Bone marrow biopsy revealed hypercellular marrow (70-80%) with trilineage hematopoiesis and approximately 10% involvement by atypical large CD20+, BCL2+, BCL6+ atypical B-cells, negative for CD10, MUM1, CD30, P53, and Cyclin D1. CMYC expression was equivocal (~30%). FISH analysis demonstrated complex chromosomal abnormalities with polysomy in a small subset (2%) of cells, below the diagnostic threshold but supportive of cytogenetic instability. Flow cytometry showed no blast proliferation or aberrant myeloid markers. B-cells comprised 2.01% of marrow cells. Liver biopsy showed infiltration by large atypical lymphoid cells, consistent with involvement by the patient's DLBCL. These histopathologic and immunophenotypic findings, along with the liver biopsy showing infiltration by large atypical lymphoid cells, collectively confirm the diagnosis of DLBCL. Broad-spectrum antibiotics were initiated for possible infection but later discontinued following negative infectious workup, including blood culture, urinalysis, and respiratory and urine cultures. The patient was started on prednisone (1 mg/kg) for hemolytic anemia. Lack of laboratory improvement with steroid therapy further supported the diagnosis of CAHA. Patient's hemoglobin dropped to 6.9 g/dl during hospitalization and required 1 unit of packed red blood cells transfusion. He was later discharged in stable condition with plans for oncology follow-up to initiate treatment for DLBCL; however, specific details regarding the appointment or the intended oncology provider were unavailable, suggesting he may have sought care elsewhere. Therapeutic measures were taken as a result of cold type haemolytic anaemia.; Sender's Comments: There is not a reasonable possibility that the reported event cold agglutinin hemolytic anemia was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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. More
2849308 07/10/2025 COVID19
 PFIZER\BIONTECH
Death Death
died; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and ge... died; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: 3 of reporter's good friends died, after getting the so-called mRNA covid shots. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500081193 same product/event, different patient;US-PFIZER INC-PV202500081194 same product/event, different patient;; Reported Cause(s) of Death: Unknown cause of death More
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2849309 07/10/2025 COVID19
 PFIZER\BIONTECH
Vaccination site bruising, Vaccination site pain Vaccination site bruising, Vaccination site pain
prolonged soreness at the injection site; in the arm that bruised; This is a spontaneous report rece... prolonged soreness at the injection site; in the arm that bruised; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete; manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 2023, outcome "unknown", described as "in the arm that bruised"; VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "not recovered", described as "prolonged soreness at the injection site". The event "prolonged soreness at the injection site" required physician office visit. Additional information: The patient sought advice as their healthcare providers could not determine the cause. Patient got all the different Covid vaccine and the last vaccine has residual side effects and his family doctor can't figure out why. He is wondering why he is having that soreness still in the arm that bruised. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849310 07/10/2025 COVID19
 PFIZER\BIONTECH
Urticaria Urticaria
As someone with a family member who has had hive reaction to Pfizer vaccines; This is a spontaneous ... As someone with a family member who has had hive reaction to Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20250630000008 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "As someone with a family member who has had hive reaction to Pfizer vaccines". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849316 4 F CO 07/10/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB
Erythema, Skin warm, Swelling Erythema, Skin warm, Swelling
Pt had redness, swelling, hot to the touch within a few hours of vaccine being given on 7/8/25. Swe... Pt had redness, swelling, hot to the touch within a few hours of vaccine being given on 7/8/25. Swelling, redness, and heat has further progressed since vaccine was given and pt was seen for examination on 7/10/25. More
2849317 17 F MS 07/10/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 H4279
H4279
Blood pressure decreased, Cold sweat, Dizziness, Heart rate decreased, Pain; Pal... Blood pressure decreased, Cold sweat, Dizziness, Heart rate decreased, Pain; Pallor, Paraesthesia More
patient felt light headed nauseous, got clammy and pale, left hand tingling, left left tingling, sor... patient felt light headed nauseous, got clammy and pale, left hand tingling, left left tingling, soreness throughout body blood pressure and heart rate dripped signuficantly. came on suddenly lasted about 15 minutes. paramedics called but patient stabilized and was not taken to the hospital More
2849318 4 M UT 07/10/2025 TDAP
 SANOFI PASTEUR
 U825AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
There was no Adverse event report we just want to report the mistake There was no Adverse event report we just want to report the mistake
2849319 10 F AZ 07/10/2025 HPV9
 MERCK & CO. INC.
 X024560
Inappropriate schedule of product administration Inappropriate schedule of product administration
Given too soon Given too soon
2849320 68 M GA 07/10/2025 COVID19
 PFIZER\BIONTECH
 EJ1685
Alopecia universalis Alopecia universalis
Alopecia Universalis (global alopecia) Alopecia Universalis (global alopecia)
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2849321 41 M CA 07/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ME6072
ME6072
Arthralgia, Dry throat, Dysphagia, Injection site pain, Musculoskeletal pain; Pr... Arthralgia, Dry throat, Dysphagia, Injection site pain, Musculoskeletal pain; Pruritus, Throat irritation More
Day 1: sterile abscess at injection site. Day 2: deep muscle pain in deltoid, spreading to trapezius... Day 1: sterile abscess at injection site. Day 2: deep muscle pain in deltoid, spreading to trapezius. Day 3: pain extended to scapula. Sudden onset of throat dryness + itchiness, simultaneous arm itchiness. Mild difficulty swallowing. Itchiness in throat and pain still ongoing on day 3 (today july 10th) More
2849322 5 F UT 07/10/2025 TDAP
 SANOFI PASTEUR
 U8252aa
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
There was no adverse event report we, would just like to report the mistake made. There was no adverse event report we, would just like to report the mistake made.
2849323 0.5 M CA 07/10/2025 COVID19
 PFIZER\BIONTECH
 LN6739
No adverse event, Product storage error No adverse event, Product storage error
The covid vaccine multidose vial was mixed on 7/8/2025. Was placed in med cabinet, not thrown away a... The covid vaccine multidose vial was mixed on 7/8/2025. Was placed in med cabinet, not thrown away at the end of the day. A new Covid vaccine vial was mixed on 7/10/25 in the AM. In the afternoon, this patient was to get covid vaccine, MA accidentally pulled dose from the 7/8/2025 vial, not from the 7/10/2025 vial. Dose was given along with the other 6m vaccines. (pediarix, hiberix, rotateq and prevnar 20). No adverse reactions noted at time of administration More
2849341 11 F UT 07/10/2025 DTAP
 SANOFI PASTEUR
 3CA55C1
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 to report, but a wrong kind of vaccine applied to. It was applied Daptacel instead ... NO adverse event to report, but a wrong kind of vaccine applied to. It was applied Daptacel instead of the correct one to apply according her age, Adacel More
2849342 81 F PA 07/10/2025 PNC21
 MERCK & CO. INC.
 Y019158
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
PATIENT EXPERIENCED LOCAL SWELLING, REDNESS, AND ITCHINESS AT INJECTION SITE. SWELLING, REDNESS, AN... PATIENT EXPERIENCED LOCAL SWELLING, REDNESS, AND ITCHINESS AT INJECTION SITE. SWELLING, REDNESS, AND ITCHINESS HAS IMPROVED AND HELPED WITH ICING. More
2849343 23 F WA 07/10/2025 CHIK
 BAVARIAN NORDIC
Product preparation error Product preparation error
patient was given Ceftriaxone 500mg with 1 ml diluent instead of Bicillin L-A 1,200,000 units/2 ml patient was given Ceftriaxone 500mg with 1 ml diluent instead of Bicillin L-A 1,200,000 units/2 ml
2849344 10 M UT 07/10/2025 DTAP
 SANOFI PASTEUR
 3CA55C1
No adverse event, Wrong product administered No adverse event, Wrong product administered
NO adverse effect happened, but a wrong kind of vaccine given,; instead of Tdap (Adacel), it was adm... NO adverse effect happened, but a wrong kind of vaccine given,; instead of Tdap (Adacel), it was administered Dtap (Daptacel) More
2849345 64 F IL 07/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3J2S2
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Patient presented with severe pruritis, erythema, swelling to left arm where she received #2 dose of... Patient presented with severe pruritis, erythema, swelling to left arm where she received #2 dose of Shingrix on 7/9/2025. Lot #3J2S2 expires 3/27/2027. First dose received 4/28/2025 to the left arm without complications. Patient states the erythema does not hurt but it is very itchy. The entire left upper arm, from shoulder to elbow, is red with swelling (7 cm diameter) around the injection site. No fever or pain. More
2849346 16 F TX 07/10/2025 MENB
 PFIZER\WYETH
 HP9989
Cold sweat, Cyanosis, Headache, Heart rate increased Cold sweat, Cyanosis, Headache, Heart rate increased
Headache, pale blue lips, rapid heartbeats, cold sweats, with in 20 minutes of administered injectio... Headache, pale blue lips, rapid heartbeats, cold sweats, with in 20 minutes of administered injection More
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2849347 4 F CA 07/10/2025 DTAP
 SANOFI PASTEUR
 JF7DM
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Patient had redness, swelling and itching on her thigh. Including bumps on her lips. Patient had redness, swelling and itching on her thigh. Including bumps on her lips.
2849348 50 F MS 07/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3273H
Urticaria Urticaria
Patient stated hives on both arms roughly 3 hours after vaccination - recommended go to hospital to ... Patient stated hives on both arms roughly 3 hours after vaccination - recommended go to hospital to have it looked at More
2849349 16 F ND 07/10/2025 MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
U7450AA
Back pain, Electroencephalogram abnormal, Joint noise, Muscle spasms, Myoclonic ... Back pain, Electroencephalogram abnormal, Joint noise, Muscle spasms, Myoclonic epilepsy; Neck pain, Seizure, Unresponsive to stimuli; Anxiety, Computerised tomogram normal, Confusional state, Dyskinesia, Electroencephalogram abnormal; Fatigue, Gaze palsy, Loss of consciousness, Magnetic resonance imaging head normal, Muscle contractions involuntary; Muscle rigidity, Muscle tightness, Myalgia, Nervousness, Poor quality sleep; Seizure, Tremor; Back pain, Electroencephalogram abnormal, Joint noise, Muscle spasms, Myoclonic epilepsy; Neck pain, Seizure, Unresponsive to stimuli; Anxiety, Computerised tomogram normal, Confusional state, Dyskinesia, Electroencephalogram abnormal; Fatigue, Gaze palsy, Loss of consciousness, Magnetic resonance imaging head normal, Muscle contractions involuntary; Muscle rigidity, Muscle tightness, Myalgia, Nervousness, Poor quality sleep; Seizure, Tremor More
1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and n... 1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and neck. I also began to develop muscle spasms that have gradually worsened ever since receiving the vaccine. These spasms would last up to 30 minutes at a time. Recently, on July 3rd, 2025, I had a significant round of muscle spasms that ended in a seizure. I was unresponsive and went to the hospital, where they diagnosed me with myoclonic epilepsy. More
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2849350 87 M WA 07/10/2025 PNC21
 MERCK & CO. INC.
 Y011819
Chest discomfort, Dyspnoea, Pneumonia, Walking aid user Chest discomfort, Dyspnoea, Pneumonia, Walking aid user
PATIENT WENT TO HOSPITAL 2 DAYS LATER, HEAVY IN THE CHEST AND PROBLEMS BREATHING. DEVELOPED UPPER LO... PATIENT WENT TO HOSPITAL 2 DAYS LATER, HEAVY IN THE CHEST AND PROBLEMS BREATHING. DEVELOPED UPPER LOBE PNEUMONIA AND WAS PLACED ON ANTIBIOTICS. EVER SINCE, HAS NEEDED CONTINOUS OXYGEN SUPPLEMENTATION, GOING OUT AND BUYING A PORTABLE MACHINE AND NEEDS TO USE A WALKER. More
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2849351 1.5 M GA 07/10/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY


Developmental delay, Dyskinesia, Electroencephalogram abnormal, Gliosis, Magneti... Developmental delay, Dyskinesia, Electroencephalogram abnormal, Gliosis, Magnetic resonance imaging head abnormal; Muscle twitching, Myoclonic epilepsy, Screaming, Seizure, Tremor; White matter lesion More
My son was a healthy, normally developing child with no prior medical issues, seizures, or neurologi... My son was a healthy, normally developing child with no prior medical issues, seizures, or neurological concerns. He was born full-term without complications, and reached all developmental milestones early ? standing at 7 months, walking at 10 months, and talking before his first birthday. He had never experienced any high fever, infection, or unusual symptoms. On 02/11/2025, he received routine childhood vaccinations, including DTaP, Polio, Hep B, HIB, administered by intramuscular injection into his left/right thigh. Within a few hours of receiving the vaccine, while sleeping, he let out a loud, sudden scream and was found by his mother in an active seizure ? involving body shaking and jerking. He had no fever at the time. This was his first-ever seizure. Following this event, he began experiencing recurrent myoclonic seizures, primarily during sleep but occasionally while awake. These included sudden jerks, dropping objects, and body twitches. His pediatrician referred him to a pediatric neurologist. An EEG confirmed abnormal electrical activity consistent with myoclonic epilepsy. An MRI of the brain revealed multifocal white matter abnormalities with gliosis, indicating brain scarring from a prior injury. He was prescribed Levetiracetam (Keppra) for seizure control, which he continues to take daily. Despite treatment, seizures have persisted. There is growing concern from the family that this was a vaccine-induced neurological injury, as the onset of symptoms was immediate and no other cause (genetic, metabolic, infectious, or traumatic) has been identified. His development, although initially advanced, has shown some slowing since the incident. More
2848965 1 TX 07/09/2025 HPV9
 MERCK & CO. INC.
 Z005055
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse effects were reported; HCP called to report inadvertent administration of GARDASIL 9 to a... No adverse effects were reported; HCP called to report inadvertent administration of GARDASIL 9 to a 12 month old infant on 6/17/2025.; HCP stated it wasn't product confusion, the nurse just grabbed the wrong vaccine; This spontaneous report was received from other health professional and refers to an 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Jun-2025, the patient was inadvertent vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, 0.5 ml (route of administration, vaccination scheme, and vaccination site were not provided; lot #Z005055 which has been verified to be a valid number, expiration date reported and validated as 27-Feb-2026) as a prophylaxis (inappropriate age at vaccine administration). It was not a product confusion; the nurse just grabbed the wrong vaccine (wrong vaccine administrated). No adverse effects were reported. More
2848966 32 F CA 07/09/2025 HPV9
 MERCK & CO. INC.
Injection site erythema, Injection site nodule, Injection site pain Injection site erythema, Injection site nodule, Injection site pain
HCP noted that there was a patient that had pain, soreness on the injection side; redness on the inj... HCP noted that there was a patient that had pain, soreness on the injection side; redness on the injection site; with a nodule measuring 4x2cm in size, which has lasted for a month; This spontaneous report was received from a Physician and refers to a 32-year-old female patient (also reported as gender queer, biologically female). The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On 10-JUN-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, administered as Prophylaxis (dose, vaccination scheme frequency, anatomical site of injection, route of administration, lot number and expiration date were not reported). On that same date (10-JUN-2025) the patient experienced pain, soreness and redness on the injection site with a nodule measuring 4x2cm in size, which has lasted for a month (Vaccination site pain, Vaccination site erythema, Vaccination site nodule). The reporter inquired about additional data regarding extended side effects with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). At the reporting time, the patient had not recovered from Vaccination site nodule, while the outcome for Vaccination site pain and Vaccination site erythema was not provided. The causal relationship between Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the events was not reported. More
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