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|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|HPV4: HPV (GARDASIL) / MERCK & CO. INC.||- / UNK||- / -|
Administered by: Unknown Purchased by: ??
Symptoms: Death, Papilloma viral infection, Human papilloma virus test positive, Product quality issue
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Diagnostic Lab Data: Test Name: Human papilloma Virus test; Test Result: Positive
CDC 'Split Type': US0095075131909USA012618
Write-up: died from Hpv vaccine; HPV 16 11 18 (first vial tested and turned out to be positive); PQC present: Yes/sent me at the first vial so i tested and it turned out to be positive altogether 16 vials; This spontaneous report was received from a consumer via social media referring to a patient of unknown age and gender. The patient''s pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, anatomical location, lot# and expiry date not reported) for prophylaxis. On an unknown date, the patient died from quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was reported that, the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive with strains HPV 16, 11, 18 (Human papilloma virus test positive and product quality issue). Cause of death was unknown and it was unknown whether autopsy was performed. The outcome of papilloma viral infection and product quality issue was unknown. The reporter considered the event of death as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for human papilloma virus test positive and product quality issue was not reported. This is one of the several reports received from the same reporter.; Sender''s Comments: US-009507513-1909USA012460:same reporter US-009507513-0807USA02497:same reporter; Reported Cause(s) of Death: unknown cause of death
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