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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': US0095075131909USA012460
Write-up: died after hpv vaccine; HPV 16,11,18 (first vial tested and turn out to be positive); PQC Present: Yes; This spontaneous report was received from a consumer via social media referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient died after administration of 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 (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 and human papilloma virus test positive as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for product quality issue was not reported. This is one of the several reports received from the same reporter.; Sender''s Comments: US-009507513-0807USA02497:Same reporter US-009507513-1609USA002149:Same reporter; Reported Cause(s) of Death: unknown cause of death
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