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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of death nos in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On the morning of the 28 September 2009 the patient received unspecified dose of CERVARIX (1 injection). On 28 September, within 30 minutes after vaccination with CERVARIX, the patient experienced a possible anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection. The patient had to be resuscitated by the paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient. The attempt was not successful and the patient was declared dead on 28 September 2009. It was unknown whether an autopsy was performed. Verbatim text: On the 28th September 2009 a public health consultant reported that a 14 year old female patient was administered a dose of CERVARIX ( Batch: AHPVA043BB, expiry: 09/2010) at school, in the morning of the 28th September 2009 as part of a school immunization program. The consultant reported that within 30 minutes after the administration of the CERVARIX the patient experienced what they believed was an anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection, she had to be resuscitated by paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient but it was not successful and the patient was declared dead. There was no further information available at the time of reporting. Follow-up information received via regulatory authority on 30 September 2009: The patient was taking CERVARIX for the prevention of premalignant cervical lesions and cervical cancer. The patient had no known allergies. She was being treated for migraines with propranolol (unknown dose or presentation) but his has not been confirmed by patient''s GP or family. The patient received her first dose of CERVARIX (Batch Number: A1-IPVA043BB) at 10:45 on Monday 28th September
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