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Administered by: Private Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of unconscious in a 12-year-old female subject who was vaccinated with Havrix, Gardasil for prophylaxis. The subject was reported to be "otherwise healthy". The subject experienced on adverse events following previous vaccinations. There were no concurrent medications. On 13 April 2007 at 11:00, the subject received the 1st dose of Havrix (.5 ml, unknown, left arm). On 13 April 2007 at an unspecified time, the subject received the 1st dose of Gardasil. On 13 April 2007, 2 minutes after vaccination with Havrix and an unspecified time after vaccination with Gardasil, the subject experienced two episodes of dizziness and fainting within five minutes of dosing. The subject was unconscious for a minute or less with each episode. This case was assessed as medically serious by manufacturer. On 13 April 2007, the events were resolved. 06/17/10 Follow-up information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that on 13-Apr-2007 a 12 year old female was vaccinated with the first dose of GARDASIL (lot# 656049/0187U) 0.5 mL, injection. Concomitant therapy included HAVRIX, (Lot # AHAVB148AA). On 13-APR-2007, the patient fainted and had pseudo seizure like symptoms. The patient had dreams about receiving the shot and the physician felt that the reaction was anxiety related. The patient had the following laboratory diagnostic tests performed after the incident: glucose 85, blood pressure 135/75 mm Hg, pulse 85 and one hour later, after the incident the blood pressure was 97/63 mm Hg, pulse 73, oxygen saturation (pulse oximetry) was 99% and serum glucose was 85. No BENADRYL was given to the patient. Subseqeuntly the patient recovered from the events that same day. Conversion disorder, Nightmare and syncope were considered non-serious. VAERS # 277319. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
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