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Administered by: Private Purchased by: Private
Life Threatening? Yes
Write-up: About 1 hour and 15 minutes prior to receiving Menatra and Gardasil vaccinations in our office, the patient felt acute onset of throat tightness, throat burning, flushed face and trouble breathing. 05/30/07-records received-5/27/07-trouble breathing. shortness of breath. flushed face. lips slightly swollen. DC: anaphylactic reaction most likely to either Gardasil or Menactra This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician, his office manager and an allergist via medical records concerning an 18 year old (previously reported as 17 year old) female with no known drug allergies and a history of nasal congestion and sneezing after exposure to cut grass who on 25-MAY-2007 was vaccinated IM with the first 0.5mL dose of GARDASIL (lot #657737/0522U) and concomitant suspect therapy MENACTRA (lot #U2278AA). Additionally, information has been received through the Freedom of Information Act pertaining to this case. It was reported that the patient left the physician''s office feeling fine after the vaccinations, and subsequently, returned home. The patient ate a turkey sandwich and a kiwi, and "I hour after receiving the vaccine", the patient experienced an acute onset of throat tightness, throat burning, flushed face and trouble breathing. The patient returned to the physician''s office with throat tightness, throat burning, flushed face, shortness of breath and lips were slightly swollen. The patient was diagnosed with an anaphylactic reaction and was treated with one EPI-PEN injection, prednisone, 60 mg and BENADRYL, 50 mg. The patient''s breathing returned to normal, and subsequently, the patient recovered from the anaphylactic reaction. On 18-JUN-2007, the patient was seen by an allergist who reported that percutaneous skin testing was performed on the patient and revealed positive reactions to kiwi and grass pollen. The patient was diagnosed with a kiwi allergy and grass pollen allergy with seasonal allergic rhinitis. ImmunoCap allergy testing to kiwi, other fruits, pollens and Latex was also performed on the patient (results pending). The patient was instructed on the proper technique and indications for EPI-PEN use and follow-up was pending laboratory results. The reporting physician considered the anaphylactic reaction to be a disabling immediately life-threatening and medically significant event and felt it was most likely related to either therapy with GARDASIL or MENACTRA, although, the allergist felt that the "vaccines were not likely the cause of her reaction" and recommended that an attempt to proceed with the GARDASIL series "can be done in a closely monitored and equipped setting." A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
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