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Administered by: Other Purchased by: Unknown
Life Threatening? No
Write-up: Initial report was received by the regulatory authority on 05/Jan/2016 from a member of the public which concerns a 22 year old female patient who experienced Swelling, Nausea, Eating disorder, Sleep disorder, Heart rate irregular & Blood pressure fluctuation following vaccination with Gardasil for Prophylaxis. Concomitant medications: None. Medical history/concurrent conditions: The reporter indicated that the patient had no previous drug reactions. The patient was vaccinated with Gardasil at a dose of 0.5ml in her left deltoid on 30/Sep/2011. Post vaccination the patient experienced swelling, nausea, an eating disorder, sleep disorder, serious joint pain, heart rate and blood pressure irregularities & Postural orthostatic tachycardia syndrome (POTS). Some of these reactions developed immediately and some developed later and were slowly diagnosed. The patient has undergone numerous tests and POTS was eventually diagnosed. At the time of reporting the patient''s symptoms were still ongoing. On further review of the initial case details by the regulatory authority it was noted that the patient''s age at time of reporting was 22, with no information provided on the patient''s age at the time of the event. The batch number was amended from GO05669 to G005669. The reporter considered all the events to be serious, medically significant due to disability.
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