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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # IE-1577272925-2016004775) as part of business agreement on 28-APR-2016. This case was received from RA in Ireland (Ref no. IE-HPRA-2016-026477) on 27-APR-2016. Initial case received from a consumer/other non health professional concerns a 14-year-old female adolescent patient received GARDASIL (batch number NN40800) on 14-SEP-2011, GARDASIL (batch number NP26080) on an unknown date, GARDASIL (batch number GO14502) on 13-MAR-2012. Concomitant medications: None. Medical history/concurrent conditions: Not reported. The patient experienced headaches, swelling of injection site, difficulty breathing, severe chest pain, postural tachycardia syndrome, palpitations, seizures - with many bangs on the head on 14-MAR-2012, constantly fainting and chronic fatigue on an unknown date. The reporter assessed the causal relationship between Headache, Swelling of injection site, Difficulty breathing, Chest pain, Postural orthostatic tachycardia, Palpitations, Seizures, Fainting, Chronic fatigue and GARDASIL as Unknown. Corrective treatment: The patient has attended GPs and hospitals and has commenced sodium, SSRI medication and an additional medication (to be confirmed). The patient''s outcome was reported as Not Recovered/Not Resolved.
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