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Administered by: Other Purchased by: Unknown
Life Threatening? No
Write-up: This spontaneous report was received from a 13 years old female patient regarding herself via TV Show. The patient''s medical history and concurrent conditions were not reported. On 21-SEP-2016, the patient was vaccinated with the first dose of GARDASIL intramuscularly in the left arm (vaccinated without the consent of their parents) for prophylaxis (# lot, expiry date, dose unspecified). Concomitant vaccination included DTP vaccine administered in the patient''s right arm on the same day. On the same day (21-SEP-2016), after the vaccination, the patient experienced pain in the arm (not specified which arm), fever, swelling on her right arm persisted, returning repeatedly to the emergency room. The patient was administered with serum, pain medication (unspecified) and treated with many anti-allergic medications including chlorpheniramine, betamethasone without favorable results in the emergency room, and then presented with immobility of the right arm. On 28-OCT-2016 (reported as "on Friday"), the pain in her arm was transferred to the right leg and in the morning, the patient could not walk since her foot was swollen and folded (paralysis right limbs) and the patient was hospitalized from that day. On 02-NOV-2016 (reported as "on Wednesday"), the patient was transferred to another hospital, where she was performed with various tests (unspecified), without obtaining a definitive diagnosis. The evolution of the patient had been unfavorable. According to information provided by the health authority (HA), the patient was assessed by an infectious disease doctor, who diagnosed an inflammatory local reaction in the right arm possibly by the vaccine. The patient was referred to a neurologist to continue the studies, who noted that the diagnosis was a brachial plexus neuropathy. The outcome of the events paralysis right limbs, brachial plexus neuropathy, pain in the arm, right arm swelling was reported as recovered/resolved in approximately 2016. The outcome of the event pyrexia was unknown. The reporter did not provide causality assessment between events and the suspect therapy. No more information was provided. The events brachial plexus neuropathy (Neuralgic amyotrophy), paralysis right limbs (Hemiplegia) were medically significant, had led to hospitalization and disability. The events pain in the arm, right arm swelling and pyrexia were reported as non-serious. The new information was reported by the patient''s parents via a radio station on 28-NOV-2016. The father reported that his daughter was healthy before the vaccination. The symptoms of severe pain and swelling that ended with loss of mobility of the upper limb and hand were reported to have started within minutes of vaccination. The patient''s parents insisted that GARDASIL produced the symptoms. The HA continued to report that the symptoms were more likely to be due to the DTP vaccine, than due to GARDASIL, therefore the DTP vaccine was considered to be a co-suspect vaccination (administered intramuscularly, dose, lot# and expiry date were not reported). Additional information is not expected since no follow up was required or available. This is an amended report, as corrected. For Follow up #1, the Follow-up receipt date should have been entered as 28-NOV-2016. The Follow-up Central Receipt date should have been entered as 29-NOV-2016. Sender''s Comments: MERCK 1611CHL003145:Mfr number.
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