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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: A 14-yer-old female patient had received the first dose of GARDASIL (batch number not reported) on 02-Apr-2013. On 03-Apr-2013, the patient presented with paradoxal movements during sleep (seen by her mother who slept with her), cold hands, musculoskeletal pain, headache and dizziness. The patient''s mother informed the physician who saw the patient again on 08-Apr-2013. She had then recovered from sensitive disorders i.e. paradoxal movements, cold hands, musculoskeletal pain and dizziness. Only cephalgia, concentration impairment and extreme fatigue persisted. Follow-up information received on 29-Oct-2013: The patient received the vaccine (batch and lot number H015737, exp. 28-FEB-2015) via intramuscular route in the left arm. The physician reported that dizziness occurred 12 hours post-vaccination and lasted 3 days. He considered this symptom as moderate. Paradoxal movements at night occurred 4 hours post-vaccination and lasted 24 hours. The reporter considered this symptom as minimal. The patient also experienced subjective disturbances 12 hours post-vaccination and recovered within 3 days, symptom of moderate severity according to the reporter. The physician also reported that the patient experienced shifting widespreading pain 12 hours post-vaccination, symptom he considered as severe and which resolved within 3 months. Concentration impairment, headache and extreme fatigue were no more reported. The final diagnosis assessed by the reporter was sensorymotor neurological disturbances following a first injection of GARDASIL. According to the reporter, it was an atypical picture with predominance of subjective disturbances: sensory, algetic (difficult to assess) but compatible timewise (starting on day 0, 12 hours post-vaccination, continuing the following days) with relatedness between vaccine administration and the reported reactions which were already listed in the summary of product characteristics. Considering how invalidating and prolonged the diffuse pains were, the patient consulted a neurologist and an electromyography of upper and lower limbs was performed. No objective evidence of neuropathy was found. No corrective treatment was given. Upon internal review, the company judged relevant to upgrade the case and add the following criterion of severity: "involved persistence or significant disability or incapacity." To be noted that the reported considered the case as non serious.
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