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Administered by: Other Purchased by: Military
Life Threatening? No
Write-up: This is a spontaneous report from a contactable pharmacist via a physician and via a consumer (patient mother) and then the contractable physician. A 19-year-old female patient received TRUMENBA (lot number J29203, expiration date JUN2016) at 0.5 ml single dose intramuscular in the left deltoid on 23FEB2015 at 15:20. Relevant medical history was not reported. The patient had no illness at time of vaccination. Concomitant medications included ongoing methylphenidate ER 36mg once daily since 23FEB2015, ongoing methylphenidate 5mg tablet since 23FEB2015 and ongoing citalopram 20mg at 1.5 DF daily since 24FEB2015. On 24FEB2015, 24 hours after vaccination, the patient experienced blinding headache (reported as headache by the pharmacist) and fever ($g101F$g24hr). On 25FEB2015, 48 hours after vaccination, the patient experienced joints/muscles neck spine shoulders hurt. Additional the pharmacist reported that the patient had muscle pain all over on unspecified date in FEB2015. According to the reporting physician blinding headache and fever recovered 24 hr after onset on 25FEB2015, joints/muscles neck spine shoulders hurt recovered 48 hrs after onset on 27FEB2015. Outcome of the event muscle pain all over was unknown. No specified tests or treatment were required. The physician considered there a reasonable possibility that the events were related to TRUMENBA. Follow-up (20MAR2015): New information received from a cont actable physician includes: gender, causality assessment, product details, new events (fever and joints/muscles neck spine shoulders hurt), updated event description( (from headache to blinding headache), concomitant medications, info on treatment/tests, outcome. Follow-up (27APR2015): This is a spontaneous report from the non-clinical study program"IBCC (Inbound Call Center for HCP''s)". No additional information was obtained. Follow up attempts completed. No further information expected.
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