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Life Threatening? No
Write-up: very cold; Vaccination Site Pain; very stiff; Vaccination Site Pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300125432. A 16 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 02Dec2021 11:15 (Lot number: PCA0030) at the age of 16 years as dose 2, single and administration date 11Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (death) with onset 02Dec2021 14:30, outcome "fatal", UNRESPONSIVE TO STIMULI (death) with onset 03Dec2021 07:00, outcome "fatal" and all described as "Vaccination Site Pain"; FEELING COLD (non-serious), outcome "unknown", described as "very cold"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 03Dec2021, outcome "unknown", described as "very stiff". The patient date of death was unknown. The reported cause of death was vaccination site pain, unresponsive to stimuli. It was not reported if an autopsy was performed. As assessed by a pediatrician the patient had not reported adverse reaction or any untoward incident after her fist dose. On 02Dec2021 at around 8PM the patient replied to her aunt as she was okay. On 03Dec2021, at around 7 AM the patient was found with her face down on her bed, unresponsive, very cold and very stiff. " No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Vaccination Site Pain; unresponsive to stimuli
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