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Life Threatening? No
Write-up: Difficult to lift arm due to pain Hard to operate gears and handbrake in car due to pain; pain/Intense pain at injection site and upper arm extending down to elbow; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106012044357120-VRYYU.Safety Report Unique Identifier (GB-MHRA-ADR 25401414). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Batch/Lot Number: EW3143) as 1st dose, single dose for COVID-19 immunisation. Medical history included injury from an unknown date and unknown if ongoing. No other medication or injury. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient had no concomitant medications. The patient experienced pain on 01Jun2021. The clinical course was reported as follows: intense pain at injection site and upper arm extending down to elbow. Difficult to lift arm due to pain. Hard to operate gears and handbrake in car due to pain. The event was reported as serious (disabling and medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. The outcome of the pain was not recovered while for the other event was unknown. No follow-up attempts are possible. No further information is expected.
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