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Life Threatening? No
Write-up: Painful arm; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106042318512560-RZEML Safety Report Unique Identifier GB-MHRA-ADR 25424767. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot number was not reported) at age of 32-year-old as single dose for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced painful arm and headache on 04Jun2021 with outcome of not recovered. The events were serious as medically significant. Clinical course: Severe headache for 10 minutes somewhat immediately after, persistent headache again late in evening. Continual upper arm ache/pain since vaccination. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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