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Life Threatening? No
Write-up: This is a spontaneous report from a contactable consumer (the patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109121901312860-ZGDRY; safety report unique identifier: GB-MHRA-ADR 25929334). A female patient, of unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FE3380), via an unspecified route of administration, on Sep 11, 2021, single dose, for COVID-19 immunisation. Medical history not reported. The patient did not have symptoms associated with COVID-19. Patient not enrolled in a clinical trial. Concomitant medications included paracetamol for an unknown indication from Sep 10, 2021 and unknown if ongoing. On Sep 11, 2021 (on the same day of vaccination), patient had swollen lymph nodes in the armpit where the patient received the vaccine. On an unknown date in Sep 2021, patient experienced shaking, severe headache, fever, nausea, fatigue, shivering and muscles pain; all the events reported serious (medically significant). On an unknown date, patient underwent a COVID-19 virus test: negative result. The patient has not tested positive for COVID-19 since the vaccination. The outcome of swollen lymph nodes in the armpit: not recovered; while that of severe headache, shivering, shaking, fatigue, fever, muscles pain and nausea: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
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