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Life Threatening? No
Write-up: Painful arm; felt run down; Swelling arm; Stiffness/arm started feeling stiff; flu symptoms; Spaced out; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021953568110-NCO3Q, Safety Report Unique Identifier is GB-MHRA-ADR 25408052. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 31May2021 at 18:30, as first dose, single dose for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. She was not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced spaced out on an unspecified date in 2021; flu symptoms on Jun2021; painful arm and felt run down on 02Jun2021 at 00:30; swelling arm on 02Jun2021; and stiffness on 01Jun2021 at 06:30. The events were reported as serious, with seriousness criteria of other medically important condition. The clinical course was reported as follows: The patient received her jab at 18:30 on 31May21. Her arm started feeling stiff about 12 hours after her jab. After about 30 hours, she woke up in the night with very painful arm, which would not settle, has been painful for about 20 hours but was lessening. Have felt run down for the same amount of time since arm became painful. But not full flu symptoms. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 virus test on an unspecified date which resulted negative (No - Negative COVID-19 test). The outcome of event spaced out was recovered on an unspecified date in 2021. The outcome of events flu symptoms and swelling arm was recovered on Jun2021. The outcome of event "felt run down" was unknown, while outcome of the remaining events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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