Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site in right deltoid; Low grade fever; Headache; General aching; Fatigue; This is a spontaneous report from a contactable physician. A 63 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:45 (Batch/Lot Number: EP-6955) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:45 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. triamcinolone acetonide (NASACOR T), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history and concomitant medications were not reported. The patient experienced soreness at injection site in right deltoid causing vaccination site pain on 24Mar2021 21:00 with outcome of recovering, low grade fever causing pyrexia on 24Mar2021 21:00 with outcome of recovering , headache on 24Mar2021 21:00 with outcome of recovering, general aching on 24Mar2021 21:00 with outcome of recovering, fatigue on 24Mar2021 21:00 with outcome of recovering. Therapeutic measures were taken as a result of this with Tylenol 500mg x 1  Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable physician. This physician reported for the patient in response to the below mentioned query:  Query: The Pfizer Drug safety unit recently received the attached report submitted by you. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events.  This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  Please ensure to reply all to this email.  Response: This report was for events that occurred after my second COVID vaccine and so awareness dates would be the same as the AE start dates. Soreness at injection site in right deltoid started on 24th March 2021 and so this would be the awareness date for that event. The other reported AEs of low grade fever, headache, general aching and fatigue all started on 25th March 2021 and so that would be the awareness date for each of these events. Hopefully this will provide the information that you require around these events.  The Pfizer Drug safety unit recently received the attached report submitted by you via Pfizer safety reporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events.  This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that Pfizer became aware of the adverse events.   Please ensure to reply all to this email.  No follow-up attempts are needed. No further information is expected.