Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: body aches; developed body aches that disrupted sleep; fatigue; sore arm/tenderness in arm (in injection arm).; sore arm/tenderness in arm (in injection arm).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 09:45 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number 1, product: COVID19, brand: Pfizer, lot number: EL3248,, administration time: 09:45 AM, vaccine location: Left arm), administration date: 03Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Mar2021 14:00, outcome "recovered" (Mar2021), described as "fatigue"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 24Mar2021 14:00, outcome "recovering" and all described as "sore arm/tenderness in arm (in injection arm)."; PAIN (non-serious) with onset 25Mar2021 14:00, outcome "recovered" (Mar2021), described as "body aches"; SLEEP DISORDER (non-serious) with onset 25Mar2021, outcome "unknown", described as "developed body aches that disrupted sleep". Therapeutic measures were not taken as a result of fatigue, tenderness, pain, sleep disorder.   Additional information: For dose 2, Lot number: 3248 (as reported). Vaccine Facility information available. Ethnicity information is available. Race information is available.Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was reported as no. Approximately 4-5 hours after vaccination, experienced fatigue and sore arm/tenderness in arm (in injection arm). During the night, developed body aches that disrupted sleep. The body aches and fatigue resolved. The sore arm is resolving. My awareness date for the fatigue and sore arm was 24Mar2021. The awareness date for the body aches was 25Mar2021. The Drug safety unit recently received the attached report submitted by you via the internet. 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 company receipt date of the report and reflects the earliest date that any colleague learned of the adverse event. If you learned of these events from another colleague, please provide the date that the first colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a colleague became aware of the adverse events. There was no treatment received for the adverse event.  No follow-up attempts are possible. No further information is expected.