Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: debilitating joint pain; swelling in bilateral wrists and hands; swelling in bilateral wrists and hands; daily activities such as washing hair and getting dressed were affected; memory loss; profound fatigue; This is a spontaneous report and received from Physician.  A 48-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), in Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Cold Sores" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; VALACYCLOVIR [VALACICLOVIR]; ALLEGRA ALLERGY. The patient had no Known allergies. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset Jan2021, outcome "recovered with sequelae" (Jan2022), described as "daily activities such as washing hair and getting dressed were affected"; ARTHRALGIA (disability) with onset Jan2021, outcome "recovered with sequelae" (Jan2022), described as "debilitating joint pain"; AMNESIA (disability) with onset Jan2021, outcome "recovered" (Jan2022), described as "memory loss"; FATIGUE (disability) with onset Jan2021, outcome "recovered" (Jan2022), described as "profound fatigue"; JOINT SWELLING (disability), PERIPHERAL SWELLING (disability) all with onset Jan2021, outcome "recovered with sequelae" (Jan2022) and all described as "swelling in bilateral wrists and hands". Therapeutic measures were taken as a result of arthralgia, joint swelling, peripheral swelling, loss of personal independence in daily activities, amnesia, fatigue included NSAIDs. Clinical course: Within two days of the injection, the patient experienced debilitating joint pain and swelling in bilateral wrists and hands. This was so severe that even daily activities such as washing hair and getting dressed were affected. The severity decreased over 10 days but persisted severely for almost 1 year to the point that she was having to modify work and daily activities to accommodate the pain. It still intermittently flares. At the time of the vaccine, she also experienced memory loss (whole conversations forgotten) and profound fatigue (in bed by 4 in the afternoon). These two side effects gradually waned over 1 month time and have now resolved completely.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based from suspected vaccines safety profile, the causal association of reported events fatigue and arthralgia cannot be totally excluded. The rest of the events are assessed as intercurrent medical conditions and not related to suspected vaccines  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate