Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: booster; after taking the vaccine later that day her legs hurt so much; Exhausted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Sep2021 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation; ofatumumab (KESIMPTA) (Batch/Lot number: unknown). Relevant medical history included: "her legs hurt" (not ongoing); "exhausted" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), administration date: 2021, for COVID-19 Immunisation; BNT162B2 (Dose 2), administration date: 2021, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021, outcome "recovering", described as "after taking the vaccine later that day her legs hurt so much"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Exhausted".  Additional information: This report was received based on the information received by Pfizer from Novartis (manufacturer control number: VSC2021US016261_NS). Clinical Course:  Patient reported that she initially started Kesimpta in Jan2021. Patient reported that the COVID-19 vaccine opened up for her group and she consulted with her HCP who advised her to stop Kesimpta in preparation for receiving the COVID-19 vaccine. Patient reported that she stopped Kesimpta, and weeks went by without receiving an appointment for her COVID vaccine. Patient contacted the Health Department and was told it would be weeks or months before she would get it the COVID-19 vaccine. Patient then contacted her HCP who told her to restart Kesimpta, which she did. Patient reports she was then contacted by the Health Department to get her COVID-19 vaccine and therefore she stopped Kesimpta again per HCP. Patient reported she had her first dose of the COVID-19 vaccine and then three weeks later had the second dose of the COVID vaccine. Patient reported it had been three weeks since the second dose of her COVID-19 vaccine and she was told to wait for three weeks before restarting Kesimpta. Patient restarted Kesimpta on 03May2021 and restarted with the monthly dosing schedule per HCP. Update 07Oct2021: Patient talked about this again during today's call and reports that she had the 3rd dose of the COVID-19 vaccine on 29Sep2021, she reported after taking the vaccine later that day her legs hurt so much, she went to sleep and when she awoke the next day she felt better but has been exhausted since getting the vaccine. She reported that she had also been doing so much lately, and this may be contributing to how she feels, and she has felt this way in the past also. Patient's most recent dose of Kesimpta was 24Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.