Sex: F
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, Pain in extremity, Peripheral vascular disorder, Raynaud's phenomenon, Skin discolouration
Clinical narrative: mast cell activation syndrome; almost like a Raynauds; vascular and peripheral symptoms like of her hands and her feet, severe pain, discoloration; vascular and peripheral symptoms like of her hands and her feet, severe pain, discoloration; vascular and peripheral symptoms like of her hands and her feet, severe pain, discoloration; This is a spontaneous report received from a contactable reporter (Physician) from medical information team for a Pfizer sponsored program.  A 58 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single; Batch/Lot number: unknown), for COVID-19 immunization. The following information was reported: MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown," described as "mast cell activation syndrome"; RAYNAUD'S PHENOMENON (non-serious), outcome "unknown," described as "almost like a Raynauds"; PERIPHERAL VASCULAR DISORDER (non-serious), PAIN IN EXTREMITY (non-serious), and SKIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "vascular and peripheral symptoms like of her hands and her feet, severe pain, discoloration." All the events were evaluated at the physician office visit. The reporter assessed the case as non-serious. The reporter would like to discuss how to treat an adverse event that occurred in one of his/her patients. The patient believed she had the mast cell activation as a result of the vaccine and the reporter was asking for any consultants to put in touch with the patient to help her with her symptoms. The patient was of course willing to do a zoom consultation or travel if needed. The reporting physician added that the patient received Pfizer 1st and 2nd dose, and ever since her second dose, she believed she might have what they call mast cell activation syndrome; she got a lot of vascular and peripheral symptoms like of her hands and her feet, severe pain, discoloration, so she got like, almost like a Raynauds. The reporter believed that the patient had a conversation with the pain management doctor. The reporting physician did not know if Pfizer has any sources or resources for the patient to get evaluated and managed at least to see if that was what was going on with her or not. The reporter had had a hard time finding someone who could manage that situation for her.  The batch/lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on possible temporal association the causal role of BNT162b2 cannot be excluded and assessed as related for the reported event Mast cell activation syndrome.  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