Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Axillary pain, Blood thyroid stimulating hormone, C-reactive protein, Erythema
Clinical narrative: Swelling three days after second dose of Pfizer COVID vaccine; left sided cheek swelling and redness; Left sided cheek swelling and redness; Then her right arm started swelling and extended down to her hand and fingers and up around the right shoulder. Also, there is left hand swelling in one finger ( middle finger); Decreased sensation/numbness in both hands primarily her right hand; Right Arm is painful and axilla is painful but the biceps and lower right arm is the worst; Right Arm is painful and axilla is painful but the biceps and lower right arm is the worst; Can't use her arm; Inflammation; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A 18 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (ongoing). Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: SWELLING (disability, medically significant) with onset 2021, outcome "recovered" (2021), described as "Swelling three days after second dose of Pfizer COVID vaccine"; SWELLING FACE (disability, medically significant) with onset 2021, outcome "recovered" (2021), described as "left sided cheek swelling and redness"; ERYTHEMA (disability, medically significant) with onset 2021, outcome "recovered" (2021), described as "Left sided cheek swelling and redness"; PERIPHERAL SWELLING (disability, medically significant) with onset 2021, outcome "not recovered", described as "Then her right arm started swelling and extended down to her hand and fingers and up around the right shoulder. Also, there is left hand swelling in one finger ( middle finger)"; HYPOAESTHESIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "Decreased sensation/numbness in both hands primarily her right hand"; PAIN IN EXTREMITY (disability, medically significant), AXILLARY PAIN (disability, medically significant) all with onset 2021, outcome "not recovered" and all described as "Right Arm is painful and axilla is painful but the biceps and lower right arm is the worst"; LIMB DISCOMFORT (disability, medically significant) with onset 2021, outcome "not recovered", described as "Can't use her arm"; INFLAMMATION (disability, medically significant) with onset 2021, outcome "not recovered", described as "Inflammation". The events "swelling three days after second dose of pfizer covid vaccine", "left sided cheek swelling and redness", "left sided cheek swelling and redness", "then her right arm started swelling and extended down to her hand and fingers and up around the right shoulder. also, there is left hand swelling in one finger ( middle finger)", "decreased sensation/numbness in both hands primarily her right hand", "right arm is painful and axilla is painful but the biceps and lower right arm is the worst", "right arm is painful and axilla is painful but the biceps and lower right arm is the worst", "can't use her arm" and "inflammation" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: antinuclear antibody: (2021) normal; blood thyroid stimulating hormone: (2021) normal; c-reactive protein: (2021) normal; fibrin d dimer: (2021) normal; full blood count: (2021) normal; metabolic function test: (2021) normal; rheumatoid factor: (2021) normal; thyroxine: (2021) normal; tri-iodothyronine: (2021) normal. Therapeutic measures were taken as a result of swelling, swelling face, erythema, peripheral swelling, hypoaesthesia, pain in extremity, axillary pain, limb discomfort, inflammation included: prescribed an antibiotic. Clinical course: The patient had been to primary care and rheumatology. The patient started having swelling three days after second dose of Pfizer COVID vaccine. It was very unusual swelling. The physician thought it was related to the vaccine. It had been two months now. The physician stated what's causing it was definitely inflammation and now patient had some numbness in her hand. Seriousness Criteria was Medically Significant and somewhat disabling because the patient couldn't use her arm.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.