Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Tachycardia, Throat tightness, Tonsillar hypertrophy, Weight
Clinical narrative: paresthesias x 4 extremities; nausea; airway tightness from epigastrum to throat; enlarged right tonsil; dyspnea; abd. pain; anorexia; weight loss; cognitive dysfunction; brain fog; Headaches; dizziness; confusion; chest pain; SOB (Shortness of breath); tachycardia; activity intolerance; rashes; arthralgias; myalgias; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2020 11:45 (Lot number: EJ1685) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic rhinitis" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: PRAVACHOL; SINGULAIR; TRAZODONE. The following information was reported: PARAESTHESIA (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "paresthesias x 4 extremities"; NAUSEA (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "nausea"; THROAT TIGHTNESS (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "airway tightness from epigastrum to throat"; TONSILLAR HYPERTROPHY (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "enlarged right tonsil"; DYSPNOEA (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "dyspnea"; ABDOMINAL PAIN (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "abd. pain"; DECREASED APPETITE (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "anorexia"; WEIGHT DECREASED (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "weight loss"; COGNITIVE DISORDER (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "cognitive dysfunction"; FEELING ABNORMAL (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "brain fog"; HEADACHE (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "Headaches"; DIZZINESS (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "dizziness"; CONFUSIONAL STATE (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "confusion"; CHEST PAIN (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "chest pain"; DYSPNOEA (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "SOB (Shortness of breath)"; TACHYCARDIA (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "tachycardia"; DECREASED ACTIVITY (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "activity intolerance"; RASH (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "rashes"; ARTHRALGIA (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "arthralgias"; MYALGIA (disability) with onset 22Dec2020 11:45, outcome "not recovered", described as "myalgias". The events "paresthesias x 4 extremities", "nausea", "airway tightness from epigastrum to throat", "enlarged right tonsil", "dyspnea", "abd. pain", "anorexia", "weight loss", "cognitive dysfunction", "brain fog", "headaches", "dizziness", "confusion", "chest pain", "sob (shortness of breath)", "tachycardia", "activity intolerance", "rashes", "arthralgias" and "myalgias" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (03Dec2020) negative; (05Jan2021) negative; (02Apr2021) negative; weight: (unspecified date) loss. Therapeutic measures were taken as a result of paraesthesia, nausea, throat tightness, tonsillar hypertrophy, dyspnoea, abdominal pain, decreased appetite, weight decreased, cognitive disorder, feeling abnormal, headache, dizziness, confusional state, chest pain, dyspnoea, tachycardia, decreased activity, rash, arthralgia, myalgia. Adverse event: Immediate paresthesias x 4 extremities, nausea, airway tightness from epigastrum to throat, enlarged right tonsil, dyspnea. This was followed in the next few weeks with abd. pain, anorexia, weight loss, cognitive dysfunciton, brain fog, Headaches, dizziness, confusion, chest pain, SOB, tachycardia, activity intolerance, rashes, widespread arthralgias and myalgias. Persistent now for one year. Patient did not take any other vaccination in four weeks. Patient received benadryl, pepcid, prednisone as treatment for adverse events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Paraesthesia , Nausea, Throat tightness, Tonsillar hypertrophy, Dyspnoea, Abdominal pain, Decreased appetite , Weight decreased , Cognitive disorder , Feeling abnormal, Headache , Dizziness, Confusional state, Chest pain , Tachycardia, Decreased activity, Rash, Arthralgia , Myalgia cannot be totally excluded.   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.