Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate abnormal, Muscle spasms, Myalgia
Clinical narrative: 1st dose was fine, but the 2nd dose had me bed ridden for 3 weeks; Couldnt breath; rampant heart rate; fatigued; brain fog; full sinus areas mostly in ethmoid behind eyes; blurred vision; pain in all joints and muscles; pain in all joints and muscles; muscle spasms in all different areas; depression; 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 23Jul2021 20:00 (Lot number: FA7484) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (unspecified vitamins). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Arm Left, Vaccine Administration Time: 08:15 PM), administration date: 02Jul2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: BEDRIDDEN (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "1st dose was fine, but the 2nd dose had me bed ridden for 3 weeks"; DYSPNOEA (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "Couldnt breath"; HEART RATE ABNORMAL (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "rampant heart rate"; FATIGUE (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "fatigued"; FEELING ABNORMAL (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "brain fog"; SINUSITIS (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "full sinus areas mostly in ethmoid behind eyes"; VISION BLURRED (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "blurred vision"; ARTHRALGIA (disability), MYALGIA (disability) all with onset 25Jul2021 08:00, outcome "not recovered" and all described as "pain in all joints and muscles"; MUSCLE SPASMS (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "muscle spasms in all different areas"; DEPRESSION (disability) with onset 25Jul2021 08:00, outcome "not recovered", described as "depression". The events "1st dose was fine, but the 2nd dose had me bed ridden for 3 weeks", "couldnt breath", "rampant heart rate", "fatigued", "brain fog", "full sinus areas mostly in ethmoid behind eyes", "blurred vision", "pain in all joints and muscles", "pain in all joints and muscles", "muscle spasms in all different areas" and "depression" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (25Jul2021) unknown results; sars-cov-2 test: (30Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bedridden, dyspnoea, heart rate abnormal, fatigue, feeling abnormal, sinusitis, vision blurred, arthralgia, myalgia, muscle spasms, depression and include a lot of doctor visits and blood work.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Bedridden, Dyspnoea, Heart rate abnormal, Fatigue, Feeling abnormal, Sinus disorder, Vision blurred, Arthralgia, Myalgia, Muscle spasms and Depression, and BNT162B2.  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.