Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Lethargy, Malaise, Muscle spasms, Muscular weakness
Clinical narrative: Angioedema/swelling in face + neck (angioedema); Tinnitus; Rash on face, neck and abdomen developed; Hyperacusis; Muscle weakness; Fatigue; Fever; Chills; Muscle aches; lethargy; Abnormally vivid dreams; Memory loss; Extreme muscle cramping; Functional neurological disorder; Severe malaise; This is a spontaneous report from a contactable pharmacist (patient). A 40-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FH8020, Expiration date was not reported), via intramuscular in arm left on 24Oct2021 at 12:30 PM (at the age of 40-years-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19, ongoing COVID long haulers from 04Jul2020, pertinent details: Hair loss/Non growth SOB, loss of taste/smell, memory issues from 04Jul2020 and ongoing. The patient's concomitant medication(s) received within 2 weeks of vaccination included lisdexamfetamine mesilate (VYVANSE), via oral, taken for binge eating disorder (reported as B.E.D) from an unspecified start date and ongoing, fexofenadine hydrochloride (ALLEGRA), via oral, taken for allergies from an unspecified start date and ongoing, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), via nasal, taken for allergies from an unspecified start date and ongoing, norethindrone acetate, via oral, taken for birth control from an unspecified start date and ongoing. The patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccinations were reported as none. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 24Oct2021 at 23:00, the patient experienced severe malaise, abnormally vivid dreams, memory loss, functional neurological disorder, extreme muscle cramping. On 25Oct2021 at 11:00, the patient experienced hyperacusis, on 25Oct2021 at 09:00, the patient had muscle weakness/fatigue/fever/chills. On 26Oct2021 at 14:00, the patient had experienced tinnitus. On 06Nov2021 at 09:00, the patient experienced angioedema and resulted in physician office visit. It was reported that, the vaccine was given on 24Oct2021, beginning on 25Oct2021, the patient experienced fever chills, muscle aches & lethargy continuing every day through 04Nov2021. Beginning on 26Oct2021, rash on face, neck and abdomen developed with swelling in face + neck (angioedema) Benadryl 50mg Q5h, famotidine 20mg BID Started. Stated that, symptoms were worsening over the following 24 hrs. Topical Betamethasone applied and prednisone 40mg oral started on 28Oct2021, increased to 60mg on 27Oct2021 with tapering of 40mg, 20mg, 10 mg, 5mg over the next 2 weeks. Albuterol inhaler used for Sob. Hyperacusis began on 25Oct2021 and continued until present day has not resolved. Tinnitus began 26Oct2021 and lasted them on 29Oct2021. The reporter seriousness for the events hyperacusis, muscle weakness/fatigue/fever/chills, angioedema, tinnitus was reported as non-serious. Stated that, the patient provided information regarding the reported adverse event(s) with the use of the product was reported as yes and the Pfizer product had a causal effect to the adverse event was reported as yes. Stated that, the patient had weakened immune system due to Covid long haulers. The events hyperacusis, muscle weakness/fatigue/fever/chills and tinnitus did not require the initiation of new medication/other treatment/ procedure. Treatment medication included ibuprofen. The event angioedema required the initiation of new medication/other treatment/ procedure was reported as yes, Prednisone, Pepcid, EpiPen, topical Betamethasone, Benadryl 50 mg Q4, Albuterol. Therapeutic measures were taken as a result of angioedema/swelling in face + neck, severe malaise, abnormally vivid dreams, memory loss, extreme muscle cramping, functional neurological disorder. Hospitalization prolonged was reported as no. The specific relevant test for thromboembolic with thrombocytopenia was reported as none. On 28Jul2020, the patient underwent lab tests and procedures which included Covid (SARS-CoV-2 test), resulted as false negative, MD confirmed false negative. The device date was on 27Oct2021. The outcome of the events for severe malaise, hyperacusis, abnormally vivid dreams, memory loss, functional neurological disorder, extreme muscle cramping and lethargy was not recovered and events angioedema/swelling in face + neck, muscle weakness, fatigue, fever, chills and tinnitus was recovering while for the other events rash on face, neck and abdomen developed and muscle aches was unknown.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event angioedema cannot be excluded.  The case will be reassessed if additional information becomes available. 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.