Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Drug ineffective, Dyspnoea, Head discomfort, Insomnia
Clinical narrative: SARS-CoV-2 test: (27Jan2022) Positive; SARS-CoV-2 test: (27Jan2022) Positive; tachycardia; blood pressure fluctuations; shortness of breath; vertigo; tremors; tinnitus and severe insomnia; tinnitus and severe insomnia; Condition was disruptive enough to require accommodations allowing me to work from home; internal vibrations; tingling/burning in fingers/hands; tingling/burning in fingers/hands; weakness in arms or legs; chest discomfort; pressure at back of head/neck; shoulder, neck/ tingling/burning; shoulder, neck/ tingling/burning; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: F18757) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (prev dose product: COVID 19, prev dose brand: Moderna, prev dose brand unknown: False, prev dose lot number: 039A21A, prev dose lot unknown: False, prev dose administration date: 30Mar2021 prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 30Mar2021, when the patient was 39-year-old, for Covid-19 immunization; moderna covid-19 vaccine (prev dose product: COVID 19, prev dose brand: Moderna, prev dose brand unknown: False, prev dose lot number: 012A21A, prev dose lot unknown: False, prev dose administration date: 02Mar2021 prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 02Mar2021, when the patient was 39-year-old, for Covid-19 immunization. The following information was reported: DISABILITY (disability) with onset 17Dec2021, outcome "recovering", described as "Condition was disruptive enough to require accommodations allowing me to work from home"; BLOOD PRESSURE ABNORMAL (disability) with onset 17Dec2021, outcome "recovering", described as "blood pressure fluctuations"; CHEST DISCOMFORT (disability) with onset 17Dec2021, outcome "recovering"; JOINT VIBRATION (disability) with onset 17Dec2021, outcome "recovering", described as "internal vibrations"; HEAD DISCOMFORT (disability) with onset 17Dec2021, outcome "recovering", described as "pressure at back of head/neck"; DYSPNOEA (disability) with onset 17Dec2021, outcome "recovering", described as "shortness of breath"; BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 17Dec2021, outcome "recovering" and all described as "shoulder, neck/ tingling/burning"; TACHYCARDIA (disability) with onset 17Dec2021, outcome "recovering"; BURNING SENSATION (disability), PARAESTHESIA (disability) all with onset 17Dec2021, outcome "recovering" and all described as "tingling/burning in fingers/hands"; TINNITUS (disability), INSOMNIA (disability) all with onset 17Dec2021, outcome "recovering" and all described as "tinnitus and severe insomnia"; TREMOR (disability) with onset 17Dec2021, outcome "recovering", described as "tremors"; VERTIGO (disability) with onset 17Dec2021, outcome "recovering"; ASTHENIA (disability) with onset 17Dec2021, outcome "recovering", described as "weakness in arms or legs"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "SARS-CoV-2 test: (27Jan2022) Positive". The events "sars-cov-2 test: (27jan2022) positive", "tachycardia", "blood pressure fluctuations", "shortness of breath", "vertigo", "tremors", "tinnitus and severe insomnia", "condition was disruptive enough to require accommodations allowing me to work from home", "internal vibrations", "tingling/burning in fingers/hands", "weakness in arms or legs", "chest discomfort", "pressure at back of head/neck" and "shoulder, neck/ tingling/burning" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (17Mar2022) Positive, notes: Blood test; SARS-CoV-2 test: (27Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of tachycardia, blood pressure abnormal, dyspnoea, vertigo, tremor, tinnitus, insomnia, disability, joint vibration, burning sensation, paraesthesia, asthenia, chest discomfort, head discomfort, burning sensation, paraesthesia. Clinical information: After receiving the Pfizer booster, I experienced tachycardia, blood pressure fluctuations, shortness of breath, vertigo and tremors. This continued for four weeks at which point the tremors subsided and were replaced with internal vibrations, vertigo, tinnitus and severe insomnia. Four months later, I continue to experience these symptoms, along with occasional other symptoms like tingling/burning in fingers/hands, shoulder, neck and/or under scalp, pressure at back of head/neck, weakness in arms or legs, and chest discomfort. Condition was disruptive enough to require accommodations allowing me to work from home. No covid prior vaccination. Patient tested covid positive post vaccination.; Sender's Comments: Based on the available information in the case, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.