Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Loss of personal independence in daily activities, Magnetic resonance imaging, Migraine, Myalgia
Clinical narrative: Migraines; dizziness; blurred vision; extreme light sensitivity; depression; hypersomnia; elevated blood pressures; palpitations; Debilitating, now cannot work; nausea; fatigue; myalgias; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 40-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 2, single (Lot number: FF8841) at the age of 40 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "generalized anxiety since symptoms started" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number= EW0100), for Covid-19 Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset 08Oct2021, outcome "not recovered", described as "Debilitating, now cannot work"; VISION BLURRED (disability) with onset 08Oct2021, outcome "not recovered", described as "blurred vision"; DEPRESSION (disability) with onset 08Oct2021, outcome "not recovered"; DIZZINESS (disability) with onset 08Oct2021, outcome "not recovered"; BLOOD PRESSURE INCREASED (disability) with onset 08Oct2021, outcome "not recovered", described as "elevated blood pressures"; PHOTOPHOBIA (disability) with onset 08Oct2021, outcome "not recovered", described as "extreme light sensitivity"; FATIGUE (disability) with onset 08Oct2021, outcome "not recovered"; HYPERSOMNIA (disability) with onset 08Oct2021, outcome "not recovered"; MYALGIA (disability) with onset 08Oct2021, outcome "not recovered", described as "myalgias"; NAUSEA (disability) with onset 08Oct2021, outcome "not recovered"; PALPITATIONS (disability) with onset 08Oct2021, outcome "not recovered"; MIGRAINE (disability) with onset 09Oct2021, outcome "not recovered", described as "Migraines". The events "migraines", "dizziness", "blurred vision", "extreme light sensitivity", "depression", "hypersomnia", "elevated blood pressures", "palpitations", "debilitating, now cannot work", "nausea", "fatigue" and "myalgias" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: elevated; Magnetic resonance imaging: Negative. Therapeutic measures were taken as a result of migraine, dizziness, vision blurred, photophobia, depression, hypersomnia, blood pressure increased, palpitations, loss of personal independence in daily activities, nausea, fatigue, myalgia.  Clinical course: Migraines started 09Oct2021; ongoing since then (current date 21Jun2022. Debilitating, now cannot work. nausea, dizziness, blurred vision, extreme light sensitivity, fatigue, depression, hypersomnia, elevated blood pressures, myalgias, palpitations. MRI negative, multiple medications tried without resolution, being treated by neurology without resolution. Patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Other medical history: HTN and generalized anxiety since symptoms started. AE treatment: amytriptilline, sumatriptan, maxalt, propanolol, botox injections, ajovy, ibuprofen, Tylenol.; Sender's Comments: As there is limited information in the case provided, the causal association between the serious reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   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.