Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Mental status changes, Sleep disorder, Speech disorder
Clinical narrative: Mental changes; anxiety; Cognitive issues; Speech issues; Chills; Headache; Diarrhea; Low appetite; Sleep issues; crying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 11:00 (Lot number: EW0150) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bipolar" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LITHIUM; VENLAFAXINE; LORAZEPAM; ATORVASTATIN. The following information was reported: MENTAL STATUS CHANGES (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Mental changes"; ANXIETY (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "anxiety"; COGNITIVE DISORDER (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Cognitive issues"; SPEECH DISORDER (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Speech issues"; CHILLS (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Headache"; DIARRHOEA (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Low appetite"; SLEEP DISORDER (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "Sleep issues"; CRYING (non-serious) with onset 31Mar2021 06:00, outcome "recovering", described as "crying". The events "mental changes", "anxiety", "cognitive issues", "speech issues", "chills", "headache", "diarrhea", "low appetite", "sleep issues" and "crying" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of mental status changes, anxiety, cognitive disorder, speech disorder, chills, headache, diarrhoea, decreased appetite, sleep disorder, crying.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination with lithium, venlafaxine, lorazepam, atorvastatin, multivi. The adverse event result following in doctor (other healthcare professional) office (clinic visit). The patient had not been tested for COVID-19 since the vaccination. Known allergies reported as unknown. It was reported as no for serious, seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered was public health clinic/administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 reported as unknown. Allergies to medications, food, or other products reported as unknown.    No follow-up attempts are possible. No further information is expected.