Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Mania, Muscle fatigue, Myalgia, Sneezing, Somnolence
Clinical narrative: Fatigue (general and lingering), made it difficult to wake up and groggy the next morning and day; Fatigue (general and lingering), made it difficult to wake up and groggy the next morning and day; muscle fatigue and soreness (mainly in legs); muscle fatigue and soreness (mainly in legs); irritability; higher heart rate and resting heart rate than usual; stomach cramps late the first night (didn't feel like hunger); anxiety; stress; worry; lethargy lasting into the next day; Dry mouth; felt dehydrated; sneezing; felt manic and slightly depressed well into the next day; felt manic and slightly depressed well into the next day; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma/asthmatic bronchitis" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Peanuts/legumes allergy" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; FLOVENT; PREDNISONE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE;  MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE;  MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering"; FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 30Oct2023 at 17:00, outcome "recovering" and all described as "Fatigue (general and lingering), made it difficult to wake up and groggy the next morning and day"; ANXIETY (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering"; DEHYDRATION (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering", described as "felt dehydrated"; MANIA (non-serious), DEPRESSED MOOD (non-serious) all with onset 30Oct2023 at 17:00, outcome "recovering" and all described as "felt manic and slightly depressed well into the next day"; HEART RATE INCREASED (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering", described as "higher heart rate and resting heart rate than usual"; IRRITABILITY (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering"; LETHARGY (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering", described as "lethargy lasting into the next day"; MUSCLE FATIGUE (non-serious), MYALGIA (non-serious) all with onset 30Oct2023 at 17:00, outcome "recovering" and all described as "muscle fatigue and soreness (mainly in legs)"; SNEEZING (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering", described as "stomach cramps late the first night (didn't feel like hunger)"; STRESS (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering"; ANXIETY (non-serious) with onset 30Oct2023 at 17:00, outcome "recovering", described as "worry". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, somnolence, muscle fatigue, myalgia, irritability, heart rate increased, abdominal pain upper, anxiety, stress, anxiety, lethargy, dry mouth, dehydration, sneezing, mania, depressed mood.  Additional Information: The patient did not experience COVID prior to vaccination and was not tested post vaccination. The patient did not have other vaccine in four weeks. The patient received dose 5 of Comirnaty on 30Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.