Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Facial paralysis, Lethargy, Malaise, Somnolence
Clinical narrative: Mouth is drooping/Headache; Got the Moderna Bivalent vaccine and he is not doing very well; Lethargic; Falling asleep; No energy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FACIAL PARALYSIS (Mouth is drooping/Headache) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced FACIAL PARALYSIS (Mouth is drooping/Headache) (seriousness criterion medically significant), MALAISE (Got the Moderna Bivalent vaccine and he is not doing very well), LETHARGY (Lethargic), SOMNOLENCE (Falling asleep) and ASTHENIA (No energy). At the time of the report, FACIAL PARALYSIS (Mouth is drooping/Headache), MALAISE (Got the Moderna Bivalent vaccine and he is not doing very well), LETHARGY (Lethargic), SOMNOLENCE (Falling asleep) and ASTHENIA (No energy) outcome was unknown.            No concomitant medications were reported.  The caller thought that the patient might be having a stroke.  No treatment drugs were reported.  Company comment: This spontaneous case concerns a male patient of an unspecified age, with no medical history reported, who experienced the expected serious (medically significant) event of Facial paralysis (reported as Mouth is drooping) that occurred unknown days after receiving an unspecified dose of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available.  It was reported that patient was unwell, lethargic , sleepy and had no energy. Patient's sister felt that he might be having a stroke. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unspecified age, with no medical history reported, who experienced the expected serious (medically significant) event of Facial paralysis (reported as Mouth is drooping) that occurred unknown days after receiving an unspecified dose of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available.  It was reported that patient was unwell, lethargic , sleepy and had no energy. Patient's sister felt that he might be having a stroke. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.