Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep deficit, Vaccination site pain
Clinical narrative: sweating profusely from his palms and feet; dizziness; could not breathe; severe headache; Confusion; Sleep deprivation; High BP; chills; sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), CONFUSIONAL STATE (Confusion), SLEEP DEFICIT (Sleep deprivation), BLOOD PRESSURE INCREASED (High BP), HYPERHIDROSIS (sweating profusely from his palms and feet), DIZZINESS (dizziness) and DYSPNOEA (could not breathe) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced CHILLS (chills), VACCINATION SITE PAIN (sore arm) and PYREXIA (Fever). On 29-Aug-2021, the patient experienced HEADACHE (severe headache) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), SLEEP DEFICIT (Sleep deprivation) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (High BP) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization) and DYSPNOEA (could not breathe) (seriousness criterion hospitalization). On 06-Sep-2021, the patient experienced HYPERHIDROSIS (sweating profusely from his palms and feet) (seriousness criterion hospitalization). The patient was hospitalized on 06-Sep-2021 due to BLOOD PRESSURE INCREASED, CONFUSIONAL STATE, DIZZINESS, DYSPNOEA, HEADACHE, HYPERHIDROSIS and SLEEP DEFICIT. At the time of the report, HEADACHE (severe headache), CONFUSIONAL STATE (Confusion), SLEEP DEFICIT (Sleep deprivation), BLOOD PRESSURE INCREASED (High BP), DIZZINESS (dizziness) and DYSPNOEA (could not breathe) outcome was unknown, HYPERHIDROSIS (sweating profusely from his palms and feet) and VACCINATION SITE PAIN (sore arm) had not resolved and CHILLS (chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Blood pressure measurement (97-166): 166/97 (High) High. On 30-Aug-2021, Computerised tomogram: abnormal (abnormal) Cat Scan were splotches showing on the white matter of his brain they released him. On 06-Sep-2021, Blood pressure measurement (97-166): 178/110 (High) High.         Concomitant medication was not provided Treatment medication was not provided  Company Comment: This case concerns a 51 year-old male patient, with no medical history reported, who experienced the unexpected adverse events of HEADACHE, DIZZINESS, DYSPNOEA, CONFUSIONAL STATE, SLEEP DEPRIVATION, BLOOD PRESSURE INCREASED and HYPERHIDROSIS. Events of headache, dizziness, dyspnoea, confusional state, sleep deprivation and blood pressure increased occurred 4 days after the second dose of Spikevax. Event of hyperhidrosis occurred approximately 12 days after the second dose of Spikevax. Negative rechallenge remains a confounder. The benefit-risk relation of Spikevax is not affected by this report. Further information is expected for assessment.   This case was linked to MOD-2021-321038 (Patient Link).; Sender's Comments: This case concerns a 51 year-old male patient, with no medical history reported, who experienced the unexpected adverse events of HEADACHE, DIZZINESS, DYSPNOEA, CONFUSIONAL STATE, SLEEP DEPRIVATION, BLOOD PRESSURE INCREASED and HYPERHIDROSIS. Events of headache, dizziness, dyspnoea, confusional state, sleep deprivation and blood pressure increased occurred 4 days after the second dose of Spikevax. Event of hyperhidrosis occurred approximately 12 days after the second dose of Spikevax. Negative rechallenge remains a confounder. The benefit-risk relation of Spikevax is not affected by this report. Further information is expected for assessment.