Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Somnolence, Vaccination complication
Clinical narrative: Confusion; FREEZING; Fever 101 F; Chills; Extreme Fatigue; Confusion after Second Shot; Sleepy after Second Shot; Less Severe Reaction after Second Shot; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), FEELING COLD (FREEZING), PYREXIA (Fever 101 F), CHILLS (Chills) and FATIGUE (Extreme Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. # 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Blood pressure high, Cholesterosis and Seizure. Concomitant products included SIMVASTATIN for Cholesterosis, METOPROLOL TARTRATE for Hypertension, VALPROATE SEMISODIUM (DEPAKOTE) for Seizures, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (Fever). On 29-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion after Second Shot), SOMNOLENCE (Sleepy after Second Shot) and VACCINATION COMPLICATION (Less Severe Reaction after Second Shot). On 14-Jun-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), FEELING COLD (FREEZING) (seriousness criterion hospitalization), PYREXIA (Fever 101 F) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and FATIGUE (Extreme Fatigue) (seriousness criterion hospitalization). The patient was hospitalized from 15-Jun-2021 to 17-Jun-2021 due to CHILLS, CONFUSIONAL STATE, FATIGUE, FEELING COLD and PYREXIA. On 31-Mar-2021, CONFUSIONAL STATE (Confusion after Second Shot), SOMNOLENCE (Sleepy after Second Shot) and VACCINATION COMPLICATION (Less Severe Reaction after Second Shot) had resolved. At the time of the report, CONFUSIONAL STATE (Confusion), FEELING COLD (FREEZING), PYREXIA (Fever 101 F), CHILLS (Chills) and FATIGUE (Extreme Fatigue) had not resolved and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 29-Mar-2021, Pyrexia: 103 f Fever 103 Fahrenheit. On 15-Jun-2021, Blood glucose: normal normal.         No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226361 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.