Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: lot of sleeping; diarrhea; fever of 102 Degrees Farenheight; nausea; widespread muscle aches; fatigue; Felt bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), HYPERSOMNIA (lot of sleeping), DIARRHOEA (diarrhea), PYREXIA (fever of 102 Degrees Farenheight) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 033F21A, 014M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Felt bad). On 05-Apr-2022, the patient experienced HYPERSOMNIA (lot of sleeping), DIARRHOEA (diarrhea), PYREXIA (fever of 102 Degrees Farenheight), NAUSEA (nausea), MYALGIA (widespread muscle aches) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (Felt bad), HYPERSOMNIA (lot of sleeping), DIARRHOEA (diarrhea), PYREXIA (fever of 102 Degrees Farenheight), NAUSEA (nausea), MYALGIA (widespread muscle aches) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2022, Body temperature: 102 (High) Had a fever of 102 degrees Fahrenheit.         No concomitant drug reported. The patient complains of no adverse reactions or side effects after her first and second dose of Moderna COVID-19 vaccine. No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a 68 year old female patient with no medical history reported who experienced Non-serious , unexpected. AESI event of hypersomnia  which occurred 2 days post vaccination with the 4th dose ( 2nd booster dose ) of mRNA-1273 vaccine. The other 3 previous Covid 19 vaccine of this patient was also mRNA-1273 vaccine. This was accompanied by other non-serious , unexpected events of feeling abnormal , diarrhea ( expected for SmPC)  and non-serious , expected events of pyrexia , myalgia , fatigue and nausea . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of all of the events was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up contains No new information.; Sender's Comments: This spontaneous case concerns a 68 year old female patient with no medical history reported who experienced Non-serious , unexpected. AESI event of hypersomnia  which occurred 2 days post vaccination with the 4th dose ( 2nd booster dose ) of mRNA-1273 vaccine. The other 3 previous Covid 19 vaccine of this patient was also mRNA-1273 vaccine. This was accompanied by other non-serious , unexpected events of feeling abnormal , diarrhea ( expected for EEA SmPC)  and non-serious , expected events of pyrexia , myalgia , fatigue and nausea . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of all of the events was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.