Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Extreme weakness/Energy level has dropped; Trouble staying awake; severe generalized pain; Diarrhea; Lower extremities; loss of appetite; felt very sick; Arthritis pain had been worse since the vaccine, specifically below the waist; Feeling cramps and increased bowl movement; Feeling cramps and increased bowl movement; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extreme weakness/Energy level has dropped), SOMNOLENCE (Trouble staying awake), PAIN (severe generalized pain), DIARRHOEA (Diarrhea) and MUSCULAR WEAKNESS (Lower extremities) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0301A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was reported.  Concurrent medical conditions included Chronic disease and Arthritis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Extreme weakness/Energy level has dropped), SOMNOLENCE (Trouble staying awake), PAIN (severe generalized pain), DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Lower extremities), DECREASED APPETITE (loss of appetite), ILLNESS (felt very sick), ARTHRITIS (Arthritis pain had been worse since the vaccine, specifically below the waist), ABDOMINAL PAIN (Feeling cramps and increased bowl movement), FREQUENT BOWEL MOVEMENTS (Feeling cramps and increased bowl movement) and FATIGUE (fatigue). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Extreme weakness/Energy level has dropped), ARTHRITIS (Arthritis pain had been worse since the vaccine, specifically below the waist), ABDOMINAL PAIN (Feeling cramps and increased bowl movement) and FREQUENT BOWEL MOVEMENTS (Feeling cramps and increased bowl movement) had not resolved and SOMNOLENCE (Trouble staying awake), PAIN (severe generalized pain), DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Lower extremities), DECREASED APPETITE (loss of appetite), ILLNESS (felt very sick) and FATIGUE (fatigue) outcome was unknown.            Patient received COVID vaccine on 15Mar2021 in the left arm. Patient trouble staying awake, severe generalized pain, extreme weakness. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided  The patient reported that the events: arthritis, feeling cramps, increased bowel movement, and energy level dropped had been getting worse since the vaccine. However, the patient reported that events are improving with time. Updated these events to Recovering/Resolving.    Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Significant follow up appended to AER On 12-May-2021: Second dose details were updated. On 24-Jun-2021: New events were reported and outcome updated.