Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Hypotension, Myalgia
Clinical narrative: left extremely weak; shakey; hypotensive; abdominal pain; explosive diarrhea that was brown and watery/gooey slimy and green; aches and pains; Soreness on arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Soreness on arm), DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green), TREMOR (shakey), HYPOTENSION (hypotensive) and ABDOMINAL PAIN (abdominal pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included BPH since 01-Jan-1995. Concomitant products included FINASTERIDE (PROSCAR) from 01-Jan-1995 to an unknown date and TERAZOSIN HYDROCHLORIDE (HYTRIN) from 01-Jan-2021 to an unknown date for BPH.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness on arm). On 19-Jan-2021, the patient experienced MYALGIA (aches and pains). On 20-Jan-2021, the patient experienced DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green) and ABDOMINAL PAIN (abdominal pain). On 21-Jan-2021, the patient experienced TREMOR (shakey) and HYPOTENSION (hypotensive). On an unknown date, the patient experienced ASTHENIA (left extremely weak). On 18-Jan-2021, PAIN IN EXTREMITY (Soreness on arm) had resolved. On 19-Jan-2021, MYALGIA (aches and pains) had resolved. On 22-Jan-2021, DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green), TREMOR (shakey) and HYPOTENSION (hypotensive) had resolved. At the time of the report, ABDOMINAL PAIN (abdominal pain) and ASTHENIA (left extremely weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test negative: negative (Negative) NEGATIVE.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green) and ABDOMINAL PAIN (abdominal pain) to be not related. No further causality assessments were provided for PAIN IN EXTREMITY (Soreness on arm), TREMOR (shakey), HYPOTENSION (hypotensive), ASTHENIA (left extremely weak) and MYALGIA (aches and pains).    The patient denied taking any treatment for the events.  He did follow-up with an infectious diseases doctor who recommended he receive the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient demographics, medical history, concomitant medication details and event details updated. New events (weakness and abdominal pain) added. 2nd dose events reported. On 05-Jul-2021: The patient reportedly saw an infectious diseases doctor who did not think the events diarrhea and abdominal pain were related to the vaccine. Causality updated to not related for those events.