Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nappropriate schedule of vaccine administered; trouble sleep/difficulty sleeping; slight upset stomach/gastrointestinal  distress/discomfort and fullness in my bowels; feeling not good in bowels/bowel movement was loss; fatigue; nauseas/light nausea; muscle ache; loss of appetite; loose BM (but not diarrhea); chills; slight headache; slight sorenessin arm/Muscle ache especially in ankle/slight aches in the muscles in my arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (nappropriate schedule of vaccine administered), INSOMNIA (trouble sleep/difficulty sleeping), ABDOMINAL DISCOMFORT (slight upset stomach/gastrointestinal  distress/discomfort and fullness in my bowels), BOWEL MOVEMENT IRREGULARITY (feeling not good in bowels/bowel movement was loss) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertensive heart disease (controlled via medication) on 07-Nov-2008, Sleep apnea (controlled by Bi-PAP) on 20-Aug-2009, Obesity (losing weight) on 15-Jul-2004, Osteoarthritis (osteoarthritis, seronegative rheumatoid arthritis,   increased dosage of methotrexate) on 02-Jul-2019 and Venous stasis ulcer (treating with DuoDERM) on 16-Sep-2021. Concomitant products included MONTELUKAST for Allergic rhinitis, FOLIC ACID for Anemia, DULOXETINE HYDROCHLORIDE (DULOXETINE [DULOXETINE HYDROCHLORIDE]), GLUCOSAMINE, CHONDROITIN and CURCUMA LONGA, PIPER NIGRUM (TURMERIC & BLACK PEPPAR) for Arthritis and Pain, POTASSIUM (POTASSIUM 99) for Electrolyte imbalance, NIACIN ALUMINIUM for High cholesterol, FAMOTIDINE for Hyperacidity, ATENOLOL, DILTIAZEMUM, MINOXIDIL, OLMESARTAN MEDOXOMIL and TORSEMIDE for Hypertension, ZOLPIDEM for Insomnia, MOMETASONE FUROATE for Nasal congestion, METHOTREXATE for Rheumatoid arthritis, FUROSEMIDE, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D3 for an unknown indication.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 29-Sep-2021, the patient experienced MYALGIA (slight sorenessin arm/Muscle ache especially in ankle/slight aches in the muscles in my arms and legs). On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (nappropriate schedule of vaccine administered), INSOMNIA (trouble sleep/difficulty sleeping), ABDOMINAL DISCOMFORT (slight upset stomach/gastrointestinal  distress/discomfort and fullness in my bowels), BOWEL MOVEMENT IRREGULARITY (feeling not good in bowels/bowel movement was loss), FATIGUE (fatigue), NAUSEA (nauseas/light nausea), MYALGIA (muscle ache), DECREASED APPETITE (loss of appetite), DIARRHOEA (loose BM (but not diarrhea)), CHILLS (chills) and HEADACHE (slight headache). The patient was treated with ACETAMINOPHEN (oral) for Arthritis and Pain, at a dose of 500 mg/2000 mg pm. On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (nappropriate schedule of vaccine administered), INSOMNIA (trouble sleep/difficulty sleeping), BOWEL MOVEMENT IRREGULARITY (feeling not good in bowels/bowel movement was loss), FATIGUE (fatigue), MYALGIA (slight sorenessin arm/Muscle ache especially in ankle/slight aches in the muscles in my arms and legs), NAUSEA (nauseas/light nausea), MYALGIA (muscle ache), DECREASED APPETITE (loss of appetite), DIARRHOEA (loose BM (but not diarrhea)) and CHILLS (chills) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (slight upset stomach/gastrointestinal  distress/discomfort and fullness in my bowels) and HEADACHE (slight headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has allergies to medications, food and other products: some medical tape adhesives. Treatment included flushing with fluids, taking 1000 mg of acetaminophen each day, and rest for two days First Dose: 12Feb2021 LOT:031M20A Second Dose: 12Mar2021LOT: 002A21A   This case was linked to MOD-2021-341305 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Significant Follow-up received on 04-Oct-2021. Patient medical history updated. Concomitant medication added. Event outcome updated.