Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Body temperature, Decreased appetite, Diarrhoea, Haematochezia
Clinical narrative: fever; bloody stool; kidney infection; ureteric reflux; Calculus of ureter; appetite absent; diarrhea; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (bloody stool), KIDNEY INFECTION (kidney infection), VESICOURETERIC REFLUX (ureteric reflux), URETEROLITHIASIS (Calculus of ureter), DECREASED APPETITE (appetite absent), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 029L20A) for COVID-19 immunisation.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Atrial fibrillation, Gout, Diabetes mellitus, Gastrointestinal disorder, Arthritic pains and Surgery (gall bladder removed) in 1980. Previously administered products included for an unreported indication: POTASSIUM. Concurrent medical conditions included Adhesive tape allergy (manifested by blisters) and Drug allergy (Codeine- spasm of duct). Concomitant products included PARACETAMOL (TYLENOL) for Arthritic-like pain, APIXABAN (ELIQUIS) and DILTIAZEM for Atrial fibrillation, NATEGLINIDE and INSULIN DETEMIR (LEVEMIR) for Diabetes mellitus, DICYCLOVERINE HYDROCHLORIDE (BENTYL) and PANTOPRAZOLE for Gastrointestinal disorder, ALLOPURINOL for Gout, METOPROLOL for Heart rate, TRIAMCINOLONE for Psoriasis, FOLIC ACID and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   In 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 ml. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (fever) (seriousness criterion hospitalization). In April 2021, the patient experienced HAEMATOCHEZIA (bloody stool) (seriousness criteria hospitalization prolonged and medically significant), KIDNEY INFECTION (kidney infection) (seriousness criteria hospitalization prolonged and medically significant), VESICOURETERIC REFLUX (ureteric reflux) (seriousness criterion hospitalization prolonged), URETEROLITHIASIS (Calculus of ureter) (seriousness criterion hospitalization prolonged), DECREASED APPETITE (appetite absent) (seriousness criterion hospitalization prolonged), DIARRHOEA (diarrhea) (seriousness criterion hospitalization prolonged) and ABDOMINAL DISCOMFORT (upset stomach) (seriousness criterion hospitalization prolonged). At the time of the report, HAEMATOCHEZIA (bloody stool) and DIARRHOEA (diarrhea) had resolved, KIDNEY INFECTION (kidney infection), URETEROLITHIASIS (Calculus of ureter), DECREASED APPETITE (appetite absent) and ABDOMINAL DISCOMFORT (upset stomach) was resolving and VESICOURETERIC REFLUX (ureteric reflux) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: high (High) 101.6 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional history of patient includes: Tobacco user, 3.75 packs a day since 1974. Consumption of alcohol consisting of 3 glasses of vodka and cranberry soda daily since 1984  On ??-APR-2021, a CT scan was ordered, however results were not provided.  Treatment for the event included cefpodoxime.  This report refers to a case upon  the product administration for mRNA1273, lot# (029L20A) as second dose last April 8, 20201 and developed fever as an adverse event, however the patient experienced some reaction approximately three weeks later. Based on available information and no clear temporal association between the use of the product and start date of events, a casual relationship was assessed as unlikely related. the patients age and co-morbidities are strong confounders.; Sender's Comments: This report refers to a case upon  the product administration for mRNA1273, lot# (029L20A) as second dose last April 8, 20201 and developed fever as an adverse event, however the patient experienced some reaction approximately three weeks later. Based on available information and no clear temporal association between the use of the product and start date of events, a casual relationship was assessed as unlikely related. the patients age and co-morbidities are strong confounders.