Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Scar
Clinical narrative: tiny dots of scars in the affected area; hyponatremia; circular red rash that looked like a shingles rash on the lower end of her spine; itchy pustules on both sides of her spine; itchy pustules on both sides of her spine; bowel cramps; weakness; fatigue; nausea; chills; This spontaneous case was reported by a nurse and describes the occurrence of GASTROINTESTINAL PAIN (bowel cramps), ASTHENIA (weakness), RASH ERYTHEMATOUS (circular red rash that looked like a shingles rash on the lower end of her spine), PUSTULE (itchy pustules on both sides of her spine) and SCAR (tiny dots of scars in the affected area) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001b21a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Scleroderma (autoimmune condition undifferentiated mixed connective tissue disease, Lupus scleroderma which is advanced), Hyponatremia since October 2020 and Gastro-intestinal disorder NOS since October 2020. Concomitant products included HYDRALAZINE, METOPROLOL, SIMVASTATIN, HYDROXYCHLOROQUINE, PREDNISONE, ALPRAZOLAM (XANAX), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (bowel cramps), ASTHENIA (weakness), NAUSEA (nausea) and CHILLS (chills). 11-Mar-2021, the patient experienced FATIGUE (fatigue). On 13-Mar-2021, the patient experienced RASH ERYTHEMATOUS (circular red rash that looked like a shingles rash on the lower end of her spine), PUSTULE (itchy pustules on both sides of her spine) and PRURITUS (itchy pustules on both sides of her spine). On 15-May-2021, the patient experienced HYPONATRAEMIA (hyponatremia). On 21-May-2021, the patient experienced SCAR (tiny dots of scars in the affected area). On 12-Mar-2021, GASTROINTESTINAL PAIN (bowel cramps), ASTHENIA (weakness), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, RASH ERYTHEMATOUS (circular red rash that looked like a shingles rash on the lower end of her spine), PUSTULE (itchy pustules on both sides of her spine), SCAR (tiny dots of scars in the affected area), PRURITUS (itchy pustules on both sides of her spine) and HYPONATRAEMIA (hyponatremia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood sodium: 34 (Inconclusive) normal on lab work drawn on 19May2021  recheck of her sodium level today was 34.. On 19-May-2021, SARS-CoV-2 test: negative (Negative) showed no antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-162320 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162320:first dose