Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site rash, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of DIARRHEA (Diarrhea), PRURITUS (Generalized itching, some icthy areas on lower extremities), ERYTHEMA (generalized redness), ABDOMINAL PAIN (Abnormal cramping) and COLITIS (Colitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Hypertension, GABAPENTIN for Nerve pain, DICLOFENAC, OMEPRAZOLE and MIRABEGRON (MYRBETRIQ) for an unknown indication. On 03-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 09-Feb-2021, the patient experienced PRURITUS (Generalized itching, some icthy areas on lower extremities), ERYTHEMA (generalized redness), ABDOMINAL PAIN (Abnormal cramping), VACCINATION SITE URTICARIA (generalized hives, concentrated around injection site.) and VACCINATION SITE RASH (Generalized rash on arms, concentrated around injection site). On 11-Feb-2021, the patient experienced RASH (Bi-lateral rash both arms). On 15-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced COLITIS (Colitis). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, RASH (Bi-lateral rash both arms) had resolved. On 15-Feb-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 23-Feb-2021, PRURITUS (Generalized itching, some icthy areas on lower extremities), ERYTHEMA (generalized redness), ABDOMINAL PAIN (Abnormal cramping), VACCINATION SITE URTICARIA (generalized hives, concentrated around injection site.) and VACCINATION SITE RASH (Generalized rash on arms, concentrated around injection site) had resolved. At the time of the report, DIARRHOEA (Diarrhea) was resolving and COLITIS (Colitis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Colonoscopy: normal (normal) Normal. On 15-May-2021, Colonoscopy: irrited area (abnormal) Showed an irritated area. On an unknown date, Bacterial test: negative (Negative) Negative. On an unknown date, Colonoscopy: irritated area like colitis (abnormal) Showed an irritated area like colitis. On an unknown date, Culture stool: negative (Negative) Negative. On an unknown date, Parasite stool test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Updated patient demographics, lab data. Added Vaccine facility information. Added 2nd dose details.Updated Concomitant medication omeprazole and gabapentin dose,route of administration and indication. Added new concomitant medications Lisinopril, simvastatin and myrbetriq. Added new events -rash, urticaria, itching, erythema, abdominal pain with diarrhea. Updated outcome of the event diarrhea from unknown to recovering. On 20-Jun-2021: The follow-up was received on 20-Jun-21 contains no significant information.