Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, Pruritus, Pyrexia, Rash
Clinical narrative: Lymph node in both armpits neck on both sides of groin area were swollen for weeks; Heart felt like skipping a beat for no reason; Itchy neck area; Rash /hives neck area; Achy joints; Low grade fever; Chills; Achy neck/throat area; Chest pain with burning sensation; Loose stools; Sore gums; GI issues; Bloody diarrhea; Ringing/ hum noise in ear/ felt like indides were tremoring; Nausea; Joint and muscle aches over entire body; Didn't feel good/ felt awful; Not getting 2nd dose; Heacy feeling in chest; Bad headache; Fatigue; Mildly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 927A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Arthritis in numerous joints) since 2005, Sulfonamide allergy, Bee sting hypersensitivity, Latex allergy, Hashimoto's disease since 1992, Hypothyroidism since 1992, Vitiligo since 1968, Ulcer since 1985 and Migraine since 1999. Concomitant products included IBUPROFEN for Arthritis, LIOTHYRONINE SODIUM (CYTOMEL) for Hypothyroidism, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine.    On 20-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced CHEST DISCOMFORT (Heacy feeling in chest), FEELING ABNORMAL (Didn't feel good/ felt awful), PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) and FATIGUE (Fatigue). 20-Mar-2021, the patient experienced HEADACHE (Bad headache). On 21-Mar-2021, the patient experienced MYALGIA (Joint and muscle aches over entire body). On 23-Mar-2021, the patient experienced TINNITUS (Ringing/ hum noise in ear/ felt like indides were tremoring) and NAUSEA (Nausea). On 24-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (GI issues). On an unknown date, the patient experienced NECK PAIN (Achy neck/throat area), CHEST PAIN (Chest pain with burning sensation), DIARRHOEA (Loose stools), GINGIVAL PAIN (Sore gums), PAIN IN EXTREMITY (Mildly sore arm), PRURITUS (Itchy neck area), SWELLING (Lymph node in both armpits neck on both sides of groin area were swollen for weeks), EXTRASYSTOLES (Heart felt like skipping a beat for no reason), RASH (Rash /hives neck area), ARTHRALGIA (Achy joints), PYREXIA (Low grade fever) and CHILLS (Chills). On 20-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea), TINNITUS (Ringing/ hum noise in ear/ felt like indides were tremoring), NECK PAIN (Achy neck/throat area), CHEST PAIN (Chest pain with burning sensation), CHEST DISCOMFORT (Heacy feeling in chest), GINGIVAL PAIN (Sore gums), FEELING ABNORMAL (Didn't feel good/ felt awful), PRURITUS (Itchy neck area), SWELLING (Lymph node in both armpits neck on both sides of groin area were swollen for weeks), EXTRASYSTOLES (Heart felt like skipping a beat for no reason), RASH (Rash /hives neck area), ARTHRALGIA (Achy joints), PYREXIA (Low grade fever), CHILLS (Chills), MYALGIA (Joint and muscle aches over entire body) and FATIGUE (Fatigue) outcome was unknown, DIARRHOEA (Loose stools), GASTROINTESTINAL DISORDER (GI issues), NAUSEA (Nausea) and HEADACHE (Bad headache) had not resolved and PAIN IN EXTREMITY (Mildly sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient didn't went to the physician. Patient experienced sore gums with two sores that were bleeding which lasted for 48 hours. Patient had been to the dentist and had a routine cleaning in Jan 2021.  No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 927A21A with associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 included patient demographics, historical conditions, concomitant medications, additional events, outcome of the events was updated and the case was updated to serious case dur to the event diarrhoea haemorrhagic.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 927A21A with associated AEs.