Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dyspepsia, Fatigue, Headache
Clinical narrative: extreme sinus discomfort; Thick saliva; Diarrhoea; Light sensitivity; Decreased hunger; Abdominal pain; Headache; sickness; swelling of breast; Digestion problem; Cold sweats; Pain; Joint pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), BREAST SWELLING (swelling of breast), DYSPEPSIA (Digestion problem), COLD SWEAT (Cold sweats) and PAIN (Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045a21a and 031l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Most antibiotics-Vomiting, joint and muscle pain.), Drug allergy (Dilantin-severe muscle ties and movement), Drug allergy (Fosamax-bone infection-Jaw(left)), Drug allergy (Aspirin-migraines), Drug allergy (motrin-migraines), Drug allergy (ibuprofen-migraines), Food allergy (Coconut-sever prolonged vomiting and diarrhea MSG -sever prolonged vomiting and diarrhea  Mammal milk products and nightshade-diarrhea and constipation hive , sinuses blow-up  Garlic), Smoke sensitivity, Familial mediterranean fever, Allergy to silk (black silk sutures : flu like symptoms) and Medical procedure (PCN - swelling). Concomitant products included COLCHICINE for Familial mediterranean fever, CALCIUM GLUCONATE, ERGOCALCIFEROL (CALCIUM GLUCONATE AND VITAMIN D) and ESTRADIOL ACETATE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ILLNESS (sickness), BREAST SWELLING (swelling of breast), DYSPEPSIA (Digestion problem), COLD SWEAT (Cold sweats), PAIN (Pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced SINUS DISORDER (extreme sinus discomfort), SALIVARY HYPERSECRETION (Thick saliva), DIARRHOEA (Diarrhoea), PHOTOPHOBIA (Light sensitivity), DECREASED APPETITE (Decreased hunger), ABDOMINAL PAIN (Abdominal pain) and HEADACHE (Headache). The patient was treated with NAPHAZOLINE HYDROCHLORIDE (ALLEREST [NAPHAZOLINE HYDROCHLORIDE]) on 16-Mar-2021 at a dose of children pills and CANNABIDIOL at a dose of 1 dosage form. At the time of the report, ILLNESS (sickness), BREAST SWELLING (swelling of breast), DYSPEPSIA (Digestion problem), COLD SWEAT (Cold sweats), PAIN (Pain), SINUS DISORDER (extreme sinus discomfort), SALIVARY HYPERSECRETION (Thick saliva), DIARRHOEA (Diarrhoea), PHOTOPHOBIA (Light sensitivity), DECREASED APPETITE (Decreased hunger), ABDOMINAL PAIN (Abdominal pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also stated that she undergone surgeries - in 2016, One ovary and 2 fallopian tubes were removed, In 2018, Biopsy of removal of cyst polyp from uterus, in 2014, infection in bone of face-surgery done, in 2017, gall bladder removed. She also stated that she had taken satapentin-300 ml at bed time, Probiotics- D3 500 mg, COQ-200 mg, Prednisone+cortisone, Opioids, Atropine, Sulfa.   This case was linked to US-MODERNATX, INC.-MOD-2021-047934 (E2B Linked Report). This case was linked to MOD-2021-047934 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 contains significant information. Patient's height, weight, race, ethnicity,  medical history and events were updated. On 22-Jun-2021: Follow up contains No significant information.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported a causal relationship cannot be excluded.  Joint pain,  chills and fatigue are consistent with the known safety profile of mRNA-1273 .; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047934:1st dose