Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Fatigue, Headache
Clinical narrative: unable to perform daily activities; Injection site pruritus; injection site warmth; Fever 99.2 F degrees; Headache; joint pains; muscle and body aches; Injection site swelling; injection site redness; Diarrhoea; Injection site pain; fatigue and tiredness; Nausea; Flu-like Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to perform daily activities), INJECTION SITE PRURITUS (Injection site pruritus), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and INJECTION SITE WARMTH (injection site warmth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Ceclor), Multiple myeloma (Not receiving any oncology medical treatment- Newly Diagnosed) on 19-Oct-2020, Sick sinus syndrome on 01-Jun-2017, Asthma on 02-Jan-1976, Sleep apnea on 01-Jun-2000, Hypotension on 31-Dec-2000 and Drug allergy (Codeine). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) from 01-Jan-2016 to an unknown date for Angina attack, IVABRADINE HYDROCHLORIDE (CORLANOR) from 01-May-2018 to an unknown date for Hypertensive, GABAPENTIN (NEURONTIN) from 01-Jan-2019 to an unknown date for Neuropathy, RIVAROXABAN (XARELTO) from 01-Aug-2019 to an unknown date for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like Symptoms). On 02-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), FATIGUE (fatigue and tiredness), NAUSEA (Nausea) and INJECTION SITE PAIN (Injection site pain). On 03-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to perform daily activities), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE WARMTH (injection site warmth), PYREXIA (Fever 99.2 F degrees), HEADACHE (Headache), ARTHRALGIA (joint pains), MYALGIA (muscle and body aches), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (injection site redness). The patient was treated with PARACETAMOL (TYLENOL) on 02-Mar-2021 at a dose of 1 dosage form. On 11-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like Symptoms) had resolved. On 04-Mar-2021, PYREXIA (Fever 99.2 F degrees) had resolved. On 05-Mar-2021, DIARRHOEA (Diarrhoea), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to perform daily activities), INJECTION SITE WARMTH (injection site warmth), FATIGUE (fatigue and tiredness), HEADACHE (Headache) and MYALGIA (muscle and body aches) had resolved. On 06-Mar-2021, INJECTION SITE PRURITUS (Injection site pruritus), NAUSEA (Nausea) and ARTHRALGIA (joint pains) had resolved. On 09-Mar-2021, INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (injection site redness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 99.2 (Inconclusive) 99.2 F degree. On 04-Mar-2021, Body temperature: 98.9 (Inconclusive) 98.9 F degrees.   Concomitant medication Rivaroxaban is indicated for used as Anticoagulant. Concomitant product includes: Xopenex Nebulizer Solution/ Xopenex Inhaler of strength 1.25mg 3mL/ 45mcg, Indicated for use as Bronchospasms/ Bronchodilator started on 01-OCT-2018 Treatment Medication includes: Tylenol Action taken with mRNA-1273 in response to the events is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant Follow Up was received on 20-May-2021 patient demographics, concomitant medication, medical history, first dose details,second dose additional eventsand event outcome was updated.