Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: could not do regular home chores; Fatigue; fever; Body aches; nausea; vaccination site urticaria; Chills; hypersensitivity reaction; autoimmune disorder; difficulty breathing; taste unusal; Generalized itching; redness; palpitation; diarrhea; abdominal cramping; itchy eyes; Sneezing; Swallowing difficult; wheezing; Hoarseness; Chest tightness; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune disorder) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MWA and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Hay fever, Hypersensitivity reaction, Psoriatic arthritis, Rheumatoid arthritis, Coronary artery disease, Hypothyroidism, Type 2 diabetes mellitus, Chronic kidney disease, Immunocompromised, Drug allergy (Cimzia), Drug allergy (Remicade Hyperglycemia and High blood pressure), Drug allergy (Methotrexate), Drug allergy (Morphine), Drug allergy (Prolia Reaction included Lack of breath and fatigue.) and Drug allergy (Evenity). Concomitant products included VITAMIN D3 and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Chronic kidney disease.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced AUTOIMMUNE DISORDER (autoimmune disorder) (seriousness criterion medically significant), DYSPNOEA (difficulty breathing), AGEUSIA (taste unusal), PRURITUS (Generalized itching), ERYTHEMA (redness), PALPITATIONS (palpitation), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), EYE PRURITUS (itchy eyes), SNEEZING (Sneezing), DYSPHAGIA (Swallowing difficult), WHEEZING (wheezing), DYSPHONIA (Hoarseness), CHEST DISCOMFORT (Chest tightness), HYPOAESTHESIA (Numbness), NAUSEA (nausea), VACCINATION SITE URTICARIA (vaccination site urticaria), CHILLS (Chills) and HYPERSENSITIVITY (hypersensitivity reaction). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not do regular home chores), FATIGUE (Fatigue), PYREXIA (fever) and MYALGIA (Body aches). The patient was treated with PREDNISONE (oral) on 30-Mar-2021 for Adverse event, at an unspecified dose and frequency. On 30-Mar-2021, AUTOIMMUNE DISORDER (autoimmune disorder), PRURITUS (Generalized itching), ERYTHEMA (redness), PALPITATIONS (palpitation), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), EYE PRURITUS (itchy eyes), SNEEZING (Sneezing), DYSPHAGIA (Swallowing difficult), WHEEZING (wheezing), DYSPHONIA (Hoarseness), CHEST DISCOMFORT (Chest tightness), HYPOAESTHESIA (Numbness), NAUSEA (nausea), VACCINATION SITE URTICARIA (vaccination site urticaria), CHILLS (Chills) and HYPERSENSITIVITY (hypersensitivity reaction) had resolved. At the time of the report, DYSPNOEA (difficulty breathing), AGEUSIA (taste unusal) and FATIGUE (Fatigue) had not resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not do regular home chores), PYREXIA (fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Blood pressure measurement: 221/100 (High) 221/100 mmHg. On 25-Aug-2021, Body temperature: 94.1 (normal) 94.1 degree Fahrenheit. On 25-Aug-2021, Heart rate: 88 (normal) 88 bpm. On 25-Aug-2021, Respiratory rate: 90 (High) 90 breaths per minute. On 28-Aug-2021, Blood pressure measurement: 186/85 (High) 186/85 mmHg. On 28-Aug-2021, Body temperature: 96.2 (normal) 96.2 degree Fahrenheit. On 28-Aug-2021, Heart rate: 106 (High) 106 bpm. On 28-Aug-2021, Respiratory rate: 92 (High) 92 breaths per minute. On 31-Aug-2021, Blood pressure measurement: 189/88 (High) 189/88 mmHg. On 31-Aug-2021, Body temperature: 98.2 (normal) 98.2 degree Fahrenheit. On 31-Aug-2021, Heart rate: 115 (High) 115 bpm. On 31-Aug-2021, Respiratory rate: 92 (High) 92 breaths per minute. On 12-Sep-2021, Blood pressure measurement: 216/104 (High) 216/104 mmHg. On 12-Sep-2021, Body temperature: 98.6 (normal) 98.6 degree Fahrenheit. On 12-Sep-2021, Heart rate: 103 (High) 103 bpm. On 14-Sep-2021, Blood pressure measurement: 206/84 (High) 206/84 mmHg. On 14-Sep-2021, Body temperature: 94.1 (normal) 94.1 degree Fahrenheit. On an unknown date, Body temperature: 104 (High) 104 degree Fahrenheit.         Company comment: This case concerns a 69 year old female patient, with medical history of asthma, psoriatic arthritis, rheumatoid arthritis, diabetes type II, chronic kidney disease, coronary artery disease, hypothyroidism  and past drugs allergic reactions, who experienced non serious unexpected events of autoimmune disorder, dyspnoea, ageusia (AESI), chest discomfort and hypoaesthesia after second dose of mRNA-1273. The events occurred the same day after the second dose of mRNA-1273. Patient´s medical history of autoimmune disease (such as diabetes mellitus type II, rheumatoid arthritis and hypothyroidism) remains a confounder for the event autoimmune disorder and medical history of asthma remains a confounder for the event dyspnoea. The benefit-risk relationship of Spikevax in not affected by this report. Event autoimmune disorder was automatically upgraded as serious as per Regulatory Authority list. However, based on information available and as per medical judgement was assessed as non-serious.   This case was linked to MOD-2021-310310 (Patient Link).; Sender's Comments: This case concerns a 69 year old female patient, with medical history of asthma, psoriatic arthritis, rheumatoid arthritis, diabetes type II, chronic kidney disease, coronary artery disease, hypothyroidism  and past drugs allergic reactions, who experienced non serious unexpected events of autoimmune disorder, dyspnoea, ageusia (AESI), chest discomfort and hypoaesthesia after second dose of mRNA-1273. The events occurred the same day after the second dose of mRNA-1273. Patient´s medical history of autoimmune disease (such as diabetes mellitus type II, rheumatoid arthritis and hypothyroidism) remains a confounder for the event autoimmune disorder and medical history of asthma remains a confounder for the event dyspnoea. The benefit-risk relationship of Spikevax in not affected by this report. Event autoimmune disorder was automatically upgraded as serious as per regulatory authority list. However, based on information available and as per medical judgement was assessed as non-serious.