Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Urticaria
Clinical narrative: Hives/urticaria; Irregular heart rate/palpitations/Heart rate >100 beats per min; Feeling hot; Brain fog; 10 pounds (LBS) of fluid in the legs; feeling weak; having difficulty to walk; certain foods and water tasted bad to her/unusual taste; developed fluid at bases of both lungs; difficulty in breathing; Hypersensitivity reaction; Generalized itching; rash has not gone away/skin rash that started on right arm, chest, shoulder, and progressed across chest to left shouldera and left arm and back; joint pain; muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (feeling weak), GAIT DISTURBANCE (having difficulty to walk), TASTE DISORDER (certain foods and water tasted bad to her/unusual taste), PRURITUS (Generalized itching) and PULMONARY OEDEMA (developed fluid at bases of both lungs) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pseudogout (more joint and wrist pain and extreme swelling of both legs) since 30-Sep-2017, Atrial fibrillation (more episodes of atrial fib and PAC's) since 15-Jan-2019, Hypothyroidism, Atrial fibrillation and Hypertension. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, SOTALOL for Atrial fibrillation, AMLODIPINE for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RASH (rash has not gone away/skin rash that started on right arm, chest, shoulder, and progressed across chest to left shouldera and left arm and back), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 02-Apr-2021, the patient experienced PRURITUS (Generalized itching) and HYPERSENSITIVITY (Hypersensitivity reaction). On 02-Aug-2021, the patient experienced PULMONARY OEDEMA (developed fluid at bases of both lungs) and DYSPNOEA (difficulty in breathing). On an unknown date, the patient experienced ASTHENIA (feeling weak), GAIT DISTURBANCE (having difficulty to walk), TASTE DISORDER (certain foods and water tasted bad to her/unusual taste), URTICARIA (Hives/urticaria), PALPITATIONS (Irregular heart rate/palpitations/Heart rate >100 beats per min), FEELING HOT (Feeling hot), FEELING ABNORMAL (Brain fog) and FLUID RETENTION (10 pounds (LBS) of fluid in the legs). In June 2021, FLUID RETENTION (10 pounds (LBS) of fluid in the legs) had resolved. At the time of the report, ASTHENIA (feeling weak), GAIT DISTURBANCE (having difficulty to walk), TASTE DISORDER (certain foods and water tasted bad to her/unusual taste), RASH (rash has not gone away/skin rash that started on right arm, chest, shoulder, and progressed across chest to left shouldera and left arm and back) and ARTHRALGIA (joint pain) had not resolved, PRURITUS (Generalized itching) and MYALGIA (muscle pain) was resolving and PULMONARY OEDEMA (developed fluid at bases of both lungs), DYSPNOEA (difficulty in breathing), HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (Hives/urticaria), PALPITATIONS (Irregular heart rate/palpitations/Heart rate >100 beats per min), FEELING HOT (Feeling hot) and FEELING ABNORMAL (Brain fog) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 140/80 mmhg (abnormal) 140/80 mmHg. On 02-Apr-2021, Body temperature: 99 (High) High. On 02-Apr-2021, Heart rate: 106 abnormal. On 02-Apr-2021, Respiratory rate: 18 breaths per minute (normal) 18 breaths per minute. On an unknown date, Blood test: negative (Negative) negative for heart failure or pulmonary embolisms. On an unknown date, Computerised tomogram: negative (Negative) negative for heart failure or pulmonary embolisms. On an unknown date, Echocardiogram: negative (Negative) negative for heart failure or pulmonary embolisms. On an unknown date, Heart rate: >100 beats per min >100 beats per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction) and FLUID RETENTION (10 pounds (LBS) of fluid in the legs) to be possibly related. No further causality assessments were provided for ASTHENIA (feeling weak), GAIT DISTURBANCE (having difficulty to walk), TASTE DISORDER (certain foods and water tasted bad to her/unusual taste), PRURITUS (Generalized itching), PULMONARY OEDEMA (developed fluid at bases of both lungs), DYSPNOEA (difficulty in breathing), URTICARIA (Hives/urticaria), PALPITATIONS (Irregular heart rate/palpitations/Heart rate >100 beats per min), FEELING HOT (Feeling hot), FEELING ABNORMAL (Brain fog), RASH (rash has not gone away/skin rash that started on right arm, chest, shoulder, and progressed across chest to left shouldera and left arm and back), ARTHRALGIA (joint pain) and MYALGIA (muscle pain).    Patient still has not received her second dose of vaccine due to ongoing events.  The patient's height was 63. All these symptoms are still mildly present to this day. No oral or topical medication has resolved the skin rash, which continued to disappear and reappear on it's own. After visiting her primary care physician, tests were ordered to find the cause of the bilateral pleural effusions. All blood work, echocardiogram, and CAT angiograms wre negative for heart failure or pulmonary embolisms.   This case was linked to MOD-2021-214369 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2021: Added patient demographics, added events, added concomitant medication , added  lab test, added  medical history, added  dose details and  added narrative .