Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Dyspnoea
Clinical narrative: Diagnosed with Pleurisy in the lungs; Inability to take a deep breath; Cough; Feeling hot; Right side of rib hurts with taking deep breaths/ inability to take a deep breath; Body Aches; Joint Pain; Chills; Fever 100.1F; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of PLEURISY (Diagnosed with Pleurisy in the lungs) and DYSPNOEA (Inability to take a deep breath) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21 and 048A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Atrial fibrillation (Atrial fibrillation/Supra ventricular tachycardia) since 05-Apr-2020. Concomitant products included VERAPAMIL from 05-May-2017 to an unknown date, ACETYLSALICYLIC ACID (BAYER ASPIRIN) from 01-Feb-2003 to an unknown date and TAMSULOSIN HYDROCHLORIDE (TAMSULIN) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Right side of rib hurts with taking deep breaths/ inability to take a deep breath), PAIN (Body Aches), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever 100.1F) and MYALGIA (Muscle Aches). On an unknown date, the patient experienced PLEURISY (Diagnosed with Pleurisy in the lungs) (seriousness criterion medically significant), DYSPNOEA (Inability to take a deep breath) (seriousness criterion medically significant), COUGH (Cough) and FEELING HOT (Feeling hot). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) for Pleurisy, at a dose of 500 milligram twice a day and TRAMADOL HYDROCHLORIDE (ULTRAM [TRAMADOL HYDROCHLORIDE]) ongoing since an unknown date for Pleurisy, at a dose of 50 milligram. At the time of the report, PLEURISY (Diagnosed with Pleurisy in the lungs), DYSPNOEA (Inability to take a deep breath), COUGH (Cough), FEELING HOT (Feeling hot), MUSCULOSKELETAL CHEST PAIN (Right side of rib hurts with taking deep breaths/ inability to take a deep breath), PAIN (Body Aches), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever 100.1F) and MYALGIA (Muscle Aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 101.1 (High) 101.1 degrees Fahrenheit. In 2021, Body temperature: 104 (High) 104. In 2021, Fibrin D dimer (Unknown-500): 3500 (High) 3500. In 2021, White blood cell count: elevated (High) Elevated.         On 05-May-2021 patient visited emergency room and Upon arrival from emergency room visit patient was given a CT scan of lungs.   This case was linked to MOD-2021-103270, MOD-2021-109892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional events added. On 25-Jun-2021: Follow up email uploaded. Added outcome of events. On 13-Jul-2021: Follow-up received on 13-JUL-2021. Patient demographic details and medical history updated. Product batch numbers updated. Concomitants-Verapamil, Bayer, Tamsulin were added. Event cough and feeling hot was added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.