Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pneumonia, Product dose omission issue, Pulmonary fibrosis, Pulmonary oedema
Clinical narrative: Painful hips/Lot of pain in hips with Humira (adalimumab); Arthritis; Asthma; Lot of pain in her ribs; Seasonal allergy; The first covid vaccine injection left a big knot on her arm, so she had not gotten the second one; COVID-19 pneumonia; COVID-19; Right middle lobe pneumonia/Pneumonia in right lung; Vaccination site nodule/COVID vaccine left big knot on arm; Injection site itching/Injection site itchy like a mosquito bite; Lung edema/ Fluid in lungs which was restricting airflow; Lung scarring/ Scarring in lungs which was restricting airflow; Injection site burning/Burning after injection; Injection site redness/Injection site red like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Right middle lobe pneumonia/Pneumonia in right lung), VACCINATION SITE NODULE (Vaccination site nodule/COVID vaccine left big knot on arm), ARTHRALGIA (Painful hips/Lot of pain in hips with Humira (adalimumab)), ARTHRITIS (Arthritis), ASTHMA (Asthma), PULMONARY OEDEMA (Lung edema/ Fluid in lungs which was restricting airflow), PULMONARY FIBROSIS (Lung scarring/ Scarring in lungs which was restricting airflow), COVID-19 (COVID-19) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Automobile accident (The patient was in a car wreck on 06-Aug-2021, a deer hit her car. Patient was completely stopped but when took her foot off the brake, the deer ran into the car spinning it around and going over the top. It completely totaled patient's vehicle. Patient thought that why her next two injections were red and itchy.) on 06-Aug-2021.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE NODULE (Vaccination site nodule/COVID vaccine left big knot on arm) (seriousness criterion medically significant), PULMONARY OEDEMA (Lung edema/ Fluid in lungs which was restricting airflow) (seriousness criterion medically significant), PULMONARY FIBROSIS (Lung scarring/ Scarring in lungs which was restricting airflow) (seriousness criterion medically significant), INJECTION SITE PRURITUS (Injection site itching/Injection site itchy like a mosquito bite), INJECTION SITE PAIN (Injection site burning/Burning after injection) and INJECTION SITE ERYTHEMA (Injection site redness/Injection site red like a mosquito bite). In November 2021, the patient experienced PNEUMONIA (Right middle lobe pneumonia/Pneumonia in right lung) (seriousness criterion medically significant). In December 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant) and COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Painful hips/Lot of pain in hips with Humira (adalimumab)) (seriousness criterion medically significant), ARTHRITIS (Arthritis) (seriousness criterion medically significant), ASTHMA (Asthma) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (Lot of pain in her ribs), SEASONAL ALLERGY (Seasonal allergy) and PRODUCT DOSE OMISSION ISSUE (The first covid vaccine injection left a big knot on her arm, so she had not gotten the second one). The patient was treated with Manual therapy (Respiratory therapy twice a week) for COVID-19 pneumonia. At the time of the report, PNEUMONIA (Right middle lobe pneumonia/Pneumonia in right lung), VACCINATION SITE NODULE (Vaccination site nodule/COVID vaccine left big knot on arm), ARTHRALGIA (Painful hips/Lot of pain in hips with Humira (adalimumab)), ARTHRITIS (Arthritis), ASTHMA (Asthma), MUSCULOSKELETAL CHEST PAIN (Lot of pain in her ribs) and SEASONAL ALLERGY (Seasonal allergy) had not resolved, PULMONARY OEDEMA (Lung edema/ Fluid in lungs which was restricting airflow), PULMONARY FIBROSIS (Lung scarring/ Scarring in lungs which was restricting airflow), COVID-19 (COVID-19), INJECTION SITE PRURITUS (Injection site itching/Injection site itchy like a mosquito bite), INJECTION SITE ERYTHEMA (Injection site redness/Injection site red like a mosquito bite) and PRODUCT DOSE OMISSION ISSUE (The first covid vaccine injection left a big knot on her arm, so she had not gotten the second one) outcome was unknown and COVID-19 PNEUMONIA (COVID-19 pneumonia) and INJECTION SITE PAIN (Injection site burning/Burning after injection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Chest X-ray: showed some remaining fluid in lungs and scarring (abnormal) Showed some remaining fluid in her lungs and scarring in her lungs which is restricting airflow. In December 2021, SARS-CoV-2 test: positive with delta and omicron (Positive) Positive with delta and omicron variants around Christmas.. On an unknown date, Oxygen saturation: dropped below 70 twice (abnormal) dropped below 70 twice.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not provided by the reporter. The first COVID vaccine injection left a big knot on patient's arm, so had not gotten the second one. Patient  was sick for the last three weeks as of 24 Nov 2021 and was diagnosed with pneumonia in her right lung. Patient was feeling tired from working more hours. Patient was diagnosed with COVID both with delta and omicron variants in Dec-2021. It got progressed into COVID pneumonia. Patient was going to a respiratory therapy twice a week. Patient was still in a lot of pain in her ribs and hips as of 17-Feb-2022.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Primary reporter did not have the lot number information, because the packaging was discarded. Treatment information was not provided. Company comment: This is a spontaneous case concerning a 63 year-old, female patient with no reported medical history, who experienced the serious (medically significant) unexpected AESI events of arthritis, pulmonary oedema, covid-19, covid-19 pneumonia and unexpected serious (medically significant) events of  pneumonia, vaccination site nodule, arthralgia, asthma, pulmonary oedema, pulmonary fibrosis, which occurred unspecified days after first dose of mRNA-1273 vaccine. It is reported that patient was diagnosed with pneumonia, patient was feeling more tired from working more hours, patient diagnosed with covid both delta and omicron variants it got progressed into covid-19 penumonia, patient went to respiratory therapy twice a week, patient was still in lot of pain in her ribs and hips. Chest X-ray showed some remaining fluid in lungs and scarring (abnormal) in her lungs which is restricting airflow. SARS-CoV-2 test was positive with delta and omicron (Positive), Oxygen saturation: dropped below 70 twice. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow-up document received on 17-Dec-2021 with Events added, Narrative updated. On 28-Feb-2022: Follow-up document received on 28-Feb-2022 with Events, lab data and Narrative updated, Seriousness criteria updated. On 06-Jun-2022: Follow-up document received on 06-Jun-2022 with Events, Lab data added, Narrative updated.; Sender's Comments: This is a spontaneous case concerning a 63 year-old, female patient with no reported medical history, who experienced the serious (medically significant) unexpected AESI events of arthritis, pulmonary oedema, covid-19, covid-19 pneumonia and unexpected serious (medically significant) events of  pneumonia, vaccination site nodule, arthralgia, asthma, pulmonary oedema, pulmonary fibrosis, which occurred unspecified days after first dose of mRNA-1273 vaccine. It is reported that patient was diagnosed with pneumonia, patient was feeling more tired from working more hours, patient diagnosed with covid both delta and omicron variants it got progressed into covid-19 penumonia, patient went to respiratory therapy twice a week, patient was still in lot of pain in her ribs and hips. Chest X-ray showed some remaining fluid in lungs and scarring (abnormal) in her lungs which is restricting airflow. SARS-CoV-2 test was positive with delta and omicron (Positive), Oxygen saturation: dropped below 70 twice. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.