Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Hypersensitivity, Menstrual disorder, Nasopharyngeal swab, X-ray
Clinical narrative: COVID-19 pneumonia/difficulty breathing complications/lingering cough; Allergy aggravated/Allergies flares up; Menstrual disorder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia/difficulty breathing complications/lingering cough) and HYPERSENSITIVITY (Allergy aggravated/Allergies flares up) in a 57-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 Ankylosing spondylitis and Rheumatoid arthritis.    Patient had blood pressure.  The patient's past medical history included Cellulitis. Concurrent medical conditions included Allergy to plants (Oak trees allergy), Dust allergy, Pollen allergy (Patient had flower allergy also), Non-tobacco user, Abstains from alcohol, Diabetes, Ankylosing spondylitis and Rheumatoid arthritis. Concomitant products included LEVONORGESTREL (MIRENA) for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 1 wk). On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free (1 in 1 wk). On 08-Apr-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia/difficulty breathing complications/lingering cough) (seriousness criteria hospitalization and medically significant). In April 2021, the patient experienced HYPERSENSITIVITY (Allergy aggravated/Allergies flares up) (seriousness criterion hospitalization). On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstrual disorder). The patient was hospitalized from 12-Apr-2021 to sometime in April 2021 due to COVID-19 PNEUMONIA and HYPERSENSITIVITY. In 2021, COVID-19 PNEUMONIA (COVID-19 pneumonia/difficulty breathing complications/lingering cough) had resolved. At the time of the report, HYPERSENSITIVITY (Allergy aggravated/Allergies flares up) outcome was unknown and MENSTRUAL DISORDER (Menstrual disorder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Nasopharyngeal swab: (Positive) COVID 19 positive. In April 2021, X-ray: Pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has other concomitant therapy of unknown medication of blood pressure and diabetes. On 08 Apr 2021, the patient had difficulty breathing complications. The causality for difficulty breathing was not related. She was ended up in hospital on 12 Apr 2021 with COVID-19 pneumonia and allergies that flares up. She had some lingering cough due to the pneumonia. Patient was hospitalized for 13 days. Patient had these symptoms after getting the first shot of Covid 19 vaccine. Patient stated that did not think it was Covid 19. Patient was advised to stop Humira for two weeks when she was in hospital. She was on Mirena and she had a menstrual cycle so physician referred her for an ultrasound of abdomen to make sure everything was okay with the Mirena. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case concerning a 57-year-old female patient with medical history of allergies (Oak trees, Dust, Pollen, Flowers), who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of COVID-19 pneumonia and the unexpected, serious (hospitalization) event of Hypersensitivity. 3 days after receiving the first dose of mRNA-1273 vaccine, the patient had difficulty breathing complications. 4 days after the onset of difficulty breathing the patient was hospitalized due to COVID-19 pneumonia (SARS-CoV-2 test positive and X-ray showed pneumonia) and allergies that flares up. She was treated with COVID antibodies and was hospitalized for 13 days. The event COVID-19 pneumonia had resolved within the same year and the outcome of the event Hypersensitivity was unknown at the time of the report. Medical history of allergies remains a risk factor for the event Hypersensitivity. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 57-year-old female patient with medical history of allergies (Oak trees, Dust, Pollen, Flowers), who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of COVID-19 pneumonia and the unexpected, serious (hospitalization) event of Hypersensitivity. 3 days after receiving the first dose of mRNA-1273 vaccine, the patient had difficulty breathing complications. 4 days after the onset of difficulty breathing the patient was hospitalized due to COVID-19 pneumonia (SARS-CoV-2 test positive and X-ray showed pneumonia) and allergies that flares up. She was treated with COVID antibodies and was hospitalized for 13 days. The event COVID-19 pneumonia had resolved within the same year and the outcome of the event Hypersensitivity was unknown at the time of the report. Medical history of allergies remains a risk factor for the event Hypersensitivity. The benefit-risk relationship of mRNA-1273 is not affected by this report.