Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oedema peripheral, Organising pneumonia, Pneumonia, Pyrexia
Clinical narrative: Hypothyroidism; Hyperparathyroidism secondary not renal; GERD; Heart burn; Hypertension; Major depression disorder; Hypoxia; Pneumonia; Shortness of breath/having trouble breathing; Organizing pneumonia; Cough; Fever; Chest pain; Edema on their legs; Feel sick/not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORGANISING PNEUMONIA (Organizing pneumonia), PNEUMONIA (Pneumonia), HYPOXIA (Hypoxia), DYSPNOEA (Shortness of breath/having trouble breathing), HYPOTHYROIDISM (Hypothyroidism), HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary not renal), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DYSPEPSIA (Heart burn), HYPERTENSION (Hypertension) and DEPRESSION (Major depression disorder) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Implantable cardiac monitor insertion since 19-Sep-2021. Concurrent medical conditions included Drug hypersensitivity (Bactrim - hand turning red, developed a rash on the face and back and itching hands.). Concomitant products included LEVOFLOXACIN, OMEPRAZOLE, LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), AMLODIPINE and ZOLEDRONIC ACID (RECLAST) from 22-Apr-2021 to an unknown date for an unknown indication.  On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ORGANISING PNEUMONIA (Organizing pneumonia) (seriousness criteria hospitalization and medically significant). On 23-Feb-2021, the patient experienced MALAISE (Feel sick/not feeling well). On 25-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath/having trouble breathing) (seriousness criterion hospitalization), CHEST PAIN (Chest pain), OEDEMA PERIPHERAL (Edema on their legs), COUGH (Cough) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). On 02-Mar-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria hospitalization and medically significant), HYPOTHYROIDISM (Hypothyroidism) (seriousness criteria hospitalization and medically significant), HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary not renal) (seriousness criterion hospitalization), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) (seriousness criterion hospitalization), DYSPEPSIA (Heart burn) (seriousness criterion hospitalization), HYPERTENSION (Hypertension) (seriousness criterion hospitalization) and DEPRESSION (Major depression disorder) (seriousness criterion hospitalization). The patient was hospitalized on 02-Mar-2021 due to DEPRESSION, DYSPEPSIA, DYSPNOEA, GASTROOESOPHAGEAL REFLUX DISEASE, HYPERPARATHYROIDISM SECONDARY, HYPERTENSION, HYPOTHYROIDISM, HYPOXIA, ORGANISING PNEUMONIA and PNEUMONIA. At the time of the report, ORGANISING PNEUMONIA (Organizing pneumonia) and PNEUMONIA (Pneumonia) had not resolved and HYPOXIA (Hypoxia), DYSPNOEA (Shortness of breath/having trouble breathing), HYPOTHYROIDISM (Hypothyroidism), HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary not renal), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DYSPEPSIA (Heart burn), HYPERTENSION (Hypertension), DEPRESSION (Major depression disorder), CHEST PAIN (Chest pain), OEDEMA PERIPHERAL (Edema on their legs), MALAISE (Feel sick/not feeling well), COUGH (Cough) and PYREXIA (Fever) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Patient was on oxygen while in the hospital and continued to use oxygen after get discharged. Patient stated that was getting better and on 16 Mar 2021, she experienced trouble breathing and it was reported that she had a relapse for pneumonia affecting both lungs, before only the right lung was affected. Patient is still under doctor's care.  Company Comment - This case concerns a 77 year-old female patient with a history of drug hypersensitivity who experienced the unexpected events of dyspnea, pneumonia, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, depression, organizing pneumonia. The event of dyspnea occurred approximately 21 days, pneumonia: 24 days, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, and depression: 26 days after the first dose of mRNA-1273. The event of organizing pneumonia occurred at an unknown date after the first dose of mRNA-1273. The rechallenge was not applicable as only information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-325684 (Patient Link).; Sender's Comments: This case concerns a 77 year-old female patient with a history of drug hypersensitivity who experienced the unexpected events of dyspnea, pneumonia, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, depression, organizing pneumonia. The event of dyspnea occurred approximately 21 days, pneumonia: 24 days, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, and depression: 26 days after the first dose of mRNA-1273. The event of organizing pneumonia occurred at an unknown date after the first dose of mRNA-1273. The rechallenge was not applicable as only information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.