Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Pneumonia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and NEAR DEATH EXPERIENCE (Near death experience) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis. The patient's past medical history included Pneumonia (several times), Nonsmoker, Alcohol use and Gallbladder removal in 1995. Concurrent medical conditions included Migraine, Irritable bowel syndrome and Plaque psoriasis (Moderate to severe). In March 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and NEAR DEATH EXPERIENCE (Near death experience) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) and NEAR DEATH EXPERIENCE (Near death experience) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Patient was prescribed with unspecified antibiotics when she had the pneumonia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality of Humira with right wrist carpal tunnel syndrome, pneumonia and near death experience was reported as not provided. Regulatory Authority opinion is that the event of PNEUMONIA/NEAR DEATH EXPERIENCE onset in August 2021 is not assessable. Company comment: This spontaneous case concerns a 51-years-old female patient with relevant medical history of Plaque psoriasis treated with the co-suspect ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) event of Pneumonia and Near-death experience that occurred in context to first dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The patient was treated with  unspecified antibiotics when she had the pneumonia. The Clinical course and Concomitant medication details were not provided, and the event outcome was resolved. The medical history of Plaque psoriasis treated with ADALIMUMAB (HUMIRA) the co-suspect could be the risk factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. This case was linked to MOD-2022-628748 (Patient Link). Sender's Comments: This spontaneous case concerns a 51-years-old female patient with relevant medical history of Plaque psoriasis treated with the co-suspect ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) event of Pneumonia and Near-death experience that occurred in context to first dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The patient was treated with unspecified antibiotics when she had the pneumonia. The Clinical course and Concomitant medication details were not provided, and the event outcome was resolved. The medical history of Plaque psoriasis treated with ADALIMUMAB (HUMIRA) the co-suspect could be the risk factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.