Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Septic shock
Clinical narrative: POSSIBLE SEPTIC SHOCK; INFECTION IN LUNGS; This spontaneous case was reported by a consumer and describes the occurrence of SEPTIC SHOCK (POSSIBLE SEPTIC SHOCK) and PNEUMONIA (INFECTION IN LUNGS) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SEPTIC SHOCK (POSSIBLE SEPTIC SHOCK) (seriousness criteria hospitalization and medically significant) and PNEUMONIA (INFECTION IN LUNGS) (seriousness criterion medically significant). The patient was treated with PENICILLIN [PENICILLIN NOS] (intravenous) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SEPTIC SHOCK (POSSIBLE SEPTIC SHOCK) and PNEUMONIA (INFECTION IN LUNGS) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Reportedly, the patient was in patient for 9 days and was close to septic shock. Patient had stop taking Humira about 2 months due to infection in lungs. He had been on intravenous penicillin for about 5 weeks and it was continuing as of 20-Apr-2022.  The reporter's causality for an event(s) of SEPTIC SHOCK  with Humira was no reasonable possibility and for an event(s) of INFECTION IN LUNGS with Humira was not provided.  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, reported by a consumer, concerning an elderly male patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) events of Pneumonia and unexpected serious (hospitalization, medically significant) events of Septic shock reported as possible septic shock, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The co-suspect drug Adalimumab, which is an immunosuppressant and increases the susceptibility of patient to acquire infection, and may lead to the events Pneumonia and Septic shock. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow up information received contains updated event verbatim for Septic shock and narrative.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly male patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) events of Pneumonia and unexpected serious (hospitalization, medically significant) events of Septic shock reported as possible septic shock, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The co-suspect drug Adalimumab, which is an immunosuppressant and increases the susceptibility of patient to acquire infection, and may lead to the events Pneumonia and Septic shock. The benefit-risk relationship of mRNA-1273 is not affected by this report.