Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pain, Pneumonia, Pyrexia
Clinical narrative: Pneumonia; Back pain/ if stood still too long back start hurting; Bronchitis; Pain; Stomach upset; Dizziness; Severe Chills; Headache; Fever; Knotting up back/ hips; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 69-year-old male 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) for Ankylosing spondylitis.    No Medical History information was reported.   On 04-Dec-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) Citrate Free, Solution for injection in pre-filled pen. In 2021, the patient experienced MUSCLE SPASMS (Knotting up back/ hips). In December 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DIZZINESS (Dizziness), CHILLS (Severe Chills), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), BACK PAIN (Back pain/ if stood still too long back start hurting), BRONCHITIS (Bronchitis) and PAIN (Pain). At the time of the report, PNEUMONIA (Pneumonia), BACK PAIN (Back pain/ if stood still too long back start hurting), BRONCHITIS (Bronchitis) and MUSCLE SPASMS (Knotting up back/ hips) outcome was unknown and PAIN (Pain), ABDOMINAL DISCOMFORT (Stomach upset), DIZZINESS (Dizziness), CHILLS (Severe Chills), HEADACHE (Headache) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. In April 2021, the patient experienced COVID. In Dec-2021, Body temperature, result was unknown. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment information was reported.  Company comment: This is a spontaneous case concerning a 69-year-old male patient with medical history of Ankylosing spondylitis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event pneumonia, on an unknown date after receiving the first dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured .  Use of concomitant medication Adalimumab could be a potentially co-suspect. The benefit-risk relationship of mRNA-1273 is not affected by this report.  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.; Sender's Comments: Company comment: This is a spontaneous case concerning a 69-year-old male patient with medical history of Ankylosing spondylitis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event pneumonia, on an unknown date after receiving the first dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured t.  Use of concomitant medication Adalimumab could be a potentially co-suspect. The benefit-risk relationship of mRNA-1273 is not affected by this report.