Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Feeling abnormal, Inappropriate schedule of product administration, Pneumonia
Clinical narrative: Lung infection; week after his 2nd dose he couldn't breathe, week after his 2nd dose he couldn't go more than a couple of minutes without symptoms, couldn't  go to the bathroom and back without being out of breath and having to sit down; Week after his 2nd dose he had no energy; Thought he was going to die when taking shower; Inappropriate schedule of vaccine administration; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Lung infection) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, 022M20A and 0035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On an unknown date, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant), DYSPNOEA (week after his 2nd dose he couldn't breathe, week after his 2nd dose he couldn't go more than a couple of minutes without symptoms, couldn't  go to the bathroom and back without being out of breath and having to sit down), ASTHENIA (Week after his 2nd dose he had no energy) and FEELING ABNORMAL (Thought he was going to die when taking shower). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. At the time of the report, PNEUMONIA (Lung infection), DYSPNOEA (week after his 2nd dose he couldn't breathe, week after his 2nd dose he couldn't go more than a couple of minutes without symptoms, couldn't  go to the bathroom and back without being out of breath and having to sit down), ASTHENIA (Week after his 2nd dose he had no energy) and FEELING ABNORMAL (Thought he was going to die when taking shower) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient was prescribed 3 inhalers for treatment and that did not help.  Company comment: This case concers a 69 year old male patient with no relevant medical history reported, who experience non serious unexpected events of dyspnoea, asthenia and feeling abnormal a week after the second dose and on unknown date lung infection. The rechallenge is unknown. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-329750 (Patient Link).; Sender's Comments: This case concers a 69 year old male patient with no relevant medical history reported, who experience non serious unexpected events of dyspnoea, asthenia and feeling abnormal a week after the second dose and on unknown date lung infection. The rechallenge is unknown. The benefit-risk relationship of Spikevax is not affected by this report.