Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal pain, Myalgia, Nausea, Pulmonary mass
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules) and PULMONARY MASS (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MALAISE (woke up felling sick), MUSCULOSKELETAL PAIN (Muscular skeleton pain), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (muscular aches and pain "muscular skeleton pain"), HEADACHE (headache for saying felt like the top head was going to blow off, never had a headache before), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Exhausted, couldn't get up the bed/ Fatigue lasted a couple of days more then went away/ the next day, Saturday, could get up and sit on the couch). On an unknown date, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules) (seriousness criterion hospitalization), PULMONARY MASS (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules) (seriousness criterion hospitalization) and IMPAIRED WORK ABILITY (I wouldn't be able to work on those days). The patient was hospitalized on sometime in August 2021 due to PULMONARY MASS and RESPIRATORY SYNCYTIAL VIRUS INFECTION. At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules), MALAISE (woke up felling sick), IMPAIRED WORK ABILITY (I wouldn't be able to work on those days), MUSCULOSKELETAL PAIN (Muscular skeleton pain), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (muscular aches and pain "muscular skeleton pain"), HEADACHE (headache for saying felt like the top head was going to blow off, never had a headache before), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown, PULMONARY MASS (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules) had not resolved and FATIGUE (Exhausted, couldn't get up the bed/ Fatigue lasted a couple of days more then went away/ the next day, Saturday, could get up and sit on the couch) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) diagnosed with RSV call pulmonary nodules, and t 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodule. On an unknown date, X-ray: abnormal (abnormal) diagnosed with RSV call pulmonary nodules, and t 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodule.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MALAISE (woke up felling sick), MUSCULOSKELETAL PAIN (Muscular skeleton pain), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (muscular aches and pain "muscular skeleton pain"), HEADACHE (headache for saying felt like the top head was going to blow off, never had a headache before), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Exhausted, couldn't get up the bed/ Fatigue lasted a couple of days more then went away/ the next day, Saturday, could get up and sit on the couch) to be possibly related. No further causality assessments were provided for RESPIRATORY SYNCYTIAL VIRUS INFECTION (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules), PULMONARY MASS (diagnosed with RSV call pulmonary nodules/ongoing studies patient states having a recent 2nd CT scan that showed the nodule has duplicate the size, and found multiple other nodules) and IMPAIRED WORK ABILITY (I wouldn't be able to work on those days).    The reporter (retired nurse) had an unusual response to the 2nd dose, as stated.  The patient received the 1st dose on 27-Jan-2021 (lot# 030L20A), and the 2nd dose on 25-Feb-2021 (Lot# 022M20A). The night after receiving the vaccine the patient woke up felling sick, had nausea and vomiting, and then muscular aches and pain "muscular skeleton pain", headache (for saying felt like the top head was going to blow off, never had a headache before), chills and fever, felt exhausted and couldn't get up the bed. The next day, Saturday, the patient could get up and sit on the couch, and on Sunday went out to a walk. The patient was "keep saying to himself/herself that he/she is not sick, that it was a side effect". Fatigue lasted a couple of days more then went away.  It was stated that the patient wouldn't be able to work on those days.  Patient was staying most of the pandemic at home except for taking walks with mask on, and stated that felt that the capacity of the lungs never have had back been the same.  In August this year, the patient was admitted to the hospital and had a chest X-Ray and CT scan, diagnosed with RSV call pulmonary nodules. The patient think could be a coincidence, and the most recent 2nd CT scan showed the nodule had duplicate the size, and found multiple other nodules.  No concomitant medication was reported. No treatment medication use was reported.; Sender's Comments: This case concerns a 72-year-old patient of an unknown gender, with no relevant medical history provided, who experienced the unexpected serious events of Respiratory syncytial virus infection and Pulmonary mass (reported as "RSV call pulmonary nodules and as per the latest CT scan nodules had duplicated the size and multiple other nodules were also found). The patient also experienced non serious unexpected events of Malaise and Impaired work ability, as well as non serious expected events of Nausea, Vomiting, Myalgia, Musculoskeletal pain, Chills, Headache, Pyrexia and Fatigue. Except the events Respiratory syncytial virus infection and Pulmonary mass, which were confirmed by X-Ray and CT scan approximately six months after the administration of the second dose of Moderna COVID-19 Vaccine, the remaining reported events occurred the day after the second dose had been administered. The event of Fatigue had resolved at the time of the report. The event of Pulmonary mass did not resolve, while the outcome for the remaining events was not specified at this moment. The rechallenge cannot be assessed as the booster dose was not administered at the time of the report and the outcome was unknown for majority of the events. The benefit risk relationship of vaccine is not affected by this report.