Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus infection
Clinical narrative: Respiratory syncytial virus infection; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (Respiratory syncytial virus infection) in an elderly 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 Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen, citrate free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, citrate free. On an unknown date, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (Respiratory syncytial virus infection) (seriousness criterion hospitalization). The patient was hospitalized from sometime in October 2021 to sometime in November 2021 due to RESPIRATORY SYNCYTIAL VIRUS INFECTION. At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (Respiratory syncytial virus infection) was resolving.            Company comment: This is a spontaneous case concerning an elderly female patient with Chron´s disease on treatment with Adalimumab, who experienced the serious unexpected event Respiratory virus syncytial infection, approximately 6 months after the second dose of  mRNA-1273. It was reported that patient was hospitalized from October 2021 until November 2021. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The patient took JANSSEN COVID-19 VACCINE(COVID-19 VACCINE NRVV AD26 (JNJ 78436735)) on 17-DEC-2021.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was reported as no reasonable possibility. The reporter's causality for the event with Janssen COVID-19 vaccine was possible. 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.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received included no new information.; Sender's Comments: Company comment: This is a spontaneous case concerning an elderly female patient with Chron´s disease on treatment with Adalimumab, who experienced the serious unexpected event Respiratory virus syncytial infection, approximately 6 months after the second dose of  mRNA-1273.  It was reported that patient was hospitalized from October 2021 until November 2021. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.