Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Human metapneumovirus test, Metapneumovirus infection
Clinical narrative: HMPV diagnosis; affected her vascular system; This spontaneous case was reported by a patient family member or friend and describes the occurrence of METAPNEUMOVIRUS INFECTION (HMPV diagnosis) and ANGIOPATHY (affected her vascular system) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch nos. 049D22A and 046H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: moderna COVID-19 vaccine (dose 1, batch :029L20A) on 22-Jan-2021, moderna COVID-19 vaccine (dose 2, batch :022M20A) on 26-Feb-2021, moderna COVID-19 vaccine (dose 3, batch :022C21A) on 20-Oct-2021, moderna COVID-19 vaccine (dose 4 and batch :00S21A) on 12-Apr-2022; for Product used for unknown indication: RSV VACCINE and FLU. Past adverse reactions to the above products included No adverse event with FLU, RSV VACCINE, moderna COVID-19 vaccine, moderna COVID-19 vaccine, moderna COVID-19 vaccine and moderna COVID-19 vaccine. Concurrent medical conditions included Allergy to antibiotic (Flagyl), Allergy to antibiotic (Azithromycin), Drug allergy (Percocet) and Non-smoker. Concomitant products included OXYGEN for an unknown indication.   On 25-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On 20-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) dosage was changed to 1 dosage form. In March 2023, the patient experienced METAPNEUMOVIRUS INFECTION (HMPV diagnosis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ANGIOPATHY (affected her vascular system) (seriousness criterion hospitalization). The patient was hospitalized on 18-Mar-2021 due to METAPNEUMOVIRUS INFECTION, and then from 18-Mar-2023 to 24-Mar-2023 due to ANGIOPATHY. At the time of the report, METAPNEUMOVIRUS INFECTION (HMPV diagnosis) and ANGIOPATHY (affected her vascular system) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2023, Human metapneumovirus test: Positive.         The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient took the 7th dose on 26-Oct-2023. The patient had 2 infusions on May 2023 and June 2023. The patient will receive the next Rituxan infusion in December.  Company Comment: This is a spontaneous case concerning a 68-year-old, female patient with medical history of allergies (Flagyl, Azithromycin and Percocet), who experienced the serious (due to medically significant and Hospitalization) unexpected events of Metapneumovirus infection (HMPV diagnosis) and Angiopathy (affected her vascular system). The events occurred approximately 4, 5 months after the 5th dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5). The patient had also received Moderna COVID-19 vaccine (dose 1, batch :029L20A) on 22-Jan-2021, Moderna COVID-19 vaccine (dose 2, batch :022M20A) on 26-Feb-2021, Moderna COVID-19 vaccine (dose 3, batch :022C21A) on 20-Oct-2021, Moderna COVID-19 vaccine (dose 4 and batch :00S21A) on 12-Apr-2022 and RSV VACCINE and FLU. The reporter explained that his wife, who is the patient, had to receive her next Rituxan infusion in December and he wanted to take the vaccine in October to space it out. The reporter stated that his wife received this infusion for lung inflammation due to the HMPV diagnosis in March 2023, and that she never smoked; "Her lungs are bad", as reported, and this diagnosis affected her vascular system also and was hospitalized for 1 week on 18-Mar-2023. The patient had had 2 infusions to date, May 2023 and June 2023. The outcome of the events was not reported. The events were considered as not related to Moderna vaccine due to long latency and lack of biological plausibility as Metapneumovirus infection is an infectious disease, and the angiopathy was a consequence of the infection. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.