{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T23:51:54Z","timestamp":1777679514499,"version":"3.51.4"},"reference-count":22,"publisher":"The Pediatric Pharmacy Association","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,23]]},"abstract":"<jats:p>Respiratory syncytial virus (RSV) is one of the most common causes of acute lower respiratory tract infections in children. Immunization with nirsevimab has had a positive impact in reducing the number of emergency department (ED) visits for RSV. Clinical trials have shown that most adverse events associated with nirsevimab administration were mild, with no significant difference compared with placebo. We report on a 13-day-old female newborn who was brought into the ED because of hypotonia and unresponsiveness after administration of nirsevimab. During the 48-hour hospital stay, the only relevant clinical finding was mild axial hypotonia, which gradually resolved without treatment. A cerebral function monitor showed a continuous normal voltage tracing with no signs of seizures, and a complete electroencephalogram revealed normal background activity. Given that all the investigations were normal and the main event preceding the events was the administration of immunoprophylaxis with nirsevimab, a possible association between the clinical symptoms and the medication was suggested. Although there is robust evidence to recommend nirsevimab for reducing hospitalizations, we must bear in mind that, as a relatively new drug, we believe it is essential to emphasize continued monitoring of side effects, particularly in neonates.<\/jats:p>","DOI":"10.5863\/jppt-25-00013","type":"journal-article","created":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T02:39:05Z","timestamp":1774406345000},"source":"Crossref","is-referenced-by-count":1,"title":["Hypotonia and Lethargy as Potential Adverse Effect to Nirsevimab Administration in a Newborn Infant"],"prefix":"10.5863","author":[{"given":"Virginia Mar\u00eda Velasco","family":"Molina","sequence":"first","affiliation":[{"name":"Neonatology Department (VVM, STR, PLO, GSG), Hospital General Universitario La Paz, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda Nimo","family":"Mallo","sequence":"additional","affiliation":[{"name":"Department of Pediatrics (MNM), Hospital Ram\u00f3n y Cajal, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samantha Tandr\u00f3n","family":"del R\u00edo","sequence":"additional","affiliation":[{"name":"Neonatology Department (VVM, STR, PLO, GSG), Hospital General Universitario La Paz, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paloma","family":"L\u00f3pez-Ortego","sequence":"additional","affiliation":[{"name":"Neonatology Department (VVM, STR, PLO, GSG), Hospital General Universitario La Paz, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gonzalo","family":"Sol\u00eds-Garc\u00eda","sequence":"additional","affiliation":[{"name":"Neonatology Department (VVM, STR, PLO, GSG), Hospital General Universitario La Paz, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3883","reference":[{"key":"JPPT-25-00013-b01","series-title":"Lancet","first-page":"946","article-title":"Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study","volume":"390","author":"Shi","year":"2017","unstructured":"Shi T, McAllister DA, O\u2019Brien KL, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017;390:946\u2013958."},{"issue":"5","key":"JPPT-25-00013-b02","series-title":"N Engl J Med","first-page":"415","article-title":"Single-dose nirsevimab for prevention of RSV in preterm infants","volume":"383","author":"Griffin","year":"2020","unstructured":"Griffin MP, Yuan Y, Takas T, et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med. 2020;383(5):415\u2013425."},{"issue":"4","key":"JPPT-25-00013-b03","series-title":"An Pediatr","first-page":"257","article-title":"Nirsevimab for the prevention of respiratory syncytial virus disease in children. Statement of the Spanish Society of Paediatric Infectious Disease (SEIP)","volume":"99","author":"Francisco","year":"2023","unstructured":"Francisco L, Cruz-Canete M, P\u00e9rez C, et al. Nirsevimab for the prevention of respiratory syncytial virus disease in children. Statement of the Spanish Society of Paediatric Infectious Disease (SEIP). An Pediatr. 2023;99(4):257\u2013263."},{"issue":"5","key":"JPPT-25-00013-b04","series-title":"J Antimicrob Chemother","first-page":"1143","article-title":"Nirsevimab: review of pharmacology, antiviral activity and emerging clinical experience for respiratory syncytial virus infection in infants","volume":"78","author":"Jorgensen","year":"2023","unstructured":"Jorgensen SCJ. Nirsevimab: review of pharmacology, antiviral activity and emerging clinical experience for respiratory syncytial virus infection in infants. J Antimicrob Chemother. 2023;78(5):1143\u20131149."},{"issue":"2","key":"JPPT-25-00013-b05","series-title":"JAMA Netw Open","first-page":"e230023","article-title":"Monoclonal antibody for the prevention of respiratory syncytial virus in infants and children: a systematic review and network meta-analysis","volume":"6","author":"Sun","year":"2023","unstructured":"Sun M, Lai H, Na F, et al. Monoclonal antibody for the prevention of respiratory syncytial virus in infants and children: a systematic review and network meta-analysis. JAMA Netw Open. 2023;6(2):e230023."},{"key":"JPPT-25-00013-b06","article-title":"Recommendations for the prevention of RSV disease in infants and children","year":"2024","unstructured":"American Academy of Pediatrics. Recommendations for the prevention of RSV disease in infants and children. February 21, 2024. Accesed November 5, 2024. https:\/\/publications.aap.org\/redbook\/resources\/25379\/AAP-Recommendations-for-the-Prevention-of-RSV?autologincheck=redirected"},{"issue":"9","key":"JPPT-25-00013-b07","series-title":"N Engl J Med","first-page":"837","article-title":"Nirsevimab for prevention of RSV in healthy late-preterm and term infants","volume":"386","author":"Hammitt","year":"2022","unstructured":"Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med. 2022;386(9):837\u2013846."},{"key":"JPPT-25-00013-b08","series-title":"Front Pediatr","first-page":"1132740","article-title":"The efficacy and safety of nirsevimab for the prevention of RSV infection among infants: a systematic review and meta-analysis","volume":"11","author":"Turalde-Mapili","year":"2023","unstructured":"Turalde-Mapili MWR, Mapili JAL, Turalde CWR, et al. The efficacy and safety of nirsevimab for the prevention of RSV infection among infants: a systematic review and meta-analysis. Front Pediatr. 2023;11:1132740."},{"issue":"31","key":"JPPT-25-00013-b09","series-title":"Vaccine","first-page":"5875","article-title":"Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: case definition and guidelines for data collection, analysis, and presentation","volume":"25","author":"Buettcher","year":"2007","unstructured":"Buettcher M, Heininger U, Braun M, et al. Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2007;25(31):5875\u20135881."},{"issue":"41","key":"JPPT-25-00013-b10","series-title":"Vaccine","first-page":"6152","article-title":"Recurrence risk of a hypotonic hyporesponsive episode in two Australian specialist immunisation clinics","volume":"36","author":"Crawford","year":"2019","unstructured":"Crawford NW, McMinn A, Royle J, Lazzaro T, et al. Recurrence risk of a hypotonic hyporesponsive episode in two Australian specialist immunisation clinics. Vaccine. 2019;36(41):6152\u20136157."},{"issue":"1","key":"JPPT-25-00013-b11","series-title":"Clin Pharmacol Ther","first-page":"239","article-title":"A method for estimating the probability of adverse drug reactions","volume":"30","author":"Naranjo","year":"1981","unstructured":"Naranjo CA, Busto U, Sellers EM, Sandor P, et al. A method for estimating the probability of adverse drug reactions. 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Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med. 2020;383(5):415\u2013425."},{"issue":"4","key":"JPPT-25-00013-b03","series-title":"An Pediatr","first-page":"257","article-title":"Nirsevimab for the prevention of respiratory syncytial virus disease in children. Statement of the Spanish Society of Paediatric Infectious Disease (SEIP)","volume":"99","author":"Francisco","year":"2023","unstructured":"Francisco L, Cruz-Canete M, P\u00e9rez C, et al. Nirsevimab for the prevention of respiratory syncytial virus disease in children. Statement of the Spanish Society of Paediatric Infectious Disease (SEIP). 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Monoclonal antibody for the prevention of respiratory syncytial virus in infants and children: a systematic review and network meta-analysis. JAMA Netw Open. 2023;6(2):e230023."},{"key":"JPPT-25-00013-b06","article-title":"Recommendations for the prevention of RSV disease in infants and children","year":"2024","unstructured":"American Academy of Pediatrics. Recommendations for the prevention of RSV disease in infants and children. February 21, 2024. Accesed November 5, 2024. https:\/\/publications.aap.org\/redbook\/resources\/25379\/AAP-Recommendations-for-the-Prevention-of-RSV?autologincheck=redirected"},{"issue":"9","key":"JPPT-25-00013-b07","series-title":"N Engl J Med","first-page":"837","article-title":"Nirsevimab for prevention of RSV in healthy late-preterm and term infants","volume":"386","author":"Hammitt","year":"2022","unstructured":"Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. 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Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2007;25(31):5875\u20135881."},{"issue":"41","key":"JPPT-25-00013-b10","series-title":"Vaccine","first-page":"6152","article-title":"Recurrence risk of a hypotonic hyporesponsive episode in two Australian specialist immunisation clinics","volume":"36","author":"Crawford","year":"2019","unstructured":"Crawford NW, McMinn A, Royle J, Lazzaro T, et al. Recurrence risk of a hypotonic hyporesponsive episode in two Australian specialist immunisation clinics. Vaccine. 2019;36(41):6152\u20136157."},{"issue":"1","key":"JPPT-25-00013-b11","series-title":"Clin Pharmacol Ther","first-page":"239","article-title":"A method for estimating the probability of adverse drug reactions","volume":"30","author":"Naranjo","year":"1981","unstructured":"Naranjo CA, Busto U, Sellers EM, Sandor P, et al. 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