Age: 0.08
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Somnolence, Wrong product administered
Clinical narrative: little bit dull; feeling drowsy/sleeping; The other thing is spitting; digestion issues; 40-day-old daughter received the Abrysvo vaccine on 27Dec2023 in error from the clinic instead of Nirsevimab; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 5-week-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Dec2023 at 10:00 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) at the age of 5 weeks intramuscular, in left thigh for immunisation. The patient didn't receive nirsevimab (NIRSEVIMAB). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Dec2023, outcome "unknown", described as "40-day-old daughter received the Abrysvo vaccine on 27Dec2023 in error from the clinic instead of Nirsevimab"; FATIGUE (non-serious), outcome "unknown", described as "little bit dull"; SOMNOLENCE (non-serious), outcome "unknown", described as "feeling drowsy/sleeping"; INFANTILE SPITTING UP (non-serious), outcome "unknown", described as "The other thing is spitting"; DYSPEPSIA (non-serious), outcome "unknown", described as "digestion issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, somnolence, infantile spitting up, dyspepsia.  Additional information: A 40-day-old daughter received the Abrysvo vaccine on 27Dec2023 in error from the clinic instead of Nirsevimab. The reporter further stated, "We're concerned about her well-being and are seeking details on potential side effects for infants. While I reached out to the CDC for information, they directed me to the vaccine manufacturer for details on any clinical studies regarding Abrysvo's effects on infants. Any guidance or information you can provide would be greatly appreciated". As o 02Jan2024, the patient's father reported that the patient was having cough sort of things, a little bit, so the reporter (patient's father) visited the clinic to check whether it was any flu sort of thing because the patient was also using the formula, they have done the RSV check and the COVID check, and they confirmed nothing was there, and suggested a vaccine, and in the clinic, they messed up actually, mistakenly given the Abrysvo vaccine, instead of Nirsevimab to the patient on 27Dec2023, at probably around 10 o'clock. The patient used to be active and perfectly fine and was now feeling drowsy or a "little bit dull" after the vaccine. The patient used to listen to the reporter and something but now it was like most of the time she was sleeping. The other thing was spitting. The reporter didn't know whether the digestion issues or something. No treatment was given. No medication was given.  Follow-up (02Jan2024 and 04Jan2024): This is a spontaneous follow up report received from the same Consumer.  Updated information: patient's information (name, weight, body height, race, age), vaccination time, dose, route, anatomical location, new events (Fatigue, Somnolence, Infantile spitting up, Digestion impaired), clinical course.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.