Age: 0.33
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Somnolence
Clinical narrative: infant received 0.5 mL x 2 doses for a total of 240 mcg  - 1 mL of abrysvo; infant received 0.5 mL x 2 doses for a total of 240 mcg  - 1 mL of abrysvo; sleeping too much; This is a spontaneous report received from a Physician from a sales representative.  A 4-month-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 30Oct2024 at 11:11 as dose 1, 0.5 ml single (Lot number: HY1813, Expiration Date: 30Sep2025) at the age of 4 months, in right thigh and on 30Oct2024 at 11:11 as dose 2, 0.5 ml single (Lot number: HY1813, Expiration Date: 30Sep2025), in right thigh, all intramuscular for immunisation. The patient's relevant medical history included: "low birth weight (2000-2499) g", start date: 03Jul2024, stop date: 03Jul2024; "respiratory distress syndrome of NB", start date: 03Jul2024, stop date: 03Jul2024; "atopic eczema", start date: 30Oct2024, stop date: 30Oct2024. Concomitant medication(s) included: HIB taken for immunisation, on 30Oct2024 as dose 2, single; PEDIARIX taken for immunisation, on 30Oct2024 as dose 2, single; PREVNAR 20 taken for immunisation, on 30Oct2024 as dose 2, single; ROTAVIRUS VACCINE oral taken for immunisation, on 30Oct2024 as dose 2 single. Vaccination history included: Rotavirus vaccine (dose 1), for immunisation; Hib (dose 1), for immunisation; Prevenar (dose 1), for immunisation; Pediarix (dose 1), for immunisation. The following information was reported: OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 30Oct2024, outcome "unknown" and all described as "infant received 0.5 mL x 2 doses for a total of 240 mcg  - 1 mL of abrysvo"; SOMNOLENCE (non-serious) with onset 30Oct2024, outcome "recovered" (2024), described as "sleeping too much". Therapeutic measures were not taken as a result of overdose, product administered to patient of inappropriate age, somnolence.  Additional information: Patient has not received other vaccines within 4 weeks. Patient was not allergic to previous vaccinations, food or other products. Factor considered to be responsible of the medication error were: misleading/the was no info on the box and confusion regarding the product name. The outcome of the event sleeping too much was reported as favorable. The reporter assessed the events as non serious and no Physician nor ER visit was required.   Follow up (16Dec2024):  New information received from a Physician.     Updated information: Patient details (weight, height), vaccination facility information, suspect details (date, lot #, exp date, dose numbers, route), concomitant vaccines details, historical vaccine, no other vaccines within 4 weeks. Factor considered to be responsible of the medication error. New event (sleeping too much). Events onset date. No treatment. 20The reporter assessed the events as non serious and no Physician nor ER visit was required. No treatment. No allergies. Relevant medical history.  Amendment: This follow-up report is being submitted to amend previous information. The at risk classification has been deleted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400299155 Same reporter/vaccine/AE, diff patients;