Age: 0.25
Sex: F
Vaccine: RSV, RSV
Symptoms: Crying, Product administered to patient of inappropriate age
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; crying a lot; This is a spontaneous report received from a Physician from a sales representative.  A 12-week-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Oct2024 at 11:46 as dose 1, 0.5ml single (Lot number: HY1813, Expiration Date: 30Sep2024) at the age of 12 weeks intramuscular, in left thigh and on 18Oct2024 at 11:46 as dose 2, 0.5ml single (Lot number: HY1813, Expiration Date: 30Sep2024), in right thigh for immunisation. The patient's relevant medical history included: "congenital heart disease", start date: 26Jul2024 (ongoing). Concomitant medication(s) included: FUROSEMIDE taken for heart disease congenital; CLOPIDOGREL taken for heart disease congenital; ASPIRIN [ACETYLSALICYLIC ACID] taken for heart disease congenital. Vaccination history included: rotavirus merck (oral, Lot # 2032351, Exp 06Oct2025), administration date: 27Sep2024, for immunisation; hib gk (right thigh, Lot # 3S4H4, Exp 13Jul2026), administration date: 27Sep2024, for immunisation; pediarix gsk (left thigh, Lot # 9P329, Exp 06Mar2026), administration date: 27Sep2024, for immunisation; prevenar pfizer (left thigh, Lot # LC1281, Exp 31Jan2026), administration date: 27Sep2024, for immunisation. The following information was reported: CRYING (non-serious) with onset 18Oct2024, outcome "unknown", described as "crying a lot"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Oct2024 at 11:46, outcome "unknown" and all described as "infant received 0.5 mL x 2 doses for a total of 240 mcg  - 1 mL of abrysvo".  Additional information: The patient had no allergies. The female infant received 0.5 mL x 2 doses for a total of 240 mcg 1 mL of abrysvo. At this current time no ADEs to report. The patient received 2 doses of ABRYSVO at the same time on different thigh. Vaccine was administered at Physician office. The patient has not received other vaccines on the same date. 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 crying was reported as favorable. The reporter assessed the events as non serious and no Physician nor ER visit was required. No treatment received.   Amendment: This follow-up report is being submitted to amend previously reported information: added dose as 0.5 ml and second dosage regimen, add an event overdose.  Follow up (13Nov2024):  New information received from a Physician.     Updated information: Patient details (Date of birth, age, heigh, weight, name, address). Medical history. No allergies. Facility administration. Suspect details (vaccination date, Batch/Lot number, Anatomical Location, route, Dose Numbers), no other vaccines on the same date. Concomitant medications. Historical vaccine. Factor considered to be responsible of the medication error. New event (crying). Events onset date. The reporter assessed the events as non serious and no Physician nor ER visit was required. No treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400298784 Same reporter/vaccine/AE, different patients;