Sex: U
Vaccine: RSV, TDAP
Symptoms: Foetal exposure during pregnancy, Hydrocephalus, Laboratory test, Magnetic resonance imaging head, Neonatal seizure
Clinical narrative: brain bleeds; seizures; brain damage; hydrocephalus; Cerebral Palsy; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2786461 (VAERS ID).  A neonate patient was exposed to the rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Feb2024 via a maternal patient, who received the vaccine while pregnant as dose 1, single (Lot number: HF5018) via intramuscular on right arm for maternal immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), on 23Feb2024 via a maternal patient, who received the vaccine while pregnant as dose number unknown, single (Lot number: MX2Z9) via intramuscular on left arm for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Medical history of the mother included polycystic ovarian syndrome and sulfa allergy, all unknown if ongoing. Infant outcome was congenital malformation/anomaly.  The following information was reported: CEREBRAL PALSY (medically significant) with onset 2024, outcome "unknown"; CEREBRAL HAEMORRHAGE NEONATAL (hospitalization, congenital anomaly, disability, medically significant, life threatening) with onset 2024, outcome "unknown", described as "brain bleeds"; BRAIN INJURY (hospitalization, congenital anomaly, disability, medically significant, life threatening) with onset 2024, outcome "unknown", described as "brain damage"; HYDROCEPHALUS (hospitalization, congenital anomaly, disability, medically significant, life threatening) with onset 2024, outcome "unknown"; NEONATAL SEIZURE (hospitalization, congenital anomaly, disability, medically significant, life threatening) with onset 2024, outcome "unknown", described as "seizures". The clinical course was reported as follows: The mother received both the Abrysvo and Boostrix vaccines on 23Feb2024. The due date for the baby was 24Mar2024; however, the time of birth was early after having received the Abrysvo (RSV) vaccine. The mother was concerned by the information regarding possibility of pre-term due to the vaccine. The mother experienced water breaking without having contractions. After birth, the baby experienced brain bleeds and seizures, which resulted in hydrocephalus and brain damage. Treatment was ongoing for baby at this time. Baby's birth weight was 6 pounds 5 ounces. The baby required shunt placement, magnetic resonance imaging (MRI's), computerised tomogram (Cat Scans), and ultrasounds. The baby required seizure medications. The baby was now in occupational therapy. The neurologist suspected the possibility of cerebral palsy, but results were inconclusive at this time. The baby was required to receive MRI's on an annual basis due to shunt placement. Neurologist appointments were ongoing. The patient underwent the following laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of cerebral haemorrhage, seizure, brain injury, hydrocephalus, cerebral palsy.  No follow-up attempts are possible.  Amendment: This follow-up report is being submitted to amend previously reported information: event data (recoded: cerebral hemorrhage to cerebral hemorrhage neonatal and seizures to neonatal seizures).; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400132896 mother case;