Age: 38.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pre-eclampsia, Premature delivery, Seizure, Tinnitus, Twin pregnancy
Clinical narrative: Seized at 11:15 am /eclamptic seizure; Began to lose eye sight at 11am; preeclampsia; Premature delivery; threw up bagel; Felt I could hear blood circulating in head; malpresentation; headache/Headache continued/Hurt worse when laid down; Did not sleep well; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2750154-1 (VAERS ID).  A 38-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Nov2023 at 16:30 as dose number unknown, single (Lot number: 0796542-10690) at the age of 38 years intramuscular, in left arm for maternal immunisation. The patient's relevant medical history was not reported. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). Concomitant medication(s) included: NATURE MADE MULTI PRENATAL; IRON. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 17Nov2023, outcome "not recovered", described as "Did not sleep well"; HEADACHE (non-serious) with onset 17Nov2023 at 21:00, outcome "not recovered", described as "headache/Headache continued/Hurt worse when laid down"; TINNITUS (non-serious) with onset 18Nov2023, outcome "unknown", described as "Felt I could hear blood circulating in head"; FOETAL MALPRESENTATION (medically significant) with onset 18Nov2023, outcome "unknown", described as "malpresentation"; PRE-ECLAMPSIA (hospitalization) with onset 18Nov2023, outcome "unknown", described as "preeclampsia"; VOMITING (non-serious) with onset 18Nov2023 at 09:30, outcome "unknown", described as "threw up bagel"; BLINDNESS (hospitalization, medically significant) with onset 18Nov2023 at 11:00, outcome "unknown", described as "Began to lose eye sight at 11am"; ECLAMPSIA (hospitalization, medically significant) with onset 18Nov2023 at 11:15, outcome "unknown", described as "Seized at 11:15 am /eclamptic seizure"; PREMATURE DELIVERY (medically significant) with onset 18Nov2023 at 17:28, outcome "unknown". The patient was hospitalized for blindness, eclampsia, pre-eclampsia (start date: 18Nov2023, discharge date: 22Nov2023, hospitalization duration: 5 day(s)). The first baby was delivered premature, via cesarean route, delivery date 18Nov2023. The baby weighed 1871.068 grams. The second baby was delivered premature, via cesarean route, delivery date 18Nov2023. The baby weighed 1729.32 grams. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (14Nov2023) 137/34, notes: higher than normal (~137/94) but not in range where need for concern (according to doctor); Electrocardiogram: (unspecified date) unkown results; Laboratory test: (unspecified date) unkown results. Therapeutic measures were taken as a result of pre-eclampsia, premature delivery. Clinical course: Patient was 32 weeks pregnant on 16Nov2023 with twin boys and did not have issues or concerns throughout pregnancy. She was overall healthy with no chronic conditions. She visited maternal fetal specialist on 14Nov2023 for routine appointment, they took baby measurements and noticed slight swelling of her ankles and hands but said not to be concerned. She was recommended to take blood pressure and she began tracking blood pressure evening of 14Nov2023 and was higher than normal (~137/94) but not in range where need for concern (according to doctor). Patient received rsv vaccine prot.subunit pref 2v at 4:30 pm in left arm on 17Nov2023. In evening of 17Nov2023, she began to experience headache at 9 pm. It was also reported that she did not sleep well. Patient's headache continued into morning of 18Nov2023 in which she made a doctor's appointment and at 9:30 am she threw up bagel. Patient's headache continued and hurt worse when she laid down. She also felt like she could hear blood circulating in her head. She began to lose eye sight at 11am and seized at 11:15 am. Patient was taken to the hospital, her cervix was dilated at 3cm. and doctor required magnesium sulfate treatment for preeclampsia after found to have eclamptic seizure. Proceeded with delivery of twin boys at 17:28 and 17:29 due to malpresentation and eclampsia. They were delivered via cesarean section. The first baby weighed 1871.068 grams and the second baby weighed 1729.32 grams. The next day, patient had D&C procedure.  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400221743 baby case (1st baby);US-PFIZER INC-202400221744 baby case (2nd baby);