Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Acoustic stimulation tests abnormal, Foetal exposure during pregnancy, Gastroenteritis, Human metapneumovirus test
Clinical narrative: HMPV; GASTROENTERITIS; BABY WAS LARGE FOR GESTATIONAL AGE; BABY FAILED THE HEARING TEST; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate. The patient was enrolled in a non-company sponsored study: COVID 19 Vaccines International Pregnancy Exposure Registry number. The patient's weight was 4.56 kilograms, and height was 56 centimeters. No concurrent conditions were reported. The patient's parent's medical history: in vitro fertilization, and concurrent conditions included: anxiety, and multigravida. Maternal obstetrical history included two previous pregnancies, one resulting in a live baby, while the outcome of the other was not reported. The mother had no history of tobacco or alcohol use, however reported recreational drug use before current pregnancy. Maternal first day of the last menstrual period (LMP) was calculated to be 18-Oct-2020. The estimated delivery date (EDD) was reported to be unknown. Type of pregnancy was reported as singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin: transplacental, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for covid-19 immunisation. Concomitant medications included famotidine, minerals nos/vitamins nos, paracetamol, and sertraline hydrochloride.  On 18-JUL-2021, at gestational age 39 weeks, the mother delivered vaginally a live, full-term, male neonate. The mother spent two days in the hospital for the delivery. The neonate's birth weight was 10 pounds and 1 ounce (large for gestational age), body length 22 inches. On unspecified date in JUL-2021 after the delivery, the neonate had a hearing test. Patient passed in one ear and was planned to get re-tested on 18-Aug-2021. On 08-JAN-2022, the patient experienced hMPV (human metapneumovirus) infection, and was hospitalized on same day. Laboratory data included: hMPV test (NR: not provided) diagnosed with hMPV. Number of days of hospitalization were not reported. The patient experienced low oxygen levels and high white cell count. Treatment medications (dates unspecified) included: cefdinir, acetaminophen and ibuprofen. On 02-FEB-2022, Laboratory data included: SARS-CoV-2 test (NR: not provided) not reported. On 15-MAR-2022, baby's weight was 20 pounds and 5 ounces, body length unknown. No birth defects, genetic or inherited disorders had been diagnosed since birth. On an unspecified date, the patient experienced gastroenteritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 18-JUL-2021, and the outcome of baby was large for gestational age, baby failed the hearing test, HMPV and gastroenteritis was not reported.  The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and hmpv, and gastroenteritis as not related, and between covid-19 vaccine ad26.cov2.s, and baby was large for gestational age, and baby failed the hearing test as unassessable. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and baby was large for gestational age, and baby failed the hearing test was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy, hmpv, and gastroenteritis  was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20210800945.  This case was reassessed as serious based on additional information received from consumer on 15-MAR-2022. The following information was updated and incorporated into the case narrative: Patient birth info, height and weight were added. Parent details were added. Additional events metapneumovirus infection and gastroenteritis were added. Seriousness criteria Hospitalization and Other Medically Important Condition was selected for metapneumovirus infection. Seriousness criteria Other Medically Important Condition for event gastroenteritis. Drug used to treat adverse event cefdinir, and ibuprofen were added. Laboratory data was added and narrative was updated.  Upon review the following information was amended: Onset date for event baby was large for gestational age updated to 18-JUL-2021, and baby failed the hearing test updated to JUL-2021.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: patient demographics, parent details added, Additional serious events metapneumovirus infection and gastroenteritis were added. Drug used to treat adverse event cefdinir, and ibuprofen were added. Laboratory data was added and narrative was updated.  Upon review the following information was amended: Onset date for event baby was large for gestational age updated to 18-JUL-2021, and baby failed the hearing test updated to JUL-2021.  20210932326-covid-19 vaccine ad26.cov2.s-Metapneumovirus infection. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.  20210932326-covid-19 vaccine ad26.cov2.s-gastroenteritis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related.