Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Foetal exposure during pregnancy, Large for dates baby, Respiratory tract infection, SARS-CoV-2 test
Clinical narrative: RESPIRATORY INFECTION; BIRTHWEIGHT 8 POUNDS AND 14 OUNCES; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate. The patient's mother was enrolled in a non-company sponsored study. The patient's weight was 8 pounds and 14 ounces and height was 22 inches.  The patient's pre-existing medical conditions included: No birth defects, genetic or inherited disorders have been diagnosed since birth. The patient's parent's medical history: The mother was a 32-year-old White female. Maternal medical history included alcohol abuse, anxiety, asthma, bipolar disorder, depression, high blood pressure and polycystic ovary syndrome. Body mass index (BMI) was 45.822. Maternal obstetrical history included four previous pregnancies, all resulting in live birth. The mother had no history of tobacco, alcohol, or recreational drug use. Type of pregnancy was reported as singleton. Maternal first day of the last menstrual period (LMP) was calculated to be 17-FEB-2021. The estimated delivery date (EDD) was reported to be 24-NOV-2021.  The patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 01 total administered on 27-MAR-2021 for covid-19 prophylaxis.  The patient's mother's concomitant medications included prenatal vitamins (minerals nos/vitamins nos) and hydroxyzine HCl for dug used for unknown indication.  On 27-MAR-2021, at gestational age five weeks and three days, the mother of the neonate received the Janssen vaccine (fetal exposure during pregnancy). On 17-NOV-2021, at gestational age 39 weeks, the mother delivered a live, full-term, male neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be a previous C-section. The mother spent four days in the hospital for the delivery. The neonate's birth weight was 8 pounds and 14 ounces, body length 22 inches.  On NOV-2021, Laboratory data included: Hearing test Not Reported.  On 01-JAN-2022, the patient was hospitalized due to a respiratory infection. The number of days hospitalized was not reported. On the same day, Laboratory data included: SARS-CoV-2 test Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 17-NOV-2021, and the outcome of respiratory infection and birthweight 8 pounds and 14 ounces was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy as not related.  The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and respiratory infection, and birthweight 8 pounds and 14 ounces. Company causality between covid-19 vaccine ad26.cov2.s, and respiratory infection, and birthweight 8 pounds and 14 ounces was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20211111001.; Sender's Comments: V0: 20221104236-Respiratory infection. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.