Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Body temperature, Breech presentation, COVID-19, Croup infectious
Clinical narrative: BABY WAS IN BREECH OR ABNORMAL PRESENTATION; CROUP COUGH; CONFIRMED COVID-19 INFECTION; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a female neonate of an unspecified race and ethnicity. The patient's mother was enrolled in a non-company sponsored study. The patient's weight was 6.9 pounds, and height was 19 inches. No concurrent conditions were reported. The patient's parent's medical history included obsessive-compulsive disease. The patient's mother had no relevant obstetrical history. The patient's mother did not use alcohol, tobacco and recreational drugs in pregnancy. The patient's mother last menstrual period (LMP) was calculated to be 21-OCT-2020. The estimated delivery date (EDD) was reported to be 28-JUL-2021. Type of pregnancy was reported as singleton. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for covid-19 immunisation. Concomitant medications included doxylamine succinate, iron, minerals nos/vitamins nos, paracetamol, and quetiapine fumarate.  On 09-APR-2021, at the gestational age of 24 weeks and two days, the patient experienced foetal exposure during pregnancy. On an unspecified date, the patient experienced baby was in breech or abnormal presentation. On 17-JUL-2021, at gestational age 38 weeks and three days, the mother delivered a live, full-term, female neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be a breech or any abnormal presentation of the baby. The patient's mother spent three days in the hospital for the delivery. On JUL-2021, Laboratory data included: Hearing test not reported. On 07-JUL-2022, the patient experienced confirmed covid-19 infection. Laboratory data included: SARS-CoV-2 test Positive. On 09-JUL-2022, the baby started to experience symptoms of covid-19, cough, fever of 101 degrees Fahrenheit and vomiting. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment included Pedialyte as covid-19 vomiting treatment. On 11-JUL-2022, the baby recovered from fever and vomiting. On 13-JUL-2022, the baby developed croup cough and was treated with albuterol and prednisone. On 22-JUL-2022, the baby recovered from cough and covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from baby was in breech or abnormal presentation, and foetal exposure during pregnancy on 17-JUL-2021, and confirmed covid-19 infection on 22-JUL-2022, and the outcome of croup cough was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and croup cough, baby was in breech or abnormal presentation, and foetal exposure during pregnancy as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and confirmed covid-19 infection. Company causality between covid-19 vaccine ad26.cov2.s, and confirmed covid-19 infection was not related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210729028.; Sender's Comments: V0:20230526719- Croup cough. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration. 20230526719-baby was in breech or abnormal presentation. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.