Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, COVID-19, Cardiac function test, Foetal exposure during pregnancy, Pneumonia respiratory syncytial viral
Clinical narrative: PNEUMONIA DUE TO RSV; PREMATURE BIRTH; FOETAL EXPOSURE DURING PREGNANCY; COVID-19; This solicited pregnancy report received from a consumer concerned a female neonate of an unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines Pregnancy Exposure Registry. The patient's weight was 3.51 kilograms (7 pounds and 12 ounces) and height was not reported. No concurrent conditions were reported.  The maternal medical history of the patient's mother (44 years old) included anxiety, low blood pressure. The maternal obstetrical history of the patient's mother included five previous pregnancies of which four resulted in live newborn. The body mass index (BMI) for the patient's mother was 19.68. The mother had no history of tobacco use, however reported history of alcohol and recreational drug use. Maternal first day of the last menstrual period (LMP) for the patient's mother was calculated to be 10-AUG-2020, the estimated delivery date (EDD) was reported to be 17-MAY-2021. The mother had singleton pregnancy and on 10-MAY-2021 at gestational age of 39 weeks, the mother delivered vaginally live, pre-term female neonate and the mother spent two days in the hospital for the delivery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1805025 and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 for covid-19 immunisation. Concomitant medications included zyrtec (cetirizine hydrochloride) (drug started on 10-AUG-2020), pepcid AC (famotidine) (drug started on 15-NOV-2020) and minerals nos/vitamins nos. On 06-MAR-2021, the patient had foetal exposure during pregnancy. Duration of the event, foetal exposure during pregnancy was reported as 66 days. On 10-MAY-2021, the patient had premature birth. On MAY-2021, cardiac function test and hearing test were performed and results were unknown (not reported). On 16-OCT-2021, the patient experienced pneumonia due to RSV (Respiratory syncytial virus). On 16-OCT-2021, the patient was hospitalized. The number of days of hospitalization was not reported. It was unknown if the patient was discharged. On 06-FEB-2022, the patient was diagnosed with covid-19 and on the same day laboratory data included: SARS-CoV-2 test and result was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 10-MAY-2021, and the outcome of pneumonia due to RSV, premature birth and covid-19 was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and pneumonia due to RSV, premature birth, foetal exposure during pregnancy, and covid-19 as not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20210726619.; Sender's Comments: V0: 20220918409-covid-19 vaccine ad26.cov2.s-Pneumonia due to RSV. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.  20220918409-covid-19 vaccine ad26.cov2.s-Premature birth. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY(Advanced maternal age and high parity). Therefore, this event(s) is considered not related. 20220918409-covid-19 vaccine ad26.cov2.s-Foetal exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.