Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Conductive deafness, External auditory canal atresia, Foetal exposure during pregnancy
Clinical narrative: This solicited pregnancy report received from a consumer concerned a female neonate. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registry number Unknown. The patient's weight was 3.06 kilograms, and height was 48 centimeters. No past medical history or concurrent conditions were reported. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: 203A21A expiry: Unknown) dose was not reported, 1 total administered on 18-JUN-2021 for Covid-19 immunization. The neonate route of administration was reported as transplacental. Concomitant medications included prenatal vitamins minerals NOS/vitamins NOS (UNK, qd, route: transplacental) for drug used for unknown indication. On 18-JUN-2021, the patient experienced fetal exposure during pregnancy. On an unspecified date the patient failed the hearing test. Then again patient was re-tested and failed the hearing test in the right ear. ENT was scheduled for 18-Jan-2022. On an unspecified date, the patient experienced conductive hearing loss in the left ear due to closed ear canal was diagnosed (external auditory canal atresia). For now the patient was using a hearing device. At the time of the reporting baby's weight was 10 pounds and 5 ounces, body length 22 inches. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 03-DEC-2021, and the outcome of my baby does have conductive hearing loss in the left ear due to a closed ear canal (External auditory canal atresia) and my baby does have conductive hearing loss in the left ear due to a closed ear canal (Conductive hearing loss) was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s, and my baby does have conductive hearing loss in the left ear due to a closed ear canal (External auditory canal atresia), and my baby does have conductive hearing loss in the left ear due to a closed ear canal (Conductive hearing loss) as unassessable. The reporter did not provide a causality assessment between Covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy. Company causality between Covid-19 vaccine ad26.cov2.s, and my baby does have conductive hearing loss in the left ear due to a closed ear canal (External auditory canal atresia), and my baby does have conductive hearing loss in the left ear due to a closed ear canal (Conductive hearing loss) was related, and between Covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related. This report was serious (Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20210800645. 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 case narrative: Concomitant medication added in narrative (prenatal vitamins), Events added ((my baby does have conductive hearing loss in the left ear due to a closed ear canal) (External auditory canal atresia and Conductive hearing loss)), Lab result updated. Upon review following information was amended: Therapy end date added, frequency 01 total added; Sender's Comments: V1: Follow up information received in the current version is regarding concomitant medication added in narrative (prenatal vitamins), Events added ((my baby does have conductive hearing loss in the left ear due to a closed ear canal) (External auditory canal atresia and Conductive hearing loss)), Lab result updated. 20220257682-Covid-19 vaccine ad26.cov2.s-my baby does have conductive hearing loss in the left ear due to a closed ear canal) (External auditory canal atresia and Conductive hearing loss). The event(s) has a compatible/suggestive 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 related. 20220257682-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.