Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Body temperature, COVID-19, Cardiac function test, Foetal exposure during pregnancy
Clinical narrative: This solicited pregnancy report received from a parent concerned a 2-month-old male infant of an unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 2.78 kilograms, and height was 16 inches. No past medical history or concurrent conditions were reported. The patient-initiated treatment with covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821286, expiry: unknown) dose was not reported, 1 total, administered on 20-MAY-2021 for covid-19 immunisation. The child route of administration was reported as transplacental. Concomitant medications included prenatal vitamins, metoclopramide, and ondansetron. On 20-MAY-2021, at gestational age 18 weeks, the patient experienced fetal exposure during pregnancy. At gestational age 38 weeks, the mother delivered a live, male, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported as previous C-section. The mother spent six days in the hospital for the delivery. The neonate's birth weight was 6 pounds and 2 ounces, body length 16 inches. The neonate was in the intensive care unit (NICU) after the delivery due to problems with breathing. No birth defects, no genetic or inherited disorders have been diagnosed since birth. On OCT-2021, Laboratory data included: Acoustic stimulation tests (NR: not provided) baby passed the hearing test. On 02-JAN-2022, the patient was diagnosed with COVID-19. Diagnosis was made based on a test with a sample from the nose or back of the throat. The patient experienced symptoms of cough, diarrhea, fever, tiredness, and difficulty breathing. Highest measured temperature was 103.1 Fahrenheit (Covid-19). Laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test (NR: not provided) Positive. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.1 F, and Cardiac function test (NR: not provided) baby's heart was fine. The action taken with covid-19 vaccine was not applicable. The outcome of the problem with breathing, covid-19 and fetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine, and problem with breathing was related, and between covid-19 vaccine, and covid-19, and fetal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20210807762.; Sender's Comments: V0: 20220122145-covid-19 vaccine Problem with breathing. This event is considered related. The event 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). 20220122145-covid-19 vaccine -Fetal exposure during pregnancy. This event is considered not related. The event 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.