Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination failure
Clinical narrative: FLUID WAS LOW; MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; NAUSEA; HEADACHE; SUSPECTED CLINICAL VACCINE FAILURE; COVID-19; This solicited pregnancy report received from a consumer concerned a 32 year female. The patient was enrolled in a non-company sponsored study. The patient's weight was 61.224 kilograms, and height was 160 centimeters. The patient's past medical history included: recreational drug use and concurrent conditions included: asthma, non-smoker and no alcohol use. The patient was gravida 1, para 0. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, frequency time 1 total, administered to the left arm on 01-APR-2021 for covid-19 immunisation. Concomitant medications included docosahexaenoic acid and topiramate. The date of the patient's last menstrual period was 16-NOV-2020 and expected delivery date was 23-AUG-2021. Type of pregnancy was reported as singleton. On the same day (01-APR-2021), the patient experienced ache in the left arm where she was injected (sore arm) and also experienced maternal exposure during pregnancy. Several hours later, around bedtime, the patient experienced headache and felt nauseous. She took some Tylenol and woke up the next morning feeling fine, except for the ache in her left arm. The left arm continued to ache for several days, but eventually resolved on 05-APR-2021. On 26-AUG-2021, it was identified that patient's amniotic fluid was low, which led to induction of labor. The patient vaginally delivered a live, full-term, female neonate. The patient spent one day in the hospital for the delivery. The neonate's birth weight was 6 pounds and 10 ounces and body length was 20 inches. On an unknown date in 2021, the patient was diagnosed with COVID-19 (coded as COVID-19 and suspected clinical vaccine failure). No medication was used to treat COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 05-APR-2021, and nausea, and headache on 01-APR-2021, and the outcome of maternal exposure during pregnancy, fluid was low, covid-19 and suspected clinical vaccine failure was not reported.  The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and fluid was low as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, suspected clinical vaccine failure, covid-19, sore arm, nausea, and headache. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, suspected clinical vaccine failure, and covid-19 was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, nausea, and headache was related.  This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000197037.  This case was reassessed as serious based on additional information received from a consumer on 06-OCT-2021. The following information was updated and incorporated into the case narrative: added patient race, medical history, expected delivery date (23-AUG-2021), end of pregnancy date (27-AUG-2021) and delivery details. Added events fluid was low, suspected clinical vaccine failure and covid-19. Updated outcome of event maternal exposure during pregnancy to Unknown. Added docosahexaenoic acid as concomitant medication and Tylenol as drug used to treat AE. Start date for topiramate. Vaccination site. Narrative updated accordingly.; Sender's Comments: V1: 20210805745-covid-19 vaccine ad26.cov2.s-fluid was low. This event(s) is considered related. 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). 20210805745-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. This event(s) is considered not related. 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 20210805745-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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