Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein, Arthralgia, Body temperature, Chills, Exposure during pregnancy
Clinical narrative: RAISED AFP LEVELS, POTENTIAL FOR NEURAL TUBULAR DISORDERS; JOINT PAIN; FEVER; MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; This solicited pregnancy report received from a patient concerned a 33 year old female of unspecified ethnic origin. The patient was enrolled in a non-company sponsored study.  The patient's weight was 63.039 kilograms, and height was 173 centimeters. The patient's past medical history included: miscarriage, and concurrent conditions included: multigravida, no tobacco use, and no alcoholic beverage consumption, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination, Body Mass Index (BMI) was 21.13, no history of exposure to drugs for recreational use. The type of pregnancy was singleton. The patient was gravida 3, para 1, abortions 2. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, not reported) batch number: Unknown expiry: Unknown, dose was not reported, 1 total administered on 11-APR-2021 for covid-19 immunisation. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers Concomitant medications included minerals nos/vitamins nos for drug used for unknown indication On 11-APR-2021, the patient had maternal exposure during pregnancy. On the same day, the patient experienced chills and fever. The date of the patient's last menstrual period was 17-MAR-2021 and expected delivery date was 22-DEC-2021. Chills and fever were improved. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 12-APR-2021, the patient experienced joint pain and improved on same day. On 15-JUL-2021, the patient experienced raised afp levels, potential for neural tubular disorders. Laboratory data included: Alpha 1 fetoprotein (NR: not provided) Raised. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, and fever on 12-APR-2021, and the outcome of maternal exposure during pregnancy and raised afp levels, potential for neural tubular disorders was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and raised afp levels, potential for neural tubular disorders, chills, joint pain, and fever was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from patient on 02-NOV-2021, the following information was updated and incorporated into case narrative. Patients Race, weight (63.039 kilograms), Gestation period (3 week), Para (1), Gravida (3), abortions details, Event (raised afp levels, potential for neural tubular disorders) Cessation date and Outcome for Events (Chills and Fever and joint pain), Past condition (miscarriage), Concurrent conditions (multigravida, no tobacco use, and no alcoholic beverage consumption) and Concomitant drugs (minerals nos/vitamins nos).; Sender's Comments: V1: 20210755629-covid-19 vaccine ad26.cov2.s- Raised ALP levels, potential for neural tubular disorders. 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).  20210755629-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