Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction, Ultrasound antenatal screen
Clinical narrative: PRE-ECLAMPSIA; GALLBLADDER INFLAMMATION; COVID-19; GESTATIONAL DIABETES; WHOLE BODY TYPE IV ALLERGIC RASH; SEVERE IRON DEFICIENCY; MATERNAL EXPOSURE DURING PREGNANCY; PREMATURE DELIVERY; JOINT PAIN; CHILLS; SORE ARM; This solicited pregnancy report received from a consumer concerned a 39 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 79.365 kilograms, height was 173 centimeters, and body mass index (BMI) was 26.604. The patient's past medical history included: miscarriage of pregnancy (1 miscarriage), and artificial insemination, and concurrent conditions included: multigravida (2 past pregnancies / 1 live baby), blood pressure high, body mass index increased, non-tobacco user, abstains from alcohol, and abstains from recreational drugs. The patient gravida (including present pregnancy) was 3, and para was 2. On 06-JUL-2021, Laboratory data included: Antenatal sonogram No abnormalities detected, and Prenatal screening test No abnormalities detected. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-OCT-2021 for covid-19 immunisation. Age at time of vaccination 39 years old. Concomitant medications included acetylsalicylic acid, prenatal vitamins and famotidine.  On 02-OCT-2021 at gestational age 19 weeks and one day, the patient was exposed to vaccine (maternal exposure during pregnancy), and had sore arm. On 03-OCT-2021, the patient experienced joint pain, and chills. Treatment included Tylenol. The date of last menstruation period (LMP) was 21-MAY-2021. The estimated delivery date (EDD) was reported to be 25-Feb-2022. Type of pregnancy was reported as singleton. On 01-NOV-2021, the patient was diagnosed with severe iron deficiency. She became very weak, with heart palpitations. After multiple tests determined ferritin levels were only 9, the patient received iron infusions in a clinic. On 15-NOV-2021, the patient experienced whole body type IV allergic rash. The rash started on both legs symmetrically, and over the course of two days spread to the back of the legs and started on the arms and torso as well. The rash was extremely itchy and prevented the patient to sleep. Treatment with prednisone, administered twice daily, was initiated to control the rash. On 22-NOV-2021, type IV allergic rash resolved and treatment with prednisone was discontinued. On the same day, the patient was diagnosed with gestational diabetes. She was unable to eat normally due to high blood sugar and stopped gaining weight. On 26-DEC-2021, the patient was diagnosed with COVID-19. Laboratory data included: SARS-CoV-2 test Not reported. On an unknown date, the patient developed pre-eclampsia. On 16-JAN-2022, the patient was diagnosed with inflammation of gallbladder and admitted to the hospital. Liver enzymes were elevated (hepatic enzyme increased). Treatment included antibiotics and fluid (unspecified). The patient could not undergo gall bladder removal at the time, due to the baby. On 30-JAN-2022, at gestational age 36 weeks and two days, the patient delivered vaginally a live, pre-term, female neonate. The reason for pre-term labor was reported to be gestational diabetes, pre-existing high-blood pressure, pre-eclampsia, and gallbladder inflammation. Additionally, the labor was reportedly induced due to elevated liver enzymes and gallbladder inflammation. The patient spent four days at the hospital for the delivery. Baby's birth weight was 6 pounds and 12 ounces and body length was unknown.  The number of days hospitalized for gallbladder inflammation, gestational diabetes, Pre-eclampsia, Type IV hypersensitivity reaction, Iron deficiency and COVID-19 were not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from premature delivery, and maternal exposure during pregnancy on 30-JAN-2022, whole body type iv allergic rash on 22-NOV-2021, joint pain on 04-OCT-2021, chills on 03-OCT-2021, and sore arm on 05-OCT-2021, had not recovered from gallbladder inflammation, gestational diabetes, severe iron deficiency, and covid-19, and the outcome of pre-eclampsia was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and gallbladder inflammation, gestational diabetes, premature delivery, pre-eclampsia, whole body type iv allergic rash, severe iron deficiency, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and covid-19, joint pain, chills, and sore arm was related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20220929959.  Additional information received from consumer on 16-AUG-2022. The following information was updated and incorporated into the case narrative: Patient history (blood pressure high, body mass index increased, non-tobacco user, abstains from alcohol, and abstains from recreational drugs), Pregnancy information (pregnancy outcome updated from continuing to live birth, Child information (sex), Event (Gallbladder inflammation, Gestational diabetes, Pre-eclampsia, Premature delivery, Type IV hypersensitivity reaction, Iron deficiency and COVID-19) added, Event maternal exposure during pregnancy (outcome updated from unknown to recovered, cessation date added), concomitant drug (prenatal vitamin), treatment drug (Tylenol, prednisone, iron), Laboratory test (hepatic enzymes increased, sars-cov-2 test, ferritin, body mass index) added.; Sender's Comments: V1:F/U add Pt history, Pregnancy info, new events, conmeds, treatment drug, Lab test. Case updated to serious. 20211142332-covid-19 vaccine ad26.cov2.s-Gall bladder inflammation, Gestational diabetes, Severe Iron deficiency. The case causality is considered NOT RELATED. Rationale: Underlying pregnancy status provides more plausible explanation Pre-eclampsia. The event has unknown temporal relationship, is unlabeled, has unknown scientific plausibility. There are other factors more likely to be associated with event than drug Specifically: MEDICAL HISTORY (advanced maternal age, history of high BP) Therefore, this event is considered not related Premature delivery. The event has a compatible temporal relationship, is unlabeled, has unknown scientific plausibility. There are other factors more likely to be associated with event than the drug. Specifically: MEDICAL HISTORY (advanced maternal age, history of high BP) (concurrent event of Gall bladder inflammation, Gestational diabetes, Pre-eclampsia present as risk factor for premature delivery) Therefore, this event is considered not related  Type IV hypersensitivity reaction. The event has a compatible temporal relationship, is unlabeled, has unknown scientific plausibility There are other factors more likely to be associated with the event than the drug. Specifically: OTHER SUSPECT DRUGS (patient received iron infusions 15 days prior to event). Therefore, this event is considered not related Maternal exposure during pregnancy.  Event has a compatible temporal relationship, is unlabeled, has unknown scientific plausibility There are other factors more likely to be associated with the event than the drug Specifically: SPECIAL SITUATIONS. Therefore, this event is considered not related COVID-19. event has a compatible temporal relationship, is unlabeled, has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, this event is considered related