Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Premature rupture of membranes, Suspected COVID-19
Clinical narrative: Suspected COVID-19 infection; Premature rupture of membrane; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREMATURE RUPTURE OF MEMBRANES (Premature rupture of membrane), SUSPECTED COVID-19 (Suspected COVID-19 infection) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 immunisation.    Concurrent medical conditions included Anxiety, Endometriosis, Hypothyroidism, Irritable bowel syndrome, GERD and Obsessive-compulsive disorder. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS], RANITIDINE HYDROCHLORIDE (ZANTAC) from 01-May-2021 to 01-Jun-2021, LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Mar-2021 to an unknown date, CALCIUM CARBONATE (TUMS CHEWIES) from 01-Apr-2021 to an unknown date, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 01-Mar-2021 to an unknown date, PANTOPRAZOLE from 01-Mar-2021 to an unknown date and FLUOXETINE from 01-Mar-2021 to an unknown date for an unknown indication.   On 25-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 18-Mar-2021 and the estimated date of delivery was 23-Dec-2021. On 05-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Dec-2021, the patient experienced PREMATURE RUPTURE OF MEMBRANES (Premature rupture of membrane). On an unknown date, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19 infection). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) beginning around the  first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 05-Nov-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, PREMATURE RUPTURE OF MEMBRANES (Premature rupture of membrane) and SUSPECTED COVID-19 (Suspected COVID-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Company comment:This spontaneous case reported by another pharmaceutical company (Janssen) concerns a 35-year-old-female patient with no relevant medical history who experienced the unexpected, non-serious AESI of Suspected COVID-19 infection. The onset date of the event and test results are unknown.  Non-serious events of Premature rupture of membrane and Maternal exposure during pregnancy were also reported to occurred 16 days after the first dose of mRNA-1273 vaccine (second dose in series for COVID-19 vaccination/First dose in series from Janssen). Interchange of vaccine products is also noted in this case and the patient received 1 dose of Janssen COVID-19 vaccine approximately 8 months prior to administration of mRNA-1273 vaccine.  Clinical course and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 in not affected by this report; Sender's Comments: This spontaneous case reported by another pharmaceutical company (Janssen) concerns a 35-year-old-female patient with no relevant medical history who experienced the unexpected, non-serious AESI of Suspected COVID-19 infection. The onset date of the event and test results are unknown.  Non-serious events of Premature rupture of membrane and Maternal exposure during pregnancy were also reported to occurred 16 days after the first dose of mRNA-1273 vaccine (second dose in series for COVID-19 vaccination/First dose in series from Janssen). Interchange of vaccine products is also noted in this case and the patient received 1 dose of Janssen COVID-19 vaccine approximately 8 months prior to administration of mRNA-1273 vaccine.  Clinical course and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 in not affected by this report